By Peter Liese - 28th March 2013
Sponsors of non-commercial clinical trials suffer severely from the burden of the current directive
The EU’s revised clinical trials directive must reduce bureaucracy while guaranteeing the highest levels of protection, argues Peter Liese
We still cannot treat most life-threatening and debilitating diseases and even when we can treat them we must, however, accept certain side effects. That is why research in new pharmaceuticals is as urgent as ever. After experiments with computer models, cell cultures, and animal testing, one has to test the new drugs on human beings. That is why clinical trials are an unavoidable and necessary step in this development.
On July 17 2012, the European commission presented a proposal for a regulation on clinical trials. The proposal is supposed to initiate the process of simplification and harmonisation of clinical trials all over Europe and replace the directive from 2001. This directive has brought many benefits and improved the protection of patients, but it also has critical vulnerabilities.
In general, I welcome the proposal of the European commission to make multinational clinical trials less bureaucratic. Not only will the pharmaceutical industry benefit, but, in particular, independent researchers will also gain from the directive, providing better services to patients all over Europe. Low risk clinical trials, for example, are mainly conducted by non-commercial sponsors like NGOs, scientific organisations and charities. They normally use existing drugs. Sponsors of non-commercial clinical trials suffer severely from the burden of the current directive. That is why simplification is needed. However, the protection of patients within this process should not be reduced
An established and internationally recognised standard practice of protecting the research involving human subjects is the use of an independent, interdisciplinary ethics committee which needs to consider, comment on, and approve research projects. The proposal does not contain such explicit requirements and refers to a self-dependent organisation of each member state. I am convinced that this must be changed to ensure patient protection. The role of the ethics committee is especially important because the regulation will set a standard for third countries. Many clinical trials that lead to market approval in Europe are done in third countries like India or African countries. If we do not explicitly mention ethics committees how can we demand their use in third countries?
A further weakness of the proposal is that the protection of children and mentally disabled persons – people who are not able to give informed consent – has been weakened compared to the current directive. This is unacceptable and would undermine the credibility of the proposal. That is why I believe the text of the current directive needs to be re-examined.
The third issue that has to be improved is the relationship between the reporting member states that performs a risk benefit assessment for clinical trials and other concerned member states. I think the role of the other concerned member states needs to be strengthened to guarantee the highest possible safety standards. The debate in parliament’s environment, public health and food safety committee – which is responsible for this dossier – has shown a lot of progress. In the current form, the text is not acceptable, but I am optimistic that in the end it will bring about the necessary simplification while simultaneously guaranteeing the highest possible protection standards.
Peter Liese is parliament's EPP group health spokesperson