Compulsory Licensing of Pharmaceutical Products & Access to Essential Medicines in Developing Countries
Independent thesis Advanced level (degree of Magister), 10 points / 15 hpStudent thesisAlternative title
Tvångslicensering av patenterade läkemedel och tillgång till livsnödvändiga mediciner i utvecklingsländer (Swedish)
For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs.
Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world.
By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.
Place, publisher, year, edition, pages
Ekonomiska institutionen , 2005. , 53 p.
Compulsory Licensing, TRIPS Agreement, 30 August Decision, Patents, Pharmaceutical Products, Pharmaceuticals, Medicines, AIDS
Law (excluding Law and Society)
IdentifiersURN: urn:nbn:se:liu:diva-5488ISRN: LIU-EKI/AJP-D—05/028—SEOAI: oai:DiVA.org:liu-5488DiVA: diva2:21332