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 countries 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.
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.