There is no cure for HIV/AIDS. Certain drugs, however, can halt its progression and modify its consequences. In the context of national AIDS control programmes, there is a limited but critical role for such drugs when provided in conjunction with proven preventive measures.
Effective application of these drugs can extend the duration and quality of life, reduce the risk of infecting partners and offspring and permit successful parenting. As a consequence, good treatment can maintain the economic, social and emotional integrity of the family.
There are two main categories of drugs for the treatment of HIV/AIDS:
Essential medicines such as antibiotics, anti-fungals, or pain killers. These are used for the treatment of secondary infections (particularly tuberculosis) and palliative care to improve the quality of life in the terminal stage of illness.
Anti-retroviral drugs . These limit the spread of the virus and allow some recovery of the immune system. They can protect infants born to infected mothers against HIV infection. Different types of ARVs are used in combination to sustain their clinical effectiveness and reduce resistance.
Access to treatment for people living with AIDS implies a continuous supply of quality drugs unimpeded by any physical, social and financial constraints. In turn, this requires a primary health care service that reaches the affected population and is staffed by trained health workers providing skilled supervision. In most situations access by the poor implies free or low cost provision by government and not-for-profit services, making the market price of such drugs a critical factor.
While in many cases essential medicines remain unavailable to those infected with HIV in poorer countries, much of the recent international debate has focused on the non availability of anti-retroviral drugs in these situations and the effect of patents on market prices. Industry insists that profit margins generated by patented drugs are necessary to recover research and development costs and finance the development of new products. It calculates the cost of bringing a new drug to market at $500 million, but critics estimate it to be nearer $150 million.
Industry also argues that patent protection and associated price levels are not the limiting factors in access. They indicate that many poor countries lack the necessary health delivery systems to ensure safe and effective use of their products. Conversely, critics argue that treatment regimes for HIV are now greatly simplified and can be readily provided and supervised by non-professional community health workers.
Activists , notably Oxfam and Medecins Sans Frontiers, argue that patents substantially increase the price of essential medicines and effectively put them beyond reach of the poor. For example, an Indian pharmaceutical company is offering to provide high-quality generic ARV drug combinations for US$350 per person/year through public health services and not-for-profit organisations. The same company now produces a three-in-one formulation to be taken at sunrise and sunset, which costs only US$460 per person/year. The current cost of such therapy in the USA and Europe is around US$10-12,000 per person/year.
Article 31 of World Trade Organisation's Agreement on Trade-related Aspects of Intellectual Property Rights contains specific provisions for public health emergencies which permit national governments to over-ride patents by issuing compulsory licenses or authorising parallel imports. Compulsory licensing permits local manufacture of a drug regardless of its patent status, while parallel importing allows governments to purchase a drug from another country where it is available at lower cost.
While these provisions appear to be adequate to deal with public health emergencies few countries have availed of them, either because they lack local production facilities or because of disagreement over conditions under which parallel imports can take place. Significantly, a recent threat by the US Government to utilize such provisions to ensure an emergency supply of the drug ciprofloxacin for the prevention and treatment of anthrax resulted in immediate and deep price cuts by the patent-holding manufacturer.
The pharmaceutical industry on its part has responded to these humanitarian crises, as well as to international opinion, with deep price cuts and donations of patented medicines, including key drugs for rare diseases such as river blindness and trachoma. Critics argue that even with price cuts of up to 90 per cent essential medicines remain unaffordable by the poor, that the scale of donations is insufficient to meet need and that widespread use is limited by special conditions.
In response to international pressure, the WTO examined the use of TRIPS flexibilities in public health emergencies at its summit meeting two weeks ago in Doha, Qatar. A WTO Ministerial Statement on the issue clarified the scope and use of such flexibilities. The statement indicated that TRIPS does not and should not prevent members from taking measures to protect public health, and that its flexibilities can and should be interpreted and implemented in a manner supportive of WTO members' rights to protect public health by ensuring access to medicines for all.
In addition, the transition period for compliance with TRIPS rules in respect of patented medicines has been extended from 2006 to 2016 for 40 least developed countries - these include most countries benefiting from Ireland Aid.
It remains to be seen whether these clarifications and concessions will result in wider use of TRIP's flexibilities by poor countries for health emerging such as HIV/AIDS.