The African Union Vaccine Manufacturing member states ministers of health and their representatives Gathered for the first manufacturers’ marketplace meeting and inaugural ministerial working group in Marrakech, Morocco, from 29 September 2023 to 1 October 2023.
The meeting was represented by eleven (11) of the thirteen (13) vaccine manufacturing Member States: Botswana, Egypt, Ethiopia, Ghana, Kenya, Morocco, Nigeria, Senegal, South Africa, Rwanda, and Uganda, including National Regulatory Authorities (10), African Continental Free Trade Area (AfCFTA), Regional Economic Communities (3), Gavi, UNICEF and UNECA and manufacturers from potential African vaccine manufacturing countries. The delegates deliberated on the submission by Africa CDC and UNECA on the proposed Legal Instrument for the adoption of AU Pooled Procurement Mechanism (PPM).
1. Recalls the 55th Decision of the African Union (AU) Assembly (AU/Dec.55 (IV), during the Abuja Summitin January 2005, requesting the AU Commission to develop the pharmaceutical Manufacturing Plan for Africa (PMPA);
2. Further recalls the establishment of the Partnerships for African Vaccine Manufacturing (PAVM) in April2021 and endorsement by the Executive Council (EX.CL/ Dec.1129(XXXIX));
3. Recognizes the call by the AU Heads of State and Government for Member States, Regional Economic Communities, and Regional Mechanisms (RMs) to adopt measures to promote resilience against future pandemics, including investment in domestic vaccine manufacturing capacity (Assembly/AU/Dec. 829(XXXV));
4. Further recognizes the significant role played by AfCFTA, Africa Medicines Agency (AMA), to enhanceaccess to quality medical products and boost trade;
5. Cognise the recommendations of the May 2022 Communiqué of the Video Teleconference meetingof the Bureau of the Assembly of the AU Heads of State and Government extended to African vaccine manufacturing countries to (i) Establish a working group for vaccine manufacturers in Africa, coordinated by the Africa CDC as part of the Partnership for Africa Vaccine Manufacturing, inclusive of other Countries aspiring to produce vaccines; (ii) Set up a procurement mechanism for public health products through AVAT/T, Africa CDC, and Common African Pooled Procurement Systems for public health products to ensure certainty of demand for African-manufactured vaccines and other relevant pharmaceutical products by the end of 2022; (iii) Set up a mechanism to support manufacturers with business case development (iv) Engage high-level advocacy with the GAVI, COVAX, African governments and stakeholders to encourage support for the merging African Vaccine manufacturing industry, and (v) Committed to increasing the demand of vaccines in Africa with a political will and commitment to reach the vaccination targets agreed by the AU and to meet the 70 percent target set by WHO by the end of the year. As such, we committed to fulling the significant lag in deliveries relative to the contractual delivery program through AVAT/T and Afreximbank and called on Member States to take delivery of their contracted vaccine doses and make payment payments on due dates.
6. Commends Gavi on its efforts to uphold the recommendations of the May 2022 communiqué and urge Gavi to move swiftly to adopt the African Vaccine Manufacturing Accelerator (AVMA) by the end of 2023 with a provision of $1 billion;
7. Encourages AVMA to be fit for African Manufacturers, including through preferential procurement by African Union Member States and strengthening of National Regulatory Authorities (NRA);
8. Acknowledges the need for expansion of ongoing efforts of vaccine manufacturing and other health products as per the recommendations of the Ministerial meeting at the sidelines of the 76th World Health Assembly;
9. Appreciates the urgent need for an African mechanism to jointly procure vaccines and other health products by sharing information, conducting market research, negotiating, contracting, tendering, forecasting, supplying, delivering, and administering which can lead to cost savings and promote the growth of the continent’s industry;
10. Pronounces that such a mechanism requires demand and production information, evidence-based policiesand programs, adequate resources, and a procurement framework.
11. Commits to advocating for empowering the African National Regulatory Authorities and African manufacturers through lessons learned and good practices worldwide to aggregate demand for health products.
The meeting recommended the following next steps:
1. A Framework Agreement for pooled procurement of vaccines, medicines, and other health products shall beprepared by the Africa CDC to facilitate the pilot pooled procurement mechanism for vaccines while awaiting a legal instrument to expand regional health product manufacturing. The framework will be submitted to the Africa CDC Governing Board and the Committee of the Heads of State and Government for approval, while the draft legal instrument will be tabled for approval at the next AU Summit in February 2024.
2. The framework can be administered through Service Level Agreements, which can be tailored to individual Member States or manufacturers when the need arises. These Service Level Agreements shall;
(a) Encourage regional manufacturing of good quality vaccines, medicines, and other health products in African Union Member States;
(b) Ensure uniformity in the contract for the pooled procurement. The contract shall include transparentclauses about pricing, quantitates, production and delivery timelines, rights and liabilities, and conflicts of interest.
(c) Ensure timely access to vaccines; AU Member States shall focus on infrastructure and digitalization for efficient acquisition and distribution;
(d) Establish a specific funding mechanism, along with the utilization of existing financing arrangements, to support the relevant investment and procurement of essential medical supplies;
(e) Invest in developing local technical skills with continuous training and promoting collaborationbetween the manufacturers and regulators.
3. The Africa CDC will prepare and implement an activity rollout plan for the negotiations for a legally binding instrument to:
(a) Resolve to develop the “Common African Legal Instrument for Pooled Procurement of Vaccines, Medicines, and Other Health Products” under the African Union Legal framework;
(b) Advocate for global partners to join in seizing this unprecedented opportunity to accelerate regionalmanufacturing;
(c) Call Upon WHO to support and expedite the Prequalification of African manufactured products toenable donor-funded markets for vaccines, medicines, and other health products;
(d) Urge Gavi and UNICEF to consider alternative prequalification processes, such as recognized African regulatory authorities at maturity level 3, that provide adequate processes to ensure the safety and quality of vaccines;
4. Call Upon the Heads of State and Government to approve the roadmap for the Platform for Harmonized African Health Products Manufacturing (PHAHM) to be developed by Africa CDC, to ensure the expansion of regional manufacturing for all health products;
5. Uphold the principles stated in this Communiqué by ensuring and advocating for alignment with domestic legislation.