Existing EU legislation on clinical trials is a failure. All stakeholders - patients, pharmaceutical laboratories and researchers - are extremely critical. In view of this fact, the European Commission proposed, on 17 July, to replace Directive 2001/20/EC with a regulation(1). Health Commissioner John Dalli wants to "reverse the trend" by simplifying procedures, making a distinction between trials in terms of risks and imposing greater transparency.
Research is waning in the EU: from 2007 to 2011, there was a 25% decline in clinical trials due to a regulatory framework that imposes burdensome administrative formalities, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Commission. The EU executive is fully aware of the difficulties faced by the pharmaceuticals sector and notes that staff in charge of clinical trials has had to be doubled to deal with administrative tasks. As a result, research is relocating to emerging countries (Asia, Russia and Latin America). In India, for example, more than 150,000 people are involved in at least 1,600 clinical trials being conducted by the big Western pharmaceutical firms like AstraZeneca, Pfizer and Merck, says MEP Peter Liese (EPP, Germany). Rules and controls are less strict in this country. The Independent(2) has reported that Indians sometimes participate in several clinical trials simultaneously to earn more money; some (often poor and illiterate) have even been accepted without really giving informed consent.
Clinical trials are investigations in humans intended to discover the effects of a medicinal product based on a research protocol. One quarter of trials are multinational, especially large-scale trials and those concerning rare diseases. The procedure is bureaucratic and long, however. The proposal is meant to simplify it. The authorisation procedure will be harmonised, evaluation will be flexible and speedy, a rapporteur' member state will be appointed and precise time limits will be set. …