Statement on threats levelled at SA Health Products Regulatory Authority

We note with extreme concern the unwarranted accusations levelled against the South African Health Products Regulatory Authority (SAHPRA) recently, relating to its ongoing evaluation of several vaccine candidates for approval in South Africa.

The Economic Freedom Fighters (EFF) has recently alleged, without evidence, that SAHPRA has “disallowed” registration of the Sputnik V and Sinovac (CoronaVac) vaccines because SAHPRA is “captured”, “controlled by the West’s pharmaceutical establishment” and “used by politicians and major capitalist interests”.

This reckless rhetoric echoes similar attacks on the institution by parties such as AfriForum and special advocacy groups and lobbies unhappy with SAHPRA’s evidence-based stance on ivermectin, alleging that the institution was “irresponsible”, “biased” and abetting the “destruction of lives”.

On 18th June, the EFF demanded that SAHPRA finalises the approval of both these vaccines within seven days, failing which it threatens “militant” mass action against the regulator. The party has also reportedly levelled physical threats against SAHPRA personnel and members of its governing board, in a crude attempt to intimidate and bully an independent authority.

We condemn such behaviour and fully support the vital regulatory role that SAHPRA plays in ensuring that all medications and vaccines undergo rigorous examination to assess the safety, efficacy and quality of products prior to them being registered or authorised for use in the country.

It is in the interests of the public that SAHPRA is allowed to exercise its constitutional responsibility to ensure that only medicines where data addressing benefit against harm has been carefully weighed before being approved for use by the public.

It is essential that SAHPRA, as a statutory body, is insulated from untoward political interference and protected from the threats that have recently been levelled against the organisation and its members.

Safeguarding the integrity of a statutory body is a constitutional obligation of the government, and any physical threats against its personnel or governing board members is a law enforcement matter that should be taken up immediately by the relevant agencies.

We affirm the vital importance of SAHPRA’s important regulatory task and call on all members of society who value the role of SAHPRA to refrain from all actions that serve to undermine this function.

Signed,

Wits University Faculty of Health Sciences - https://www.wits.ac.za/health/

South African Medical Research Council (SAMRC) - https://www.samrc.ac.za

Southern African HIV Clinicians’ Society (SAHCS) - https://sahivsoc.org

Progressive Health Forum (PHF) - www.progressivehealthforum.net

South African Medical Association (SAMA) – www.samedical.org

Infectious Diseases Society of South Africa (IDSSA) – https://www.fidssa.co.za/federation- members/idssa

South African Antibiotic Stewardship Programme (SAASP) - https://www.fidssa.co.za/federation-members/working-group-saasp

South African Academy of Family Physicians - https://saafp.org

Gauteng General Practitioner Collaboration (GGPC)

Public Health Association of South Africa (PHASA) - https://phasa.org.za

Health Justice Initiative (HJI) - https://healthjusticeinitiative.org.za

People’s Health Movement – South Africa (PHM-SA) - https://www.phm-sa.org

SAPHRA Press Release - 24 June 2021