Meeting the Need for Treatment: The Initiatives: How Do You Stimulate Research and Development (R&D) for New Drugs, Vaccines and Diagnostics, for Which There Will Never Be a Lucrative Market?
Gerhardsen, Tove Iren S., Bulletin of the World Health Organization
Many diseases prevail because drugs are old and ineffective, or simply do not exist. Tuberculosis (TB) is a major killer in poor countries, but no new anti-TB drug has been developed since the 1960s. There are rare, often life-threatening diseases, defined in Europe as affecting fewer than one in 2000 people, for which more "orphan drugs" need to be developed. There are diseases that are highly prevalent, such as HIV/AIDS in southern Africa, but while new, effective medicines exist, millions of people and their governments cannot afford them or they are not available at all. Neglected tropical diseases, such as malaria, affect millions of people, but most are too poor to constitute a market that is lucrative enough to justify drug research and development (R&D) in industry terms.
Over the last decade, the world has recognized the problem and started to spend more on health research and product development for these diseases. There has been a flurry of initiatives to address the lack of treatment for people in developing and developed countries. Many of these are outlined by WHO's Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), an independent panel of experts, in their final report: Public Health, Innovation and Intellectual Property Rights which was published on 3 April 2006 (see p. 351). For example, public-private partnerships have become a leading force in the development of drugs for neglected diseases; 46 such projects were in the pipeline in 2005, according to a Wellcome Trust report. The generic drugs industry provides cheap copies of brand-name medicines, has pushed down drug prices overall through competition.
Access-to-medicines campaigners and generic drugs companies argue that patents are a major barrier to meet the huge demand for affordable drugs, vaccines and diagnostics in developing countries.
In contrast, the R&D-based pharmaceuticals industry, which comes up with innovations and patents them to recoup the R&D costs, argues that the bottleneck is not the fault of patent restrictions, but the lack of funds to buy these products and inadequate infrastructure to deliver them.
The global generic pharmaceuticals industry produces cheap copies of patented medicines for diseases such as HIV/AIDS, often pushing down the prices of the original patented medicines in the process. India is a major exporter of generic medicines to other developing countries. Of the more than 60 000 HIV/AIDS patients in nearly 30 countries in Medecins Sans Frontieres' projects, 84% receive generic medicines made in India.
The generic industry helped establish the US Orphan Drug Act of 1983 to promote the development of medicines for small patient populations by providing incentives, such as tax benefits and exclusive marketing protection.
Some say this model could be used to promote the R&D for drugs for neglected diseases. The generic drugs industry sees several threats to its business model, such as "evergreening" by pharmaceutical companies to extend their patent rights and data exclusivity, i.e. denying the release of information required to advance science.
Public-private partnerships show that costly drug development can be combined with social responsibility.
Under a 2002 agreement with US pharmaceuticals company Chiron Corporation, the Global Alliance for TB Drug Development obtained exclusive world rights to the compound, PA-824, and its derivatives, which may be developed into a new TB medicine. Chiron agreed to make the compounds royalty free in endemic countries, while retaining the right to develop and commercialize them for non-TB indications.
Another example is a 2004 agreement between the International Partnership for Microbicides and Tibotec Pharmaceuticals, a Belgian subsidiary of pharmaceutical company Johnson & Johnson, to develop a microbicide to protect women from infection with HIV. …