EU institutions must speed up the implementation of the new rules regarding the clinical trials, according to a statement by the European S&D party.
The left-center party underlined a tragic accident in France in mid-January, when one person was left brain-dead and five others were in serious condition after participating in a drug trial in the northwestern French city of Rennes. The fate of the five people hospitalized remains unknown but on January 15 a doctor said that at least three of the patients may suffer irreversible brain damage in case they survive.
In January, the Portugal-based pharmaceutical group Bial, launched a clinical trial at a facility in Rennes led by the research company Biotrial. According to France24, the trial was at Phase I, in which healthy volunteers took the medicine which aimed at easing pain and mood and anxiety troubles, as well as motor problems linked to neurodegenerative illnesses.
After the tragic incident, which is considered the worst-ever in the drug trial history of the country, French prosecutors have launched a manslaughter investigation into the case.
On 2 February, S&D reported that the EU must speed up the implementation of the new clinical trials rules, as it will force the researchers to publish the results of the Phase 1 trials. The left-center party said that this is vital as it will help to avoid dangerous or ineffective studies being carried out repeatedly.
According to Science magazine, Phase I studies are designed to test safety and tolerability of a drug, as well as how, and how fast, the chemical is processed by the human body. Most of these studies are carried out by research contract companies and the subjects are usually healthy volunteers who receive modest financial compensation.
Gilles Pargneaux MEP, S&D member of the health and environment committee, said about the shocking case in France: “It’s very alarming that the French health authorities were only informed four days after the trial had been halted by the company carrying out the tests on behalf of the Portuguese laboratory…This case shows that it’s difficult to have complete transparency when it comes to clinical trials and the interests of pharmaceutical companies.”
Moreover, Matthias Groote MEP, S&D spokesperson on health and environment, added: “In order to explore the effects and side effects of new drugs, we have to have Phase I clinical trials. These studies however, need to be carried out after a strict approval process and under close medical supervision. The safety of patients should always come before economic interests….It is vital that there is public access to the results of all clinical trials, which is currently not the case in Phase 1 trials. As this regulation will not come into force before 2018, the S&D Group wants clarification from the European Commission on the progress of the implementation of this new regulation, as well as more details on the case of the clinical trial in France.”