BioWorld International Correspondent

BRUSSELS, Belgium - The European biopharmaceutical industry still is claiming to be optimistic about the future of Europe's clinical trials regime, despite its trenchant criticisms of the system, and despite explicit reluctance among European regulators to bring in major changes.

EuropaBio - the European association for bioindustries - effusively congratulated the European authorities for the discussion they organized on the subject at the European Medicines Agency on Oct. 3, at which industry members riled about clinical trial rules. It "led to a broad understanding of the issues," EuropaBio said. Nonetheless, the association re-emphasized its continuing concerns. "The general consensus among EuropaBio members is that the clinical trials directive fails to bring the necessary harmonization across member states. EuropaBio continues therefore to call for the review of this directive and its implementation into national laws," it said in a statement issued after the meeting.

EuropaBio continues "looking toward the future," and is proposing "a parallel legislative path to cover clinical trial developments for the new generations of innovative therapies and products covered by the Advanced Therapies Regulation."

Christine-Lise Julou of the European Federation of Pharmaceutical Industries and Associations told BioWorld International that she had been "encouraged that the EU authorities have recognized that there is a real problem." EFPIA, too, favors some form of single clinical trial authorization system, at least for new therapies. But she said she recognizes that this could be created only via new legislation - which EU member states are currently unlikely to countenance.

Detlef Niese of Novartis AG, and a board member of EuropaBio, said it might be possible to win political approval for an improved system if member states can be convinced that the stakes are high enough in terms of preserving Europe's high-tech biopharma industry. "No one imagined that the advanced therapies legislation would pass so easily," he remarked, suggesting that the rapid EU agreement earlier this year of new rules to ease marketing of gene and cell therapy products could be interpreted as a sign of a new readiness by EU member states to improve the industry's operating context.

That guarded optimism contrasts sharply with the view of Eamonn Corcoran of the Irish Medicines Board, who is doubtful about the political prospects for any dramatic advance in harmonization. National resistance to any centralized system has increased rather than decreased, he told BioWorld International.

The fact that the European Union now has 27 members - nearly double the size in 2001, when it adopted the current clinical trial directive - made it highly unlikely that the necessary unanimous agreement could be reached to impose a system that deprived individual member states of the powers they guard so jealously.

As Thomas Lönggren, executive director of the European Medicines Agency, made clear, it will require "a political decision" to change the system. The agency handles only some of the technical work on clinical trials, such as site inspections and data bases.

"It is not involved in clinical trials legislation. That is in the hands of the member states and it is their responsibility," he underlined.