22 November 2001

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 (copy attached).

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:

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.

* Message sent by Adrian Otten

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