African Medicines Agency: A pathbreaking initiative in healthcare sector

Goal 3 of the Sustainable Development Goals (SDG) pertains to ensuring healthy lives and promote wellbeing for all at all ages. Goal 3 calls for supporting the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, substantially increase health financing and the recruitment, development, training and retention of the health workforce in developing countries, especially in least developed countries and small island developing States and strengthening the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks. Non-Aligned Movement, as the leading voice of the Global South, recognizes the need for an effective healthcare system in the developing world. The Movement has also stressed the importance of South-South cooperation in the field of healthcare.

In Africa, a landmark initiative for ensuring healthcare to all is currently shaping place. In May 2018, African Ministers of Health, meeting in Geneva, Switzerland as a Working Group of the Specialised Technical Committee on Health, Population and Drug Control unanimously adopted the Treaty for the establishment of the African Medicines Agency (AMA). The treaty was drafted with the goal of aiding the expansion of universal health coverage across the continent. “The African Medicine Agency is a key element of the architecture for harmonisation of continental, institutional, scientific and regulatory resources to improve access to safe, efficacious and quality medicines”, Ambassador Ajay Kumar Bramdeo, the Permanent Observer of the African Union to the United Nations Office at Geneva remarked.

Once the treaty is ratified by the national governments of at least 15 of the 55 African Union member states, the AMA will formally come into being as the continent’s regulatory body. The agency will then coordinate existing efforts to reduce the spread of false, substandard, and dangerous medical technologies. The stated goal of this move is to improve access to medicine that is both affordable and effective even for those who live in the most remote rural areas of Africa. As of now, the treaty has been signed by Algeria, Rwanda, Saharawi and Madagascar.

AMA seeks to ensure coordination and strengthening of continental initiatives to harmonise medical products regulation, provide guidance and technical support to improve access to quality, safe and efficacious medical products and health technologies on the continent. AMA will work within the existing continental architecture of Regional Economic Communities (RECs) and Regional Health Organizations (RHOs) to support AU Member States.

According to Article 3 of the Draft Treaty, the main objective of AMA is to improve access to quality, safe and efficacious medical products on the continent through: a) coordination and strengthening of ongoing initiatives to harmonize medicines regulation, promote cooperation and mutual recognition of regulatory decisions; b) carrying out regulatory oversight of selected medical products and providing technical guidance to State Parties and RECs; and c) pooling expertise and capacities and strengthening networking for optimal use of the limited resources available.

The African Medicines Agency will promote the adoption and harmonization of medical products regulatory policies and standards, and scientific guidelines, and coordinate existing regulatory harmonization efforts. It will further provide regulatory guidance, scientific opinions and a common framework for regulatory actions on medical products, as well as priority and emerging issues and pandemics. It may be mentioned here that AMA will not replace national regulators, which will continue their work to register drugs that are safe and efficacious for their populations.

The Specialised Technical Agency will also provide regulatory guidance and provide technical assistance on regulatory matters to countries that lack the capacity and resources to do so. It will further provide guidance on the regulation of clinical trials on medical products and health technologies. African countries are committed to the swift ratification and implementation of the continental AMA treaty. Amira Elfadil, AU Commissioner for Social Affairs, has applauded the four AU member countries that have already signed the AMA treaty documents. “As the AU’s Commission for Social Affairs, we will continue to advocate and engage various stakeholders to promote the implementation of interventions and address the health challenges on the continent,” Elfadil remarked.

By Dr. Ankit Srivastava, Editor

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