28 January 2002
Dear Members of the TRIPS council,
We are writing to present our views on the issue of exports of
medical technologies under the WTO TRIPS rules for patents.
Paragraph 6 of the Doha Declaration on the TRIPS Agreement and
Public Health instructed the Council for TRIPS to find a
"solution" to difficulties in using compulsory licenses when
countries have insufficient or no manufacturing capacity.
The Doha Declaration on TRIPS contains both a promise and an
obligation to interpret and implement the TRIPS Agreement in a
manner supportive of a WTO members right to protect public health
and promote access to medicines for all. Now that the Doha
meeting has been concluded, it is the duty of the TRIPS council
to implement the entire Doha Declaration in good faith, ensuring
that the safeguards of the TRIPS work for both rich and poor
countries, for countries with large or small domestic markets,
and for countries with different levels of technological
development.
Of particular interest are proposals that Article 30 of the TRIPS
Agreement be interpreted to permit countries to export medicines
and other inventions to address health needs. This approach was
endorsed by public health groups in the 1999 "Amsterdam
Statement" on trade and public health, in several resolutions
adopted by the Trans Atlantic Consumer Dialogue (TACD is a US/EU
trade consultation group), by a group of public health groups
engaged in recent European Commission (EC) consultations on trade
policy and access to medicines, and in a developing countries
proposal submitted prior to the Doha meeting.
We urge the WTO to consider an interpretation of Article 30 that
is similar to that proposed in Paragraph 9 of the October 4, 2001
communication by the developing countries,1 perhaps with
modifications to ensure that it is broader than medicines, and
does not raise concerns regarding Article 27.1 restrictions on
discrimination by field of technology. One possible statement
would be:
While we support a strong Article 30 approach to the export
issue, we also urge the WTO to ensure that other solutions
4 to the export issue are available to developing
countries, thus making good the promise in Doha that the WTO
will seek to implement the TRIPS in a manner consistent with
seeking to promote access to medicines for all. Anything less
would be a failure to implement the Doha Declaration in good
faith, and would undermine future trust in the fairness of the
trading system.
Yours sincerely,
Ellen 't Hoen
1 "9. Under Article 30 of the TRIPS Agreement, Members may,
among others, authorize the production and export of medicines by
persons other than holders of patents on those medicines to
address public health needs in importing Members". (WTO,
IP/C/W/312, WT/GC/W/450, 4 October 2001, (01-4803), Council for
Trade-Related Aspects of Intellectual Property Rights, General
Council, Proposal by the African group, Bangladesh, Barbados,
Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Haiti,
Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay,
Philippines, Peru, Sri Lanka, Thailand and Venezuela.)
"6. We recognize that WTO Members with insufficient or no
manufacturing capacities in the pharmaceutical sector could face
difficulties in making effective use of compulsory licensing
under the TRIPS Agreement. We instruct the Council for TRIPS to
find an expeditious solution to this problem and to report to the
General Council before the end of 2002."
Paragraph 6 of the Doha Declaration addresses one particular
concern with the TRIPS agreement, namely the case where a country
that has a patent on a medicine cannot find an efficient,
affordable and reliable source of medicines, due to TRIPS
restrictions on production and export of medicines. Of course
the same problem exists also for countries where there is no
patent on a medicine or other health care technology, including
the least developed countries that avail themselves of the
automatic extended transition period (until 2016) recently agreed
at Doha. We urge the members of the WTO to find solutions that
address both cases, in order to ensure that poor persons,
wherever they live, will have opportunities to obtain better
access to health care.
Under Article 30 of the TRIPS agreement, Members may provide an
exception to the exclusive rights conferred by a relevant patent
to permit all acts associated with the production for export to a
third country of a patented product or a product produced by a
patented process; where the export addresses health needs in the
third country; and the product and/or process is either (a) not
patented; or (b) a compulsory license has been granted or
government use made of the relevant patent in the third country.
The Article 30 approach to addressing the issue of exports of
medicines (and other health care inventions) is not the only
possible solution to this problem, but it has many advantages,
including for example:
We also urge the WTO to reject proposals to tie Article 30 export
exemptions to overly restrictive or complex conditions, such as
those proposed in the 2001 UK/French non-proposal, that would
require, inter alia, importing countries to justify their
rejection of various tiered pricing schemes. The WTO does not
have the competence to regulate price negotiations, and we are
very wary of any measures that add additional uncertainly and
complexity to the TRIPS framework.
Coordinator Globalisation Project
Access to Essential Medicines Campaign
M‚decins Sans FrontiŠres
Email :
ellen.t.hoen@paris.msf.org
James Love
Director
Consumer Project on Technology
Email:
love@cptech.org
Michael Bailey
Oxfam International
Email:
mbailey@oxfam.org.uk
Asia Russell
Coordinator, International Advocacy
Health Gap Coalition
Email:
asia@CritPath.Org
Cecilia Oh
Third World Network
Email:
ceciliaoh@yahoo.com
Robert Weissman
Co-director
Essential Action
Email:
rob@essential.org
2 For example, legal traditions vary on such topics as exhaustion
of patent rights or in accepting a foreign country decision to
issue a compulsory license, two of the alternative approaches
considered in recent TRIPS council discussions.
3 In a typical Article 31 approach, the producing country would
have to make the determination regarding the grounds for issuing
a compulsory license.
4
Developing countries have explored a number of options for
addressing the export issue, including those mentioned in the
October 4, 2001 communication to the TRIPS council, the EC
consultations have considered such issues as permitting exports
within trade unions, and there are opportunities to export under
Article 31.k of the TRIPS when the use is authorized to remedy
anticompetitive practices.
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