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South African Health Technologies Advocacy Coalition

Update on Covid-19 Therapies – PATH and SAHPRA webinar

The South African Health Products Regulatory Authority (SAHPRA) in partnership with experts hosted an hour-long virtual webinar titled “Update on Covid-19 Therapies”, moderated by Sibusiso Hlatjwako, PATH’s Country Representative in South Africa.  The webinar took place on 21 February 2022 and was attended by 181 participants including South African and regional public, policy makers, research institutions, development partners, civil society, public health experts and the media. The webinar provided a platform for dialogue and information sharing on scientific evidence and regulatory guidance in terms of COVID-19 therapies.  The expert panel shared information on regulatory requirements for Covid-19 vaccines and therapies, current SA recommendation of COVID-19 therapies and vaccines, emerging data on the effectiveness of Covid-19 therapies and lastly, global recommendations on use of vaccines and therapies for management of Covid-19.

SAHPRA CEO Dr Boitumelo Semete- Makokotlela highlighted the different types of mechanisms that SAHPRA utilizes to authorize products as guided by the Medicines and Related Substances Act. She emphasized that SAHPRA is currently sitting with a healthy pipeline of COVID-19 therapies that are either in review or have been approved.

Co-chair of the National Essential Medicines List Committee (NEMLC) and Chair of the NEMLC for COVID-19, Prof Andy Parish contextualized the difference between registration decision which SAHPRA makes and purchasing decision which the National Department of Health (NDoH) makes. He noted that medication registration ensures safety and efficacy and that a defined and rigorous process to support state purchasing decision is followed which takes into consideration other factors such as equity, implementability, cost effectiveness, affordability, consideration of competing products and lastly, quantification of benefit in terms of clearly defined pre-determined patient relevant outcomes.

Dr Jeremy Nel, member of the Ministerial Advisory Committee (MAC) on COVID-19 therapeutics and NEMLC MAC on COVID-19 shared topical COVID-19 therapies which NEMLC MAC recently reviewed, and highlighted reasons why recommendations for or against such therapies were made.

SAHPRA Board Chair, Prof Helen Rees described the local framework followed in order to introduce a particular product into the country and how that framework compares to global frameworks. She emphasized the importance of working closely with the World Health Organization (WHO) and other regulatory authorities to ensure safety of all therapeutics and collectivize emerging data around vaccine safety.

 

  • The webinar attracted media attention including articles by local media such as News 24, Daily Maverick..
  • Included here is a link to the discussion
  • Presentations shared during the webinar can be found here

 

 

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