Economic and Legal Research Commission on the exploitation of pharmaceutical patents

Committee Chairman - Lawyer Giovanni A. Pedde

The ongoing discussions within the WTO Twelfth Ministerial Conference on a possible weakening of the rules of the TRIPS agreement, aimed at facilitating access to COVID-19 vaccines, treatments and diagnostic tests, have rekindled the debate as to what extent the existing intellectual property framework can prevent global access to pharmaceutical products, particularly by lower-income nations and during global health crises. The theme of a balance between public health interest, including access to quality and safe products and technologies, and the needs of a competitive and innovative pharmaceutical industry is not new. But the pandemic has exacerbated conflicting positions, turning the debate into a highly charged political matter for the WTO conference.

Growth and innovation in the pharmaceutical sector is largely dependent on a commercial environment capable of sustaining continuing research and industrial competitiveness. Intellectual property rights function as essential incentives for pharmaceutical companies to continue developing and testing new medicines, as well as to extend the range of applications and safety of existing products. Resulting new inventions may be protected by patents which ensure an exclusivity of use that compensates the high costs of research, development and innovation. At the same time patents render the invention publicly available thus enabling the preparation for generic versions at such time as the patent expires. As long as these conditions are preserved and patent protection is enforced, pharmaceutical companies can often focus significant resources to push the boundaries of science and achieve results in record time, with COVID-19 response being an illustrative example having marked the fastest ever vaccine development.

The possibility that there should be inroads into the rules of the existing TRIPS agreement in connection with the Covid-19 global crisis, so that developing countries could authorize vaccine production without the consent of the rights holder, was suggested by South Africa and India in late 2020 and secured initial backing by the Biden administration before being hampered by the EU, Switzerland and the UK on grounds that this could undermine innovation in the pharma sector. Aside from the specific reference to Covid-19, however, the WTO debate is renewing a wider confrontation on the global utilization of patents and on the need to identify a fair balance between trade and health issues, something that only a widely shared consensus can help to achieve.

The scope and goal of this Research Commission is, in addition to thoroughly framing and examining the economic and legal framework of the subject matter, to sparkle as wide a confrontation and cooperation as possible towards generating proposals potentially suitable to reconcile the recognized public health needs with those underlying intellectual property protection and market dynamics.