TransparencyDisclosure PlatformsNational Experience (NL)
Matthijs M. van Blokland, LLMGeneral CounselIPCC Madrid May 21-23, 2013
The trigger. An opportunity?
Health Care Minister A. Klink (VWS) in 2009
I consider to legislate on transparency but I will first allow the parties involved to develop self-regulation. He requests ‘Association Codecommittee Drugadvertising’ (Stichting CGR) to develop a code of conduct.
Development : the Dutch ‘Poldermodel’ of regulation
Regulation = compromises and emphasis on self-regulation
National Disclosure/Transparency Approaches
Regulatory approach Examples Jurisdictions
Statutory basis.Legislation.
Slovakia, France, USA
Voluntary basis. Self-regulation.
The Netherlands
Combination UK: (Bribery Act + ABPI code)
Legislation vs. self regulation
Preference: Self regulation
• Effective• Flexible • Buy-in from stakeholders
Partners in the development process
Process Driver
CGR = Foundation Code Committee Pharmaceutical Advertising
Development. Start: Identification Stakeholders
Nefarma’s roles
-contacting-connecting-collecting input -creating-communicating-negotiating-get endorsement.
High Level of Legitimacy
•
Developed by stakeholders
• Commitment by stakeholders
• Approved by the administration
• Financial contribution to develop register by administration
Implementation (main points)
•2013 disclosure of 2012 payments• Q1 uploading info to central register• Q2 info open to public
•Service and sponsor agreements
•Companies : agreements + administrative organisation
•Nefarma: provide boilerplates & training programmes
•Administration: will fund the incorporation of public register
Management
moduleFarma
‐By hand‐Webservice
XML
Publicwebsite
‐Search function‐Max. 3 years
Managementmodule
HCP / Inst.‐By hand‐Control
FarmaOutput ‐Overview‐XML output
ERP/CRM/CMS
Services
Sponsoring
Code of Conduct CGR
Transparantieregister Foundation
Database. Table types
11
Services Consultancy. General advice, for example writing an
article,
scientific paper;12
Services Advisory Board. Meeting of HCP’s
in which the company is
advised;13
Services Speaker. Speaking/presenting;14
Services Non‐interventional Study;15
Services other.
21
Sponsoring meeting. Scientific meeting not organised
by a
pharmaceutical company;22
Sponsoring project. Innovative or quality improving activities which
direct or indirectly are aimed at improving care to patients or the
progress of medical science and are not (completely) financed in
the
regular way.
Database - links
•
BIG-register number (Name including initials, m / f, specialism, domicile)
• Chamber of Commerce register number (Company name, seat, place of establishment)
• HCO – own table – Create
• ID Farma - own table - Create
System Management by Pharma Companies
• Management Module – login-module
• 2 input methods: Web service, XML and Excel
• Each line item separately supplied
• No relationships between line items
• Amount > 500 € must be reported. < 500 € can be reported.
System Management by HCO / HCP
• Management Module HCO / HCP – login-module.HCP via existing KNMG management module (tab)
• Input line items only via Dashboard
• Each line item separately and no relationships between line items
• RelationNumberFI: tab request extension table
• Overview input line item (e mail alert)
Public website
•Search functions for public•Searches on annual basis •3 years public – 4 year in database •Security – no search engines – no external queries.
Ensuring Compliance
Nefarma Initiatives and Services•Newsletters•Training programmes•P.R.•Coalition with HCP’s organisations•Company lawyers briefings•Cooperation with member companies’ managers•Liaise with administration
Critical issues
Technical issues, like:• Access to info at operational level• Conversion from local to central• Use of unique identifiersCommunication issues, like:• Develop clear explanatory notes• Design and content of the website• Press releasesOther, like:• Disclosure of personal data• Treatment of VAT
Critical Issues
Technical issues, like:•
Access to info at operational level
•
Conversion from local to central•
Use of unique identifiers
•Communication issues, like:•
Develop clear explanatory notes
•
Design and content of the website•
Press releases
•Other, like:•
Disclosure of personal data
First impression
Technical hick ups:• Numbering;• Relevant data sets;• Unique Identifier ↔ Excel;• No identifier.
Communication
Communication is KEY• Newletters;• Q&A pre-launch• Q&A post launch• Website
• General info• Presentations• Standard clauses