Commission aims to boost clinical research
By Ophélie Spanneut | Tuesday 17 July 2012
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. Intrinsically national aspects (civil liability rules) or ethical aspects (informed consent) are clearly separated from elements that come under cooperation between member states.
The draft regulation imposes the publication of results in an official register, including when the outcome is unfavourable. The challenge is to avoid redundant studies and wasted time and money. Research conducted in third countries will also be listed in the register; for now, this rule applies only to paediatric clinical trials.
The proposal obliges third countries to comply with regulatory requirements at least equivalent to those in the Union. It also provides a legal basis for carrying out controls. Part of the budget of the Health for Growth 2014-2020 programme will cover controls and inspections carried out by Commission staff.
The Commission also proposes to make a distinction between regulatory constraints in terms of the risks involved in the study. Nearly 40% of clinical trials are conducted by non-commercial sponsors: academics or groups like cancer research associations that wish to test the effectiveness of a medicine already on the market at lower doses to reduce side effects for patients. Parliament made this request in 2000, during the negotiation of the current directive, but it was turned down by the Council on the “poor pretext of subsidiarity,” according to Liese.
Since the nature of the existing text, a directive, has led to diverging applications in member states, the proposal will take the form of a regulation.(1) Documents are available at ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd(2) ‘Without consent: How drugs companies exploit Indian ‘guinea pigs’’ - 14 November 2011