Impact case study database

This body of research addresses the problem of access to supplies and medicines in Africa and the extent to which local manufacturing improvement can assist. The issue is now very high profile, as the Covid-19 pandemic generates nationally protective responses across the globe. The OU research group and its international network were early leaders in researching and shaping this policy field, in a manner now recognised as prescient, resulting in the following policy and practitioner impacts (organised by type of stakeholder and influence).

(i) Local health sector manufacturers and manufacturing associations (practitioner impact)

In Eastern and Southern Africa, the OU research was utilised “ to really fill the gaps” in advocacy papers concerning incentives for local manufacturing, and that expertise has been “ practically very useful” in “ meetings where we had manufacturers and politicians together”, as an African pharmaceutical manufacturer and head of a regional manufacturers association [C1] confirmed in 2020. He further commented that without that expertise, “ the quality of our arguments would be less […] we really would not have picked up the policy coherence” requirement “ because we don’t think that way”. Two EAC officials supported by German development cooperation [C1] also confirmed in 2020 that the research “ inspired the justification which we wrote for the EAC pharmaceutical bill”. This justification was requested by “ many high level decisionmakers [...] secretary generals of the EAC” and was written “ based very strongly” on this research. The officials also confirmed that the research has “ *inspired the lobby and advocacy work of FEAPAM [Federation of East African Pharmaceutical Manufacturers’ Associations]*”; the “strong impact […] provided a coherent narrative on local production of pharmaceuticals” in relation to work on the East African Regional Pharmaceutical Manufacturing Plan of Action [C1]. Routes to these policy impacts have centrally involved the local research teams, for example, a presentation by Wangwe to the 1st East Africa Manufacturing Business Summit (Uganda 2015), where participants indicated messages were taken seriously because they came from independent research [C1]. The project book Making Medicines in Africa, launched by invitation at the Africa Pharmaceutical Summit East, March 2016, has been very widely downloaded (now over 79,000 downloads) and is “ extensively quoted by authors across Africa regarding local production” [C1].

(ii) East African health and industrial policy makers (national policy influence)

National policy impact in Tanzania is evidenced by the use of text and findings from our Policy Briefs on reversing manufacturing decline in the Tanzanian Second Five-Year Development Plan (2016) [C2] in support of a decision to prioritise pharmaceutical manufacturing development; that commitment was followed by a sharp increase in budgeted government funding for purchase of medicines, recognising the local synergies identified. Government members requested summary findings from the research team to feed into that document [C2]. The route to this striking national impact was through the close involvement of Tanzanian research team members in policy-oriented research design; involving policy makers in research question identification; and through workshops for mutual feedback between senior policy makers and the research team leading, for example to citation of the team’s findings by the Deputy Permanent Secretary of the Ministry of Industry and Trade in Tanzania at an EAC workshop in September 2015 [C2]. The research team also contributed on request detailed policy recommendations in June 2015 to a high-level task force chaired by COSTECH (which manages scientific research in Tanzania); while a 3-day UNCTAD-COSTECH workshop in Tanzania November 2015 on industry-health links included an invited presentation from the team. At EAC level, the “ justification” for an EAC Pharmaceutical Bill, discussed in the Ugandan parliament in May 2020 was “ inspired” by the research evidence [C1].

(iii) International UN bodies and donor governments (international policy influence)

This body of research has influenced UNIDO policy work since 2009. Two UNIDO officials [C3] reported that guidance from Mackintosh and Banda, research team members, “ formed the backbone of the policy advice disseminated in the UNIDO guide” on incentives for pharmaceutical production in Africa, published in 2019 (no date on text) [C3]. In particular, Mackintosh “ persuaded [the official] that market protection is a very important tool”, when previously he “ was quite opposed”. The research “ has certainly influenced what we [UNIDO] say”. Without the research UNIDO “ would not have the evidence base we have”; the research is “ cited on regular occasions” and “ has had quite a profound influence on our thinking and the way forward”. “ The international community is now aligned” behind the local production agenda, and this research “ certainly contributed a lot to that” culminating in the joint agencies’ declaration at the World Health Assembly (WHA) in 2019 [C3]. UN and other multilateral policy documents that have cited our work include UNRISD 2016 Flagship report on Policy Innovations for Transformative Change [C3]; the World Bank on Creating Markets in Kenya [C3]; and the UNDP Access and Delivery Partnership report on local pharmaceutical production in Tanzania [C3]. The unique research impact in the field is attested by the invitation to Mackintosh as the only academic presenting at the Ministerial-level UNCTAD-UNAIDS-African Union side-event at the World Investment Forum 2016 on pharmaceutical manufacturing. Additionally, a UNIDO official [C3] stated that the OU research programme is still “ ahead of the curve” on research and policy.

A German development cooperation official [C4] stated in 2020 that she commissioned an evidence brief [C4] from the team that was “ able to show that it [local manufacture of pharmaceuticals] has spin-off effects into the wider health context”, including regulatory improvement and emergency preparedness. The report was presented at a WHO consultation, and the official stated that this was “ very helpful” in providing evidence where previously it was “ very sketchy”. She further noted that WHO people are “ quite sceptical” about the local production agenda, but it has now “ found its way back onto the roadmap of access to medicines at the WHO”. The research has helped German Development Cooperation “t o communicate the wider impacts of local pharmaceutical production […] very well”.

In South Africa, a Department of Trade and Industry official [C5] attended a 2015 workshop on biopharmaceutical industry associations at the OU. She stated that this meeting facilitated a better understanding of the policy role of trade associations and generated new contacts for her work especially outside South Africa. In the UK, the project [G2] was the sole case selected in 2017 to showcase the impact of the DfID/ESRC Growth Programme to a new DfID Minister [C5]. A major follow-on project on industry-health synergies for cancer care has been funded [G4]: the funding panel feedback recognised the scope to build on the earlier project’s impact networks and pathways.

International NGOs (influence on policy thinking)

Some growing impact of this research can be evidenced on policy thinking by international NGOs. The OU team’s evidence that locally produced medicines reach rural areas more effectively than imports [O4] is cited in the South Centre’s report on TRIPS and medicines [C6]. Mackintosh was consulted in 2016 on institutional policy by Médicins sans Frontières (MSF), which at the time was reconsidering its role in global health policy and wished to reflect on its sources of supplies. Following the meeting, an MSF official [C6] stated that “ I think you have contributed a lot to helping people to think differently about some common assumptions in MSF”. The team was also consulted in 2017 as a stakeholder by the Access to Medicines Foundation on the methodology for their 2018 Index. A Foundation official wrote that the input on local manufacturing capacity building had been “ so valuable” [C6].

Summary

This research has contributed strongly, as evidenced, to a major shift in policy thinking, decisions and action, and to manufacturers’ involvement in that process, on the subject of health-related local manufacturing in Africa and its importance for local health care quality and access. The impact is evidenced within the private sector; at national, regional and international level; and increasingly in NGO thinking. The Covid-19 pandemic has dramatically increased recognition, among African and international stakeholders, of the importance of African industrial supply capabilities for local health care systems, and the research team is continuing to work actively in this field both in research and responding to requests for policy involvement.