Multinational trials Meanwhile, the European Forum for Good Clinical Practice is turning its attention to the equally thorny question of whether
it is possible to achieve a single clinical trials authorization (CTA) in multinational clinical trials. It has chosen the
rather pessimistic title of "Dream or Option?" for the workshop it is organizing in Brussels in July. It is, however, promising
to offer views on the current situation in the European Union from the viewpoints of regulatory authorities and of commercial
and academic sponsors, with a focus on how the authorities interact in a pan-European, investigator-driven trial. Current projected solutions include a form of voluntary harmonization, and versions of the current centralized or mutual recognition
procedures that apply to marketing authorizations in Europe. The difficulties are evident as soon as discussion turns to how
far European research ethics committee procedures—notoriously divergent in Europe—could be harmonized, or the review process
and accreditation of research ethics committees in Europe could be coordinated. Pessimism is likely to turn to gloom, however, as the workshop includes titles such as "Can We Agree on a Common Priority
List of Deficiencies in the Current CTA System?"Europe slipping behind While Europe continues to labor over the creation of a credible system for regulating clinical trials, it is falling ever
further behind in the international innovation stakes, according to a study released in early summer by the European chambers
of commerce. As disappointing 2009 growth forecasts confirm the scale of the global recession, the EU continues to lose ground on its global
competitors, says the latest edition of Eurochambres' annual "Time-distance study." This study—which compares the distance
between the main global economies in terms of years—confirms that the 27-member EU still lags well behind the United States,
while the gap with so-called BRIC countries (ie., Brazil, Russia, India, and China) remains significant, but is narrowing
dramatically. The EU27 is lagging behind the United States for all key economic indicators (GDP per capita, productivity, investment in
R&D) by an average of 24 years. This means that the current performance of the EU for these indicators was reached by the
United States in the 1980s. Investment in R&D is the worst indicator, with the current level of European investment in research
and development having been attained by the United States 30 years ago, says the study. If the growth rates presented today are confirmed in the long term, the EU will only catch up with the current level of U.S.
GDP per capita in 2047, it warns. Arnaldo Abruzzini, Secretary General of Eurochambres, said: "These figures tell us that
if the EU is to maintain and enhance its global competitiveness, it must put in place not only a short-term strategy to exit
the recession, but also long-term structural reforms. Time is not on our side...we cannot afford to delay any longer much
needed investment in R&D and skills. Policy makers must provide businesses with the right framework conditions to drive Europe's
recovery and future growth." The same theme was picked up recently by the president of the European Federation of Pharmaceutical Industries and Associations
(EFPIA), Arthur Higgins, who is also the boss of Bayer Healthcare. On the eve of the EFPIA's annual conference, he warned
that Europe's neglect of innovative industries was obliging companies to move their operations "to where the markets are"—which
was, he said, increasingly in the BRIC and other emerging economies. He lamented the European tendency in this time of recession to provide support only for industries that were already weakened
(EU governments have been bailing out their ailing automotive manufacturers), instead of backing strong industries with a
sustainable future—notably the pharmaceutical sector. Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
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