The Pharmalaw

By Karen du Toit

I submitted dossiers in accordance with the revoked Regulations as amended in 2013: 

9 December 2019

What to do next?

The General Regulations to the Medicines Act published on 25 August 2017 repealed the General Regulations published on 10 April 2003 (Regulations 2003), as amended in 2013. Section 48C of the Regulations 2003, which contained call up procedures and right of sale provisions, has been omitted in the Regulations, 2017.

What are the implications for those who already submitted dossiers?

In order to determine the effect, if any, of the repealed legislation, the provisions of the Interpretation Act 33 of 1957 have to be taken into consideration. Unless the contrary intention appears, the repeal shall not inter alia affect the previous operation of any repealed law or anything duly done under the law so repealed.

This notion is supported by the common law presumptions that legislation does not contain futile or meaningless provisions and that legislation is not presumed to be retrospective in nature. Continued processing and finalisation of dossiers submitted under Regulations, 2003 will attest to the
fact that the process started under Regulations, 2003 is valid and will be completed.

The notion that original deadlines for submission of applications for registration prescribed by regulation 48C of Regulations in 2013 were deleted by the General Regulations in 2017 thus does not hold water from a legal perspective as set out above.

Furthermore, should this process not be completed according to the requirements and timelines set at the relevant time, members of the industry who adhered to this process will be severely prejudiced.

If you submitted and are wondering, where to from here, we would like to hear from you.

Disciplines, pertaining to which professions?

5 December 2019

The General Regulations 2003, as amended 2013 called up discipline-specific complementary medicines (DS CMs) falling within the ambit of the narrow definition provided.

The definition of DS CMs in the Regulations 2003 required that DS CMs should be used in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982.

Which professions?

The Allied Health Professions Act defines allied health professions as the profession of Ayurveda, Chinese medicine and acupuncture, chiropractic, homeopathy, naturopathy, osteopathy, phytotherapy, therapeutic aromatherapy, therapeutic massage therapy or therapeutic reflexology, or any other profession the Minister may, at the request of the council, by notice in the Gazette declare the provisions of this Act to be applicable to. The discipline of Unani Tibb has been included in 2007.

Where do I find a description of the practice of these professions?

Since the definition in the Regulations 2003 required CMs to be used in accordance with the practice of the above professions, the scope of practice associated with the professions as provided for in the regulations to the Allied Health Professions Act will have to be examined in order to determine whether a DS CM is actually used in accordance with the practice of the professions.

Again…which professions?

However, the definition of DS CMs has been widened in 2017 and disciplines are currently determined by SAHPRA and not the Allied Health Professions Act. Interestingly, there seems to be discrepancies between the six major disciplines recognised by the South African Health Products Regulatory Authority (SAHPRA) namely Aromatherapy, Ayurveda, Homeopathy, Traditional Chinese Medicine, Unani Tibb and Western Herbal Medicine and the disciplines recognised by the Allied Health Professions Council.

In order to obtain clarity, the disciplines determined by SAHPRA will have to be defined in such a way that industry can identify use in accordance with these disciplines. Also, where a discipline is listed and the scope of practice detailed in the Allied Health Professions Act and its regulations but excluded or modified by SAHPRA it may lead to confusion.

If you wish to discuss this matter further, please let us know.