March 14th, 2012 - (EU Commision) -Healthcare Regulatory update

The Commission is preparing a proposal for the revision of the Clinical Trials Directive for later this year. Clinical trials are crucial to many people! They provide hope for patients and relatives; essential testing for researchers and industry to develop new medicines and treatments; are key for the creation of growth and jobs in the public health sector and; play a major role in R&D accounting for investments of over €20 billion per year in the EU.

Authorisation for approximately 4400 new clinical trials is given each year and, at any point in time, some 12 000 clinical trials are ongoing in Europe. But, worryingly, there has been almost a 15% decline in trials in the EU in recent years. Costs - resources and bureaucracy - have doubled and delays have increased by 90%. It is immensely important that we facilitate multinational clinical trials in Europe - 25% of EU trials take place in more than one Member State - not only to keep this innovative research in Europe but to guarantee state of the art cures.

There are several factors contributing to the decline of clinical trials in the EU, such as the commitment of industry to R&D, the relationship between industry and academic research, availability of investment or return on that investment. However, the bureaucracy of the process is clearly also one important factor.

The Commission wants to improve the regulatory framework and address concerns that have been voiced:

• Creating a simpler single portal for submission of clinical trials applications;

• Developing a faster, lighter system for assessments while maintaining patients' rights and safety and;

• Increasing cooperation between Member States.