HIV / Aids - A Special Focus on Children in Kenya

	What is a Compulsory licence? The term used when a government grants a licence to a company for local production without permission from the patent holder, on grounds of public or national interest What are Essential drugs? WHO has a model list of essential drugs selected for their efficacy, safety and price. This list meets the priority health needs in a given country or region, and evolves to take account of changing situations. What is Generic drug? This is a pharmaceutical product, usually intended to be interchangeable with the innovator product, which is generally manufactured without a licence from the innovator company, and marketed after the expiry of patent or other exclusivity rights. Generic drugs are marketed either under a non-proprietary or approved name, rather than a proprietary or brand name What is Intellectual Property Rights? Intellectual property rights are granted by the State for the exclusive exploitation of intellectual creations. They fall into two categories: those rights relating to industrial property (invention, patents, industrial designs and models, marks, and geographical appellations), and those relating to literary and artistic property (copyright). The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) covers the whole domain of intellectual property law. What is a Licence? This is a contract whereby the holder of an industrial property right cedes to a third party, in whole or in part, the enjoyment of the right to its working, free of charge or in return for payment of fees and royalties. What is Parallel imports? This is the importation of a drug from a third country, where it produced or sold with the consent of the patent-holder. Purchasing from the cheapest source can save a country substantial sums. What is Patent? This is a title granted by the public authorities conferring a temporary monopoly for the exploitation of an invention upon the person who reveals it, furnishes a sufficiently clear and full description of it, and claims this monopoly. Why do major pharmaceutical companies charge so much? Major pharmaceutical companies argue that their prices reflect the amount of research and development required to manufacture the drug. However, though it is not always easy to tell exactly how much money is spent by large pharmaceutical companies in different areas, much of their profits are thought to go on executive salaries, publicity, advertising, promotion, corporate sponsorship and branding, rather than R&D. Why don’t more countries with AIDS epidemics produce their own drugs? Any country wishing to produce generic drugs faces similar problems to India, unless they are a ‘least developed’ country that doesn’t have to implement TRIPS rules until 2016 (and even then, many already have some form of established patent laws). As well as problems with IP, there are many practical issues to be overcome when establishing generic manufacturing capacity too. Pharmaceutical industries require expertise and substantial resources to set up, as well as a readily available source of basic raw ingredients, good infrastructure and a skilled workforce. A method of regulating drugs is also needed within any country that produces them. At present the WHO does run a very successful scheme to assess generic drugs on a global scale and ensure they are bioequivalent (i.e. the same in potency and effectiveness) to their proprietary counterparts, but even they stress that they are not a regulatory or drug-safety body and should not be treated as such. Generic production can also give rise to political difficulties. Any country that copies drugs originally manufactured by a large Western nation may risk a lack of investment from that nation and potential cuts in bilateral aid. The US in particular sees generic manufacture as damaging international trade and American company profits. To avoid this, it is therefore trying to set up “TRIPS Plus” legislation in the form of bilateral free-trade agreements in many nations (see below). What is ‘TRIPS Plus’? 'TRIPS Plus’ laws are those that go beyond the requirements of TRIPS to protect intellectual property. Such laws are often drawn up as part of ‘bilateral free trade agreements’ with the United States. Is there any other way to get round a patent, other than a compulsory licence? Major pharmaceutical companies can decide to bypass the TRIPS system and make it easier for their drugs to be produced generically by issuing voluntary licenses. This basically means that the patent holder allows other people to copy their drugs under certain conditions. Obviously pharmaceutical companies are not going to do this as it means they take a significant cut in profits. But they are a valid option in some circumstances and often seen as preferable to a compulsory license, which may not allow the original drug producer to negotiate any royalties or conditions. Are there any benefits to TRIPS? The purpose of TRIPS is arguably to encourage research and development, and in theory, this applies to generic manufacturers as well as brand-named companies. There are some that believe that by making the simple 'reverse-engineering' of other company's drugs more difficult, generic drugs manufacturers will start to invest more in research and development, and will ultimately come up with original low-cost medicines themselves. Is there any alternative to TRIPS? Some have suggested that the only way forward is to abolish the TRIPS system for medicines altogether, and replace it with an alternative form of remuneration and reward for innovative research and development. Alternative ideas have included R&D ‘taxes’, public-private partnerships and ‘prize funds’. However, such concepts are controversial, and are unlikely to be implemented or even considered by the WTO for a number of years. List of sources World Health Organisation, November 1977, Geneva, November 1997, Globalisation and access to drugs: Implications of the WTO/TRIPS Agreement, German Velasquez and Pascale Boulet, `WHO Action Programme on Essential Drugs Health Action International, http://www.haiweb.org/ Medicins Sans Frontieres, http://www.msf.org/ Consumer Project on Technology, http://www.cptech.org/ Back to top