't Hoen, Ellen, von Schoen-Angerer, Tido, The World Today
Around three million people living with AIDS indeveloping countries have access to treatment, a ten-fold increase in just a few years. A key factor in this dramatic achievement was the availability of low-cost drugs produced in India, the pharmacy of the developing world. Companies there could produce AIDS drugs generically because the country did not grant medicine patents until 2005. However, this is now changing. India has begun granting patents on medicines to meet its obligations under the 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The prices of newer essential medicines are likely to rise, threatening the viability of many AIDS treatment programmes - and access to medicines more broadly. An international patent pool for essential medicines could help address this looming crisis.
tHE IDEA BEHIND A PATENT POOL IS THAT different patent-holders, such as companies, universities and research institutes, would make their patents available to others on a non-exclusive basis through the pool. Generic manufacturers could then access patents in the pool to producemedicines, and tomake further improvements to them. Patent holders would receive royalties fromthose using the patents.
Recently UNITAID, a new multilateral financing mechanism for the purchase of medicines, has taken the initiative to develop an international medicines patent pool through which medicine patents could be made available to produce generic versions of AIDS drugs. It could also ease the development of adapted formulations such as three-in-one combination pills andmedicines for children.
Any qualified company that wanted to use the inventions could get a licence from the pool. The UNITAID pool would be voluntary, and the resulting medicines would be available only in developing countries.
Under the scheme the products cannot 'leak' into western markets because they are produced by a third company under its own name and possibly brand. Such a company would have to ask for marketing authorisation in countries where the products are under patent and where the pool licenses would not be valid. If they did this they would immediately be confronted with legal action by the patent holder. This is why today, for example, you do not see Indian generic antiretrovirals in Europe or the US. The same would be the case for the generics produced under pool licences.
WHY IS A POOL NECESSARY?
Many patients need access to newer AIDSmedicines, either because they are safer treatment options, or because drug resistance renders older drugs less effective. However, newer drugs are widely patented, including in key producing countries such as India.
As a result, the prices of AIDS medicines are on the rise again. At $600-1000 per patient per year, using originator products, the improved first-line treatment recommended by the World Health Organization (WHO) costs six to ten times as much as the currently most widely used regimen. Furthermore, children's needs continue to be overlooked: of the 22 antiretrovirals available, nine are not approved for paediatric use and seventeen are not available in paediatric formulations.
The high cost of newerAIDS drugs has led to trade disputes when countries have decided to set patents aside through compulsory licensing to access lower cost generic drugs. High profile political conflicts over intellectual property rights involving the United States, the European Union and patent holding pharmaceutical companies on one side, and Thailand, Brazil, SouthAfrica or other developing countries on the other, have drawn attention to this issue in recent years.
The patent pool would provide a more predictable way of managing medicines-related intellectual property by easing the licensing process to achieve two main objectives: to lower the price ofmedicines by encouraging competitive production, and to stimulate development of combination pills that can be more easily taken by the patient. …