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EMA confirms that access to clinical study reports for preparation of Health Technology Dossiers will be permitted within the new EMA Disclosure Policy

According to the minutes of a meeting between the European Medicines Agency (“EMA”) and the European Network for Health Technology Assessment (“EUnetHTA”) held on 9 December 2014, the EMA has clarified that pharmaceutical companies may use clinical data made available as part of the EMA’s new Disclosure Policy as part of a Health Technology Assessment (“HTA”) dossier. The EMA further stated that this use would not be considered a breach of the Terms of Use governing such disclosure.

Section 3 of Annex 1 to the new Disclosure Policy sets out the Terms of Use that govern the access and use of clinical data made available to users for general information purposes. Such users can include pharmaceutical companies. According to the Terms of Use, the relevant user is not permitted to:

  • use the clinical data to support an application for a marketing authorisation and any extensions or variations thereof for a medicinal product anywhere in the world;
  • share the user’s username, password or other account details with a third party or otherwise provide a third party with access to the user’s account;
  • make any unfair commercial use of the clinical data.

Similar conditions are imposed on users of the clinical data for the academic and other non-commercial research purposes referred to in Annex 2 to the Disclosure Policy. Any failure by the user to comply with these conditions would result in the revocation of the users’ right to access and use the clinical data.

The Questions and Answers Document on the EMA Disclosure Policy clarifies that HTA bodies are permitted to access and use clinical data for the purposes of their institutional activities. In such circumstances, the HTA bodies could download, transcribe, cut and paste and print the data in accordance with the Terms of Use governing academic and other non-commercial research purposes.

According to Section 6 of the minutes of the meeting discussed above, the EMA confirmed that enabling comparative effectiveness research is in the interest of public health. In such circumstances, use of the clinical data released as part of the Disclosure Policy for scientifically sound relative effectiveness comparisons would not be considered unfair commercial use of the clinical data that would constitute a breach of the Terms of Use. This clarification applies to the use of clinical data by pharmaceutical companies as part of their preparation for a dossier to be submitted to HTA bodies. The EMA agreed that the Questions and Answers Document on the Disclosure Policy will be updated to reflect this position.