Better access to drugs, especially in poor countries, could save 10 million lives each year, four million of them in Africa and South East Asia, an independent UN expert said as he unveiled a set of draft guidelines for pharmaceutical companies on access to drugs.
The 50 draft provisions drew a mixed response from interested parties. They were welcomed by groups that advocate for access to affordable drugs but were strongly criticised by the industry.
Announcing the guidelines, Paul Hunt, the United Nations' special rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, said, “Almost two billion people lack access to essential medicines. Improving access to existing medicines could save 10 million lives each year.
Professor Hunt, who is professor at the department of law and the human rights centre at Essex University, continued: “Access to medicines is characterised by profound global inequity, as 15% of the world's population consumes over 90% of the world's pharmaceuticals.”
The 12 pages of recommendations, which are available for public comment until the end of 2007, are likely to be finalised next year, he said. They were drafted “to help pharmaceutical companies enhance their contribution to these vital human rights issues” and “to assist those who wish to monitor the human rights performance of the pharmaceutical sector in relation to access to medicines.”
Professor Hunt said, “It is time to identify what pharmaceutical companies should do to help realise the human right to medicine. How can we expect pharmaceutical companies to respect human rights if we fail to explain what they are to do?”
The draft terms, which UN officials say are not mandatory, include recommendations on public policy influence, advocacy and lobbying; research and development of neglected diseases; patents and licensing; quality and technology transfer; pricing, ethical promotion and marketing; clinical trials; public-private partnerships; and corruption.
Thiru Balasubramaniam, the Geneva representative of the advocacy group Knowledge Economy International, said, “They look quite encouraging, specifically on the section on patents and the fact that companies should respect the letter and the spirit of the Doha declaration [the World Trade Organization declaration on trade related aspects of intellectual property rights (TRIPS)].”
The Doha declaration, which was brokered in August 2003, calls on states to issue compulsory licences for exports to poor nations that don't have a drug manufacturing capacity.
Moreover, on patents and licensing, Professor Hunt recommends that companies should make a public commitment “not to lobby for more demanding terms in poor developing nations than those required under World Trade Organization norms governing protection of TRIPS.” Recent free trade agreements between the United States and developing nations in Latin America and Asia have resulted in so called “TRIPs plus” accords.
Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations, said that the draft guidelines seemed to be “a fairly biased approach, even in the consultation phase.” He complained that the worldwide pharmaceutical research and development sector had had little input in the initial drafting and that the draft guidelines made no reference to manufacturers of generic drugs or to companies in developing countries.
He also criticised the lack of reference to “para-statals,” the state owned companies that are prominent in countries such as Brazil, Thailand, and China.
Dr Bale said that strong protection of intellectual property rights could help improve the quality of drugs, which were often of poor quality or counterfeited in countries where intellectual property was a problem.
He also noted that standards of bio-equivalence were often mediocre in countries that do not have to adhere to stringent global standards in manufacturing practices.
The draft guidelines are at www2.essex.ac.uk/human_rights_centre/rth/.