Reuters
European
Union lawmakers voted on Wednesday in favour of new rules that will ensure more
open reporting of clinical trials results, even when they are negative, and
also simplify the process for getting studies started.
The
legislation approved by the European Parliament is expected to take effect in
2016 and will require results of all new clinical trials to be published within
a year of the trial ending.
European Ombudsman Emily O'Reilly, whose office
investigates complaints about maladministration in EU institutions, said the
move was "a triumph for transparency" in European healthcare.
There has been a growing clamour for greater
disclosure of detailed clinical trial results by pharmaceutical companies
following a series of scandals over the safety of drugs such as Merck &
Co's now withdrawn painkiller Vioxx.
A number of senior doctors have argued that in too
many cases the decision on how and when to prescribe drugs relies on selective
evidence controlled by manufacturers.
The new rules mean it will in future be possible for
independent researchers to verify whether medicines are as safe and effective
as they are claimed to be.
Ben Goldacre, a British doctor and author of "Bad
Pharma", who has led a campaign called AllTrials urging study disclosure,
welcomed the vote by parliamentarians as "an excellent small step
forward".
But he remains concerned that the new EU Clinical
Trials Regulation only covers new clinical trials and does not address access
to full study results carried out on older medicines already on the market.
In addition to forcing greater transparency, the new
law will also reduce the red tape surrounding the approval process for studies
on medicines, including simplifying rules for running multinational trials.
Taken together, the measures should save research
institutions and companies conducting clinical trials in the EU some 800
million euros ($1.10 billion) a year in regulatory costs, EU Health
Commissioner Tonio Borg said in a statement.