A panel of European Parliament lawmakers gave unanimous backing on Wednesday (29 May) to new draft EU rules on clinical trials that could represent a huge step forward for research on new, life-saving drugs.
The purpose of the EU's Clinical Trials Directive update is to design simpler and more uniform rules that will encourage research while keeping patients safe.
The new text, which was adopted unanimously by MEPs sitting on the Parliament's Environment, Public Health and Food Safety Committee (ENVI), makes specific provision for low-risk trials, clarifies the duties of ethics committees and details how to obtain informed consent from patients.
British MEP Glenis Willmott, from the Socialists and Democrats group (S&D), is steering the legislation through Parliament. She said after the vote that clinical trials are essential for developing new medicines.
However, between 2007 and 2011, the number of clinical trials started in Europe fell by 25%. Much criticism has been directed at the existing directive, which is widely believed to have led to an increase in unnecessary bureaucracy.
"The aims of the directive were admirable, but many of the requirements were geared towards trials sponsored by pharmaceutical companies, while those with non-commercial sponsors were overlooked, and true harmonisation was never achieved," Willmott said.
"Getting better legislation in place soon is crucial to enable and encourage life-saving research."
The new law features simplified reporting procedures, and empowers the European Commission to conduct checks. Once a clinical trial sponsor has submitted an application dossier to an EU member state, it will have to respond within fixed deadlines.
MEPs amended the draft text to improve transparency, by requiring that detailed summaries be published in a publicly accessible EU database, with full Clinical Study Reports published once a decision on authorisation is complete.
Sponsors who do not comply with these requirements would receive fines.
For low-risk clinical trials, compensation for damages would be covered by the general compensation system established under the national security or healthcare system.
For other clinical trials, the sponsor would be deemed liable for damages, but could make use of a national indemnification system which all member states should set up to reduce high insurance costs.
MEPs also clarified the role of ethics committees in authorising a clinical trial. Rules on obtaining a person's informed consent to taking part in a trial are laid down in detail to ensure proper access to information and compensation for damages.
Specific rules would also apply to clinical trials on pregnant or breastfeeding women, on persons deprived of liberty and on people with specific needs.
A huge "step forward" for clinical research
French MEP Philippe Juvin, the European People's Party's (EPP) spokesperson on the legislation, said the report was a huge step forward for clinical research in Europe.
"It will allow important progress, such as shorter assessment timelines. Compared to our Canadian and American competitors, these timelines will be more competitive. Then, the regulation will finally cover the emergency clinical trials. This category has been covered by American law since 1996 and by French law since 1988," the MEP said.
The European Consumers' Organisation (BEUC) said ahead of the vote that while it applauds some elements of the revision, it fears the transparency aspect will go down the drain. At present only half of the clinical trials results are published and some are not even registered, it said.
“When participating in clinical trials, volunteers put their lives at risk for the sake of scientific progress. To hide the results means that what these persons go through is ignored. The results of the trials belong not only to the pharma companies, but also to each and every one of us," said Monique Goyens, BEUC director-general.
Goyens added that concealing the clinical trials results would be a missed opportunity to provide consumers with full information on medicines’ safety.
Willmott has now received a mandate to negotiate an agreement with EU ministers.
The Greens welcomed the outcome of the vote, with Green health spokesperson Margrete Auken stating:
"It is essential that citizens can have utmost faith in clinical trials and their ability to guarantee that authorised medicines pose no unacceptable risks for those using them. Confidence in the effectiveness and reliability of clinical trials has been hit by a host of scandals with different medicines in Europe. MEPs have taken a step towards addressing this by voting to strengthen access to the results and the supporting data from clinical trials under the proposed legislation."
Richard Bergström, director general of the European Pharmaceutical Industries and Associations (EFPIA), said in a statement:
“EFPIA member companies support ongoing efforts to continue improving the diverse means of sharing clinical trial data to benefit patients, foster scientific discovery and support ongoing investment into innovation. This requires industry, regulators, researchers and society to work together to ensure that patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research are maintained. Together with our international colleagues, we are now working to enhance data sharing with researchers and to enhance access to clinical study results after approval in the interests of advancing science and patient health. The details and mechanisms will be developed in the next few months in close collaboration with stakeholders including the scientific and patient community."
The EU's Clinical Trials Directive was adopted in 2001 with a view to improving research standards and protecting patients.
But the directive has been heavily criticised by researchers who say insurance costs and red tape has increased without bringing any major benefit to patients, researchers or industry.
The Commission has therefore proposed revamping the directive to address those challenges.
Enhancing the competitiveness of clinical research was a primary aim of the directive's revision amid claims that Europe would become an unattractive place to conduct large-scale trials on potentially lucrative new medicines.
The new draft directive also speeds up how researchers get ethical approval for medical trials and seeks to improve standards in how new medicines are tested and manufactured.
- 8 Oct.: Indicative plenary sitting date with first reading.
- Fostering EU's attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines (17 July 2012)
- Clinical Trials homepage
- Proposal for a Clinical Trials Regulation - Questions and answers
- Environment, Public Health and Food safety Committee: Website