EU set to simplify clinical trial rules

2012-07-10 22:33

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Brussels - The European Union's executive is due to propose new rules next week to make it easier for drug companies and researchers to carry out cross-border clinical trials, in a bid to cut costs and red tape.

The European Commission says the number of clinical trials carried out in the EU has fallen by 15% in recent years, while administrative costs and delays have doubled.

Medical researchers blame the extra costs and red tape on EU rules introduced in 2001, which aimed to impose tighter controls on monitoring and reporting drug trials, to boost patient safety.

Under the current rules, companies or researchers wanting to hold clinical trials in more than one EU member state often have to submit separate applications in each country where the trial is being conducted.

The European Union's health and consumer commissioner, John Dalli, has said the new rules, due to be presented on July 17, will introduce a harmonised EU submission system for trials, meaning that applicants will only have to submit information once.

Cross-border trials are particularly important for testing treatments for rare diseases, where there are often too few potential trial patients in a single country. About a quarter of all EU trials currently involves between three and five countries, the Commission said.

In an attempt to further streamline the rules, the Commission is expected to replace the current EU directive - which each member state must transpose into its own national law - with an EU regulation applying equally in all 27 countries.

Once published, the Commission's proposal will have to be jointly agreed by EU governments and the European Parliament, which could take up to two years.

Fix mistakes

Peter Liese, a German member of the Parliament and health spokesperson for the centre-right EPP group, said he aimed to fix mistakes in the original directive that hampered trials in Europe and pushed them into poorer countries, such as India.

Under current rules, trials done outside Europe must be conducted under "equivalent standards to the EU", to be used as the basis for approving new drugs.

But Liese argued that overseas standards are difficult to verify and that foreign trials should therefore not be used to approve new medicines.

"It's a delicate balance, but we think we have a responsibility there for the poor people that risk their life in India, but also for the patient in Europe that might not be treated in the optimal way when the data are not generated under reliable conditions," Liese said.

Liese also wants different rules for non-commercial trials carried out by academics, charities or patient organisations, allowing them to start faster and operate with less regulation.

Such trials are considered less risky than commercial trials because they experiment with drugs already on the market. 

Read more on:    europe  |  health  |  research

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