The CTAA, in collaboration with Schindlers Attorneys intends to launch proceedings against the Department of Health (“DOH“) and the South African Health Products Regulatory Authority (“SAHPRA“), in order to challenge the DOH’s/SAHPRA’s unjust and irrational scheduling of cannabidiol (“CBD“). We have invited members of the public, businesses and other civil society organisations to participate in such legal proceedings, however, we are under pressure as the deadline to launch such proceedings is around the corner. We have therefore requested that those interested reach out to us at firstname.lastname@example.org or email@example.com by no later than 23 April 2021.
The current regulation of low-dose CBD products (making no medical claims) as a complementary medicine (implemented on 22 May 2020 by way of amendment to the schedules to the Medicines and Related Substances Act) is, in our view, excessive and creates unjustifiable barriers to entry into the market. Furthermore, product specifications such as the limiting of product package sizes to 600mg of CBD per sales pack and providing for a maximum daily dose of 20mg of CBD, does not seem to be rooted in science. In fact, we wrote to SAHPRA requesting reasons for the 22 May 2020 amendments and, as was expected, we did not receive a satisfactory response. SAHPRA stated as follows:
“The daily dose limit of 20 mg of CBD permitted for complementary medicines, is based on safety data, and consideration of the therapeutic dose for CBD in CBD-containing medicine registered by other regulatory authorities.“
Absolutely no references or specifics were provided for the above statement and therefore the “safety data” relied on by SAHPRA, the source of their conclusion as to what constitutes a “therapeutic dose for CBD”, which registered “CBD-containing medicine” they’re referring to, and who these “other regulatory authorities” are, remains a mystery.
“The amendment, however, recognised the need to regulate the available pack size,s (sic) in order to prevent the misuse of the substance for purposes other than those intended by the Schedules and to guard against accidental overuse.“
Guard against accidental overuse? We were perplexed. What evidence had been relied upon to reach this conclusion? Such vague and unsupported responses confirmed our worst fears; SAHPRA has not relied on any evidence or rationale when composing and implementing these 20 May 2020 amendments. Such action by a public body constitutes a failure of the standards of administrative action and shows that they have not been working in the public’s best interest and is therefore vulnerable to challenge.
SAHPRA went on to confirm that:
“Any person who imports or manufactures a CBD-containing complementary medicine, must be in possession of, or undertake the process of applying for, a licence issued in terms of section 22C(1)(b) of the Medicines Act and must comply with all regulations relevant to complementary medicines, including current Good Manufacturing Practice (cGMP) standards (in line with SAHPRA Guideline 7.02 which will provide amended timeframes for this process to occur);“
Such onerous requirements will no doubt hinder competition and participation in this market. As the CTAA, we are not calling for no quality assurance or safety measures designed to protect the public, however, any such measures must be reasonable and proportional to any potential harm. We wish to set a precedent and put SAHPRA on notice that their decision-making and regulation of cannabis and cannabis related products will be under scrutiny and that arbitrariness and irrationality will not be tolerated by the public.
Our aim is to ensure that we get common-sense regulations which create a workable and sustainable commercial sector, while simultaneously protecting the end user and the public in general. We therefore urge the public and those passionate about creating accessible cannabis markets and a thriving commercial industry to consider our appeal to support the pending litigation against SAHPRA and the challenge the excessive and irrational regulation of the low-dose CBD market.