Europe looking to revamp clinical trial laws
pharmafile | July 25, 2012 | News story | Research and Development, Sales and Marketing | EFPIA, EU, Europe, clinical trials
The European Commission has put forward new proposals aimed at revamping clinical trial laws.
The legislation will replace rules that have been in place since 2001 and aims to encourage the development of new treatments.
The aim is to reduce the bureaucratic and regulatory burden on pharma, academic researchers and patients, and make the whole process more streamlined and transparent.
The legislation will make it easier to conduct multinational clinical trials by introducing a simplified authorisation procedure to ensure faster assessment of an application by all EU countries.
Reporting procedures are also being streamlined, removing the need for researchers to submit largely identical information to different bodies and authorities.
The European Commission says that the 2001 Directive has brought about “important improvements in the safety and ethical soundness of clinical trials in the EU and in the reliability of clinical trials data”.
But it adds that the Clinical Trials Directive is “arguably the most heavily criticised piece of EU-legislation in the area of pharmaceuticals”, adding that this criticism is voiced by all stakeholders – patients, industry, and academic research.
It says the costs of conducting clinical trials has shot up in recent years and application for new studies have declined by 25% since 2007, with the increase in cost coming mainly as a result of an increased administrative burden.
The EC says this situation is unsustainable and that it ‘is now time to act’. Its new proposal to replace the 2001 Directive is looking to stem the tide of these criticisms by reducing administrative burdens and therefore reducing cost, making it more attractive to conduct clinical trials in the European Union.
John Dalli, the EU’s health commissioner, said he hoped these changes could save around €800 million a year in costs.
Many trials are now being conducted in Asia and South America and Europe does not want to fall behind – it will hope the new changes will reduce the decline in trials across the continent, and make things easier for all involved.
Richard Bergström, director general of EFPIA, said: “A workable administrative and scientific co-operation for large scale clinical trials is the key to make the new system effective.
“We call on the European Parliament and Member States to take a responsible, ambitious and pragmatic approach when debating the Commission’s proposal.
“They need to make sure that the new Clinical Trials Regulation provides a legal framework that is fit for the future so that all European patients have an equal chance to swiftly access the latest medical research,” he added.
Ben Adams
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