An Update on The South African Commenplentary Regulatory Environment – 14/11/2020

• The Alliance of Natural Health Products South Africa (ANHPSA), won a high-court case against SAHPRA during the first week of October 2020
• The ruling was against SAHPRA regulating low risk CAMs and Health supplements to the same extent as they regulate prescription-only medicines
• The ruling was suspended for 12 months, which means that the above current regulations effectively, still apply
• What may happen in the next 12 months:
  • SAHPRA has 12 months to come up with better regulations
  • This may be the prime opportunity for Industry Associations to engage with SAHPRA/DoH/SAPC to initiate better CAMs and Health Supplements (HS) alternatives which are based on workable and industry appropriate global norms
  • SAHPRA may well choose to appeal the judgement
  • HPSA may choose to interdict
  • This could be deemed to be a fair judgement in favour of the CAMs and HS industry and validates a different approach by SAHPRA and DoH to more comprehensively engage with industry on fair and appropriate regulatory environment for these products
  • Going forward SAHPRA/DoH will need to undertake a risk-analysis or impact study to determine the risk of any proposed new regulations on an industry that promotes and provides good health and wellness. The onerous requirements for licensing, responsible pharmacist, amongst other major concerns have since 2013, stifled innovation at the heart of CAMS – and had the potential to enforce the removal of tens of thousands of CAMS/HS supplements, safely accessible for years, from South Africans who rely upon them, by personal choice, for the maintenance of health.
• On 19 October, a Notice of Appeal against the above ruling, was published:
  The Minister of Health and the SAHPRA intend to appeal as follow. “TAKE NOTICE that the application to appeal will be made on a date and at a time to be assigned by the Registrar. TAKE NOTICE FURTHER that the Applicant contends that the appeal would have a reasonable prospect of success, on the grounds set out in “Annexure A” hereto”.
• “Annexure A” is a document specifying on how the learned judge erred in his / her findings leading up to the court ruling of 1 October 2020.
• When reading Annexure A, it is not surprising that SAHPRA has not published any changes to the current requirements and timelines for CAMs companies as yet. It is therefore our Understanding, as well as that of other Industry Stakeholders, that CAMs Companies, including New Image SA, still need to apply for an Applicant license by end 2021, whereafter the call-up for product registration will start.
• All indications are that SAHPRA intends to amend the definition of a medicine to include complementary medicines and not to change their requirements for Applicants to obtain a Licence to register their products going forward. This is of course a lengthy process, as the definition is taken up in the Medicines Act and amending an Act takes months to years (in South Africa).
• It was also communicated that an Applicant Licence will be required as of the end of the above deadline – end June 2021 – and that licenses will be uploaded onto the database of Port Health to regulate the importation of Complementary Medicines.