1. An agency of the European Union Presented by: Emer Cooke and Truus Janse-de Hoog Update on Transparency Progress report from HMA/EMA TF on Transparency

2. Update on Transparency 2 Content Requests for disclosure of dossiers – Classification of CTD sections with regard to Commercial Confidential Information and Personal Data Protection Consultation procedure between NCAs in the EU when third parties request access to assessment reports that have been written in the context of an European procedure Need for EMA/Member States further collaboration on Transparency

3. Update on Transparency 3 Classification of CTD sections with regard to Commercial Confidential Information and Personal Data Protection Procedure Rapporteur PT Discussed in TF HMA/EMA Discussed in meeting 17 March, CMDh members and legal experts from national agencies invited Presented to HMA 28 April

4. Update on Transparency 4 The structure of the MA dossier has been classified according to 4 criteria: CRITERIA PPD CBC CBR CCI CCI - Commercially Confidential Information; PPD - Protection of Personal Data; CBC (Case-by-Case analysis); -CBR (Can Be Released) all of the section is okay to be released

5. Update on Transparency 5 CCI (Commercially Confidential Information) Commercial confidential information: “shall mean any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information” (definition agreed by HMA and EMA) the section contains commercially confidential information and therefore cannot be released Redact the section of MA dossier Example: 3.2.S.2. – Manufacture (API): This information refers to the manufacturing process of the active substance and therefore, can reveal industrial secrecy.

6. Update on Transparency 6 PPD (Protection of Personal Data) Dealing with Curriculum vitae: the general principle should be redacting personal details (e.g. address, personal contact details). Information on technical or professional qualifications should be disclosed in accordance with article 12 of Directive 2001/83/CE. In the future CV should no longer contain personal data Any specific national legislation or national court decisions have to be followed the section contains personal data (PD) must be regarded as confidential Redact the section of MA dossier Example: 1.4.1. – Quality: The CV of the Quality expert is enclosed in this section, hence remove address and personal contact details before disclosing the document. Redact the PD from the section of MA dossier, before release or

7. Update on Transparency 7 the section may have commercially confidential information or personal data Case-by-case analysis Redact the section of MA dossier Example: Sub-module 3.1. (ToC): Generally can be disclosed. Nevertheless, if the contents are detailed, there might be need for redaction. Redact the PD/CCI from the section of MA dossier, before release or CBC (Case-by-Case analysis)

8. Update on Transparency 8 Example: 2.MARKETING AUTHORISATION APPLICATION PARTICULARS 2.4.1. – Marketing authorisation holder: This information is publicly available. Means that all of the section is okay to be released. CBR-Can Be Released

9. Update on Transparency 9 This document aims to provide guidance for NCA and EMA in order to establish a common approach when releasing parts of the MA dossier ! Any specific national legislation or national court decisions have to be followed

10. Update on Transparency 10 Feedback on Specific Issues requested during consultation phase Release of personal data (e.g CV and signatures) Contractual arrangements between different companies Protection of experts dealing with the assessment of animal data Proposal: Following endorsement by HMA, proceed to consultation with stakeholders Broadest view could be published for consultation

11. Update on Transparency 11 Next steps Consultation with industry for a 3 month period TF HMA/EMA will review comments Final version presented to HMA in November Publication final version on HMA/EMA websites In the consultation phase industry should be requested to make a proposal on how within the CTD structure a dossier can be created where the confidential information (CCI) and personal information (PPD) can be concentrated in a single section. That would save resources within the agencies if dossiers have to disclosed without CCI and PPD.

12. Update on Transparency 12 Consultation procedure between NCAs in the EU when third parties request access to assessment reports that have been written in the context of an European procedure –Recommendation to MSs to facilitate a common approach between NCAs and NCAs and EMA –When a request is received in a NCA as a first step reference will be made to a public assessment report (PAR) –When PAR is not available or not acceptable it is the duty of receiving MS to delete CCI and PPD –Same general principles should be followed for CCI and PPD as in other Guidance documents –RMS should always been consulted when request is received by CMS –Other CMSs may be consulted, if appropriate –Recommendations from RMS should be taken into account, however NCAs have to make their own judgement based on national legislation

13. Update on Transparency 13 Documents circulated through European mailboxes –MS circulate assessment reports and other correspondence via mailboxes only accessible to other NCAs and EMA. –MSs and EMA have access to documents and reports, also for procedures for which they have not received a dossier –Possibility for access does not mean for most MSs that they are considered as holders of the documents as such –If not superseded by national legislation, these MSs would normally not provide access (Not applicable to all MSs) –If access to these documents cannot be denied they will act in accordance with the agreed principles in this recommendation

14. Update on Transparency 14 Need for EMA/Member States further collaboration on Transparency New pharmacovigilance legislation places increasing emphasis on transparency Strengthen safety of medicines in the EU Increased level of transparency of safety information European and national webportals =>Joint EMA/MSs implementation necessary

15. Update on Transparency 15 Transparency and communication Transparency Web portal Coordination of safety announcements Public hearings Four concept papers to highlight the problem statement, resources, requirements and deliverables.

16. Update on Transparency 16 Transparency It is an overarching concept paper, its objective is to ensure: that all considerations regarding transparency in the legislation are taken into account that the principles of commercially confidential information and the protection of Personal Data are consistently applied (joint HMA-EMA Transparency Group) 16

17. Update on Transparency 17 New Pharmacovigilance legislation (cont) Publication of information via Web-portal National medicines web-portal - Link to Agency’s web-portal (Art 26 of R 1235/2010, Art 106 of D 2010/84/EU) Close EMA /Member States interaction and collaboration Consistency in the content of released info Consistency in the timing of released info

18. Update on Transparency 18 New Pharmacovigilance legislation (cont) EMA/Member States close collaboration on web portals Common understanding Consistency on the content of the info released “ any Information of a personal or commercially confidential nature shall be deleted unless its public disclosure is necessary for the protection of public health ” (Art 106a of D 2010/84/EU) EMA/HMA Transparency Group discussions CCI/PPD Agreement on high level principles

19. Update on Transparency 19 New Pharmacovigilance legislation (cont) Consistency on the content / timing of the info released (web portals) Which documents? e.g. –Safety announcements (Art 106a of R 1235/2010) –Publication of agendas and minutes –Flow of activities required in the publication documents on the European/National web-portals –e.g. Conclusions of assessments, recommendations, opinions, approvals by PRAC/CHMP/Coordination Group (Art 26j of R 1235/2010) EMA/Member States close collaboration and agreement

20. Update on Transparency 20 Concept paper on Transparency Summary of issues identified: Provision of more info to the public-Impact –Legal provisions –Proactive Publication Closer EMA-Member States interaction Overlap of deliverables: Interaction with other sub-project teams on PhV

21. Update on Transparency 21 Next steps Concept papers on Web portal, Coordination of Safety Announcements and Public hearings presented at the Project Coordination group on 13 April Concept paper on Transparency for finalisation in May Feed into EMA/HMA Transparency policy 21