BRUSSELS, Belgium - The European Union's proposed directive on clinical trials was adopted by the European Parliament and the Council of Ministers, 10 years after the EU first tried to bring in legislation in this area.
The final text is still subject to legal review, after a series of last-minute compromises from all sides, but the essence of it now is clear.
There is a blanket ban on clinical trials involving gene therapy, defined by the Parliament as therapy that modifies the germ line of the subject - modifications that are hereditary to all descendants. And there are tougher controls on clinical trials for biotechnology-derived products than for classical pharmaceuticals. But in most cases, the possibilities have been reduced for national authorities to impose indefinite delays before authorizing trials for biotechnology products.
The final text from the Parliament provides that while authorizations for trials must generally be given without extension beyond a total of 60 days, further extensions will be allowed "in the case of trials involving medicinal products for gene therapy and somatic cell therapy, in which case an extension of the period by a maximum of 45 days, which in duly justified exceptional cases may be extended by a further 45 days, shall be permitted."
In the case of xenogenic cell therapy there shall be no time limit to the authorization period.
It also said written authorization "shall be required before commencing clinical trials involving medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms. No trials may be carried out that result in modifications to the subject's germ line genetic identity."
The European Federation of Pharmaceutical Industries and Associations gave the new rules a reserved welcome. It welcomed the formal introduction of good clinical practice principles into the conduct of trials, and said the tighter regulation of trials in children and people incapable of giving their informed consent - inserted by the Parliament as part of a last-minute compromise - "will protect participants to trials without preventing the research necessary to improve the patients' treatments and life conditions."
It particularly welcomed the introduction by the European Parliament of a maximum time limit for the approval period to initiate clinical trials involving gene and cell therapy medicines. "This should at least give some encouragement to the pharmaceutical industry to invest in research for future treatments and cures building on key developments in our scientific understanding," EFPIA Director General Brian Ager said.
But industry pointed out that although the original aim of the new rules was to harmonize the national regulations, "this purpose was not completely achieved," and much of the detail is still left up to member states, particularly on time frames and procedures for starting trials. EFPIA said it hopes member states will use this implementation flexibility to the benefit of patients and of the competitiveness of the European pharmaceutical industry.