RE-LAUNCH Invitation to Manufacturers of Essential Health Products to Submit an Expression of I ...

To maximize the opportunities arising from African Continental Free Trade Area (AfCFTA), African Medicines Agency (AMA) and to realize the objectives of the Pharmaceutical Manufacturing Plan for Africa, the United Nations Economic Commission for Africa (ECA) in collaboration with the African Union Commission (AUC), the African Union Development Agency (AUDA-NEPAD), WHO, UNAIDS and other relevant UN agencies, is commissioning an AfCFTA-anchored pharmaceutical project in select African countries (Seychelles, Madagascar, Comoros, Mauritius, Djibouti, Eritrea, Rwanda anchored by Ethiopia, Kenya, Sudan, and IGAD with a specific aim to bring ideas into action through successful operationalization of the AfCFTA. The AfCFTA-anchored Pharma pilot project leverages on the establishment of the AMA and AfCFTA which brings on board a market of 1.3 Billion people, a gross domestic product (GDP) of $2.5 trillion, across 55 member states of the Africa Union (AU). The Agreement is expected to make a significant contribution to Africa’s ongoing efforts to materialize the aspirations and goals contained in Agenda 2063 and the 2030 Agenda for Sustainable Development Goals. The AfCFTA-anchored Pharma initiative has a three-pronged approach; localized production; pooled procurement and a harmonized regulatory and quality framework focusing on maternal and child health care (MCH) products to address persistent challenges in MCH burden, unmet needs and access to reproductive health products across the region but also to the necessity and efficacy of investment in initiatives that address women's health as a key component of inclusive and sustainable economic development. The emphasis on pharmaceuticals is driven by inadequate access to medicines for many infectious and Non-Communicable Diseases (NCDs) across Africa as well as the undue strain on both the public and consumer budget. Medicines consume a large proportion of African nation's healthcare budget. One of the reasons is related to issues of inefficient pharmaceutical procurement models, as well as long lead times for international orders, high transport and distribution costs, poor logistic and storage capacity, limited public finances, and gaps in global and local production of medicines, among others. These in turn lead to slow progress towards SDGs. Also, the current supply of medicines to Africans does not meet demand. Africa manufactures "less than 2 percent of the medicines it consumes" while it imports about 70 percent of its needs from outside the continent at an annual cost of $14.5 billion. This invitation is one of the several recommended regional harmonization efforts envisioned by the Head of States of the African Union (AU) for "A prosperous Africa based on inclusive growth and sustainable development". In as much as sustainable development depends on health workers, the health of the society depends on the supply of quality-assured and affordable medicines. To realize the aspirations of the Africa we want without leaving no one behind, one of such strategic approaches is to bring the African nations to work together in the assessment of medicines quality assurance. In principle, products are eligible to be funded through AfCFTA-anchored Pharma pilot procurement resources if, • prequalified by WHO prequalification program, OR • approved for marketing authorization within Stringent Regulatory Authority region which is also referred to as WHO and/or ICH recognized member countries, OR • approved and marketed within regional harmonization communities, for example, Intergovernmental Authority on Development (IGAD), East African Community (EAC), South African Development Community (SADC), Economic Community of West African States (ECOWAS) OR • approved and marketed within SIDS OR • reviewed and listed by GDF and/or other procurement agencies participating in WHO ERP program, AND • accepted, reviewed, and permitted for use by an independent technical review panel (TRP) organized by ECA as described under item number 4 and 5 below.