Our overriding preoccupation is the lack of transparency that surrounds clinical trials and their delocalisation by pharmaceuticals companies in countries where the regulation is inadequate and the population vulnerable. To protect these patients and put a stop to these practices, Public Eye demands...
...of the Federal Council:
- that it require Swissmedic to establish enhanced additional ethical controls for clinical trials conducted in developing and emerging countries as part of the procedure for the marketing authorisation of drugs in Switzerland.
- that it reinforce the ethical control of clinical trials used in the authorisation of the marketing of drugs in the northern countries. This measure is all the more urgent as an increasing amount of the scientific data thus gathered comes from developing or emergent countries where the legislative framework is often incomplete and the socio-economic and political climate very unstable.
- that it examine via on-the-spot inspections the conditions in which are conducted delocalised tests that can be potentially used as a basis for the authorisation of the marketing of drugs in Switzerland. The revised law on Medicinal Products and Medical Devices (LTA) now provides a legal basis allowing Swissmedic to perform inspections outside of Switzerland.
- that it demand of promoters that all clinical trials used for the authorisation of marketing in Switzerland – including delocalised tests – be included in the new complementary Swiss register which, for the moment, only covers clinical trials performed in Switzerland.
- that it work towards increased transparency by publishing the entire set of documentation used as a basis for decisions to authorise the marketing of drugs.
...of the pharmaceuticals industry:
- that the pharmaceutical industry stop using countries in the southern and eastern hemispheres as giant experimental laboratories, where vulnerable people are used as human guinea-pigs purely for reasons of profit. Clinical trials should not be conducted offshore unless those populations benefit directly and in real terms from the results: the trial must be of a treatment related to a specific disease that affects those people in particular, and the sponsor must make sure that the treatment will be available and accessible to that same population if it proves more effective than existing treatments.
- that pharmaceuticals multinationals that conduct such tests – Roche and Novartis first and foremost – respect their duty of diligence. Pharmaceuticals companies have an obligation to respect human rights, as stipulated by the guiding principles for business and human rights unanimously adopted by the United Nations in 2011. Our research shows, however, that they do not yet take their responsibilities sufficiently seriously or take adequate measures. They must therefore evaluate scrupulously, and in a transparent way, the risks of ethical violations and mitigate these as far as possible (duty of reasonable diligence). This aspect is demanded, in particular, by our initiative for responsible multinationals.