Local production of essential medicines including Antiretroviral drugs a necessity in Africa

Issued: Department of Health

24 August 2005

SA Minister of Health Dr Manto Tshabalala-Msimang has endorsed the statement of the Executive Board of the World Health Organisation (WHO) on local production of essential medicines.

"We endorse the statement of the Executive Board that policy decisions about whether to import essential medicines from reputable sources or to promote local manufacture should be based on careful situation analysis and realistic appraisal of the technical feasibility and financial viability underpinned by sound regulatory systems," said the Minister during a session on local production of medicines at the WHO-AFRO Regional Committee meeting in Maputo, 22-26 August.

Dr Tshabalala-Msimang said that local production of essential medicines should be viewed in the context of defining "local" as meaning African continent.

The Heads of States, within the African Union context, took a decision that medicine production would be strategically located within the region. "This strategy anticipates a market size that would ensure sustainability as well as technical and financial viability," she added.

According to the WHO-AFRO Regional Office, local production of essential medicines, including antiretroviral drugs, has become a necessity in Africa in the light of the increasing burden of diseases, and yet, Africa's share of world medicine production continues to decline. The region accounts for only 2,6% of global output.

The availability of local production is influenced primarily by the size of the market, existence of other production capacity in the Region, size and procurement preferences, especially of public sector market, physical infrastructure and human resources.

Most production of medicines in the region is limited to compounding and packaging, repacking, and processing bulk medicines into dosage forms using imported raw materials.

Mainly generic medicines are produced, and they satisfy only a small proportion of national requirements.

"South Africa would recommend that the continent should look at diversifying between primary and secondary level production," said the Minister.

Primary level production includes the manufacture of active pharmaceutical ingredients and intermediates from basic chemical substances. The secondary level includes the production of finished dosage forms from raw materials.

"This is particularly important in the light of Intellectual Property Rights time frames. For complex molecules, technology transfer and partnerships between South-South and even North-South are imperative," Dr Tshabalala-Msimang added.

The Minister also suggested that the issue of primary level production should be looked at "in the context of our own indigenous knowledge systems, which will further be enriched or advised by local relevant and appropriate research."

However, emphasised the Minister: "This cannot be achieved without taking provisions within the Trade Related Intellectual Property Rights (TRIPS) Agreement into consideration. The question should be asked whether provisions within the TRIPS Agreement sufficient to enable developing countries to develop a robust industry that not only caters for local needs but for export as well."

Dr Tshabalala-Msimang said the challenge was to ensure that the implementation of intellectual property rules was based on pro-public health and pro-access principles. "It should ensure a rapid and effective response to public health needs, sustainability of supply of quality medicines at affordable prices."

The Minister said that competition, through the facilitation of a multiplicity of potential suppliers and provision for a wide range of medicines and other health technologies should also be promoted.

She added that access for countries in need, irrespective of their level of technological capacity, manufacturing capacity, and their membership in the World Trade Organisation (WTO) should be ensured as well.

The Minister also made the following recommendations on behalf of South Africa:

1. That WHO facilitates the alignment of the AU decision with regional activities in promoting local production.
2. That there should be a comprehensive and integrated strategy on intellectual property and trade agreements which can anticipate and address the needs of member states
3. That the Ministers of Health, Trade and Finance should dialogue on this urgent issue, and that WHO facilitates this multisectorial dialogue.
4. That WHO supports operational research into the sustainability and viability of primary and secondary production.

South Africa also supported the indicated roles and responsibilities of Governments during the session. "We have gone a long way into facilitating the implementation of these issues. Our legislative framework provides for the utilisation of the TRIPS Agreements as clarified by the Doha declaration," Dr Tshabalala-Msimang, said.

The roles and responsibilities of Governments include the following:

• Create an enabling policy and economic and regulatory environments for technology transfer, and facilitate the development of local production capacity for essential medicines;
• Use regional economic integration to improve local production and encourage countries to join regional economic communities;
• Enhance collaboration among the various ministries (health, trade, industry, finance), patent offices, private sector and other development partners;
• Undertake economic appraisal of alternative options to ensure sustained supply of essential medicines;
• Enhance pharmaceutical research and development, especially using locally-available medicinal plants and other raw materials, in order to generate data on safety, efficacy and quality needed for large-scale production;
• Build national medicines regulatory capacity to enable implementation of Good Manufacturing Practice and TRIPS safeguards such as compulsory licensing.

Contact: Charity Bhengu 083 679 7424