BLANTYRE, Malawi – Key Malawian key stakeholders have given the nod for the country to ratify the African Medicines Agency (AMA) treaty, the country’s Ministry of Foreign Affairs and International Cooperation has confirmed.

The AMA is being established as a specialised agency of the African Union (AU) dedicated to improving access to quality, safe and efficacious medical products in Africa.

Malawi would be the eighth African country to sign the AMA Treaty in the southern and eastern region of the continent following Kenya’s signature in February 2023.  Significantly, however, the region’s biggest economic powerhouse, South Africa has yet to sign the treaty. 

Cabinet Secretary @DrAlfredMutua has today signed the African Medicines Agency (AMA) Treaty on the sidelines of the ongoing 42nd Session of the African Union Executive Council in Addis Ababa, Ethiopia. 1/6 pic.twitter.com/mCi974PN59

— State Department for Foreign Affairs | Kenya (@ForeignOfficeKE) February 16, 2023

However Malawi officials say that they are now keen to follow Kenya’s recent lead. Chimwemwe Chamdimba, Head of Programmes for Africa Medicines Regulation Harmonisation (AMRH), said the signing of the AMA Treaty by Kenya is an important milestone for the continent towards operationalising the Agency.

“The step that Kenya has taken to sign the Treaty gives us hope that, very soon, their Parliament will look at the documents of ratification. This is an exciting time for the continent as we see the first-ever continental medicines agency coming into being. This will ensure the African people access to quality-assured medical products and promote the pharmaceutical sector growth across the continent,” she said.

Chamdimba said African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD) is providing technical support for countries to ratify the treaty and also operationalise the treaty.

“We have developed guidance notes and briefs for countries to use in the ratification process. We have also developed an overarching AMA Country Engagement Strategy which we are currently updating to use in providing support to countries. We have been organising advocacy and training sessions for member states on AMA ratification. We are available for any member state requiring technical and advocacy support.”

Economies of scale

Following Kenya’s signing, some 35 of the AU’s 55 member states have now come out formally to support the AMA treaty – either by signing it, ratifying it, or both.  That makes Malawi one of just 20 countries not yet signed.

Dr Evelyn Gitau, Director of Research and Related Capacity Strengthening at the African Population and Health Research (APHRC), says that, in principle, Africa needs economies of scale to make the African pharmaceutical manufacturing industry grow and be sustainable.

“We need to grow our pharma, vaccines and diagnostics industries. We have been relying on imports, been engaged in outbreak or pandemic response. No global market has grown without industry protection, usually in the form of tariffs or other barriers protecting domestic manufacturing. Africa can’t get away with this. It needs to implement the African Continental Free Trade Area. There is need for internal continental mobilisation to leverage the population as part of reaching scale,” she noted.

Gitau however urged for the need for continental harmonisation, including “regulatory frameworks to ensure that what is good enough in one country is good enough in the next country”. 

African countries also each have to deal with different regulators including the European Medicines Agency and the US Food and Drug Administration or World Health Organisation  Performance Quality and Safety to access parts of the medicines markets, and AMA would assist to streamline this, Gitau added.

Kenya became the 31st country to sign the Treaty in February, while 23 other countries have already ratified and are parties to the Treaty.

Senior Advocacy Policy Officer at PATH Kenya, John-Paul Omollo, urged all the remaining AU member states to ratify the AMA in order to achieve a harmonised regulatory system, and to catalyse the pharmaceutical manufacturing ecosystem. 

“AMA will also ensure regulatory convergence and reliance which promotes faster introduction of new and advanced medical products into the market hence quicker access by patients at a lower cost because the final cost of accessing medical products is a composite of time taken and fees paid during regulation of such products,” Omollo observed.  He notes that while the treaty may have been signed by Kenya, it still has to be ratified by the parliament. Following ratification, the treaty instrument is then deposited with the African Union as the final step. 

“I am supporting the Government of Kenya in instituting the process. So far, the documents are to be tabled in parliament for debate. Once approved in parliament, it will be taken for signing by the President. Then the Ministry of Foreign Affairs will submit the instruments of ratification to AUC. It’s only after this that we will be considered fully ratified,” he explained.

Malawi’s commitment 

Malawi Ministry of Foreign Affairs and International Cooperation spokesperson John Kabaghe said that a number of internal processes, however, still need to be completed prior to signing and ratifying a treaty instrument, including consultations and synergizing the obligations under the treaty with existing government policies, have been finalised.

“So far, experts have recommended that Malawi should ratify the treaty. The obligations under the instrument have been thoroughly checked by the Ministry of Foreign Affairs and there is an indication that Malawi will sign it without reservations,” he told Health Policy Watch.

Kabaghe disclosed that all obligations under the treaty are achievable in the context of Malawi laws and government policies.

“Final preparations of having the instruments signed are underway and it will be deposited very soon,” he said.

Maziko Matemba, the Executive Director for Health and Rights Education Programme, says AMA has the potential and opportunity to enable Malawi to build skills and expertise including manufacturing of medicines.

“Drug shortages have been a major issue in Malawi. Malawi has been struggling to access affordable medicines that it can sustain buying with its budget. If we have AMA established, it may give countries like Malawi bargaining power for the benefit of their citizens,” he said.

There is no deadline for countries to ratify the Treaty of the AMA, Chamdimba revealed, but countries are encouraged to ratify it as soon as possible to benefit from its services.

“We need to move together as a continent in harmonising the regulatory environment, which is important for ensuring access to quality-assured medical products to our population,” said Chamdimba. 

“We cannot wait to provide this human right to our citizens. The time is now for the AU and its Member States. We do not want to leave any country behind in this journey,” she stated.

The AMA Treaty was adopted by the AU Assembly on 11 February 2019 and a minimum of 15 member states are needed to ratify the AMA Treaty in their national parliaments, for AMA to come into force. So far 33 of the AU’s 55 member states are now aligned with the AMA treaty. 

Track the ratification and operationalisation of the AMA treaty here:

Image Credits: Geneva Design/Health Policy Watch .