SAHPRA Counters ‘Falsehoods’ Circulating over Its Draft B-BBEE Policy
In a press release, the South African Health Products Regulatory Authority (SAHPRA) has hit back over what it terms “unfounded fallacies and misrepresentation” that has been “churned out by some media organisations without verification” over its draft B-BBEE Policy.
SAHPRA states that this policy “is proposed in order to comply with requirements of the Broad-Based Black Economic Empowerment Act, 53 of 2003, in particular Section 10(1)(a), which demands of all state entities to enact policy that can encourage inclusive economic participation.”
It states that the draft B-BBEE policy does not set “racial requirements” for the registration of medicines, as the first falsehood suggests, stating that it is not reflected in any of the documents.
The second falsehood is that “SAHPRA will use the B-BBEE to assess medicine registration applications and thus affect access to medicines”, which it says is a deliberate misrepresentation. The product registration processes “would continue to solely rely on the safety, quality, efficacy, and performance of the health products.”
The third falsehood is that the draft policy is aligned with NHI, seeking to exclude certain persons from state procurement. SAHPRA says that the policy is a move develop sector codes and/or criteria to comply with the B-BBEE Act, as has been done in other sectors of the economy.
SAHPRA states that the fourth and final falsehood is that the policy will deny participation by pharmaceutical SMEs as they may be unable to get B-BBEE certificates. The agency contends that compliance affidavits will be an acceptable alternative, and that in any case, the B-BBEE level of a business does not affect the medicines registration process – which will remain the case even after policy implementation.
