Overview of the Benefits of the Doha Agreement on TRIPS and Public Health.
Here is a quick tour of primary benefits of the Doha agreement on TRIPS
and public health.
James Love love@cptech.org
Paragraph 4 is where the WTO agrees that the TRIPS can and should be
interpreted and implemented in a manner supportive of public health, and
"in particular, to promote access to medicines for all." This makes it
clear that public health is the priority in terms of intepretation, and
it even tells countries to implement the TRIPS in a way that protects
public health. By singling out public health as a special issue for
intellectual property, the WTO is making it clear that member countries
can do the same.
In this connection, we reaffirm the right of WTO Members
to use, to the full, the provisions in the TRIPS
Agreement, which provide flexibility for this purpose.
For the press, PLEASE NOTE THAT THE TRIPS AND THE DOHA DECLARATION
COVER MUCH MORE THAN COMPULSORY LICENSES WHEN THERE IS AN EMERGENCY.
Indeed, the strategy of the US and some European countries was to narrow
the declaration to things like emergencies or essential drugs, or to
infectious diseases. And while there are some references to special
cases involving some diseases or epidemics, these are not in any way
limiting in terms of the overall declaration, and even here, within the
special case of an emergency, the cases are illustrative, but not
limiting. Countries, could, for example, adopt a much different
definition of an emergency, such as a poor life expectancy or more
generally conditions such as lack of access to medicines. I can't
imagine even one country in Africa that could not use 5(c) to very
broadly embrace automatic licensing of large categories of
pharmaceuticals products and medical devices. But it is also not
necessary for any country to even use 5(c), unless they want to
eliminate the prior negotiation on voluntary licenses, for commerical
applicants for a compulsory license. Indeed, for most countries, the
provisions of 5(b) will probably be more important and useful, so long
as they can develop fast tract methods of making 5(b) work, and take
advantage of existing TRIPS language on government use.
Paragraph 6 was our biggest disappontment, but only because we set our
sights so high, and it still represents a significant and imporant
victory. The WTO recognizes the problems in 31.f of the TRIPS, and
agrees to find a solution by next year. All of the NGOs pushed hard on
this one, pushing for a broad acceptance of the use of Article 30 for
the export of medicines, a proposal tabled by developing countries in a
September 19 in TRIPS council non-paper, and again by Peru during the
Doha meeting. I believe we will get this in the TRIPS council, but it
will be discussed next year.
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4. We agree that the TRIPS Agreement does not and
should not prevent Members from taking measures to
protect public health. Accordingly, while reiterating
our commitment to the TRIPS Agreement, we affirm that
the 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.
Paragraph 5 provides various "clarifications" of the agreement, which
are completely consistent with the interpretations that public health
groups have asked for. All four are important, but I would highlight
(b) and (c):
5 (b) Each Member has the right to grant compulsory licences
and the freedom to determine the grounds upon which such
licences are granted.
This makes it clear that Member countries can choose any grounds upon
which to grant compulsory licenses, including of course such issues as
high prices or the need to promote broader access to health care, but
also to promote technology transfer to or achieve other social
objectives.
5 (c) Each Member has the right to determine what constitutes
a national emergency or other circumstances of extreme urgency,
it being understood that public health crises, including those
relating to HIV/AIDS, tuberculosis, malaria and other epidemics,
can represent a national emergency or other circumstances
of extreme urgency.
This paragraph clarifies Article 31.b language on national
emergencies or circumstances of extreme urgency, which permit countries
to waive TRIPS requires for prior negotiation with patent owners, prior
to overriding a patent. What is significant here is that the WTO agrees
that this is not only for "time is the essence" problems, but for
situations that can exist for decades, an important clarification, in my
opinion. Under 5(c), countries can adopt fast tract proceedures for the
issuance of compulsory licenses, featuring automatic licensing of
generic drugs, to address broad health care problems, and the Member
Countries, not the WTO, will determine what constitutes an emergency or
urgent circumstance.
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 7 gives LCD members until 2016 to implement TRIPS for
pharmaceutical products, and at the insistence of the developing
countries and with the agreement of the US, without prejudice to ask for
further extensions. Among other things, this will provide a place
where pharmaceuticals can be manufactured for export markets, until
2016, if the WTO does not solve the 31.f problem sooner.
7. We reaffirm the commitment of developed-country
Members to provide incentives to their enterprises and
institutions to promote and encourage technology
transfer to least-developed country Members pursuant
to Article 66.2. We also agree that the least-developed
country Members will not be obliged, with respect to
pharmaceutical products, to implement or apply Sections
5 and 7 of Part II of the TRIPS Agreement or to enforce
rights provided for under these Sections until 1 January 2016,
without prejudice to the right of least-developed country
Members to seek other extensions of the transition periods
as provided for in Article 66.1 of the TRIPS Agreement.
We instruct the Council for TRIPS to take the necessary
action to give effect to this pursuant to Article 66.1
of the TRIPS Agreement.