By Paola Testori Coggi - 28th March 2013
I am confident that the new regulation, once in force, will be a game changer for clinical research in the EU
Paola Testori Coggi
New clinical trials legislation will aid economic recovery while encouraging pharmaceutical innovation and healthcare investment, writes Paola Testori Coggi
Last summer, the European commission tabled a proposal to revise the current legislation on clinical trials. The proposed regulation will repeal the 2001 clinical trials directive which has been heavily criticised for the excessive red tape, high administrative costs and long authorisation delays it has brought about. The commission recognises that the original directive has been, to a large extent, responsible for a significant drop in clinical trials applications in recent years. The figures show a 25 per cent drop in applications for clinical trials in the EU between 2007 and 2011. This is not surprising, as the data also show the related administrative costs went up by 98 per cent and the average delay for launching a clinical trial up by 90 per cent to 152 days.
One aspect of the 2001 directive that has withstood criticism is the level of protection it ensures to trial volunteers. With the new clinical trials proposal we have endeavoured to rectify the shortcomings of the previous legal framework while maintaining the high standards of patient safety. I am confident that the new regulation, once in force, will be a game changer for clinical research in the EU. It will serve as an incentive for clinicians and researchers to apply for and conduct clinical trials in Europe, encourage more multi-national trials – essential, for example, for research on rare diseases, and ultimately resulting in new and more innovative medicines on the EU market.
Before I outline some of the features I find the most interesting in this proposal, let me explain what clinical trials are and why we need them in Europe.
Clinical trials are a means of testing the safety and effectiveness of new medicines or new indications for existing medicines on human volunteers. They are thus a vital step in the development of new and safe medicines and in the improvement of existing treatments. They are crucial for patients affected by serious or rare diseases – as they are the only way for them to have access to the most advanced, life-saving treatments. A recent, long-term study published in the Oxford annals of oncology supports this, with its clear conclusion that access to clinical trials drives dramatic increases in survival from childhood cancer.
Conducting clinical trials in Europe is also good for economic recovery, as clinical research is an important step in pharmaceutical innovation and investment in healthcare. This is a booming sector in the EU, with over €20bn being spent every-year on healthcare-related research and development.
So how will this proposal bring about positive changes? First off, the legal act will now be a regulation which gives less leeway for interpretation and should result in uniform implementation by member states. Simplification of current rules include a ‘one-stop’ database for submitting applications, a flexible and quick assessment procedure, a simplified reporting system and clearer, simpler rules for running multi-national trials. The proposal also introduces procedures balanced to the risks for trial volunteers, for example comparing two already authorised medicines is, in principle, less risky than a trial with a new drug, while upholding the highest safety standards. Possibilities for enforcement are also factored in to the proposal as it will allow the commission to conduct controls in the EU and beyond.
Other interesting features are the introduction of the concept of ‘co-sponsorship’ with the clarification that in cases where a clinical trial is conducted by more than one sponsor - they are able to split the responsibility between them, and new rules on compensation for damages. On this second issue, the proposed regulation acknowledges that clinical trials are not always riskier than treatment in normal clinical practice and makes a distinction in indemnity rules between trials that do and that do not pose additional risks for the human subjects.
Many people agree that these new rules make sense. Since its adoption, the proposal has been presented to and discussed by a broad range of stakeholders. It has received enthusiastic support from non-commercial and commercial organisations alike, who have openly stated that the proposed regulation “will give clinicians and researchers a better framework for developing and testing treatments, to benefit patients across Europe, while maintaining the high standards of patient safety that currently exist in European clinical research”. The proposal is now being discussed in the council and parliament and we are confident that the discussions between the co-legislators will go smoothly and the proposal adopted quickly. The sooner the regulation is adopted, the faster it will help further enhance the health of patients and clinical research in Europe.
Paola Testori Coggi is director general of the European commission's DG health and consumers