On international trade agreements and pharmaceuticals, WHO has five key public health messages.
First, patent protection is a necessary and effective incentive for research and development for needed new drugs. Essential drugs are not just another ordinary commodity. Patents must therefore be managed in an impartial way to benefit both the patent holders and the public. Protectionism has never benefited public health. WHO supports governments to enact national legislation which can draw advantage from more open trade and a better regulated international system. WHO also supports governments in incorporating the safeguards that have been built into the WTO/TRIPS Agreement to protect the rights of the public.
Second, priority-setting for research and development in the pharmaceutical market is imperfect. There are also striking market failures when there is a desperate demand for products that are available - but not within the reach of those in need. WHO has initiated with other partners innovative mechanisms to stimulate research and development in areas of high public health need such as malaria and tuberculosis. WHO is actively encouraging public sector financing for critical public health problems and neglected tropical diseases.
Third, WHO strongly supports the development of mechanisms for preferential low prices for essential drugs in lower-income countries. Lower-income countries simply cannot be expected to pay the same price for essential drugs as the wealthier countries. For governments, industry, and other stakeholders, there is a range of measures which might be used to achieve preferential pricing. But where there is an abuse of patent rights, where patented essential drugs are not on the market, or where a national emergency exists, recourse to compulsory licensing is a legitimate measure consistent with the TRIPS Agreement.
Fourth, WHO supports the implementation of the TRIPS Agreement to ensure prompt availability of generic drugs upon patent expiration. WHO has long promoted the use of generic drugs of assured quality. Experience from countries with “generic-friendly” policies clearly demonstrates that the market competition created by these policies increases affordability of medicines, stimulates true innovation within the research-based industry, and encourages increased production efficiency by the generic industry.
Fifth, trade agreements should not create barriers to trade. An important WTO principle is that technical regulations, standards and assessment procedures should be based on international standards, guides and recommendations. In the area of pharmaceuticals, WHO norms, standards and guidelines represent such international consensus. WHO will actively promote these guidelines.