Background back
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Now largely settled is the question of how to ensure that patent
protection for pharmaceutical products does not prevent people in poor
countries from having access to medicines — while at the same time
maintaining the patent system’s role in providing incentives for
research and development into new medicines.
The remaining task is to convert a General Council decision of
30 August 2003 into a permanent amendment of the TRIPS Agreement.
Underlying the deliberations are flexibilities such as “compulsory
licensing” that are written into the TRIPS Agreement — governments
can issue compulsory licenses to allow a competitor to produce a
patented product or use a patented process without the permission of the
patent holder, under certain conditions aimed at safeguarding the
legitimate interests of the patent holder.
Parallel importing is also possible. This is where a product sold
by the patent owner more cheaply in one country is imported into another
without the patent holder’s permission. Countries’ laws differ on
whether they allow parallel imports. The TRIPS Agreement states that
governments cannot bring legal disputes to the WTO on this issue; the
Doha declaration on TRIPS and public health clarified that this means
countries are free to set up their rules and procedures dealing with
parallel imports.
(These flexibilities do not have to be put into practice to have an
effect. They are sometimes used as a means of bargaining. For example
the threat of a compulsory licence can encourage a patent holder to
reduce the price.)
The Doha mandate
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Before the 2001 Doha Ministerial Conference, some governments were
unsure of how these flexibilities would be interpreted, and how far
their right to use them would be respected. The African Group (all the
African members of the WTO) took the lead in pushing for clarification.
A large part of this was settled when WTO ministers issued a special
Declaration on TRIPS and Public Health at the Doha meeting in
November 2001, alongside their main Doha Declaration.
In the main declaration, they stressed that it is important to implement
and interpret the TRIPS Agreement in a way that supports public health —
by promoting both access to existing medicines and the creation of new
medicines.
In the separate declaration, they agreed that the TRIPS Agreement does
not and should not prevent members from taking measures to protect
public health.
They underscored countries’ ability to use the flexibilities that are
built into the TRIPS Agreement, in particular compulsory licensing and
parallel importing.
And they agreed to extend exemptions on pharmaceutical patent protection
for least-developed countries until 2016. (The TRIPS Council completed
the legal drafting task on this in mid-2002.)
On one remaining question, they assigned further work to the TRIPS
Council — to sort out how to provide extra flexibility, so that
countries unable to produce pharmaceuticals domestically can import
patented drugs made under compulsory licensing. (This is sometimes
called the “Paragraph 6” issue, because it comes under that paragraph in
the separate Doha declaration on TRIPS and health.)
The issue arises because Article 31(f) of the TRIPS Agreement says
products made under compulsory licensing must be “predominantly for the
supply of the domestic market”. This applies directly to countries that
can manufacture drugs — it limits the amount they can export when the
drug is made under compulsory licence. And it has an indirect impact on
countries unable to make medicines — they might want to import generics
made in countries under compulsory licence, but find that Article 31(f)
poses an obstacle to other countries supplying them.
The TRIPS Council was instructed to find a solution and report to the
General Council on this by the end of 2002. However it was not until
30 August 2003, shortly before the Cancún Ministerial Conference, that
consensus could be reached.
The agreement takes the form of a General Council decision to
waive provisions of Article 31(f) subject to certain conditions. It
enables countries with production capability, to export drugs made under
compulsory licence to countries that cannot manufacture them.
The waiver will last until the TRIPS Agreement is amended. It includes
provisions on transparency (which give a patent-owner some opportunity
to react by offering a lower price), and special packaging and other
methods to avoid the medicines being diverted to other markets. An annex
describes what a country needs to do in order to declare itself unable
to make the pharmaceuticals domestically.
Over 30 developed countries have made a commitment within the decision
not to import under this decision. And, as recorded in a statement by
the General Council chairperson, a number of others stated they will
only do so in emergencies or extremely urgent situations.
Consensus was achieved with the aid of a Chairman’s statement, made at
the time the waiver was adopted, which sets out a number of shared
understandings about the waiver.
The decision refers to drugs needed to address the public health
problems recognized in Paragraph 1 of the original declaration that
ministers issued in Doha. This says: “We recognize the gravity of the
public health problems afflicting many developing and least-developed
countries, especially those resulting from HIV/AIDS, tuberculosis,
malaria and other epidemics.”
Since then … back
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The final step is to convert the waiver into a permanent amendment of
the TRIPS Agreement. The decision said members would complete this by
the end of June 2004, but consensus has not yet been reached on how to
achieve this. Part of the discussion is about the best way to handle the
text, for example how much to put in Article 31 itself and how much in
an annex to the TRIPS Agreement.
But members also differ on how closely the amendment should follow the
waiver and how to handle the separate chairperson’s statement made at
the time the General Council adopted the decision. Some developing
countries want to drop provisions that they consider to be unnecessary
for an amendment. Some developed and other countries say the waiver was
so difficult to negotiate that it should be translated directly into an
amendment in order to avoid further delays.
Although the waiver is temporary, so long as there is no agreement on a
permanent amendment the waiver will continue to be in force. |
