ATC231114: Report of the Select Committee on Health and Social Services on the Ratification of the Treaty for the establishment of the African Medicines Agency, dated 14 November 2023

NCOP Health and Social Services

Report of the Select Committee on Health and Social Services on the Ratification of the Treaty for the establishment of the African Medicines Agency, dated 14 November 2023

 

The Select Committee on Health and Social Services (henceforth, the Committee), having considered the ratification of the Treaty for the establishment of the African Medicines Agency (AMA), reports as follows:

 

Background

The establishment of the AMA was first discussed at the meeting of African Ministers of Health. The meeting was jointly convened by the African Union (AU) Commission and the World Health Organization (WHO) in Luanda, Angola, in April 2014.

The African Union (AU) Assembly of Heads of State adopted the Treaty at the 32nd Ordinary Session of 10-11 February 2019, in Addis Ababa, Ethiopia. Rwanda was selected to host the headquarters of AMA by the AU Executive Council at a meeting held in Lusaka, Zambia in July 2022.

 

Purpose

The AMA aims to enhance the capacity of State Parties and AU-recognised Regional Economic Communities (RECs). In addition, it aims to regulate medical products to improve access to quality, safe and effective medical products in the African continent.

The mission for the AMA is to coordinate and strengthen ongoing initiatives to harmonise medicines regulation, promote cooperation and mutual recognition of regulatory decisions. This includes conducting regulatory oversight of selected medical products and providing technical guidance to State Parties and RECs. This will be done through pooling together expertise and capacities and strengthening networking for optimal use of resources from across the continent.

AMA intends to develop improved access to quality-assured medical products. Further, AMA plans to be more visible by facilitating the following core activities: safety monitoring, market surveillance, marketing authorisation, oversight of clinical trials, coordination of quality control laboratory services; and joint assessments and good manufacturing practice inspections.

 

Role-players

To achieve its mandate, AMA intends to work with technical partners such as the WHO, European Medicines Agency (EMA) and the United States (US) Food and Drug Administration (FDA).

Value proposition for South Africa

• This will help mitigate the effects of the coronavirus (COVID-19) pandemic by allowing the free movement of pharmaceuticals and personal protective equipment (PPE).
• There will be a consistent voice on regulatory issues, standards, and guidelines for quality, safety, and efficacy. That will aid with reducing the prevalence of substandard and falsified medicines and vaccines.
• South Africa can participate in the African Continental Free Trade Area (AfCFTA), which will anchor the pharmaceutical initiative of localised production, pooled procurement, and quality frameworks.

 

Parliament Process

The ratification for the establishment of the AMA Treaty was tabled in Parliament on the 14 February 2023, and referred to the Committee on 26 October 2023. The Committee received a briefing on the AMA Treaty from the Department of Health on the 14 November 2023.

The Committee recommends that the House, in terms of Section 231(2) of the Constitution of the Republic of South Africa 1996, approves the AMA Treaty.

 

Report to be considered.