Lincoln TsangLincoln Tsang, member of the BIA Regulatory Affairs Committee and a partner of Arnold & Porter LLP, provides an account of the European Medicines Agency’s (EMA) latest policy on publication of clinical data. He advised the BioIndustry Association in the negotiations during the development of the EMA Publication Policy and the EU Clinical Trials Regulation.

After nearly 18 months of internal and external consultations, the EMA’s Management Board finally approved the Agency’s policy on publication of clinical data on 2 October. The EMA has characterised this new policy as a landmark step that will provide an unprecedented level of access to clinical reports and set new standards for transparency in public health and pharmaceutical research and development. However, this does not stop third parties requesting for access to documents held by the EMA independently of the proactive publication policy.

The EMA has consistently defended its transparency and data access policy as a necessity in its service delivery to patients and society at large because (a) it instils trust and confidence in the regulatory decision-making process; (b) there is an ethical responsibility to the patients enrolled in the trials; (c) data-sharing can open up new horizon for future research for the benefit of patients and public health.

The proactive publication policy reflects a balanced view of the disclosure of the information within a marketing authorisation dossier, with controls in place if the data might be unfairly used by competitors. The policy also accepts that there is a public interest in clinical trial data being released and considered by academics and healthcare professionals.

The adopted policy will apply from 1 January 2015 onwards for all new marketing authorisation applications that are evaluated under the European Centralised procedure, and for all line extensions of approved products from 1 July 2015. The policy applies to clinical data that have been submitted to the EMA, but clinical data not held by the Agency and pharmacovigilance data on individual case safety reports are not within the scope of the new policy.

The policy will be applied stepwise. To start with, only clinical data contained in clinical reports will be published. Then, individual patient data (IPD) will be published after the Agency puts in place structures to systemically collect and evaluate individual patient data after a targeted public consultation with all concerned stakeholders. The implementation of the IPD publication must be approved by the Management Board and the Agency will also notify the European Data Protection Supervisor to ensure the structures are in compliance with the data protection laws.

The policy recognises the need to protect personal data, commercially confidential information as well as to ensure future investment in pharmaceutical research and development is not harmed. The Agency declares that sustained and extensive pharmaceutical research activity is a precondition for future improvements in public health. For this reason, the policy is designed to guard against unintended consequences arising from disclosure such as breaches of intellectual property rights that might ‘disincentivise’ future research and development efforts.

Commercially confidential information is defined as any information contained in the clinical reports submitted to the Agency by the applicant or marketing authorisation holder that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant or holder. The definition in itself is not viewed as controversial, but how the commercial harm is assessed in practice by the Agency will become critical. The policy provides that such an assessment should take into account the justification provided by the applicant or marketing authorisation holder in respect of the nature of the product, the competitive situation of the therapeutic market, the approval status in other jurisdictions, the novelty of the clinical development and new developments by the same company. Annex 3 to the policy contains specific information that may be viewed as commercially confidential to justify redaction. For example, information about the specifications relevant to assay development could be considered as commercially confidential as such information may bring significant advantages to competitors if published.

In order for a third party to access the clinical data, the person is required to agree to the terms of use (ToU). There are two sets of ToU: one for general non-commercial use and the other for academic and other non-commercial research purposes. The data may be viewed on-screen or downloaded. The rules for those wanting to download, save or print are stricter than for those who want to view on screen. If one wants to download the data, then the identity of the person must be provided to the Agency. The applicant for or holder of the marketing authorisation can enforce the terms through third party rights as expressly provided in the ToU.

The new EMA policy should be viewed as a complementary tool to the requirements set out in the EU Clinical Trials Regulation. It is inevitable that the transparency requirements will likely demand greater resources for life science companies to manage the process properly, and the associated costs in an increasingly challenging financial environment.