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Editorial

The AIDS response catalysing economic and social transformation: the importance of local pharmaceutical production

Michel Sidibé1,*

1Executive Director, UNAIDS, Geneva, Switzerland

*Corresponding author e-mail: sidibem@unaids.org

Citation: Antiviral Therapy 2014; 19 6:3-4
doi: 10.3851/IMP2894

Date accepted: 03 September 2014
Date published online: 13 October 2014

Copyright (c) 2014 International Medical Press, all rights reserved.

During the past 10 years, the global community has seen a considerable increase in the coverage of people living with HIV (PLHIV) on antiretroviral therapy (ART) in resource-limited countries, which is increasing life expectancy in many parts of the world, including sub-Saharan Africa. Countries across the world agree that efforts to end the HIV pandemic require a sustainable programmatic approach that needs to include the strategic development of local pharmaceutical production. 'Local' production in this context refers to national or regional production of antiretroviral drugs (ARVs). Unless a ‘cure’ can be found for HIV infection, PLHIV can anticipate having to take ARVs their whole lives. Today, we know that ARVs are also a very effective HIV prevention method. Therefore, the need for effective and affordable ARVs with few adverse effects will continue to increase.

Like many great endeavours, the task of ensuring reliable and sustainable manufacturing of medicines and other health technologies is a complex undertaking. The global community therefore needs to continue to focus on three key pillars that will help ensure access to medicines: political vision and commitment, partnerships, and sharing of knowledge and technologies.

The first pillar is political vision and commitment. As Brazil and South Africa have shown, the first step towards the development of national and regional pharmaceutical production capacity is the recognition by political leaders of its necessity and that requires mid- to long-term investment to achieve this ambition at country or regional levels. All African leaders have demonstrated a strong interest in the local manufacturing of essential health technologies [1,2]. For instance, the current African Union Commission Chair, Mme Dlamini Zuma, President John Dramani Mahama of Ghana, President Paul Kagame of Rwanda and many others have in recent years clearly stated they would be prepared to lead the way in this area.

The local production of health commodities in countries must be viewed from the perspective of promoting both industrial development and public health in alignment with the national goals for these: both must be advanced in unison [3]. The development of local production and access to ARVs should explicitly serve the needs of local populations, including key and vulnerable populations, to ensure that no one is left behind. The recently adopted Common African Position on Post-2015 [4] clearly outlines the commitment of African member states to local manufacturing of pharmaceutical equipment and implementation of the Abuja Declaration [5]. Leaders at regional levels, such as the Economic Commission for Africa [6] and the African Union, have demonstrated this vision to date. There is here a clear political momentum to build on as the world plans the agenda for development in the next era.

The second pillar is highly accountable and strategic partnerships. There is a need to build on the collaboration between countries, multilateral agencies, donors and pharmaceutical companies, including the private sector, to defragment markets and increase the sustainability of manufacturing through economies of scale. The BRICS countries – Brazil, the Russian Federation, India, China and South Africa, which are home to many world-class researchers and strong pharmaceutical industries – and others, can assist in building capacity for local production and strengthening regulatory capacities in a variety of countries and continents.

International and regional organization can support these strategic partnerships. For instance in Africa, UNAIDS, UNIDO and the WHO are working closely with governments and regional authorities to better coordinate inter-agency efforts to support countries to implement the Pharmaceutical Manufacturing Plan for Africa (PMPA) [1]. Universal health coverage promoted by the WHO, and the mandate of UNIDO to encourage inclusive and sustainable industrial development [7], can support local manufacturing of essential commodities to improve global public health. For instance, African Union Member States, through the Regional Economic Communities in Africa, are strengthening their national regulatory authorities and fostering regulatory harmonization across countries and sub-regions. The African Medicines Regulatory Harmonization (AMRH) [8] initiative is supported by many agencies, including NEPAD, the World Bank, the WHO and UNAIDS. The WHO’s Prequalification Programme has a broad impact on the continent as a growing number of manufacturers comply with Good Manufacturing Practice (GMP) guidelines. Continental platforms, like the AMRH, the Roadmap on Shared Responsibility and Global Solidarity [2] and the PMPA, are country-driven efforts to bring together and harmonize international partners, including the BRICS countries and developmental agencies

The third pillar is the sharing of knowledge and technologies and the use of implementation science. To ensure sufficient availability of ARVs, the research and development, production, distribution and access to generic ARVs and ART regimens need to be scaled-up. Availability and quality of medicines is non-negotiable and must be assured through the strict application of GMP and other quality assurance systems across the pharmaceutical chain. Because of the complexity of these issues, this Supplement brings together experts from many fields to describe the process from research and development, production of generic ARVs, their delivery to countries and subsequently to PLHIV in low- and middle-income countries. A major aim was to highlight how each of these steps are interrelated, how the production and delivery of these drugs to PLHIV in resource-limited settings can be made more effective and efficient, and what the lessons are for the production and delivery of a broader set of generic drugs to people in low- and middle-income countries. Much more work is needed, however, to support the development of the global technical capacity to take forward this essential agenda.

The political commitment and partnerships are developed and we have the tools and science to advance this agenda. To meet this challenge, all partners must come together to cultivate a strong vision, backed up by an actionable plan, political leadership and sufficient and sustainable resources. As we see life-expectancy growing in many parts of the world, as continents like Africa rise with thriving economic development and as the health needs of populations all over the world increase, the global community needs to address the critical issue of ensuring access to medicines for all. The AIDS response has often been at the forefront of the development agenda and again in this case must lead the way.

Disclosure statement

The author declares no competing interests.

References

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1. African Union Commission. Pharmaceutical manufacturing plan for Africa: business plan. Addis Ababa, African Union, 2012. (Accessed 28 August 2014.) Available from http://sa.au.int/en/sites/default/files/pmpa%20bp%20ebook.pdf
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2. African Union. Roadmap on shared responsibility and global solidarity for AIDS, TB, and malaria response in Africa. Addis Ababa: 2012. (Accessed 28 August 2014.) Available from http://www.au.int/en/sites/default/files/Shared_Res_Roadmap_Rev_F%5B1%5D.pdf
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3. World Health Organization. Local production for access to medical products: developing a framework to improve public health. Geneva, 2011. (Accessed 28 August 2014.) Available from http://www.who.int/phi/publications/Local_Production_Policy_Framework.pdf
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4. African Union. Common African Position (CAP) on the Post-2015 development agenda. 22nd Ordinary Session of the Assembly of the Union. Addis Ababa, Ethiopia, 31 January 2014. (Accessed 28 August 2014.) Available from http://www.nepad.org/sites/default/files/Common%20African%20Position-%20ENG%20final.pdf
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5. African Union. Declaration of the Special Summit of the African Union on HIV/AIDS, Tuberculosis and Malaria. Abuja, Nigeria, 16 July 2013. (Accessed 28 August 2014.) Available from http://sa.au.int/en/sites/default/files/2013%20Abuja%20Declaration.pdf
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6. UNAIDS. Cooperation for the local manufacturing of pharmaceuticals in Africa intensifies. Geneva/Abuja, 29 March 2014. (Accessed 28 August 2014.) Available from http://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2014/march/20140329ecapharmaceuticals/
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7. United Nation Industrial Development Organization. Lima declaration: towards inclusive and sustainable industrial development. Vienna, 2013. (Accessed 28 August 2014.) Available from http://www.unido.org/fileadmin/user_media_upgrade/Media_center/2013/News/GC15/UNIDO_GC15_Lima_Declaration.pdf
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8. African Medicines Regulatory Harmonization. (Accessed 28 August 2014.) Available from http://www.amrh.org/

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