Approved in 2001, the EU Clinical Trials Directive (Directive 2001/20/EC) aims to harmonise the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and make consistent the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.  Central to this campaign is legislative change to the rules and regulations regarding clinical trials in Europe.

We have seen that individual Member States have imposed different requirements – some of which go beyond those set out in the Directive, others that appear disproportionate to the  objective of protecting safety of trial subjects – resulting in different regulatory standards being
applied by the Member States in granting clinical trial authorisations.  Our campaign is about offering recommendations for reform of the regulatory environment for the approval and conduct of clinical trials in the European Community.

The Directive was an important first step towards consistency in the requirements and
processes for clinical trials across and between EU Member States. The Directive could provide potential for synergies and time savings. However, these potential benefits have not been realised. The challenges are especially apparent in the uneven and inconsistent implementation.

We believe that there is an urgent need to address the following related issues:

• Lack of harmonisation for applications for clinical trial authorisations as a result of different national dossier requirements and/or discrepant application of Community law,

• Increased bureaucracy and uncertainty as a result of variable national requirements placed on industry, particularly in respect of multi-centre clinical trials conducted in two or
  more Member States,

• Different interpretation of the definition of Investigational Medicinal Product,

• Other Good Managements Practices related issues in some Member States, and

• Varying requirements for safety reporting across the Member States.

Such differences have adversely impacted healthcare biotech companies in the initiation and continuation of multi-centre and multi-national clinical trials for biotech medicines across Europe. The situation is even worse for clinical trials with treatments designated for orphan or rare diseases, which affect only a small fraction of the population. Small and medium-sized enterprises (SMEs) do not have the financial and manpower resources to effectively deal with different national requirements imposed by the Member States.

The administrative burden to identify and comply with local clinical trial requirements is significant, and Europe is now regarded as less attractive to undertake clinical development. Indeed, some companies have already decided not to conduct their clinical studies in the EU. If the current situation is not addressed and improved, it will be particularly damaging to the continued viability of the bioscience sector in the EU. Our campaign pursues legislative change   in order to achieve transparency and consistency in the approval and conduct of clinical trials across EU Member States. This will facilitate efficient development of biotech medicines in Europe, which would in turn have a direct benefit of improving access by patients to innovative medicines.

Another significant drawback to disharmony in clinical trials is that it increases the cost and time in bringing new treatments to market so that they can start making a difference in patients' lives. 

Watch this space as our campaign develops.