African Medicines Agency to be established in 2018

ADDIS ABABA, June 8 (ANA) – The African Medicines Agency (AMA) which is intended to be an organ of the African Union legally mandated by Member States to provide a platform for coordination and strengthening of on-ongoing initiatives to harmonise medicine regulation is finally to be launched by the end of 2018.

“We are going to be looking at the business plan that has been drafted, legal institutional framework and recommendation that would really be applicable to the technical group with members from across the continent, regulators, experts of legal and public health to see whether we can really align to the requirements,” Dr. Janet Byaruhanga, Director for Social Affairs at the African Union Commission told the African News Agency (ANA).

“So, we have few years to work out all of these processes and see that by 2018 the African heads of states will launch this initiative; and we have had definitely from many member states that this is a good initiative and we really drew from existing initiatives to harmonise whereby you have a set of guidelines that are used across the region and then to all other countries.”

The AMA is intended to be an organ of the AU, legally mandated by Member States (MS) to coordinate national and sub-regional regulatory systems for medical products, provide regulatory oversight of selected medical products to start with, as well as promote cooperation, harmonisation and mutual recognition of regulatory decisions. It will serve as a catalyst for stronger regulatory oversight to curtail substandard medical products and hopefully enable competitiveness of locally produced medicines particularly those for diseases that disproportionately affect Africa.

As a continental agency, AMA will serve the purpose of pooling expertise and capacities and strengthening networking for optimal use of the limited resources available for regulatory authorities and complement and enhance the efforts of on-going harmonisation initiatives.

The AMA will be established within the framework of a new memorandum of understanding between the AUC and the WHO signed in 2013, and the first meeting of the African Ministers of Health jointly organized by the two organizations that was held in Luanda, Angola in April 2014.

It is increasingly becoming evident that no single country, including well-resourced countries can efficiently and effectively regulate its own market alone in this globalised market, according to Byaruhanga.

As such, AMA as a continental agency would be able to galvanize technical support, expertise in various countries and RECs, and resources at a scale that cannot be matched at national or regional level.
However, AMA will not replace National medicines regulatory Authorities (NMRAs) or sub-regional Medicines Regulatory Authorities, which will be established by the Regional Economic Communities (RECs), she clarifies.

“This agency will really boost the capacities and also try and pool resources and also support regional regulatory centers that have been identified through African Medicines Regulatory Harmonization Program,” she adds.

“Sub-optimal investment in the healthcare delivery systems continues to hamper Africa’s progress not only in reaping the economic potential of a healthy human capital but has also affected other sectors of already fragile economies of countries.”

Three quarters of the world population is in developing countries. However, these countries account for less than 10 percent of the global pharmaceutical market. Ten countries – Algeria, Egypt, Kenya, Ivory Coast, Libya, Morocco, Nigeria, South Africa, Sudan, and Tunisia – account for 70 percent of the 20.8 billion dollars African pharmaceutical market. Due to economic growth, the market is expected to grow to 35 billion dollars by 2018. It is estimated about 95 percent of API (active pharmaceutical ingredients) and 75 percent of finished products are imported from outside the continent.

“For example, while Africa accounts for 69 percent of the world’s 40 million people living with HIV, it imports more than 80 percent of its antiretrovirals.”

– African News Agency (ANA)

Disclaimer: This story is pulled directly from the African News Agency wire, and has not been edited by Mail & Guardian staff. The M&G does not accept responsibility for errors in any statement, quote or extract that may be contained therein.

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