Opinion of the European Economic and Social Committee on the Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions — A Stronger European-based Pharmaceutical Industry for the Benefit of the Patient — A Call for Action (COM(2003) 383 final)
Date: 2004-06-02
Institutions: European Economic and Social Committee
Subjects: EU industrial policy, competitiveness, drug surveillance, health policy, pharmaceutical industry, research and development

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9. Conclusion

The Committee calls on the Commission, once corrections
have been made, to complete work on the regulation as rapidly
as possible so that it can enter into force. The Commission
should:

— clarify the relationship between the Article 5 of the regu-
lation and Article 4(1) of the directive on unfair competi-
tion and adapt the explanatory memorandum accordingly;

— reconsider whether giving the injured party the choice of
applicable law in cases involving violation of the environ-
ment (Article 7) is really appropriate;

— clarify the relationship between Article 9(3) and (4), on the
one hand, and Article 9(1) and (2), on the other, in the text
of the regulation;

— consider whether,

it would not be more
appropriate to declare applicable the system of law of the
place where the transaction takes place;

in Article 9(4),

Brussels, 2 June 2004.

— consider whether Article 9(5) should be made a general

principle of the regulation and inserted in Section 3;

— amend the title of Section 3 to read ‘Common Provisions’;

— make it clear in Article 13 that the rules of safety and
conduct applied shall be those in force at the place where
the event occurred;

— reword Article 24 to read as follows:

‘The application of a provision of the law designated by this
Regulation shall give rise to no claim for damages only
where such damages would clearly serve purposes other
than the appropriate compensation of the injured party.’

The President

of the European Economic and Social Committee

Roger BRIESCH

Opinion of the European Economic and Social Committee on the ‘Communication from the
Commission to the Council, the European Parliament, the Economic and Social Committee and the
Committee of the Regions — A Stronger European-based Pharmaceutical Industry for the Benefit
of the Patient — A Call for Action’

(COM(2003) 383 final)

(2004/C 241/02)

On 16 October 2003, the European Commission decided to consult the European Economic and Social
Committee, under Article 262 of the Treaty establishing the European Community, on the ‘Communication
from the Commission to the Council, the European Parliament, the Economic and Social Committee and
the Committee of the Regions — A Stronger European-based Pharmaceutical Industry for the Benefit of
the Patient — A Call for Action’.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on this subject, adopted its opinion on 4 May 2004. The rapporteur was Mrs O'Neill.

At its 409th plenary session of 2 and 3 June 2004 (meeting of 2 June), the European Economic and Social
Committee adopted the following opinion by 164 votes to 1 with 10 abstentions.

1. Background

1.1
It has long been recognised that the European-based
pharmaceutical industry plays a critical role in both the indus-
trial and health sectors. Within European institutions there has
been considerable emphasis on developing the various compo-
nents which make up the industry and the consequent advan-
tages to patients.

1.2
To this effect the Lisbon Council in 2000 set the EU a
strategic goal of ‘building the most competitive and dynamic

knowledge-based economy in the world, capable of sustainable
economic growth with more and better jobs and greater social
cohesion’, in which the pharmaceutical industry would play a
vital role.

1.3
The Council of Ministers, in its conclusions on Medical
Products and Public Health in June 2000, underlined the
innovative medicines, with significant added
importance of
therapeutic value,
to the attainment of both industrial and
public health sector goals.

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1.4
A report ‘Global Competitiveness in Pharmaceuticals: a
European perspective (1)’ (usually referred to as the Pammolli
Report) was presented to the Commission in November 2000.
The Report identified a number of issues that needed to be
addressed and concluded ‘Europe was lagging behind the USA
in its ability to generate, organise and sustain innovative
processes that are increasingly expensive and organisationally
complex’.

1.5
The background to the Communication from the
Commission is to consider the issues identified both in the
Pammolli Report and subsequent reports because the pharma-
ceutical industry is recognised as playing an important health,
social and economic role in the European Union.

2. Purpose of the communication

The purpose of the communication is to ‘set out how
2.1
the Commission sees the G10 recommendations being taken
forward in the current context’. In areas of national competence
the Commission sets out a proposed direction it believes
Member States could take and what the Commission can do to
facilitate the process and in particular to have the important
function of monitoring change and effectiveness.

In this context the Commission sets out in its communi-
2.2
cation five broad themes which encompass the issues within
Europe:

1.6
Important progress has been made with the establish-
ment of the Community marketing authorisation procedures
and the creation of the European Medicines Evaluation Agency
(EMEA) in 1995.

— benefits to patients;

— developing a competitive European based industry;

1.7
In March 2000 a health policy advisory group to the
Commission stated that the public health goal of the pharma-
ceutical sector is ‘to make readily accessible, efficacious, high
quality safe medicines, including the more recent and innova-
tive ones, to all those who need them, regardless of their
income or social status’ (2).

— strengthening the EU science base;

— medicines in an enlarged European Union;

— Member States learning from each other.

1.8
The Commission remains committed to completing the
single market in pharmaceuticals by encouraging research and
development (3) through making the EU more attractive for
investment and establishing systems which provide more
patient choice through the affordability and availability of
medicines.

1.9
In addition the Commission set up a new High Level
Group on Innovation and the Provision of Medicines (G10
Medicines) (4) which was intended to take a fresh look at the
problems
in relation to
national and community competencies which govern it and to
come up with creative solutions.

facing the pharmaceutical

sector

The G10 Group published its report ‘High Level Group
1.10
on innovation and provision of medicines’ in May 2002 and
the consensus approach it adopted in the 14 recommendations
made by the Group forms the basis of the Commission's ‘Call
for Action’ on which the EESC is invited to provide an opinion
(Appendix).

The position has been further

1.11
reinforced by the
Council Resolution on ‘Pharmaceuticals and Public Health Chal-
lenges — Focusing on Patients’ (5).

(1) Enterprise papers No 1/2001.
(2) Created by the High Level Committee on Health.
(3) Internal Market Council Conclusions 18.5.1998.
(4) European Commission High Level Group on Innovation and Provi-

sion of Medicines a Call for action. G10 Medicines 7.5.2002.

(5) Council Resolution of 2.12.2003.

3. The text — general comments

The pharmaceutical industry is one which has complex
3.1
inter-relationships with health care systems, research, patients,
and competitor companies. It is a large employer within the
European Union. The industry is required to be innovative and
to function well with different systems in the USA and Japan.
The emphasis of this Communication is to engender an inte-
grated approach in order to build advantage for the industry
and patients as well as to stimulate its continued development
as a major contributor to a dynamic knowledge-based, compe-
titive economy in Europe. The EESC acknowledges that this is a
major task.

The competitiveness of

3.2
the industry is a matter of
considerable concern and comparisons are frequently made
with the success of the industry in the USA. It is important to
emphasise that this is not because of any intrinsic weakness on
the part of the pharmaceutical industry, but is the consequence
the markets, which remain highly
of
the fragmentation of
level. This results in a fragmented
differentiated at national
approach to research, innovation and the classification of medi-
cines into prescription and non-prescription categories. This
arises because of dependence on the decision-making process
of 25 national governments and the resulting differences in
their social security and health policies. This affects investment
in research and development, the availability of products and
ultimately the benefit to patients in a consistent way across the
Member States.

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3.3
It is vitally important that the role of the industry is
considered in relation to the established health care systems in
the Member States, how and to what extent they are financed
and how to ensure that patients in each of the Member States
have access to every medicine authorised in the EU. Whilst this
is a key objective for the Commission the EESC recognises the
divergence that exists in ensuring the availability of medicines
and the ability within the Member States to fund this aspiration
and the EESC is particularly concerned about the potential
impact on the accession States.

3.4
The EESC recognises the growing importance of invol-
ving patients in decision making and in developing partner-
ships between public, private and patient groups for mutual
the EESC welcomes the inclusive approach
benefit. Whilst
proposed by the Commission it was disappointed that the G10
group on medicines did not have a wider representative base.

sectors, allied companies, universities and the health sector.
There is, however, concern that without a more coherent
approach to research and innovation in Europe, accompanied
by adequate investment, that skilled employees will be lost to
the sector in Europe.

3.9 Whilst the EESC is aware of the difficulties in achieving
the single market within existing and future Member States it
wishes to see clear strategies in place to achieve this goal in the
pharmaceutical industry because of the divergence between EU
level and national competencies on the marketing of medicinal
products and particularly because of the differing health care
and funding systems in each Member State. The EESC would
again emphasise the great importance it attaches to the fact
that protection of human health should take precedence over
all other areas of regulation as stated in previous opinions and
because of the public health goal of the pharmaceutical sector
to make high quality safe medicines, including innovative ones
available to all who need them regardless of their income or
social status (2).

competitiveness of

The EESC acknowledges that evidence shows the decline
3.5
in the
the European pharmaceutical
industry. However, whilst weaknesses in the European model
for the industry have been identified, it is important to focus
on the available skills, established structures and achievements
within Europe rather than assuming that
is
necessarily the best or only way forward taking into account all
is to
the interests at stake. The key aim in the EU model
achieve efficiency of the health-care systems that meets the
needs of patients, whether medical, economic or social, whilst
promoting the economic activities of
the pharmaceutical
industry.

the US model

3.6
The basis of the Communication from the Commission
is very wide and the EESC would draw attention to its
previously expressed concerns
required to
achieve progress in these areas have been slow to date and is
concerned as to how the Commission will be able to achieve
more rapid progress in the light of this communication (1).

the steps

that

The Commission emphasises the importance of moni-
3.7
toring and evaluating the achievements against defined perfor-
mance indicators. The EESC echoes these concerns about the
lack of consistent statistical information and evidence on which
to judge progress and proposed development. Better processes
are required with which to define what information should be
collected and the EESC would wish to see a much more proac-
tive and transparent system being established.

It

is acknowledged that

sector
3.8
provides high quality employment
that goes beyond the
immediate industry employees as it involves other research

the pharmaceutical

4. Proposed action from the Commission

4.1 Benefits to patients

4.1.1
The responsibility for health care is becoming increas-
ingly shared with patients taking a more active interest in their
own health and care options. The importance of involving
patients has been recognised by the Commission and the EESC
welcomes the emphasis on creating and supporting ways of
ensuring patient involvement at all levels.

4.1.2
The recently formed European Patients Forum will
provide a useful mechanism through which to channel patient
views which can enhance the EU Health Forum established in
2001 to bring together a range of European health stakeholders
which should include social organisations with health related
interests. These initiatives recognise the respective roles of State
and non-governmental organisations in public health which
need to be supported.

4.1.3
In this context it is important that individual patients
or patient groups involved in such decision-making processes
should be well briefed on the processes involved and the extent
to which influence needs to be exerted.
It is essential that
mutual trust be established between those who have profes-
sional and technical expertise and those whose role it is to
ensure that the public receives accurate and comprehensible
information on medicines.

(1) Opinion of the EESC on the proposal of a Regulation, OJ C 61/1 of

(2) Opinion of the EESC on the proposal for a Decision OJ C 116/18

14.3.2003.

of 20.4.2001.

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The EESC views it as critically important that

the
4.1.4
quality and availability of
information to patients and the
public are strengthened particularly in relation to their objec-
tivity and availability. This was acknowledged by the Council of
Ministers in the conclusion on Medicinal Products and Public
Health in June 2000. To this end the EESC would strongly
support the proposal for the development of a ‘kite mark’ to
establish ‘quality criteria for health-related websites’ and that
this should also apply to the other forms of information provi-
sion. It is essential that information should be used to inform
individuals and where appropriate encourage them to seek
advice from health care professionals, as the avoidance of an
over or inappropriate consumption of medicines must be a
priority.

The proposal to establish a collaborative public private
4.1.5
partnership involving a range of contributors to inform, advise
and monitor information provision is welcomed and the EESC
would encourage the bringing together of pharmaceutical
companies, representatives of patients, academic, social, mutual
and disabled persons' organisations, scientific and health profes-
sionals which can contribute to improved patient information
and health education. Such partnerships could provide essential
information to governments, the EU Parliament, Commission
and Council of Ministers on a range of issues pertaining to the
industry and the health care of individuals.

‘added therapeutic value (ATV) being a composite of clinical
effectiveness compared to other treatments and the cost effec-
tiveness per se’. However, it is recognised that there might be
some difficulties in Member States adopting this approach so it
is important that sufficient time is allowed to encompass this
effectively.

4.2.2
The EESC recognises the importance of ensuring the
increasing availability of -effective (not least in terms of cost),
new and safe medicines for the greatest number of people. The
application of
the relative effectiveness criteria in Member
States will have a direct impact on prices and reimbursement
that are the responsibilities of each Member State. The EESC
wishes to draw attention to the impact on social care budgets
the
which differ between Member States which prevent
prescription of
the most efficacious medicine because of
budgetary constraints.

4.2.3
It would be advisable to promote the exchange of
experience in evaluating cost-effectiveness, in order to improve
the evaluation techniques used in the various Member States.

The use of

information dissemination to enhance
4.1.6
public health in the Member States will be one of the important
elements to enable greater harmony and promote valid collec-
tion and analyses to be carried out more effectively.

4.3 Pharmacovigilance

4.1.7
the
The EESC strongly endorses the proposal
prohibition on advertising prescription medicines to the public
should remain. The issue of advertising non-prescription medi-
cines needs to be handled with great care to ensure the appro-
priate use of medicines.

that

4.1.8
The EESC would endorse the view that responsible
self-medication is best achieved when the potential user bene-
fits from advice from a knowledgeable health professional.
Inappropriate self-medication can lead to delays in starting
treatment
interactions with
cases
prescribed medicines.

and in some

adverse

4.2 Relative effectiveness

4.2.1
The EESC strongly supports the definition of ‘relative
effectiveness’ as adopted by the Commission in relation to
health-care technologies such as medicines. This comprises the

involved

4.3.1
The EESC is in agreement that a strong pharmacovigi-
lence system is vital and believes that existing systems must be
strengthened. All health professionals
in the
prescribing or dispensing processes, as well as patients, should
participate in an effective post marketing surveillance system
applied to all medicines. This spontaneous reporting system
should be particularly stringent for newly marketed medicines.
Additionally, should the move to more rapid licensing take
place it would be necessary to complement this with careful
pharmacovigilance using observational studies to seek evidence
of the expected safety of the medicines in question, or any
unexpected toxicity as rapidly as possible.

4.3.2 Whilst randomised controlled clinical
trials are the
accepted way to demonstrate efficacy of medicines, they are
usually of insufficient size or are conducted on patients who
are unrepresentative of all potential users of the drug. These
trials are therefore unable to provide evidence of potential
risks, especially in vulnerable categories of patients. Thus the
observational studies add a different type of information to the
controlled trials, and indeed complement them. Observational
studies can only rarely give information about desired effects,
although they can sometimes give details of when an antici-
pated (good) effect did not occur.

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4.4 Developing a competitive European-based industry

patients receiving healthcare in Europe are not in a less favour-
able position than those who are receiving treatment in the US.

4.4.1
The EESC recognises the position of the pharmaceu-
tical industry in its contribution to the European trade balance
in high technology and in meeting social and public health
goals. It is a key source of highly skilled jobs. It is therefore
critically important that the legislative and regulatory frame-
works operate smoothly to encourage and support the industry
and that EU Member States act at national level to ensure that
new medicines with added therapeutic value are available to
their patients as quickly as possible. It is important to promote
and support research to enhance the development of new treat-
ments.

4.4.4
Support for the development of innovative medicines
through the 6th Framework Programme for Research (FP6)
with its thematic priority of research into ‘Life sciences, geno-
mics and biotechnology for health’ is welcomed as a first step.

4.4.5
There would be additional benefits in moves towards
reducing the time between the initial patenting of a potential
medicine and submission of a request for marketing authorisa-
tion by avoiding unnecessary procedures.

4.4.2 Whilst the EESC endorses the key actions proposed by
the Commission it is of the view that:

— it is essential to reduce the length of time that a new
chemical entity spends in the development phase before
licensing. The ability to pick up on adverse events after clin-
ical use begins also needs to be faster;

— the more stringent data-protection regulations are making it
very difficult to conduct the necessary observational studies
to determine the safety of medicines in everyday use.
Observational studies are the only practical way to identify
infrequent adverse (safety) issues. They depend upon linking
disparate pre-existing data sets (e.g. prescribing data, demo-
graphic data and outcome data such as hospitalisation and
or death-certificate data). Personal identifiers are usually the
only method to link these data sets. Recent
legislation
forces patient approvals to be sought
for such use of
personal information even where anonymisation takes place
after the linkage occurs. If a significant number of indivi-
duals withhold such approval or just ignore the request, the
resulting data set then contains unknown biases, which can
render it much less valuable, as it is no longer representa-
tive of the parent population (1);

— the EESC would draw attention to its previously stated view
on this issue ‘that there should be a systematic approach,
which can be fully implemented without individual data,
using only aggregated anonymous information’ (2).

The EESC would support the Pharmaceutical Review
4.4.3
to improve the functioning of
the Centralised and Mutual
Recognition procedures in order to speed up the evaluation
process and to shorten the time for the final decision to be
taken. The fact
the Commission and the EMEA have
already reduced the length of their own internal procedures is
to be welcomed but further improvement is needed to bring
new therapies to European patients in a timely manner, so that

that

(1) Ibid.
(2) Ibid.

4.4.6 Whilst the proposal to harmonise data protection at
ten years is supported by the EESC, where additional informa-
tion is provided for special sub-groups such as children, it is
felt that the possibility of extending data exclusivity for one
additional year could be subject to further debate.

4.5 Timing of reimbursement and pricing negotiations

The EESC is in agreement that the focus should be on
4.5.1
‘securing the most effective treatment for the patient within an
effective health-care system’ particularly in the light of the costs
of care rising. It should be noted that pharmaceuticals account
for 15 % of health budgets on average (3). EU Member States
also have an obligation to ensure that decisions on pricing and
reimbursement are taken transparently in a non-discriminatory
way within a precise framework (4).

4.5.2
It must be noted that Member States have clear
competence to take national measures in order to control
health-care expenditures. This leads to widely divergent prices
between States that will be exacerbated with enlargement.
However, the EESC would want to emphasise that whatever
pricing system is established it should not create a barrier to
ensuring that innovative good medicines go onto the market.
The Committee calls on the Commission to take action to
the ‘Transparency’ Directive
ensure the full application of
(Directive 89/105/EEC).

Such disparities in administratively fixed prices could
4.5.3
be detrimental to a smooth running internal market. The EESC
therefore welcomes the proposal from the Commission that a
‘reflection’ should be launched to consider alternative ways to
control national pharmaceutical-related expenditure by Member
that more dynamic and
States. The EESC is in agreement
competitive market mechanisms could facilitate the objective of
creating a more integrated market. The ‘Reflection’ should
include a review of private and public financing of medicines,
and public health.

(3) Benchmarking Pharmaceutical Expenditure published in 2001 by

the Austrian Health Institute.

(4) Council Directive 89/105/EEC, OJ L 40 of 11.2.1989.

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4.5.4 F u ll

comp e ti ti on

for me di c i ne s
pur c h a se d nor r e i mbur se d by th e Stat e

ne i th e r

4.7.3
In addition the EESC would support the proposal from
the Commission that the same trademark should be used for
both prescription and non-prescription medicines
in the
Member States that are confident that this presents no risk to
public health.

4.5.4.1
The EESC feels that when a new medicine has
received marketing authorisation (confirming its effectiveness,
it should be made available to patients
safety and quality),
without unnecessary delay when the state of
their health
requires it. The EESC supports the possibility of making new
medicines available immediately after
they have received
marketing authorisation.

Funding and monitoring of health expenditure in
4.5.4.2
Member States might constitute a barrier
to simultaneous
access by patients to new medicines across the European
Union. The EESC can support the replacement of direct price
controls by monitoring of health expenditure and would
encourage the Commission to stimulate debate on possible
methods for achieving this.
it should be
possible to consider abandoning price controls on manufac-
turers for medicines that are neither publicly purchased nor
reimbursed under mandatory healthcare insurance.

In this context,

4.6 Competitive generic market

4.6.1
The EESC would agree with the important role of
generic medicines in containing health care costs, therefore
assisting in improving the sustainability of financing health
care, but it is important to balance the use of these medicines
with the development of innovative products so that that the
industry remains dynamic and patients have more choice.

4.6.2
The EESC supports the establishment of a clearer
Community definition of generics, and in particular the need to
consider the intellectual property rights in the light of enlarge-
ment.

4.7 Competitive non-prescription market

4.7.1 Whilst it is acknowledged that non-prescription medi-
cines which can be obtained through pharmacies or through
general retail outlets have the advantage of developing competi-
tiveness in the market and the public gets greater access to
those medicines without the need for a medical consultation.
The EESC believes that it is important to ensure that these
medicines are used under conditions of absolute safety.

4.7.2
There are inconsistencies in the products that are clas-
sified as non-prescription amongst the Member States and the
EESC would endorse the proposals that greater consistency of
classification decisions should be developed in line with the
principles of the single market.

However, the EESC reiterates the concern expressed
4.7.4
about the availability of non-prescription oral antibiotics, anti-
virals or anti-fungals which should be restricted to prescription
only status. If such medicines are used for trivial indications, or
inappropriately, there is a risk of creating wider problems of
resistance that would impact in any subsequent illness particu-
larly a more critical
infection. It is therefore important that
these medicines should be seen in the context of the wider
public health agenda and their use controlled by prescription. It
is critically important that there is accurate and easy to under-
stand information provided to patients in this respect and that
the use of such prescribed drugs are monitored and included in
future research.

4.8 Strengthening of the EU science base

4.8.1
The EESC acknowledges the importance of developing
and sustaining a dynamic research and development base in the
pharmaceutical industry that draws on the expertise contained
both in the industry and allied scientific institutions.

4.8.2
The EESC supports the objective of creating virtual
institutes of health to stimulate and organise health and
biotechnology research in Europe to bring together those with
common research interests. The EESC believes
there
should be a coherent structure to bring together the knowledge
and expertise with appropriate methods of dissemination if it is
to retain the scientific skills of professionals and to be a serious
rival
in terms of R & D and innovation to the US. The 6th
Framework programme for Research (FP6) is a welcome first
step.

that

4.8.3
The EESC in a previous opinion supported the intro-
duction of a European Centre for Disease Prevention and
Control (1) in order to create a stronger science base for public
health in Europe.

4.8.4
In supporting the development of research and inno-
vation the EESC would wish to emphasise that new sources of
investment must be identified. To this end the EESC welcomes
the proposal to examine a number of ideas in relation to the
financing of research which include venture capital, low cost
loans, tax credits, guaranteed markets and the extension of
patent rights and or market exclusivity. It is important that the
synergy between universities, research faculties and industry is
better recognised and utilised.

(1) Opinion of the EESC ‘A European Centre for Disease Prevention and

Control’ — rapporteur Mr Bedossa — OJ C 32 of 5.2.2004.

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4.9 Incentives for research

4.9.1
The EESC welcomes the Directive relating to Clinical
Trials (1) that stresses that the protection of patients is of para-
mount importance in the design of a trial. The Directive also
stresses the need to simplify and harmonise the governing
administrative procedures to allow for better coordination of
trials within the Union. The provision to set up a European
clinical trials database for the first time is also welcomed.

4.9.2
The EESC would wish to emphasise that the source of
real innovation also comes from small individual companies or
individuals who have a ‘bright idea’. There is a risk that the
complex administrative procedures within the EU and Member
States or the need within larger companies to operate a selec-
tion in research projects that can be progressed simultaneously
might prevent the emergence of innovative ideas from these
sources. Allowance should be made to support this potential
and to promote collaborations between undertakings with a
view to helping the development of such ideas into new treat-
ments that have the potential of reaching the market.

4.9.3
In comparison with the US the EU and its Member
States at national level frequently focus on the need to ‘avoid
failure’ rather than taking the risk to achieve success which
might result in some failures. There is an opportunity to push
out the boundaries in this respect. The EESC supports the rapid
implementation of the Directive on the Legal Protection of
Biotechnological Inventions by all Member States as soon as
possible given that non-compliance will impede the develop-
ment of the European Biotech industry.

4.9.4
munity patent
Member State.

The EESC also supports the adoption of the Com-
legislation which will reduce costs to each

4.9.5
The EESC would wish to emphasise that at present
40-50 % of medicines for children are not licensed for children
and nor has a licence been sought for paediatric use. The EESC
would wish to recommend that targeted research to assess
appropriate doses of medicines for children, older people, men
and women be conducted. The key issue is the appropriate safe
and effective dose of the medicine for the specific circum-
stance.

4.9.6
The correct dosage is particularly relevant in relation
to older people who might be taking a number of different
medications for several
indications, whilst at the same time
have mild organ failure (e.g. kidney or liver) so the issue is the
appropriateness of medication in relation to that being
prescribed for other conditions.

(1) Directive 2001/20/EC, OJ L 121 of 1.5.2001.

4.9.7
The EESC would also wish to point out that whilst
there are conditions which are currently very rare in Europe
they may well be common in the developing world and that
the increased rate of travel combined with global warming
could cause
to become more
common and difficult to contain.

some ‘orphan (2)’ diseases

4.10 Medicines in an enlarged European Union

4.10.1
The EESC agrees that a major challenge will be the
integration of the economies and health-care systems of the
new member states into the existing Union. Most of the coun-
tries joining the Union have fewer resources to spend in their
health-care sectors than existing Member States therefore the
availability and affordability of pharmaceuticals in relation to
their public health-care systems is of great importance. This has
to be viewed in the context of rising health care costs, an
ageing population and new emerging social and health care
needs.

4.10.2
The challenge will also be to harmonise the intellec-
tual property rights that could create significant differences in
price levels and consequently lead to an increase in parallel
imports. These occur when there are systematic price differen-
tials between Member States. Individuals or organisations other
than the market authorisation holder can then purchase a
medicine in bulk in the less expensive country, import it to a
more expensive country and sell
it at a profit arising solely
from the price differential. The EESC supports the measures
proposed by the Commission to tackle this problem through a
statutory requirement to inform the marketing authorisation
holder, the competent authority in the Member State and the
EMEA, of an intention to proceed with a parallel import in a
particular Member State.

4.10.3
It is, however, noted that the legal responsibility for
enforcing intellectual property rights will remain with the
patent holder.

4.10.4
The EESC welcomes the steps taken by the Commis-
sion to ensure that the new member states have the opportu-
nity for dialogue in relation to any difficulties they might
experience in the implementation of the pharmaceutical legisla-
tive framework both before accession and following it.

(2) An ‘orphan’ disease is one which is very rare in Europe although it
may be amongst the most common diseases in the world which
occur largely,
in tropical countries with great
poverty. For such diseases there is no well-developed market for
competitively priced pharmaceuticals and hence little investment by
the pharmaceutical
industry to target these diseases. E.g. Malaria,
schistosomiasis and leprosy.

if not exclusively,

C 241/14

EN

Official Journal of the European Union

28.9.2004

4.11 Member States learning from each other

4.11.1
Fundamental to progress on the development of the
pharmaceutical sector in Europe is the ability to learn from
each other. The EESC therefore welcomes the Commission's
proposal
to establish a set of EU indicators to cover the
industry competitiveness and the public health objectives. The
setting-up of a working group to develop these indicators is
welcomed by the EESC.

4.11.2
The indicators will need to encompass the perfor-
mance of the pharmaceutical product and also those related to
health care provided in addition to:

— supply;

— demand and regulatory framework;

— industry output;

— macroeconomic factors.

5. Conclusion

The EESC welcomes

5.1
the Communication from the
Commission ‘to develop a stronger European-based Pharmaceu-
tical Industry for the benefit of the patient’ and supports the
comprehensive programme which is set out. It is recognised
that the Communication is ambitious and that it will be chal-
lenging to fulfil the objectives.

5.2
The EESC is of the view that whilst the Communication
fulfils the objectives of considering the benefits to patients,
moving forward on a competitive European-based industry,
taking steps to strengthen the EU science base, taking account
of the enlarged European Union and ensuring that Member
States learn from each other, it would wish the following issues
to be noted.

5.3
The EESC would wish to emphasise that the dependence
on the decision-making processes in the 25 national govern-
ments make the pharmaceutical
industry appear weaker in
comparison to the unified approaches that are possible in the
US or Japan in relation to research, innovation, marketing and
pricing.
It is stressed that the process begun with the G10
recommendations to reach a genuine single market should be
pursued and the impact on the health care systems and public
health in Member States must be checked through the
proposed benchmarking exercise.

5.4
The EESC would draw attention to the range of reviews,
documents and policy proposals relating to the pharmaceutical
sector over the past few years and is concerned as to how

Brussels, 2 June 2004.

more rapid progress will be achieved as a result of the G10
recommendations,
the Communication and commitments
made by the Council of Ministers.

5.5
The EESC acknowledges the difficulties in achieving an
integrated single market in respect of the pharmaceutical sector
in view of its complexity and dependence on Member States
competencies and differing systems. However,
it stresses the
importance of putting in place clear strategies to achieve this
goal.

5.6
The EESC endorses the Commission's intention to estab-
lish performance indicators to enable the evaluation and moni-
toring of progress within the industry and again emphasises
the importance of obtaining consistent statistical data and
evidence on which to judge the progress of the programme set
out in the Communication.

5.7
The EESC continues to emphasise the great importance
it attaches to the protection of human health and that it should
take precedence in all areas of regulation.

5.8
The EESC strongly supports the proposal for the devel-
opment of a 'kite mark' to establish quality criteria for health-
related websites and all other forms of information and stresses
the importance of encouraging people to seek advice from
health care professionals.

5.9
The EESC supports a strong pharmacovigilance system
which must continue to be strengthened, and a more efficient
use of epidemiological studies needs to be integrated.

5.10
The EESC believes that there is a real opportunity to
develop a better coordinated approach to the research agenda
with simpler and more harmonised administrative procedures.
investment, which might
The potential
include venture capital, low cost loans, tax credits, is welcomed
and should urgently be pursued.

for new sources of

5.11
The EESC recommends continued dialogue and the
simplification of systems to allow innovation and the sharing
of knowledge both to strengthen the industry but also to
sustain and develop the skills and employment capacity
resulting from a competitive pharmaceutical industry.

The EESC also recommends investment by the EU and
5.12
EU Member States in order to ensure that networks of excel-
lence are established and to allow funding over a reasonably
long period of time to foster innovation by providing a level of
certainty and security to sustain continuity of research team
work.

The President

of the European Economic and Social Committee

Roger BRIESCH