Challenges and Opportunities of Local Pharmaceutical Production in

Challenges (and Opportunities) of Local Pharmaceutical Production in Africa IPC Meeting 18 th June 2015 UNICEF Supply Division Copenhagen Alastair West Senior Technical Advisor UNIDO 1

Content • Benefits that can be realized from strengthening local production of pharmaceuticals in Africa • Major milestones in progressing the agenda • List of challenges faced by on the ground stakeholders • Challenges for supporting genuine and sustainable progress • Recent developments in moving the LPP agenda forward • Further urgent progress required • Conclusion 2

Benefits that can be realized • • Central tenet is that high quality, sustainable, quality assured local production can contribute to public health benefits and economic growth Key to note that challenges, benefits, requirements, and requisite actors vary for example between: – Donor funded medicines covered by PQ – Donor funded or centrally procured medicines not covered by PQ – National procurement – Private sector/out of pocket procurement Example issues that can be addressed • • For some prequalified products there are growing concerns about security of supply (e. g. tenofovir FDCs) also what happens as donor funding plateaus along with latest treatment guidelines for HIV? Persistent problems in sourcing quality assured medicines for many essential medicines (based on previous discussions at IPC – e. g. requests for sharing of audits) Evident that countries cannot rely on quality of imported products particularly given severe resource constraints of regulators – see UNFPA ergometrin and oxytocin in Ghana – what is in the box labelled “amoxicillin” (even if a genuine licensed product) Similar challenges as national procurement, but for example a lot of malaria treatments are not prequalified (see WHO study on quality in e. g. Ghana, Nigeria etc…. ) 3

Benefits – different stakeholders with different mandates can address their issues (and support the agenda) • • • No suggestion that quality requirements for PQ should be relaxed for African Manufacturers. Critical issue is investment and promise of future markets is key – forward looking statements by major procurement entities (not necessarily re price preferences but procurement policies) could act as important catalyst WHO GMP is a target for all manufacturing, with limitations to product portfolios prior to achievement – WHO has recently certified 4 Nigerian manufacturers as GMP compliant – how can these manufacturers (and others to follow) service the broader (i. e. non-PQ) donor/centrally procured markets For national procurement/private markets proper oversight for NRAs of imports is impossible (see US FDA comments re Ranbaxy). Proximity of production allows for regular inspections. Fragmented markets cannot support high quality manufacturing so regional market creation is an important contribution for example AMRH has a key role to play. 4

Major Milestones on LPP • • • 2007 Pharmaceutical Manufacturing Plan for Africa endorsed at AU Summit 2011 EAC regional pharmaecutical manufacturing plan launched 2012 AUC’s PMPA Business Plan endorsed at AU Summit 2013 early implementation begins in Ghana under invitation from president 2014 High level side event at AUC/UNECA meeting for Ministers of Finance and Economic Planning (panelists included, Mr Sidibe, Dr Mwencha, Dr Lopez, Mr LI, 2014 Joint editorial in WHO Bulletin by Mr Sidibe, Mr LI and Dr Chan supporting the local production agenda 2014 Heads of Agency meeting in Geneva when WHO, UNIDO and UNAIDS agree to support AUC in PMPA BP implementation. (GF also expressed strong interest in exploring potential involvement) 2014 ECOWAS Regional Pharmaceutical Plan developed 2015 High level ECOWAS/WAHO delegation visits Geneva and Vienna 5

Examples of challenges faced by on the ground stakeholders Context is important and different manufacturers are at different stages, but we know in general the challenges the sector faces, these include: • Access to affordable investment capital for manufacturers • Increased amount of skilled and semi skilled human resources across requisite disciplines • Access to know how and expertise for upgrading • Increased regulatory oversight of the market place • Defragmented markets and quantification of market opportunities • Need for policy coherence and time limited incentives 6

Many initiatives try to address specific aspects of these challenges Indicative examples include: • • • • Policy coherence work by WHO/UNCTAD Training in Industrial pharmacy at IPAT and Ce. PAT (USP) UNIDO strategy development and implementation in Kenya, Ghana and Zimbabwe, WHO strategy development in Ethiopia WHO PQ work with select manufacturers in Nigeria (now 4 GMP certified) + previously with Varichem in Zimbabwe Various organizations conducting training on aspects of GMP Various organizations advising on incorporation of TRIPS flexibilities/exemptions in national legislation MMV working with IMS on pilot market data gathering in Uganda and Zambia Soft loans from Government in Ghana (a similar proposal in Nigeria has yet to deliver) Under its ISID mandate UNIDO has a new investment promotion platform Various GMP roadmaps have been developed (WHO and UNIDO have discussed a common approach) Industry associations are now pushing for higher standards (e. g. PMG-MAN, FKPMA, FAPMA etc. ) WHO work on regulatory strengthening UNFPA work in support of manufacturing commodities for reproductive health AMRH initiative (and potentially the AMA) for regulatory harmonization Between us we have most of the answers. However, the overall manufacturing system is complex and the issues are interdependent. Hence, the by and large piece meal approach has not delivered stellar results. 7

Given these insights what are the challenges to achieving genuine and sustainable strengthening of the industry? The need for political will is often cited as being a prerequisite for action and progress, and whilst more needs to be done, the political level support for this agenda has been expressed strongly across institutions, however at the working/technical level progress is lagging behind the rhetoric. As identified specifically or implied above, by and large the relevant interventions exist, or we know what needs to be done, but critically to date there has been little coordination across interventions. Therefore, a fundamental requirement for progress is that we organize ourselves to deliver coordinated technical support and/or to encourage progress through addressing demand side challenges (e. g. security of supply concerns for major procurement entities). Where possible we need to avoid duplication of effort and seek alignment between different levels of intervention (e. g. national level, REC level and continental level) 8

Shared resources are key • Supporting the implementation of the various pharmaceutical industry development strategies at national regional and continental level requires capacity at technical institutions and at field level for coordinated implementation, as well as funds to provide technical cooperation this requires resources to be mobilised. • Under the PMPA BP shared resources mobilized based on a mutually developed programme is a critical component that can enable organizations to work productively together over time. • Resources can be mobilised to support the AUC’s PMPA BP which is an African owned initiative supported strongly by heads of key technical agencies. 9

Recent Developments • WHO and UNIDO in particular have allocated additional resources to increase momentum • UNIDO will soon appoint a dedicated coordinator for the PMPA BP • In April 2015 a meeting of PMPA BP consortium members took place in Addis Ababa (Attendees: AUC, NEPAD, WHO, UNAIDS, UNIDO, UNDP, UNFPA, FAPMA – Apologies ANDI) • Amongst other developments (see Zafar’s follow up) the partners worked through in detail a draft collaboration framework • The ECOWAS/WAHO high level delegation requested assistance particularly for example on establishing a regional GMP roadmap framework. 10

Urgent progress required on PMPA BP • • • A shared programme document describing different roles and responsibilities, an action plan, governance and accountability mechanisms and management/coordination structures needs to be developed. A communications strategy for multiple audiences (donors but also possible providers of FDI, DFIs, licensing partners etc. ) A resource mobilisation strategy. In the short term we are operating with many different budgets and different priorities as established by donors. Central shared resources will allow for closer collaboration and alignment of core activities, but it cannot be done in an ad hoc way. Need to engage with additional countries and regions for strategy development and early implementation work Requires that the AUC has a mechanism to guide the partners and make political decisions (see Zafar’s comments) 11

Conclusion • • Now widely agreed that strengthening the pharma industry in Africa to provide sustainable international standard essential medicines is doable and can contribute to improved health and economic growth. Agenda supported at the highest levels on the continent and amongst the international community Much work has been done by many parties and we know the challenges that stakeholders face, but technical level progress is lagging behind the rhetoric Many initiatives are in place to address specific issues However the progress is limited in part due to the lack of coordination Furthermore significant and shared resources are required to facilitate collaboration and scale up such initiatives Recently progress made in structuring the PMPA BP consortium, but much more needs to be done 12

Thank you 13