Partnering with the AUC to manufacture pharmaceuticals in Africa
Most countries in Africa rely heavily on imports for pharmaceutical products whether it is for the pandemic diseases or for the overall range of essential medicines. This situation which has economic implications regarding use of hard currency, is for some a missed opportunity in terms of economic development and job and wealth creation, and poses a threat for the sustainability of treatment programmes as and when donor fatigue sets in. Furthermore, it represents a health hazard as it is impossible for national regulators to properly oversee supplies of essential medicines that come from a vast number of manufacturing plants spread across many countries.
Strengthening and growing the industry on the continent is of strategic importance for a number of reasons including long term health objectives. Developing the pharmaceutical sector will also bring economic development benefits, including new jobs.
In March 2011, African Ministers of Industry at their conference in Algiers identified the pharmaceutical sector as being a priority for the continent and included it in the Accelerated Industrial Development of Africa Framework.
In July 2011 the African Union Commission (AUC) and the United Nations Industrial Development Organization (UNIDO) agreed to form a partnership to accelerate the implementation of the Pharmaceutical Manufacturing Plan for Africa (originally endorsed by AU Heads of State in at their summit in Accra 2007).
Why develop Africa’s pharmaceutical sector?
“Historically there has been a heated debate as to whether pharmaceutical production in Africa should be supported, with some experts stating that the objectives of improved public health and development of the sector were mutually exclusive,” says UNIDO Senior Industrial Development Officer, Juergen Reinhardt.
“However, this perception is increasingly being challenged and the AUC-UNIDO partnership is established firmly on the basis that public health benefits will be achieved through development of local production and that this can only happen through providing well conceived support to the local industry.”
Alastair West, Senior Technical Advisor, adds that there are a number of potential areas where high quality local production of essential medicines can deliver public health benefits, for example through shortening supply chains, hence helping to reduce stock outs, and by virtue of proximity, enabling resource constrained local regulatory authorities to properly oversee the quality standards of a source of essential medicines. He says that there was also evidence to suggest that locally produced products were more widely available in rural areas than imported products.
Challenges to developing the pharmaceutical industry
Whilst the idea of sustainable local production at international standards is appealing, achieving such an ambition faces significant challenges, including limited skilled human resources and investment capital, and insufficient regulatory oversight. Other matters that need to be taken into account include the competition from cheap (often substandard) imports; cost competitiveness considerations (e.g. utilities, importation of all raw materials); and opaque and fragmented markets. Whilst daunting, these challenges are not insurmountable provided a coordinated approach to implementing solutions is utilized. For example, properly structured, time limited incentives coupled with technical support for industry to strive for international standards and develop efficient production practices, along with improved regulatory oversight are central pillars of an approach to deliver long term quality and sustainability of the sector.
Currently, at the national level, some countries have active pharmaceutical sectors with 20 or more companies (Egypt, Ghana, Kenya, Nigeria, South Africa), while others have a handful of companies (Tanzania, Uganda, Zimbabwe).
The quality of manufacturing on the continent varies both between manufacturers in individual countries and between different countries. South Africa for example has a relatively strong regulator that can enforce quality standards. Some other countries are less able to enforce quality standards allowing for lower quality manufacturers to operate.
The Pharmaceutical Manufacturing Plan for Africa that UNIDO and the AUC will further develop and implement is intended to address this diverse range of contexts and is intended to complement ongoing initiatives such as the East African Community’s Regional Plan of Action for the Pharmaceutical Sector.
“Local production may not necessarily be viable for all countries, and those that do aspire to develop either a dynamic industry, or a strategic manufacturing capability will need to invest through providing incentives to the industry, and developing public-private partnerships,” says West.
He also believes that the central partnership between UNIDO and AUC will need to strengthen ongoing relationships with other UN entities like the World Health Organization (WHO) and UNAIDS, as well as national organizations such as the United States Pharmacopeia, to ensure that the many aspects of the challenge to achieve high quality pharmaceutical production in Africa can be met.
Since 2006, UNIDO has been running a project, funded by the Government of Germany, on strengthening the local production of essential generic medicines in developing and least developed countries. The project has helped advance national level strategies for development of the industry in Ghana and Kenya, support the establishment of the Southern African Generic Medicines Association (SAGMA), and conduct research into the pharmaceutical industry in a number of countries. It has also supported the industrial pharmacy course at St. Luke Foundation in Tanzania.
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