RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/M/31
10 July 2001
(01-3431)
Council for Trade-Related Aspects
of Intellectual Property Rights
SPECIAL DISCUSSION ON INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES
Held in the Centre William Rappard
during the meeting of the Council from 18 to 22 June 20011
Chairperson:  Ambassador Bo niface Chidyausiku (Zimbabwe)
Table of Contents: Page Nos .
Introduction by the Chairperson 3
Statements by Members  (in order of speaking) 3
Zimbabwe (on behalf of the African Group) 3
European Communities 6Brazil 9
Argentina 11
Venezuela 13
Norway 15
Malaysia (on behalf of ASEAN) 17Chile 18
India 21
South Africa 26
Barbados 27
Tanzania (on behalf of the Least-Developed Countries) 28
Bolivia 30
Thailand 31United States 33
Egypt 41
Switzerland 44
Japan 46
Cuba 50
Kenya 51
                                                     
1 The minutes of the meeting of the Council held from 18 to 22 June 2001 will be circulated as
document IP/C/M/32.IP/C/M/31
Page 2
Table of Contents: Page Nos .
Hungary 55
Nigeria 56
Canada 57
Ecuador 58
New Zealand 60Jamaica 60
Dominican Republic 62
Peru 64
Sri Lanka 65
Hong Kong, China 66
Honduras 66
Czech Republic 67Panama 68
Singapore 68
Indonesia 69
Turkey 71
Korea 72
Colombia 73
Pakistan 74
Guinea 75
Uruguay 76
Australia 77Uganda 77
Philippines 78
Statement by observer government
Holy See 79
Statement by observer organization
WIPO 81
Council action on further work 81
_______________IP/C/M/31
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Introduction by the Chairperson
1. The Chairperson said that, at the previous meeting, the Council had agreed, following a
request from Zimbabwe, on behalf of the African Group, to devote a full day to a special discussion of
intellectual property issues relevant to access to medicines during the course of the present TRIPS
Council meeting.  Recalling that, when this matter  had been discussed at the Council's last meeting,
two specific sub-items had been identified as to pics on which Members would exchange their views.
One was the interpretation and application of the relevant provisions of the TRIPS Agreement with a
view to clarifying the flexibility to which Members were entitled under that Agreement;  and the other
was the relationship between the TRIPS Agreement and affordable access to medicines.  As also
discussed at the informal meeting on 21 May, delegations should feel free to address also any aspect
that they considered relevant to this item.
2. As requested at the informal meeting of 21 May, the Secretariat had prepared, prior to the
present meeting, an information paper listing the m eetings relevant to intellectual property and access
to medicines, whether organized by intergovernm ental or non-governmental organizations, in which
the Secretariat had been involved over the past couple of years;  what issues had been discussed at
those meetings relating to TRIPS;  and where additional information about those meetings could be
found, for example on web-sites or published documentation.  This paper was available in documentJOB(01)/82.
3. The European Communities and their member States had submitted a paper on the
relationship between the provisions of the TRIPS Agreement and access to medicines.  This paper had
been circulated a week prior to the present meeting as document IP/C/W/280.  On 19 June, Brazil had
also submitted a paper on the matter, which was also sponsored by the African Group, Barbados,Bolivia, Brazil, Cuba, the Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica,
Pakistan, Paraguay, the Philippines, Peru, Sri Lanka, Thailand and Venezuela.  This paper would
shortly be circulated as document IP/C/W/296.
4. The following statements were then made:
ZIMBABWE (ON BEHALF OF THE AFRICAN GROUP)
Two weeks ago, world attention focused on the Heroes Acre in South Africa where young
Nkosi Johnson was laid to rest.  In a special way, young Nkosi had become the personification of the
plight of millions of people who have died and millions more waiting to die because of HIV/AIDS.
Indeed, young Nkosi reminded us of the plight of millions of young children orphaned by AIDS and
of many who will not celebrate their fifth birthday;  of families robbed of the source of their
livelihood and societies robbed of their future due to the scourge of HIV/AIDS and other life
threatening diseases.
The death toll from preventable and treatable infectious diseases is unacceptably high.
11 million people, most of them in developing countries, die each year from such diseases.  In the
case of HIV/AIDS, a human tragedy of horrific di mensions is now at hand.  In some countries in
Africa, more than a quarter of the adult population has HIV.  Life expectancy is projected to fall
dramatically.  In industrialised countries AIDS deaths have been significantly reduced partly because
of the availability of life-saving medicines to many patients.  Indeed, patients in developing countries
also deserve access to medicines at affordable prices, to treat AIDS and other diseases.
The TRIPS special discussion provides a crucial opportunity to address mounting public
perception that implementation of the TRIPS Agreement has hampered people's access to affordable
medicines.  Members must affirm that the TRIPS Agreement does not stand in the way of
urgently-needed solutions to the deepening health cris is.  By agreeing to this discussion in the TRIPSIP/C/M/31
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Council we believe Members have taken cognisance of increasing public criticism and civil society
campaigns against the perceived negative effects of the TRIPS Agreement, and are ready to respond
positively.
Members should reach a common understanding that asserts and confirms the balance in the
TRIPS Agreement that recognizes the importance of patent protection and provides that governmentsmay adopt all appropriate measures to protect the health and lives of their people.  This is the
assurance and guarantee that governments need, to enable them to adopt such measures, without fear
of litigation (either at national level or at the WTO) or that bilateral pressures will be applied on them.
The African Group is convinced that all Members, as a matter of right and at their discretion, can take
advantage of the existing provisions and safeguards in the Agreement.
The purpose of the special discussion is to begin to identify the relevant provisions of the
Agreement, and exchange views in order to fo rge a common understanding of the TRIPS Agreement.
As this important and vital task cannot be completed in one special session, Members need to agree
on a work programme to complete this work in the shortest time possible, befitting a serious response
to the current crisis.
We believe that the Ministerial Conference in Qatar in November 2001, will be an
opportunity to demonstrate Members' commitment and contribution to preventing further deaths and
saving lives through facilitating easier access to medicines at affordable prices.  Therefore, we
propose that Members issue a special declaration on the TRIPS Agreement and access to medicines at
the Ministerial Conference in Qatar, affirming that  nothing in the TRIPS Agreement should prevent
Members from taking measures to protect public he alth.  The fourth WTO Ministerial Conference will
provide an ideal opportunity for Members to affirm this common understanding.
Rather than being seen as an end in itself, intellectual property rights protection is intended as
a means to benefit society as a whole.  The mere existence and the protection of intellectual propertyrights, such as patents, does not necessarily result in the fulfilment of the objectives of the TRIPS
Agreement.  The experience of the past six years since the Agreement was established provides clear
evidence of this.
In the context of public health, patent rights should be exercised coherently to the mutual
advantage of patent holders and the users of patented medicines, in a manner conducive to social and
economic welfare and to balance rights and obligations.
Article 7 is a key provision with respect to interpreting the Agreement, as it establishes that
the protection and enforcement of intellectual property rights does not exist in a vacuum.  The
objective of the promotion of technological innovation and the transfer and dissemination of
technology locates the protection and enforcement of IPRs in the wider interests of society.  With
regard to public health, protection of intellectual  property rights, in particular patent protection,
should encourage the development of new medicines and the international transfer of technology to
promote the development of manufacturing capacities of pharmaceuticals without restraining policies
on access to medicines.
Article 8 explicitly recognizes that Members may adopt measures to protect public health,
among other overarching public policy objectives, such as nutrition and socio-economic and
technological development.
We believe that each provision of the TRIPS Agreement should be interpreted in the light of
the objectives and principles set forth in Articles 7 and 8.IP/C/M/31
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Consequently, the Agreement does not prevent Members from taking measures against abuses
of intellectual property rights or anti-competitive practices.
Compulsory licences are an essential tool for governments to carry out effective public health
policies.  Such licences are a crucial element in the prevention of abuses of patent rights, the
promotion of domestic manufacturing capacities in pharmaceuticals production, as well as insituations of national emergency and extreme urgency.  The Paris Convention, which is part and
parcel of the TRIPS Agreement, explicitly provides for the grant of compulsory licences as a means of
countering abuses of intellectual property rights.  The mere existence of a legal provision on
compulsory licences may be enough to curb anti-competitive practices.  Indeed, in the use of
compulsory licences we look towards the rich experience of our developed country partners, which
have employed compulsory licences to great effect.
In the light of Article 31, it is our understanding that Members can grant compulsory licenses
on a range of grounds, including those based on public interest, including health, or to protect the
environment.  We, therefore, affirm our understanding that nothing in the TRIPS Agreement limits the
grounds for governments to issue compulsory licences.
The Group affirms that legitimate grounds for the issuance of compulsory licences include:
(1) where there is non-working or insufficient working of a patent;  (2) for the importation of a
product under patent protection;  and (3) for the export of a product under patent protection.  It is also
affirmed that Members should undertake to recognize and give due effect to a compulsory licence
issued by another Member, to a manufacturer in their territory for the production of goods intendedfor the market of the Member issuing the licence.
Parallel importation is also an important tool to ensure adequate access to medicines.  It
should be recalled that the Preamble and Part I of the Agreement set out that an important goal of the
Agreement is to reduce distortions and impediments to international trade.  In this context, parallelimportation of a patented medicine from a country where it is sold at a lower price will enable more
patients in the importing country to gain access to vitally-needed medicines.  In this regard, parallel
importation must be regarded as a legitimate measure, which Members can adopt to protect public
health and nutrition.  Article 6 allows each Member the freedom to incorporate the principle of
international exhaustion of rights - the legal basis for parallel importation.  Members should thereforerefrain from imposing any limitations on the right of other Members to apply the principle of
international exhaustion, and thus allow them to exercise their right to parallel importation without
hindrance.
While the Group favours the establishment of differential pricing arrangements provided this
is done in a fair manner within a comprehensive and multilateral framework, these arrangements can
only be part of a broader set of initiatives to improve access to medicines.  Nevertheless, we reaffirmthat such arrangements must not prejudice the rights of Members under the TRIPS Agreement.
It is crucial that Members be given the opportunity and sufficient time to acquire the
necessary expertise, to incorporate the best possible elements and principles which they deem to be in
their national interests when formulating national laws and policies, in order to take advantage of theinherent flexibility in the TRIPS Agreement.  For many developing country Members, the
implementation process requires development of capacity and expertise in what is a new field for
them.  This will take time.  For this reason, developing country Members should be allowed a
reasonable period of time to put into place legal frameworks which properly reflect their
understanding of the TRIPS provisions, consistent with their national priorities and needs.  Therefore,the Group urges Members to seriously consider the following:IP/C/M/31
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• firstly, extending the transition period for the implementation of their TRIPS obligations
by developing country Members in relation to patent protection (both product and
process) regarding pharmaceutical drugs;
• secondly, undertaking, through a Ministerial Declaration, to adopt a moratorium in the
dispute settlement mechanism to allow Members to take measures to protect publichealth;
• thirdly, observing with immediate effect a moratorium on dispute settlement action
against developing country Members that hinder their ability to promote access tomedicines and protect public health (including compulsory licences and parallel imports)
measures.
In addition to the above measures, improvements to the TRIPS Agreement are required to
take into account recent developments and problems that have arisen in the more than six years of
implementation of the TRIPS Agreement.  The seriou sness of these problems were not anticipated at
the time the Agreement was negotiated and concluded.  With the benefit of hindsight, Members are
now in a position to improve on the Agreement and thus be able to contribute more effectively to
dealing with the crisis of AIDS and other infectious diseases.
The issues raised in this paper are not exhaus tive.  According to the developments in this
exercise of interpreting the TRIPS Agreement, we  may wish to bring (collectively or individually)
further clarifications and complements to this document.  All elements and views presented in the
document are without prejudice to individual positions that Members may take in further discussions
in the TRIPS Council or in other WTO bodies, including the dispute settlement procedures.
Finally, the African Group, together with a number of delegations, have tabled the paper
which appears in unrestricted document IP/C/W/296, which we fully endorse and commend to
Members for their consideration.
EUROPEAN COMMUNITIES
Let me first say how much the European Communities and their Member States (EC/MS)
welcome the very fact that we have this special discussion of the TRIPS Council for the very first
time - and I hope it is not for the last time - on the link between intellectual property and health
policy.
Secondly, I would wish to thank my colleague  of the delegation of Zimbabwe for a very
illuminating and appealing statement.  I think it sets the tone for a constructive and open discussion
today and, I hope, on other occasions between now and the Doha Ministerial Conference.  I also
would wish to welcome the papers which have been co-sponsored by the African Group, Brazil andquite a number of other countries.
I think that all these papers, including the paper we have tabled, have one thing in common:
all of them stress that the TRIPS Agreement and especially its application, and if need be the
clarifications to it, should be part of the solution and not part of the problem.  And I think that it is in
this spirit that we have to work together.  It is a complex matter but we are dealing with vital issues in
this area, so we should try to tackle this complexity  and to find the solutions that we collectively need.
Let me also stress that the EC/MS are fully committed to finding solutions to the problem of
access to affordable medicines in developing countries.  You are certainly aware that we have been,
for quite some time now, in the forefront of all kinds of initiatives, be it in the context of the G-7, be itIP/C/M/31
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in the context of our Round Table and the Action Plan that we tabled in September 2000, be it in the
context of very intense discussions which we ha ve had with the World Health Organization (WHO),
or together with the WHO, with the pharmaceutical industry, and be it in the context of the Resolution
of 14 May 2001 by the Council of Ministers, which endorsed the Commission's comprehensive
Programme for Action which was tabled at the beginning of this year and which targeted the combat
of the major communicable diseases.
The Resolution of 14 May 2001 focuses on three main goals:  maximizing the impact of
existing interventions (and that deals notably with what we are doing in the context of developing
cooperation and focusing on health education and other matters);  increasing the affordability of key
pharmaceuticals;  and increasing investment in research and development of specific global public
goods.
One of the key points of our approach is to encourage the pharmaceutical industry to commit
itself to a global tiered pricing (TP) system, which is, in our view, the most effective way to ensure
sustainable supply of affordable medicines to the poorest.  Although we recognize that the
establishment of such a global system is not directly linked to intellectual property protection, we
believe that the latter has an important role to play to make the system work.  The objective of a TPsystem is certainly not to deny Members the right to grant compulsory licences or to authorize parallel
imports.  Our objective is to render recourse to such measures unnecessary.
Let me turn more specifically to the link between TRIPS and health.  The EC/MS have, on
several occasions, declared their willingness to promote discussions, within the WTO, WIPO andWHO, to address the link between the TRIPS Agreement and public health protection issues.  At the
same time we have always insisted, and continue to insist, that intellectual property aspects are only
one among many aspects to be considered and cannot be dissociated from the global problem of
access to health.
The EC/MS welcome that, today, the TRIPS C ouncil will for the first time address the link
between intellectual property and health.  We remain strongly committed to the TRIPS Agreement,
because we consider that intellectual property rights provide an essential stimulus for creativity and
innovation.  These rights need to be adequately protected in order to encourage investment in research
and development into new medicines, and we need the R&D-based pharmaceutical industry to havethose new medicines.  But they should be more particularly targeted at the major communicable
diseases, as recently also stressed by the WHO.
The TRIPS Agreement has, however, sometimes b een criticized as limiting policy options in
relation to public health concerns.  In our view, the Agreement's objectives and principles, as set out
in Articles 7 and 8, special transitional arrangements and other broadly drafted provisions give
countries a sufficiently wide margin of discretion in  implementing it.  This margin enables them to set
up an intellectual property regime that meets their policy needs and is capable of responding to public
health concerns, while preserving an adequate level of intellectual property protection.  Downgrading
the level of current IP protection should certainly not be the aim of the exercise.  In that context, we
welcome the constructive contributions by other delegations.  We have to look at the different
solutions with an open mind, but also have to put a notion of caution:  each and every proposalrequires careful examination as to its potential positive effects and downsides.
To stimulate substantial and result-oriented work in the TRIPS Council, the EC/MS
Communication on TRIPS and access to medicines examines a number of provisions that are relevant
in this debate.IP/C/M/31
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One of the TRIPS provisions most cited in this context is Article 31 on compulsory licensing.
The lack of any explicit reference to public health in it is said to make some Members wary of using
the Article for fear of provoking expensive litigation.
Our view is that, in fact, compulsory licences can be issued for any reason, including of
course public health, as long as the procedural safeguards contained in Article 31, as well as otherrelevant TRIPS-provisions, are respected.
Let me remind you in this context that Article 7 of the TRIPS Agreement - and this has also
been stressed in other documents - refers to "social and economic welfare" as an objective of the
Agreement, while Article 8 allows Members to take measures necessary to protect public health,
provided such measures are consistent with the provisions of the Agreement.  Articles 7 and 8 were
clearly not drafted as general exception clauses, but they are important for interpreting otherprovisions of the Agreement, including where measures, such as compulsory licences, are taken by
Members to meet public health objectives.
It is important also to note that the requirement under Article 31 to first try to obtain a
voluntary licence can be waived in cases of public non-commercial use, a national emergency, orother circumstances of extreme urgency.  As fo r the level of HIV/AIDS infection reported in
regrettably quite a number of countries, there would, in our view, appear to be very good reasons for
describing it as a "national emergency" or as a "circumstance of extreme urgency".  I am sure that all
of us can agree on that interpretation.
Article 31 has been further criticized for requiring that goods manufactured under a
compulsory licence be "predominantly for the supply of the domestic market of the Member
authorizing such use".  This provision is sometim es said to prevent a small country that has no
production facilities of its own from obtaining cheap medicines from abroad under a compulsory
licence.  This is an important argument, as the Agreement does not appear to offer any legal certaintyon the issue.  I think that all of us should be ready to examine this issue with an open mind in order to
find solutions that could meet the consensus among all WTO Members.  The EC/MS do have that
open mind.
Another important provision is Article 39.3 on da ta protection.  Concern has been expressed
in some quarters that certain interpretations of this Article could render compulsory licensingineffective.  Let me reassure you that the EC/MS consider that Article 39.3 should certainly not be
interpreted in such a way as to weaken or nullify Members' rights under other Articles of the
Agreement, such as the "fast-track" procedure in case of emergency foreseen under Article 31(b).
Let me turn now to parallel imports, an issue which has also been addressed by the delegation
of Zimbabwe.  Much importance will also be attached to Article 6, which enables Members to allow
for parallel imports of patent protected goods which have been put on a third market by theright holder or with its consent.  While we do not want to put Article 6 into question, we would like to
emphasize that the introduction of a global TP scheme will call eventually for measures to avoid for
re-importation of TP medicines.  This problem should not be ignored.  Certain aspects may need to be
addressed by the TRIPS Council as a complementary measure to a global TP system.  You will all
agree that it is in the interest of all that TP me dicines remain in the countries to which they were
destined, and do not pop up in rich country markets, where customers can afford to pay much more
for their medicines.
To conclude, we acknowledge that intellectual property rights play an important role with
regard to access to medicines.  However, we want to emphasize that the TRIPS Agreement cannot beheld responsible for the health crisis in developing countries, while it must not stand in the way for
action to combat this crisis.  As I said at the beginning of my intervention, the TRIPS AgreementIP/C/M/31
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should be part of the solution and not part of the problem.  The EC/MS will therefore continue to
actively take part in the expanding global effort to develop a strong global response to the health
problems of the developing world.
In this context, the EC/MS are also ready to discuss to what extent technical assistance can
take into account health concerns.  To make this work, an interactive dialogue is clearly required withthe participation of all developing and least-developed countries concerned.  We also plead for closer
coordination in that respect with other organizations like WIPO and the WHO.
While we remain convinced that the TRIPS Agreement represents a delicate balance between
the interests of right holders and consumers, the EC/MS stand ready to contribute in an open way and
constructively to any discussion in the TRIPS Council or in other WTO bodies, which should lead,
where necessary, to the clarification of certain of the Agreement's provisions.  We will see to it thatwe work together in the coming months also to have a clear indication to this effect in the Doha
Ministerial Declaration.
BRAZIL
It is an auspicious sign that the exercise of discussions on "TRIPS and Access to Medicines"
takes place under the chairmanship of a representative from an African country, a continent that has
been particularly affected by health problems.  We trust that discussions under your guidance will be
productive and results-oriented.
I also wish to congratulate the African Group for taking the lead in this process.  While the
question of access to medication concerns the whole WTO membership - and developing countries
are particularly interested in achieving results from this process - the African continent deserves
special attention in light of the grave situation of AIDS, tuberculosis and malaria pandemics in that
continent.  We all have a great debt to you and the African Group in this respect.
Brazil is proud to be one of the co-sponsors of a document circulated in this Council on the
issue of "TRIPS and Public Health" (document "unrestricted" IP/C/W/296).  I will not go into detail
on the paper but will make some reference to it.  The document reflects the reading of at least
50 developing country Members – and hopefully more as we go along in this debate - on the relevantprovisions of the TRIPS Agreement related to public health.  In the drafting process of this document,
all delegations contributed actively to bring meaningful elements to the discussion.  Such a "team
work" was largely facilitated by the fact that the participants shared the same goals of ensuring that
TRIPS should not - and, indeed, in our view, does not - prevent protection of public health.  In the
substantive debate, we hope that other delegations may support the elements contained in this paper.
Confirmation that the TRIPS Agreement should not run counter to the protection of public health will
be crucial to provide clear guidance for Members, avoi ding the explicit or implicit threats of using the
dispute settlement mechanism to enforce restrictive, unbalanced and, indeed, incorrect interpretations
of the TRIPS Agreement.
The Members that subscribe to this paper consider that the special discussion on TRIPS and
Public Health at the TRIPS Council is not a one-off event.  It should be part of a process to ensure thatnarrow readings of the TRIPS Agreement do not in any way undermine the legitimate right of WTO
Members to formulate and implement their own public health policies.  In this regard, and without
prejudice to other possible actions, we believe that the Ministerial Conference in Qatar in November
this year will be an excellent opportunity to confirm this understanding in an unambiguous and
unconditional way.  This should go a long way to build the required confidence between developedand developing countries for any future negotiations we may embark on, not only on this subject.  It
would also send a powerful message to all those grow ing sectors of civil society, both in the NorthIP/C/M/31
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and in the South, that see the WTO as a soulless organization at the service of the rich and the
powerful.
As it became known to the world public opinion since the beginning of this year, Brazil has a
successful Programme for Universal Distribution of HIV/AIDS Medicines.  As you know, these
medicaments are available free of charge to anyone who requires them.  The Programme clearlydemonstrates that, important as they are, prevention policies alone are not sufficient to control the
AIDS pandemics:  indeed prevention and cure are intrinsically linked.  I was glad to read in the
Herald Tribune today an article by an American medi cal scientist, which says that experts have agreed
that prevention and treatment are inseparable, or in the authoritative words of the UNAIDS expert
committee, "their effectiveness is immensely increase d when they are used together".  So let's not be
fooled by the latest attempt to say that the whole question of AIDS relates to prevention and not to
treatment.  The two go together.  Treatment based on access of patients to AIDS drugs plays anessential role in achieving concrete results.  In Brazil, the benefits of access to drugs have been
concrete:  in the last four years, the number of deaths related to AIDS has decreased by half (although
in some hospitals in Sao Paulo, where the incidence of HIV-infected patients is the highest in the
country, the number of deaths was decreased by 71 pe r cent).  This was obtained by the use of drugs,
not by prevention alone.  While such an aggressive policy to fight AIDS justifies itself on the ethicalground, as it saves human lives and alleviates suffering of patients, it also brings concrete benefits for
the better allocation of scarce resources in developing countries:  the dramatic decrease in
opportunistic infections resulting from drugs-based treatment has reduced up to 80 per cent the
number of admissions in hospitals.  This has brought an economy of US$422 million dollars in
hospital admissions.  Not an insignificant figure for a country like Brazil.
Two elements are absolutely necessary for the success of the Brazilian Programme for
Universal Distribution of HIV/AIDS Medicines (and indeed to make it affordable to the Government):
the local production of medicines and negotiations with the pharmaceutical industry.  The two
elements are closely linked to each other and directly related to our discussions here.  In the case ofdrugs used in Brazil in the treatment of AIDS, local manufacturing has been utilized so far for
products that were already in the public domain, without any infringement of patents.  But the
possibility of issuing compulsory licenses is also an essential element of the negotiation between the
Government and the pharmaceutical industries.  Besides that, local production of pharmaceutical
products may be crucial to ensure that medications are readily available at affordable prices.  Localmanufacturing of pharmaceutical products also en courages sustainable access to medications by
insulating the price of patented medicines against currency devaluations, as well as supporting the
development of local expertise, which is vital in addressing local needs.
The Brazilian AIDS Programme is strictly co nsistent with the TRIPS Agreement.  The
Brazilian Law on Industrial Property provides strong patent protection for pharmaceutical products,
and efficient mechanisms to fulfill the objectives of the TRIPS Agreement in a coherent way with our
public health policy.  While Brazil has not as yet resorted to compulsory licences under the current
law, a recent experience of our Ministry of Health in negotiations with one pharmaceutical company
has demonstrated that the very existence of a co mpulsory licensing mechanism - together with the
political will of the Government to use it is essential to persuade patent holders not to abuse their
rights to the detriment of public health objectives.  In this case, a pharmaceutical company, which wasrefusing to bring its unreasonably high prices on tw o patented antiretrovirals down, has agreed to cut
its prices by 64 per cent and 59 per cent respectively, when the Government gave unambiguous signs
of its intention to issue a compulsory licence.  So this remains an essential element in our policy and
we intend to keep it.
As regards the issue of parallel imports, Brazil believes that Members should confirm their
right of applying regimes of exhaustion of rights in their jurisdiction.  For developing countries, in
particular least-developed countries and smaller economies, parallel importation can be a significantIP/C/M/31
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way of increasing access to medications, where the prices charged by patent holders for their products
are unaffordable.
In this respect, we favour discussions on differential prices as a means to improve access to
affordable medicines, although the issue may be best discussed in other fora with a mandate to
address public health policies, such as UNAIDS, UNICEF and the WHO, for instance.  At the sametime, discussions on differential pricing should in no way result in restriction to or modification of the
rights ensured to Members by the TRIPS Agreement to make use of provisions such as those on
parallel imports and compulsory licences, as may be necessary.
The beginning of special discussions on the issue of "TRIPS and Access to Medicines" in the
TRIPS Council is a momentous occasion for Members to  ensure that nothing in the TRIPS Agreement
will prevent, should prevent or can prevent governments from taking measures to protect publichealth.  We hope that the debate here will confirm this understanding.
Economic theory has for a long time established a link between price and value.  The nature
of such a link, however, has never been fully resolved.  In the end, our discussion today is also about
the relation between price and value, i.e. the price of medicines seen as profit-bringing commoditiesand the value of human life.  We understand that, as any other industry, the pharmaceutical producers
have to remunerate their activity.  We are not against them, but we hope that, with our help, they will
find ways of doing it without beating what should be the very purpose of their activity:  to save lives
and to alleviate suffering.
ARGENTINA
We consider these discussions to be particularly important in that they help to ensure that we,
the WTO, face up to some of the negative effects of globalization.  I think we owe special thanks to
the African Group for taking the initiative to propose this special debate, as well as the group ofcountries like the European Union on the one hand, and Brazil, India and the African Group on the
other, whose significant contributions have helped to launch serious discussions.
One way to ensure that negotiations produce an imbalanced result is to confront, at the
negotiating table, those who have very specific knowledge, objectives and interests with those who donot.  Another way is to fail to implement properly what has been agreed.  This is where the problem
lies between the TRIPS Agreement and public health objectives.
As the  European Union states in its proposal, "it will be the first time that the TRIPS Council
discusses intellectual property issues in the context of public health".
Imbalanced negotiations or implementation will obviously lead to the interests and rights of
one of the parties being ignored.  Some will exaggerate their demands.  In extreme conditions, this, in
its turn, will lead others to react in a way that could jeopardize the global system of rules as a whole.
It should be made clear before it is too late that excessive demands are not  sustainable and
that the destruction of the global system of rules is in no one's  interest.
This is exactly why we must tackle the problems by reaching a consensus interpretation , a
common understanding  of the current text of the TRIPS Agreement as regards the issue of public
health.
Without going into technical details for the moment, my Government would like to make
clear its basic position in these discussions, which we see as the initial stage  in a process that will
assume importance at the Qatar meeting, by highlighting the following fundamental principles:IP/C/M/31
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(1) Articles 7 and 8 of the Agreement recognize that a private right cannot be made to prevail
over a social benefit such as health.  Specific provisions were therefore included to prevent:
- abuse of intellectual property rights by their holders;
- recourse to practices which unjustifiably limit trade or are detrimental to the
international transfer of technology.
At the same time, the Agreement also provides for:- promotion of technological innovation;
- transfer and dissemination of technology;
- measures to protect public health and nutrition.
(2) By adhering to the Marrakesh Agreement, WTO Members not only took on obligations, but
also acquired rights, the implementation and respect of which are hierarchically just as important as
the obligations.
The TRIPS Agreement laid down minimum sta ndards for protection through a basic system
of rights and obligations.  The wording of the Agreement, which is the fruit of complex negotiations,provided considerable "flexibility" or "margin of manoeuvre" in many of the provisions to enable
Members to incorporate them in their domestic legislations.
This margin of flexibility in fact constitutes one of the rights acquired by the signatories to the
Agreement.  Thus, the Agreement enables Members to develop a legal system that strikes a balancebetween the protection of intellectual property and their public policies.
In our view, these margins do not need to be "interpreted", since some interpretations would
merely be imposed at the expense of others, which is exactly what the authors of the Agreement were
trying to avoid during the Uruguay Round.
These margins take the form of different options which the States may use in implementing
their obligations in a way that is in keeping both with the TRIPS Agreement and their domestic needs
or policies.
(3) There is a general understanding, to which Argentina subscribes, that the system of patents
plays an important role in research and development of new medicines.
There are two parallel objectives of the TRIPS Agreement whose fulfilment calls for a
uniform understanding of its provisions:
(i) due consideration for the rights of those who invest considerable sums in the
development of new medicines;  and
(ii) public health needs.We understand the second of these two objectives basically to mean fair prices, availability of
quality medicines when and in the form in which they are needed, and dissemination of know-how.IP/C/M/31
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4. To try to limit the field to a series of specif ic issues that need to be resolved, such as
"differential prices", would be to ignore the true dimension of the problem.
The negotiation of differential prices falls outside the scope of intellectual property rights, and
hence is not within the competence of this Council.  It is merely a tool to which countries and/or
enterprises may resort if they so wish, and if they th ink that this will enable them to resolve an aspect
of the problem.
As stated by the Ambassador of Brazil and the Ambassador of the European Communities, it
should in no way interfere with the legitimate right of States under the TRIPS Agreement.
5. Finally, we think it is important to take advantage of the experience of the World Health
Organization (WHO) in this area and encourage the Council for TRIPS to work on the basis of aspectsof intellectual property - public health - access to medicines  already identified by that organization.
Fortunately, the Council is not beginning its work today in a void.  At the international level,
much has been done over the past years to identify, study and seriously assess, from the public health
point of view, the provisions of the TRIPS Agreement which directly or indirectly affect accessibilityto medicines.
Alongside the respectable studies by experts in the field and recognized NGOs, and the
documents submitted by various countries to this meeting, the WHO has conducted numerous studies
in this area.
Any experience that the WHO could transmit to the Council on this subject would be of value
for its future work, which we have defined as the search for a consensus interpretation, a common
understanding of the TRIPS Agreement seen as a balance between rights and obligations.
VENEZUELA
Venezuela is fully committed to promoting health  as a fundamental social right guaranteed by
the State on the grounds that it pertains to the righ t to life.  Our Constitution gives priority to the
promotion of health and prevention of disease, and pledges appropriate treatment.  We reaffirm ourGovernment's interest in monitoring public health and assuring fair and equal access to medicines.
Health is a guarantee for development.
We are aware that health problems affect ma inly the low-income sectors of the population
and that poor health hampers domestic, and ultimately international, economic growth.  The health
problems which beset developing countries, coupled with economic crises such as that currently
affecting the African continent, make protecting intellectual property rights less viable sinceupholding these rights may adversely affect economic well-being.
The problem of access to medicines in general has taken on structural dimensions in
developing countries.  These countries are at a disadvantage, since health problems are closely related
to survival itself.  It is therefore crucial for our countries to overcome the difficulties relating toservices, health care and access to medicines.  And indeed, any proper approach to the health problem
must go well beyond the mere need to protect intellectual property.
AIDS is a scourge which needs to be dealt with as a matter of urgency, as do the other
infectious, contagious and endemic diseases which afflict the developing countries in particular, suchas dengue fever, tuberculosis, malaria, meningitis and diarrhoeal diseases.  We back international
community action designed to guarantee access to medicines and hope that the outcome gives impetusIP/C/M/31
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to the strategy of granting access at affordable prices to the medicines which help to combat such
diseases.
Venezuela attaches considerable importance to intellectual property protection in relation to
both the development of research and growth.  Su ch rights are neither incompatible with, nor
restrictive of health policies if interpreted in the light of the objectives and principles of the TRIPSAgreement.  The Venezuelan State is deeply committed to protecting the public interest when
implementing the TRIPS Agreement.
The Council for TRIPS has only recently begun to discuss the implications of the Agreement
for the implementation of public health policies.  Nevertheless, Venezuela's understanding of this
issue has been that the very foundation of the multilateral system is the fairness in allowing countries
which meet their commitments a degree of flexibil ity in implementing development policies, in this
particular case public health policies.  This is the very spirit and rationale of the paper which has been
submitted on behalf of developing countries and endorsed by Venezuela.  This paper was well
summed up by the delegation of Zimbabwe.
We shall touch but briefly on a few aspects which have already been extensively dealt with in
the proposal.  Firstly, any interpretation of the Agreement must be based on Articles 7 and 8.  We are
certain that reducing government options with regard to promoting and protecting health or applying
other related public policies is not in the spirit of the Agreement.
When some countries' interpretation of a failure to observe patent rights leads them to claim
violation of the TRIPS Agreement, they are not taking into consideration the fact that developing
countries are entitled to take the necessary measures to promote and protect health pursuant to
Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights and the
Declaration of Human Rights.
We wish to highlight the importance of compulsory licensing and parallel imports as
mechanisms for protecting public health and making medicines available at affordable prices to
people with low incomes.  Mention should also be made of the use of non-discriminatory price
controls, since this does not constitute a breach of the TRIPS Agreement.  Such instruments should be
studied in the light of the general principles of law, the Preamble to the Marrakesh Agreement and theobjectives and principles of the TRIPS Agreement.
We are concerned over restrictive interpretations of the Agreement's provisions which seek to
reduce Members' flexibility with regard to the use of compulsory licensing.  The patent rights of
pharmaceuticals should be managed in such a way as to both protect the interests of the patent owner
and safeguard the basic principles of public health.
Likewise, the international principle of exhaustion of rights must be worked into domestic
legislation.  In particular, it has come to our attention that some proposals do not refer to parallel
imports as a way of improving access to medicines.  We wish to stress the need to confirm Members'
right to apply the principle of exhaustion in their jurisdiction.
It should be noted that some interpretations of Article 39.3 could conflict with the public
interest.  Venezuela is of the opinion that a request for authorization for a product which has been
initially approved by an authority cannot, under any circumstances, be construed as illegal use of data.
Should this provision be inappropriately interpreted, it would - by preventing pharmaceuticals from
being marketed - be unjustifiably restricting access to medicines.IP/C/M/31
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It is also important to recognize the decisive role played by intellectual property in the
development of research and the transfer of technology, and to understand the conditional nature of
this relationship and, in particular, the overwhelming importance of development objectives.
Finally, the Council for TRIPS must request that these considerations and precisions be
included in the Qatar Ministerial Declaration as a core element of the development dimension.  As wehave said on previous occasions, we are referring to provisions, interpretations and forms of
implementation which enable the State to promote technical progress and stimulate dynamic
economic growth with a view to achieving more far-reaching objectives.
NORWAY
During the past century, medical science and technology have made enormous progress.  For
millions of people in developing countries, however, medicines are largely unavailable, unaffordable,
unsafe, of poor quality or improperly used.  Over the past two years or so, unprecedented efforts to
dismantle these obstacles have been undertaken by governments, various organizations, and industry.
It is important to keep in mind that access to essential medicines depends on several factors.  I
will mention some of these factors briefly:
(1) rational selection and use of medicines;
(2) sustainable adequate financing;
(3) reliable health and supply systems;  and(4) affordable prices.
Each of these issues is important if developing countries are to have proper access to
medicines.  For the purpose of our discussion today, let me make a few comments on the issue of
affordable prices .
While prices are not the only issue, price does make a difference.  This is partly because most
poor people in developing countries must pay for health care, including drugs, out of their own
pockets.  During the last year, industry has started, al though in a modest way, to sell antiretroviral and
other medicines to several developing countries at preferential prices.  The issue of how industrycould practice differential pricing in a systematic way, was indeed the theme of a joint WTO/WHO
workshop at Høsbjør, Norway earlier this year.
Differential pricing may be one way of increasing availability and affordability of medicines
in developing countries.  In addition, there are other ways whereby many of the same objectives could
be pursued.  I would just like to underline that neither differential pricing nor such other methods
should be used as an argument for not interpreting the TRIPS Agreement as flexible as possible in thearea of public health.
Today the TRIPS Council - at the request of the African Group - has embarked upon a first
discussion on intellectual property and access to medicines.  It is a very complex issue and therefore
in our view not a one-off event, but merely the beginning of a larger process.
One aim of this first discussion is to try to seek more legal clarity in the interpretation and
application of the relevant provisions of the TRI PS Agreement.  In doing so, the TRIPS Council must
examine closely relevant provisions taking into account the fundamental principles and objectives of
the Agreement.  We hope this would contribute to clarifying some of the provisions, including theflexibility to which Members are entitled under the Agreement.IP/C/M/31
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It is important to note that intellectual property standards, including those specified in the
TRIPS Agreement, take the protection of public health into account.  Moreover, the Agreement
contains several provisions which illustrate its flexibility.  These provisions, if interpreted in a
constructive manner, should enable developing countries, struggling to meet health and development
needs of their populations, to make proper use of the public health safeguards built into the
Agreement.  I agree very much with the Ambassador of Brazil when he underlined that nothing in the
TRIPS Agreement should hinder developing countries to take action.
At the same time, we should keep in mind that the main purpose of the patent system is to
provide incentives by stimulating research in and development of new technology, inter alia , in the
medical field.  Industry would generally not be prepared to take the risks involved in investing heavily
into the development of new medicines, unless it could expect to recoup these investments.  I have
noted that in the discussions so far this point has been recognized by speakers.
A number of provisions of the Agreement are particularly relevant when examining the issue
of public health.
The objectives and principles in Articles 7 and 8 point to the need to strike a balance between
intellectual property rights and other interests including those of the users.  Moreover, the protection
of intellectual property rights should contribute, amongst other, to the promotion of technological
innovation in a manner conducive to social and economic welfare and to a balance of rights and
obligations.  The need for flexibility is also taken into account and Members may adopt measures
necessary to protect public health and nutrition and promote the public interest in sectors of vitalimportance to their socio-economic and technological development.
Article 31 of the Agreement is particularly important in the context of our discussion and
must be read in light of the objectives and principles of Articles 7 and 8.  The provision allows for the
use of a patent without the patent holders' consent, under certain conditions.  Article 31 is complexand we will only offer some preliminary observations on a few points.
First, however, it should be underlined that, in principle, patented medicines should be
produced or marketed through voluntary licensing agr eements, in more or less the same ways as other
patented products.  It is therefore important that the research based industry seeks to conclude withapplicants licensing agreements for the production or distribution on a voluntary  basis.
We are therefore of the opinion that Article 31 of the TRIPS Agreement should in general
only be a last resort.  Article 31 is, however, an extremely important provision, and the mere fact that
compulsory licensing remains an option could in fact increase the likelihood of concluding voluntary
agreements.
An important function of Article 31 is to set the standard terms under which a patented
product must be offered to third parties.  Under subparagraph (b) the applicant must, within a
reasonable period of time, have made prior unsuccessful efforts to obtain authorisation from the patent
holder on "reasonable commercial terms and conditions".  The concept of "reasonable commercial
terms and conditions" should be understood to require both the interests of the patent holder as well asthose of the applicant and the consumer to be taken into consideration.
In the case of, inter alia , a "national emergency", the subparagraph provides a waiver from
the requirement to make prior efforts to obtain authorisation through voluntary arrangements.  What
constitutes a "national emergency" must be considered on a case-by-case basis.  In our opinion,however, a "national emergency" does not have to be limited to sudden or unforeseen events, but
could also encompass a continuous crisis  like the AIDS epidemic in certain Sub-Saharan countries.IP/C/M/31
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Article 31(f) states that "any such use shall be authorised predominantly for the supply of the
domestic market of the Member".  This subparagraph raises many important questions, most of which
cannot be dealt with in-depth at this stage.  To which extent the manufacturing of products covered by
a compulsory licence may take place outside the country issuing the licence is one of the important
questions, particularly for smaller developing countries.  This is because production abroad may be
the only way these countries may use the compulsory licensing provision.
Under subparagraph (h), the patent holder must be paid "adequate remuneration" "taking into
account the economic value of the authorization".  It  is difficult to give any exact guidance on the
interpretation of this provision.  Depending on the circumstances of the case, the remuneration which
must be paid under (h) may however be less than the minimum amount which the patent holder could
have requested under the concept of "reasonable commercial terms and conditions" in
subparagraph (b).  Moreover, if the compulsory li censed products are lifesaving medicines which are
urgently needed, this might also have an influence upon the level of remuneration.
Subparagraph (i) provides for the review - in one instance - at the national level of the
decision to authorize a compulsory licence, in orde r to take into consideration the interests of all
parties.  It should be noted that, in order not to delay the application of a decision to grantauthorization, national law might, under certain conditions, implement subparagraph (i) by, inter alia ,
providing for the provisional  application of such an authorisation, even though it has been appealed.
In conclusion, it is our view that the rights of developing countries to use the public health
safeguards provided for in the TRIPS Agreement must be fully respected.  It will be up to eachMember in the first place to determine the grounds for granting a compulsory licence under
Article 31, taking into account other relevant provisions as well as the principles and objectives of the
Agreement.  We would in this context urge developed country Members to show due restraint with
regard to invoking the dispute settlement procedures under the DSU in matters regarding TRIPS and
public health.
Finally, we are open as to how this issue should be pursued, as long as the objective of
securing a flexible interpretation of the Agreement as regards access to medicines is achieved.  I have
noted the statement made by the delegation of Zimbabwe on behalf of the Africa Group for action to
be taken at the fourth Ministerial Conference in Doha.  We would certainly not rule out the possibilityof an authoritative interpretation at the Ministerial Conference if our discussions identify a need for
such action.
MALAYSIA (ON BEHALF OF ASEAN)
At the outset, ASEAN would like to thank the African Group for initiating the holding of this
special session on intellectual property and access to medicines.  The discussion on this subject in theTRIPS Council is both timely and very important for Members to advance our collective
understanding of the provisions under the TRIPS Agreement that allow measures to be taken to fulfill
public health objectives and the exercise of these rights.
We would like to take this opportunity to thank the European Communities and the group of
developing countries that have provided papers to further our discussions in this area.  In particular,
ASEAN welcomes the paper as presented by Zimbabwe on behalf of almost 50 developing countries,
and support the need, as outlined in the paper, to address Members' concerns over the relationship
between TRIPS and health and in order to provide certainties as regards Members' rights to fulfill
health objectives under the TRIPS Agreement.
In negotiating the TRIPS Agreement, it was reco gnized that intellectual property rights are
private rights.  Yet at the same time, the Agreement acknowledged that the protection andIP/C/M/31
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enforcement of intellectual property rights should be done in a manner conducive to social and
economic welfare and that Members may adopt measures to protect public health.
Indeed, Articles 7 and 8 are key provisions in implementing the TRIPS Agreement, ensuring
a balance between rights and obligations and the prevention of abuse of intellectual property rights.
In particular, we note that the TRIPS Agreement provides for:
(i) the non-authorized use of a patent or otherwise known as the issue of a compulsory
licence.  The TRIPS Agreement allows Members to issue a compulsory licence, but
the grounds for the issue of such a licence are not stated in the TRIPS Agreement.
Hence, Members are free to determine the grounds for granting compulsory licences.
(ii) Further, it is noted that the TRIPS Agreement also does not specify whether the
compulsory licence can only be issued to a manufacturer in its own territory.  We
have the provision of Article 31(f) that such use should be predominantly for the
supply of the domestic market of the member authorizing such use.  Could this mean
that Members have the right to confer compulsory licences to a third countrymanufacturer provided the procedures under Article 31 are met?
(iii) The provisions of Article 31 themselves are meant to be used flexibly to meet public
interest objectives.  The choice of the words "predominantly" in Article 31(f), and the
word "adequate" in Article 31(h) are not specific and hence should lend themselves toa broad interpretation towards meeting public health objectives.  The use of the word
"predominantly" should also be taken to mean that some portion of the production
could be used for exports.
(iv) Members also have the freedom to provide for the principle of the international
exhaustion of rights in their legislation.  We note that, since the TRIPS Agreement
does not address the issue of exhaustion of rights, as stated in Article 6, this provides
the right of import from third countries.
We believe that it is important that Members recognize these rights and respect their
application.  In this context, the language for a common understanding of these rights should be
worked out for Ministers' endorsement in Doha.
Members have an excellent opportunity in Doha  to inform that the TRIPS Agreement is not
against affordable access to medicines.  On the contrary, the TRIPS Agreement has a number of
provisions that contribute to the achievement of public interest objectives.  They should be accorded
full recognition in their implementation and application.
CHILE
Today's discussions on intellectual property and access to medicines are absolutely crucial
and highly topical and come in answer to a conc erted appeal by the international community.  The
actual issue of access to medicines clearly goes well beyond the mandate, functions and competence
of the TRIPS Council, so that we must be particularly careful to ensure that our discussions remain
within the strict confines of our competence.  We feel that this issue should be addressed not only in
the light of the growing international concern over the relationship between intellectual property and
access to medicines - proof of which lies in the great  media expectations of this meeting - but also
because there is a distinct lack of information on the issue which is our responsibility to overcome.IP/C/M/31
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The following four basic questions came to mind in relation to our statement.  Do WTO
disciplines in general and the TRIPS Agreement in part icular constitute an obstacle to the formulation
and implementation of national policies on health and access to medicines?  If so, which disciplines or
rules could prevent Members from adopting decisions on this matter?  In what way would it be
possible to amend or improve those disciplines?  Who should be taking part in these discussions?
First of all, the answers to these questions , and consequently the conclusions drawn, will
depend upon the kind of policy each Member wishes to pursue and the factors taken into
consideration in its formulation.
I should like on this occasion to briefly discuss our country's experience in and interpretation
of this issue on the basis of the current provisions of the TRIPS Agreement.
The National Medicinal Drug Policy established by the Chilean Government in 1996 not only
confirmed the right of the population to access health services, including medicines, but also the
Chilean State's responsibility in the matter.
In our opinion, medicines are essential social goods which afford people the opportunity of
protecting and recovering their health.  The quality, effectiveness, safety and affordability of
medicines, inter alia , form the basis of a rational medicinal drug policy.
State intervention, through the formulation of a policy and strategic plan in the field of
medicine, can be justified by certain national real ities which, in the case of Chile, are basically as
follows:
(a) unequal access by the population to medicines;(b) unsuitable prescriptions and a lack of systems to monitor the use of medicines;(c) widespread uninformed and irresponsible self-medication;(d) the need for adequate monitoring to guarantee bioequivalence;  and(e) the upward trend in the price of medicines.
Chile has granted patent protection to pharmaceuticals since 1991.  Prior to that date, only the
right to grant process patents was recognized.  This change entailed major efforts on the part of
Chile's Industrial Property Office since it had to train specialized staff and earmark greater financial
resources for building up its capacity with a view to the technical analysis of these new patent
applications.
Even at that time, the conditions for granting patent rights were established on the basis of the
three core patentability requirements stipulated in Article 27.1 of the Agreement, i.e. that patents be
new, involve an inventive step and be capable of industrial application.  We are of the opinion that
these three core principles should not merely be upheld, but also reinforced, since coupled with thetemporary nature of industrial property rights, th ey are what allow an appropriate balance between
inventors' and creators' rights and benefits on the one hand, and those of society as a whole on the
other.
In our opinion, the basic principle applicable to the formulation of laws and regulations with
regard to health-related intellectual property is that established in Article 8 of the Agreement, underIP/C/M/31
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which States may adopt the measures necessary to protect public health, inter alia , provided they are
consistent with the other provisions of the Agreement.
In this sense, Article 27.2 of the TRIPS Agreement authorizes Members to exclude from
patentability inventions the prevention within their territory of the commercial exploitation of which
is necessary to protect human life or health, provided that such exclusion is not made merely becausethe exploitation is prohibited by their law.  Chilean legislation recognizes the right to exclude from
patentability diagnostic, therapeutic and surgical methods for the treatment of humans, pursuant to
paragraph 3 of the said Article.
The new legislation currently being reviewed in the National Congress recognizes the
principle of exhaustion of intellectual property rights, including patents.  In a globalized world, this
principle is the basis for avoiding market segmentation and permitting parallel imports, a measurewhich we consider absolutely crucial for open economies such as Chile's.  In our opinion, this
situation is fully consistent with Article 6 of the Agreement.
Chile's 1991 Law confirmed the establishment of non-voluntary licensing in the event of the
holder of industrial property rights being involved in monopolistic abuse thereof.  Such abuses arehandled by a special court on a case-by-case basis.  Chile recognizes that the granting of this kind of
licence is not necessarily contingent on a single factor.  On the contrary, there could be other grounds,
provided that they comply with the conditions stip ulated in Articles 30 and 31 of the Agreement.  In
all the years that this Law has been in force, Chile has never been asked to grant such a licence.
Apart from these exceptions to holders' rights and pursuant to Article 30, Chile also
understands to be legitimate any action taken for private, non-commercial purposes by an individual
patient who requests authorization to import a particul ar drug for personal use.  The same applies to
research and scientific experiments conducted on the basis of a patented invention and authorization
to conduct equivalency tests before the patent expires.  Such exceptions must not unreasonablyconflict with a normal exploitation of the patent or unreasonably prejudice the legitimate interests of
the patent owner, taking account of the legitimate interests of third parties.
In relation to the protection of undisclosed information furnished by companies as a condition
for obtaining marketing approval for a product, in Chile this process is bound to absolute secrecy aslong as the conditions of Article 39.2 of the Agreement remain, i.e. as long as such information is
secret, has commercial value because it is secret and has been subject to reasonable steps under the
circumstances, by the person lawfully in charge of the information, to keep it secret.  This does not in
any way mean that the health authorities must require a third party to repeat the same tests and clinical
trials backing the registration of the original product.
To sum up, Chile considers that Article 8 of the TRIPS Agreement encapsulates a basic
principle, namely the recognition that Members are entitled, when formulating and amending their
laws and regulations, to adopt measures that they themselves consider necessary to protect health,
including access to medicines, provided that such measures are consistent with the other provisions of
this Agreement, such as those referred to above.
We hope that on the matter at issue some points of interest to Members will have emerged
from this meeting and that we will be able to reach a consensus which will enable us to answer the
questions we raised earlier on.  We hope that this effort will be undertaken jointly and in coordination
with other international organizations, such as WIPO and the WHO.IP/C/M/31
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INDIA
India is particularly pleased that the WTO Council for TRIPS is discussing today one of the
most important issues facing all our countries, i.e. the issue of public health and access to medicines.
The international community has focused recently on a number of possible implications that the
TRIPS Agreement might have for adverse impact on access to medicines and thus, on protection ofpublic health.  It may be useful to recall here that as many as 11 million people die every year of
infectious diseases, the great majority of them women and children living in the third world.  Out of
these, AIDS claims an estimated 3 million lives, tuberculosis 2 million and malaria 1 million.
Affordable access to medicines for what are life-threatening diseases for people in developing
countries is a fundamental human right.  The governments in these countries therefore have a duty and
responsibility to ensure both availability and affordable prices for medicines.
As the Council is aware, India is a co-sponsor of the joint communication submitted by about
50 countries on the subject.  So, it is not necessary for me to repeat all the points made therein, to
which of course India fully subscribes.  In this intervention, India would like to make some
observations and raise some questions for further reflection by the TRIPS Council.
We wholeheartedly endorse the statement made by the distinguished delegate of Zimbabwe
on behalf of the African Group;  we also wholeheartedly endorse all the recommendations made on
behalf of the African Group.  I would also like to  associate myself with the statement made by the
distinguished Ambassador of Brazil.
First of all, we need to be clear about the mandate and the objective of this exercise.  It goes
without saying that the TRIPS Council should be discussing all issues relating  to public health and
access to medicines as they pertain to the various provisions of the TRIPS Agreement.  So, while it is
perfectly legitimate to talk about patents and compulsory licencing, for example, and their impact on
public health and access to medicines, it is not, in our view, within the mandate of this Council to talk
of the infrastructure available in different countries in terms of hospitals, availability of doctors,
nurses etc.  Equally, it may not be useful for this Council to discuss the global funds being set up in
various fora for acquiring medicines and distributi on in various countries.  The purpose of today's
meeting is therefore to examine the relationshi p between the various provisions of the TRIPS
Agreement and issues of public health and access to medicines.  I am not trying to underestimate therelevance of factors like availability of medical personnel, infrastructure etc.  What all I am trying to
say is that the job of this Council is to look at  the TRIPS Agreement from the perspective of public
health.
At the outset, it needs to be stated that protection and enforcement of intellectual property
rights contribute to creative and inventive activity and thus welfare to the society.  In the field of
pharmaceuticals, intellectual property rights have contributed to large private investments resulting inthe development of newer and often better medicines.  The exclusive rights conferred by patents
provide incentive for further investment in research and development of new and effective medicines,
a point some delegations have made today.  However, a distinction needs to be made between the
exclusive rights of the patent holder for example in the case of medicines for life-threatening diseases
on the one hand, and say beauty-enhancing and cosmetic drugs on the other hand.  Two observationsmay be pertinent here.  One, not enough research and development would appear to be targeted at
tackling diseases afflicting people in poor countries.  Two, due to price inelasticity in the
pharmaceutical sector, particularly for essential drugs, manufacturers pricing decisions are unrelated
to the market.  Add to this the market exclusivity that is granted by patents and you have a situation
where access to medicines becomes difficult if not altogether impossible for the vast majority of thepopulation.  It is therefore this aspect of the TRIPS Agreement, insofar as it impacts on the access to
medicines, that needs to be examined in detail by us in today's meeting and in future meetings on this
important subject.IP/C/M/31
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Protection of public health and nutrition is a fundamental principle governing the TRIPS
Agreement and is  reflected in Article 8.  The TRIPS Agreement grants WTO Members the right to
adopt measures necessary to protect public health and nutrition.  But it does add that such measures
would have to be consistent with the provisions of the TRIPS Agreement.
This is a rather curious formulation.  There is no need for a provision in an Agreement to say
that you are "OK" as long as you are consistent with the Agreement.   Besides, a principle which,
inter alia , incorporates an element of exception as well, cannot be tested against the yardstick of
consistency with other provisions of the Agreement.  Second, in areas like protection of environment
(protection of plant and animal life), Article XX of the GATT gives Members the right to deviate
from fundamental principles such as MFN and nationa l treatment, provided the requirements in the
Chapeau of Article XX which relate to avoidance of arbitrary or unjustifiable discrimination ordisguised restriction on international trade are met by the Member.  If this is so in the case of
environment, it seems strange that for protection of human life which is perhaps equally, if not more,
important, the TRIPS Agreement appears to suggest that Members can protect public health only if
the measures taken by them are consistent with the TRIPS Agreement.  The implication is that, if by
any chance the measures taken by a Member are deemed inconsistent with the TRIPS Agreement,then it would not be possible for that Member to have resort to those measures to protect public
health.  One of the most vehement criticisms against the TRIPS Agreement is by those who perceive
it to be placing protection of public health on a lower level of priority and giving utmost pre-eminence
to protection of the rights of the right holders.  This needs to be remedied.  Both protection of the
rights of the right holders and protection of public health are important objectives in themselves andone cannot be espoused at the expense of the other.
Secondly, in Article XX of the GATT, protection of human health is considered an exception
and hence entitles the Members to be exempt, under some carefully defined circumstances, from the
disciplines and obligations of GATT.  If this is so in the case of GATT 1994, it seems odd that in thecase of the TRIPS Agreement there is a requirement that in all circumstances the measures that a
Member takes to protect human health have to be consistent with the TRIPS Agreement.  It would
appear that in the very same organization, that is WTO, the way in which protection of human health
is dealt with in the two Agreements, namely GATT and TRIPS, are different.
Finally, is there a common understanding among all WTO Members as to what constitutes
"consistency" with the TRIPS Agreement?  Is it possible or conceivable that a measure taken by a
WTO Member in good faith to protect public health within its territory is considered "not consistent"
with the provisions of the TRIPS Agreement by either another Member or indeed by a dispute
settlement panel?  It is important that this meeting be considered the beginning of a process which
will eventually come up with a clear common understanding among WTO Members as to what
constitutes consistency with the TRIPS Agreement.  In other words, the TRIPS Agreement shouldoffer every Member a wide and broad range of measures for protecting public health.  This issue is
too important to be left either to chance or to future panels.  This is why all of us here should
collectively recognize and confirm the considerable degree of flexibility offered by the TRIPS
Agreement in this regard.
Having set out the broad parameters within which this meeting and future meetings on the
subject should dwell, let me spell out India's c oncern and position on some of the issues involved.
It is obvious to my delegation that every provision of the TRIPS Agreement must be read,
understood and interpreted in the light of Articles 7 and 8 of the TRIPS Agreement.  This is becausethe objectives and principles of the TRIPS Agreement are contained in these Articles and these are of
overarching relevance and importance for the rest of the provisions.  Apart from the fact that the
Vienna Convention on the Law of Treaties would endorse such a point of view, the fact is thatIP/C/M/31
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promotion of intellectual property rights is not an end in itself, and its effectiveness would have to be
measured not just in terms of whether or not the rights of the right holder have been protected or not,
but also in terms of whether or not public policy objectives based on Articles 7 and 8 have been
adequately met or not.  We welcome the EC's view on the overarching importance of Articles 7 and 8
as well.  After all, this is what the TRIPS Agreement is about, i.e. a balance of rights and obligations,
a balance between private rights and public policy objectives and mutual advantage for bothproducers and users of technological knowledge.  The real concern both in the international civil
society and in national jurisdictions is that the TRIPS Agreement in its current form may be
misinterpreted by some as promoting one at the expense of the other.  This concern must be taken
seriously by the TRIPS Council.
Any discussion of the relationship between the TRIPS Agreement and public health and
access to medicines has to begin by taking a look at the provisions relating to patents and the way inwhich the existing patent system operates.
As is known to all, patents confer exclusive rights on the owner  by essentially preventing any
third party not having the owner's consent from making, using or selling the product concerned.  In
the area of pharmaceutical products, it is  widely believed that patents are necessary for rewarding
inventions, but also to ensure that there is incen tive for further research and development for creating
new drugs.  This is true and no body is questioning this assumption.  The problem, however, is that by
conferring a patent on a drug, there are huge implications for its accessibility, especially for the most
vulnerable sections of the population.  For one thing, a patent generally ensures that there is no other
substitute or alternative drug for the period for which the patent protection is made available.  Foranother, because generic competition is generally prevented by a patent, the price of a patented drug
tends to be exorbitantly high.  And there are any number of studies to prove this.  In addition, it needs
to be noted that the TRIPS Agreement provides a patent term of 20 years, much more than what used
to be provided in national laws before.  Moreover, the actual term of patents may even be longer than
20 years because of the practice of "selection patents" or "evergreen patents".  All of the above factorshave enormous implications for access to such medicines in poor countries where the per capita
income is low and per capita expenditure on health is pitifully small.
It has been argued that not all existing essential drugs are on patents.  Even assuming this is
true, it seems clear that future inventions which are going to be ground-breaking, such as a vaccine forAIDS or indeed even new vaccines for old diseases like malaria, tuberculosis, etc. are going to be on
patents.  What happens then to countries which simply cannot afford to pay exorbitant prices for
medicines which may well decide between life and death for its citizens.  This then is the central issue
facing the Council today.
In these circumstances, it is important that we explore all options currently available under
the TRIPS Agreement to see how we can allow countries the maximum flexibility to take measuresfor protection of public health.
The most widely discussed provision on the subj ect is Article 31, which deals with "other use
without authorization of the right holder".  It is obvious that a broad and flexible interpretation of this
provision is critical for allowing Members the fundamental right under the TRIPS Agreement topromote and protect public health.  We are informed that there is some flexibility inherent in the
TRIPS Agreement on this particular issue.  Whether there is adequate flexibility or not will become
apparent only when we clarify the existing flexibility to the fullest possible extent, so that Members
are clear what they can do to protect public health.   It is also important that there be absolute legal
certainty in this regard.  At this stage, I would like to note that this point was forcefully made by theAmbassador of Brazil.  I would also like to thank the representative of Norway for calling upon
developed countries to exercise due restraint till the required degree of legal certainty is achieved.  Let
me also say that this is important from a public relations exercise angle.  After all, a number of NGOsIP/C/M/31
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like OXFAM, Médecins Sans Frontières have made valid criticism against the TRIPS Agreement.
The Council must demonstrate that such criticism is taken seriously and that the Council is trying to
find solutions to the problems and issues posed.
Against this backdrop, it is important that the TRIPS Council reaffirm that a Member can
resort to Article 31 on any grounds whatsoever, including of course of protecting public health.Second, it is important that in the context of efforts to obtain authorization from the right holder, the
expressions " reasonable commercial terms" and "within a reasonable period of time" are interpreted
flexibly and in the light of the practice prevalent within the territory of the Member, taking into
account the level of development and socio-economic priorities.  Furthermore, the above requirement
can be waived in the case of a national emergency or other circumstances of extreme urgency or in
cases of public non-commercial use.  A health crisis characterised by pandemics and epidemics of
major diseases such as AIDS, malaria, tuberculosis, etc. (the list is obviously not exhaustive) shouldqualify for an emergency or circumstance of extrem e urgency.  Similarly, public non-commercial use
should cover governmental health care for the poor.
It seems obvious that the TRIPS Agreement does not restrict the possibility that a compulsory
licence be executed by means of importation of the patented product.  Indeed, in countries where thesize of the market does not justify a local drug industry or local manufacturing, this may be the only
option.
A related question is the right of the compulsory licensee to import or export.  In the case of
the former, the compulsory licensee may import from a compulsory licensee in another country.  Suchimportation must be deemed as legal parallel importation.  Similarly, a compulsory licensee can
export.  However, the TRIPS Agreement does stipulate that the compulsory licensee supply
"predominantly" for the domestic market.  This needs to be interpreted flexibly and broadly.  First of
all, this limitation does not apply in some develo ped country markets when the compulsory licence
has been granted to remedy anti-competitive behaviour.  If that is so, why should the same yardsticknot be applicable for compulsory licences issued on grounds of public health?  This is something that
needs further reflection.  Secondly, the condition that compulsory licences should supply
predominantly for domestic markets makes productions unviable in small countries with a very small
domestic market and poor purchasing power.  It is inconceivable that in small countries
pharmaceutical companies would set up production facilities for catering exclusively for the domesticmarket.  For such countries to benefit from flex ibilities available in the TRIPS Agreement, various
options have to be explored.  One option is to licence import from the cheapest source.  Another is to
licence production which allows the right mix of domestic use and export that permits economies of
scale.  Still another is to encourage regional or global alliances for production by a manufacturer,
licensed or otherwise.  In this context, the European Communities, in paragraph 13 of their
submission, have raised an important issue regarding a possible interpretation of the TRIPS
Agreement that would allow a Member to issue a compulsory licence to a manufacturer in anothercountry under certain circumstances.  Our view is that this is a correct and legitimate interpretation
and therefore cannot be characterized as merely a "possible interpretation".  As to the EC's view that
such an interpretation may or may not stand scruti ny of a panel or the Appellate Body, our view is
that this issue is far too important and should be decided by Members and not through jurisprudence.
We appreciate the readiness of the European Communities and their member States to discuss theissue further.
Article 39.3 of the TRIPS Agreement obliges Members to protect undisclosed test or other
data against unfair commercial use.  It is important to understand what the obligation is in
Article 39.3.  First of all, it is about protecting certain data against unfair commercial use and notabout creating exclusive rights on such data.  Second, it applies only to those pharmaceutical products
which utilize new chemical entities.  We are concerned that there have been suggestions to adopt
standards of protection on confidential data that virtually amount to exclusive rights.  The adoption ofIP/C/M/31
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such standards may lead to a restriction of legitimate generic competition for products which are
already in the public domain.  Such an approach may also undermine the value of the compulsory
licensing system, since the compulsory licensee may face unnecessary obstacles to registration.  This
issue needs further examination by Members.
Article 6 relating to "exhaustion" in the TRIPS Agreement establishes that each Member has
full freedom to incorporate the principle of international exhaustion of rights in its national legislation.
Thus, it is clear that the TRIPS Agreement permits  parallel imports, i.e. the import and resale in a
country, without the consent of the patent holder, of a patented product which was put on the market
of the exporting country by the right holder or in any other legitimate manner.  It is clear, and the
TRIPS Council needs to reaffirm this, that parallel imports is one of the most important measures that
a Member can take to protect public health.  Thus, it is quite possible that in the market of the
exporting country, the product may well be in the public domain or under a compulsory licence.  In allthese circumstances, it is important to confirm that WTO Members have full freedom to resort to
parallel imports, so that access to medicines is achieved in the country of importation.
Article 30 provides for limited exceptions to the exclusive rights conferred by a patent.  The
exceptions provided in Article 30 are those which do not unreasonably conflict with the normalexploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent
owner.  These uses could be private and non-comm ercial use, use for research, experimental or
academic purposes and government use, etc. This would mean that the government, as part of public
health policy, can use the flexibility under Article 30 for public non-commercial activity.  While some
jurisprudence in the WTO has already been developed on the issue, it would be the suggestion of mydelegation that Article 30 be interpreted as an exception to patents and not read in conjunction with
Article 27 as suggested by some.  While we agree that the exception should be a narrow one, it is not
legally correct to allow an exception to a rule to be trumped by the rule itself!  We stand ready to
discuss this issue further.
There is yet another issue related to Article 27.3(b) which, in our view, is also relevant for the
subject being discussed today.  And that is the issue of how biological/genetic resources are dealt with
by the TRIPS Agreement.  It is no secret that a vast majority of the new drugs and medicines are
based on biological/genetic resources which are traditionally found in the South.  Patenting of such
resources results not only in misappropriation, but also might end up affecting access to medicinesbased on these biological/genetic resources.  Accord ingly, it has been suggested by us in a different
context that, first, patent applications should reveal the country of origin of the biological/genetic
resource;  second, that there be prior informed consent of the country concerned;  and, third, there be
equitable benefit-sharing.  Furthermore, the main issue would appear to be the tendency to grant
patents on the basis of mere discovery and not invention as also the tendency not to take into account
the knowledge of the traditional communities which may not always exist in written form.  Since all
these issues have to do with medicines and drugs and its access, it would be useful for the Council tolook at these issues with a view to finding appropriate solutions.
Article 64.2 provides that the non-violation provisions shall not apply to the TRIPS
Agreement for a period of five years from the date of entry into force of the WTO Agreement.
Article 64.3 requires the TRIPS Council to examine the scope and modalities and application ofnon-violation complaints made pursuant to the TRIPS Agreement and submit its recommendations to
the Ministerial Conference for approval.  Since the scope of non-violation complaints made pursuant
to the TRIPS Agreement is not yet clear to the membership and the TRIPS Council has still not made
any recommendation, the non-violation clause is not applicable to the TRIPS Agreement.  In these
circumstances, it would be extraordinary for anyone to suggest that measures taken by Members forprotection of public health should somehow be seen through the prism of non-violation!IP/C/M/31
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A number of questions and issues have been raised.  This is as it should be.  The subject is
vital, if I may say so, a matter of life and death!  While we may not today find all the answers to the
questions raised, it is important that the Council begin the task of looking at the issues raised in right
earnest.  We know that this is not going to be the last meeting.  Indeed, it marks the beginning of a
collective effort to find solutions to some of the most burning problems of our time.  I call upon our
developed country trading partners to engage in all sincerity and seriousness to find ways and meansto address the issues and concerns raised by us.  By collectively confirming that the TRIPS
Agreement does not, should not and need not come in the way of governments dealing effectively
with public health concerns and by publicly committing to the position that, even in situations of
perceived ambiguity, the TRIPS Agreement will not be allowed to come in the way of achieving
public health objectives, our Ministers at the Doha Ministerial Conference can send a powerful
message to the world that WTO cares for the people and it is not an organization, as is generally
perceived, designed just to serve the business interests of big companies.
SOUTH AFRICA
The South African delegation welcomes the opportunity provided by this meeting, to discuss
the relationship between the TRIPS Agreement and public health.  We fully associate ourselves withthe statements made by Zimbabwe on behalf of the Africa Group and by Brazil on behalf of over
50 countries.
Our intervention is simply to supplement those statements with some additional perspectives.
In our view, the objective of today's discussion is threefold:
• first, to identify the key provisions of the TRIPS Agreement as they relate to the production,
trade and affordability of drugs needed to treat serious illnesses prevalent in developingcountries;
• second, to re-affirm our common understanding that the TRIPS Agreement strikes a balance
between the importance of protecting patents and ensuring that governments are able to takeall necessary measures to provide their citizens access to medicines at affordable prices.
This common understanding among Members would establish the necessary predictability
and certainty without the need to resort to litigation;  and
• third,  to initiate an ongoing process of discussion amongst WTO Members, leading to the
fourth WTO Ministerial Conference in Doha, where Ministers should seek to confirm thatthe TRIPS Agreement is supportive of all necessary measures to promote public health
objectives.
Life-threatening diseases in South Africa, Southern Africa and Africa constitute the most
serious developmental challenge confronting our continent, and are beginning to emerge as a serious
challenge in other regions.  These threaten to obliterate progress on all other fronts.  It is an immense
challenge that will require a wide-ranging multi-faceted response over many years by Africans
themselves, and with the support of the international community.
The central question facing Members of the WTO, given this Organization's particular remit,
is:  "What will be our contribution to meeting this challenge?"
In making similar points to those contained in the Group's submissions referred to earlier, it
may be helpful to draw on South Africa's recent experience.IP/C/M/31
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In 1998, the Pharmaceutical Manufacturers Association of South Africa, together with thirty
nine pharmaceutical companies, initiated a three-year legal battle to prevent the South African
Government from implementing its 1997 Medicines and Related Substances Act.  At issue was the
Government's right to utilize the public health safeguards available under the TRIPS Agreement, with
the Association charging that the legislation in qu estion violated the Agreement.  At virtually the
same time, a major trading partner challenged South Africa's proposed health legislation on similargrounds.
Earlier this year, the Pharmaceutical Association and its affiliates unconditionally withdrew
the charges and announced that the 1997 Law was framed in a manner consistent with the TRIPS
Agreement.  In September 1999, South Africa reached an understanding with a major trading partner
that clarified that the provisions of the Medicines Act were not inconsistent with the TRIPS
Agreement.
The South African Government had always maintained that the legislation in question was
indeed consistent with the TRIPS Agreement and that both challenges were tantamount to upsetting
the delicate balance that exists in the Agreement.  In effect, both challenges were demanding
"TRIPS-plus" legislation.
A favourable outcome on both counts was a demonstration of the Government's resolve to
ensure a supply of more affordable medicines, since medicines prices in South Africa have often been
much higher than in many developed and wealthier countries, both in real and in purchasing power
parity terms.
The basic correctness of the policies, technical weaknesses in the challenges to the draft
legislation, as well as wide support from domestic an d international civil soci ety, combined to ensure
that the South African Government position prevailed.
Given that TRIPS was not drafted with current health concerns in mind, and while the
outcomes of both of these challenges were favourable, the very fact that the challenges were raised in
the first place, suggests the need to confirm, multilaterally, the existing balance in the Agreement.
It is also important to recall that, in May 2000, former President Clinton issued an Executive
Order that prohibited the US Government and its agencies from challenging any measure being
introduced by Sub-Saharan African countries to address the HIV/AIDS endemic that are consistent
with our shared understanding of the safeguard provisions in the TRIPS Agreement.
The earlier statements by Zimbabwe and Brazil have identified the relevant provisions in the
Agreement that relate to health policies, and both submissions have asserted a reading of those
provisions that supports the introduction of appropriate health measures. We subscribe fully to thereasoning contained in those statements.
In conclusion, WTO Members should consolidate and re-affirm this common understanding
by incorporating into the preparatory process lead ing to the fourth WTO Ministerial Conference in
Doha, an ongoing discussion to prepare appropriate recommendations for Ministers' consideration.
BARBADOS
First, I wish to express my delegation's thanks to the African Group for its foresight and
initiative in calling for this special session of the Council.IP/C/M/31
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Barbados believes that this special session can make a positive contribution, not only to work
within the TRIPS Council, but also in relation to the preparations for the Doha Ministerial
Conference.
My delegation is looking forward to concrete results/action coming out of this special session
in terms of reaching a common understanding on the principles and objectives of the TRIPSAgreement and the options open to governments to pursue their public health policies.  Such a result
would have a positive impact on the ongoing "confide nce-building" that is necessary if we are to have
a successful Ministerial Conference, and if all Members, including developing countries, and in
particular LDCs and small economies are to feel that they are part of the ownership of the multilateral
trading system, and can maintain their faith in its role as a tool for achieving sustainable development.
My delegation took the floor specifically to express its strong support for the paper tabled by
Brazil and co-sponsored by a large number of developing countries, including Barbados.
The Caribbean region, like many others, has experienced the negative impact of the AIDS
pandemic on its society and its productive capacity.  Within CARICOM, we have devised a regional
strategy to try to meet the many challenges which this disease poses.  We have also made a positivecontribution to discussions on differential pricing, which is an essential issue for Barbados in the
implementation of its public health policy.  The scale of the problem we face is such that it is clear
that we will need creativity, sensitivity and a deep commitment if we are to devise effective,
sustainable and long-term solutions.
It must be stressed, however, and the paper makes it quite clear, that the issue before us today
in the Council involves much more than the AIDS pandemic.  In this regard, my delegation feels that
the interpretations advanced in the paper of the various provisions of the TRIPS Agreement strike an
appropriate balance between the need to protect private rights and public health concerns.
Permit me to conclude by reiterating the im portance my delegation attaches to the issues
under consideration.  We do not expect that we will resolve all the outstanding problems today, but
we do expect and have high hopes that Members, particularly our developed country partners, will
take part in these discussions in a positive and constructive manner.
TANZANIA (ON BEHALF OF THE LEAST-DEVELOPED COUNTRIES)
Speaking on behalf of the Least-Developed Countries (LDCs), let me first commend you in
your dual capacity as the Coordinator of the African Group and as Chairman of this Council for being
instrumental for the convening of this special session devoted to the discussion of such an important
issue, that of TRIPS, access to medicines and public health.
Indeed, it was such a great anomaly that while NGOs and other groups were loudly
expressing their concern at the negative impact of the TRIPS Agreement on the greatest human
tragedy of our times - the millions of deaths due to HIV/AIDS and other killer diseases - the WTO
and especially this Council should remain silent.  Such silence was harmful to the image of the WTO
and indeed can only be disturbing to our collective conscience as members of one human family.  Thestatistics are appalling and revulsing - it is said th at more than 17 million lives have so far been lost
due to HIV/AIDS in Sub-Saharan Africa alone, and that out of 36 million people infected with the
HIV virus worldwide, more than 25 million live in Sub-Saharan Africa, making it quite legitimate for
the African Group to be in the forefront on this common concern.  For Tanzania, the figures indicate
that at least two million people have been infected  with the HIV/AIDS virus since it was first reported
in 1983 and to date we have more than one million orphaned children as a result of this devastating
pandemic.  Taking into account that many of the Sub-Saharan African countries are LDCs, this
problem is also of particular interest to the LD Cs.  I would therefore wish to fully support theIP/C/M/31
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statement made by the delegation of Zimbabwe on behalf of the African Group and endorse the
proposal that Members of the WTO, through their Ministers at Doha, issue a special declaration on
the TRIPS Agreement to facilitate easier access to medicines and ensuring that the TRIPS Agreement
should not prevent Members from taking measures to protect public health.  We also support the other
proposals made by the Group enumerated at the end of that statement.  We also endorse the paper
which has been presented by the African Group and other delegations which has already been referredto by Zimbabwe and Brazil.
We all agree that Article 7 of the TRIPS Agreement is fundamental as it encapsulates the need
for a judicious balance between the need to provid e an incentive for invention and research on the one
hand and the overriding need to apply the knowledge and technology for the social economic welfare
of the wider society.  We need to have a humane common interpretation of this Article on the basis of
our common commitment to the primacy of human life and decent human values so that, while itremains possible for the inventors to be justly rewarded, private profit must not be allowed to threaten
human lives.  And yet, over the last six years of the life of the TRIPS Agreement, this is what has
been seen to be happening when patented drugs for HIV/AIDS have been priced beyond the ability of
HIV victims, most of whom are the poorest of the poor who live below $1 a day.  When the
life-saving three-drug combination of antiretrov irals for HIV/AIDS is priced at $10,000 - 15,000, this
is a coded message to the poor that they may as well die if they cannot pay the price that will make
the boardrooms of the pharmaceuticals happy.  It should certainly arouse our ethical instincts when
we know that such prices have no rational relation with the cost of research and development for such
drugs and when it is also known that some of the cost for the research for such drugs has been borne
by public funds and not by the funds from the private companies that reap therefore super-profits.
We also believe that Article 8 of TRIPS Agreement should give our countries the maximum
flexibility to adopt such measures that are necessary to meet the challenges of the killer diseases
without the implied restriction that could be r ead into the words "provided such measures are
consistent with the provisions of this Agreement".  This is a point which Ambassador Narayanan fromIndia also referred to more extensively.  We believe this Article should be interpreted in the context of
the basic need to uphold the primacy of human life as implied in the most sensible interpretation of
Article 7 as already referred to above.  As statistics show with regard to the lives lost due to
HIV/AIDS and other killer diseases, many of our countries are losing more people than we have lost
in the two World Wars and other national and regional conflicts put together, and it is only fair toallow governments the flexibility to adopt any measures  which seek to ensure the very survival of the
nation-states.
For the same reasons as stated above, the same level of flexibility should be accorded for the
interpretation to Article 31 with regard to compulsory licensing.  The presence of this option is a clear
recognition of the fact that, where public interest is at stake, it may be necessary to take measures to
override the purely private interest, and in the light of the permanent emergency situation in ourcountries as evidenced by the stark statistics, the justification for compulsory licensing should not be
limited by the strict interpretation of the provisions of the Agreement, but must be flexible enough to
enable our countries meet the challenges of preserving human lives.  It is also known that LDCs do
not have the industrial and technological capacity to manufacture drugs even when they have the right
to resort to compulsory licensing and in this case LDCs should be allowed to invoke compulsory
licensing in favour of a firm located in another country and then be allowed to import the drugs
without being accused of infringing the Agreement.
This will also be an incentive to the firm concerned, if it can be allowed to export to a country
other than where it is located and therefore the provisions in Article 31(f) that such products undercompulsory licensing "shall be authorized predominantly for the supply of the domestic market"
should be interpreted more liberally.IP/C/M/31
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The LDCs also believe that the option of parallel importation is useful, since it allows a poor
country to buy drugs that are more affordable than if importation was restricted.  In a survey
conducted in 1995, it was revealed that 100 tablets of Zantac were sold for $2 in India, $77 in Canada,
$150 in South Africa and $97 in Tanzania.  Similar situations are in place even now where prices of
some tablets are less expensive in richer countries than in Tanzania.  The option of parallel
importation as implied under Article 6 should therefore be supported and expanded as it will enablemore patients in LDCs to have access to cheaper drug s.  With regard to differential or tiered pricing
arrangements, even if this is a matter which needs to be looked at more closely by the WHO and other
competent international bodies, if properly conceived and managed, it could provide yet another
possibility for the LDCs to get access to more affordable medicines.
For the LDCs, all this talk of using the options of compulsory licensing or parallel
importation means that these countries need to be assisted in enacting the appropriate legislation toput those options in place.  This means that there is need for the more developed Members of the
WTO to provide more technical assistance to the LDCs, and I take due note of what
Ambassador Trojan of the European Communities said earlier this morning.  In this regard, we wish
to commend the recently launched Joint WTO-WIPO Initiative to assist LDCs in fulfilling their
commitments under TRIPS when the transition period expires in 2006.  At the same time, we need toremind the more developed WTO Members of their obligations under Article 66.2 to "provide
incentives to enterprises and institutions in th eir territories for the purpose of promoting and
encouraging technology transfer to least-developed country Members in order to enable them to create
a sound and viable technological base".  As this matter will be specifically discussed again in the
course of this week, I need say no more now than just to flag it for your kind attention.
Let me conclude by agreeing with what others have said before me that this discussion today
should not be a one-off event.  The human tragedy caused by HIV/AIDS and other mass-killer
diseases is real and the potential for humanity to rise to the occasion to at least mitigate the potential
holocaust is also real if we are to use the TRIPS Agreement as part of the solution and not allow it tobe part of the problem.  In the process, we may even address more fundamental questions as to
whether the TRIPS Agreement itself, which is basically protectionist in its thrust, is in tune with the
rest of the Uruguay Round Agreements and the WTO, which are geared to market liberalization.
Even if the TRIPS Agreement remains, we may also ask if we cannot use Article 27.2 to exclude from
patentability at least medicines that are vital for saving human lives.  Clearly therefore, it is importantthat we remain engaged with this important is sue all the way to Doha, and beyond if need be.
BOLIVIA
I would like to associate myself with all that was said today by the delegations of Zimbabwe,
Brazil, Venezuela, India, South Africa and Tanzania.
For the delegation of Bolivia, which presented and endorsed the document "TRIPS and Public
Health" together with 17 other delegations and the African Group, it is highly important that the
Council for TRIPS should be addressing the issue of the relationship between intellectual property
and access to medicines as an agenda item.
The WTO's decision to incorporate this subject into its discussions was a step in the right
direction in tackling a problem with worldwide connot ations that has led civil society to question the
validity of the TRIPS Agreement, and in particular patent protection of pharmaceutical products.
While this meeting is providing public opinion with an optimistic message, the WTO must take
concrete measures to ensure that the millions of citizens in the developing countries suffering frompoverty related diseases have effective access to pharmaceutical products.IP/C/M/31
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Before initiating a discussion on the relationship between intellectual property and access to
medicines, we should establish clearly that medicines are not just ordinary goods, and should receive
special treatment.
Similarly, these discussions should be conducted in the framework of the Marrakesh
Declaration in which Ministers affirmed that the establishment of the WTO must be for the benefitand welfare of their peoples.  It should be recalled in this connection that access to medicines is a
public health priority which prevails over purely commercial considerations in that it is one of the
human rights, i.e. the right to health .
In principle, there should not be any conflict between the TRIPS Agreement and public health
in view of the different provisions contained therein, in particular Articles 6 (exhaustion of rights),
7 (objectives), 8 (principles), 27 (patentable subject-matter), 30 (exceptions to rights conferred),31 (compulsory licensing), 34 (reversal of the burden of proof), 40 (anti-competitive practices),
66 (transfer of technology to the least-developed country members) and 67 (technical cooperation).
However, in practice, some developing countries have encountered difficulties with the holders of
patents for medicines, because profit has prevailed over public health considerations.
The delegation of Bolivia is not questioning the fact that the patent system has served to
promote research, develop new medicines and provide profits to inventors and creators.  However, the
objectives and principles of the Agreement must prevail and the Agreement must be applied in such a
way as to protect and promote public health.
In this context, we consider that there are provisions in the TRIPS Agreement that enable the
developing countries to face their domestic public health problems, such as the objectives and
principles of the Agreement, compulsory licensing, parallel imports, as well as other initiatives such
as the use of generic medicines, differential pricing - a concept introduced by the WHO -,
dissemination of information on the prices of medicines, and so on.
We conclude by repeating that the fourth WTO Ministerial Conference in Doha must clearly
establish that there is no conflict between the TRIPS Agreement and public health and, if necessary,
that the existing provisions must be interpreted or a mandate provided to develop other provisions to
clarify or amend the existing ones.
THAILAND
General observations
First of all, Thailand would like to thank the African Group for taking the initiative of
organizing this meeting to address TRIPS and relate d health issues.  It is time for the WTO/TRIPS
Council to take this issue seriously and explore what Members can do to improve/respond to the
situation now occurring in developing countries where access to affordable medicines is a serious
problem.
Thailand, as one of the co-sponsors of the joint paper on TRIPS and Public Health, supports
fully the statement made by Malaysia on behalf of ASEAN and would like to make additional
observations as follows.
We think it is clear to everyone that some of the provisions in the TRIPS  Agreement,
particularly those relating to patent protection for pharmaceutical products, have significant impact onpublic health.IP/C/M/31
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We are well aware that many essential drugs are not under patent, but that is beside the point
today.  The TRIPS Council's task is to discuss the problems in making available drugs that are under
patent; problems caused by the lack of clarity in the TRIPS provisions.  The TRIPS  Agreement says
nothing about infrastructure or other pressing problems.  So the TRIPS Council has no business
discussing them at the expense of devoting precious time to the relationship between patents and
health.
Our task here is not to attack the patent system.  We are aware that the patent system can be
an effective mechanism to promote innovation in the area of pharmaceuticals.
We are all aware that TRIPS provides built-in flexibilities regarding measures WTO Members
can take to obtain medicines, both patented and non patented, from the best and cheapest sources,
both foreign and local.
However, due to lack of clarity of certain provisions of the Agreement, developing countries
seem to be reluctant to take measures that they are entitled to under the Agreement.  This is very
unfortunate, because one of the purposes of the Agreement was to establish an international
benchmark for intellectual property protection and to prevent unilateral pressure, as stated in thePreamble.
My delegation would like to suggest that, at this stage, Members attempt to identify and
explore whether such flexibilities in the TRIPS Agreement are available in practice.  Further, we
wonder why developing countries (and least developed countries) facing critical health concerns arenot pursuing the options that some Members often claim are  open to them in order to address the
inadequate access to affordable life-saving drugs.
Specific points
Firstly, we need to confirm that each Member is free to decide for itself the grounds for
granting compulsory licences under Article 31.  Without trying to embark on a narrow interpretation
of the provision, on the contrary, Members should rea ffirm that Article 31 should be read in the light
of Articles 7 and 8 of the Agreement.
Secondly, Article 27.1 does not restrict the grounds for granting compulsory licences.  The
obligation to consider applications for compulsory licences on individual merit in Article 31, if
properly applied, overrides the non-discrimination provisions under Article 27.1.
Thirdly, due to the mere fact that Article 6 explicitly indicates that the TRIPS Agreement
shall not be used to address the issue of exhaustion of intellectual property rights, Members are free to
adopt their own scheme of exhaustion of rights.  As a result, parallel imports are permitted and do notviolate patent rights.
Fourthly, in certain circumstances, Members should be able to grant compulsory licences to
producers in another country to produce patented drugs in Members' own markets.  This will enable
developing country Members with limited industrial capacity to be able to make use of compulsorylicensing and gain access to affordable drugs.  In this regard, Members could try to explore the
flexibility available under Article 31(f).
In conclusion, my delegation finds this special discussion very useful and a good start for
substantive discussion.  Due to the very nature of the problems involved, we find it necessary to havecontinued discussions on these issues.IP/C/M/31
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If I correctly judge the sentiment of all of us here today, we will not be satisfied if at the end
of the day we end up with a mere statement of recognition of the seriousness of health and access
problems while the current flexibilities are still unclear.
Without prejudging the outcome of our discussion, the Council needs to make a
recommendation to the General Council for a decision interpreting the relevant TRIPS provisions,putting beyond doubt measures which governments may take to tackle the problem and, if found
necessary, amending the TRIPS Agreement.
UNITED STATES
Before I read out my prepared statement, let me first thank Zimbabwe, the African Group and
their co-sponsors as well as the European Communities and their member States for their verythoughtful contributions in writing to our discussions today.  I also would like to thank all of those
speakers who went before me;  their interventions will be immensely valuable as we continue this
dialogue.  I believe Members will see in my statement that we share many of their views.
The HIV/AIDS crisis is a terrible tragedy - for countries, families and individuals.  The
United States is fully committed to the battle against this disease.
We very much want our discussion in this Council to make a constructive contribution to this
effort.
Policy Points
Our discussion today is intended to clarify Members' views of the interpretation and
application of relevant provisions of the TRIPS Agreement, particularly with respect to the flexibility
Members have under the Agreement in providing access to life-saving drugs.
The United States supports this discussion.  We hope that, through this dialogue, Members
will come to appreciate the important role the TRIPS Agreement plays in stimulating development
and commercialization of new life-saving drugs.  We also hope that this dialogue will result in a
clearer understanding of existing flexibility in the Agreement which enables Members to ensure that
such drugs are available to their citizens, particularly those who are unable to afford basic medicalcare.
The TRIPS Agreement strikes the proper balance between these two objectives.  Some have
quite incorrectly blamed the Agreement for health crises or claimed that it stands in the way of
resolving such crises.  Quite the contrary, Members have the ability under the Agreement to
implement their obligations in a way that fully supports their national health care objectives.
On the other hand, without the economic incentives provided by patent systems, there would
be far fewer drugs available for the treatment and cure of life-threatening diseases.
My comments first address the United States' broader policy approach to fighting infectious
diseases and life-threatening conditions.  Strong pa tent, trademark, and trade secret protection is a key
element because of the critical role such protecti on plays in the rapid innovation, development, and
commercialization of safe and effective drugs.
We are equally committed to ensure that Members are able to use the flexibility in the
Agreement where necessary to meet their health care objectives.  In February, the BushAdministration reaffirmed the commitment of the Unit ed States to a flexible approach on health and
intellectual property.  Under this policy, we have informed WTO Members that, as they take steps toIP/C/M/31
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address major health crises, such as the HIV/AIDS crisis in Sub-Saharan Africa and elsewhere, the
United States would raise no objection if Members availed  themselves of the flexibility afforded by
the WTO TRIPS Agreement.
A comprehensive approach is needed to serious health problems.  We believe that participants
in our discussion today should keep in mind that the TRIPS Agreement - its obligations and flexibility- is, at most, one element of the equation.  To deal with serious health problems, countries need to
stress education and prevention as well as care and treatment if health crises are to be eliminated.
Health experts inform us that the cost of drugs is only one of many important issues that must
be addressed in any health crises.  Effective drug treatment necessitates urgent action to strengthen
health management systems particularly directed to drug distribution and patient monitoring.
Appropriate drug selection policies and standard treatment guidelines;  training of care providers at alllevels;  adequate laboratory support to diagnose and monitor complex therapies;  and systems for
ensuring that the right drugs are used for the right purpose and in the right amount are all required to
address the HIV/AIDS crisis.
We must recognize that even if enough drugs to treat every single HIV-positive person were
provided, free of charge, an adequate infrastructure to deliver them and monitor their use does not
appear to exist in many areas most in need.  To ensure that health care is available, particularly to
those unable to afford basic medical care, health experts tell us that each country must also develop its
medical and public health infrastructure, increase the resources allocated to health care, and take other
appropriate steps.
2
That is why the United States will continue to pursue an integrated approach to fighting
disease, focusing on prevention of new infections an d training medical professionals, as well as on
treatment and care.
As tangible evidence of our commitment to th is integrated approach to fighting disease
around the world, the United States continues to be the largest bilateral donor of HIV/AIDS
assistance, providing for nearly 50 per cent of all international HIV/AIDS funding.
Recently, the United States announced a proposal for the creation of a new global fund to
fight HIV/AIDS, malaria and tuberculosis.  The United States will back this international effort by
providing US$200 million in seed money for fiscal year 2002.  The United States also will work with
other governments, private foundations, corporations, faith-based groups, and other organizations to
generate additional support for this global effort.  Just today, it was announced that the
Gates foundation has made a major contribution of the fund.
In addition to the US$200 million commitment to the new Global Fund, the United States
budget for FY 2001 increases funding to figh t the international HIV/AIDS epidemic to
                                                     
2 At the Norway conference, Dr. Brundtland closed with the following statements:
'We have heard quite clearly that the price of drugs matters, it matters to poor people, and it matters to
poor countries.  But little progress will be possible without a significant investment in building effective health
systems", and
"There were other important lessons that came out of  our review of current experience.  It reinforced
the point that just making drugs available - even at no cost - does not guarantee that they will be utilized.  Allother pieces of the picture have to be in place as well: the distribution systems, the partnerships between public
and private providers;  the agreements between govern ments and development agencies;  and clear and explicit
goals and objectives."IP/C/M/31
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US$480 million, increases to US$10.2 billion the budget of the Department of Health and Human
Services, and US$2.5 billion for the National Institutes of Health for HIV/AIDS research.
My Government invites the participation of other nations and other partners in securing the
necessary funding to address the global HIV/AIDS pandemic.
Role of IPRs in developing new health care-related technologies
Recognizing that it is but one part of a much larger equation, let me focus on the role of
intellectual property, particularly patents, in supporting effective health care.
There is no question that patent systems serve public health objectives by stimulating
discovery, development and commercialization of new products to prevent, treat, or cure illness.
Specifically, the experience of the United States has been that a period of market exclusivity
for innovated products and processes - whether provided by a patent, data exclusivity, trade secrets or
a combination of these legal protections - is essential to ensure development and commercialization of
new health care products, including pharmaceuticals, diagnostic products and medical devices.
Without this period, during which unauthorized parties cannot sell copies of the protected
invention, the private sector may be unwilling to take the immense risks associated with development
of significant new healthcare products.  Market exclusivity for the results of innovation, and not
simply the possibility of a royalty, provides the necessary incentive for companies to invest in
research to discover, develop and commercialize new products.
Contrary to what many have asserted, this exclusivity does not give right holders a monopoly.
In fact, the scope of the exclusivity provided by a patent is quite narrow.  Based in part on the
disclosure associated with the patent application, even during the patent term, competitive
manufacturers are able to develop and market their own competing drugs to treat the same illness,thus ensuring price competition and a wide choice of effective treatments for both doctors and
patients.
We understand that in the United States alone there are presently more than 100 new drugs
for the treatment of HIV/AIDS in development, more than  120 new drugs to treat heart disease and
stroke, more than 135 new drugs for treating or preventing infectious diseases, more than 400 new
drugs for treating or curing cancers, and more than 700 new drugs to address diseases associated with
aging.
These are in addition to the revolutionary treatments that have been marketed in recent years
that, every day, are saving lives that would have been lost just a few short years ago.
Many thousands of initially promising drugs never reach the market because they have been
found to be ineffective or too toxic.  It is the prospe ct of market exclusivity that continues to spur the
development and commercialization of new products despite the high number of unsuccessful
compounds.
Simply put, intellectual property protection systems, particularly patents and trade secrets,
under the TRIPS model must be available to create the environment necessary for new drug
development.  This is significantly different from an environment that merely promotes copying of
existing drugs.
UN Secretary General Annan pointed this out recently, when he said, "Intellectual property
protection is key to bringing forward new medicines, vaccines and diagnostics urgently needed for theIP/C/M/31
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health of the world's poorest people.  The United Nations fully supports the TRIPS Agreement the
safeguards incorporated within it."
We also note that the Resolutions approved by at the 21 May World Health Assembly clearly
recognize the importance of intellectual property in urging members to support, encourage and
provide incentives for increased investment in research related to HIV/AIDS, including in the
development of new preventive and therapeutic approaches and technologies, including in particular
HIV/AIDS vaccines and microbicides.
Apart from stimulating innovation, however, a st rong IPR regime - particularly a strong
patent regime - can also produce other benefits for countries, regardless of whether the countries are
developed or developing.
For example, countries that have strong patent regimes are more effective in attracting
investments and market entry by innovative companie s.  The reasons for this are fairly simple -
patents provide a greater capacity for the innovator to compete based on the innovation.  If the
innovator cannot use the innovation to provide a market advantage, there is a disincentive to enter the
market, particularly where others in that market can charge lower prices because they do not need torecover the costs of research and development, no r do they need to invest in new research and
development.
As I have already noted, another important benefit of a patent regime is that, in order to obtain
a patent, an innovator must disclose all the technical details of the invention, a requirement embodiedin Article 29 of the TRIPS Agreement.  This disclo sure stimulates a significant flow of information to
the public, including competing manufactures, that might otherwise be kept secret.  Therefore, patent
systems do not impede research and development activities nor do they discourage competition.
Patent systems encourage this activity.
Thus, patent regimes actually promote the objective of Article 7 of the TRIPS Agreement by
contributing to the promotion of technological innovation and to the transfer and dissemination of
technology.
The TRIPS Agreement Reflects the Proper Balance Between Innovation
and Access to Health Care
In establishing standards for patent regimes, and in providing certain flexibilities, the TRIPS
Agreement has struck a proper balance between offering incentives for innovation and ensuring that
there is access to needed medicines.
Indeed, two documents available on the WTO website, the "WTO Fact Sheet:  TRIPS and
Pharmaceutical Patents", and the "Technical Note:  Pharmaceutical Patents and the TRIPS
Agreement", highlight how this balance is struck by the Agreement.  We encourage Members to refer
to these documents as useful explanations of the Agreement and to avoid documents circulated by
other individuals and organizations that lack the WTO's expertise.
We also want to note the European Communities' thoughtful paper on the relationship between
the provisions of the TRIPS Agreement and access to pharmaceuticals.  We find many areas of
agreement with them and note with interest some of the questions raised about "permissive" readings
of Article 31.
Before discussing the specific articles of the Agreement most commonly associated with
access to medicines, I would like to remind delegations that among the most significant flexibilities
contained in the TRIPS Agreement are the transition periods provided to developing andIP/C/M/31
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least-developed country Members, especially the specific transition period provided to Members
which had not established patent protection for pharmaceuticals and agricultural chemicals at the time
the Agreement entered into force.
We would like to understand better what impact the TRIPS Agreement could be having on the
health care regimes of least-developed country Members given that these Members are not currentlyobligated to implement the Agreement, including its patent provisions.  We are particularly interested
because certain Members have suggested that these transition periods be further extended, even before
these Members have had any experience implementing the Agreement.
Article 30 of the TRIPS Agreement
Article 30 of the TRIPS Agreement allows Members to provide for limited exceptions to
exclusive patent rights so long as the exceptions do not unreasonably conflict with the normalexploitation of the patent or prejudice the legitimate interests of the patent owner, taking into account
the legitimate interests of third parties.
Earlier drafts of the Article reveal that negotiators had in mind exceptions for such things as
so-called prior user rights;  acts done privately and for non-commercial purposes;  acts done forexperimental purposes;  and similar activities.
We note that a WTO panel considered Article 30 in a dispute between the European
Communities and Canada, regarding the provision of Canada's patent law allowing generic
manufacturers to make use of patented drugs during the patent term solely for the purpose ofdeveloping data to obtain marketing approval for a generic equivalent.  This policy was designed to
allow introduction of generic drugs on the market quic kly after the expiration of the patent.  The panel
found that the exception in Canada's law, with one exception, was sufficiently limited to fall within
the scope of Article 30.
That means that exceptions for pre-expiration te sting similar to those provided in Canada and
the United States which significantly accelerate the availability of lower cost generic drugs can be
included in Members' patent laws without violating the Members' obligations under the TRIPS
Agreement.  This is an important flexibility in the Agreement that enhances access to drugs.
Article 31 of the TRIPS Agreement
It is apparent that Article 31 creates obligations for Members only when a particular
pharmaceutical is protected by a patent within its territory.  It should be obvious that Members have
no TRIPS obligations with respect to products that are not protected by patents within their territories,
even though those products are patented elsewhere.
Therefore, it is not necessary for a Member to grant a compulsory licence to produce a
pharmaceutical product within its territory if patent protection for that pharmaceutical product does
not exist in its territory.
As has been noted by the European Communities and others, Article 31 does not itemize the
purposes for which compulsory licences may be granted.  Instead, the Article establishes conditionsthat must be met with respect to compulsory licences, conditions that are modified, in some instances,
depending upon the purpose for which the compulsory licence was granted.
Of course, Article 31 must be read in light of the other provisions of the TRIPS Agreement,
including Article 27.1.  The latter provision prohibits discrimination in the enjoyment of patent rightsIP/C/M/31
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based on whether products are imported or domestically produced.  In other words, importation of a
product, rather than domestic production, cannot justify the grant of a compulsory licence.
Because Article 31 does not specify the circumstances under which compulsory licences may
be granted, it is understandable that it does not make express reference to public health.  Article 8.1
makes it clear, however, that public health is one concern Members may take measures to address, solong as the measures are consistent with the TRIPS Agreement's provisions.
While I will not discuss in detail each of the conditions established by Article 31, I would like
to highlight those that seem most relevant for our discussion today.
The second condition under Article 31 establishes an obligation, then provides circumstances
in which that obligation may be waived.  The obligation is that unauthorized use may be permittedonly if the party seeking a compulsory licence has been unable, within a reasonable period of time, to
obtain a voluntary licence on reasonable commercial terms and conditions.
That obligation may be waived in a national emergency or other circumstances of extreme
urgency or in the case of public non-commercial us e.  This waiver authority is, of course, very
important for our discussion today.
The possibility of such a waiver recognizes that, in the case of a national emergency or other
circumstances of extreme urgency, there isn't time to enter into negotiations with a patent owner to
obtain a voluntary licence.  Certainly, epidemics such as HIV/AIDS within a Member's territory are asmuch a national emergency or a circumstance of extreme urgency as war, civil strife, or natural
disasters for purposes of exercising the waiver authority.  The United Nations Security Council made
this point last year, and I believe most speak ers in the room have also made that point.
Paragraph (b) also permits a waiver of the requirement to seek a voluntary licence first in the
case of public non-commercial use, recognizing that requiring governments to do patent searches and
seek voluntary licences before every procurement of goods or services for the government's own use
would unnecessary delay the procurement of those goods or services and would add to their costs.
Paragraph (b) also makes clear, however, that in cases in which the requirement to seek a
voluntary licence is waived, the patentees must be notified as soon as reasonably practicable.  In
addition, paragraph (h) of Article 31 makes it clear that the patentees must be paid adequate
remuneration for the use of their patents, taking into account the value of the authorization.
Paragraph (c) specifies that the scope of a compulsory licence and its duration are to be
limited to the purpose for which the licence was authorized.  Obviously, were such a licence granted
on a patented drug in order to address a condition of extreme urgency, such as an epidemic, the useshould be limited to providing the pharmaceutical to treat those suffering from the disease or to
prevent contraction of the disease, if that is the purpose of the pharmaceutical.  The duration would
likely depend upon the duration of the epidemic.  Related to this, paragraph (g) provides for the
termination of a compulsory licence when the circumstances that led to its issuance cease to exist and
are unlikely to recur.
Paragraph (f) is also very important for our discussion today, because questions have been
raised about whether a compulsory licence can be granted under a patent to a supplier from another
country.  Paragraph (f) states that compulsory licences should be authorized predominantly for supply
of the domestic market of the Member authorizing the use.IP/C/M/31
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In our view, the nationality of the recipient of a compulsory licence is not relevant for the
purposes of Article 31.  What is relevant, in such a case, would be whether the licence results in an
infringement of a patent for the same product in the licensee's country.
Obviously, if no patent for the drug has been granted in the licensee's country, no
infringement would occur.  If such protection does exist, however, and the compulsory licensee
chooses to manufacture the drug in its country for export to the country that granted the compulsory
licence, a problem is created.  If the patentee successfully sued the producer in the other country, the
compulsory  licence originally granted would be ineffective in supplying the needed pharmaceutical.
For this reason, one must consider whether it would be appropriate to limit eligibility for
compulsory licences to those parties that can assure  the government granting the licence that they will
be able to supply the market without interruption that might result from infringement of a patent intheir own country.
The non-national could make such assurances either because no patent existed in its home
country, because it had obtained a voluntary licence from the patentee in its home country that
allowed it to produce the patented pharmaceutical for the supply of the other market, or because itplanned to  produce the patented pharmaceutical in th e territory of the country granting the
compulsory licence.
The EC has identified a possible interpretation of the Agreement with respect to whether a
compulsory licence can be granted under a patent to a supplier from another country even wherepatent infringement might otherwise be considered to have occurred.  This proposal raises questions
that should be addressed if there is further discussion of this concept.
Lastly, I would like to address two misconceptions regarding compulsory licensing.  First,
contrary to what some have asserted, compulsory licences under the TRIPS Agreement are notintended to be a mechanism for directing industrial development, protecting domestic industries
against foreign competitors, or for promoting the now widely discredited economic policy of import
substitution.
The foundation of free trade embodied in the WTO system is the removal of conditions that
lead to inefficiencies in global trade.  The WTO has long recognized the trade-distorting nature of
local content, import substitution and local production requirements.  We note that the
non-discrimination clause of Article 27.1 of the TRIPS Agreement is built on this foundation.
Pharmaceuticals are among the best examples of products where these principles are true.
Pharmaceuticals can be efficiently produced in a small number of locations and transported through
international trade to markets needing those products.  Such efficiencies in production and distributionlead to lower prices and faster supply of products to meet demands, including those caused by public
health emergencies.
Indeed, recent studies have shown that local production does not necessarily result in lower
prices.
Second, some have observed that certain Members employ compulsory licences to remedy
anti-competitive practices, as the TRIPS Agreement cl early provides, with no ill effect to their patent
system.
Certainly the United States has never suggested that compulsory licences are not a fully
appropriate and TRIPS-consistent way to remedy anti-competitive behaviour.  However, we would
point out that compulsory licences are used in this manner to remedy an abuse, and not in the normalIP/C/M/31
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course of doing business.  Therefore, it is inaccurate to suggest that US practice would support the
conclusion that there would be no negative implications for patent systems, and more importantly
incentives for developing future life-saving drugs if Members were to permit widespread use of
compulsory licences for any purpose.
Parallel Import
So-called "parallel imports" are also sometimes raised in discussions regarding access to
drugs.  To be clear, we define that term to mean legitimate goods produced by a patent owner or with
the patent owner's authorization that are purchased in one market where the price is attractive,
whether as the result of differential pricing by the patentee in recognition of the economic
development of a country, of currency differences, of price controls, etc., and imported into another
country where a patent exists, without the authorization of the patent owner.
There is no question that Article 6 denies Members the ability to avail themselves of dispute
settlement in relation to questions involving parallel imports, except when those questions involve
national or most-favoured-nation treatment.  Howeve r, Article 6 of the TRIPS Agreement does not, in
our view, authorize parallel imports.  Members must remember that Article 6 does not alter the
substantive obligations of the TRIPS Agreement, particularly those contained in Part II of theAgreement.
In our view, advocates of parallel importation overlook the fact that permitting such imports
discourages patent owners from pricing their products differently in different markets based upon the
level of economic development because of the likelihood that, for example, products sold for a lowprices in a poor country will be bought up by middle men and sent to wealthiest country markets and
sold at higher prices, for the benefit primarily of the middle men.
The lack of parallel import protection can also have significant health and safety implications.
Our law enforcement and regulatory agencies, especially the Food and Drug Administration, havecommented on how very difficult it is for them to keep counterfeit and unapproved drugs out of our
country even with the strong parallel impor t protection provided in the United States.
Advocating parallel imports, therefore, could work to the disadvantage of the very people on
behalf of whom the advocates purport to be speaking.  As Dr. Brundtland in Oslo recently noted, "Fordifferential pricing to work on a large scale, I think we can all agree that there must be watertight
ways of preventing lower priced drugs from finding their way back into rich country markets".
Article 39.3 of the TRIPS Agreement
With respect to Article 39.3, we concur with the EC's observation that the most effective way
of protecting test data against "unfair commercial use" in a manner consistent with the TRIPS
Agreement is to ensure that regulatory authorities do not rely on such data for a reasonable period oftime, such as five years, as is the case in the United States.
Conclusion
To conclude, I believe it is universally agreed that we must provide incentives for investment
in research and development of new and more effective life-saving drugs.  Effective patent systems,therefore, are crucial if we are to find better treatments and ultimately cures for HIV/AIDS and the
many other diseases and health conditions that afflict the world's population.IP/C/M/31
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The TRIPS Agreement appropriately requires that an effective patent system be provided
within every WTO Member.  It also provides sufficient flexibility by allowing certain limitations on
patent rights to, among other things, address public health issues, including diseases and conditions
that are epidemic and endemic.
We look forward to the interventions of other delegations, the in depth analysis behind such
interventions, particularly in those cases where it is being asserted that the TRIPS Agreement is not
already sufficiently flexible.  We also look forward to continuing this discussion in future meetings
and to all Members' substantive contributions.
EGYPT
In this intervention, which I hope will be quite brief, the intention is to touch upon only a
limited number of provisions in the TRIPS Agreement.
But, at the outset, let me thank the coordinator of our Group, Zimbabwe, for the statement
delivered on behalf of the African Group, which we fully subscribe to.  We also wish to express our
appreciation for the paper produced and presented by the European Communities (IP/C/W/280) whichcontributes positively to our discussions today.
The particular case of medicines is very significant and the stories behind it are very many
and also very telling.  Indeed, the developing countries have the right to use a transitional period of up
to 10 years before they become obliged to apply all the provisions of the TRIPS Agreement on equalfooting with any other country.
The question that looms in many minds is whether a 10-year period of transition is reasonably
sufficient for the transformation of a typical developi ng country to a status reasonably close to that of
a typical developed country in a manner that reasonably allows equal application of the same rules toobtain reasonably similar results.
Given the realities of differences in capacities and needs, one must look to the set of rights
and obligations as explicitly pronounced or implicitly to be understood in their international legal
instrument which all member countries must respect, namely the TRIPS Agreement.  In thatinstrument there are, to be sure, certain inflexib ilities, but there are also certain flexibilities.
We can find the flexibilities presenting themselves in some of the horizontal general
provisions and basic principles of Part I of th e Agreement.  Most importantly among these are
Articles 7 and 8, which allow governments to adopt measures necessary to protect public health and
nutrition, and to prevent the abuse of IPR's including the resort to anti-competitive practices.  These
flexibilities, however, are restricted - but not totally neutralized - by the requirements that they mustbe consistent with the provisions of the Agreement.  I wish to recall here the fact that the crucially
significant language in Articles 7 and 8 summarizes the whole drive and purpose of the Agreement,
by stating that it aims at balancing rights and obligations to the mutual advantage of producers and
users of technological knowledge, in a manner conducive to social and economic welfare.
We have also Article 6 on the exhaustion of IPRs, which consequently allows parallel
imports.  The same effect is reflected in Article 28 on the title-holder's exclusive rights where the
footnote to this Article confirms the same kind of flexibility.  In the field of medicines, this spells
much relief in many adverse health situations.  We have thus some useful permissibles which
somewhat counterbalance the pressures imposed in other places in the Agreement.
Let me also make mention of Article 30 on exceptions, which allows developing and
developed countries alike to resort to limited exceptions that may be used carefully and judiciously toIP/C/M/31
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produce beneficial effects without infringing the legitimate rights of other parties.  A set of selected
exceptions can thus provide a breathing space and some degree of freedom of action, which would
necessarily differ from country to country.  On this point, I may make mention of the Canadian
experience in the area of medicines where a single exception, the so-called springboarding-Bolar
exception, was applied with notable success.  Of course, the exceptions are not carte blanche .  They
are again restricted, since their application can encroach on other parties' rights.
Before leaving this point and having alluded at the experience of Canada in the
pharmaceuticals fields, I allow myself to make mention of a remarkable drug pricing mechanism
which is operational in Canada, namely the Patented Medicines Prices Review Board.  This, I believe,
deserves study, since it is a mechanism of a highly developed economy, a wealthy country, yet a
country, which harbours concern about the prices of medicines available to the average citizen.
What looms in many minds during this Special Discussion on intellectual property and access
to medicines, is the need to explore the permissible exceptions, both candidly and in depth, and how
they can prudently be conceived.
Compulsory Licensing (Article 31 of the TRIPS Agreement) is another area where a degree
of flexibility is available for application whenever necessary, such as in difficult and harsh times.  I
guess no times can be more difficult or harsh than when a life-saving medicine is denied or when the
price is prohibitive.  In this connection, attention has already been drawn in many quarters to
paragraph (f) of Article 31 concerning the obligation to supply "predominantly" the domestic market.
A human reading or a re-reading of the language in Article 31(f) would also lead to permitting the use
of a locally produced medicine to alleviate adverse health situations in another country.
Let me turn, from hinting at some of the fl exibilities that are pronounced in the TRIPS
Agreement, to hinting at other flexibilities that deserve to be given attention, although they are not
straight-forwardly pronounced in the Agreement, but have roots in its provisions.
Of all practices that can now be highlighted as pertinent morally and useful to all countries,
and fair to all peoples and eventually to all businesses including the pharmaceutical manufacturers
themselves, are the following:
(1) Differential pricing policies and practices, where drug selling prices are influenced by
the per capita income in different countries.
(2) Refraining from the practices of requiring expansions or extensions to the exclusive
rights of the right holder, such as demanding prolongation of the patent term, pipeline
protection, and evergreening of patents.
(3) Refraining from those restrictive forms of patenting in the area of pharmaceutical
products, that are either useless or harmful, such as what has come to be known as
broad-blocking patents and sleeping patents.
(4) Noting that a strict, but a fair reading of TRIPS Article 27.1 together with
Article 27.3(a) would not mean that the use, even if it is a new use of a known
pharmaceutical product, is in itself patentable.  Such new use is certainly a valuable
scientific finding, maybe a genuine discovery, that deserves every appreciation and
needs to be brought to the attention of the medical profession.  Such new use would
more appropriately be seen as a method  of therapy of the kind indicated in
Article 27.3(a).IP/C/M/31
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(5) The historical role of R&D in the health area, particularly the area of fighting against
or protecting from communicable diseases, cannot be over-emphasized.  What needs
now to be emphasized, however, is the need  to persuade R&D – most of which is
conducted in the developed countries and particularly in the laboratories of the MNCs
– to pay greater attention to the health problems of the poor in the developing world.
Such contributions will pay great dividends in the long run and will certainly help indismantling the wall of fear and suspicion that is sometimes visible.
(6) The principle of working a patent locally is historically cardinal in the general
philosophy of the patent system.  What is meant by working of a patent is its actual
implementation to produce the patent-protected product or the actual use of the
patent-protected process.  This is what the WIPO Model Law for Developing
Countries says.  Working is the reward that the society deservedly receives inexchange for conferring complete and strict protection of the IPRs.  This lofty goal
will be defeated if working occurs only through importation of the patented product.
It is to be remembered also that, to the Paris Convention, non-working is a kind of
abuse of the exclusive rights enjoyed by the title-holder, which can be a ground for a
compulsory licence.
(7) Major manufacturers of those medicines that have fallen into the public domain  can
do a lot of good to the peoples of developing countries.  Encouraged by their
governments, such as through the award of incentives (remember TRIPS
Article 66.2), these manufacturers can transfer technology and manufacturingknow-how relevant to medicines of impor tance to receiving developing countries
against reduced prices, or perhaps at no cost at all.
(8) My own country, Egypt, provides a package of generous incentives which, in addition
to a favourable IPR-protective environment, is aimed at attracting foreign enterprisesto establish in the country a base for their manufacturing operations.  The message is
directed with a particular appeal to manufacturers of medicines and pharmaceutical
chemicals  that have relevance to the local health problems.
Finally, there is a special message that needs to be directed to the WHO.  The presence of this
critically important organization is very much needed in all future review or revision functions as
related to or as affecting the area of medicines.  There is dire need to evoke the question of essential
drugs and how the list is constructed and updated, and how best it can be utilized, in the context of
today's deliberations, to provide real and effective relief for the poor in the developing world.
Towering above all issues is the Organization's role in the implementation (or helping in the
implementation) of the resolutions recently adopted by the 54
th World Health Assembly, including the
much needed WHO Medicines Strategy.
In conclusion, there is a general, and perceptible, feeling that deserves to be given due
consideration in respect of two procedural-substantive issues.  The first is the proposal to approve a
moratorium on dispute settlement actions in matters related to medicines, the duration of which can be
discussed and decided by general agreement.  The other issue concerns the outcome of the presentspecial discussion, which would in all probability need to be pursued for further elaboration during at
least one more meeting focussing on the same subject matter, namely access to medicines as related to
and influenced by the TRIPS provisions.
In this intervention, it is clear that only a few provisions of the TRIPS Agreement have been
touched upon by our delegation.  But a broader coverage and a more in-depth treatment of several
other TRIPS Articles will be attempted in any future meeting for follow-up on today's proceedings.
I am specifically referring to the TRIPS medicines–relevant Articles:  27.1, 27.3(a) and (b), 28.1,IP/C/M/31
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28.2, 29.1, 30, 31, 32, 33, 34, 39.3, 40, 70.8 and 70.9.  In each one of these Articles or paragraphs,
there are comments that we wish to put for your consideration, and for the consideration of this
distinguished Council.  It is also in several of them that certain inflexibilities  reside which need to be
candidly addressed.  But for now and for the sake of brevity, this delegation has limited itself to a
treatment of the most direct flexibilities subject-matter of TRIPS.
We trust, that the forthcoming WTO Doha Ministerial Conference will have the subject
matter of today's deliberations featuring high on its agenda, and that it will engage the interest and
concern of participating Ministers.
SWITZERLAND
The question of intellectual property and access to medicines is a question of utmost
importance in the context of the pandemics of HIV/AIDS which, in some parts of the world have
taken or are taking extremely worrying dimensions.  That is why at the TRIPS Council's last meeting
in April, Switzerland welcomed and supported the request of Zimbabwe on behalf of the African
Group, that this Council should set aside a full day for a special discussion on the issue of "intellectual
property and access to medicines".
We would like to thank all those delegations that enable us to come to a structured and result
oriented discussion by having provided this Council with written communications for today's meeting.
First of all, I would like to stress what the distinguished ambassador of the EC has stated this
morning:  the TRIPS Agreement should not be looked at as part of the problem but as part of the
solution.
This is, because intellectual property protection and in particular patent protection are an
important instrument in favour of research and development which again is in favour of development,especially in the field of health care.
Making drugs available at affordable prices includes as a prerequisite, that drugs have to be
available per se .  If no drugs were available at all, how could we then discuss to make them available
at lower costs?
We therefore have to make sure that enough incentives will continue to be given to the private
sector, which is responsible for research and development of new medicines which will result -
hopefully - one day to a vaccine against such a terrible illness like HIV/AIDS.  These incentives are
assured in the TRIPS Agreement, in particular by Articles 27 and 28  which define the patentable
subject-matter and the rights conferred to the patent holder.  We therefore must resist to any
temptation to downgrade these rights, or else we take the risk, to have far less medicines to distributein the end.
While addressing the issues of flexibility offered by the TRIPS Agreement, we also should
bear in mind that any move we make, could finally lead to a reaction from right holders.  In other
words:  any so-called flexibility on which we agree to be in the TRIPS Agreement should have to beconstrued in such a way, that it does not take away the incentive to research for new drugs and
vaccines, if we do not want to face at the end of the exercise a so-called "loose-loose" situation -
something which cannot be in the interest of anybody.
A delicate balance between these interests has been achieved by limiting the exclusive right
of the right holder to a specific term of protection, by determining the definition of protectable
subject-matter, and by the obligation to disclose, already during the term of protection, the inventionIP/C/M/31
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in order to disseminate new technology and therewith to encourage new research and development
and thus ensure faster progress of technology.
Beyond this balance, parties to the TRIPS Agreement have agreed to  include even further
scope for flexibility on the range of which we have started to discuss by today.  This flexibility should
enable Members to implement their TRIPS oblig ations in balance with their public health
considerations.
As for the price of medicines, like intellectual property rights, we agree it is an important
issue in the access to health discussion.  However, even if such medicines were offered at half of their
actual price or as low as at one tenth of that price, they would probably still not be affordable for
many people.  So price is a core problem that has to be addressed.  In that respect, we can only
encourage discussions between governments and the private sector in order to agree on prices andUN Secretary General Annan's call for a fund raised to finance the access to and distribution of
essential drugs in those countries which desperately are in need of such drugs.  It is, however,
important to mention that patents are only partly responsible for the price of a patented product:
First, a patent does not give the right to charge a specific price for a pharmaceutical.Second, a patent does not prevent prices for patented pharmaceuticals from being adjusted to
take into account the capacity to pay of different countries and their population.
And third, the market of pharmaceutical products is one of the most regulated in the world
and the influence of patents is hence very much reduced.
As to the flexibility of the relevant provisions  of the TRIPS Agreement, 1 would like to cut a
long story short:  My delegation would like to support what has been said by the European
Communities and their member States in document IP/C/W/280 in paragraphs 6-9 and 17-19 .  We
also fully agree with what  has been said in the same communication by the EC/MS in the bold typed
conclusions at the end of paragraphs 11-16 concerning Articles 7, 8, 30, 31 and 39 of the TRIPS
Agreement.
Since the said communication of the European Communities and their member States does
not address the issue of parallel imports and local working, we would like to focus on these two points
which in our view are of crucial importance to the problem of "access to drugs":
While in the view of this delegation, the TRIPS Agreement in its substantive provisions
supports the notion of national exhaustion (Article 28), it is recognized that Article 6  of the
Agreement prevents Members from taking action against Members that do permit parallel imports
(and let me be clear, when talking of parallel imports, I mean imports of original products put on themarket with the consent of the right holder at a cheaper price in another country than the one offered
in the country considering parallel importation).  Although this delegation still has some doubts
whether parallel importation is really for the benefit of the consumer and not rather the trader, we
recognize that Article 6 offers flexibility to developing countries in the search for patented medicines
offered at a cheaper price elsewhere in the world.
However, the concept of exhaustion and parallel import need particular scrutiny when talking
about differential pricing , which has been put forward from various sides as a possible option to
increasing accessibility to drugs in developing c ountries:  When considering differential pricing, my
delegation would like to emphasize that if such a pricing system should get the support of all thestakeholders necessarily involved in its implemen tation, one of the main prerequisite would be to
ensure that products which are sold at a lower price to developing countries are not re-exported to
industrialized countries.  Effective safeguards in that respect would be necessary and in place as soonIP/C/M/31
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as large quantities of price-reduced pharmaceutical products would be delivered to developing
countries facing a health crisis.  The risk of re-exportation would not only undermine research and
development of new products, but would also divert the products from those so urgently in need of
them, the people, who are the reason why we are having today's special discussion, that is, those
suffering from HIV/AIDS, malaria, tuberculosis or other epidemics in the developing world.  In our
view, Article 6  of the TRIPS Agreement would provide for the necessary flexibility to find an
appropriate solution for this problem, but may be this would have to be expressed by this Council in a
more explicit way, for example in a joint declaration.
As regards compulsory licensing and the requirement of local working of patents  as suggested
by some delegations, I have to say that my delegation does not see how such a requirement could be
brought into harmony with the wording of Articles 27 and 28 of the TRIPS Agreement, which
respectively prohibit discrimination between locally and imported products, and considers importation
as the working of a patent.  But may be we get further clarity on this issue during the continuation of
our discussion in this Council.
Having said this, I would like to say that Switzerland is ready to continue in this Council the
technical discussion on the issues of flexibility offered by the TRIPS Agreement when facing a healthcrisis and an "access to medicines" problem.
We are sure that the TRIPS Agreement provides us with enough flexibility in this regard.We simply would like to recall that in this disc ussion the TRIPS Council should not forget the
crucial importance of intellectual property protection and in particular patent protection as the core
incentive for the development of new, more effective medicines in our battle against health problems.
JAPAN
Japan's contribution and commitment
Japan has been consistently insisting on the importance and necessity of measures for
combating against life-threatening infectious a nd parasitic diseases, such as HIV/AIDS, malaria,
tuberculosis and polio.
Based on its recognition of serious epidemic situations in many regions of the world, Japan
has been committed to taking Actions to combat those deadly infectious and parasitic diseases.  For
example, at the occasion of the G-8 Summit last year, Japan announced the "Okinawa Infectious
Disease Initiative", which is targeted to allocate a total of 3 billion US dollars over five years in order
to enhance Japan's assistance for measures against those infectious and parasitic diseases.3
In the framework of this three billion-dollar Initiative, Japan has accelerated its formulation
and implementation of a variety of projects, programmes and schemes.  These actions are directed not
only to cooperation in the framework of intergovernmental fora such as the UN and
non-governmental international cooperation, but also to individual developing countries and regions
all over the world.  For example, Japan's initiative is directed to those countries, such as Viet Nam,Cambodia, Thailand, the Philippines, Sri Lanka, Bangladesh, India, Mongolia, Tajikistan,
South Yemen and China, in the Asian region.  Japan's commitment also covers countries in the
African region, such as the Democratic Republic of Congo, Kenya, Zambia, Tanzania, the Republic of
South Africa, Ethiopia, Ghana, Nigeria, Sudan and Burkina Faso, as well as Haiti in the Central
American region.
                                                     
3 (http://www.mofa.go.jp/policy/econom y/summit/2000/genoa/infection3.html)IP/C/M/31
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My delegation would like to stress that Japan is, and will continue to be, committed to efforts
to combating against those terrible infectious and parasitic diseases, including HIV/AIDS, which is a
terrible tragedy to countries, families and individuals.
Needs of comprehensive approach
Having said that, however, my delegation must admit that the combat against those infectious
and parasitic diseases is not an easy task.  The most important and difficult part of the problem is that
we need to address a wide range of comprehensive measures to combat against those diseases.  My
delegation is well aware of the importance and necessity of improving the accessibility and
affordability of key pharmaceuticals for those diseases.  In addition to those measures, however, we
need improvements in public health infrastructure, including building medical institutions, as well aseducation and training of medical staffs at all level.  Measures for strengthening health management
systems and enhanced prevention are also needed.  Research and development of new drugs and new
therapies are also essential for the solution to the problem.  In the view of my delegation, those issues
could be achieved only if we have a part nership with all relevant stake-holders.
Because of this very reason, the Okinawa Initiative of Japan covers a wide range of fields of
activities, such as direct assistance for control measures against those infectious and parasitic diseases,
assistance for improvement of public health infrastructure, development of research network,
assistance in basic education for preventive measures, and access to safe water.  Because of this
reason, the Okinawa Initiative calls for a partnership with governments of other countries,international organizations, such as WHO, industries, particularly the pharmaceutical industry,
academic institutions, NGOs and other relevant actors in civil society.
Japan is ready to discuss the accessibility of key pharmaceuticals for those major infectious
and parasitic diseases.  However, my delegation would like to point out that the most difficult part ofthe problem is that, again, many factors are related to the issue of drug access.  With respect to the
accessibility of drugs, for example, one of the important issues would be the method of delivery, and
medical/paramedical staffs who must ensure that the right drugs are used in the right amount for the
right time to the right patients.  With respect to th e affordability of drugs, it should be noted that the
prices of drugs are determined depending on many factors, including governmental price control,insurance system, taxes and tariffs, demand-supply situation in the market, and costs for
transportation and delivery.
In the view of my delegation, therefore, IP protection to drugs is only a part of the
complicated issues which are to be tackled in a comprehensive manner.  If we want to solve this
problem, a comprehensive and holistic approach should be taken.  When we discuss the issue of
IP protection in the context of accessibility and affordability of pharmaceuticals, we should alwayskeep that in mind.
IP protection in the context of drug access - in general
It is needless to say that ensuring an adequate access to drugs is important from the
perspective of public health.  At the same time,  development of new drugs and new therapies are
equally important to improve public health.  Viruses and bacteria are becoming more and more
resistant to the existing drugs.  Particularly, the HIV virus has a quite mutable nature, so that a new
AIDS therapy must be developed in a continuous  manner.  Without continuous R&D of new drugs
and new therapies, we would be unable to ensure public health in the future.
The development of new drugs requires a quite large amount of costs.  On the other hand, the
drugs are very easy to copy.  This is the reason why IP protection is essential for the area ofIP/C/M/31
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pharmaceuticals.  If unauthorized copies of patented drugs were to be freely made, it would be
difficult for research-oriented pharmaceutical companies to recoup the costs for R&D of new drugs.
Less likelihood of cost recovery would mean less incentive for drug companies to develop new drugs.
Less incentive for R&D in a certain area of drugs could lead to a sift of R&D efforts to other areas of
drugs.  Therefore, my delegation takes the view that appropriate IP protection is one of the key factors
for promoting R&D of new drugs for those major infectious diseases.  It should be noted that IPprotection gives an incentive for developing new drugs for infectious diseases, including HIV/AIDS.
Therefore, my delegation is not in favor of attempts to downgrade the level of protection set out in the
current provisions of the TRIPS Agreement.
My delegation would not deny that patent protection could have an impact on the accessibility
of drugs, because patent protection gives to the patent owners the limited monopoly right within the
certain time period over the manufacture, sale and importation of the patented drugs.  However, therelevant provisions of the current TRIPS Agreement provide for the appropriate balance between the
protection of inventions and the use of the inventi ons.  For example, Article 31 which stipulates "other
use without authorization of the patent owner" provides measures to secure an appropriate balance
between patent protection of inventions and use of the patented inventions by third parties.  Article 31
of the TRIPS Agreement provides for other use without authorization of the patent owner (i.e.,compulsory licence), and Members could legitimately allow the use of patented drugs to the extent
that it complies with this provision.
Also, it should be noted that some of the private sector pharmaceutical companies have
already launched a voluntary price differentiation scheme, in which they provide anti-HIV drugs(ARV) to certain developing countries at a preferential discounted price.
Therefore, my delegation is of the view that the public health concern could be
accommodated with patent protection of new drugs, and in a long-term perspective, patent protection
of new drugs would contribute to the improvement of public health.
In the view of my delegation, relevant provisions of the TRIPS Agreement have some
flexibility.  And, they could be interpreted so as to  implement an appropriate balance of patent owners
and users of the patent.  In this regard, Japan is willing to enter into the discussion aiming at clarifying
Members' views regarding the interpretation and application of the relevant provisions of the TRIPSAgreement.
Therefore, now I would like to touch upon th e views and interpretation which Japan takes
regarding some of the TRIPS provisions.
Exhaustion/parallel import - Article 6
My delegation takes the view that Article 6 allows Members' discretion as to whether national
or international exhaustion is to be taken in their national jurisdiction.  It is widely accepted that
"international exhaustion of patent rights" means that a patent right is exhausted and cannot be
exercised over a patented product, once the patented product is put on the market somewhere in the
world either by the patentee himself or by another person with the patentee's consent.  Therefore,Members have a freedom to adopt national legislation by which a patentee can no longer claim his
patent right over his patented product, if that product has been put on the market of another country
either by the patentee or another person with the consent of the patentee.  On the other hand, my
delegation takes the view that, if a patented product has been produced under compulsory licence, and
has been put on the market of another country, international exhaustion should not apply.  This isbecause such a circulation in the market has not been  made with the consent of the patentee.  Rather,
such a circulation has been made under the compulsory licence.IP/C/M/31
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Another point to be noted is the implication of international exhaustion in the context of
voluntary tiered pricing arrangements.  There are many pharmaceutical companies which have
launched voluntary price differentiation by which th ey voluntarily provide key drugs to developing
countries at a special preferential price.  If the drugs provided in such a developing country at a
preferential price are re-exported to a third country-market, those drug companies would be
discouraged to continue the tiered pricing policy.  In order to encourage the tiered pricingarrangement, measures should be examined to prevent re-exportation from such developing countries
to third-country markets.  Tiered pricing is prim arily a contractual issue between a drug company and
the government of a developing country which is a recipient of tiered-priced drugs.  Nevertheless, it
might be worth discussing to take appropriate measures.  Such measures would include that:  (1) the
recipient developing country takes measures to prevent re-exportation of tiered-priced drugs to third
countries;  and (2) third countries take measures to prevent the importation of tiered-priced drugs from
the recipient developing country.
Other use without authorization of the right holder - Article 31
(1) Condition of compulsory licence
Article 31 does not specify the grounds for compulsory licences.  My delegation takes the
view that public health consideration could be a legitimate ground for a compulsory licence, and
Members have a right to issue compulsory licences in accordance with the relevant TRIPS provisions.
Subparagraph (a) of Article 31 provides that a compulsory licence should be considered on its
individual merits.  This would imply that com pulsory licences should be primarily decided on a
case-by-case basis.  Nevertheless, some observations could be made regarding the terms and phrases
provided in the subparagraphs of Article 31.
For example, subparagraph (b) provides the "fast-track", in which the requirement of prior
negotiation is waived by a Member either in the case of a "national emergency or other circumstance
of extreme urgency" or in cases of "public non-commercial use".
Regarding the terms "national emergency" or "extreme urgency", my delegation takes the
view that, for some countries, HIV/AIDS epidemics are certainly situations of national emergency orcircumstances of extreme urgency.
Regarding the term "public non-commercial use", my delegation takes the view that
free-of-charge distribution of drugs by governme nts could amount to "public non-commercial use".
(2) Non-capacity country
There are countries which do not have sufficient production capacity in their territory to
manufacture the patented drugs.  For those countries, it has been argued whether or not a compulsory
licence can be granted to a supplier of a third country which has sufficient production capacity.  In
relation to this question, subparagraph (f) provides that a compulsory licence should be authorized
predominantly for the supply of the domestic market of the Member authorizing the use.  If acompulsory licensee is to manufacture the patented product in the third country for the sole purpose of
export to the country which does not have sufficient production capacity, the literal conflict with
subparagraph (f) would likely to take place.
In our view, however, it would not be appropriate if the drugs produced under the compulsory
licence cannot be imported to the country which does not have sufficient production capacity and
which is in a status of national emergency of HIV/AIDS epidemic.  Otherwise, the right given toIP/C/M/31
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Members under Article 31 to issue a compulsory licence in the case of national emergency would be
meaningless for those countries which have no production capacity.
Therefore, we should explore ways to justify the third-country production under a compulsory
licence, without prejudicing the provision of subparagraph (f).  Japan is ready to address this issue in a
positive and constructive manner in order to reach consensus among Members.
Undisclosed information - Article 39.3
My delegation agrees with the EC/MS that Article 39.3 neither obliges Members to have
marketing approval procedures, nor does it prescribe what those procedures should be.
In conclusion, I would like to stress once again that Japan is ready to join the international
efforts regarding drug access and intellectual property which we have started today in a positive and
constructive manner.
CUBA
Considering  that the right to life of thousands of disadvantaged human beings is constantly
dependent, minute by minute, upon legal interpretations which determine government action,
interpretations which, in their turn, are subordinated to the pace of negotiations as determined or
governed by the financial power of private holders of the rights to basic medicines on which lives
depend;  and considering  that the debate which commenced to day in this Council, in accordance with
the proposal presented by the African Group at the meeting of 2 to 6 April 2001 and endorsed by
virtually all Members, aims to clarify the flexib ility available to Members when implementing the
provisions of the TRIPS Agreement on real and effective access to medicines;  my country hereby
wishes to contribute to the discussion by presenting its own interpretation of the issue .
In the light of the Agreement's objectives as set forth in Articles 7 and 8 and given the
ambiguity of some of the relevant provisions, Members can fully accommodate their personal
interpretations to their own individual social - and in particular public health - requirements and
objectives and thus strike a balance between the public and private interests at stake.
One way of doing this is through compulsory licensing, not only in the event of a national
emergency and other circumstances of extreme urgency or public non-commercial use, but also to
ensure that patents are not used to make access to medicines solely dependent upon imports at
prohibitive prices.  In accordance with these objectives, the economic value of authorization should be
analysed in the light of the individual circumstance s of each case and should rest on prices that are in
keeping with each Member's social requirements and objectives.
In special situations such as these and whenever medicines are intended for people with zero
or very low income, payment would be according to  special, differentiated prices, respecting a
reasonable mark-up and preventing smoke screens from concealing the real costs.
Patent owners' rights should be subject to international exhaustion, so that access to medicines
through parallel imports from countries where prices are lower can constitute an alternative.  This
means of access cannot give rise to a dispute settlement proceeding within this organization.  Neither
is recourse to unilateral pressure to prevent a Member from making use of a measure which is
authorized within the framework of this Agr eement a legitimate move, since it undermines legal
certainty and confidence in multilateral commitments and is detrimental to the protection and interests
of public health.IP/C/M/31
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The implementation of the TRIPS Agreement in relation to protectable subject matter allows
therapeutic methods, inter alia , to be excluded from patentability to ensure that such applications,
being in the interests of society and public health, are not subordinated to private interests. This
equally controversial issue goes hand in hand with the need to protect second uses of already known
and patented medicines.
In this sense, inventions whose commercial exploitation must be prevented to protect the life
or health of populations, inter alia , should be excluded from patentability, once again in order to
balance public interests with the interests of private right holders.
Other uses without the authorization of the right holder must be possible;  compulsory
licensing for exports from countries where they are granted is necessary for effectively promoting the
protection of public interests, taking into consideration the small economies which are unable toacquire and hence take advantage of such licences.
The provision on the protection of undisclosed information should not be interpreted in such a
way as to override Members' rights under other Articles of the Agreement.  Such information must at
least be available in the event of a national emergency or other circumstances of extreme urgency.
The opinions stated herein do not even begin to cover the wide range of unsatisfied needs and
provisions of dubious application, whether or not available, in the TRIPS Agreement.  Consequently,
this exercise must be considered merely as the fi rst step in discussions leading to the analysis and
negotiation of means to ensure the effective implementation of the Agreement to the mutualadvantage of right holders and consumers, and conducive to a balance of rights and obligations and to
the social and economic welfare of the broad strata of society lacking an economic livelihood or
minimum income, who must be the first beneficiaries of social and public health objectives.
Ongoing research into new medicines for both l ongstanding and new diseases must not be the
cause of, or effectively result in, the side-lining of th e most sacred of all human rights, the right to life,
because the considerable expense involved, mentioned constantly but never proven, has to produce
returns.
The advocacy of a system for the protection of intellectual property rights that guarantees
general public policy objectives should not in practice result in a system which, while calling for the
recognition of the need for such guarantees, give s priority to the removal of trade barriers and
distortions with the result of nullifying or impairing the right of access to the means of protecting and
prolonging life.
This is why the discussions initiated today in this body must continue to form part of this
Council's regular work and feature on the agenda of the fourth Ministerial Conference, so thatMinisters can ensure that the results of this work are available as soon as possible for the immediate
benefit of all WTO Members, in particular the most disadvantaged.
KENYA
On behalf of the Kenyan delegation, we would like to support the statement made by
Zimbabwe on behalf of the African Group on the crisis arising from the effects of patents on prices
and affordability of pharmaceutical drugs.  We also would like to associate ourselves with the paper
that has been presented by Brazil on behalf of a number of developing countries including Kenya.
Allow me to preface my remarks by stating that this Council cannot afford to ignore the debate ragingacross the world about the role of intellectual property rights protection in dealing with health
emergencies, and pandemics such as HIV/AIDS and other life-threatening diseases.  This heated
debate is based on the demand for a balance of rights and obligations of the patent holders vis-à-visIP/C/M/31
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the right of access to health by the poor.  Specifically, we must address directly the sensitive issue of a
patient's right to access essential, life-saving and vitally needed drugs.
A human tragedy of shattering proportions is al ready at hand.  In Kenya, as in many other
Sub-Saharan African countries, a significant proportion of the population is infected with HIV and life
expectancy is projected to decline drastically in the next five to ten years.  Besides the AIDSpandemic, the cumulative human suffering and economic damage caused by malaria is immense.
Each year, an estimated 26,000 children die from malaria infection, about 170 million working days
lost to the malaria war, pregnant women suffer severe anaemia, have low birth-weight babies and run
higher risk of death from the disease-conditions aggravated by the problem of drug resistance to
conventional malaria drugs.  The crisis is compounded by the poverty facing our people.  According
to 1994 statistics, 12.6 million Kenyans lived below the absolute poverty line, 47 per cent of the rural
population and 29 per cent of the urban population below the poverty line.  Governmental,non-governmental, private sector and donor community  sources indicate that the incidence of poverty
in Kenya has increased in recent years.
In Kenya, like in most other low-income developing countries, public spending on medicines
is less than two dollars per capita per year.  In such circumstances, the cost of care falls to theindividual and the family.  Since poor people do not have access to health insurance, they have to pay
for drugs when they fall ill.  Out-of-pocket payments account for up to 90 per cent of total health care
spending.  No matter what time of the year, no matter what the state of family finances, the situation
for many is stark:  no cash, no cure.  And the result is very high mortality rates.  The ethical and
financial stakes are very high.  These issues are also very emotive and complex.  There are definitelydifferent and deeply held opinions as to the way forward, but let us be clear about the objective of our
meeting today:  achieving greater clarity about strategies that will make the prices paid for key
pharmaceuticals more closely in line with the economic circumstances of the purchasing countries.
It is noteworthy that the access debate has been aroused by the extremely high cost of some
essential, life-saving and vitally needed drugs.  Very few anti-retroviral drugs are among the essential
drugs in the WHO Model List of Essential Drugs.  Essential drugs are those that satisfy the health care
needs of the majority of the population and should therefore be available at an times in adequate
amounts and appropriate dosage forms.
Though anti-retroviral medications in the treatment of AIDS is an easy example, there are
many other cases of patented drugs used in the treatment of serious diseases that are out of reach of
millions of people especially in low-income developing countries.  The national drug policies of these
nations are, as a result, undermined by the high cost of drugs.  These policies seek to ensure the
constant availability of safe, effective and affordable drugs to all segments of the population and to
encourage self-sufficiency through local manufacture of drugs for consumption and export.
Prior to the coming into force of the TRIPS Agreement, Kenya was able to decide whether or
not to exclude pharmaceutical products from patentability on the ground that medicines are essential
in saving lives, treating diseases, and in the promotion of health.  The TRIPS Agreement now requires
the protection of intellectual property rights, including those of pharmaceutical products and
processes.  The WHO has argued that such protection would strengthen the monopoly of workingconferred on the right owner, a situation that leads to an increase in drug prices.  The Agreement,
however, leaves certain margins of freedom that can be used to limit the adverse effects on prices and
access to technology.  The WHO position is that the national laws should cover the possibility of
authorizing parallel importation of patented drugs sold at lower prices in another country, and to
establish compulsory licence provisions, to enable developing countries to meet their for public healthneeds.IP/C/M/31
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It is, therefore, worrying that obstacles have been placed in the way of developing countries
wishing to use these provisions mainly because of different interpretation.  Attempts to restrict the use
of parallel import and compulsory licensing measures, through restrictive interpretations of the TRIPS
provisions, will only further reduce access of poor people to vitally needed and life-saving medicines,
and thereby endanger more lives.  Such attempts will also add fuel to the growing public perception
that the TRIPS Agreement favours the protection of private rights over the public interest and publichealth.
It is our understanding that the TRIPS Agreement does not stand in the way of countries
taking measures to protect public health and to promote public interests.
Article 7 of the TRIPS Agreement embodies the commitments in these words, and I quote:
"The protection and enforcement of IPR should contribute to the promotion of
technological innovation and the transfer and dissemination of technology, to the
mutual advantage of producers and users of technological knowledge and in a manner
conducive to social and economic welfare, and to a balance of rights and obligations."
It is also our understanding that the objectives in Article 7 and the principles in Article 8
clearly indicate the subordination of the protection of intellectual property rights to public policy
objectives.  The TRIPS Agreement stresses the need to promote adequate and effective protection of
IPRs, but to do so as part of a series of broader economic objectives and not as an absolute and
exclusive obligation.  This means that the protection of IPRs has a role to play in relation the priority
objectives of public policy for which these rights were created.  It should be harnessed to the serviceof development, and this is the purport of the principles expressed in Article 8.1.  This makes for a
balance between the rights of patent holders and their obligations to mankind.  The application of
these provisions, however, has left a lot to be desired.  It is this gap between provision and
application, which makes us question the working of the Agreement.
The compliance dates of 2000 and 2005/6 are not sensitive to the developmental needs of
low-income developing countries and are contrary to the Article 7 commitments.  Patent protection
ought to contribute to development.  By the year 2005, all developing countries will have to grant
legal protection of patents including pharmaceutical products.  Member states have an obligation to
integrate into their patent legislation the minimum standards established by the TRIPS Agreement, i.e.patents for a minimum of 20 years, applicability of the "most-favoured-nation"  clause, and reversal of
the burden of proof.  The question is, against what developmental measures were the compliance
dates computed?  What is the commercial sense of the 20-year term of protection?  Moreover, the
protection span does not seem to take into account the medical reality of possible drug resistance and
obsolescence of drugs, or the possible development of more efficacious drugs that supersede earlier
patented drugs.
WTO Members should agree on longer transition periods based on developmental milestones
in keeping with the TRIPS commitments I have just referred to.  We need time as a nation to
industrialize, to develop our own local manufacturing and quality control capacity, time  to train the
human capital, time to revamp our depleted healthcare  infrastructures, time to put in place the proper
framework that would support the smooth operation of a rules-based international trading regime.  Wesimply need time.  These compliance dates therefore need urgent review, if the fight against
life-threatening diseases in poor nations is to be won.
The developing countries need fundamentally different IPR regimes from the ones that
developed countries have now.  They should be allowed to grant weaker protection of IPRs.  Theseshould include shorter patent life, easier compulsory licensing, compulsory working and easierIP/C/M/31
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parallel imports in the absence of local production.  These countries should also be allowed to pay
lower licensing royalty rates, graduated to a country's ability to pay.
We recognize the importance of investment in research and development, especially given the
extremely mutative nature of the HIV virus, the drug  resistant strains of tuberculosis, malaria, and
other common infections.  New and effective drugs are clearly a life necessity.  Our challenge,however, is to address the TRIPS principle of striking a balance between the question of affordable
access to drugs and industrial commercial concerns, and to avoid abuse of patent protection through
recourse to non-competitive practices.
We conclude by asserting that pharmaceutical products cannot be regarded as ordinary goods
or products, because access to essential, life-saving and vitally needed drugs are an integral part of the
realization of a fundamental human right, i.e. the right to health.  It means that policies pursued by allconcerned in the sector must aim to make drugs available for all who need to have them and at
affordable prices.  Patents affect prices by creating market monopolies, greatly hindering access to the
patented products by those who need them, most predominantly poor people who lack health
insurance.  Price is a key factor to health delivery, and it becomes to us a health concern when it
impedes access to health care.  This special impediment must be overcome as a priority in order toreverse the human suffering we are faced with.  We envision a very near future in which people,
particularly poor people, are not excluded from healthcare by virtue of their poverty.
We, therefore, request the Council to recommend :
That the Qatar Ministerial Conference shall adopt a declaration on the TRIPS Agreement and
access to medicines, affirming the following:
- That Article 7 be immediately operationalized in the spirit of commitments embodied
therein, so that the protection and enforcement of intellectual property rights shouldcontribute to development and transfer of technology.  In the context of public health
and access to medicines, patent protection should encourage research and
development of new medicines and the international transfer of technology to
promote the development of manufacturing capacities of developing countries,
without prejudice to national policies for the protection of public health andpromoting access to affordable medicines.
- That Article 8 explicitly recognizes the right of members to adopt measures to protect
public health, among a range of other interest objectives.  In the context of public
health and access to medicines, it is understood that the TRIPS Agreement does not
limit the grounds on which Members may issue compulsory licences, nor does it
prevent Members from applying the principles of international exhaustion to allowthem to exercise their right to parallel importation.
- That consistent with international human rights obligations, it is agreed that the health
crisis in many poor countries constitutes a national emergency entitling them to
operationalize the exceptions on protection enshrined in the TRIPS Agreement.
- That WTO Members agree on longer transiti on periods for introducing new industrial
property laws, based on development milestones, and that developing countries
should retain the right to produce, market, import and export affordable medicines.
- That Members observe an immediate moratorium on the dispute settlement action
against developing country Members to enable them to adopt measures to promoteIP/C/M/31
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public health and human rights considerations, as well as international developmental
objectives.
We have only touched on a few important flexibilities provided for in the TRIPS Agreement.
There are others, such as those provided for in Articles 30, 39.3 and 40, which are equally important.
We, therefore, reserve our rights to come back to this matter at a later stage.
HUNGARY
Hungary welcomes the special session in the TRIPS Council on intellectual property and the
access to medicines, which was initiated by the African Group and supported by the entire WTO
membership.
We welcome today's discussion in particular, because we recognize that the access to
affordable pharmaceutical products is a vital problem particularly and in strictu sensu of the word
vital for millions of suffering people in vary many developing countries.  In our view, it is of crucial
importance that the international community helps af fected countries effectively combat preventable
and treatable infectious diseases and that the WTO, in the sphere of its competence, contributes to thiseffort.
We believe that the issue at hand is very complex in nature and only concerted international
efforts can bring, tangible positive results.  This is reflected in the fact that different aspects of this
issue are discussed in different relevant international organisations, like the UN and its specializedagencies like WHO or WIPO.  We believe that our Council is best placed to discuss the TRIPS
implications, including the flexibilities in the relevant provisions of the TRIPS Agreement and should
not duplicate work that is going on elsewhere.  To sum it up, the WTO does have a role to play, but it
should concentrate on issues within its competence.
Against this background let me offer a few specific remarks regarding some of the TRIPS
provisions relevant to the access to drugs (but before doing so I would like to use this opportunity to
thank those delegations, which submitted their views on the relevant issues in writing, in particular the
paper presented by Zimbabwe on behalf nearly 50 developing countries and the paper presented by
our friends of the European Communities and its member States.
On the objectives and principles of the TRIPS Agreement , as Article 7 makes clear, the
purpose of the TRIPS Agreement is to promote technological innovation and the transfer and
dissemination of technology to the mutual advantage of producers and users of it.  In other words, the
protection of intellectual property rights is suppos ed to serve the society as a whole by striking a
balance between the interest of private right holders (inventors, authors and manufacturers) and the
users of their inventions.  Article 8 in turn makes clear that Members may adopt measures necessaryto protect public health, provided that those are not inconsistent with the provisions of the TRIPS
Agreement.  We share the view that all the provisions of the TRIPS Agreement should be read in light
of the principles and objectives as set forth in Articles 7 and 8 .
On compulsory licenses , we share the view expressed in the papers submitted to the Council
that Article 31 does not specify the grounds on the basis of which compulsory licences can
legitimately be granted .  Article 31 simply lays out extensive procedural safeguards to prevent abuse.
Some of these safeguards however may be waived, in cluding in cases of national emergency or other
circumstances of extreme urgency, as well as in cases of public non-commercial use.  We believe
that situations such as created by the AIDS/HIV pandemics in the seriously affected countries coulddefinitely be considered to fall under these categories.  We share the view that the absence of an
explicit reference to public health in Article 31(f) cannot be interpreted as preventing WTO Members
from invoking public health concerns, when granting compulsory licences.IP/C/M/31
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It is not clear whether, under Article 31(f), a WTO Member which does not have sufficient
domestic manufacturing capacities is allowed to grant a compulsory licence to manufacturers in
another country where the product is under patent protection.  This is a real problem and an issue that
deserves attention and further discussion in the Council.  We are ready to engage in such a discussion
and believe that when seeking a solution - preferably in the form  of interpretation - the Council should
be guided by the objective of ensuring access to reliable and most cost-effective supplies of medicines
in question.  The interpretation suggested by the EC in their paper (IP/C/W/280, paragraph 13) is
certainly one of the options the Council should look at.
On exceptions to patent rights , Article 30 allows WTO Members to maintain limited exceptions
regarding the exclusive rights conferred by a patent, including for the purposes of research.  We
believe that this particular exception is of great importance for improving, on the longer run, theaccess of all to cheaper medicines.  It has to be noted though, that such exceptions can have a
relatively limited short term effect, at least so far as the current health crisis warranting rapid action is
concerned.
Let me finish by indicating Hungary's willingness to discuss further these issues and others
raised by delegations in the Council and I would like to assure you that we will treat these problems
with the due seriousness and responsibility commensurate with the dramatic dimension of the problem
we are dealing with.
NIGERIA
Like other delegations who spoke before me, I would like to fully associate my delegation
with the statement made by Zimbabwe on behalf of the African Group on the relationship between
TRIPS and public health.  It is a positive and constructive way and a basis for addressing and finding
solutions to the problems of increased and affordable access to essential medicines or treating diseasesand saving lives.
This delegation regards this discussion as an important one, necessary in clarifying the
provisions of the TRIPS Agreement of relevance to access to medicines, to ensure that the TRIPS
Agreement does not in any way undermine the legitimate rights of WTO Members to formulate publichealth policies and implement them in a manner to promote and protect public health.  Nothing in the
TRIPS Agreement should prevent Members from achieving this goal.
We are of the view that each provision of the TRIPS Agreement should be read in the light of
Articles 7 and 8 dealing with the objectives and principles.  Our view is that nothing in the TRIPS
Agreement should inhibit or restrict the range of options available to governments to promote and
protect their public health and other overarching public policy objectives.  The TRIPS Council shouldconfirm this understanding.
Finally, we hope that the discussion should not be a one-off event.  Indeed, it should be the
beginning of a process or a more substantive di scussion.  The momentum should be sustained until a
solution is found.  The matter should be pursued further in the context of the ongoing preparatoryprocess for the fourth session of the Ministerial Conference of the WTO, and Ministers should take
action in Doha that will ensure that the TRIPS Agreement does not in any way undermine Members'
ability to take appropriate measures to protect their public health.  A satisfactory resolution of the
issue will send a positive signal and improve the image of the WTO and enhance confidence in the
system.IP/C/M/31
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CANADA
Canada is pleased to also participate in this discussion on the various issues related to
intellectual property rights and access to medicines.  We certainly share many of the views that have
already been expressed and for that reason offer only a few remarks.
The provision of HIV/AIDS drug therapies is a complex question.  It involves patent rights,
the establishment of adequate systems to deliver and monitor drug usage, as well as direct and
alternate mechanisms to finance drug purchases.
Access to essential medicines encompasses broader issues than simply cost.Developing and least-developed countries are in need of assistance to develop their health
systems and infrastructure capacity for the delivery and monitoring of complex drug regimes.
Last fall, the Canadian International Devel opment Agency released a new HIV/AIDS Action
Plan which quadrupled the HIV/AIDS budget to a to tal of $270 million from Canada for over the next
five years.
As we all know, attempts to address additional funding measures are being discussed at the
UN General Assembly Special Session on HIV/AIDS on 25-27 June in New York, and through
relevant UN agencies, including the WHO and UNAIDS, as well as through the G-8.  Canada is fully
supportive of all of these international initiatives.
However, given the scale and complexity of the HIV/AIDS problem, we recognize that it will
be difficult to see results easily or quickly.  But we must do what we can and certainly this discussion
today is an important step in reviewing the role of intellectual property rights and, in particular, patent
protection.
Although over 90 per cent of drugs on the Worl d Health Organization's List of Essential
Drugs are not covered by patents, most HIV/AIDS therapies still are.
Discussions have therefore included reducing the price of patented medicines as one part of
the solution.
Many of the pharmaceutical companies, both brand-name and generic, supplying these
medications have agreed to lower their prices for HIV/AIDS drugs in developing and least-developed
countries as part of the solution.  This is a very positive step and Canada applauds this effort.
However, to work effectively, we must ensure that prices for these medicines adequately
reflect the cost-of-living differences between developed, developing and least-developed countries.
We must ensure that differential or tiered pricing, which takes into account the ability to pay
for the drugs at whatever price, works to assist those most in need in least-developed and developing
countries.
Work should proceed quickly to further the idea of differential or tiered pricing under the
global health fund which is now under development.
It will also be important to ensure lower-cost HIV/AIDS drugs are not re-directed and sold in
more affluent markets, such as those in Europe and North America.  Fortunately, Canada already has
mechanisms in place to monitor drug imports into the country.IP/C/M/31
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To be effective, the patent system must be allowed to play its role of providing effective
patent protection so that research and development into new and better drugs will continue.  In
Canada, we also offer tax incentives to encourage research and development.
Another issue raised here is compulsory licensing.  As stated in Article 31 of the TRIPS
Agreement, there are special rules in place for "national emergencies or other circumstances ofextreme urgency" that do not require prior agreement with the patent owner.
Cooperation with the company owning the patent  may be an efficient and effective means of
addressing a health crisis, but we recognize that Members should have sufficient flexibility to use the
option granted in the TRIPS Agreement.
We recognize that some Members have doubts about the value of the compulsory licensing
provisions.  Only through discussions will we be able to explore the true merits of the TRIPS
provisions.
As already mentioned by the US and Egypt, we believe that in the EU case against Canada –
Patent Protection of Pharmaceutical Products – the Panel came to a balanced and sensible decision infavour of Canada's "regulatory review exception".  The Panel clearly determined that there is scope
for flexibility in the TRIPS Agreement.  Certainly in arguing our defence, Canada called upon the
balance that exists between the rights of those creating the inventions and health and social priorities.
The TRIPS Agreement attempts to provide the necessary balance between encouraging
innovation and development of new products, and the needs of those requiring access to such
products.  That balance, and the flexibility in the TRIPS Agreement, plays an important part in finding
a solution to the HIV/AIDS health crisis.  But we must also note that without effective patent
protection we will not have research and development and new medicines and solutions to help solve
with health crises/pandemics.
ECUADOR
It is a source of concern to Ecuador that many factors that affect the development of countries
are being aggravated by positions that go beyond the legitimate trade interests that all Members of thisOrganization should logically be defending.
Let us drop these positions and revert to principles such as those agreed upon when the WTO
was established, to which Ecuador reiterates its commitment.  According to these principles,
"relations in the field of trade and economic endeavour should be conducted with a view to raising
standards of living, ensuring full employment and a large and steadily growing volume of real income
and effective demand, and expanding the production of and trade in goods and services, whileallowing for the optimal use of the world's resource s in accordance with the objective of sustainable
development, seeking both to protect and preserve the environment and to enhance the means for
doing so in a manner consistent with their respective needs and concerns at different levels of
economic development".
Similarly, the Preamble to the Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) recognizes the "underlying public policy objectives of national systems for the
protection of intellectual property, including developmental and technological objectives".
Consequently, the implementation of the TRIPS Agreement should not impede the
development of countries or constitute a barrier to free trade as a driving force behind economic
development.IP/C/M/31
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In this context, Ecuador repeats that it considers health to be a basic human right which must
be recognized and applied without any conditions or limitations.  In other words, the protection of the
right to health cannot be made contingent on the protection of intellectual property rights or, to put it
another way, the application of intellectual property rights must be of benefit to society as a whole
and cannot aim merely to protect private rights.
Access to medicines is a prerequisite to the full exercise of the right to health.  This access
must be general, and not limited to a certain type of medicines.  Arrangements for such access must
aim at resolving or alleviating health problems as a whole:  not only one major disease, such as
HIV/AIDS, but all endemic diseases affecting above all the poorest populations, such as malaria and
dengue fever in their various forms.
If we do not deal with these diseases in a comprehensive and general way, the development of
trade, which is one of the pillars of growth in our societies, will suffer considerably.  A
disease-stricken population is not good for trade or, ultimately, for development.
The development of health policy is the sovereign right of each country, and cannot be
limited by international measures that prevent or re strict governments in their efforts to resolve the
problems caused by disease among their populations.
The granting of discounts or the donation of medicines should not be seen as a substitute for
domestic legal provisions;  nor should they be seen as an alternative to the legitimate recourse under
the TRIPS Agreement to parallel imports and compulsory licensing, legal remedies available to all theWTO Members.  These mechanisms ensure that public institutions have the invaluable possibility of
obtaining access to cheaper medicines and stimulating the necessary price competition.
Ecuador is neither denying nor minimizing the importance and complete legitimacy of the
rights of those who invest their efforts and money in the research and development of medicines.Indeed, it is important to ensure that the commi tments and international agreements are properly
applied so that they do not cause injury to intellectual property right holders.  But it is just as
important to strike a proper balance in order to protect the health of populations, especially the poorest
populations.
In this connection, Ecuador also reaffirms the principles and objectives of the TRIPS
Agreement as set forth in Articles 7 and 8, i.e. that Members may, in formulating or amending their
laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote
the public interest in sectors of vital importance to their socio-economic and technological
development (Article 8), so that intellectual property rights should contribute to the promotion of
technological innovation and to the transfer and di ssemination of technology to the mutual advantage
of producers and users of technological knowledge and in a manner conducive to social and economicwelfare, and to a balance of rights and obligations (Article 7).
4
                                                     
4 Article 7:  "The protection and enforcement of intellectual property rights should contribute to the
promotion of technological innovation and to the transfer and dissemination of technology, to the mutual
advantage of producers and users of technological know ledge and in an manner conducive to social and
economic welfare, and to a balance of rights and obligations".
Article 8:  "Members may, in formulating or amending their laws and regulations, adopt measures
necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importanceto their socio-economic and technological development, pr ovided that such measures are consistent with the
provisions of this Agreement…".IP/C/M/31
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Ecuador has endorsed the understanding discussed by a large number of developing countries
on the relationship between the TRIPS Agreement and public health, as set forth in the document
presented to Members in connection with this meeting.
The urgent public health problems of the developing countries cannot be sidelined until the
Council for TRIPS has resolved the various lacunae of the Agreement.  In Ecuador's view, thedocument of the Doha Ministerial Conference in November should contain such clarifications of the
TRIPS Agreement as are needed to ensure that prio rity is given to health, in particular among the
poorest populations, and to the development of economically stronger societies.
These clarifications should ensure that patent holders are able to exercise their rights within
the limits set forth in various TRIPS provisions, such as those relating to compulsory licensing and
parallel imports, and hence in such a way as to ensure the balance between the rights and obligationsof producers and users of technological knowledge.
Definitive agreement must therefore be reached to prevent Members from taking action
against others merely because they have obtained the appropriate means to resolve their problems
related to endemic diseases and to protect the health of their populations.
NEW ZEALAND
New Zealand would like to take the opportunity today to formally welcome this special
discussion on intellectual property issues relevant to access to medicines.  This is an importantdevelopment in the range of efforts being undertaken by a number of fora to address the current
HIV/AIDS pandemic and other public health emergencies.  We welcome the high level of positive
support that Members have shown today.
We also welcome efforts here in the TRIPS Council to contribute to better clarity in ensuring
that current disciplines can make their maximum contribution to public health responses on this issue.
We believe this contribution can, and must, be a positive and significant one.
We share interpretations of TRIPS which recognize that the gravity of the current situation is
enough to trigger the Agreement's current, but sometimes obscured, flexibilities in order to meetpublic health objectives.  For example, in the context of Article 31 on compulsory licensing, there
should be no doubt that what many Members are facing a national or extreme emergencies.
We encourage Members to seriously consider proposed interpretations which help smooth the
way for affected Members to implement health pricing policies with confidence, and also with
appropriate safeguards against deterrence of future drug development.  In this respect, we welcome
the contributions made to date, particularly the paper from the European Communities and the focusthey help bring to our discussion.
Many of these contributions indicate that Members can think creatively within the TRIPS
Agreement to focus on practical solutions.  They al so highlight the need to keep in perspective the
TRIPS aspect of this issue with respect to broader and complementary efforts on disease eradicationand poverty reduction.  We look forward to further discussions on this basis.
JAMAICA
The delegation of Jamaica expresses appreciation to the African Group for proposing a
special session of the TRIPS Council to address the issue of TRIPS and public health.  The convening
of this special session is particularly timely given the public interest, indeed the acute public concern,IP/C/M/31
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that has been aroused on the question of affordable access to medicines, and the critical role that the
TRIPS Agreement can evidently play in this area of predominant interest to all humanity.
We would hope that this TRIPS Council, meeting in special session, will recognize the
obligation that is placed on it.  Million across the globe, and particularly in the developing world, look
to enlightened leadership on the question of affordable access to medicines and, notwithstandingvaluable and important bilateral and multilateral initiatives, there is growing public awareness that
there is an inextricable linkage between this issue and the TRIPS Agreement.  We certainly hope that
this Council can respond clearly and unambiguously to the urgent need for a common understanding –
for a common recognition of the flexibilities cont ained in the TRIPS Agreement, and that these
provide a basis for Members to take measures for the protection of public health.
It is in this context that I would wish to make reference to the paper circulated by a group of
countries.  Jamaica has joined a number of developing countries in co-sponsoring this paper.  The
document is pertinent.  It addresses a number of important issues which this Council must take into
account.  And even so it is not exhaustive.  Fundame ntally, it underscores how important it is for the
provisions of the TRIPS Agreement to be read in the context of the objectives and principles of the
Agreement as contained in Articles 7 and 8.  This of necessity should be our starting-point in theCouncil - the premise for our discourse in this spec ial session.  And if this is the starting-point, we
would hope that the outcome will be the common understanding that nothing in the TRIPS Agreement
should be construed to prevent Members from adopting policies to protect public health.
Article 31 of the TRIPS Agreement is, in our view, instructive, and reflective of this
flexibility.  The Article lays down procedural requirements for the grant of compulsory licences but
does not limit the right of countries to establish compulsory licences on grounds not explicitly
mentioned in the Agreement.  The TRIPS Council should give due recognition to this.
As a small economy, Jamaica has limited capacity to manufacture pharmaceutical products to
respond to the needs of our population.  We are faced with serious constraints in seeking to provide
affordable access to medicines.  It is estimated that, for example, comprehensive care and treatment
for HIV patients would cost more annually than the entire health budget.  One approach being pursued
is discussions with supplying companies in an effort to benefit from reduced prices.  But we believe
also that the flexibility provided under Article 31 is  vital for affording governments scope to deal with
circumstances of extreme urgency that may arise.  We thus believe that it is important to agree on an
interpretation of Article 31 that does not deny small economies with limited domestic capacity any
real flexibility in regard to compulsory licensing should the need for this measure arise.
Jamaica affirms the importance of striking a healthy balance between the interest of right
holders and the wider society.  It is our considered view that appropriate balance requires, among
other factors, that the interpretation and application of the TRIPS Agreement full scope is providedfor measures that facilitate generic competition without undue delay.  In this respect, amongst the
relevant key articles of the Agreement are those relating to exceptions (Article 30) term of protection
(Article 33), data protection and exclusivity (Ar ticle 39) and transfer of technology and technical
cooperation (Articles 66 and 67).
Yet other measures can assist in improving access to medicines and, in this context, there
should be recognition and acceptance of the latitude provided to undertake parallel importation in
accordance with the principle of exhaustion of rights.
Jamaica recognizes the important role that the protection of intellectual property plays in
stimulating creativity, inventiveness, and in research  and development.  This is particularly important
to the pharmaceutical industry, although we must note that many countries, both developed and
developing, until relatively recently excluded pharmaceutical products from patentability.  In the pastIP/C/M/31
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two or three decades, and especially since the adoption of the Uruguay Round Agreements, that
situation has changed.  But the protection provided to private right holders can have no logic if it does
not thereby lead to social benefits.  Let me emphasize that we certainly do not believe that we are
engaged in a zero sum game.  In our view, there is  ample scope for all to benefit – right holders and
the public at large.  Furthermore, an important c ontribution to this objective would be the forging of
common understanding regarding the flexibilities in herent in the TRIPS Agreement.  This would
provide both the juridical and political support for Members to take appropriate measures to address
their grave public health concerns, and would give hope to millions in the developing world.
Finally, this course of action would also send a definitive signal to all regarding the
responsiveness of this Organization to the fundamental challenges and concerns of development and
of developing countries.
DOMINICAN REPUBLIC
The delegation of the Dominican Republic fully endorses the statement made by the
delegation of Zimbabwe on behalf of the African Group.  We also fully support the statements made
by Argentina, Brazil, India, Malaysia and South Africa, and would like to thank the delegations of theEuropean Communities and Norway for their constructive contributions.  Other developed countries,
unfortunately, spoke in less generous terms, and we seem to be heading towards a situation in which
the law that rules will be the law of the jungle.  Our delegation is particularly eager to ensure that this
discussion does not turn into a mere public relations exercise aimed at "demonstrating" our solidarity
with the poor people of this earth, whose human rights are at issue when doubts are expressed on theway in which our countries have exercised their multilateral intellectual property rights.  And I speak
of human rights because, as the distinguished Ambassador of Bolivia rightly pointed out, human
rights include the right to health.
The Dominican Republic, together with the group of countries that support the statement by
Zimbabwe, would like this discussion to lead to a statement, perhaps by the Council for TRIPS, or,
why not, by the Ministerial Conference, reaffirming the unlimited right of our countries to grant
compulsory licences and to permit parallel imports of any kind covered by the international
exhaustion of rights.  We heard some very interesting arguments as to why certain parallel imports
can be permitted while others cannot.  It is amusing that the countries that put forward thesearguments are the same ones that have been pushing for negotiations on competition policy in the
WTO.  I wonder whether these two stances are mutually consistent.
As regards the protection of test data mentioned in Article 39.3 of the TRIPS Agreement, the
Dominican Republic considers that one of the objectives of the health policy applied by WTO
Members, particularly the developing country Members,  is to ensure an adequate supply of medicines
at affordable prices for populations such as ours with limited purchasing power.  This means that both
the industries manufacturing generic medicines and those involved in research and development must
be able to play their proper roles in our economies.  Otherwise, we would be in a situation where what
is sown by fax is reaped by customs.  No viable and sustainable public health policy will be possible
unless both segments of the pharmaceutical industry compete on an equal footing.  It is not a matter of
import substitution, of performance requirements, of anything that was discussed this afternoon - allwe are talking about is the right to compete in equal conditions.  In particular, the disappearance of
independent industries manufacturing generic medi cines will seriously undermine the possibility of
ensuring that market forces determine the price levels of medicines.
To safeguard our economic development possibilities, it is of the utmost importance that we
avoid an interpretation of the TRIPS Agreement that would result in a restriction of competition in the
application of new technologies beyond what the patent system permits.  This would be contrary to
the basic principles of the multilateral trading sy stem - to encourage the progressive opening up ofIP/C/M/31
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trade and liberalization of markets at the national and international levels.  These basic principles
form part of the WTO agreements, and ever since the great liberal revolutions of the eighteenth
century have been firmly enshrined in our constitutions.  The patent system was considered a useful
and valid exception to these principles for a limited period of time and subject to a number of specific
conditions.  However, it is understood that, if a particular technology that is patentable (such as a
chemical molecule that could be used for therapeutic purposes) has not been patented in a particularjurisdiction, the commercial use of that technology would be open to free competition.  In other
words, that technology, as long as it has not been patented, could be copied perfectly freely.  Any
attempt to undermine the possibility of free copy ing of unpatented technology through too broad and
anti-competitive an interpretation of the TRIPS Agreement would in fact be contrary to the economic
development policies of the great majority of WTO Members.
Thus, it is important that Article 39.3 of the TRIPS Agreement should not be interpreted in a
way which would prevent or affect the entry into the market of competitive medicines.  In particular,
the interpretation must not result in the creation of a circumvention of the patent system to block or
restrict the free manufacture and distribution of pharmaceutical or agro-chemical products.  An
unjustifiably broad interpretation of Article 39.3 would severely affect or even permanently impede
the operation of our independent industries producing generic medicines, whose activities play afundamental role in maintaining the prices of medicines within limits that are affordable for a
population with limited purchasing power.
Article 39.3 of the TRIPS Agreement should be interpreted in the context in which it was
drafted and in the light of the Agreement's objectives and principles, which have been repeatedlymentioned by delegations (Articles 7 and 8).  Article 39.3 only applies to cases in which the approval
of the marketing of products which utilize new chemical entities requires the submission of
undisclosed test or other data, the origination of which involves a considerable effort.  This implies
that any procedure for the approval of the marketin g of products that does not require the submission
of such data would fall de jure  outside the scope of Article 39.3.  In particular, any interpretation of
this Article that restricted or limited the possibility of applying accelerated approval procedures
(which do not require the submission of the said data) would go beyond the obligations contained in
the TRIPS Agreement and should therefore be questioned by WTO Members.
For cases in which marketing approval procedures require the submission of test data, the
only obligations under Article 39.3 are the following:  (a) to protect the data against unfair
commercial use;  (b) to protect the data against disclosure.  It should be stressed that the TRIPS
Agreement does not establish any obligation to prohibit persons from requesting and obtaining
marketing authorizations from third persons to produce their own versions of the medicines
previously approved.  This allows any person to benefit, without discrimination, from the marketing
approval procedures for products established by WTO Members in their respective countries.
Moreover, requiring the repeated submission of data obtained through considerable research andtesting involving a large number of live and healthy human beings and animals raises the sensitive
issue of ethics governing the protection of public hea lth, particularly in view of the fact that it does
not contribute to improving the quality and effectiveness of the medicines and represents an
unjustified waste of our meagre resources.
I would like to stress a point made in the document we submitted together with the African
Group, Brazil and other countries.  Paragraph 9 of that document calls the attention of WTO Members
to the adoption by the United Nations Commissi on on Human Rights of Resolution 2001/33, which
was accepted unanimously with only one abstention.  This Resolution establishes a mechanism for
follow-up by the United Nations Committee on Economic, Social and Cultural Rights, involving,inter alia , an assessment of the use by States of trade regulations to ensure access to essential
medicines.  Any attempt to use trade regulations to impede such access will be duly condemned byIP/C/M/31
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the said Committee.  I think that this is an important point, and one which should be fully borne in
mind by all WTO Members.
PERU
Peru is a co-sponsor of the paper on TRIPS and Health submitted by the African Group,
Brazil, India and other countries.
Because of this, and in view of the statements already made on this matter, I shall not be
discussing the technical and commercial aspects of the said paper in any great detail.
My intention, is rather to say that this special session of the TRIPS Council is not just another
meeting:  it marks the beginning of a process designed to ensure that the TRIPS Agreement does notin any way affect or restrict the legitimate right of WTO Members to formulate their health policies
and protect the lives of their citizens.
This meeting is attracting a great deal of media coverage and capturing international public
attention since, for the first time ever, the man in the street has realized that the relationship betweenintellectual property and health is neither a commercial nor an economic problem but an ethical
concern.
It is an ethical concern since the majority of people wonder why health and the lives of
millions of men, women and children ravaged by AIDS and other infectious diseases carry less weightthan private intellectual property rights and multinational pharmaceutical companies.  The problem,
which exists the world over, came to the fore with the legal action which was taken (and which
backfired) by such companies in South Africa.
AIDS, tuberculosis, malaria and other infectious and contagious diseases are spreading
steadily in the developing world since, according to various different studies, the national health
services of a large number of developing countries have collapsed, not as a result of TRIPS, but of the
continual adjustments made to scale down their fiscal deficit, largely in an endeavour to repay
external debt.
This problem is exacerbated by excessive and abusive protection of intellectual property
rights to the detriment of public health in the poor countries.
The Council for TRIPS therefore faces the ethical problem of making the TRIPS Agreement
legally compatible with public health.  This is feasib le, if there is both the political will to do so and
an awareness of the possible harm to both the WTO and the TRIPS Agreement if these provisions are
not brought into line with domestic public health systems.
This means permitting the discretionary application of compulsory licensing and parallel
imports and preventing new forms of protectionism, such as the attempt by transnational
pharmaceutical corporations to influence public health authorities under Article 39.3 of the TRIPS
Agreement.
In particular, and as suggested by the African Group, the Dispute Settlement Body should
adopt a moratorium on serious cases involving public health and intellectual property.
The WTO today faces a major challenge;  but it has also been afforded a wonderful
opportunity to prove to international public opinion that it is an Organization which works for the
majority of mankind and not, as is often claimed, for multinationals and developed countries alone.IP/C/M/31
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I shudder to think, what would happen were we to be unable to successfully overcome the
ethical challenge raised by the relationship between TRIPS and public health.  We do not need a
crystal ball to be aware of the dire consequences that this would have on international public opinion.
SRI LANKA
The Sri Lankan delegation welcomes the opportunity provided by the TRIPS Council to
discuss today one of the most important issues facing all our countries – the issue of public health and
access to medicines.
Sri Lanka fully supports the two statements made by Zimbabwe on behalf of the African
Group and by Brazil on behalf of over 50 countries,  to which my delegation belongs as a co-sponsor
of the joint paper.
As the joint paper highlights comprehensively, the issues and points, it is not for my
delegation to repeat all the points contained therein.  My delegation's intervention therefore only
focuses on some additional perspectives.
First, on the mandate and objective of the exercise.  A number of delegations dealt with this
issue in great detail during the morning session.  Most of those interventions highlighted the fact that
the TRIPS Council should discuss all issues relating to public health and access to medicines as they
relate to the provisions of the TRIPS Agreement.  The delegation of South Africa in its intervention
identified three such objectives and they do merit careful examination by the Council.
Second, the relationship between the concept of a pa tent and its subject-matter.  In its present
context, the TRIPS Agreement does not differentiate between patenting of public goods versus private
goods.  Article 27 of the TRIPS Agreement identifies the patentable subject-matter but does not make
a difference between what are public or private goods.  Pharmaceuticals, particularly the essentialdrugs, included in it are not simply another commodity, those are recognized as public goods.
Hence the society, as a whole, need to be very mindful of this situation, when dealing with
protection and enforcement of intellectual property rights related to such products.  My delegation
therefore fully supports the proposal that all essential drugs as identified by WHO should be excludedfrom the patentable subject-matter.
Third, the concept that access to essential drugs is part of human rights to health.  Access to
essential drugs basically depends on:
(a) rational selection and use of medicine;
(b) affordable prices;(c) sustainable adequate financing;
(d) reliable health and supply systems.
Since access to medicines is importantly sensitive and connected to their cost and
affordability, the Members of the TRIPS Council, as a whole, have a vital role and responsibility inidentifying the most needed relationship between the TRIPS Agreement and access to medicines.  The
impact of the TRIPS Agreement is primarily felt on the prices of patented products.  It is avidly
believed that the prices of existing patented drugs and new patented drugs would remain high,
because of the restraints which the Agreement imposes on bringing out generic versions during the
20-year period of patent protection.IP/C/M/31
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Fourth, my delegation particularly thanks the Ambassador of India for reminding us how the
fundamental principle of the protection of public health and nutrition is dealt with in two WTO
agreements, namely the TRIPS Agreement and GATT 1994 in different ways.
Fifth, the provisions of the TRIPS Agreement should be interpreted in the backdrop of
Articles 7 and 8 of the TRIPS Agreement.  A number of delegations referred to this point in theirinterventions.  My delegation also welcomes the European Communities' view on the overarching
importance of Articles 7 and 8.
Finally, it has been identified and also referred to by a number of delegations who spoke
before, the remedies available to developing countries to deal with the situation under the WTO in
three areas, namely compulsory licensing, parallel imports and differential pricing.  Various proposals
concerning each area, as to how their effectiveness can be improved, are before the Council.  As theAmbassador of India said, we may not find all the answers to the questions raised today, but it is
important for the Council to commence the task of  analysing the issues raised and exploring the
possible avenues to address them.  My delegation appreciates very much the European Communities'
statement that they are open and ready to examine a number of provisions that are relevant to the
debate.  Likewise, we urge all developed country tr ading partners to engage in a serious discussion
with a view to addressing and finding solutions to issues and concerns raised by the developing
countries.
HONG KONG CHINA
Today is the first time the TRIPS Council discusses this important subject of intellectual
property and access to essential medicines.  We see it as the start of a process, the objective of which
is to clarify the scope of the flexibilities under the TRIPS Agreement for Members to pursue policy
options to address public health concerns.  I would like to thank those delegations which have
prepared papers on the subject.
Hong Kong, China is of the view that the TRIPS Agreement has been drafted with a view to
promoting effective and adequate protection of IP rights, at the same time allowing Members
flexibilities to pursue policy options to address public health concerns.  The recent events in South
Africa have not changed our views.  In this connection, we welcome the two papers on the table todayas useful starting points to facilitate and focus further discussions.  The objective is to achieve
common understanding and bring clarity regarding the interpretation and the application of the
relevant provisions of the TRIPS Agreement, and the scope for Members to address legitimate public
health concerns.
The papers by the EC and by the African Group and other co-sponsors as well as many of the
delegations who have spoken before me have indeed raised a number of pertinent issues, such as theobjectives and principles of the TRIPS Agreement;  interpretation of Article 31 relating to compulsory
licensing, including its scope in dealing with national emergencies, other circumstances of extreme
urgency, or in cases of public non-commercial use, and the circumstances under which a Member can
confer compulsory licences to a foreign country manufacturer.  We look forward to engaging in
further substantive discussion by this Council.
HONDURAS
As a co-sponsor of the proposal presented by Zimbabwe, my delegation would like to take
this opportunity to reiterate and give its full support to the statement made by the Zimbabweandelegation on behalf of all of the sponsoring countries.IP/C/M/31
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We consider that the TRIPS Agreement should be interpreted and studied in good faith within
the context of its objectives and from the point of view of its purpose.
Honduras has always been mindful of the objectives of the TRIPS Agreement, fully confident
that the protection of all intellectual property rights would favour technology transfer in our country.
However, there has been little or no discussion to date on technology transfer and dissemination in ourcountry, with the result that innovation has not been promoted and there have been no incentives to
public health.
Honduras feels that there is a need for these objectives to be fulfilled, since this would pave
the way for the development and production in each of our countries of pharmaceutical products that
would benefit society as a whole.
Likewise, we feel that the interpretation of the provisions of the Agreement that allow
safeguard measures, such as those related to parallel imports and compulsory licensing, to be applied
to public health, is a priority since these are both particularly useful instruments which could improve
access to medicines and dampen the negative social impact of the privileges enjoyed by some
transnational companies.
The Council should explore effective means of solving public health problems and of
interpreting the provisions of Articles 6, 7, 8, 31, 39, 66 and 67 in such a way as to render them truly
operative and applicable in favour of developing countries.  They should not be restricted, nor the
small degree of flexibility afforded by some of these Articles reduced in any way.
We consider the establishment of differential pricing agreements to be a very positive
initiative in terms of improving access to medicines, but they should not under any circumstances be
used to restrict the flexibility or safeguards provided for in the Agreement.
My delegation is of the opinion that, since differential pricing does not fall within the sphere
of our discussions on intellectual property rights, it should not be discussed by the Council for TRIPS,
but rather, by intergovernmental organizations such as the WHO.
Finally, we believe that the forthcoming Qatar Ministerial Meeting will prove the best
occasion for ensuring that the Agreement is not interpreted or applied in a way as to prevent Members
from protecting and promoting public health policies.
CZECH REPUBLIC
At the outset, I would like to join previous speakers in congratulating you for your role in
organizing today's meeting.  Our delegation welcome and support the Agenda of the TRIPS Councilwhere one day is devoted to the discussion on the relationship between intellectual property and
access to medicines.  As it is for the first time the TRIPS Council discusses intellectual property
issues in the context of public health, we see this as a milestone in our work and as a positive message
coming from this Organization.  We associated with those who considered this issue very urgent and
it is our understanding that contradictions taken in this regard, for example, program for actionadopted by European Commission, is a step in the right direction.
Access to medicines is an issue which presents a challenge to the human race at the beginning
of the 21
st century.  As such, it contains political, humanitarian as well as technical elements and
fingerprints all of these elements we can find in trade.  Having said that, it is our understanding thatonly comprehensive solutions may be operational and acceptable for all participants on this two-way
road traffic.IP/C/M/31
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We are of the view that the TRIPS Council shal l concentrate on intellectual property aspects.
We also support the proposal to promote discussion within other organizations.  The discussion may
be helpful in addressing the link between the Agreement and public health protection and in
identifying components for necessary balance between access to medicine and intellectual property
protection.  It is a wide-ranging task, requesting further intensive work.
We thank delegations who presented documents for the TRIPS Council.  We consider it an
excellent contribution facilitating today's discussi on.  Our delegation, while remaining constructive
and positive in further work, will use opportunities to address specific elements later.
PANAMA
The delegation of Panama would also like to associate itself with the praise expressed for
your initiative of holding this special meeting to discuss this issue which transcends the realm of the
WTO, being very much in the public eye.  We all await the results of this meeting and are eager to
know how the topic will be followed up.
The delegation of Panama listened carefully to the various statements made today and is
encouraged by what the different delegations have said, in particular its partners from the developed
countries most active in protecting the intellectual property rights of their citizens that have identified
possible room for flexibility and interpretation in the TRIPS Agreement that could be important in
finding solutions to the concerns that this very im portant issue has raised, such as the impact of the
TRIPS Agreement and other WTO Agreements on the scope of action of governments in developingpolicies and operationalizing programmes in areas that are critical to social and economic
development, for example the public health sector.  At the same time, we are somewhat disappointed
that many of these same partners, having examined the possible room for interpretation or flexibility,
have merely stated that they are ready to continue the dialogue.  We had hoped that they would be
prepared, in view of the special and differential treatment provisions of the WTO Agreements and theprinciples set forth in Article 7 and 8 of the TRIPS Agreement, to adopt, or at least not to oppose,
these interpretations when the developing countries tried to operationalize their critical social policy
in respect of access to medicines in case of emergency.
Indeed, the delegation of Panama urges these delegations to take the next critical step in the
processes we have begun here today and in other WTO fora, and commit themselves to respecting the
flexibility and the interpretations that they themselv es have identified as possible and which meet the
particular concerns of the developing countries.
Finally, we have heard the different delegations say that nothing in the TRIPS Agreement
prevents the developing countries from attending to their development needs.  On the basis of past
experience, it is important that we should hear from our partners that they will not act in such a way asto shed any doubt on these statements.
SINGAPORE
This debate is very timely and we thank the African Group for bringing up this issue and
helping the TRIPS Council to focus on the issue.  We also thank our colleagues from the EC, Brazil,
Malaysia (on behalf of ASEAN) and the many othe r delegations who are helping us to try and get a
clearer picture in terms of TRIPS as far as access to medicines is concerned.
While the question of the cost of medicines is a much more critical problem as far as
developing countries and LDCs are concerned, to us, it seems that it is a problem for all countries.
Let me just mention the case of Singapore.  Medicines concern an area which causes a lot of passion,
because people are very concerned when it comes to treatment.  In fact, in Singapore, the rising costIP/C/M/31
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of treatment, health care and so on is such that the Government has found it necessary to put aside a
part of the centre provident fund of citizens, purely for the issue of health care, because it is
something which is rising all the time.  And in that context, drugs of course play a large part.
So we treat this particular exercise as one to see how countries across the world can benefit
from the terms of TRIPS to try and ensure to th eir citizens, affordable medicines and affordable
treatment.
As regards the provisions of the TRIPS Agreement, let me stress at the outset that none of our
colleagues who have intervened has said that we should abolish the patent system.  Neither has
anyone said that there should be no reasonable retu rn for the right holders.  Nobody is saying that we
should not have a system providing for incentives for the big multinationals to invest and do research
in this area.
Having such a system, we are looking at how we can have reasonable cost of medicines.  In
this connection, one needs to look at the various provisions in the TRIPS Agreement.  Articles 7 and 8
are important provisions, but they are not easy provisions to deal with.  They are to be interpreted in
the context of each specific TRIPS provisions and in the context of the facts at hand.  There can be noone interpretation cast in stone.
Singapore joins with many colleagues who have referred to parallel imports as an important
way of trying to ensure a reasonable cost of medicine for their citizens.  As to the concern that if you
allow parallel imports there could be problems of safety of medicines, I do not think that parallelimport drugs escape checks by regulatory authorities.
Article 30 is one of those provisions which, of course, like other parts of the IP regime, deal
with what we may briefly summarize as "fair use" and certainly we ought to look at it to see whether
there are any alternatives available there in terms of medicines.
The question of compulsory licensing has been referred to by many colleagues.  Certainly
there are some factors there, whether in terms of the grounds on which you can provide compulsory
licensing;  and in terms of adequate remuneration.  We should look for flexibility in this area and the
extent of the flexibility.  However, flexibility is not the ultimate solution, because even if you give acompulsory licence to another multinational of another country producing for your country, ultimately
there is bound to be a commercial division.  But it is important to see how these provisions are to
operate;  how we can operationalize them in terms of the problems that we face today relating to the
cost of medicines.
We would also like to refer to two interesting points brought up in the EC paper, in relation to
Article 39.3 and the use of test data for marketing approval.  We note with interest the two issues;one is whether test data should continue to be protected even after a patent has expired and, second,
whether such protection could interfere with compulsory licences that you could grant.
Differential pricing may offer some solutions, but it cannot provide the answer.  It cannot
prevent us from analysing the possible flexibilities under the TRIPS Agreement.
INDONESIA
First of all, we also would like to mention that Indonesia fully associates with the statement of
ASEAN as delivered by Malaysia.  We would also like to remind Members that Indonesia is also aco-sponsor of a joint paper on this subject presented by Zimbabwe.  Nonetheless, we are asking for
the floor to make some additional comments.  Indonesia appreciates the fact that the WTO Council forIP/C/M/31
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TRIPS gives notable attention with regard to access to medicines and thanks the African Group for its
initiative to hold this special session.
As a matter of fact, the accessibility of needed drugs remains unresolved concerns in many
developing countries due to the high price of patent ed drugs.  In over 30 countries public spending on
medicines is less than two dollars per capita per year.  Particularly as an impact of depreciation of thelocal currency government spending  on drugs had reduced drastically, for example in Indonesia only
less than 50 cents per head per year.  In addition to that, few people have access to health insurance,
in Indonesia only, 15 per cent of the total 200 million population are covered by health insurance.
This means that the majority of the population have to pay for drugs out-of-pocket.  Therefore, access
to medicines is particularly price sensitive.
In our view, patents enable prices of medicines to be sold at levels that are artificially high
due to the curbing of competition.  Indonesia have  evidence to show that the prices of branded
patented products are far higher than the prices of similar medicines produced by generic.  For
example, according to the survey, the price of patented Diazepan is 45 times higher that the generic
one;  Glibenclamid, needed to - treat Diabetic patient 13x; Propanolol for Hipertension pasient 15 x:
and Cotrimoxazol, antibiotic to treat serious diseases is 10x.  Out of 50 items of the most fast movingdrugs which are being surveyed, in average price of patent drug is about seven times higher than the
generic one.
In order to obtain "discounts" governments need to negotiate bilaterally with individual
companies, drug by drug.  Just recently, Indonesia negotiated price reductions with 4 companies tomake antiretrovirals available at lower prices.  Eventually, the companies agreed to provide 90 per
cent reduction, so it is priced around US$420 per person per year.  Despite the price reduction,
however, assessing the data available, it is still higher in comparison to the generic products in other
countries.  While "differential pricing" is one of the alternatives to solve the problem, however, it
should not be a substitute to the rights available in the TRIPS Agreement in particular "compulsorylicensing" and "parallel imports" as suggested in the paper mentioned earlier.
Experiences showed that drug prices decrease when there is competition from a generic one.
Lower prices enabled governments to provide free drugs to the poor population while at the same time
help relieve the majority of the people from the burden of high drug prices.  Unfortunately, the itemsof generic drugs is limited to those which are already off patent.  In Indonesia for example, active
ingredients for generic drugs is about 232 in comparison to 1,300 available on the market.
Moreover, market share of generic drugs in terms of value is still very low.  It is only about 10 per
cent (US$100 million) of the total pharmaceutical market which is about US$1 billion in the year
2000 in Indonesia (this is equivalent to drug consumption of US$5 per capita per year).  On the other
hand, the generic market covers more than 65 per cent of the population who need health care.
To prevent the negative impact of TRIPS, implementation which could worsened the existing
situation, we are of the view that prompt introduc tion of new generic drugs is vital.  Therefore, we
believe that options available under the TRIPS Agreement, in particular the exception to exclusive
right which permit early testing and approval of generics known as "Bolar" provision should be
clarified in such a way so that avoid countries interpret differently.  Besides this, to ensure that theneeded medicines can be made available at affordable prices, adequate provision for the granting of
compulsory licences is crucial.  To give you a better illustration of the manufacturing capacities of
pharmaceuticals in Indonesia, from the total 198 pharmaceutical industries, around 60 per cent of the
total pharmaceutical market is held by only 20 companies, of which 15 companies are multinationals.
Many countries now provide for compulsory licensing through national legislation, however, since theTRIPS Agreement provides for non-discrimination between locally produced and imported products,
a compulsory licence should also be provided for importation to satisfy local needs.IP/C/M/31
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Surveys on retail prices of essential drugs have reported wide price variations  between
countries.  The retail prices of several essential drugs have been found to be higher in developing
countries than in the wealthy industrialized countri es.  This findings showed that companies setting
different prices in different markets in order to  maximize profits rather than according to the
purchasing power of the community.  This makes medicines even less affordable.  For this reason,
Indonesia delegation shares the position that countries should have their rights to import equivalentpatented drugs marketed at lower prices in other countries.
We are fully aware that the TRIPS Agreement can stimulate generic competition and reduce
the prices for off-patents drugs, but the TRIPS Agreement may also significantly delay the
introduction of new generic drugs, depending on the way in which national legislation is designed and
implemented.
Based on experience, developing countries have been hindered in applying legal options to
increase access because of intense economic and political pressure placed upon them by a number of
powerful related business interest.  Countries with least capacity for interpreting and acting on
international trade agreement have most at risk in terms of access to medicines.
Recognizing the importance of patent in stimulating research and development, Members
must find a balance between assuring the right of individual to have access to medicine and protecting
IPRs.
Against this background, it is very crucial for the WTO as an international trade organization
to take a strategic  role in ensuring the accessibility of needed medicine and preventing countries from
TRIPS-plus requirements.  WTO has to ensure that national legislation should be consistent and must
not be more stringent than the TRIPS requirement.
Indonesia is of view that some clarifications and where appropriate some amendments of the
TRIPS Agreement are needed in order to promote public health and ensure access to affordable
medicines.  To enable developing countries to exercise their rights, they must be allowed the
maximum flexibility in interpreting and implementing the TRIPS Agreement's provisions.
TURKEY
First of all, I would like to express our satisfaction for the initiation of this debate at the
TRIPS Council.  Turkey is one of the many countries that had supported this initiative from the very
beginning.  Needless to say, the relationship between  the relevant provisions of the TRIPS Agreement
and access to medicines is an important issue and therefore it has to be addressed accordingly at the
WTO, as well as at other related international forums, namely WHO, UN and others.
This issue also has other humanitarian, social, political, ethic and medical aspects.  Needless
to say, here at the TRIPS Council our primary focus should be on TRIPS-related and trade-related
aspects of this issue.  At this stage, we regard TRIPS Council as the appropriate organ to carry out
these discussions.  However, as our work progresses, other organs may also be involved in this
process.  We also consider the fourth Ministerial Conference to be held in Doha in November, as agood opportunity to give us guidance.
Especially, in this period during which WTO and the multilateral trading system are bitterly
and unjustly criticized on humanitarian and social grounds, this issue cannot be excluded from our
work agenda.  It has to be discussed thoroughly and according to the conclusions of our discussions,in our view, Members should take the necessary action, in order to find a satisfactory solution to the
problems necessitating this and further meeting.IP/C/M/31
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This can also be in the form of a mandate given by the Ministerial Conference for future work
in this field.
Our discussions on trade-related aspects of access to medicines should not exclude any
relevant issue and be open ended in nature.
On the other hand, we welcome the written submissions of the European Union and the
African Group and some other Members, which provide us with a good starting-point for our
discussions.  We wish to come back to them with more substantial comments, after having carefully
studied these papers in detail.
Nevertheless, having followed the general observations, we wish to make some preliminary
comments on both papers.
In the knowledge-based global economy in which we live, intellectual creativity is the main
asset of individuals and societies to find means to increase their productivity in order to achieve better
living standards.  Increased productivity and scientific development can be achieved in a stable
environment, where individuals and societies are given sufficient opportunities to use their creativityand being aware of the fact that they will benefit from their innovations, which have a trade value.  If
the stability concerning the protection of intellectual property is carried  on to the international level,
this increased productivity and new innovations can spread further as well.  This is especially the case
for pharmaceutical industry.
However, the health of individuals and public health are such sensitive issues that they cannot
be left to merely trade-oriented concerns and one's life cannot be directly connected to the trade
concerns and commercial considerations.
Therefore, at this junction we do not intend to discuss the validity of the patent protection
provisions.  We are not discussing or revisiting the TRIPS Agreement itself either.  We are rather
interested in the possibility of some flexibility within the TRIPS system itself.  In our view, the TRIPS
system and especially Articles 7 and 8 of the Agreement give us enough space to manoeuvre in this
context.
We support the points made by the EU in their recent paper.  We believe that the
starting-point of our discussion should be the interpretation of the relevant articles of the TRIPS
Agreement.  While doing so we believe that an overall balance of the Agreement and the established
system should be preserved.
As for the paper of the African Group, we support many points raised by the sponsors in their
paper.  However, we also believe that we need more discussion on some concepts such as  the extent
of accommodation of national policy objectives in the TRIPS system, the benefits of the society,
extension of transitional arrangements, granting compulsory licence to third countries and
moratorium.  We have no preliminary objection to the discussion of any issue raised by the African
Group and other co-sponsors.
KOREA
My delegation would like to join the other delegations in appreciating the initiative by the
African Group and other countries for submitting their papers and their contributions to this meeting.
We believe it is quite appropriate for the TRIPS Council to deal with this very important and
urgent issue.IP/C/M/31
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My delegation sincerely hopes that this special session will be result-oriented on the basis of
balancing two objectives enshrined in Articles 7 and 8 of the TRIPS Agreement.  The first objective
related to providing essential medicines at affordable prices to people in need and the second, to
promoting technological i nnovations on new medicines.
First, with regard to interpretation and application of relevant provisions of the TRIPS
Agreement, it is our view that some flexibility is al ready provided in the relevant provisions to ensure
balance between socio-economic policies and patents.  For example, as I have already mentioned,
Articles 7 and 8 clearly refer to this balance.  We have other provisions at our disposal to tackle this
issue.  My delegation does not wish to go into a technical discussion on these provisions at this stage,
however, we would like to point out that provisions like Article 31 (compulsory licensing) and
Article 30 (exception to exclusive rights) are relevant to this issue.  Article 31 could be interpreted to
allow Members to alleviate conditions for compulsory licences on essential drugs.  However,safeguards measures should be in place against the possible abuse of this clause.  Regarding
Article 30, it is our view that the notion of the third parties in this article is understood to include
general public and their legitimate interest of consumers should be taking into account to purchase
medicines at affordable price.
Relationship between the TRIPS Agreement and affordable access to medicines
By stipulating that Members may adopt measures necessary to promote public interest in
sectors of vital importance to their socio-economic development, Article 8 can be interpreted to allow
for discretionary room for policy on price and reimbursement.  In this connection, we would like tonote that the possibility of introducing a differential pricing system was discussed at the international
level.  We think that it would represent a positive step forward to talk about differential pricing among
countries, rather than to restrict patent protection on the grounds of access to essential drugs.
Future work programme
Apart from intellectual property rights and pr icing, this issue comprises price-sharing of
medicines and strengthening the supply and distribution system of medical services.
Therefore, it is important to seek a solution in cooperation with the WHO while paying due
attention to the proper competence of the TRIPS Council.
COLOMBIA
In view of the numerous contributions that have  already been made to these discussions, I
shall be very brief.
My delegation considers that the process we have initiated today is of the utmost importance.
While it involves a number of technical issues, it also has a moral and ethical dimension.  We would
like to give our special thanks to the Members that  submitted documents to this meeting.  Regarding
the document submitted by the European Union, we share the view that public health issues must be
addressed on the basis of a comprehensive approach.  The most important, although not the onlyelement of this comprehensive strategy for a country like Colombia is the price of medicines, and this
is the element which falls within our competence in  this forum.  As regards the document submitted
by India, Brazil and other countries, we agree with certain elements that would be worth analysing,
such as parallel imports and compulsory licensing, on the understanding that the TRIPS Agreement
leaves considerable latitude for the development of domestic policies aimed at improving access tomedicines.  At the same time, we think that the extension of the period for non-violation complaints
will play a central role in policy-making.IP/C/M/31
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We have also heard different proposals for our future work.  Some have referred to collective
interpretation, and others to a political statement confirming a margin of manoeuvre to be applied to
each particular case.  We would be inclined to favour a balanced interpretation of the TRIPS
Agreement as a result of our discussions.
We continue to be interested in participating constructively in this effort to define the scope of
obligations under the TRIPS Agreement in the hope that we can help to come up with the solution that
the multilateral trading system must provide to an issue on which we cannot remain indifferent.
PAKISTAN
Pakistan welcomes this special session of the TRIPS Council to discuss intellectual property
and access to medicines issues.
Pakistan is one of the sponsors of the paper contained in document IP/C/W/296 introduced by
my colleague from Zimbabwe in the morning session today.  Therefore, I will avoid making a long
intervention.
In Pakistan's view, the existing model for protecting intellectual property rights is heavily
tilted in favour of right holders and is against the public interest.  Due to the monopoly exercised by
patent holders, drug prices have gone much beyond the access of those who really need them.
Every day, infectious diseases kill 30,000 in the developing world.  The HIV/AIDS pandemic
has claimed more than 17 million lives in Sub-Saharan Africa.
To say that the TRIPS Agreement strikes a carefully negotiated balance between private
rights and public policy objectives, seems, at least to this delegation, much of a rhetoric, especially
when the existing flexibilities in the relevant provision hardly do much to provide space to manoeuvredue to the fact that either the relevant provisions have been drafted in a manner which takes away the
possible flexibility or these countries lack at the moment in technical expertise and also
entrepreneurial skills to undertake production of generic drugs:
- The World Health Organization defines the meaning of "equitable availability and
affordability of essential drugs with an emphasis on disease of poverty".
- It therefore follows from the above definition that price is a crucial factor in having
access.
- Patents affect the price of a drug and therefore accessibility.
Under the TRIPS Agreement, the Members are required to provide exclusive marketing rights
to holders of patents on pharmaceutical products for a period of at least 20 years.  This imposes
restrictions on what governments can do in regard to production, marketing and import of low-cost
generic drugs.
The effect of these restrictions are two-fold:
(a) reduced competition;(b) increased prices for drugs essential in the treatment of HIV/AIDS and other common
diseases.IP/C/M/31
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This creates a situation where accessibility to life-saving drugs virtually becomes an
impossibility for a large number of the world's population.
This situation, in the creation of which the TRIPS Agreement certainly has a role, needs to be
the focus of our attention.
In Pakistan's view, all provisions of the TRIPS Agreement must be interpreted in line with the
objectives and principles set out in Articles 7 and 8 of the Agreement.  These Articles attempt to strike
a balance between private rights and public policy objectives.  The apprehensions that the existing
provisions lend priority to private rights over public policy objectives needs to be viewed seriously.
The Ambassador of India has rightly pointed out the need to explore all options currently
available under the TRIPS Agreement to see how developing countries could be allowed to havemaximum flexibility to adopt measures for protection of public health.
Pakistan therefore shares the views expressed by the Ambassador of Brazil that:(a) the TRIPS Agreement should not run counter to the public health interests;  and(b) the need to evaluate and interpret the provisions of the TRIPS Agreement in the
public health context to ensure accessibility of medicines which is a fundamental
human right.
I will avoid, as I said, making reference to various provisions in the TRIPS Agreement
because most of the Members have already explained these provisions in great detail and in a much
more comprehensive and lucid manner.
The benefits of the WHO and the UN proposals for differential pricing of pharmaceutical
products are likely to be marginal.  Particularly in relation to HIV and AIDS Drugs, almost all of each
can still claim patent protection for more than 10 years from now.
Another issue that may have to be addressed is how far the rules permit exports of generic
versions produced under compulsory licences during the validity of the patent protection period.
The issue we are discussing today brings to focus the concerns most of the developing
countries are voicing in the context of the implications of the TRIPS Agreement has for them.
It underpins the fact that there is a development deficit in the existing disciplines.Pakistan is of the view that the public health issue highlights the need for a substantive review
of the Agreements to ensure how developmental objectives can be taken into account in the TRIPS
Agreement.
GUINEA
My delegation would like to begin by congratulating the delegation of Zimbabwe, which
spoke on behalf of the African Group, and expressing its support for a statement which reflects the
concerns felt by a number of countries in which millions suffer from HIV/AIDS and other pandemic
diseases that impede social, and, in particular, economic development.
In 1999, at the ministerial round table entitled  "HIV/AIDS:  Strategies for sustaining an
adequate response to the epidemic", the WHO informed us that in urban areas of highly affected
countries in the developing world, 50 per cent to 70 per cent of hospital beds were occupied byIP/C/M/31
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HIV/AIDS patients, increasing the risk of spreading infections such as tuberculosis, malaria and other
diseases affecting public health.
These figures are highly disturbing.  This is why the developing countries need parameters
that enable them to combine trade policy with policies aimed to improve individual welfare.  The
developing countries should be able to have recourse to the public health safeguard measurescontained in the TRIPS Agreement.
It is impossible to ensure economic stability without establishing a guaranteed threshold for
certain minimum rights, beginning with access to essential medicines.
On the question of public health, my Government's objective is to introduce a health system
that is accessible to all and that is able to respond to the health needs of its poor populations.
This means creating conditions in which it is possible to reduce public health complications,
which, in turn, inevitably implies access to medicines at affordable prices.
The role of WTO Members in this debate is  unique.  This is why it is essential and
appropriate that the fourth Ministerial Conferen ce in Doha should play an active role in the
discussions on access to medicines at affordable prices.  This would add a human dimension to the
TRIPS Agreement, and would be further evidence of the commitment of the international community
to the combat against pandemic diseases affecting the poor populations of our countries.
URUGUAY
We welcome the opportunity for this Council to discuss, at this meeting, the TRIPS
Agreement and access to medicines.
The document prepared by the Secretariat is of great value and reveals the importance of this
issue at the international level, reflecting concerns  at the national level with respect to intellectual
property protection and public health, a matter of legitimate interest of our governments.
Uruguay shares these concerns, which involve weighing public health interests against the
commercial aspects of intellectual property.
In our view, the TRIPS Agreement provides for a considerable margin of flexibility, enabling
Members to conciliate the protection of intellectual property rights with public interests which, in this
particular case, means access to medicines.  Indeed, the Agreement enables a number of relevant
instruments to be considered in domestic legislation, such as the exhaustion of rights, compulsory
licensing and interpretation of the provisions of the Agreement in the light of its guiding principlesand objectives set forth in Articles 7 and 8.
The African Group, Brazil and a group of other countries have made an important
contribution to the consideration of this topic, which will be studied in-depth in our capital, since this
is the beginning of a discussion process leading up to the next Ministerial Meeting.
Finally, these discussions should enable the Council to reach a common understanding that
will clarify the balance between intellectual property rights and such highly sensitive areas as the life
and health of our populations, basic human rights which we should all be able to enjoy.IP/C/M/31
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AUSTRALIA
Australia welcomes all the contributions that are made to this very important debate today and
I think it's a debate that will be significant for the re st of the time that we have, for the rest of this
year.  Australia's understanding of the TRIPS Agreement is that it provides sufficient scope and
flexibility to address health emergency situations.  The TRIPS provides a balance of benefits for thepublic and right holders, which enables us to deal with the very serious health situation we have been
discussing today and we look forward to discussing  these issues in more depth at future meetings.
It may be appropriate for this Council to encourage, for example, WIPO, to ensure that as the
expert body providing technical assistance to inform countries in the drawing up of their
TRIPS-consistent legislation, that significant care is taken to enable Members to enact all the
provisions of the TRIPS Agreement.
Given the very detailed and substantive discussion that has taken place, it will assist our
future discussions if the Secretariat could find a way to ensure that Members are provided with either
copies of the statements or early delivery of their records.  I think that if we can take this message
back to capital, it would really help future discussions.
UGANDA
Permit me to start by fully associating myself with the statement made by Zimbabwe on
behalf of the African Group.  The Ugandan delegation also endorses the statement made by Tanzaniaon behalf of the LDCs.
The Ugandan delegation fully recognizes the need and the importance of having this special
session to discuss the TRIPS Agreement and access to drugs and public health.  At a time when
millions of people in poor countries are unable to afford essential medicines and when public health isbeing threatened by a combination of new diseases and drug-resistant variants of killers, it is only
reasonable and understandable to examine the TRIPS Agreement to see how it can be interpreted if at
all in a manner which would not have adverse effects nor further reduce access to new medicines by
effectively extending the monopolies of drug companies and restricting generic competition.
Many delegations have spoken in detail on the various aspects of the importance of access to
drugs and public health.  My delegation will not repeat some of the technical and legal arguments
advance to which we subscribe.  However, my delegation will try to highlight only a few areas and
make a detailed written submission to the Secretariat.
Uganda is no stranger to the horrors and tragedies inflicted by the HIV/AIDS pandemic nor
the effects of Malaria.  The HIV/AIDS pandemic is a human tragedy of horrific dimensions.  I cannotbut agree with the statement made by the Ambassador of India earlier that the cry for affordable
access to medicines for what are life-threatening diseases for people in developing countries is a cry
of a fundamental human right of nature.  Statistics show that more than a quarter of the adult
population in some countries in Africa are infected with HIV.  Those victims, I believe, deserve being
given hope.  Hope that they to can have access to those very vital drugs at affordable prices.  Mydelegation agrees with previous speakers that the TRIPS Agreement should be part of the solution and
not the problem.  We believe that this can be done through affirming and confirming that the
Agreement has clear and sufficient flexibility which allows governments to adopt appropriate
measures to protect the health and lives of their people.  Governments need the assurance that they
can adopt such measures without fear of litigation through the WTO or other bilateral pressures.
Regarding the intellectual property aspect, my delegation is convinced that IPRs are intended
as a means to benefit society as a whole rather than as an end in itself.  The mere existence andIP/C/M/31
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protection IPRs such as patents does not necessarily result in the fulfilment of the objective of the
TRIPS Agreement.  A case is the example of the recent controversy around the excessive price of
patented HIV/AIDS medicines in South Africa.  This case graphically illustrated the negative impact
of the TRIPS Agreement on access to medicines.
As has been stated by other delegates before me, Article 8 explicitly recognizes that Members
may adopt measures to protect public health among other overreaching public policy objectives such
as nutrition and socio-economic and technological developments.  We agree with this approach.  My
delegation concurs with the African Group that each provision of the TRIPS Agreement should be
interpreted in the light of objectives and principles set forth in Articles 7 and 8 as has been stated by
other delegations previously.
My delegation believes that parallel importation is an important tool to ensure adequate
access to medicines.  Parallel importation of a patented medicine from a country where it is sold at a
lower price will save the lives of thousands in an importing country like Uganda by giving them
access to that very much-needed medicine.
Regarding differential pricing, my delegation favours this arrangement, provided it is done in
a fair manner and within a comprehensive and multilateral framework.  My delegation believes that
this should be part of a bigger set of initiatives to improve access to medicines.
On the way forward, my delegation fully endorses the call of observing, with immediate
effect, a moratorium on dispute settlement action against developing country Members hinder their
ability to promote access to medicines and protect public health.
And finally, I would like to say that my delegation agrees with the many speakers that this
dialogue, and this Council that we have been backed on today is just the beginning and the subject
should not end here.  This dialogue, we believe, should serve as a basis for a further debate on thematter in the coming months, indoor and beyond.
PHILIPPINES
Being one of the co-sponsors of document IP/C/W/196, we welcome this discussion and
similar future discussions, particularly in light of the objective of rendering more clarity to the
provisions of the TRIPS Agreement as those provisions impact on the ability of Members to formulate
and implement measures to promote public health.
Absence of clarity or insufficient clarity causes uncertainty.  In other fora in the WTO, the
phrase "chilling effect" has been applied to trade, refe rring to an adverse effect of uncertainty.  In this
instance, uncertainty could have worse consequences, as it could have a "chilling effect" on theformulation and implementation of measures to  promote public health, a paramount concern.
In associating ourselves with the objective of rendering clarity, we are not necessarily taking
the position that the TRIPS Agreement is so unclear and so ambiguous as to cast doubt on the ability
of Members to formulate and implement measures to promote public health.  We believe that the
TRIPS Agreement does authorize these measures.
Uncertainty is not necessarily a function of the perceived clarity – or lack of clarity – of the
relevant provisions.  Indeed, uncertainty could also arise from extrinsic factors such as the widely
disparate negotiating positions of Members, each seeking to assert their respective rights as theyperceive it.IP/C/M/31
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We may all be legally equal as Members, but there are intrinsic advantages to being
economically dominant, and the temptation to act on the basis of an economically dominant position
is always there.  And if such temptation is yielded to, the most clear of rights could be – to borrow a
phrase used by New Zealand in a slightly different context earlier– rendered obscured.  In short,
rendered uncertain.
We should endeavour to minimize unclarity, uncertainty.
Rendering more clarity to the relevant provisions of the TRIPS Agreement is a significant
step in this regard.
That process means listening, in order that one may truly understand the position of other
Members.  At the same time, it also means that we must render ourselves capable of being understoodby other Members.
Having listened to others the whole day, we now focus on the need to render ourselves
capable of being understood by other Members.  It is in this context that we present to you in an
abbreviated form our understanding of certain relevant provisions of the TRIPS Agreement.
Article 30 of the TRIPS Agreement provides that Members may provide limited exceptions to
the exclusive rights conferred by a patent, provided, among others, that such exceptions do not
unreasonably conflict with a normal exploitation of the patent.  We take this to mean that Members
may provide exceptions which reasonably conflict with  a normal exploitation of the patent.  It also
state that such exceptions must not unreasonably prejudice the legitimate interests of the patent owner.
In respect of Article 31, we are gratified to note, based on the interventions we have heard,
that no one expresses serious doubt on the ability of Members to provide, to authorize, to grant a
compulsory licence, subject only to the essentially procedural requirements specified in that Article.
It is the prerogative of each Member to decide for itself whether or not it would have the
ability to resort to parallel imports.  This is based on footnote no. 6 to Article 28, in relation to
Article 6 of the TRIPS Agreement.  In this regard, there is no need for the Member concerned to
require the issuance of a compulsory licence to import as a condition to such importation.  This isbecause the rights of the patent holder over the products which are to be imported have already been
exhausted.  And "exhausted" means just that.
We look forward to further discussions on this ma tter, with the end in view of minimizing the
"chilling effect" on the formulation and implementation of measures to promote public health.
HOLY SEE
The Holy See, as an observer state, has prepared a short note which, I hope, with the
permission of the Council can be made available to all.
I will limit myself here to briefly explain the reasons why the Holy See addresses the
question.
The first reason is the gravity of the HIV/AIDS pandemic as well as the re-emergence of
other infectious diseases, with the consequent disastrous effects on the lives of people of developing
countries, especially in Africa.
We cannot overlook the fact that a heavy burden of disease has serious negative effects on
economic development.  An improvement in health enhances those human resources which are theIP/C/M/31
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driving force of development and economic growth.  WTO cannot ignore the link between health and
economic development.
The second reason why the Holy See addresses the question, is it challenges the very
credibility of this body today.  Public opinion is  watching how this Council will address the question
of access to essential medicines.
The credibility of the WTO is linked with its ability to use flexibility in interpreting TRIPS
rules, other way in which it will not show that ability but public opinion will judge how we behave.
The manner it can interpret its rules in such a way as to achieve the pro-development stance of the
whole legal body.
Availability of medicines is not the only aspect of access to health.  It is, however, an
essential aspect.  Accessible price always remains a determinant factor.
The tension between the duty of solidarity with  victims of disease and the need to protect
intellectual property.
A broad-based commitment of solidarity is the best way to prevent poor countries from
falling into any temptation of weakening the intellectual property rights framework.
The solution to the problem of access to basic medicines is far beyond the mandate and the
means of the Council for TRIPS.  However, the Council for TRIPS could make a fundamentalcontribution, by means of an authoritative interpretation of the TRIPS rules:
• consistent with a unified vision of law;
• based on respect for human rights;
• and especially applying those articles of the WTO treaty that call for a pro-development
interpretation of the whole legal body.
Such a legal interpretation might affirm:
• that any TRIPS clause should not be understood in a way that becomes a practical
obstacle to rapid, efficient and universal access to basic medicines, for those who are the
victims of the actual dramatic health emergency;  and
• that nothing in the TRIPS Agreement should prevent countries, including small countries
with limited domestic manufacturing ability, from implementing sound health policies.
This would contribute to a broad rather than a restrictive interpretation of Articles 30 and 31,
which allow that licensing fees may be fixed in accordance with the real purchasing capacity of thepoorest country, balanced with a system that blocks the re-exports of the licensed products to the
original markets.
We have talked a lot about private property but private property has a fundamental social
function, indeed we can say that a "social mortgage" on all private property, which requires to be
directed to the benefit of the common good.IP/C/M/31
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Today, that "social mortgage" must be applied today to "intellectual property" and to
"knowledge".5  The law of profit alone cannot be applied to that which is essential for the fight against
hunger, disease and poverty.
WIPO
The World Intellectual Property Organization (WIPO) welcomes the opportunity offered by
this special TRIPS Council to clarifying discuss th e relationship between public health issues, the
patent system and the TRIPS Agreement.
The delegation of WIPO notes a general support today on an essential role of the patent
system in stimulating the development of essential drugs, including anti-AIDS drugs.  Without the
patent system, existing anti-AIDS drugs would not have been produced.  Without the patent system,new and better drugs needed to overcome the increasing resistance of the AIDS virus would not be
developed.  Without the patent system, key technica l information on new drugs would be kept secret,
and drug manufacturers would have to reinvent the wheel.  Given the severity of the crisis, no one can
afford to spare such resources and time.
WIPO considers it important to strike a proper balance between public health concerns and
the interest of the patent owner.  This balance exists within the patent system.  The delegation of
WIPO notes that, in the meeting today, a number of delegations agreed that the TRIPS Agreement
provides the necessary flexibility to achieve that balance and to accommodate the needs of the
countries deeply affected by HIV/AIDS.
WIPO has no mandate to interpret the TRIPS provisions.  However, within its mandate,
WIPO will continue to provide legal-technical assistance to countries on the implementation of the
TRIPS Agreement.  In fact, within the framework of the WIPO-WTO cooperation agreement
concluded in 1995 and technical assistance programmes for developing countries launched in 1998,more than 100 developing countries have received a wide range of assistance regarding the TRIPS
implementation.  As the Ambassador of Tanzania on behalf of the LDCs stated in the morning
session, on 14 June last week, WIPO and WTO launched another initiative and signed a joint
communication to assist LDCs in implementing TRI PS Agreement and in using intellectual property
as a tool for technological advancement, economic  growth, knowledge and wealth creation.  WIPO is
convinced that LDCs should be able to stimulate local research activities and make joint efforts,
through effective use of the patent system, to develop and produce anti-AIDS drugs.
WIPO is ready to share with you its expertise and experience gained through WIPO's
assistance programmes and to contribute to this important exercise and the discussions on the issues
before us.
Council action on further work
5. Following these statements and on the basis of subsequent consultations, the Chairperson
proposed that the Council proceed with its work on this matter as follows:
- that the Secretariat prepare a checklist of all Articles of the Agreement that Members
made reference to in their interventions and all matters that delegations raised in
relation thereto, in which the Articles be listed in the order in which they appear in
the Agreement.
                                                     
5 JOHN PAUL II, Message to the "Jubilee 2000 Debt Campaign" Group, 23 September 1999.IP/C/M/31
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- that this checklist be circulated to Members as soon as it is compiled and be the basis
of an informal meeting to be held on 25 July.
- that Members extend the formal meeting of the Council in September 2001, presently
scheduled for two days, to three days and set aside a full day at that formal meeting to
deal with the issue of the TRIPS Agreement and access to medicines.
6. The Council so agreed.
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