On June 20, more than a third of the WTO Membership co-sponsored a paper that sets out their common understanding of the provisions of TRIPS Agreement related to public health issues. A large number of Members have also added their support to several elements contained in the joint developing country paper. However, we take note of some questions raised by a number of delegations, and we look forward to reaching agreement on those points, so that we may proceed swiftly towards achieving a tangible result for our discussions, in time for Doha.
In the interest of maintaining the momentum of our important discussions, we take the opportunity of this meeting to do the following:
Before we address the substantive issues raised, we wish take note of the Secretariat's document; the “Checklist of Articles of the TRIPs Agreement and matters raised in relation to them at the Council’s special discussion on intellectual property and access to medicines” (document JOB 01/113).
We thank the Secretariat for its efforts in preparing this document. Although the Checklist does not adequately reflect the high degree of convergence amongst the WTO Membership on key issues raised during the Special Discussion, we nonetheless understand the need for the Secretariat to maintain its position of neutrality on matters related to the interpretation of WTO Agreements. In this connection, we refer to the US statement on June 20, which invited other Members to refer to some documents prepared by the Secretariat for “explanations” on the provisions of the TRIPS Agreement. We do not consider it appropriate for the WTO Secretariat to provide interpretations of the provisions of the TRIPS Agreement, and would strongly suggest that the Secretariat strives to maintain its objectivity in such matters.
We have read with particular interest the interventions made by a number of delegations, including the United States, the European Communities and Switzerland. We would like to provide some preliminary comments on their respective interventions, in the interests of moving forward.
Mandate of TRIPS Council
In its statement on June 20, the US urged the adoption of a “comprehensive approach” to deal with serious health problems. Certainly, in other international fora and at the national level, our respective governments are engaged in the serious work of identifying and implementing various solutions to address public health issues. It is not within the mandate of the TRIPS Council to talk of the infrastructure in different countries, in terms of hospitals, doctors and nurses. Nor will be useful for this forum to discuss the global funds and other initiatives for the purchase and distribution of medicines. These issues are belong and are being addressed in their appropriate fora and institutions.
Insofar as our present work in the TRIPS Council is concerned, it is to address the impact of the TRIPS Agreement on public health and access to affordable medicines. We must be clear about the mandate and objective of our exercise in this forum; that is, to examine the relationship between the various provisions of the TRIPS Agreement and issues of public health and access to medicines, and most importantly, to ensure that the implementation of the TRIPS Agreement does not amount to an obstacle to the promotion of access to affordable medicines and the protection of public health.
Members have the right under the TRIPS Agreement to determine the grounds on which compulsory licences can be issued. The US has said that Article 31 of the TRIPS Agreement does not "itemize the purposes for which compulsory licenses may be granted", rather it establishes the conditions to be met with respect to compulsory licences. The EC and Switzerland have also said that, “compulsory licenses can be issued for any reason, including of course public health”.
Under the TRIPS Agreement, Members are free to determine the grounds upon which to issue compulsory licenses. In addition, Members are free to determine and implement in national law the meaning of terms in the TRIPS Agreement.
Regarding the relationship between Article 31 and Article 27.1, we reiterate that both sets of provisions address different matters and circumstances. As stated in the paper co-sponsored by developing countries, Articles 27.1 and 28 do not limit the right of Members to issue compulsory licenses. We do not believe that these provisions prohibit the grant of compulsory licences in cases where the patent fails to be worked or is insufficiently worked. As with all other provisions of the TRIPs Agreement, Articles 31 and 27.1 should certainly be read in light of the objectives and principles of the TRIPs Agreement.
Under Article 31(b), requirement to obtain authorization from the patent holder can be waived in cases of national emergency, extreme urgency and for public non-commercial use. The US reading of this provision seems to suggest that the application of the waiver depends on the time element. It is clear that Article 31(b) is not limited to a question of time, but rather is dependent on situations of critical and extreme importance in which governments deem it necessary to issue compulsory licenses. In this respect, governments have the prerogative to determine when a situation constitutes one of national emergency or extreme urgency.
The Africa Group has already stated its understanding that legitimate grounds for the issuance of a compulsory license may include the following: (1) where there is non-working or insufficient working of a patent; (2) for the importation of a product under patent protection; (3) for the export of a product produced under compulsory licence; and (4) for a foreign manufacturer to produce goods intended for the market of the Member issuing the license. We also said that with respect to item (4), Members should undertake to recognize and give due effect to such compulsory licenses. We note that the EC has referred to such an interpretation and we look forward to discussing this issue to secure consensus on this point.
As regards “parallel imports”, we believe that a restrictive view of Article 6 will only work towards limiting access to affordable medicines. Article 6 confers upon Members the right to adopt the principle of international exhaustion of rights in their national legislation. Article 6 is a crucial element in the balance of rights and obligations in the TRIPS Agreement, and should be regarded as an essential tool in a country's arsenal of national health policies. This fact is evidenced in the practice of certain developed countries.
We further wish to clarify that parallel importing is allowed under the TRIPS Agreement in several circumstances including the following: (1) where the patented product has been marketed in another country, by the patent holder or with his consent, or (2) where the product is sold in another country under a compulsory license, or (3) where the product is marketed in another country through other legitimate means without the authorization of the patent holder (such as where the product is not patent protected in the exporting country).
The Africa Group also wishes to reiterate its position that on-going discussions and initiatives in other fora should not prejudice the rights of governments to adopt policy options available under the TRIPS Agreement. Therefore, the discussions on the global tiered pricing scheme should not affect the affect the right of Members to adopt parallel import measures.
Preparatory work for Doha
In view of the wide support for the TRIPS and public health issue to be addressed at the Doha Ministerial Conference, we believe that it will be appropriate for Members to consider the course of action to be pursued. In our opinion, we think that our work in the TRIPS Council should be co-ordinated with that of the preparatory process for the Doha Ministerial Conference.
Mr Chairman, for this purpose, we would recommend that you begin to initiate the necessary processes to identify the elements for inclusion into the Doha Ministerial Declaration. From our perspective, the vital elements would include the following: