The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted a joint guidance document, providing, for the first time, a consistent Europe-wide approach to the identification of commercially-confidential information and personal data in a marketing authorisation (MA) application.
In what the agencies describe as "a major step for transparency," regulatory authorities in the European Economic Area (EEA) will in future apply the same principles to identify which parts of an application dossier can or cannot be released in response to requests. This will apply regardless of whether the product concerned has been authorised using the centralised, mutual recognition or decentralised procedures.
The guidance document limits the scope of what information in an MA application regulators will consider to be commercially confidential. The exceptions mainly relate to information about quality and manufacturing of a product, as well as about facilities or equipment and some contractual arrangements between companies.
The document also sets out how personal data, as defined by EU Directive 95/46/EC, will be protected if it can lead to a person's identification, and gives further guidance on how to identify personal data relating to experts, staff or patients that should be redacted.
"This initiative will help authorities in the network to cope with a growing number of requests for access to clinical and safety data contained in an MA application," say the agencies.
The guidance was released for public consultation during June 1-September 1 last year, and 24 stakeholders, including companies, associations and other organisations sent comments. Their main concerns related to the release of contractual arrangements between companies, person data of experts and clinical and non-clinical data. Pharmaceutical companies raised specific concerns relating to the disclosure of non-clinical data, while the release of clinical data was generally supported, say the EMA and HMA.
Commenting on the initiative, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said it welcomes all moves to remove perceived secrecy, as long as legitimate trade secrets are protected.
"it is important that the general public trust regulatory agencies to be independent and the pharmaceutical industry to do the right thing," said EFPIA director general Richard Bergstrom.
In large part, the new guidance builds on input from EFPIA involving most of its members, so the Association is confident that commercial interests will be protected, he said. However, the worry in the industry is not that data itself is made available, but the fact that data will be available for all sorts of re-analyses; therefore, it is important that EMA communicate best practices for re- and meta-analysis of data, Mr Bergstrom emphasised.
He also noted that, despite EFPIA's reservations, EMA has decided to also release non-clinical (preclinical) data.
"An important consequence of the release of all this information is that we must update the concept of regulatory data protection [RDP], ie, that second applications cannot refer to submitted data until after 10 years. Similar provisions, but with different timelines, are in place in many countries around the world. As most of the data is now made public, the understanding must be that it is not the privacy of data that is protected, but the 'reliance on data' that is not allowed," said Mr Bergstrom, who stressed that the international community must agree that interpretation, “as the notion of 'confidential data' is now markedly reduced."
- The EMA and HMA point out that, despite the new guidance, the national and European authorities will remain bound by their respective legislations. Also, dossiers such as orphan designations, paediatric investigation plans and veterinary medicines are not covered by the new guidance; together with those applications that have been withdrawn or rejected, these will be handled by regulators according to their existing practices and legal provisions.