The doubts back
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Inventors are allowed patent rights in order to promote research and
development. That includes the creation of new drugs. The TRIPS
Agreement, which has been in force since 1995, also enshrines in
public international law, governments’ right to take various kinds of
measures that qualify or limit intellectual property rights, including
for public health purposes.
However, some members and public interest groups queried whether the
flexibility written into the TRIPS Agreement was sufficient to ensure
that it supports public health, especially in promoting affordable
access to existing medicines while also promoting research and
development into new ones.
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Different views were expressed about the nature and scope of the
flexibility in the TRIPS Agreement, for example about compulsory
licensing or parallel imports (see explanation in
fact sheet).
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Questions were asked as to whether this flexibility would be
interpreted by the WTO and its members in a broad, pro-public-health
way.
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There was concern about whether governments would feel free to use
this flexibility to the full, without fearing pressure from trading
partners or industry.
The declaration’s response back
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The special declaration responds to these concerns in a number of
ways.
First, it emphasizes that the
TRIPS Agreement does not and should not prevent WTO members
governments from taking measures to protect public health. It
reaffirms the members’ rights to use fully the provisions of the TRIPS
Agreement, which provide flexibility for this purpose.
These important statements are a signal from all WTO members: they
will not try to prevent each other from using these provisions.
Second, the declaration makes it
clear that the TRIPS Agreement should be interpreted and implemented
in a manner that supports WTO members’ right to protect public health
and, in particular, to promote access to medicines for all.
It also highlights the importance of the objectives and principles of
the TRIPS Agreement for interpreting its provisions. Although the
declaration does not refer specifically to Articles 7 (“Objectives”)
and 8 (“Principles”) of the TRIPS Agreement, developing country
members attach particular importance to these provisions.
These statements therefore provide important guidance both to
individual members and — in the event of disputes — to WTO dispute
settlement bodies.
Third, the declaration contains a
number of important clarifications of some of the flexibilities
contained in the TRIPS Agreement. It does this while maintaining
members’ commitments under the TRIPS Agreement.
On compulsory licensing, the declaration makes it clear that each
member is free to determine the grounds upon which the licences are
granted. This, for example, is a useful corrective to the view
sometimes expressed that some form of emergency is a pre condition for
compulsory licensing.
The TRIPS Agreement does refer to national emergencies or other
circumstances of extreme urgency in connection with compulsory
licensing. But this is only to indicate that in these circumstances
there is no need to try to obtain a voluntary licence before resorting
to compulsory licensing.
The declaration makes it clear that each member has the right to
determine what constitutes a national emergency or other circumstance
of extreme urgency, and that public health crises can fit the bill,
including HIV/AIDS, tuberculosis, malaria and other epidemics.
The declaration also refers to the “exhaustion” of intellectual
property rights, and therefore a member’s right to allow parallel
imports (for an explanation see fact
sheet.
The TRIPS Agreement says that a member government’s practices in this
area cannot be challenged under the WTO dispute settlement system.
The declaration makes it clear that the TRIPS Agreement’s provisions
on exhaustion in effect leave each member free to establish its own
regime without challenge — subject to the general TRIPS provisions
prohibiting discrimination on the basis of a person’s nationality.
Countries’ follow-up back
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While WTO members have clarified the flexibility in the TRIPS
Agreement and their right to use it to the full, the story does not
end there. It is a country’s domestic law that has direct legal force
within that country. Therefore, the declaration does not remove the
need for each country to take the necessary steps domestically to use
this flexibility where necessary if it wants to ensure that medicines
are available at affordable prices.
For least-developed country members of the WTO, the declaration says
they do not have to protect patents and undisclosed information rights
for pharmaceuticals until 2016. For these rights, the least-developed
countries therefore have 10 years added to their transition period for
applying the TRIPS provisions.
Doha assignment back
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An issue which arose in the work on the declaration was the question
of countries with limited manufacturing capacities and how they could
make effective use of compulsory licensing.
It is not in dispute that members can issue compulsory licences to
import as well as for domestic production. The concern that has been
expressed is about whether supplies of generic medicines made in other
countries will be available for importing, particularly in the light
of the provision of Article 31(f) of the TRIPS Agreement.
This states that any compulsory licences granted to generic producers
in those other countries shall be “predominantly for the supply of the
domestic market of the Member” granting the compulsory licence.
This concern may become greater as countries with important generic
industries, such as India, are obliged to provide patent protection
for pharmaceutical products from 2005. In this regard, the declaration
recognizes the problem and instructs the TRIPS Council to find an
expeditious solution to it and to report on this before the end of
2002. (Members failed to reach consensus by that deadline. In the
preparations for the Cancún Ministerial Conference, attempts are
underway to try to break the deadlock.)
More on the Doha Development Agenda
here; more on the
TRIPS Council’s work here.
Importance of intellectual property
protection back
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While emphasizing the scope that the TRIPS Agreement gives to
governments to take measures to promote access to medicines, the
declaration also recognizes the importance of intellectual property
protection for developing new medicines. It also reaffirms WTO
members’ commitments under the TRIPS Agreement.
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