Written by: Anthony Rees (National Chairman : TNHA)
More than a decade after the idea for the African Medicines Agency (AMA) was broached at the 60th session for the World Health Organization Regional Committee for Africa, the agency will officially begin operating the 5th of November 2021 under the African Union (AU). Instead of acting as a stand-alone regulatory body at inception, it will coordinate national and regional regulatory efforts. The new agency hopes to take full advantage of recently adopted AU African Continental Free Trade Area (AfCFTA), and to open up pharmaceutical markets to the entire continent.
Over time it is expected to expand its scope by harmonizing medicines regulation across the entire continent, similar to the way the European Medicines Agency (EMA) operates across Europe.
The EMA is a networking organisation and its activities depend on experts drawn from across European countries that are members of the European Union. In this regard, the EMA model has not held back harmonization in Europe. Each European Union country still has its own national regulatory body, and they cooperate as needed within the EMA network.
We predict a similar fate with the AMA over time, as globalist funders and sponsors of the AMA project set their sights on harmonising the continental and regional regulatory bodies, and then sewing them all up to form a single global regulator. AMA will be the second continental health agency after the Africa Centres for Disease Control and Prevention (Africa CDC).
According to the AU, the AMA’s future role on the continent will be to:
- Support the growth of local pharmaceutical production, a key objective of the Pharmaceutical Manufacturing Plan for Africa (PMPA). It will further play a critical role in catalyzing trade in support of the Africa Continental Free Trade Area (AfCFTA).
- To evaluate medical products for the treatment of diseases as determined by the African Union.
- To regularly inspect, coordinate and share information about products that are authorised for marketing.
- To coordinate joint reviews of clinical trial applications for vaccines and assessment of “highly complex” product dossiers such as bio-similars. AMA will also coordinate joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.
- to collaborate with Regional Economic Communities (RECs) and National Medicines Regulatory Authorities (NMRAs) in the identification of substandard and falsified medical products (SFs) and facilitate information sharing across countries.
- To develop common standards and regulations, AMA will also be responsible for harmonising legislation.
African leaders endorsed the AMA Treaty in May 2018 and needed 15 countries to sign, ratify, and deposit their instrument of ratification to begin. Cameroon was the last requisite country, joining Algeria, Benin, Burkina Faso, Gabon, Ghana, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leone, and Zimbabwe on the 7th of October.
TRADITIONAL MEDICINES, COMPLEMENTARY MEDICINES AND HEALTH SUPPLEMENTS WILL BE REGULATED BY THE AMA
Both the AMA Treaty and African Union Model Law on Medical Products Regulation include African Traditional Medicines in their definitions of medicines falling under the AMA’s control, despite there having been ZERO call for this inclusion by African Traditional Medicines stakeholders, and no consultation with them while these founding policies were drafted.
In our previous reports 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:
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 –
Below are the individual definitions as they appear in the new Treaty:
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.
It is the TNHA’s opinion that this is an unprecedented and opportunistic power grab over African Traditional Medicines, and a Neo-Colonial and Western Pharmaceutical Sector serving imposition over African traditions and innovations which have been passed down for millennia. By regulating these remedies as pharmaceutical drugs, and requiring vast and massively expensive clinical and safety studies before pre-market approval will only serve large foreign pharmaceutical interests, while rendering all non-approved (non-evaluated) remedies as illegal and/or banned medicines.
Equally, non-indigenous manufactured complementary medicines and health supplements will also to be controlled by this non-representative body.
There are no recognized African Traditional Medicine, Complementary Medicine, or Health Supplement sector experts attached to this new body, either by being represented on its non-elected and bureaucratic governance board, nor on its so-called ‘expert advisory committees’, despite African Traditional Medicine being utilized by over 70% of the African population.
No other traditional or natural health products representative organization has recognized and covered this threat, except us, the TNHA. The TNHA are currently networking with African Traditional Medicine stakeholders across the African diaspora, to begin responding with this looming threat, as the AMA’s aim to regulate African Traditional Medicines under pharmaceutical development regimes spells the beginning of the end for time-honored and sacred African traditions.
SOUTH AFRICA’S ROLE IN THE AMA
South Africa is not yet a signatory to the Instrument of Ratification and Accession of the AMA, although it was one of the first signatories of the African Union Model Law on Medical Products Regulation, which was a strong indication that it will join for an AMA in the future.
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, also copied word-for-word. All indications are that South Africa will soon sign the Treaty and that its own medicines regulator, the SAHPRA, may bid to host the AMA as its official hosting agency.