SAHPRA TO FALL UNDER AFRICAN MEDICINES AGENCY’S HARMONIZATION TREATY

South Africa’s Cabinet Approves African Medicines Agency Treaty

By Anthony Rees – National Chairman (TNHA)

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The South African cabinet has finally given the green light to sign the African Medicines Agency Treaty and adoption of the African Union Model Law on Medical Products Regulation.

Cabinet has approved the signing of the African Union treaty establishing the African Medicines Agency (AMA), and submitted it to Parliament for ratification, according to a government statement on 23 September.

South African Health Minister Mathume Joe Phaahla affirms support for the AMA on a February 2022 visit of WHO Director-General Dr Tedros Adhanom Ghebreyesus.

The African Union Model Law on Medical Products Regulation [hereafter referred to as the ‘model law’] process began in early 2014 with the development of a zero draft, on which comment was invited from a range of stakeholders and experts. Subsequently, a first draft was presented at regional stakeholder consultations within the AU regions during the period from 2014 to 2015. The draft was then amended after inputs were received at the regional meetings. Next, the draft incorporating the feedback from the regions was submitted through the governance structures of the AU, and the final version of the AU Model Law was officially adopted by African Heads of State and Government at the AU Summit in January 2016, in Addis Ababa, Ethiopia.

The Model Law provides a template for countries to harmonize their regulatory frameworks in a cookie-cutter manner, fashioned on the 27-state European Medicines Agency, and outlines the key functions and standards that should form part of the pan-African regulatory system. These provisions will eventually harmonize all medicines regulations on the African continent, including regulations over the manufacture and sale of ‘other regulated products‘, defined as complementary medicines, cosmetics, food and related products. This means that each signatory will have to adhere to the standards adopted by the AMA to give effect to the Treaty. Slowly, but surely, individual national state Medicines Regulatory Authorities will cede more regulatory functions and policy-making to the AMA, rendering them mere satellite AMA Treaty enforcers.

The AU is now supporting its Member States in domesticating the Model Law into their national legislation. The African Union Development  Agency (AUDA) and New Partnership for Africa’s Development (NEPAD) are coordinating capacity-building and providing technical assistance to enable countries to review their legislation in place on medical products regulation and affect the requisite amendments in order to align them with the Model Law.  The respective Regional Economic Communities are actively involved in facilitating this process.

NEPAD is based in Johannesburg South Africa and has taken advantage of inserting large chunks of our 2015 Medicines and Related Substances Control Amendments Act of 2015 into the Model Law. This is evident in the common definition of a medicine and other articles in the Model Law which are line-for-line identical by comparison. The implementation of this scheme is referenced in the newly released policy guideline of the AMA titled ‘A Guidance Document For Domestication Of The African Union Model Law On Medical Products Regulation‘.

In terms of the legal and policy coherence guidelines relating to the Treaty and Model Law, the guideline stipulates that ‘there should be no conflicting provisions between the model Law and other applicable national domestic laws‘, meaning that the Model Law and it’s final Regulations or Directives will take precedence over our Medicines Act and its regulations.

According to the Guideline and Article 5 of the AMA Treaty, the AMA has wide powers under the Model Law, which will finally be incorporated into domestic legislation and regulations, as appropriate. Such powers will include: granting/withdrawing authorization for medical products, clinical trials and licenses to various actors in the supply chain; investigating and prosecuting offences; levying fees, and prescribing standards for categories of products. This will include complementary medicines, cosmetics, food and related products and African Traditional Medicines. Above is an official AMA infographic which further explains the functions of the new authority.

It is worthy to note the definition of harmonisation in terms of the AMA Treaty, which reads – “harmonisation” means alignment or adjustment of differences and inconsistencies among different [domestic] laws, regulations, methods, procedures, schedules, specifications, or systems of National Medical Products Regulatory Agencies/Authorities.“

Thus far four African countries have already fully domesticated their national legislation and Authority structures to the Model Law harmonisation standards. These include Malawi, Mozambique, Rwanda and South Africa.

Rwanda was selected to host the headquarters of the AMA by the Executive Council of the African Union at a meeting held in the Zambian capital of Lusaka on the 16th of July this year.

WHAT DOES THIS MEAN FOR SAHPRA?

As soon as President Ramaphosa ratifies the AMA Treaty by signing it and depositing it with the AU Parliament in Addis Ababa, the South African Health Products Regulatory Authority (SAHPRA) will fall under the prescripts and jurisdiction of the AMA and will have to observe and implement the Articles of the Model Law and the Guidelines For the Domestication Of The African Union Model Law On Medical Products Regulation. As the AMA gains momentum and begins the process of formulating common regulatory standards, the SAHPRA will need to adopt them into our domestic law and enforce them.

Effectively this will mean that SAHPRA will cede more and more of its power to the AMA in the coming years and years, and in turn, local medicines manufacturers will have to adopt AMA standards decided in Rwanda by the signatories of the AMA Treaty. Essentially we will lose sovereignty over our own medicines regulation.

WHAT DOES THIS MEAN FOR SOUTH AFRICAN COMPLEMENTARY MEDICINES, AFRICAN TRADITIONAL MEDICINES, FOODS, COSMETICS and HEALTH SUPPLEMENT INDUSTRY?

Although the complementary medicines regulations gazetted in 2017 under the Medicines and Related Substances Act have been declared unconstitutional by the Gauteng North High Court on the 1st of October 2020, and further declared unlawful by the Supreme Court of Appeal on the 11th of April 2022, partly due to our efforts under the banner of the Alliance for Natural Health Products [South Africa], we believe our Minister of Health and the SAHPRA will rely on the AMA and Model Law on Medicinal Products to usher in harmonised regulations and guidelines adopted by the AMA to regain full control our domestic market.

We sincerely hope that our fatally flawed and overzealous complementary medicine regulations, which have been found to be unconstitutional, are never tabled as a model framework and taken seriously by other AMA member states in future. Many foreign companies selling natural health products in South Africa have told us that our complementary medicine regulations are the most draconian and inappropriate regulations they have encountered worldwide.

This all means that our organization and our partners will have to broaden our reach to form a broad alliance to represent the complementary medicines and health supplement sector, as well as lobby those in the cosmetic and African Traditional Medicines sectors to join us. This will entail expanding our capacity, networking and lobbying efforts to preserve the public’s right to choose natural health products without overzealous pharmaceutical regulation which inevitably removes public choice, kills innovation and disenfranchises and criminalizes small and medium sized enterprises already involved in the sector.

The upshot of all this is that the AMA will have to establish expert committees and run them in a democratic and transparent manner. In drafting regulations for the natural health product sector they will have to take into account the varying levels of development of countries in the African diaspora. This levelling of the playing field will hopefully curtail Big Pharma-captured regulators like our SAHPRA, and spoil their ambitions to regulate the natural health products industry out of existence in favour of exclusively approving pharmaceutical interventions like they have domestically.

This will mean the TNHA will have to seek accreditation with the African Union as a Regional NGO and apply to be admitted to observe and participate in AMA meetings relating to the drafting of regulations for our sector.

The TNHA will keep you informed on all future developments in this regard.

Read our previous articles on this subject matter:

• THE AFRICAN MEDICINES AGENCY (AMA) – SOUTH AFRICA NOT YET A MEMBER (23 Nov 2021)
• AFRICAN MEDICINES AGENCY (AMA) TO LAUNCH IN NOVEMBER (23 Act 2021)
• AFRICAN TRADITIONAL MEDICINE PHARMA DEVELOPMENT USED AS LURE FOR AMA ESTABLISHMENT (24 Sep 2020)
• TRADITIONAL & NATURAL HEALTH PRODUCTS TO BE REGULATED BY THE AFRICAN MEDICINES AGENCY (09 Feb 2020)
• AFRICAN MEDICINES REGULATORY HARMONIZATION (08 Feb 2016)