Before new treatments reach patients, they must be tested in clinical trials. Clinical trials are tests of medicines in humans. Human volunteers participate in different types of clinical trials that are conducted either to demonstrate safety and effectiveness of new medicines, to test new indications for existing medicines or to compare two standard treatments. These trials are conducted by the pharmaceutical industry and by other non-industry actors such as academics, foundations or hospitals.
The proposed regulation eases administrative constraints and financial burdens- Josette Grech
Clinical trials are vital to develop medicines and optimise existing ones. The information obtained from such trials is then published in medical journals. Besides adding to the knowledge base upon which medical professionals can base their decisions, the data obtained from clinical trials can be used by companies to put their medicinals on the market.
The European Commission has recently put forward a proposal for a regulation that will replace the current Clinical Trials Directive of 2001, which came into force through implementing national measures in May 2004. This directive tightly regulates the conduct of clinical trials in the EU and offers proper protection for the rights and safety of clinical trial participants.
However, the directive has been dubbed the most heavily criticised piece of EU legislation in the pharmecutical field. Criticism of it hinges on its disproportionate regulatory requirements and its divergent implementation in the member states.
To address the lack of harmonised rules, the newly proposed legislation, unlike its predecessor, is in the form of a regulation, which will have automatic application across the EU. More harmonised rules governing clinical trials and a more uniform application of such rules are expected to be in place throughout the EU once the regulation is adopted, as it will do away with the requirement of implementation by the EU member states.
The proposed regulation revamps the current regulatory framework by easing the administrative constraints and financial burdens.
Processes leading to authorisations of clinical trials is harmonised. The proposed regulation provides for a harmonised application dossier, which can be submitted to a single EU portal managed by the Commission.
The proposed regulation imposes less onerous requirements than previously authorised clinical trials. Modifications can be carried out without the need of re-approval, except where such modifications have a substantial impact on the safety or rights of the subjects or on the reliability of the data generated in the clinical trial.
The current Clinical Trials Directive is based on the concept of a single sponsor per trial. Such single sponsor is responsible for the trial vis-à-vis the national competent authority. To reflect current practices, the proposed regulation formally introduces the concept of co-sponsorship, permitting actors in the field to join forces when conducting trials. In these cases, co-sponsors can determine between them how to split their responsibility, and in the absence of such an arrangement, responsibility will jointly lie with all of them.
The current directive imposes an obligation on clinical trials’ investigators or sponsors to obtain an insurance cover for possible injury or death of the trial subject. This general obligation does not take into account low risk trials and increases the costs for all clinical trials, whether high or low risk.
To address this, the proposed regulation excludes low-intervention clinical trials from the obligation to provide insurance. In these cases, the insurance of the medical practitioner, the health care institution or the sponsor is considered to provide sufficient cover. With respect to those trials that still require insurance, the proposed regulation obliges member states to set up a national indemnification mechanism, which will be free of charge for studies that are not intended to obtain data to support increase of business.
The proposal constitutes a renewed attempt by the EU to harmonise and simplify the clinical trial legal framework after the current directive’s failings. It still requires the approval of the European Parliament and Council that could see the regulation’s adoption as distant as 2016. If adopted, it will significantly change the contours of how clinical trials are regulated in the EU.
jgrech@demarcoassociates.com
Dr Grech is an associate with Guido de Marco & Associates and heads its European law division.