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10 Oct 2020
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VICTORY – HIGH COURT RULES COMPLEMENTARY MEDICINES REGULATIONS UNLAWFUL

Written by:  Anthony Rees (National Chairman: TNHA)

Judgement in the Alliance for Natural Health Products South Africa (ANHPSA) vs. Minister of Health and the South African Health Products Regulatory Authority (SAHPRA) was delivered on Thursday the 1st of October in the Pretoria High Court , and found in favour of the applicant.

In her judgement Judge Elizabeth Kubushi found that not all complementary medicines and health supplements are necessarily medicines requiring pre-approval (registration) by the SAHPRA, and by extension companies selling such products would not be required to be licensed as pharmaceutical importers, wholesalers, or distributors.

It is only when manufacturers sell natural health products and make claims that they can cure a disease, that they could potentially become subject to regulation.

This reinforces the provisions of the Medicines and Related Substances Act of 1965 since in inception over half a century ago.
She found the definitions of complementary medicines and health supplements gazetted in the 2017 General Regulations were inconstant with the definition of medicines in the principle Act, and declared them ulta vires, and therefore beyond the Minister’s legal power or authority.

Par. 124 – ” I’m inclined to agree with the applicant on its point that the Medicines Act does not empower the Minister to regulate all complementary medicines. For complementary medicines to fall within the proper contextual definition of a medicine in the Medicines Act, only those that purport to be suitable for use, manufactured or sold for use for a therapeutic purpose, that is, for the prevention and treatment of a malady, may be regulated. Hence, only those complementary medicines and health supplements that purport to be used or manufactured for use or sale to address the prevention, diagnosis, treatment, mitigation or modification of physical or mental disease ought to be regulated “

In her judgement she relied on a 2006 Constitutional Court judgement in favour of the Affordable Medicines Trust, when dealing with the question of whether the Minister’s actions were ultra vires in similar circumstances. Below is the paragraph referenced in the judgement.

“In exercising the power to make regulations, the Minister had to comply with the Constitution, which is the supreme law, and the empowering provisions of the Medicines Act. If, in making regulations the Minister exceeds the powers conferred by the empowering provisions of the Medicines Act, the Minister acts ultra vires (beyond the powers) and in breach of the doctrine of legality. The finding that the Minister acted ultra vires is in effect a finding that the Minister acted in a manner that is inconsistent with the Constitution and his or her conduct is invalid. What would have been ultra vires under common law by reason of a functionary exceeding his or her powers, is now invalid under the Constitution as an infringement of the principle of legality. The question, therefore, is whether the Minister acted ultra vires in making regulations that link a license to compound and dispense medicines to specific premises. The answer to this question must be sought in the empowering provisions.”

Judge Kubushi noted that the broad meaning [of the definition for complementary medicines] as suggested by the respondent (SAHPRA and Minister) will lead to a number or absurdities when evaluating what is and isn’t a medicine.

Health promoting fruits and vegetables would be considered medicines according to the obtusely broad definition of complementary medicines and health supplements.

Par. 128 – “A fundamental tenet of statutory interpretation is that the words in a statute must be given their ordinary grammatical meaning, unless to do so would result in an absurdity. There are three important interrelated riders to this general principle. namely: (a) that statutory provisions should always be interpreted purposively; (b) the relevant statutory provision must be property contextualized: and (c) all statutes must be construed consistently with the Constitution, that is, where reasonably possible, legislative provisions ought to be interpreted to preserve their constitutional validity. This proviso to the general principle is closely related to the purposive approach referred to in (a).”

Paragraphs 132 and 145 of the judgment Judge Kubushi finally settles the central issue.

Par. 132 –  “Once the respondents have conceded that those products that do not diagnose, treat, mitigate, modify or prevent disease are not complementary medicines and will, therefore. not be regulated’. it is the end of the story. The impugned Regulations’ introduction of any other product renders them ultra vires to that extent. This is what the applicant’s complaint is and this is what the definition of complementary medicines and health supplements in the impugned Regulations does. Consequently. to that extent, the impugned Regulations are ultra vires and the applicant should be granted the declaratory order It seeks.”

Par. 145 – “Section 35 of the Medicines Act, as it has been said, empowers the Minister, in consultation with the Authority, to make Regulations. The Minister may make different Regulations in relation to different medicines or scheduled substances, or different categories of medicines or scheduled substances. The upshot is that the regulatory scheme only permits the regulation of substances that are ‘medicines’ or contain ‘scheduled substances’. Any regulation promulgated under the Act that purports to regulate substances that are neither ‘medicines’ nor contain ‘scheduled substances should not be permitted.”

TAKEAWAYS FROM THE ORDER GRANTED

Only medicines defined strictly according to Section 1 of the Medicines Act are required to be registered.

The definition of ‘medicine’ in section 1 of the Medicines and Related Substances Act, No. 101 of 1965 is declared to apply only to substances that are used or purport to be suitable for use or are manufactured or sold for use in the diagnosis, treatment, mitigation, modification or prevention of maladies. in order to achieve a medicinal or therapeutic purpose, in human beings and animals.

The inclusion of complementary medicines as defined under the 2017 General Regulations under the Medicines Act are ultra vires, and therefore unlawful.

The General Regulations promulgated on 25 August 2017 under General Notice 859 in Government 41064 are declared unlawful to the extent that they apply to ‘complementary medicines’ and ‘health supplements’ that are not ‘medicines’ or ‘Scheduled substances’ as defined in section 1 of the Medicines and Related Substances Act, No. 101 of 1965.

By extension, this has the consequence that companies selling products (complementary medicines and health supplements) not falling within the strict definition of medicines need not apply for pharmaceutical licenses in terms of Section 22(c) of the Medicines Act, i.e import licenses, wholesale licenses or distribution licenses. This also means the Port Health Authority & SAHPRA jointly may not prohibit imports of the said products. Such seizures would be unlawful.

The Court has however suspended the above declaration of invalidity of the regulations for a period of 12 months, giving the Minister and SAHPRA time to remedy their regulatory defects in the law, however we believe that the fundamental nature of the ultra vires provisions will remain for many natural health products no matter how the Minister and SAHPRA attempt to tweak them.

The declaration of invalidity is suspended for a period of twelve (12) months to allow the South African Health Products Regulatory Authority an opportunity to correct the defect.

The ANHPSA were awarded costs for two counsel in this case which the Minister and SAHPRA are ordered to pay jointly.

Representing the ANHPSA were Adv. David Borgström SC , and Cliffe Dekker Hofmeyr (CDH) legal representatives Yana Van Leeve and Imraan Abdullah.

THNA SPECIFIC COMMENTS

The TNHA is a member of the ANHPSA and contends that the 12 month suspension of the order must be taken up on cross appeal, as it will be untenable for the natural health product industry to continue to be subjected to costly compliance requirements as laid out in the licensing and registration compliance roadmap for the year ahead. This will expose companies to further costs. Money  which will be unnecessarily spent on a fatally flawed and unworkable regulatory regime, potentially leading to more court challenges. Continuing to enforce the regulations over the next 12 months will result in severely restricting the public’s access to the natural health products of their choice. Many small and medium sized companies producing thousands of unique and valuable health-promoting and wellness products will have no choice but to voluntarily close down. This is not acceptable and the ANHPSA are consulting with the ANHPSA legal team to prepare the next possible steps.

RADICAL REFORM IS NEEDED – AND NOT UNDER SAHPRA

We at the TNHA believe this judgment clearly demonstrates that South Africa desperately needs a separate Traditional & Natural Health Products Bill to be tabled in Parliament in due course, so that our lawmakers can pass a new Act and establish a new separate Regulatory Authority to regulate such products in a fair, responsible and appropriate manner like in many other countries around the world.

This will effectively separate traditional and natural health products from pharmaceutical medicines legally, allowing each sector to protect the public under fair and appropriate regulatory frameworks, guarantee the public the freedom to choose the healthcare products of their choice and end the tension between the sector and the government. A win-win for all.

The Medicines Act and SAHPRA are historically and technically geared to regulate novel drugs (new to man chemical entities) and other pharmaceutical substances, and are in our opinion neither qualified nor representative of the natural health product sector. This is evidenced with no complementary medicine experts serving on its Board or in its management structures.

Relations between the natural health products sector and SAHPRA have reached an all time low, and this judgement makes it even harder for the natural health products industry to trust the SAHPRA going forth, or whether to believe they are objective or fair when dealing with the sector.

We have separate statutory health professions Councils regulating different groups of healthcare professionals from orthodox / allopathic medicine, complementary medicine and indigenous traditional medicine in South Africa, so why should the remedial tools of those modalities and paradigms be regulated any differently?

If anyone in high up in government is reading this report, please ponder the possibilities and positives of such a way forward for all.

Click below for a copy of the Full Judgement.

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