Peter O'Donnell
|
The European Union lurches into another difficult year, with—for the first time ever—the Czech Republic holding the rotating
chairmanship for the next six months, and consequently largely responsible for setting the agenda. In addition to coping with
the challenges of energy security, climate change, the credit crunch, and constitutional reform, the Czech government has
also listed its priorities in relation to health.
The Czech health program includes efforts to provide patients with new rights to high-quality health care across all 27 member
states, increased provision for health care workers to move around within the EU, tighter controls on quality and safety in
organ transport and storage, stricter measures for infection control in European hospitals, reassessment of the financial
sustainability of health care funding, and interoperability of health care information systems.
"What has all this to do with clinical trials?" one might ask. The answer to that question is, "A lot." And for two reasons.
One reason is that the Czech health program also includes some elements directly related to the development and use of pharmaceuticals
in Europe—notably, additional support for research into rare diseases; tighter pharmacovigilance systems; and what are officially
described as measures to "improve and guarantee the high quality and safety of pharmaceuticals, while maintaining cost-effectiveness."How far it gets with these proposals will depend heavily on how far it gets with its overall program—not just in health care
but in its overall objectives. Because in the EU, hardly anything is dealt with in isolation. Most decisions are made as compromises
among many conflicting currents of national opinion and priorities in 27 national capitals.
So if the Czech presidency runs into difficulties in winning support for its measures to overcome the economic crisis or loses
face in diplomatic debacles in the Middle East or with Moscow, it will be less able to pursue other elements of its program
effectively.
Call of the community
The other reason is related not so much to the Czech presidency's program as to the clearly expressed concerns of the clinical
trials community in Europe.
Any hopes that Europe's much-maligned clinical trials directive is likely to be amended and improved received another blow
just at the end of 2008. The principal conclusion of many leading European clinical trials professionals is that now the deficiencies
in the directive are going to be completely neglected by the EU authorities for years unless there is a major push to bring
in the improvements many are calling for.
It was at a major conference in Brussels in December on EU legislation and clinical trials that the evidence of official indifference
was exposed. The conference, on the Impact on Clinical Research of European Legislation, was the culmination of the "ICREL"
project, funded by the EU itself to provide objective data and arguments about the need for adaptations to current legislation
so as to make European clinical research more competitive.
The background is well known. Concerns have been raised by investigators and sponsors ever since the adoption in 2001 of the
EU's Clinical Trials Directive (2001/20/EC). Many stakeholders believe that the directive has largely failed in its objective
of simplifying and harmonizing the conduct of trials, and has imposed unnecessary administrative burdens and costs.
As the ICREL study confirms, part of the problem is divergent implementation across the EU member states—giving rise to a
total of 122 legislative or guidance measures. The result has been inconsistent interpretation of the rules, duplicative demands
for information, longer procedures, and differences even over which languages may be used.
Problems galore
The introduction of the directive has been especially problematic for investigator-initiated clinical research, whose advocates
insist on the value of independent clinical research for patients, for science, and for more efficient use of health care
budgets.
Respected academic researchers told the meeting that the new framework provides little or no visible improved protection for
trial patients, has failed to harmonize regulation, and has certainly not improved competitiveness. Instead, it has made international
trials more difficult to conduct and has decreased or delayed access for patient to innovative meds.
But the commercial sector is equally concerned, and industry executives have reported recent trends toward more questions,
requests for additional data, and increasingly divergent decisions. Sponsors have had to invest heavily in developing new
systems to cope with the requirements and have then had to devote resources to much more paperwork related to GCP, contracts
with investigators, hospitals and CROs, more complicated insurance issues, and expedited reports.
More guidelines are not the answer, say industry executives. Nor is mutual recognition the solution for clinical trial authorizations.
That approach is incapable of supplying the high degree of reactivity, quick decisions, and rapid information flow needed
in clinical trial decision-making. As things stand, bioequivalence studies have already moved substantially outside Europe,
largely to Canada and Asia, say industry executives.
For ethics committees too, differences in the structure and function are a problem throughout the EU.
