Access to medicines

Improving poor people's access to essential medicines means strengthening drug policy and health care delivery systems, constructing access-enabling domestic intellectual property legislation, building effective domestic or regional drug regulatory systems, and providing sustainable finance for affordable and effective drugs.

Although the majority of WHO's recommended essential drugs are off-patent products and subject to generic competition, access to newer on-patent drugs is also needed, to combat anti-microbial resistance to TB and malaria, for example, and to treat HIV and AIDS. Issues of access to medicine for all, affordability and innovation require international, as well as national, policy and action.

The World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) impacts access to medicines both by globalising minimum standards of patent protection and by providing key flexibilities for bypassing intellectual property barriers while still providing some compensation to patent holders.

Intellectual property rights, particularly in rich country markets, provide incentive for R&D investment, by conferring patent ownership for a specified time period, thus guaranteeing an exclusive market and supra-competitive pricing. But global incentives to encourage investment in R&D for new products are not ordinarily dependent on small-volume sales in poor countries and even minimal incentives must be balanced by the imperative of affordable prices for poor consumers.

The effect of TRIPS on prices of newer essential medicines and the counter-balancing effects of generic competition are of particular concern for developing countries. Vital flexibilities are set out in principle in TRIPS, to enable poor countries to import patented drugs from the cheapest source (parallel importing), and to compulsorily license generic production to meet a wide range of public health needs.

The importance, indeed primacy of public health, was clarified in the WTO Doha Declaration on the TRIPS Agreement and Public Health and flexibilities for exporting and importing generic medicines pursuant to compulsory licenses were further expanded in the WTO Decision of 30 August 2003 Implementing Paragraph 6 of the Doha Declaration. However, may poor countries do not yet have legal and administrative frameworks in place that would enable them to make appropriate use of available flexibilities, and some of the flexibilities are now being threatened in bilateral and regional trade agreements as well.

Donations, when made according to international guidelines on good practice, can also contribute to access to medicines. Similarly, heavily discounted or differential pricing - where companies voluntarily shape prices to poor consumers' purchasing power - can play an important role in increasing affordability of patent drugs, when arrangements with purchasers are sustainable, predictable and transparent.

However, in the long-run, it is ordinarily competition arising from generic medicines of assured quality that leads to price reductions that dramatically increase access.