Companies worried about the potential adverse consequences of open access to clinical-trial data should submit to the European Medicines Agency any “objective examples” of circumstances where these consequences “have happened or could happen, so that a viable workaround solution can be developed”, says the UK’s Ethical Medicines Industry Group.
EMIG has elaborated on its previously outlined data-transparency stance in a comprehensive position paper addressing the European Medicines Agency’s (EMA) proposals to release clinical-trial data once an opinion has been given on a marketing authorisation application.
The Group, which represents small to medium-sized pharmaceutical companies in the UK, wants to see a resolution to the data-transparency debate that first and foremost benefits patients, while safeguarding the commercial interests of companies developing innovative medicines for use in Europe.
Patients first
“EMIG has always been supportive of campaigns to allow greater access to clinical research,” said the Group’s chairman, Leslie Galloway.
“Current moves to overhaul the system to ensure more collaborative sharing of data across the life sciences sector – both from industry and academia – are undoubtedly positive. However, it is important to remember that first and foremost in all of this must be patients.”
EMIG has again stressed, though, that “an information ‘free for all’, in which ‘raw data’ are available for anyone to use without restrictions” would not be a desirable outcome.
Wrong conclusions
The position paper highlights ways in which fully open, uncontrolled access to data could result in ‘cherry-picking’ of “parts of the full dataset, which could give rise to erroneous conclusions, consequent to not evaluating the ‘whole’ and putting the new results in their correct context”, EMIG notes.
It proposes instead an application process, to be run by the EMA as gatekeeper, for anyone wishing to access the data.
The default position of all data sponsors should be to make their research findings public, EMIG says.
“If this is not possible, it will be the responsibility of the owner of the data to articulate the reasons why releasing clinical trial data would have a disproportionately detrimental impact on their ability to bring a new medicine to market,” the Group adds. “The EMA would act as the arbiter in these situations.”
Commercial challenges
Dr Mark Edwards, EMIG’s research and development director, acknowledged there were some issues relating to products reliant on data-protection laws, rather than patents, to secure their commercial interests that could make publishing clinical data commercially damaging.
“We know there will be challenges in the new system and our paper sets out some potential ways of overcoming these, including a suggestion for an International Conference on Harmonisation (ICH) working party to review the current global data protection environment,” Edwards commented.
At the same time, patients involved in clinical trials “deserve our utmost respect and concern”, he emphasised. “It is vital that they are given a full understanding of the benefits their participation can deliver in terms of medical advancement.”
