The data-transparency bandwagon is rolling rapidly across Europe, energetically propelled by regulators, health campaigners, and generic manufacturers.
Much of the research-based industry is stepping out of the way of what looks like an unstoppable juggernaut, hoping at best to nudge it into a less damaging direction as it roars past.
The new boss at the European Medicines Agency, Guido Rasi, has become one of the leading transparency crusaders, determined to turn trickles of drug information into a flood. Since 2012, it has been releasing documents submitted as part of marketing authorization applications, including clinical and non-clinical information, on request.
And under Rasi’s leadership it is now developing a transparency policy that it says will provide for greater clarity and openness in all areas of its operations — which could include pro-active release of data, rather than simply responding to requests. The agency ambition is to introduce its new policy from the start of 2014, and it has, this autumn, just closed a public consultation on its plans.
But two companies are resisting the trend, and have stepped straight into the path of the transparency juggernaut, shouting: “Stop!”
Pharmaceutical execs in Europe are watching open-mouthed to see whether these lone protestors will be crushed under the wheels or manage to arrest the momentum and turn themselves into industry heroes.
This month, a hearing took place at the European Union’s court of justice in Luxembourg in cases that AbbVie and InterMune have brought against the agency to prevent it releasing information about two of their products.
This was the follow-up to actions earlier this year, when the agency decided it would accede to parallel requests, from UCB for data on AbbVie’s Humira, and from Boehringer Ingelheim for data on InterMune’s Esbriet. Both companies immediately appealed to the European court against the decisions, and at the same time sought – and won – injunctions granting them relief on a temporary basis, pending the outcome of the substantive case.
The European Medicines Agency then applied for an early hearing to get the temporary injunction lifted — the subject of the hearing that took place this month. It may take weeks for the court to deliver its decision on this appeal, but meanwhile everyone is sticking to their guns.
The two sides then remain locked in conflict over the limits of transparency and the scope of disclosure. Of course nearly everyone involved in this debate makes routine genuflections both to transparency and to the need to maintain some measure of protection of data. No-one wants to be depicted as an extremist.
AbbVie says it is “committed to transparency regarding the clinical trials we sponsor”. InterMune says it would “never preclude disclosure of any information concerning its research that needs urgently to be made public to ensure the safety of patients”. And the EMA says it takes care to balance the need for transparency “with the protection of commercially confidential information and personal data”. But these are little more than polite forms of words, so imprecisely defined that they have more diplomatic than lexical significance….
Meanwhile, arguments are starting to appear that the medicines agency might be overstepping the bounds of what is reasonable with its determination to provide wide disclosure. A UK-based lawyer in a practice serving, notably, biopharmaceutical clients has been suggesting that more caution should be exercised by the agency in its approach.
As Alexander Denoon, a partner in Lawford Davies Denoon, sees it, the agency has moved from an initial policy of blanket prohibition of release tow
ards a policy of blanket disclosure. As such, the agency risks running headlong into conflict with international trade rules. “Under international trade agreements to which the EU is signed up – notably the World Trade Organisation — all signatory countries must have adequate IP protection in place.” The sort of blanket disclosure that is being envisaged would breach that international obligation, he says.
Dunoon predicts a win for international trade obligations over “enthusiasm for transparency among regulators”. And wider signals of dissension are starting to be heard over the EMA’s plans – and over related demands for greater transparency, particularly in the context of the parallel attempts to update the EU’s clinical trials use.
Industry responses that are now just starting to emerge to the agency’s consultation share concern over threats to innovation. But health campaigners’ responses focus more on the merits of wide disclosure. And in November discussions will heat up over transparency provisions in the EU’s clinical trials rules, too.
The transparency bandwagon may well be in for a bumpy ride.