In the United States, the healthcare industry is familiar with the Sunshine Act’s tracking and reporting requirements related to payments and transfers of value to physicians, as well as to physician ownership and investment interests.
And around the world, new rules and policies are seeking to increase transparency.
For example, the Norton Rose Fulbright’s UK briefing, “Clinical Studies – the EMA’s new approach to transparency”, explains that the European Medicines Agency (EMA) has recently adopted a new policy for the proactive disclosure of clinical reports that will make them more widely accessible to the public.
The new approach will result in data from clinical reports being published by the EMA following the grant, refusal or withdrawal of the relevant application. Applicants//Marketing Authorisation Holders (MAHs) will have a limited ability to redact data they consider to be commercial confidential information (CCI).
Once published, the clinical data will be available for use for certain non-commercial purposes, subject to compliance with the EMA’s Terms of Use which will confer rights directly upon the applicant/MAH.
Applicants/MAHs will need to carefully consider what data in the clinical reports to be submitted they wish to redact and to clearly articulate their justifications for any proposed redactions. It will also be necessary for applicants/MAHs to understand what rights they have to challenge a decision of the EMA, their rights against the registered users of the data under contract and how they may be able to prevent misuse by any third party.
Read Norton Rose Fulbright’s briefing, “Clinical Studies – the EMA’s new approach to transparency”, on the current disclosure approaches and the new proactive approach.
