Europe's pharmaceutical industry sets out alternative to EU data plans
Must we choose between patient safety or protection of industry?BRUSSELS, BELGIUM | August 29, 2013
The group EFPIA claims its move – first flagged in July – reflect member companies’ “strong support” for sharing clinical trial data to benefit patients and foster scientific discovery “in a way that maintains patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research.”
The commitments center on improving the way data gets shared with researchers, making public access to clinical study information easier, promising to share results with patients who participate in clinical trials, certifying producers for sharing clinical trial information and publishing clinical trial results.
And speaking at an event organised by the group in Brussels this week [27 August] its director Richard Bergström claimed such “ethical commitments” will prevent public health problems in the future.
But Bergström also used the opportunity to repeat EFPIA’s claim that these commitments are better than EU plans for fuller transparency – as this would threaten European biopharmaceutical companies’ commercial interests.
"We don’t want our competitors to learn too quickly about how we go about the clinical trials. We believe that a framework which is run by the industry itself is much more likely to take care of these balances," Bergström told attendees.
Critics of the industry’s approach to information sharing, led by the UK’s Ben Goldacre, author of a book on alleged data malpractice called Bad Pharma, says EFPIA’s moves are insufficient, however. "It’s important that we do get hold of clinical study reports because there can often be methodological shortcomings in the design of the trial which are glossed over in the brief reports in academic journals or a regulator website," he said at the same event.
Goldacre claimed EFPIA's new commitments do not go far enough, as they would only cover new clinical trials, while Susanna Palkonen, vice president of the European Patient's Forum, told delegates at the event that it is vital “both clinicians and patients have access to all relevant information to make informed decisions about the drugs they use.”
EFPIA’s commitments are endorsed by its US equivalent – the Pharmaceutical Research and Manufacturers of America (PhRMA).