The following statement was delivered at the 19th session of the WIPO Standing Committee on the Law Of Patents (SCP) after presentations by the secretariats of WIPO, WHO and WTO on the trilateral report.
26 February 2013
Thank you Chair and we take this opportunity to thank the Committee for providing KEI the opportunity to comment on the trilateral report by the Secretariats of WHO, WIPO and WTO on Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. We would like to limit our remarks the following two points: 1) cost-sharing approaches to implementing Article 39.3 of the TRIPS Agreement and 2) the human rights dimension in relation to de-linkage and the R&D treaty.
With respect to obligations of WTO members to implement Article 39.3 of the TRIPS Agreement, the report states thats:
During the Uruguay Round negotiations, the option of making data exclusivity an explicit obligation under the TRIPS Agreement was discussed, but negotiators instead adopted the general wording of the current Article 39.3.The report makes it clear that although making an explicit reference to data exclusivity was mulled in the Uruguay Round negotiations, this position did not receive sufficient support and thus, adopting the more general wording of the current TRIPS Article 39.3 was the only acceptable option for the Uruguay Round negotiators.
Perhaps the most interesting part of the report’s treatment of test data protection is in its description of state practice in implementing Article 39.3. The trilateral report describes the concept of cost-sharing as an alternative to data exclusivity which would permit the reliance on originator data provided that the “generic supplier participates in the costs of generating the data”.
The report notes that,
The United States, for example, provides both data exclusivity and a mandatory data compensation system of this kind in relation to data submitted in applications for regulatory approval of pesticides (but not pharmaceuticals). The European Free Trade Association (EFTA)–Korea FTA (Article 3, Annex XIII) also admits a compensation scheme as an alternative to data exclusivity.Countries currently involved in free-trade and plurilateral trade agreements may want to further examine the cost-sharing approach.
Chapter II A(1) deals with the human rights dimension in relation to trade rules and intellectual property. The report presents the human rights framework as an “important mechanism to further the public health policy goals of ensuring and improving access to medicines for those who are most in need” in light of the double burden of infectious and noncommunicable diseases faced by low and middle-income countries Perhaps the most surprising portion of the report’s language on human rights is contained in the following passage which states:
In the context of neglected diseases where innovation in medical technologies has not kept with the needs of developing countries, the right to health includes an obligation for states to promote R&D of new medical technologies.
This human rights dimension should be at the forefront of current international discussions to “secure an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries”.
In its treatment of these WHO discussions, we note the trilateral report’s emphasis of the de-linkage concept. The report described de-linkage in the following manner:
One important concept that evolved from this discussion is the concept of delinking price of the final product from the costs of R&D. This concept is based on the fact that patents allow developers to recoup the costs and make profits by charging a price in excess of the costs of production. This way of financing R&D is viewed as constituting a barrier to access to medicines in countries where populations pay out of their own pockets for medicines and thus cannot afford to pay high prices. The principle of delinking is based on the premise that costs and risks associated with R&D should be rewarded, and incentives for R&D provided, other than through the price of the product.We would would urge the SCP to further analyze and examine the de-linkage and R&D treaty concept in future discussions on patents and health.