EU lawmakers voted in favour of draft legislation on Wednesday that would require drugmakers and academic researchers to post results of all their European clinical trials in a publicly-accessible database. The European Parliament stated that the proposed legislation, which is expected to take effect in 2016, also aims to "streamline the rules on clinical trials across Europe, facilitating cross-border cooperation to enable larger, more reliable trials, as well as those on products for rare diseases."
The Parliament said that in a bid to "improve transparency," the new regulations call for pharmaceutical companies to publish detailed study summaries in a public database, as well as full clinical trial reports once a decision on marketing authorisation is made or the application is withdrawn. Drugmakers who fail to comply with the guidelines would be subject to fines. The Parliament added that the proposed legislation also "simplifies reporting procedures, and empowers the European Commission to do checks."
The Parliament's rapporteur on the matter, Glenis Willmott, whose report was approved by a margin of 594-17, with 13 abstentions, said the proposed legislation "will make trials more transparent…and boost the number of skilled research jobs here in Europe." Meanwhile, EU Health Commissioner Tonio Borg estimated that the measures should reduce regulatory costs for clinical studies among drugmakers and research institutions by 800 million euros ($1.1 billion) annually, "removing the most significant barrier to keeping clinical research within EU borders."
Commenting on the news, Esteban Herrero-Martinez, head of regulatory affairs at the Association of the British Pharmaceutical Industry, said the organisation "welcomes" the outcome of the European Parliament's plenary vote toward adopting the new Clinical Trials Regulation. However, he noted that "successful implementation [of the law] depends on appropriate member state engagement and the development of the relevant IT infrastructure by the European Medicines Agency, including a European clinical trial database."
Last year, the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America jointly announced commitments to greatly increase the amount of clinical data released to the public by drugmakers. Meanwhile, a number of drugmakers, including GlaxoSmithKline, Pfizer and Novartis, as well as Roche and Sanofi, have revealed initiatives to increase access to clinical trial data. In addition, Johnson & Johnson disclosed in January that the Yale School of Medicine's Open Data Access Project will independently review requests for access to data from the company's clinical trials.
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