Three more countries, Kenya, Cape Verde and Democratic Republic of Congo, have ratified the African Medicines Agency (AMA) Treaty recently – and Kenya’s ratification now means that most major East African countries are on board with the treaty.

Twenty-six countries have now fully ratified the treaty, one of the steps required for the establishment of the specialised agency of the African Union (AU) dedicated to improving access to quality, safe and efficacious medical products in Africa.

Countries are required to both sign and officially ratify the AMA Treaty in their parliaments in order for it to become applicable in their country.

“Specifically, Kenya’s signing and ratification is a huge milestone in the journey to regulatory harmonisation being that this is one of the biggest economies in our region. AMA needs more support from the big economies,” Maureen Okoth, project coordinator for the Coalition for Health Research and Development (CHReaD), told Health Policy Watch.

In terms of what it takes to bring the “big countries” on board, Okoth said that one of the gaps experienced when engaging with different countries is the fact that AMA needs to be demystified over and over, “We need to demonstrate practically what and how the different countries will benefit from AMA.

Strengthening advocacy efforts

“This is exciting… We continue to strengthen our advocacy efforts so that we have more ratifications being done. We’re doing advocacy to ensure that we really talk to the member states that have ratified and those that haven’t,” said Chimwemwe Chamdimba, head of the Africa Medicines Regulation Harmonization (AMRH) programme, during a webinar on the next steps in operationalisation of AMA.

Chamdimba said that a lot of advocacy was underway with member states to encourage those that have not signed to do so, as well as to encourage those that have signed but not ratified the treaty to take that final step.

While the process of countries’ signing and ratification, which began in 2019, may seem prolonged, the AMA Treaty has received more support, faster, than almost any other treaty in AU history, Chamdimba noted. 

“It just tells you why everybody realised that we need this, especially after the COVID pandemic,” she added.

The approval process has been outpaced only by the treaty approving a continent-wide free trade area that was launched on 30 May 2019.

However, Okoth observed that details of AMA operationalization need to be shared more widely – including the cost implications to build confidence and enable countries to make informed choices. 

AMRH expects that the AMA will help Africa to access quality, safe products and leverage pharmaceutical markets.

Operationalising the AMA 

In a wide-ranging discussion, Chamdimba and other participants also discussed the next steps in AMA operationalisation, including the division of work between the AMA and national regulatory authorities, the appointment of AMA’s Executive Director and how to include patient voices.  

AMRH revealed that the Rwandan government has provided a fully furnished building with a space to expand for AMA. The Rwandan government won the bid to host AMA in 2022. Uganda, Algeria, Egypt, Morocco, Tanzania and Zimbabwe also submitted expressions of interest but did not succeed.

Administratively, the secretariat is setting up systems and structures and systems – including human resources, finances, procurement – that are required for the organisation to function. 

The AMA Treaty mandates the AU Commission to drive the operationalization of AMA. 

AMA will pick up from what the AMRH has been doing over the years, ensuring that it is now done within an organisation that is more sustainable and systematic for the continent.

Currently, Chamdimba says, there is an AU task team on AMA formed by the different entities of the AU, including the AU Commission to guide AMA’s operationalization.

“We also have the Conference of State Parties, which has been meeting in the last two years to provide leadership in setting up the structures of the AMA. The Conference of State Parties is composed of ministers of health from countries that are parties to the treaty,” Chamdimba said.

Appointment of AMA board and staff

Currently, AMRH is in the process of setting up the AMA Board. Nominations from the different regions have been received, and the board is expected to be functional in the next two months.

The board will take up the responsibility of recruiting AMA’s Director General (DG). The terms of reference have been finalised but are currently waiting for the Board to be set up so that it can provide oversight on the DG recruitment. The DG will then be responsible for the recruitment of the rest of the staff, dealing with AMA structural and administrative issues, according to AMRH.

Aside from its continental operations, AMA will also operate at the national level, where a member state’s national regulator will make decisions and at the regional level, where the regional economic communities will build their capacity to support and implement AMA decisions.

“AMA will not deal with 55 countries alone but depend on already available country capacities… So we look at these three levels being able to be interlinked, interrelated, sharing information and working together,” Chamdimba said.

AMA is also not expected to deal with all medical products, but “provide support where there’s limited capacity” – such as providing guidance on traditional medicine and responding to emergencies. 

But some products will be dealt with by member states and regional economic communities.

Patient involvement

During the webinar, International Alliance of Patient’s Organisations CEO Kawaldip Sehmi, asked how the AMA framework will provide for meaningful engagement with patients and academia in Africa.

Chamdimba assured Sehmi, who has passed away since the webinar, that patient groups and non-governmental organisations will be involved in AMA operationalisation.

“It would be a missed opportunity if we don’t even consult on the set-up terms. So when we have a draft ready, we would like to open for comments. We will ensure to reach out for input so that patients are effectively represented,” she said.

“[Patients’] lived condition can effectively contribute to setting the AMA systems. Whatever decisions made may directly impact on them.”

AMRH has been working on harmonised standards and regulations in the regional economic communities namely the East African community, Southern African Development Community (SADC), the Economic Community of West African States (ECOWAS), and the Economic Community of Central African States.

“We have tested harmonisation systems in the regional economic communities. They’re working. But we realise that there’s also a need for cross-leveraging and cross-harmonisation so that we look at Africa as a whole. Then move from the regional economic communities to one continent, especially when it comes to sharing of capacities across the regions,” said Chambimba.

To assist with the preparation of AMA, an Africa Regulatory Conference is being held from 12-15 September with the theme ‘Together for patients – Transforming the regulatory ecosystem in Africa’.

The AMA Treaty was adopted by the AU Assembly on 11 February 2019 and a minimum of 15 member states needed to ratify the AMA Treaty in their national parliaments for AMA to come into force.

Image Credits: Marco Verch/Flickr, Luigi Guarino .