[Ip-health] South Centre Series on Manufacturing Capacity for Covid-19 Vaccines: The Experience of Butantan-Sinovac

Anna Bernardo Bernardo at southcentre.int
Thu Mar 18 03:32:01 PDT 2021


South Centre Series on Manufacturing Capacity for Covid-19 Vaccines: The Experience of Butantan-Sinovac


23 March 2021, 09-10h São Paulo / 13h00-14h00 CET

Register: https://zoom.us/webinar/register/WN_HWOsFdOOTBaOj9J3v3t-pg

Simultaneous Translation in English, Spanish and Portuguese


Expanding access to Covid-19 vaccines requires scaling up manufacturing capacity. While a number of successful vaccines have been developed in record time, with significant support from governments, the current production capacity is absolutely unfit for global demand. Despite global efforts such as the Covax Facility, most developing countries will not be able to provide wide access to Covid-19 vaccines before 2022 or beyond. Developed countries are also struggling with shortages and major delivery delays. The exclusivities-based model of patents and trade secrets, despite ample public funding for pharmaceutical R&D, allows companies to determine the range of licensees and sublicensees for production, which drastically limits the number of potential producers.


Developing countries’ play a crucial role in the global manufacturing of vaccines. Current leading Covid-19 vaccine producers argue that scaling up manufacturing in developing countries is hindered by lack of capacity, including insufficient technological and human resource skills for emerging mRNA vaccines. This however is not the full picture. There is in fact ample capacity in multiple countries. This series of webinar discussions aims at sharing information about the capacities for vaccine manufacturing in developing countries, how these are built and could be expanded; exchange on concrete experiences in addressing issues of technology transfer, know-how and intellectual property in contractual agreements with Covid-19 vaccine manufacturers; and advance ideas on how the challenges that arise could be addressed.


In the first session, the South Centre has the delight to have the participation of Dr. Ricardo Palacios, Director of Medical Research, and Mr. Tiago Rocca, Strategic Partnerships and Business Development Manager, from Institute Butantan, São Paulo, Brazil, to share the Institute’s experiences with R&D, clinical trials, technology transfer and local manufacturing  based on an agreement with Sinovac Life Sciences for the Coronavac vaccine. In particular, the following guiding questions will serve as basis for the discussion:


– What are the main challenges for developing countries’ governments, public institutions and companies to negotiate effective technology transfer for Covid-19 vaccines (e.g. national laws and regulations, expertise in contractual negotiation, liability and arbitration requirements, available information, financial constrains)?

– What are the main issues to ensure effective technology transfer and what is actually feasible/difficult (e.g. skilled staff, infrastructure, availability of materials for manufacturing, intellectual property rights and trade secrets, size of country and population, size of economy and preparedness for pharmaceutical manufacturing)?

– What are the lessons learned from the Butantan-Sinovac experience in technology transfer? Would they be replicable or not in other developing countries, if so, under which conditions? If not, what could be done to ensure it?

– What are the lessons learned from the Butantan-Sinovac experience in clinical trials? Has it facilitated technology transfer or are they two separate issues? How to ensure that benefits of clinical trials in developing countries really benefit their populations, rather than purely being sites of trials?


South Centre
International Environment House 2
Chemin de Balexert 7-9
PO Box 228
1211 Geneva 19
Switzerland
Telephone: (41 22) 791 8050
Email: south at southcentre.int
https://www.southcentre.int/

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