African Health Ministers Green Light Establishment Of African Medicines Agency

By John Zarocostas for Health Policy Watch

African ministers of health – meeting as a working group on 19 May – unanimously adopted the Treaty for the establishment of the African Medicines Agency (AMA). The accord is expected to be endorsed by heads of states and governments of the African Union at their next major summit in January 2019 and will enter into force after 15 member states have ratified it.

Margaret Angama-Anyetei from the African Union Commission discusses with Health Policy Watch the scope, aspirations, and challenges ahead for the new regulatory agency for the AU. Since 2016, Dr Angama-Anyetei has been head of the African Union’s Health, Nutrition & Population Division, setting policies at the continental level and supporting member states. Previously she worked at the UNFPA regional office in South Africa, and as resident representative in DR Congo, and earlier with UNAIDS in Ethiopia.

Dr Margaret Angama-Anyetei

HEALTH POLICY WATCH (HPW): How did the idea to create an AMA come about?

MARGARET ANGAMA-ANYETEI: There was a meeting of ministers of health from all parts of the African Union and of WHO and they met in Luanda, Angola in April 2014 and the concern at the time was that sub-standard and counterfeit drugs had flooded African markets causing disabilities and deaths. They recommended the establishment of a regulatory continental body, because not all AU members had that capacity, and which was supported by AU leaders. In 2014, the continent thought it was ambitious to set up a regulatory body which will oversee the regulation of medicines and medical products on the continent, both manufactured and imported. Nobody thought it was going to happen. But with the advent of the Africa Centres for Disease Control and Prevention (Africa CDC) in 2017, everybody knew it was going to happen one day. The question was when. When the Ministers of Health in 2014 approved the establishment of the agency they set for it to be established by 2018. We expect the heads of state and governments of the AU to endorse the establishment as approved by the Ministers on  May 19 at the January 2019 summit.

HPW: Where will the AMA be headquartered?

ANGAMA-ANYETEI: That has not yet been decided, because our member states have the option to host the agency.  Of course, it will come with criteria which will guide the selection of the host country because it will have to meet the criteria set out by the legal department of the African Union Commission.

HPW: What is the prospective workforce envisaged for the AMA and will the agency receive technical or financial support from donor countries or will it largely be financed by AU member countries?

ANGAMA-ANYETEI: I can’t give an exact figure for the number of staff at the moment but it’s expected to be a lean agency. Why? Because it’s going to rely on national regulators and it’s not going to override or supersede national sovereignty. But regulation of medicines and medical products is not available in all the member states. So, based on requests to this continental body it will be able to draw on other member states to provide support to the member states in need.

HPW: But will the new agency also set new standards that will be applied continent-wide?

ANGAMA-ANYETEI: Yes, and it will have a governing board advised by experts, and it will set standards. Its function is expected to be comparable to other continental regulatory bodies.

HPW: What are some of the regulatory gaps the agency will address?

ANGAMA-ANYETEI: The main concerns are: i) pharmaceutical manufacturing on the continent – a standard for manufacturing of medicines and medical products in accordance with standards basically set by the World Health Organization but overseeing that those standards are adhered to and there is compliance with the standards that have been set;  ii) providing support to set regulatory laws within member states. We do already have what is the model law which can then be used to develop their national laws. However, the agency will provide further support in ensuring the standards are kept and any other function under the umbrella of regulation which will be requested by member states.

HPW: A major problem in many African countries has been the use of substandard and counterfeit drugs with serious adverse health effects. How will the AMA deal with this issue?

ANGAMA-ANYETEI: The agency will have the clout, based on data, based on information that is received, to trace, monitor and deal with countries in the region where these drugs are being imported. It will also have the clout to deal directly also with governments to enforce regulation at the national level. These drugs and medical products are coming through ports, airports, etcetera, and it’s important to have enforcement. But it is also timely, given the continent has just signed a continental free trade agreement, and it’s particularly important because the free movement of goods and persons of countries that ratify that protocol will have an implication for medicines and medical products. Therefore the endorsement of the AMA is timely.

HPW: Will AMA also have oversight of clinical trials for new medicines and vaccines?

ANGAMA-ANYETEI: Once the body is set up, some of these other areas will be defined. It’s going to start most likely dealing with excessive regulatory procedures and widen the scope depending on capacity and support.

HPW:  What about external support, in particular from multilateral agencies?

ANGAMA-ANYETEI: Primarily, we expect AU governments to provide domestic financing and money from the continent to be put into the agency. But of course under the umbrella of partnership, if we have donors -who will be aligned with our vision and constitution of the agency, yes partnerships will be welcomed. But it definitely has to have support from the  WHO,  given that the WHO sets normative standards and guidelines and is a global body.

HPW: Is the establishment of the AMA also expected to attract Foreign Direct Investment (FDI) for the manufacture of medicines and medical products in Africa for the  1.2 billion people strong market, given the lack of a harmonized standards has been viewed as an impediment to such investments?

ANGAMA-ANYETEI: Yes, I also think that the pharmaceutical industry itself is a multi-billion dollar industry and we haven’t even begun to link it with active ingredients which can be produced on the continent. Its a big job market for young people-Africa has the largest young population in the world- There’s lots of room for innovation, and major opportunities. Most external investors look at laws, they always want to feel they are protected when they invest in foreign markets.

HPW: What about the issue of Intellectual Property Rights. Will the AMA also oversee IP and international norms such as those of the  World Trade Organization?

ANGAMA-ANYETEI: Most of the AU members have also signed up to the WHO and the WTO and have good intentions of respecting the WTO TRIPS Agreement. However, Africa also has not taken advantage of the TRIPS [World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights].

HPW:
Like the TRIPS flexibilities?

ANGAMA-ANYETEI: Yes, so the opportunity is right there and of course, regulating bodies like this (AMA) should build the capacity of member states to take advantage of the TRIPS given the opportunities that are available.

HPW: Any final thoughts?

ANGAMA-ANYETEI: I think the media have an important role in supporting the continent and showing that we are able to establish agencies and encourage donors and multilateral entities to partner with us to make sure that it is established. After all, it is a win-win for everybody. There is a 1.2 billion market out there and there’s a place for everybody. Of course, the more the continent is able to stand on its feet and advance in the right direction, the more the opportunities for everybody.

 

Image Credits: John Zarocostas.

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