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Traditional & Natural Health Products to be regulated by the African Medicines Agency (AMA)

In February 2016 the TNHA published a report detailing strident, yet little publicized steps taken by the African Union Commission (AUC), the Pan-African Parliament (PAP), the NEPAD Agency’s African Medicines Regulatory Harmonization Programme and various international donors to establish a supra-national Medicines Regulatory Agency for the entire African continent, styled similarly to the European Medicines Agency (EMA) in Europe.

In the past, five Regional Economic Communities have tried to harmonize their medicines laws with limited success due to chronic capacity constraints. There is now a major drive on the continent and from interests outside the continent to sew up this patchwork of Regional Communities and to consolidate the power to regulate medicines under the umbrella of a single agency, namely the African Medicines Agency (AMA)

The first formal step to establish the Agency followed the ratification of the African Union Model Law on Medical Products Regulation by African Heads of State and Government at the African Union (AU) Summit in Addis Ababa, Ethiopia in January 2016.

In terms of the founding prescripts of this the AMA, African Union States which signed to the Model Law are at liberty to adapt and domesticate (harmonize) their medicines regulatory policies with the the Model Law, and to assure alignment with their Constitutional principles and legal systems.

 

 

This essentially means that existing National Medicines Regulatory Agencies in each individual African country will begin to divest many of their statutory functions and powers, and hand the levers of control and decision-making to the centralized AMA headquarters somewhere yet to be announced on the African continent.

As can be seen in a newly released info-graphic published by the NEPAD Agency relating to the AMA’s harmonization strategy, it is evident that the current domestic functions and responsibilities of National Medicines Regulatory Authorities, including the registration of medicines, the issuing of manufacturing and distribution licenses, conducting site inspections and the overseeing of appeals procedures will be conferred to the AMA once it has launched and becomes fully operational.

 

According to official position statements by the NEPAD Agency, the AMA is expected to provide leadership, to ensure that there are harmonized (one size fits all) and strengthened regulatory systems, which govern the regulation of medicines and medical products on the African continent. The AMA will regulate the access to safe, effective, good quality and affordable medicines and health technologies.

PHOTO – Health Ministers from various African countries at a meeting of a Working Group of the Specialised Technical Committee on Health,
Population and Drug Control unanimously adopted the Treaty for the establishment of the African Medicines Agency (AMA) – June 15, 2018.

The AMA will be the second important technical institution to be established by the AU after the Africa Centers for Disease Control and Prevention.  The African CDC was launched on the 31st of January 2017 and is modeled  on the Centers for Disease Control and Prevention [“CDC”] in the USA, and retains a collaborative partnership through a Memorandum of Collaboration. The Memorandum states that the USA will provide technical expertise for the African CDC Surveillance and Response Unit, as well as advise African CDC leadership in strategic planning for future development.

According to the Observer Research Foundation, an independent think tank based in India, Africa accounts for only 3 percent of the global medicine production and that 95 percent of the medicines consumed in the continent are imported.

While some countries like South Africa and Morocco produce 70 – 80 percent of their medicines, certain central African countries import close to 100 percent of their needs, the foundation said.

THE AMA IS EXPECTED TO BE LAUNCHED SOON

The formal launch of the AMA is now imminent, following the AU adopting its 31-page Treaty for the Establishment of the African Medicines Agency on the 11th of February 2019.

According to Article 38 of the Treaty the signatures of a mere fifteen member states to the Instrument of Ratification and Accession will trigger the official launch of the AMA. There are currently 55 current AU Member States.

Withing thirty days of the fifteen signatories ratifying the Instrument of Ratification and Accession, the AMA will come into being.

According to the current status list of signatory countries which have signed the Instrument of Ratification and Accession at the date of this publication, eleven countries have signed up, with Chad being the last to join on the 24th of January 2020. The AU is now actively urging other countries to sign up to the Treaty, with only four countries to go.

The AMA may launched in a matter of weeks or months from now.

WHAT ABOUT SOUTH AFRICA?

South Africa is not yet a signatory to the Instrument of Ratification and Accession, although it was one of the first signatories of the African Union Model Law on Medical Products Regulation, which was a strong indication of it will support for an AMA going forward.

We have also witnessed bi-lateral regulatory alignment of our recently amended Medicines and Related Substances Act (Act 101 of 1965) with many paragraphs, copied and pasted word for word with the Model Law, and now the new Treaty seemingly aligning itself with definitions and paragraphs of our amended Medicines and Related Substances Act, copied word for word. All indications are that South Africa will soon sign the Treaty.

With President Ramaphosa being sworn in as the revolving Chair of the AU for the next year last week, its a given South Africa will want to lead by example.

South Africa was the launchpad nation of the NEPAD Agency, having been tied to former President’s Mbeki’s GEAR program. South Africa has been a key driver of the NEPAD Agency’s initiatives to harmonize African trade and economic policies ever since. It is rumored that the recently launched South African Health Products Regulatory Authority (SAHPRA) which replaced the Medicines Control Council in February 2017 will bid to become the permanent headquarters of the AMA.

Just how much influence has the NEPAD Agency had on the current ‘full steam ahead’ harmonization drive between the SAHPRA, the Model Law and Treaty, and visa versa ?

Curiously there have been key philanthropic donors who are invested in the international pharmaceutical industry, and are globally active in an agenda to expand the pharmaceutical marketplace into the developing world, which have been showering the SAHPRA, the NEPAD Agency and the AMA Project with generous ‘obligation fee’ grants over the last few years.

Coincidence?, we think not!

This should be of concern, but it appears nobody is questioning the motives and agendas of these foreign interest groups.

TRADITIONAL & NATURAL HEALTH PRODUCTS HAVE BEEN INCLUDED IN THE TREATY WITHOUT REPRESENTATION OR TRANSPARENCY

In our previous report we noticed the first vague inclusion of “other regulated products” in the text of the Model Law.

In the list of definitions of the Model Law this definition reads as thus:

other regulated products” may include complementary medicines, cosmetics, food and related products;

This definition has now expanded greatly in the newer overarching Treaty, and now includes complementary medicines, food supplements, traditional medical products (African Traditional Medicines) and even cosmetics.

It is noteworthy to note the expansion of the definition of “other regulated products” which now reads as thus –

Other Regulated Products” means complementary medicines, traditional medical products, cosmetics, food supplements and related products

Below are the individual definitions as they appear in the new Treaty:

Complementary Medicines” means any of a range of health therapies that fall beyond the scope of conventional medicine but may be used alongside it in the treatment of diseases and other medical conditions.
Traditional Medical Product” means an object or substance used in traditional health practice for: (a) the diagnosis, treatment or prevention of a physical or mental illness; or (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or well-being in human beings, but does not include a dependence-producing or dangerous substance or drug.
Food Supplement” means a product intended for ingestion that contains a dietary ingredient intended to add further nutritional value to (supplement) the diet.

The TNHA rejects the unilateral inclusion of traditional & natural health substances under the future jurisdiction of the AMA.  At no point were the stakeholders involved in these industries and affected health professions consulted about having their products and traditional health substances included in either the Model Law or Treaty.

Any regulatory harmonization imposed on these sectors will have a huge influence on the health choices of 1.2 billion Africans who consume and trade in traditional & natural health products.

At no point have National Medicines Regulatory Authorities been transparent about all of these developments. In South Africa the SAHPRA and it’s predecessor the Medicines Control Council haven’t made public their intended relationship with the AMA, or been able to explain the synchronous text of their 2015 Medicines Amendment Act and the Model Law and Treaty.

In fact, meetings have been attended by unelected technocrats and bureaucrats of the AU, the NEPAD Agency and individual National Medicines Regulatory Agencies behind closed doors with no civil society oversight.

Which handful of undetected bureaucrats will be appointed to the AMA to make decisions for complimentary medicines, food supplements, traditional medical products and cosmetics?

What qualifications will be required to represent these sectors at the AMA, or to serve on it’s Technical Working Groups?

Why aren’t representatives of these sectors eligible to serve on the AMA Board?

Why is there no mechanism for national and Pan-African NGO’s or Stakeholder interest groups to attend AMA meetings and to engage with its Technical Working Groups?

15% of the world’s population will soon have their health choices dictated to by this new unelected bureaucracy. As it stands, the AMA will be staffed by proponents of orththodox / pharmaceutical medicine, and no mention is made of incorporating experts in the field of complementary medicine, food supplements, or African medical products or cosmetics.  This can only pave the way for the restrictive and inappropriate regulation of these products, as has been witnessed in some individual countries in Africa and in the North.

The AMA should not be used as a tool for the pharmaceutical expropriation of natural health products, substances and choices.

JOIN OUR PAN-AFRICAN CAMPAIGN TO REJECT THE INCLUSION OF TRADITIONAL & NATURAL HEALTH PRODUCTS UNDER THE JURISDICTION OF THE AMA WITHOUT A PEOPLE’S MANDATE

The TNHA invites all African stakeholders involved in the manufacture, import/export, distribution, prescribing and utilization (consumer groups a & patient groups) of complementary medicines, food supplements, traditional medical products (African Traditional Medicines) and natural cosmetics to make contact with the TNHA so we can explore launching a Pan-African stakeholder Organization to engage on these issues with the AMA, the Pan African Parliament and other African Union structures.

Feel free to contact the TNHA on +27 72 3777 598 or email us.


UPDATE:

The 15 signatories required to officially launch the AMA was reached on the 9th of February 2020.
According to Article 38 of the Treaty, the AMA must launch 30 days after the 15th signatory has signed the Instrument of Ratification and Accession.
The AMA will therefore officially come into operation on the 30th of March 2020.

  1. Ethiopia (11 Feb 2019)
  2. Guinea (11 Feb 2019)
  3. Rwanda (02 Jun 2019)
  4. Sahrawi Arab Democratic Republic (08 Jul 2019)
  5. Algeria (08 Jul 2019)
  6. Madigascar (01 Aug 2019)
  7. Ghana (02 Aug 2019)
  8. Tunisia (22 Sep 2019)
  9. Mali (21 Oct 2019)
  10. Morocco (22 Oct 2019)
  11. Chad (27 Jan 2020)
  12. Benin (27 Jan 2020)
  13. Seychelles (09 Feb 2020)
  14. Niger (09 Feb 2020)
  15. Senegal (09 Feb 2020)

16. Gabon (20 April 202)

SADC countries are now being urged to join, with COVID-19 being the driver.

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