Industry Committee debates medical research transparency and European Commission claims reporting requirements hurt small non-commercial researchers
Today the Industry, Research and Energy Committee debated their opinion of the Clinical Trial Regulation. The rapporteur of the Opinion is French Green Michelle Rivasi. This opinion will be voted in late March, a month before the final vote in the lead Envi committee.
Rivasi made a very strong case in favor of transparency. She mentioned a number of recent scandals produced by the lack of transparency and denounced the case being brought by a pharmaceutical company against the EMA for releasing clinical trial data. She rejected the suppression of the role of ethics committees, criticized the weakening of standards for “low-intervention trials” and called for a clear open-data policy. She spoke of the need of harmonizing EU ethics requirements because France had 200 while Italy had 2000.
Spanish conservative De Castillo spoke in the name of French conservative Grostette. She harshly criticized Rivasi´s proposal of Clinical Study Reports and open data because “it goes far beyond what is needed, threatens competition, intellectual property rights and data protection”. She defended that each EU member state should have its own ethics committee and policy in accordance with the subsidiarity principle. She defended very low requirements for “low risk clinical trials”.
Portuguese Socialist Correira de Campos, former minister of health, stated that there was “no link between clinical trials and specific cures”. He supported different rules for different levels of risk. He called for a better definition of what a trial should be. He admitted that data on secondary effects was often destroyed and said it would be dangerous for sponsors to pick the laxest country in EU to carry out clinical trials. He is against short deadlines for scientific evaluation because “science should not have deadlines”.
Swedish Liberal Johansson welcomed the “simplification of the Commission proposal” and agreed that ethics should be on national level. He supports complete, accessible clinical report studies and access to raw data but is worried about when and how the access is granted as to not hurt competition.
Stefano Soro for the European Commission stated the 30 to 40% of clinical trials are carried out by non-commercial academic researchers and that most of the clinical trials not registered and lost are from here. He insisted that requirements of producing a Clinical Study Report cannot be met by non-commercial academics and small companies.
The Commission supports the new policy on openness of the EMA but insists that this policy cannot by applied to all clinical trials carried out. Otherwise small research groups and academics will be hurt. He defended much lower demands on “low-intervention trials on products already authorized.” with no special insurance.
“Assessment of clinical trials will be supervised by the EC but it is a purely national decision”, declared Soro who added that any national assessment must be honoured in all the EU.