TRIPS and Public Health

Mr. Chairman, India has always been of the view that the Declaration on the TRIPS Agreement and Public Health, adopted at Doha, constitutes a major landmark in the short history of this organisation. It is a landmark because it recognises the primacy of public health needs and the sensitivity of this organisation to the problems faced by the poor in the less developed countries. It is unfortunate that it took us so long to reach a solution in respect of one segment of the Declaration, namely, the mechanism to be put in place to meet the requirements of developing and least developed countries that have insufficient or no manufacturing capacities in the pharmaceutical sector.

I am glad that we are finally seeing the end of this problem. We feel that the apprehensions of some sections of the pharmaceutical industry were largely misplaced. The Declaration clearly indicates that it is intended to address public health problems, afflicting many developing and least developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. While it recognises the importance of intellectual property protection for the development of new medicines, it emphasises the fact that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health and, in particular, to promote access to medicines for all. The Declaration recognises the right of each Member to grant compulsory licences and the grounds upon which such licences are granted and also the right to determine what constitutes a national emergency or other circumstances of extreme urgency.

In our view, there were no grounds also for doubts regarding the manner in which the system established under paragraph 6 of the Declaration would be utilised. This system is intended for use by WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector to address public health problems. We have always maintained that countries with some manufacturing capacity would resort to use of this mechanism only when their domestic industry is unable to meet their needs. There is already existing flexibility under the TRIPS Agreement for issue of compulsory licences and wherever the domestic industry can fully meet at reasonable cost public health needs arising as a consequence of the kind of problems alluded to in the Decision, it would make no commercial sense to import products. Such countries would, however, need to use this facility whenever their domestic industry is incapable of meeting their requirements at reasonable cost or when it is found that domestic capacity is insufficient.

We are also of the view that sufficient safeguards have been provided in the draft Declaration of 16 December 2002 to deal with problems of possible diversion of products and the misuse of the mechanism. We feel, therefore, that there was really no ground for any doubts regarding the operation of the system. The 16 December text was sufficient in itself to deal with all such problems. It may be noted also that this was intended to be a temporary mechanism until amendment of the TRIPS Agreement and that work on preparation of such an amendment was to commence by the end of 2003 with a view to its adoption within six months.

With reference to your statement, Mr. Chairman, we note that in order to promote transparency and avoid controversy, notifications under paragraph 2(a)(ii) of the Decision would include information on how the Member in question had established, in accordance with the Annex that it has insufficient or no manufacturing capacity. It has been clarified to us during the consultations that this does not involve provision of a great deal of technical or other information but only to indicate briefly and concisely the methodology for determination of insufficient capacity and the conclusions that were drawn on the basis of available data.

With regard to the reasonable measures taken to prevent diversion of medicines, special packaging, labelling and/or colouring should be used to distinguish products produced under the Decision, provided such distinction is feasible and does not have a significant impact on price. In general special packaging and/or special colouring or shaping should not have a significant impact on the price of pharmaceuticals. With regard to packaging of active ingredients, it was clarified to us during the consultations that special labelling including indication of the destination country would meet the requirements.

While this is essentially an attempt to respond to special circumstances, any production process would necessarily have a commercial dimension since it involves buying and selling of products. We would expect pharmaceutical companies in all parts of the world to contribute to this noble cause by paring their costs and making available pharmaceutical products at the lowest possible cost to our ailing brethren. We would also expect that the results accruing from this mechanism are not negated by the creation of cumbersome systems that would lead to huge delays in reaching across medicines at reasonable cost to those that need them or discourage Members from using the system for the benefit of the people. In order to make this system successful, sincere collective effort is required on the part of all Members and the entire pharmaceutical industry.

Mr. Chairman, we joined the consensus on this Decision in December last year. We are delighted that today it has been possible for the entire Membership to join.

Return to: CPTech Home -> Main IP Page -> CPTech Page on WTO -> Paragraph Six Page