[Ip-health] NGO letter to WTO regarding medical technology exports and TRIPS patent provisions
James Love
love@cptech.org
Mon, 28 Jan 2002 13:15:13 -0500
The following is a 28 January 2002 letter to the WTO TRIPS Council,
signed by six NGOs (MSF, CPTech, Oxfam, Health Gap Coalition, Third
World Network and Essential Action). The letter asks the WTO to endorse
an "Article 30" exception to patent rights for exports of technologies
to address health needs. The letter focuses on paragraph 6 of the Doha
Declaration on TRIPS and Public Health, which tells the Council on TRIPS
to find a "solution" to problems countries may face if they lack the
domestic capacity to produce medicines, given the TRIPS restrictions on
exports of goods produced under a compulsory license. The NGOs ask the
WTO to recognize a limited exception to patent rights under the existing
Article 30 of the TRIPS, setting out the rationale and advantages of the
Article 30 approach. The NGOs also ask the WTO to ensure that other
solutions to the export issue are also available to developing countries.
James Love <love@cptech.org>
http://www.cptech.org/ip/health/art30exports.html
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.
"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.
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:
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:
1. It is the most direct, administratively simple, and least
contentious approach to addressing the need to permit exports, in
that an activity falling within a 'classic' Article 30 exception
is not an infringement of the patent and does not therefore need
permission from the patent holder (or even that notice be given
to the patent holder) or compensation to the patent holder. In
addition, it could be limited to only the health problems the
Doha declaration seeks to solve.
2. It would permit a mechanism where the patent owner is
compensated in the country where the product is consumed,
according to the norms for compensation in that country. This
approach would avoid problems of double compensation where
patents exist in both the producing and exporting countries, and
would only fail to provide compensation when consumption took
place in countries where the inventor did not have a patent
(typically in smaller markets of marginal economic importance).
This ensures that the inventor benefits when the product is used
in countries where the inventor obtained a patent, while
permitting patients to seek the most efficient suppliers of
medicines and other medical technologies.
3. It would also permit exports to countries that lack the
capacity for local production including those that have granted a
patent, countries where the patent has not been filed or granted,
or countries that do not issue patents. In contrast, some
proposals from the EC would restrict exports to those countries
that have patents and have issued a compulsory license.
4. It would permit exports from the widest number of countries,
including those, for example, that could not under domestic law
implement some of the alternative approaches2.
5. Unlike an Article 31 approach, it would not imply that the
necessary conditions for the grant of a compulsory license be
determined in the exporting countries, which would result in
tying the problems of the exporting and importing countries
together3.
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.
While we support a strong Article 30 approach to the export
issue, we also urge the WTO to ensure that other solutions4 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
Coordinator Globalisation Project
Access to Essential Medicines Campaign
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
------------------------Notes-----------------------------------
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.)
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.
--
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org, mailto:love@cptech.org
voice: 1.202.387.8030 fax 1.202.234.5176 mobile 1.202.361.3040