Market access challenges and opportunities for Bangladesh pharmaceutical products under TRIPS

Abstract

Pradip Royhan is in the Bangladesh Civil Service, currently on study leave pursuing doctoral studies at Macquarie Law School, Sydney. Developing countries have been motivated by concern that higher levels of intellectual property protection under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) would involve a substantial commitment of insufficient government resources, producing a significant net outflow of royalties to foreign rights holders and increasing domestic prices. Now those countries are more concerned about strong patent protection as they believe that this would be harmful for their emerging pharmaceutical industries and for access to affordable medicines. Bangladesh has been taken as a case study as its pharmaceutical industry is now meeting around 97 per cent of total domestic demand, but it must still ensure TRIPS compliance within the extended period ending on 1 January 2016 if it is not to face negative consequences regarding patent protection and access to affordable medicine. Its compliance does not depend only upon the consequential negotiations but mostly upon Bangladesh domestic regulations and the role of the regulatory agencies responsible for enacting adequate regulations. Based on a qualitative methodology, this article examines the patentability exceptions regarding environmental requirements under TRIPS that might have depressing consequences on Bangladesh pharmaceutical products' market access as a least developed country (LDC). It also explores the market access challenges of Bangladesh's pharmaceutical sectors as a whole by examining the domestic regulations of Bangladesh as well as specific international rules. This research argues for reform of domestic regulations and an accelerated negotiation for further reform in the international rules.