Evaluating the Efficacy of the Patent Compulsory Licensing System to Improve Access to Protected Medicines for Developing Countries During Health Crises

Abstract

Inventors in the medical and pharmaceutical industries can acquire patents to safeguard their products against imitation and unauthorised use by others for a period. Patent laws that promote innovation make it more difficult to produce medicines that might save lives and provide them at reasonable prices. Nevertheless, international agreements and national regulations have attempted to address this gap in order to facilitate access to medicines by adopting a system of compulsory licensing of patented medicines during health crises. This research argued that the compulsory licencing system under TRIPS is ineffective in improving access to patented medicines in developing countries facing health crises. The research focuses on developing countries' access to protected medicines during health crises under TRIPS. It focuses on India and Brazil as developing countries that have the capacity to manufacture pharmaceutical products, and they implemented the obligations of the TRIPS in varying ways. However, Brazil made certain improvements to the system of compulsory licencing of pharmaceutical patents by requiring negotiation with the patent holders of medicines before issuing the licence, while India benefited from gradual implemented of obligations of the TRIPS in improving its health system and manufacturing capability, avoiding it from issuing compulsory licencing of medications even during health emergencies. As facing health crises in developing countries requires access to protected medicines in a timely manner and at reasonable prices, our findings indicate that the existing compulsory licence system is not the ideal way to achieve this purpose. We have concluded that the use of compulsory licence as a threat tool to obtain protected medicines at reasonable prices during health crises seems to be useful for developing countries if the country has adequate manufacturing capacity. Developing countries should also strengthen national policies and mechanisms to reduce the risk of a negative impact and improve access to medications during health emergencies. Developing countries should invest in the development of their capacity to produce essential medicines, as this will strengthen their negotiating position when they use their authority to issue compulsory licence as a threat during health crises. Developing countries without industrial capacities should also invest in building a production capacity for vital medicines. The significance of this research is to improve access to protected medications during upcoming health emergencies and how developing countries can develop their national systems to deal with the compulsory licence system effectively.