Main tenets of the AU Pharmaceutical Manufacturing plan for Africa

1 Unreliable medicine supply systems continue to hamper access. Some of the perceived benefits of local production include:

• • Local production will save foreign exchange;
  • Local production creates jobs, thus alleviating poverty and promoting social development;
  • Technology transfer is aided by local production facilitates;
  • Local production will stimulate exports;
  • Raw materials produced locally will be readily available and at a lower cost;
  • Local production will improve self-sufficiency in drug supply.

2 The leadership of the African Union is committed to ensuring access to essential medicines for countries in need, irrespective of their level of technological development and manufacturing capacity.

3 Pharmaceutical production is capital, technology and knowledge intensive. Technical expertise is absolutely critical, both in terms of sufficient numbers and appropriate skills. The critical factor is the ability of education systems to produce sufficient numbers of skilled personnel in a sustainable manner. It will be necessary to form strong linkages with universities and funders to ensure a sustainable supply of required skills. Africans in the Diaspora can probably assist in this regard, although incentives may have to be identified. At this moment there are very few technical experts with the appropriate qualification and experience to enable the continent to go into large scale primary manufacturing.

4 At national and regional level, the legislative framework needs to be conducive to regionalised local production. This extends beyond legislation that ensures good manufacturing, distribution, laboratory and clinical practice, but also extends to legislation regulating related duties on imported raw materials and intermediates, in addition to related taxes.

5 Pricing policies and legislation linked to market size also have an impact on the extent to which local production can be expanded.

6 A strong link between academic and industrial research needs to be fostered. Technology transfer can meaningfully occur when there is a level of primary production. Innovative manufacturing is in the hands of a few multinationals that have drastically reduced the number of manufacturing sites to a few niche areas around the globe, ideally located close to the more lucrative markets. Location is also influenced by favourable labour costs. A few examples of technology transfer from the north have been for diseases of the developing world, and old technologies that are no longer profit making, such treatment for tuberculosis.

7 Other than manufacturing plant and laboratory equipment; reliable, sustainable, reasonably priced electricity and water supplies, and modern IT and telecommunication technologies are critical. Reliable distribution networks are also important. Singapore has highlighted its infrastructure in order to promote pharmaceutical production.

8 Production on the continent is in the hands of the private sector. WHO advises that this may be the best arrangement so that governments concentrate on regulatory mechanisms.

9 The plan must investigate and suggest criteria for determining what is to be produced. Though the primary focus may understandably be on the diseases which contribute more to the burden of disease, like HIV/AIDS, TB and malaria, an investigation needs to be made into whether concentrating only on these priority conditions will lead to sustainability.

10 An honest appraisal of when regulatory systems can be adequately strengthened is a key milestone. Several models to strengthen regulatory systems may be explored. Countries within a region may pool their resources together and form a regulatory system similar to the EU. Countries with weaker regulatory systems would then eventually up-scale their regulatory skills within this umbrella.

11 The plan must have safeguards against monopolistic tendencies by the approved centres. Tools to measure efficiency the fairness and competitiveness of prices must be developed, implemented and continuously monitored. A strategy needs to be developed for countries that do not have manufacturing capacity to share benefits and tasks from the plan, other than medicines.

12 Manufacturing requires highly skilled scientists, engineers, technicians, etc. Modern production is technology driven and may not create many entry level jobs. There are however possibilities of job creation across the value chain if we embark on research through development, production and distribution. Jobs can be created in public research organisations, small and medium biotech companies, upstream in engineering and downstream in public health services.

13 Export markets can only be achieved with innovation, competitive prices and quality. Government-driven procurement often protects local products through preference margins in government tenders. This may distort the market, as local small companies may not even attempt to be competitive. Raw materials and intermediates are manufactured by a few players and the quantities produced are not too large. An analysis would have to be made to establish whether manufacturing raw materials is cheaper than importing them.