AIDS vaccine volunteers need protection, says rights group

The Botswana human rights group, Ditshwanelo, has criticised the government for not passing legislation to protect individuals taking part in HIV/AIDS vaccine trials. Botswana is one of three sites (the other two are in the United States) conducting phase 1 trials of a vaccine developed by the US drug company, Epimmune. In Botswana, the trials are being run by Harvard University, among a small group of volunteers at Princess Marina Hospital in the capital, Gaborone. Ditshwanelo is part of a Community Advisory Board set up under an AIDS research partnership between the Botswana government and Harvard University to ensure that the trials respect human rights, dignity and the safety of the participants. But according to Ditshwanelo director, Alice Mogwe, there is very little legal protection for people participating in the Botswana vaccine programme. "The Community Advisory Board is a group of people from different categories of society. The Community Advisory Board does not have a legal personality and cannot sue or be sued if anything adverse were to happen to trial participants," she said. Mogwe noted that although the government has ratified the International Covenant on Civil and Political Rights (ICCPR), it had not "domesticated" the principles of the ICCPR to make them legally binding in Botswana. "The government has not made this principle a part of the domestic laws of Botswana by enacting legislation to make the principles of the ICCPR a part of the laws of Botswana," she pointed out. Article 7 of the covenant states that "no one shall be subjected to torture or to cruel, inhumane or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation." But officials working with the Botswana and Harvard partnership maintain that the issue of informed consent and the need for sufficient sensitivity to sociocultural norms had been adequately addressed. "For example, the issue of consent in Setswana culture involves much wider consultation than in Western culture. Broad-based community support is more important than soliciting individual consent," said Reverend Rupert Hambira, senior community education advisor for the Maiteko a Tshireletso (meaning "effort to protect" in Setswana) HIV Vaccine Initiative. "Community Advisory Boards comprising 20 members of the community ensure that there is sensitivity to sociocultural norms, ethical matters and informed consent," he added. The Maiteko a Tshireletso HIV Vaccine Initiative is dedicated to developing the infrastructure and community awareness necessary to conduct vaccine trials in Botswana. Government officials argue that the rights of volunteers participating in the trials are protected by the Drugs and Related Substances Act. "There is also the Health Research and Development Committee, whose job it is to look after all health-related research taking place in Botswana to make sure it is done in a scientific manner," said Dr Patson Mazonde, director of health services in the Ministry of Health. "We also follow established international guidelines on research that affect human beings. One of the requirements is that no research can be approved in Botswana, if the country where investigators originate from has not approved it," he noted. Ministry of Health officials contend that volunteers participating in the trials are not paid because this would constitute a form of coercion for individuals coming from economically disadvantaged backgrounds. "Our policy is that you do not get paid for particpating in a trial. In those instances where there is a need for transport and meal allowances, we would be quite happy to give the volunteers that," said Mazonde. The Ministry of Health has also rejected criticism that despite the collaborative nature of the research with Harvard, if the vaccine proved successful, the patent held by the San Diego-based company, Epimmune, would not be shared with the Botswana government. "We are not the manufacturer of the vaccine, we are just ensuring access for our people. If the vaccine works, our people should benefit," said Mazonde.