WRITTEN QUESTION E-0130/03 by Margrietus van den Berg (PSE) to the Commission. Implementing paragraph 6 of the Doha Declaration on TRIPS and public health.
Date: 2003-01-28
Institutions: European Parliament, Provisional data
Subjects: TRIPS, medicinal product, patents licence, pharmaceutical expenses, public health

8.4.2004

EN

Official Journal of the European Union

C 88 E/589

The Commission does not consider opinion polls as a suitable instrument for a quantitative assessment of
the migration potential. Answers are usually subjective and indicate intentions, not choices. This is one of
the lessons of the German Socio-Economic-Panel (GSOEP), where every year the population in Eastern
Germany is asked whether they intend to move to Western Germany. The results show that only around
five per cent of those who announced their intention to move to Western Germany in the early 1990s did
indeed move there five years later.

(2004/C 88 E/0601)

WRITTEN QUESTION E-0130/03

by Margrietus van den Berg (PSE) to the Commission

(28 January 2003)

Subject: Implementing paragraph 6 of the Doha Declaration on TRIPS and public health

Paragraph 4 of the Doha declaration states that ‘… the TRIPs Agreement does not and should not prevent
members from taking measures to protect public health’ and that ‘the [TRIPs] Agreement can and should
be interpreted and implemented in a manner supportive of WTO members’ right to protect public health
and, in particular, to promote access to medicines for all’.

Furthermore, paragraph 5(b) of the Declaration reaffirms the right to grant compulsory licences and the
freedom of each WTO Member to determine the grounds upon which such licences are granted.

Does the Commission recognise that neither the Doha Declaration nor the TRIPs Agreement restricts the
application of these principle to certain types of public health problem, to the exclusion of others; nor do
they limit eligibility to certain types of country?

Does the Commission recognise the intention of paragraph 6 of the Doha Declaration to ensure that WTO
members without adequate manufacturing capacity benefit in full from the provisions of that declaration,
on the same terms as WTO members who do have such capacity?

Does the Commission therefore recognise that to impose additional or new constraints as part of the
solution to the paragraph 6 problem would violate the spirit of the Doha Declaration, and be justifiably
seen by developing countries as evidence of bad faith?’

Answer given by Mr Lamy on behalf of the Commission

(25 February 2003)

The Doha Declaration on the Trade Related Intellectual Property Rights (TRIPs) Agreement and Public
Health confirmed and clarified the existing flexibilities under the TRIPs Agreement, especially compulsory
licences and parallel import, and re-affirmed the importance of Articles 7 and 8 of the TRIPs Agreement in
its interpretation. It has an important legal value as it gives guidance to the interpretation of the TRIPs
Agreement.

Paragraph 6 of the Declaration deals with an issue that could not be resolved in Doha, and for which the
TRIPs Agreement does not provide a tailor-made solution. So, strictly speaking, paragraph 6 is not about
implementing the Doha Declaration. The Doha Declaration in itself can be implemented by all members
without need for further international legal instruments. Paragraph 6 is about adding an additional layer of
flexibility to the TRIPs Agreement and to the Doha Declaration. It purports to creating new possibilities
under the TRIPs Agreement in order to resolve the problems of countries without manufacturing capacities
in the pharmaceutical sector, by allowing them to have effective recourse to compulsory licensing.

The major difference with compulsory licensing as already provided for under the TRIPs Agreement is that
production takes place in one country, and that the entirety of the production is then exported to another
country (under the current rules of TRIPs, production and consumption of a predominant part of the
production must take place in the same country). Therefore, the conditions attached to the use of such
licences must be adapted to this reality. So this is not a question of imposing additional and burdensome

C 88 E/590

Official Journal of the European Union

EN

8.4.2004

constraints, but to adapt conditions to different circumstances. This is what has been done in the draft
decision of 16 December 2002 (1), which contains minimal safeguards against trade diversion and which,
moreover, specifies (as proposed by the Union) that such measures should be proportionate to the
administrative capacities of the countries concerned. This arrangement, which has been endorsed by all
World Trade Organisation (WTO) Members (minus one), and which would effectively allow countries
without manufacturing capacities to benefit from compulsory licences, fully respects the spirit of the Doha
Declaration.

As the Honourable Member knows, the Union fully endorsed the 16 December 2002 text, including its
disease scope by reference to paragraph 1 of the Doha Declaration. The Commission regrets that the
United States did not join the consensus and the Union will continue its efforts in order to secure a
multilateral solution as soon as possible. It cannot accept that these negotiations end in failure. WTO
Members have taken the commitment in Doha to find a multilateral solution, so this commitment must be
upheld. To this effect, the Union has recently taken the initiative to propose recourse to the World Health
Organisation in order to guarantee flexibility in applying the system, in line with the scope of the Doha
Declaration.

(1) Draft Decision of the President of the TRIPs Council of the WTO (Reference: JOB (02) 217).

(2004/C 88 E/0602)

WRITTEN QUESTION E-0170/03

by Bob van den Bos (ELDR) to the Commission

(29 January 2003)

Subject: Bangladesh

On 21 November 2002 the European Parliament adopted an urgent resolution on Bangladesh following
reports of alleged violations of human rights committed under the Bangladesh military’s ‘Operation Clean
Heart’ and an apparently deteriorating human rights situation in that country.

In the European Parliament resolution, we call on the Commission to ‘engage with the Government of
Bangladesh under the EU-Bangladesh Cooperation Agreement to ensure that violations stop (and) human
rights are protected’. Can the Commission inform us what action it has taken so far in that respect?

What (other) initiatives is it planning to take in order to encourage the Government of Bangladesh to
protect human rights in its country?

(2004/C 88 E/0603)

WRITTEN QUESTION E-0242/03

by Nirj Deva (PPE-DE) to the Commission

(4 February 2003)

Subject: Human rights in Bangladesh

Is it correct that the Government of Bangladesh since the 2001 elections has instigated a regime of terror?
It is alleged by Amnesty International amongst others that assassinations have become common, freedom
of the press has been curtailed and the army has been given indemnity from prosecution for its actions
during Operation Clean Heart (16 October 2002 to 9 January 2003).

What does the Commission propose to do to ensure that this indemnity is stopped and that those who are
accused of gross human rights violations are brought to justice?