April 2 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
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
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Merck & Co's now withdrawn painkiller Vioxx.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
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.
($1 = 0.7263 Euros)
(Reporting by Ben Hirschler, editing by David Evans)