South American Ministers vow to avoid TRIPS-plus measures

The Ministers of Health of ten South American countries have issued ajoint declaration on intellectual property committing themselves toavoid 'TRIPS plus' provisions in bilateral and regional trade agreements,to facilitate the use of compulsory licensing and parallel importing and toavoid broadening the scope of patentability and the extension ofpatentable areas.

Explaining the rationale for their commitments, the Ministers said there wasa significant increase in drug prices which affects government programmesand consumers. They attributed this as a consequence of the patent systemwhich affects health products that are essential for the prevention andtreatment of serious public health conditions, leading to the worsening ofthe problem of access to essential drugs.

They pledged to continue regional dialogue on IPRs and access to drugs,leading to measures 'that ensure the supremacy of the public interest overcommercial concerns.'

The Declaration of Ministers of South America over Intellectual Property,Access to Medicines and Public Health was adopted in Geneva on 23 May by theHealth Ministers of Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador,Paraguay, Peru, Uruguay and Venezuela.

The ministers met on the sidelines of the World Health Assembly meeting herethis week. Intellectual property rights is a major agenda item at the WHA,which will discuss the report of the WHO Commission on IntellectualProperty, Innovation and Health, and negotiate two resolutions relating toIPRs and health related research and development.

The draft resolutions are strongly supported by developing countries, whilesome developed countries have been opposing many parts of the drafts.The South American Ministers' Declaration said that access to medicines andcritical raw materials is an integral part of the right to health, which isa basic human right of every individual and a fundamental prerequisite thatgovernments have a duty to ensure.

Medicines and critical raw materials are key in the healthcare of people.Nonetheless, large populations particularly people in developing countrieslack or have very limited access to these health tools.

The provision of patents in the pharmaceutical sector has gained increasedrelevance in the region since the enforcement of the WTO's TRIPS Agreement.The Ministers said they are aware of the soaring burden of diseases andconditions that disproportionately affect their countries, and particularlythose illnesses that mostly affect women and children, as well as of thehealth problems that are emerging or re-emerging, including neglected andnon communicable diseases.

Significant price increase is being recorded in the area of governmentprogrammes related to pharmaceuticals and in the direct costs to consumers,as well as in the market prices, said the Declaration. It added that this isa consequence of the patent system which affects health products that areessential for the prevention and/or the treatment of serious public healthconditions, leading to a deterioration of access to essential drugs.

The Ministers said their countries have in different ways adopted all theflexibilities and safeguards in their national legislations, as provided bythe TRIPS Agreement and as reiterated in the Doha Declaration on TRIPS andPublic Health.

They added that a growing concern is emerging globally, made explicit inseveral Resolutions and Declarations by international and intergovernmentalbodies, in relation to governments' responsibility to grant access toessential medicines and tools to respond to public health needs.

Both in the Andean countries' group and in the MERCOSUR, Ministers of Healthhave developed their work on the issue of access to essential medicines,thereby considering aspects of intellectual property and public health.The Declaration said a continued dialogue must be fostered at the regionallevel concerning the impact of intellectual protection on access to drugs,leading to the adoption of concerted measures in order to ensure thesupremacy of the public interest over commercial concerns.

In the action part of their Declaration, the Ministers declared theircommitment to undertake 7 sets of actions.

First, they committed to promote the implementation of the Doha Declarationon TRIPS and Public Health in their own countries (and particularly thedecision of the TRIPS Council (Decision IP/C/W/405, dated 30/08/2003), inrelation to the provisions regulating paragraph 6 of the Declaration),including the granting of compulsory licences and use of parallel importingmechanisms.

Second, they committed to promote public awareness about the importance ofIPRs and Public Health in terms of the successful implementation of thesafeguards and flexibilities included both in the TRIPS agreement and in theDoha Declaration.

Third, they committed to strengthen international cooperation initiativesseeking technological capacity by means of (a) promotion of strategicalliances for technology transfer; (b) promotion of strategic alliances forthe development of science, technology and innovation; and ( c) creation ofa Technical Assistance Network for their countries, to be limited to issuesof intellectual property that are relevant to health.

Fourth, they committed to maintaining the flexibilities provided in theTRIPS Agreement in bilateral and regional agreements, while seeking to:

-- facilitate the use of compulsory licences, parallel importing and 'Bolarexceptions';

-- avoid the broadening of the scope of patentability and the extension ofpatentable areas (for example: therapeutic methods, plants and animals), andsecond uses;

-- avoid the linkage between the granting of patents and the granting ofmarketing approval, in addition to avoiding any other clause that mayinclude 'TRIPS plus' arrangements.

[The process of marketing approval of drugs is undertaken by the healthauthorities, and the process usually involves safety and efficacyrequirements; however there have been pressures by the United States innegotiations on bilateral trade agreements that marketing approval forgeneric versions of drugs be denied if there are branded versions of thedrugs that have been granted patents.]

Fifth, they committed to seek the active role of their Ministries of Healthin the negotiation of bilateral trade agreements, in the negotiation amongregional groups as well as in the process of modification, updating andconsolidation of national intellectual property rights norms, by means of:

-- affirming the needs of the health sector with technical supports, basedon the Doha Declaration on TRIPS and Public Health, and the UN MillenniumDeclaration;

-- training health professionals in the domain of IPRs, including theircurrent and future repercussions with regards to access to essentialmedicines.

Sixth, they committed to promote and support the continued internationaldialogue on the impact of patent protection on access to essential medicinesand critical raw materials, by means of research initiatives and exchangesof experiences.

Seventh, they recommended the promotion of studies to monitor drug pricesand the effects of the TRIPS Agreement in the area of public health in theircountries, with the aim of identifying alternatives to the current systemthat may contribute to the promotion of innovation and the transfer oftechnology, while favouring social appropriation at affordable cost.