Over the next few days, African governments will take important steps towards ensuring that vital medicines reach patients in need, when the New Partnership for Africa’s Development (NEPAD) Agency hosts the ‘African Medicines Regulatory Harmonization’ (AMRH) Week in Kigali, Rwanda.
This timely event comes as countries across Africa are accelerating efforts towards two targets agreed to in the 2030 Sustainable Development Goals (SDGs): eradicating infectious diseases afflicting the continent and achieving universal health coverage for all people. One of the key barriers to realizing these goals in each country is securing regulatory approval for the use of new medicines. Standardizing the approach to regulating new medicines across Africa – or regulatory harmonization – will help accelerate the movement of new medicines from the laboratory to the shelves of local pharmacies and to patients in need.
Currently, countries are applying varying approaches to medicines regulation, making it difficult for manufacturers and suppliers to obtain approval for new medicines as they navigate the unique requirements and procedures in each country. Additionally, many countries have insufficient regulatory capacity due to the under-resourcing of key institutions, among other reasons.
This problem is highlighted by the case of bedaquiline – an effective new medicine for treatment of drug-resistant tuberculosis (TB). Despite being approved for use by the Food and Drug Administration in the United States as early as 2012, bedaquiline has yet to gain full regulatory approval in a large number of low- and middle-income countries, including several in Africa that have high burdens of TB.
AMRH Week aims to address these issues, with the ultimate goal of strengthening and harmonizing medicines regulation across the continent. Achieving this goal will go a long way in accelerating the approval of new medicines such as bedaquiline, and shortening the time between their discovery and administration to patients, thus saving lives and slowing the spread of disease.
In recent years, substantial investments in research and development have expanded the pipeline of new medicines and other health technologies that will soon be ready for introduction to the market. In order to reach many of the 2030 Agenda’s health goals and targets, it is vital that health and regulatory systems are resilient and adaptable, and that they are ready to ensure appropriate new health technologies reach people in need as quickly as possible.
One avenue to fast-track regulatory harmonization is through national adaptation of the AU Model Law for Medical Products Regulation, which was adopted by African Union (AU) Heads of State and Government in January 2016. It promotes a coordinated approach for medicines regulation by ensuring that laws are aligned across AU Member States.
Arrived at through extensive collaboration with stakeholders, the Model Law identifies key functions and standards that any regulatory system should contain, but which have been missing in many AU Member States. It covers registration and marketing of health technologies, granting manufacturing and distribution licenses, conducting quality and safety inspections, authorizing clinical trials and overseeing appeals procedures.
The Model Law is currently at different levels of adaption and implementation in a number of AU Member States, including Burkina Faso, the Republic of Burundi, Côte d’Ivoire, the Kingdom of eSwatini, the Gambia, Lesotho, the Republic of Mozambique, Namibia, the Republic of Rwanda, Seychelles, Swaziland, the United Republic of Tanzania (Zanzibar) and Zimbabwe.
The next phase entails ongoing work on the domestication of the Model Law across Africa and laying the foundations for the establishment of the African Medicines Agency (AMA). Establishing a unifying regulatory agency for Africa has the potential to accelerate the harmonization process and strengthen regulatory capacity. The Treaty to establish the AMA was approved by African Ministers of Health in May and the AU Special Technical Committee on Justice and Social Affairs in November. It will be considered by the AU Executive Council prior to the meeting of the assembly in February 2019. Once established, the AMA will coordinate regional harmonization programmes, working on behalf of 54 AU Member States and their 1.2 billion citizens.
Despite reaching these significant milestones, there remains much to do. Firstly, ongoing collaboration between AU Member States on medicines regulation is essential because while the AMA will provide guidance and scientific opinion on new and traditional medicines, it will not replace national regulatory bodies.
Secondly, as set out in the AMRH strategic plan (2016–2020), the AU is committed to domesticating the Model Law in at least 25 Member States by 2020. In order to reach this target, governments across Africa must take ownership of the process, learn from each other and be proactive in making use of existing expertise and support.
Thirdly, there is a need for renewed focus at a national level on building the capacities of personnel and institutions responsible for medicines regulation.
Finally, donors’ and development partners’ continuing financial, technical, strategic and political support is critical for sustaining the momentum of the AMRH process, now that harmonization is within sight.
The NEPAD Agency, UNDP and other partners are committed to working with AU Member States to follow through with these actions. The AMRH Week is an opportunity for key stakeholders to share experiences and collaborate, on harnessing the benefits of the AU Model Law to fast-track improved accessibility of new medicines in all Member States. This pan-African ambition of eradicating infectious diseases and achieving universal health coverage for the continent’s peoples can only be realized with concerted and committed effort by all.
Author information: Dr Ibrahim Assane Mayaki is the CEO of the NEPAD Agency and Dr Mandeep Dhaliwal is the Director of the HIV, Health and Development Group at UNDP.