The management board of the European Medicines Agency (EMA) agreed on June 12 to approve a new policy that would require drug companies to share certain clinical trial data with the public.
In response to concerns over accessibility, the EMA board says in a statement that it has revised the policy, adding "more user-friendly amendments," including one that will allow patients to "download, save and print the trial data for academic and noncommercial research purposes." The board claims the policy "will not prejudice citizens' rights under existing access to documents legislation and the new clinical trials regulation."
The policy has yet to be published, so health and consumer advocacy groups are still in the dark about the details of the initiative.
The EMA's promise to disclose clinical study reports on every drug it has reviewed has stirred controversy since the agency first announced the initiative back in 2010. In January 2013, AbbVie ($ABBV) and InterMune filed lawsuits against the EMA in an effort to resist the new policy. But AbbVie dropped its lawsuit in April and Intermune followed suit in May after the EMA agreed to loosen some of its transparency requirements.
The move sparked criticism from the likes of the British Medical Journal and clinical research advocacy group AllTrials, which claimed that the proposed regulations water down the EMA's original transparency goals. Documents between AbbVie and the EMA revealed that the agency was considering making clinical study reports available to registered users only through controlled access and only on screen.
In a June 11 statement in response to the growing apprehension, the EMA said the draft policy is a "compromise approach that takes into account different stakeholders' competing interests," adding fuel to the fire.
But a day later, the EMA attempted to quell the criticism, saying the revised policy is an "important step forward" toward greater transparency in the regulation of medicines in Europe.
"[The policy] takes the agency beyond its legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines," the EMA management board said in a statement.
The new regulations are expected to be finalized and adopted by mid-July and will take effect on Oct. 1.
- read the EMA's June 12 press release on the policy approval
- get the EMA's June 11 statement in response to accessibility concerns