The inaugural African Medicines Manufacturing Trade Exhibition and Conference (AMMTEC) hosted by FAPMA, Vizuri, and H4D brought together pharma manufacturers, government representatives, Africa CDC, donors USAID, TGF; the UN agencies, and implementing agents from across the continent.
This conference included showcasing manufacturers and their capability to manufacture and supply essential medicines across Africa.
ARC was invited to speak on its experiences in providing Market Shaping assessment in Kenya, supporting UNECA in undertaking a pooled procurement pilot in 10 African countries and supporting WAHO in setting up a pooled procurement mechanism.
II- Key Statements from the Conference
1- From the manufacturers: There was a request to the AU and member states to commit to action by facilitating manufacturers to get to a position where they can sufficiently and profitably respond to the call for manufacturing of health products on the African continent. This call in summary, represents a position manufacturers have held ever since the Essential Medicines Programme was initiated by WHO. It also represents the frustration manufacturers have had with the lack of concrete support to the industry by governments, donors, and the general public, which has resulted in poor investment in the local pharma industry.
2- From the AU: As represented by Africa CDC, there was clarity on the operationalization of its mandate to implement the Africa Pooled Procurement Mechanism (APPM). Firstly, pooled procurement (PP) will be designed to procure those products that are made on the African continent. That is, the APPM will not be for products from outside Africa. The intention is to support manufacturers based in Africa and that way supper and grow the African industry. Further, the PP will not be operated by Africa CDC; rather, its responsibility is to support the application of the APPM framework, while the actual PP will be operated by other entities. This means that the Regional Economic Communities (REC) such as WAHO, SADC, and others can set regional PPM operations.
Further still, that these regional PPM are not expected to be operated by the RECs themselves, but can be contracted out to specialist service providers that can provide the service on behalf of the member states in the region. Additionally, the APPM will target a small list of critical health products that can be managed in the first instance.
3- The role of the Africa CDC will be to ensure that principles for PP are in place, such as negotiated volumes broke the required products, manufacturers are contracted on a long-term basis, unit prices are negotiated and agreed upon, member states can then tap into those arrangements and join the PPM or use the framework agreements to undertake their own procurement of those health products .
4- For Governments as stated above, are expected to support the APPM by using the framework either through participating in PP, or by using the framework to carry out their own procurement of those products under the APPM framework.
5- For manufacturers, the advice to them was to work with health product regulatory authorities and commit to meeting the standards set by their national or other stringent regulatory authority (eg, WHO, FDA, MRHA, and those that have met Level 3 of WHO pre-qualification requirements. Manufacturers were also advised that in some cases the WHO Pre-Qualification requirements (or similar) would not apply if these manufacturers are already prequalified by other stringent authorities, including their own NRA.
III- Resolution from AMMTEC
1- Regarding support from policymakers: Required to put in place policies that provide for investment in local/continental manufacturers underpinned by procurement policies that support and favour the African manufacturers. This is intelligent protectionism.
2- Health product regulators: Commitment to supporting local / manufacturers underpinned by harmonized, common pre-qualification and regulatory frameworks that are recognized across the continent. That way, NRA are natural partner of the pharmaceutical industry and together protect and preserve public health.
3- Financiers in the pharmaceutical industry: The call was for long-term affordable financing to enable industries to invest, produce, and have returns that can service loans.
4- To pharmaceutical industry players: A call was made for collaboration among industry players for the common good and that way develops the industry.
IV- Implications for ARC
1- The Market Shaping and pilot PP work that ARC did has proven to be of pivotal importance in the positioning of APPM on the continent and how member states and their RECs will move forward in activating the APPM.
2- Secondly, our role must be to help identify the many manufacturers on the continent that make basic health products that can meet diagnostic and treatment requirements on priority programmes, with a view of linking these companies to RECs.
3- Support to pharmaceutical industry development initiatives through RECs is critical, as is enabling their Health Desks to be operational.
4- Additionally, we need to recognize that not all pharmaceutical companies on the continent will wish to be involved in the frontline manufacturing of health products. We need to recognize that some of these companies will wish not to participate as such, selecting to grow with the general growth of the industry. Some of these smaller companies may play the role of sub-contractors to manufacture certain products for the larger pharma companies. Therefore, the governments we serve need to be pragmatic and position investment in such a way that regional manufacturing is enabled and supported by other minor players.
5- The application of the APPM will also support the private sector in member states, thereby ensuring that the demand volumes remain consistently significant per product.
6- Finally, regional supply chain infrastructure for health needs to be supported for resilience through optimization, and use that to secure the supply chain as a critical component of the regional PPM.
The AMMTEC was the inaugural trade exhibition and conference for the industry with a presence of partner organizations that will make pharmaceutical industry development and the APPM a reality.
The call for action was made to the member states of the AU primarily to correct a long-seated perception that the African pharmaceutical industry would remain a minor player in the global pharma manufacturing and supply to meet critical health needs on the continent.
Commitments to reverse that perception require direct investments on a number of fronts, essentially on financing to enable industries to develop or strengthen their businesses. The clarity on the way the APPM shall be applied is very welcome, which now provides for different approaches to setting and provision of PP services.
Also very clear was that while some countries may select not to use a PP platform, they can still benefit from the long-term framework and pricing arrangements that will have been set up under the APPM.
Resources and support that BMGF had invested in ARC to undertake Market Shaping have contributed to this clarity on the setting up and operationalization of the APPM initiative by the AU, as well proving the options available to member states of the AU.
Bonnie Fundafunda – Co-CEO
