Biomed Analysis: Why Africa must make its own drugs
There is a pressing need for Africa to bolster its pharmaceuticals industry, and that requires the right policy framework, argues Priya Shetty.
Many resource-poor countries, especially those in Africa, have always depended on other countries for their drug supplies, either through foreign aid or buying cheap generics from the pharmacy of the developing world — India.
Next month, policymakers and researchers will gather at a global health conference to discuss how developing countries can move beyond aid. The Council on Health Research for Development (COHRED) forum, to be held in South Africa in April 2012, will discuss how resource-poor nations can become more self-sufficient. Most importantly, the meeting is based on the premise that they are capable of doing so.
To break free of its dependence on donor money and supplies from India, Africa must develop its own pharmaceutical pipeline by creating policy frameworks that encourage a fledgling drug industry.
Time is precious
According to WHO estimates, less than 60 per cent of people in the developing world have access to generic medicines that are available at a fraction of the cost of brand-name drugs.
Like other stakeholders in global health, COHRED has been pushing for some time for African countries to boost their own drug-development capacity — and this has never been more urgent.
Although India’s drug industry continues to churn out generics against killer diseases such as HIV/AIDS, malaria and tuberculosis, there is no end to resistance from global pharmaceutical companies wanting to extend the duration of market exclusivity on their brand-name drugs to prevent competition from generics.
This month, for instance, drug giant Novartis is going to India’s supreme court to challenge patent laws in a case that has many health activists, such as Médecins Sans Frontières, extremely worried.
And a free-trade agreement between the European Union and India, still in protracted negotiations, could hamper the country’s ability to supply cheap drugs to the rest of the developing world.
There’s another reason why African countries should experiment with developing a drugs industry — the least-developed nations have until 2016 before they are bound by the international agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which dictates patent protection for new drugs.
With careful negotiation they might be able to extend the deadline, buying precious time to develop the framework for a robust pharmaceuticals industry.
Laying the foundations
One major driver of drug development is the presence of a market — but most Africans who need essential drugs can’t afford them.
A recent report by the UN Conference on Trade and Development (UNCTAD) recommends that African countries take steps to ensure a market exists. For example, a government can provide advance purchase commitments to guarantee the purchase of drugs from a company that are then donated or sold to poor patients at a lower price.
With limited initial capacity, countries need to be prudent about which drugs are developed. Different countries have different needs, and selection must be made through dialogue between government ministries, pharmaceutical companies, and local drug regulatory authorities, suggests the UNCTAD report.
Good regulation is crucial, yet could prove most challenging. Many African states have patchy regulatory systems for quality assurance and little means to ensure drugs testing follows ethical guidelines. They will need to create and enforce watertight regulations to ensure that substandard or ineffective medicines don’t flood the market.
A joint report by the WHO, UNCTAD and the International Centre for Trade and Sustainable Development (ICTSD) points out that “local producers find it difficult to meet regulatory standards, including those for WHO prequalification, and medicine regulatory authorities in Africa are not considered to be meeting their own national or international standards.” [2]
Building capacity
Some African countries are already making moves towards self-sufficiency. In February South Africa announced a US$211 million venture with Swiss therapeutics firm Lonza to manufacture the key chemical components (the ‘active pharmaceutical ingredients’) of antiretrovirals — the first time an African country has set out to develop any active ingredients.
This is a critical move in the right direction, as South Africa’s HIV/AIDS epidemic requires a quarter of all antiretrovirals used worldwide.
But the development of a robust pharmaceutical industry in Africa can’t, and shouldn’t be, uniform. States are extremely varied in their scientific ability, level of manufacturing regulation, and financial capacity to invest.
Some countries could first set up a system to simply manufacture drugs based on existing formulations, before progressing to research and development. Others with more advanced biotech industries, such as South Africa, will have the know-how to innovate in drug development.
Africa will not bolster its pharmaceutical capacity without considerable incentive — by subsidising land to build manufacturing plants, for example, or reducing import taxes on chemicals — from national governments, and perhaps from donors in the short term.
It will require extraordinary collaboration between industry and government agencies. But if it works, it will produce the most important set of public-private partnerships yet.
