Currently access to drugs, diagnostics and vaccines is severely limited in the developing world due a lack of affordable, effective or appropriate tools. By relying on patents (and therefore big profits) to re-coup R&D costs, the system ensures that commercial interests are placed high above patient needs in developing countries. When a pharmaceutical company develops a new drug it can apply for a patent, giving them a 20 year monopoly on production and sales. As no other company can make the same drug during this time period, it means they can charge whatever price they want, often leading to exorbitant prices – a case highlighted with the recent FDA approval of Gilead’s ‘Stribild’ at a market price of $28,500 per patient per year.
By this nature, R&D is driven by market forces. Innovation tends to focus on areas of the world which will provide the largest rewards, primarily not the developing world whose health needs go unmet. This affects R&D in two ways.
- Rich country needs are prioritised. So either; the tools and drugs aren’t developed in the first place; or; where they do exist they are developed in high infrastructure settings and can be impractical or unsuitable for roll out in resource limited settings.
- Drugs, diagnostics and vaccines are often priced out of reach of the poor. Because innovators are trying to re-coup their losses in development, so they charge huge prices.
What does this mean for the HIV response?
There is a lack of HIV treatment for children. 90% of children being born with HIV live in Sub-Saharan Africa. These children don’t represent a worthwhile market for pharmaceutical investment, thus their needs go overlooked. The WHO recommends immediate treatment for children under 2 years old, however most formulas are currently too toxic, the wrong dosages, or unsafe. The right medicines simply do not exist.
Also currently many newer antiretroviral regimens are priced out of reach of the poor. This means that people in the developing world who experience harsh side effects or even treatment failure from 1st line treatment, may have limited options for 2nd line (let alone 3rd line) treatment. In some cases countries can’t afford to move away from toxic medicines as better treatments are too expensive, for example the WHO recommends that all countries move away from using Stavudine (d4T) yet many can’t afford the alternative.
There is an urgent need for a complementary system to drive and fund innovation for people in developing countries.
Improving the system: a binding convention
At the World Health Assembly in April 2012, the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) proposed a binding convention, which would create a sustainable system of medical innovation able to deliver products based on the health needs of the poor.
How could this work?
- The R&D priorities across all medical areas would be established in order to steer innovation towards developing country needs that commercial R&D is failing to address (including HIV/AIDS, TB, antibiotic resistance, vaccines, and neglected tropical diseases).
- This would be linked with adequate and sustainable financing to ensure money is driven into areas deemed as medical priority areas. All countries would commit 0.01% of GDP to R&D needs. The CEWG recommend indirect taxation methods such as a Robin Hood Tax to raise these funds.
- All funding raised through the R&D convention should be spent with the best value for money to avoid wasting precious resources. In this way collaborative approaches should be taken to deliver R&D in the most cost effective manner, as well as encouraging openness and sharing of medical research to ensure that the fruits of R&D are seen as public goods.
Based upon the evidence of gaps in R&D in developing countries, the Stop AIDS Campaign supports the recommendations laid out by the CEWG. Previous attempts at ad hoc R&D initiatives have yielded important results, but have not improved innovation and access efforts in a sustainable or adequate way and thus a binding convention is needed to ensure the delivery of products that are focused on the priority health needs of developing countries. We urge the UK government to support the proposal for a binding Convention under the auspices of the WHO.