London, 22 November 2012: Today’s workshop gave a constructive insight into the different views on the sensitive issue of clinical data transparency. It is impossible to ignore these differences. We as an industry along with all the stakeholders involved must work together constructively to find answers that will balance the needs and interests of all involved.
EFPIA 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. 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). Furthermore, many EFPIA member companies already respond to requests for access to their clinical trial data on case-by-case basis. Each EFPIA company will continue to make its own judgements on what level of its own data it wishes to disclose.
EFPIA and its companies will therefore seek to ensure appropriate access to clinical data information and especially to legitimate scientific researchers.
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. 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.
Moving forward, EFPIA believes it is important the following considerations should be made with regards to clinical-trial data transparency:
- That requests to release information provided by industry as part of a marketing authorisation (MA) 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 (PPD); thus sustaining industry’s innovative capabilities while shielding individuals’ personal rights.
- The HMA/EMA must always consult the MA holder (MAH), so that the MAH has an opportunity to seek appropriate redactions prior to any disclosure. Companies will make different decisions based on their own policies and the circumstances of their products.
- The nature of the information at issue, the proposed recipient and the purpose of the disclosure are relevant to determining whether CCI information is disclosable. For example, 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. The former offers significant opportunities to conduct further research and to advance medical science; the latter risks innovation and know-how being unfairly and unreasonably used by a competitor.
- Information on withdrawn or negative opinion 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 realization that the public interest in transparency is lessened in the case of a product that is not marketed.
EFPIA believes there have been steps in the right direction from a regulation perspective on this issue. The HMA/EMA’s initiative to devise a common approach towards transparency across all EU competent authorities, for example, is a first step that will help ensure consistency and avoid multiple applications for the same information to be made public.
Richard Bergström, Director General of EFPIA, stated: “This is a complicated issue where we as an industry must tread carefully while continuing to work with all stakeholders involved. There are too many contentious policy and legal issues to be able to implement single approach throughout the EU. There must therefore be a case by case review to respect the specificity not only of the product but also of its stage in the lifecycle and views of the individual companies. There must also be consideration for the protection of intellectual property rights, without such protections, biomedical innovation and the research-based economy in Europe will be put at risk.
To that end, EFPIA will continue to work with EMA/HMA and other stakeholders to develop an appropriate and balanced approach to fostering transparency while protecting the legitimate interests of sponsors and MAHs and promoting innovation”.
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 37 leading pharmaceutical companies, EFPIA provides the voice of 1,900 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. The pharmaceutical industry invests 27.5 billion on research and development per year in Europe and directly employs 660,000 people including 116,000 in R&D units in Europe.
EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
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