Access to essential drugs is a human right
Access to essential drugs is part of the human right to health. Access to essential drugs depends on: (1) rational selection and use of medicines (2) sustainable adequate financing (3) affordable prices and (4) reliable health and supply systems. Since most poor people in developing countries currently pay for health care, including drugs, out of their own pockets, access to medicines is particularly sensitive to cost. Governments, the UN family, the private sector and civil society each have vital roles and responsibilities in achieving universal access to essential drugs. (See Box 5.)
Patent protection has been an effective incentive for research and development for new drugs
Patent protection has been an incentive for research and development for new drugs. But questions remain as to whether the patent system will ensure investment in medicines needed by the poor. Of the 1223 new chemical entities developed between 1975 and 1996, only 11 were for the treatment of tropical diseases. The market fails when it comes to ensuring adequate pharmaceutical research and development (R&D) for neglected diseases such as malaria, a range of other tropical diseases and tuberculosis. Strong public sector involvement, including through public-private partnerships, is necessary to ensure development of new drugs for developing country priority health problems.
Affordability of essential drugs is a public health priority
Current financial resources are woefully inadequate for meeting the health care and medicine needs of the world’s poorest populations. Governments, donor agencies and development banks all have a vital role to play in increasing those resources. But affordable prices are also very important.
Among the four elements needed to ensure access, the affordability of essential drugs - specifically those still on patent - is most likely to be affected by trade agreements. Patent protection awards exclusive rights to an invention and prevents generic competition. But poorer populations in developing countries should not be expected to pay the same price as do the wealthy for newer essential drugs. TRIPS-compliant mechanisms can be used to lower drug prices.
Other options to improve affordability include exchange of price information; price competition and price negotiation within public procurement and insurance schemes; price controls; reduced duties and taxes; improved distribution efficiency; reduced distribution and dispensing costs and reduced marketing expenses.
Essential drugs are not simply another commodity - TRIPS safeguards are crucial
WHO supports its Member States in the use of WTO/TRIPS-related safeguards, as appropriate, to enhance affordability and availability of existing medicines, while not discouraging the development of needed new medicines. These safeguards include setting standards for patentability which reflect public health concerns, legislative provision for compulsory licensing, exceptions to exclusive rights and other measures which promote generic competition, and extension of the transitional period. Parallel importation of a patented drug from countries where it is sold more cheaply can also be authorized by governments.
Based on available experience, WHO does not recommend applying TRIPS-plus requirements or extending TRIPS requirements to non-WTO Members before the public health impacts of so doing have been fully assessed.
Box 5 - WHO perspectives on access to drugs
1. Access to essential drugs is a human right.
2. Essential drugs are not simply another commodity - TRIPS safeguards are crucial.
3. Patent protection has been an effective incentive for research and development for new drugs.
4. Patents should be managed in an impartial way, protecting the interests of the patent-holder, as well as safeguarding public health principles.
5. WHO supports measures which improve access to essential drugs, including application of TRIPS safeguards.
Countries must develop informed approaches to health and trade
Countries with least capacity for interpreting and acting on international trade agreements have most at risk in terms of access to medicines. WHO will continue to provide independent data and technical assistance to countries to help them develop informed approaches to trade and health at national, sub-regional and regional levels. Countries are advised to carefully monitor the implementation of the TRIPS Agreement in order to formulate comprehensive proposals for the future review of the TRIPS Agreement as provided for in Article 71:1. A network of legal experts who have specialized knowledge and understanding of international trade agreements, pharmaceuticals and public health is also being developed as a resource for developing countries.