There are “too many contentious policy and legal issues” to take a single approach to the transparency of clinical-trial data across the European Union, insists the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Instead, there should be a “case by case review to respect the specificity” not only of the products concerned but also of their particular stage in the drug development lifecycle, as well as the views of individual companies, says EFPIA director general Richard Bergström.
The federation also wants consideration to be given to the protection of intellectual property rights, without which “biomedical innovation and the research-based economy in Europe will be put at risk”.
EFPIA was commenting on last week’s workshop on access to clinical-trial data, held at the European Medicines Agency (EMA) in London.
The EMA has declared its commitment to the proactive publication of clinical-trial data once a drug has completed the marketing-authorisation process.
Last week the agency announced that broad-based advisory groups would start working on the key issues raised by clinical-data transparency – protecting patient confidentiality; clinical-trial-data formats; rules of engagement; good analysis practice; and legal aspects – early next year.
The expectation is that proactive publication of clinical-trial data will then come into force at the beginning of 2014.
In EFPIA’s opinion, the workshop gave a “constructive insight” into the different views around “the sensitive issue” of clinical-data transparency.
“It is impossible to ignore these differences,” the federation adds, saying it would “continue to work with EMA/HMA [the Heads of Medicines Agencies] and other stakeholders to develop an appropriate and balanced approach to fostering transparency while protecting the legitimate interests of sponsors and MAHs [Marketing Authorisation holders] and promoting innovation”.
According to EFPIA, it “recognises the benefits of transparency in relation to the development, regulation and approved use of new medicines to support an informed society with informed patients”.
At the same time, the federation maintains that pharmaceutical companies currently register “extensive information on their clinical trials at the time of initiation and publish information on their results, both positive and negative, through numerous channels (e.g., peer reviewed publications, EudraCT and clinicaltrials.gov)”.
Many EFPIA member companies already respond to requests for access to their clinical-trial data on case-by-case basis, the federation adds. “Each EFPIA company will continue to make its own judgments on what level of its own data it wishes to disclose.”
It has been suggested, for example, that GlaxoSmithKline’s public support for the British Medical Journal’s decision only to publish studies of drugs and medical devices where there is a commitment “to make the relevant anonymised patient level data available on reasonable request” may not be entirely in line with the stance taken by the Association of the British Pharmaceutical Industry.
Used and interpreted
EFPIA has once again voiced its concerns about how clinical-trial data might be used and interpreted if they are made widely available.
“The implications of the release of patient-level data on innovation and on individual patient protection and public health through re-evaluation of data by third parties need careful consideration,” it states.
“Discussion among regulators, patients, academia and industry needs to identify the best solution to balancing the desire for transparency and the benefits of sharing data for valid scientific enquiry, with the need to foster innovation.”
In particular, EFPIA says, it is important that:
• Any requests to release information provided by industry as part of a marketing-authorisation dossier should be “handled in accordance with EU and international rules and regulations regarding the protection of commercially confidential information (CCI) and protected personal data; thus sustaining industry’s innovative capabilities while shielding individuals’ personal rights”.
• The HMA/EMA should always consult the marketing authorisation holder in these circumtances, “so that the MAH has an opportunity to seek appropriate redactions prior to any disclosure”.
• Whether CCI is disclosable will depend on the “nature of the information at issue, the proposed recipient and the purpose of the disclosure. For example, EFPIA argues, “there is a difference between providing access to data to other researchers for valid scientific enquiries and disclosure to other companies to inform their business and development strategies”.
• Information on withdrawn or negative-opinion MA applications “should not be made public by health authorities other than the information that is already published (i.e., summaries of opinion, withdrawal public assessment reports, and Q&A), in recognition of the applicant's continuing commercial interest and the realisation that the public interest in transparency is lessened in the case of a product that is not marketed”.
Despite its objections to a “single approach” to clinical-data transparency being taken across Europe, EFPIA believes the regulatory intentions at least are pointing in the right direction.