The South African Health Products Regulatory Authority (SAHPRA) has rejected what it calls a misinformation campaign related to its draft B-BBEE Policy, which it says is a result of a “robust consultation process with all material stakeholders”.
MedicalBrief reports that in a statement on its website, the regulator said the “misinformation campaign” was premised on “deliberate falsehoods that do not exist”.
Certain misrepresentations, on which the draft policy had clearly expressed itself, had been addressed by the SAHPRA executive with stakeholders and interested parties at engagement meetings as part of the consultation process, the most recent being in June 2024, attended by more than 300 delegates from across the health products industry.
SAHPRA addresses all the of falsehoods currently in circulation:
Falsehood 1: SAHPRA’s draft B-BBEE policy sets “racial requirements” for the registration of medicines
Truth: The draft policy has not set any quotas for the ownership of pharmaceutical businesses based on race or gender. This is not within SAHPRA’s mandate and does not exist in any legislative frameworks that govern SAHPRA’s work and/or those that SAHPRA is responsible for implementing.
This lie is dismissed with the contempt it deserves, as it lacks any basis in facts and does not exist anywhere within SAHPRA documents.
Falsehood 2: SAHPRA will use the B-BBEE to assess medicine registration applications and thus affect access to medicines
Truth: This is a deliberate misrepresentation of SAHPRA’s draft B-BBEE Policy. The draft policy clearly and prominently indicates that this would not be the case, and that SAHPRA’s health products registration processes would continue to solely rely on the safety, quality, efficacy, and performance of the health products.
Any insinuations to the contrary are mischievous and do not exist in the policy currently or in SAHPRA’s future plans.
Falsehood 3: The draft B-BBEE policy is aligned with the National Health Insurance and seeks to exclude certain persons from state procurement
Truth: The draft policy seeks to ensure that the pharmaceutical industry moves towards developing sector codes and/or criteria similar to what has been successfully implemented in various other sectors of the economy including agriculture, mining, finance, tourism, and defence, among others. This is in compliance with the requirements of the B-BBEE Act and has no bearing whatsoever on any assumed conspiracies.
Falsehood 4: The policy will deny participation in the pharmaceutical industry by SMEs as they may not be able to acquire B-BBEE certificates
Truth: SAHPRA is on record reiterating the following facts:
B-BBEE compliance affidavits by small businesses will be acceptable in the place of B-BBEE certificates; and
The B-BBEE level of a business is of no effect in the medicines registration process, and this will stay the case even once the policy is implemented.
The policy seeks to increase participation by previously marginalised persons and has no intent whatsoever to decrease participation by or exclude any persons based on race or gender.
SAHPRA is on record indicating this, and this is also clearly stipulated in the policy.
SAHPRA remains committed to executing its legislative mandate and all Health Product registration processes in line with its core purpose, to assess and register medicines, medical devices and in-vitro diagnostics (IVDs) in line with the requisite standards to protect the health and well-being of South Africans – being to ensure the safety, efficacy, and quality of health products.
SAHPRA invites all stakeholders and interested persons to peruse the draft policy available on the SAHPRA website at https://www.sahpra.org.za/documents-for-comments/ and submit substantiated comments by 9 September 2024.
See more from MedicalBrief archives:
SAHPRA policy seeks B-BBEE compliance for healthcare licence approvals