Written by: Anthony Rees (National Chairman: TNHA)
Signatories to the new African Medicines Agency Treaty have now reached 28 countries – more than half of the African Union’s 55 member states – with the balance tipping as Uganda signed the treaty instrument last week. On Friday, 5 November, after more than a decade of preparations, the African Medicine Agency (AMA) Treaty also came into force officially – clearing the way for the AMA to begin operations as a formal supranatural regulatory authority.
But with the AMA treaty coming into full force, exactly one month after the first 15 countries ratified and deposited the treaty instrument, no one is losing time. An African Union meeting, set for February 2022, will select a country to host the new AMA headquarters of operations (hosting agency).
Will South Africa sign the Treaty before the next February and offer to host the AMA secretariat and its bureaucracy in South Africa at the South African Health Products Regulatory Authority (SAHPRA)?
Quite possibe, considering the AMA is the product of The New Partnership for Africa’s Development (NEPAD) which was launched and coordinated from Johannseburg, South Africa.
Ever since 2002 NEPAD has been blamed for insufficient civil society participation in its policies and processes. Equally in the case of the lockstep approach to establishing the AMA, there has no demonstrable civil society participation in the drafting of its Model Law on Medical Products Regulation and AMA Treaty. Only 40 patient and civil society organizations have participated in the establishment of the AMA thus far by selective invitation, along with pharmaceutical industry lobby groups. All of which are funded by global institutions supportive of the expansion of the Western pharmaceutical industry.
Products such as ‘complementary medicines’, ‘health supplements’ and ‘African Traditional Medicines’ have been unilaterally inserted into the founding legal instruments of the AMA without any participation or mandate from the relevant sectors across the continent.
The African Medicines Agency will work to harmonize regulations on products such as pharmaceutical medicines (drugs), vaccines, medical devices, blood products, diagnostic tools, complementary medicines and traditional medicines across Africa. The agency would follow a similar mandate to other global medicine regulatory agencies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), which craft central agreements on regulations that govern the vast territories they cover.
The TNHA will continue to montor the establishment of the AMA and will lobby the AMA by representing the Pan-African traditional & natural health product sector.
Previous TNHA articles on this subject:
African Medicines Agency (AMA) to Launch in November – (23 October 2021)
African Traditional Medicine Pharma Development used as Lure for AMA Establishment – (24 September 2020)
African Medicines Regulatory Harmonization – (08 February 2016)