International

The SP is seeking an immediate clarification regarding an illegal experiment alleged to have been carried out in India on a new pharmaceutical. The experiment was the subject of revelations made today on the television programme “Netwerk”. SP Member of Parliament and health spokeswoman Agnes Kant, commenting on the affair, said: "If is confirmed that under the guise of a conventional contract an experiment was carried out illegally on a pharmaceutical product, the so-called 'Axxion-stents' produced by the Dutch firm Occan, this is from an ethical point of view entirely unacceptable, as it would mean that people in developing countries would be irresponsibly exposed to enormous health risks."

If a new product is to be tested, a medical ethics committee for testing is supposed first to look into the safety aspects, the protection of the patient and whether the patient is well informed and has given permission. None of this appears in this case to have happened. Patients did not know that they were participating in an experiment. They were even required to pay - €1600 – something which should not happen in such experiments.

If TNO (the official Dutch medical and scientific authorisation body) has approved a new product without looking into whether the research findings presented to them were obtained in an ethical manner, the institute has failed by some distance to fulfil its responsibilities. In Agnes Kant's opinion, “the product must be even at this stage rejected if this sort of practice is to be prevented in the future.” She is also presenting a parliamentary question to Health Minister Hans Hoogervorst to determine whether legal action might be taken if there should turn out to be evidence of serious breaches of the regulations, and to urge him to bring pressure to bear on the European Commission to make such rules binding in order to stamp this kind of practice out. At the same time, it is TNO which has the responsibility to investigate such matters.

“The most important thing,” Ms Kant said, “is that we prevent pharmaceutical corporations from testing new products illegally in developing countries, products which, if the results of the tests turn out well, will bring in fat profits through being placed more rapidly on the market in developed countries.”