The situation in Poland is unclear. The country's new law on clinical trials is still under preparation, to replace some 13
separate legal acts and regulations. But it is not possible to say when the legislative process will come to an end. The draft
currently contains a section relating to protection of particular groups of clinical trial participants, which is aimed at
covering, among others, trials involving persons under age. It also envisages additional conditions for clinical trials and
content of the trial protocol, and arrangements where there is lack of parental consent or for consent of under age participants.
The work evolves Meanwhile, the latest news from the EU's pediatric medicines committee in London, which met right at the end of July, provides
further demonstration of how it is shaping up to its new task. Positive opinions were adopted on PIPs for four more medicines:
Boehringer Ingelheim's dabigatran etexilate and Bayer's recombinant thrombin alfa, both in hematology and hemostaseology;
and Boehringer Ingelheim's pramipexole dihydrochloride monohydrate and Valeant's retigabine, both in neurology. The committee also adopted negative opinions on PIPs for MSD's ezetimibe and simvastatin, and nicotinic acid, simvastatin
and laropiprant, both in endocrinology and metabolism, but then went on to provide—on its own initiative—positive opinions
on full waivers for these medicines in all subsets of the pediatric population on the grounds that they do not represent a
significant therapeutic benefit over existing treatments. It was also agreed that the obligation to submit data obtained through
clinical studies with children be waived in all subsets of the pediatric population for Janssen-Cilag's bortezomib in oncology.
The pediatric committee meeting also endorsed plans for instant enforcement of the new rule, bringing some additional clarity
to the clearance procedures. As of July 26, 2008, companies submitting an application for a marketing authorization for a
medicine have to provide the results of studies in children conducted in accordance with a fully and finally approved PIP
that has been endorsed by the Medicines Agency decision, unless it can show it has received a formal confirmation of a waiver
or deferral. This will apply from January 26, 2009, for medicines that are already authorized and for which a company is submitting
an application for an extension of indication. The pediatric committee's role will be to assess and formulate an opinion on how far the application for marketing authorization
has complied with the agreed pediatric investigation plan—that is to say, it will assess whether all measures agreed in a
PIP have been carried out in accordance with the terms of its formal approval. If compliance is inadequate, not only may the
application run into approval problems, but the product will also fail to qualify for the rewards and incentives provided
for by the scheme. Transatlantic cooperation As part of the efforts to create a framework for global pediatric development plans, the EU pediatric committee meeting was
attended by a representative of the U.S. FDA. This relatively unusual occurrence is likely to become more frequent. So-called
"principles of interaction" have been established between the London Agency and the FDA in relation to pediatric therapeutics,
and these allow EU staff to attend meetings of the FDA's pediatric implementation team, and FDA staff to attend EU pediatric
committee meetings. The aim is to help regulators from both agencies observe operational activities, to optimize mechanisms
and timing of information exchanges, and overall to avoid exposing children to unnecessary clinical trials. Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
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