Towards greater production of medicines in Africa?

Current situation


Despite the efforts done in the last decade by governments and global organizations, about 2 million Africans have no access to essential medicines. 74% of drugs against HIV/AIDS are still under the monopoly of big pharmaceutical groups and 77% of Africans still lack access to treatment. As a result, tuberculosis, AIDS and malaria still kill more than 6 million people on the continent each year.  A possible solution to this situation would be the production of generic drugs in the continent. Being 70-90% cheaper than brand name drugs, generic drugs are more affordable for a large majority of Africans.


The continent has 14% of the world population but produces only 3% of the world medicines. While the overall pharmaceutical market in sub-Saharan Africa is worth USD 3.8 billion annually, the pharmaceutical manufacturing sector in Africa contributes only 25-30 per cent of the continent’s needs. The production of life-saving drugs is furthermore concentrated in very few African countries: 70% of pharmaceutical manufacturing takes place in South Africa and an additional 20% in Nigeria, Ghana and Kenya. Apart from Morocco, more than 85% of drugs sold in Africa are imported. Senegal imports 80% of its medicines. Currently most generic come from India. Though they are cheap the high cost of transport makes it difficult for governments and national health systems to provide treatment for all those who need it. In Kenya, more than 400,000 HIV-positive people are receiving ARVs, but another 600,000 require the drugs and have no access to them. An estimated 1.5 million Kenyans are infected with HIV.


Today no African country, whatever its size and level of economic development, is entirely self-sufficient in pharmaceuticals. This is a concern for governments and patients. To answer this need, in 2001 the 55 members of the African Union (AU) signed the Abuja Declaration to support the development of a plan for pharmaceutical innovation in Africa. The 2005-AU Assembly decided to develop a Pharmaceutical Manufacturing Plan for Africa within the framework of NEPAD. The AU Conference of Ministers of Health that followed with the support of some partners decided took practical steps to produce generic medicines on the continent and to make full use of the flexibilities within the Trade and Related Aspects of Intellectual Property Rights (TRIPS) and DOHA Declaration on TRIPS and Public Health. 


The 59th World Health Organization Regional meeting for Africa discussed the issue and the AU Commission in collaboration with the World Health Organization (WHO) conducted a drug production capacity mapping exercise. A series of questions were raised: was it better to strengthen local production of essential medicines or to import essential medicines from reputable sources? A realistic appraisal and analysis was needed before deciding on local manufacturing. A number of issues had to be taken into account: technical feasibility, financial viability, sound regulatory systems, market size necessary to ensure sustainability as well as technical and financial viability.


Current Production


Pharmaceutical production occurs at three levels:

  1. The primary level includes the manufacture of active pharmaceutical ingredients and intermediates from basic chemical and biological substances.
  2. Secondary production includes the production of finished dosage forms from raw materials and excipients.
  3. The tertiary level is limited to packaging and labelling of finished products or repackaging of bulk finished products.

Out of the 46 countries in the WHO-African Region[1] 37 have pharmaceutical industries, of them 34 have secondary level production and 25 have tertiary production. Only South Africa has limited primary production. Nine countries have no production capacity.


Many countries in the continent rely mainly on India and in less measure on China for imports of affordable generics and raw materials. The fact that since 2005 India had to comply to the TRIPS and change its patent laws is seen as a potential threat to affordability and access to essential drugs in Africa. Patents often make drugs more expensive. Added to this is the fact that Indian producers target more and more rich countries markets and they are less orientated towards African countries diseases. African countries need to decide on alternatives for African specific diseases such as malaria.


Medicines and international AID


The role played by the global health community has been decisive in the supply of affordable drugs to fight against neglected diseases. International Health organizations and Western governments have provided the majority of medicines that the continent needs. They have played an important part in the diminishing of deaths from malaria, HIV/AIDs and TB, and of the diminishing cases of river blindness among others. They have also contributed to the increasing number of HIV/AIDs patients treated by antiretroviral drugs (ARV). But these advantages bring with them some dangers. These International groups set up the agenda for health research and drug development in Africa. It is important that countries be allowed to set their own priorities and formulate their own strategies in order to meet the needs of their populations. They need to take measures not to rely so much on international aid.


The efforts towards medicine production


Till now in most African countries the production units were made up of subsidiaries of foreign pharmaceutical firms. They import almost all of the raw material. In the ECOWAS region there are 17 production units including 8 in Ivory Coast, and 4 in Senegal, but they ensure only 10% of the needs of the region.


Backed by the African Union (AU), several African countries have launched into the production of generic drugs for HIV/AIDS, tuberculosis, and malaria. Kenya, Nigeria, South Africa and Tanzania, among others, have adopted policies to invest into the development, production and procurement of drugs for their populations.


Cameroon and Gabon have have developped their own production of generic drugs. In April 2010, Cinpharm-Cameroon opened a factory in Douala, that is the most modern pharmaceutical company in West and Central Africa. . It will produce painkillers, antibiotics, anti-malarial, intestinal parasiticid, anti-inflammatory, antibiotics (repetition), antiretroviral and TB drugs. Eventually, the production should meet 25% of national needs.


With the help of the government Aspen Pharmacare in Port Elizabeth (South Africa) produces under license eight generic antiretroviral drugs. Aspen in (is) Africa’s largest pharmaceutical manufacturer and has become the world's leading manufacturer of generic triple therapy and is also among the three producers of generic ARVs (the other two are Indian) approved by the World Health Organization (WHO). Aspen has four sites in South Africa, one in Kenya and one in Tanzania.


In November 2011, Universal Corporation, a Kenyan pharmaceutical company has been granted the   prequalification certification by the World Health Organization (WHO) allowing the production of Lamizido, a combination ARV drug of Zidovudine and Lamivudine, that will be produced in 150 and 300 gram doses. The prequalification means that the WHO has tested the safety, quality and efficacy of medicinal products before they are released to the public. The cost of the Kenyan drugs is supposed to be cheaper by at least 30% than the drugs bought currently from foreign manufacturers.


The Quality Chemicals plant, in Kampala (Uganda), has got a WHO pre-qualification process, which means the manufacture plant has passed a severe quality check. It is the first production plant in sub-Saharan Africa, except from South Africa, to get WHO pre-qualification. Now the company is trying to get the pre-qualification, for the malaria and HIV/AIDS drugs the firm produces. Once it is obtained, international agencies such as UNICEF, will be allowed to buy from the company. The success of Quality Chemicals is in part due to one of India's leading generic pharmaceutical companies, Cipla, which designed the plant (a carbon copy of Cipla's facility in Goa, India). Cipla sent its experts to train Ugandan staff and even applied for WHO pre-qualification certification on behalf of Quality Chemicals.


SOGAMA in Gabon was the first plant to produce generic antiretrovirals and antimalarials. The plant supplies also the member countries of the CEMAC (Economic and monetary Community of Central Africa) which represents a market estimated at 30 million people.


In Senegal there are four production units (Sanofi Aventis, Pfizer, Canon and Valdafrique WestAfrica Pharma) that provide the licensed production of specialty and generic, which is exported (20 to 30%). A project for the production of generic ARVs is finding a lot of difficulties.


South Africa, Nigeria, Ghana, Marroco, but also Ethiopia, Tanzania, Uganda, Kenya and other countries have different kind of pharmaceutical production.


Pharmaceutical companies from Democratic Republic of the Congo to Ethiopia are being helped to reach international standards too. German development agency GTZ is even sending individual inspectors from the German regulator to Africa to do personal plant assessments. Although no substitute for a full WHO pre-qualification, the process helps identify improvements necessary to reach international standards.


Today even Western Pharmaceutical Companies are targeting the main African countries. They have realized that big African countries are a “potential market”. They try to get a part of this market either by buying small production companies or through licensing agreements with local manufacturers.


Benefits of local production


The lack of access to basic generic medicines is a good reason to produce local medicines and to be less dependent from other countries. Local production can facilitate access to medicines for those in need.


Most Africans have no health insurance, so either the government buys and import the drugs from foreign companies to distribute them in the national health system; or the patient has to pay from his own pocket.


A series of benefits are expected as a result of local production: save of foreign exchange; creation of jobs; increase of exports; technology transfer; raw materials produced locally will be cheaper; improvement of self-sufficiency in drug supply. The problem is that these benefits are not always there when drugs are produced. Local manufacturing is supposed to make the drugs cheaper, accessible to more people, thus resulting in significant savings for the government's treatment programmes, but sometimes the price cannot compete with those from India and China.


Difficulties in the path to production


A series of bottlenecks make difficult the production and the selling of medicines produced in Africa: heavy taxation, lack of access to inputs and raw materials, strong competition from foreign laboratories, lack of research and development, a proven system of pharmacovigilance and qualified human resources ... These factors are sometimes responsible of pharmaceutical production behind in Africa.


Intellectual Property Rights. To help Africa produce its own drugs, it is urgent to remove the barriers of intellectual property, which block the rapid spread of cheap versions of existing life-saving drugs. Specific provisions of international law already exist. The flexibilities within the Trade and Related Aspects of Intellectual Property Rights (TRIPS) and DOHA Declaration on TRIPS and Public Health allow for "compulsory licensing". This means that a country for reasons of public health can lift the patent on certain drugs, provided royalties on the sale of the generic versions are paid to the laboratory that owns the patent.


Infrastructure. Unreliable water and electricity supplies, difficulties of transport, the need to import machinery, packaging, and active pharmaceutical ingredients (APIs) result of a weak chemical production in many African countries are constant difficulties that that contribute to making the product more expensive. Furthermore the business environment in Africa has many deficits.


Quality. The big challenge is to produce high quality drugs. The operating environment can be difficult and the weaknesses at plant level in reaching and maintaining quality standards in line with established international standards (WHO) can be hard.


Human Resources. The production of good medicines and the maintenance of  the facilities needs pharmaceutical experts and technical personnel with high and specialized skills that are missing in many African countries. The lack of high quality education at university is the main cause. Another difficulty is the lack of expertise and of means in drug regulatory authorities, responsible for approving the marketing of these drugs. To succeed in the production of medicines Africa needs good pharmacists, biologists, chemists, doctors, and technicians.


Material Resources. Low level of investments and of capital constitutes a main strain. The drug regulatory authorities often are understaff and they have not funds. This makes it difficult to approve the medicines.


Legislation. The lack of regulation and of clear political will does not allow an investment security. The pharmaceutical sector lacks effective support functions among others by regulatory authorities and quality control labs.


Small domestic markets. In Africa markets are small because the countries are small and the many in the population do not have the means of buying the medicines. The small size of domestic markets diminishes the prospects for achieving optimal production efficacy.  E. g. Uganda has a population of 30 million, not enough market for a production unit. The creation of bigger markets like the East African Community can be a solution. The difficulty is that each country wants to have its own production unit.


Prize. Manufacturers in Africa face a multitude of expenses: high cost of inputs (energy, packaging), transport and imported commodities, together with small volumes produced raise the cost of medicines beyond those from India and China. Prizes offered by local producers are cheaper than those from Northern companies but higher than those from India and China, that can produce cheaper thanks to their huge markets.


Economic viability of local production, is hard particularly where the production is undertaken by private entrepreneurs as a commercial venture. The sustainability of the production will depend on factors such as the size of the market and the demand for the produced medicine, as well as the ability to export such medicines.




Despite the difficulties met by the production of medicines in Africa, the adventure continues and Africa is developing its own production of generic drugs. This is a sign of hope for all those who care for a better health for the African people.

For the local production of pharmaceuticals to be effective and efficient, African countries, donors and International Health Institutions need not only words, but the political will, investments and actions that will lead to a local production of essential generic medicines of quality in the continent, so that all Africans may have access to medicines of quality.


Begoña Iñarra, AEFJN Brussels Secretariat

[1] The World Health Organization (WHO) African Region is formed by all countries of the continent except Morocco, Tunisia, Libya, Egypt, Sudan and Somalia that belong to the WHO-Eastern Mediterranean region.

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