TWN Info Service on Intellectual Property Issues (Dec23/01)
6 December 2023                                     
Third World Network

Webinar: Improving Drug Regulation for Greater Access to Biologics and Vaccines

Friday, 08 December 2023

8 am US Eastern Time/ 2 pm Central European Time/ 6.30 pm India

Registration: CLICK HERE

Third World Network invites you to a one-hour discussion (with Q&A) on how we can improve the drug regulatory system to create better access to biologics and vaccines. We will be discussing the second chapter of the recent paper from TWN+AccessIBSA: Monopolies on Biologics, including Vaccines.

In the immediate aftermath of a pandemic characterised by monstrous gaps in access to life-saving biologics and vaccines, we will discuss a lesser-known monopoly system, which is conferred by the drug regulatory agencies that regulate these pharmaceuticals. Beginning with recent changes in the way biosimilars can be brought to market, we will discuss the new WHO guidelines, which could reduce by almost two-thirds the cost and time taken for bringing non-vaccine biologics to the market. We will then move to vaccines, and discuss the lack of a similar reform in the guidelines there, as well as the potential for abbreviation of this process by immuno-bridging trials, rather than repeating the full suits of clinical trials. We will also discuss the potential for comparing the equivalence of mRNA vaccines, which stem from the lack of cell-based biology in these products. The authors of the paper will present their analysis, followed by commentary from our invited experts from around the world. The webinar will be introduced by Gopakumar KM, and proceedings will be conducted in English.

Featuring:

Chetali Rao is a Biotechnologist and IP/trade Lawyer working on equitable access to medicines, health technologies and pharmaceutical innovation (India)

Achal Prabhala is the Coordinator of the AccessIBSA project for access to medicines (Bangalore, India)

Michel de Wilde is an International Vaccines Expert (Belgium/USA)

Soumya Swaminathan is the Chair of the MS Swaminathan Research Foundation in Chennai, India and former Chief Scientist, WHO (India)

Barney Graham is a Professor at Morehouse School of Medicine and former Deputy Director of the NIAID's Vaccine Research Center (USA)

One hour long, with presentations followed by Q&A

Based on the recent TWN+AccessIBSA paper: Monopolies on Biologics, including Vaccines- Click Here