Masterarbeit

Identification of Commercially Confidential Information and Protection of Personal Data - New transparency guidance (1st publication: June 2011) of EMA and HMA especially from the point of view of service companies

Judith Leyendecker (2012)

Summary

Language: English

Transparency is a living process, which has to deal with the increased demand for access to documents but also with the protection of personal and commercially confidential data. Within our society the self-dependant citizen expects more and more information. To satisfy this need there are already several databases which provide different kind of information. Also the NCAs publish certain information about each authorised medicinal product. Directives and Regulations have been adopted to assure the appropriate handling of such requests, which are often based on FOI. Further guidance documents and recommendations have been published in order to give detailed advice.

In June 2011 the HMA and EMA released the draft guidance document on the "Identification of Commercially Confidential Information and Protection of Personal Data" and invited all stakeholders to comment and to express their thoughts with regard to this topic. The final guidance document was then adopted in March 2012; it is applicable for medicinal products for human use, authorised via CP, DCP or MRP. It gives guidance on the identification of CCI and PPD and categorise the complete CTD structure in 4 categories. There are documents, which can be released and documents, which need to be redacted because they contain CCI and PPD. The purpose of this guidance is to give an insight into the decision-making process for the public. Therefore the focus lies on the release of Module 4 and 5, because they contain safety information, which are of public interest. The quality part is regarded as CCI and can therefore not be disclosed.

Furthermore the release of contractual arrangements within the dossier was discussed intensively. Especially from the point of view of service companies it is in fact not favoured to release such details since this reveals confidential information. In the end it was agreed on disclosing only contractual arrangements concerning Module 4 and 5 (e.g. with CROs of the biostudy), any information on Module 3 is considered to be CCI.

The impact of this guidance document is hard to define. It might lead to an increased demand for access to documents, and in this regard the workload for the authorities will become higher. In addition a harmonised handling of such requests cannot be guaranteed unless the national legislation has been adopted. However, it might be a first step towards a harmonised handling within the EU with regard to transparency. In the end it is always a balancing act between the FOI on the one hand and the CCI and the PPD on the other hand.

Pages: 44