The European Federation of Pharmaceutical Industries and Associations (EFPIA) has sounded another cautionary note on the drive to introduce full transparency for data generated from clinical trials.
While recognising its “responsibility to show leadership in advancing transparency”, EFPIA has warned of “a potential for significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way”.
In the association’s view, it is “both feasible and necessary to balance the needs of personal privacy and commercial confidentiality while providing the level of transparency needed to support public health decision-making”.
EFPIA made clear its position on “working towards responsible transparency” as the European Parliament prepared to discuss the European Commission’s proposed regulation on overhauling the European Union’s much-criticised clinical trial Directive, 2001/20/EC.
The proposed regulation envisages stepping up transparency around both patient recruitment for clinical trials and study results. That would mean more public access to trial outcomes, whether they are positive or negative.
The industry evidently does not want to see the parliamentary debate hijacked by too narrow a focus on data transparency.
Campaigners such as the BMJ, the Cochrane Collaboration and Bad Pharma author Dr Ben Goldacre have been lighting a fire under that issue in recent weeks, while GlaxoSmithKline has welcomed the BMJ’s decision only to publish studies where there is a commitment “to make the relevant anonymised patient level data available on reasonable request”.
Nonetheless, there is palpable unease in industry over the implications of what could turn into a ‘data dump’, particularly with respect to commercial confidentiality and the potential for selective and opportunistic filleting of data (something industry itself is often accused of) by parties ill-equipped to conduct objective meta-analyses.
“We must also not forget to address the other parts of this larger question of clinical trials, such as development countries and ethics,” EFPIA cautioned. “This is a larger debate than transparency alone and no stakeholder should be left out of the debate.”
Disclosure timingFor one thing, the association would like to see “further reflection” on the timing of data disclosure and its “implications for the regulatory decision-making process”.
For example, EFPIA noted, “many products and new uses are not protected by patents but by regulatory data protection. It would be damaging to companies if competitors could circumvent this by printing all the data from the internet”.
Responding in September 2011 to a draft guidance document put out for consultation by the European Medicines Agency (and the Heads of Medicines Agencies, EFPIA suggested that, in future, virtually all data from relevant clinical trials should be disclosed as soon as a new medicine were cleared for marketing.
The association did have some caveats, though. These revolved in particular around:
• The risk that scientific journals might regard immediate disclosure of clinical-trial data as ‘prior publication’.
• Publishing certain chemistry, manufacturing and controls as well as non-clinical data following EU approval could “enhance the ability of non-innovators to obtain approval outside the EU based on the originator’s data”.
• Releasing “a vast amount” of clinical data would raise the bar for regulatory agencies to make sure current versions of the data were made public.
• Regulators should take care in determining the conditions under which clinical data could be re-analysed by third parties – for example, the same standards should apply to any subgroup analysis, regardless of who were conducting it.
EFPIA insists the pharmaceutical industry worldwide is committed to “responsible” transparency, as evidenced by initiatives like the Joint Position on Disclosure of Clinical Trial Information, agreed by the International Federation of Pharmaceutical Manufacturers and Associations European with EFPIA, the Japanese Pharmaceutical Manufacturers’ Association and the Pharmaceutical Research and Manufacturers of America.
The European Medicines Agency is holding a workshop in London on 22 November to help it “define the modalities of proactive access to clinical-trial data, in a way that best serves patients and public health”.