WTO DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

[Guest guest]

The following is a short note that the WTO's Otten sent to

UNAIDS. I thought it was quite clear and useful.

22 November 2001:

WTO DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

The Fourth Ministerial Conference of the World Trade

Organization, which was held in Doha, Qatar, adopted on 14

November 2001 by consensus a Declaration on the TRIPS

Agreement and Public Health

The purpose of the Declaration is to respond to the

concerns that have been expressed about the possible

implications of the TRIPS Agreement for access to drugs. The

TRIPS Agreement enshrines in public international law the

right of countries to take various kinds of measures which can

qualify or limit intellectual property rights, including for

public health purposes. However, some doubts had arisen as to

whether the flexibility in the TRIPS Agreement was sufficient

to ensure that it is supportive of public health, especially

in promoting affordable access to existing medicines while

also promoting research and development into new ones:

- first, different views were being expressed about the nature and scope of the

flexibility in the TRIPS Agreement, for example in regard to compulsory

licensing or parallel imports;

- second, questions were being raised as to whether this flexibility would be

interpreted by the WTO and its Members in a broad, pro-public health way;

and

- third, there was concern about the extent to which governments would feel

free to use to the full this flexibility without the fear of coming under

pressure from trading partners or industry.

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 Members

from taking measures to protect public health and reaffirms the right of Members

to use, to the full, the provisions of the TRIPS Agreement which provide

flexibility for this purpose. These important declarations signal an acceptance

by all WTO Members that they will not seek to prevent other Members from using

these provisions.

Second, the Declaration makes it clear that the TRIPS Agreement 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. Further, it highlights the importance of the objectives and principles of

the TRIPS Agreement for the interpretation of its provisions. Although the

Declaration does not refer specifically to Articles 7 and 8 of the TRIPS

Agreement, which are entitled, respectively, " Objectives " and " Principles " , it

should be noted that developing country Members attach particular importance to

these provisions. These statements thus provide important guidance to both

individual Members and, in the event of disputes, WTO dispute settlement bodies.

Third, the Declaration contains a number of important clarifications of some of

the flexibilities contained in the TRIPS Agreement, while maintaining Members'

commitments in the TRIPS Agreement. It makes it clear that each Member is free

to determine the grounds upon which compulsory licences are granted. This, for

example, is a useful corrective to the views often expressed in some quarters

implying 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, the usual condition that

first an effort must be made to seek a voluntary licence does not apply. The

Declaration makes it clear that each Member has the right to determine what

constitutes a national emergency or other circumstances of extreme urgency and

that public health crises, including those relating to HIV/AIDS, tuberculosis,

malaria and other epidemics, can represent such circumstances.

In regard to the exhaustion of intellectual property rights, and therefore a

Member's right to permit parallel imports, the TRIPS Agreement states that a

Member's practices in this area cannot be challenged under the WTO dispute

settlement system. There has been much debate about what exactly this means in

regard to a Member's freedom to choose its own regime for exhaustion and

parallel imports. The Declaration makes it clear that the effect of the

provisions in the TRIPS Agreement on exhaustion is to leave each Member

free to establish its own regime without challenge - subject to the general

TRIPS provisions prohibiting discrimination on the basis of the nationality of

persons.

While WTO Members have clarified the flexibility in the TRIPS Agreement and

Members' right to use it to the full, it should not be forgotten that it is not

the TRIPS Agreement but each country's domestic law that has direct legal force

in regard to acts relating to intellectual property on its territory. Thus, the

Declaration does not obviate the need for each country to take the necessary

steps at the national level to avail itself of this flexibility where necessary

to secure the availability of medicines at affordable prices.

In regard to the least-developed country Members of the WTO, the Declaration

accords them an extension of their transition period until the beginning of 2016

in regard to the protection and enforcement of patents and rights in

undisclosed information with respect to pharmaceutical products. Therefore, in

the meantime, these countries are exempt from these TRIPS obligations and need

not occupy themselves with any of the concerns mentioned above.

An issue which arose in the work on the Declaration was that of the ability of

countries with limited manufacturing capacities to make effective use of

compulsory licensing. It is not in dispute that Members can issue compulsory

licences for importation as well as for domestic production. However, the

concern that has been expressed is about whether sources of supply from generic

producers in other countries to meet such demand will be available, particularly

in the light of the provision of Article 31(f) of the TRIPS Agreement which

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, come under an

obligation to provide patent protection for pharmaceutical products as from

2005. In this regard, the Declaration recognizes the problem and instructs the

Council for TRIPS to find an expeditious solution to it and to report on this

before the end of 2002.

It should also be noted that, while emphasizing the scope in the TRIPS

Agreement to take measures to promote access to medicines, the Declaration also

recognizes the importance of intellectual property protection for the

development of new medicines and reaffirms the commitments of WTO Members in the

TRIPS Agreement.

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