EU Transparency Roundtable The EFPIA Response

Transcription

1 EU Transparency Roundtable The EFPIA Response Dr. Michael Bartke, Director Compliance Management Daiichi Sankyo Europe GmbH Co-Chair EFPIA Compliance Committee Pharmaceutical Compliance Congress & Best Practice Forum Madrid, May 2013

2 EU Transparency Roundtable EFPIA response Where are we now? The new EFPIA Disclosure Code Chances & Risks Open Questions DR. M. BARTKE, EFPIA DISCLOSURE CODE 2

3 Where are we now? Transparency Obligations Transparency Obligations by Code Law DR. M. BARTKE, EFPIA DISCLOSURE CODE 3

4 The EFPIA Disclosure Code - Content Level of Disclosure Aggregate Individual HCO following the money Individual HCP following the money 2016 based on 2015 data Research & Development ToV to HCPs/HCOs related to the planning and conduct of: a.non-clinical studies (as defined in the OECD Principles of GLP) b.clinical trials (as defined in Directive 2001/20/EC) c.non-interventional studies that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, HCPs specifically for the study (cfr Section of the EFPIA HCP Code) Donations & Grants to HCOs Contribution to costs of events Sponsorship agreements with HCOs/third parties appointed by HCOs to manage an event Registration fees Travel & accommodation Fee-for-service & consultancy Fees Related expenses agreed in the fees for service or consultancy contract Contribution to costs of events Registration fees Travel & accommodation Fees for service & consultancy Fees Related expenses agreed in the fees for service or consultancy contract Each company shall publish a note summarising the methodologies used in preparing their disclosures and identifying transfers of value for each category described above. DR. M. BARTKE, EFPIA DISCLOSURE CODE 4

5 The Disclosure Code Timeline EFPIA General Assembly adopts changes to EFPIA Code June 2013 EFPIA Board to approve pre-final wording for changes to EFPIA Code 15 February 2013 Codes Committee Review of Code transposition (report to the Board) April 2014 Member Associations Individual disclosure deadline for period begins transposition into Code of Practice 31 December 2013 Data collection by member companies for individual disclosure DR. M. BARTKE, EFPIA DISCLOSURE CODE 5

6 EFPIA map: member associations * Expected: 2015 start tracking 2016 reporting Transparency Obligations by Code Law * incl. affiliate member associations: 33 DR. M. BARTKE, EFPIA DISCLOSURE CODE 6

7 Chances & Risks Chances (Voluntary) Code sets a new common standard in Europe across borders Could increase the level of reputation of the pharmaceutical Industry Could prevent stricter local regulation Prevent the risk of misusing financial interaction between industry and HCPs opens the door for nonjudgement discussion of the interaction between industry and HCPs / HCOs DR. M. BARTKE, EFPIA DISCLOSURE CODE 7

8 Chances & Risks Risks Delay re Transfer of EFPIA Code into local Codes Content diluted by transfer into national Codes and result into a variety of different national codes Implementation at company level complex and resources needed often underestimated Critical reaction of public (media) at start.. DR. M. BARTKE, EFPIA DISCLOSURE CODE 8

9 Open Questions Approval of the EFPIA Disclosure Code in June? Identification of pitfalls? What about non EFPIA organized Companies - is there a 2 Class scenario...? Involvement / Communication of important stakeholder? internal external How to support companies re implementation esp. mid size companies...? DR. M. BARTKE, EFPIA DISCLOSURE CODE 9

10 Dr. Michael Bartke Director Compliance Management Daiichi Sankyo Europe GmbH Zielstattstr Munich Germany Phone: DR. M. BARTKE, EFPIA DISCLOSURE CODE 10

11 BACK UP DR. M. BARTKE, EFPIA DISCLOSURE CODE 11

12 Final Draft Disclosure Code Formal approval at EFPIA General Assembly 24 June 2013 Preamble Applicability of the Code Applicable Law or Regulation Article 1 Article 2 Platform of Disclosure Applicable National Code Article 3 Disclosure Obligation Form of Disclosure Individual and Aggregate Disclosure Methodology: each member company will publish a note summarising the methodologies used by it in preparing the disclosures and identifying Transfers of Value for each category of disclosure Article 4 Article 5 Enforcement Amendments to, and Guidance Regarding Compliance with the Code Schedule 1 Definition of Terms Schedule 2 Disclosure Template Schedule 3 Scope of Disclosure Schedule 4 Implementation and Procedure Rules DR. M. BARTKE, EFPIA DISCLOSURE CODE 12

13 DR. M. BARTKE, EFPIA DISCLOSURE CODE 13

14 EFPIA Brussels Office Leopold Plaza Building Rue du Trône 108 B-1050 Brussels - Belgium Tel: +32 (0)