New WTO Decision on Patents and Public Health
Uncertainties as to the status and effect of, and need for, the declarations and waivers at Doha and Cancun came to an end yesterday, with a decision of the General Council amending the TRIPS agreement in respect of public health. The decision, which must still be ratified by two thirds of WTO members (by December 2007), is the first amendment of TRIPS, and is a refreshing development for those (such as myself) who thought that, sadly, it would never happen.
A new provision article 31 bis is to be added to TRIPS. This provides that there CAN be export of pharmaceutical products made under compulsory licence. Details are then included about "adequate remuneration" in the light of economic value to the importing country (suspect we might be debating this for some time); and "free movement" of products exported under compulsory within a free trade area mainly made up of LDCs.
An Annex deals with the need to avoid diversion of these pharmaceutical products to other markets, and the Chairman's statement (query its status) includes details of possible labelling and colour coding procedures which could be adopted to reduce the risk of this. The Annex also recognises the importance of competition law and policy and notes that members undertake to co-operate and pay special attention to the transfer of technology and capacity building in the pharmaceutical sector. Could be a long road, but competition is becoming ever present is such instruments.
The statement also stresses the shared understanding of members that this decision is to be used in good faith to deal with public health problems, not to further industrial or commercial policy objectives.
All in all, a highly positive step forward. It is likely that the two thirds approval will be obtained and TRIPS amended. The broader question is the use which may be made of these procedures, as the documents note that this regime will build on the existing ones, in respect of which some countries have committed themselves to not making use of the provisions, and some only in the case of national emergency. Will free trade agreements be used to insist upon further op-outs?
A new provision article 31 bis is to be added to TRIPS. This provides that there CAN be export of pharmaceutical products made under compulsory licence. Details are then included about "adequate remuneration" in the light of economic value to the importing country (suspect we might be debating this for some time); and "free movement" of products exported under compulsory within a free trade area mainly made up of LDCs.
An Annex deals with the need to avoid diversion of these pharmaceutical products to other markets, and the Chairman's statement (query its status) includes details of possible labelling and colour coding procedures which could be adopted to reduce the risk of this. The Annex also recognises the importance of competition law and policy and notes that members undertake to co-operate and pay special attention to the transfer of technology and capacity building in the pharmaceutical sector. Could be a long road, but competition is becoming ever present is such instruments.
The statement also stresses the shared understanding of members that this decision is to be used in good faith to deal with public health problems, not to further industrial or commercial policy objectives.
All in all, a highly positive step forward. It is likely that the two thirds approval will be obtained and TRIPS amended. The broader question is the use which may be made of these procedures, as the documents note that this regime will build on the existing ones, in respect of which some countries have committed themselves to not making use of the provisions, and some only in the case of national emergency. Will free trade agreements be used to insist upon further op-outs?
posted by Dr Abbe Brown at 8:09 am
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