The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies

Abstract

The vision of the African Medicines Agency (AMA) is to ensure that all Africans have access to affordable medical products that meet internationally recognized standards of quality, safety and efficacy for priority diseases/conditions. The AMA is being established by a treaty which had to be ratified by a minimum of 15 African countries. Although there was no deadline, the ratification process has been slower than expected. This study therefore analysed the rationale, perceived benefits, enabling factors and challenges of the AMA's establishment. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of 45 African countries. The Heads of NRAs and a senior NRA staff member were contacted to complete self-administered questionnaires. The existence of mature NRAs, the desire to have harmonized regulatory systems, the presence of strong political will and appropriate advocacy to expedite treaty signing are all enabling factors for AMA treaty signing. The challenges reported include the fact that the process is slow and there is limited understanding of the process. Competing national priorities, changes in office bearers in the public system and stagnation of the process at the ministerial level were also challenges reported. This study has improved the understanding of the treaty signing and ratification process and the perceived benefits and enabling factors of signing and ratification from African NRAs' perspective. NRAs also highlighted challenges encountered in the process. Addressing these challenges will result in effective medicines regulation by galvanizing technical support, regulatory expertise and resources at a continental level.

Keywords: African Medicines Agency; African Medicines Regulatory Harmonization initiative; Medicines regulatory harmonization; treaty for the establishment of the African Medicines Agency; treaty ratification.

Figure 1.

The common process followed to ratify the AMA treaty. The general responsibility for treaty initiation is the National Executive, and this may be delegated to a relevant State Department. In this regard, the CS responsible for Health is required to undertake public participation to seek and obtain the views of the public on the treaty. Upon undertaking public participation, the CS, in consultation with the Attorney General, is required to submit the treaty to the Cabinet together with the accompanying memorandum. Upon approval for ratification by Cabinet, the CS is required to submit the treaty and a memorandum on the same to the Speaker of the National Assembly. Parliament may then approve the ratification with or without reservations to specific provisions of the treaty. Where ratification is approved without any reservations to the treaty, the CS shall, within 30 days from the date of approval of the ratification of the treaty, request the CS responsible for Foreign Affairs, to prepare the instrument of the ratification of the treaty. However, if there is approval with reservations, the treaty shall be ratified with those reservations to the corresponding article in the treaty. If it is refused by Parliament, the Government shall not ratify the treaty. All instruments of ratification of a treaty shall be signed and deposited by the CS responsible for Foreign Affairs at the AU Commission and a copy thereof shall be filed with the Registrar of Treaties. The Ministry responsible for Health in the country is also obliged to take measures to inform and create awareness to the public about the effects and benefits of the treaty