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Transparency Disclosure Platforms National Experience (NL) Matthijs M. van Blokland, LLM General Counsel IPCC Madrid May 21-23, 2013

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  • TransparencyDisclosure PlatformsNational Experience (NL)

    Matthijs M. van Blokland, LLMGeneral CounselIPCC Madrid May 21-23, 2013

  • Presentation

  • The Dutch Process

  • 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.

  • Presentation

  • The product

    Code of Conduct on Transparency of Financial Relations

  • 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

  • ‘Polder’ partners in Transparency

    HCP’s Pharma

  • Presentation

  • Disclosure Platform

    • Timeline

  • Timeline Development Disclosure Platform

  • Timeline Development Disclosure Platform

  • Disclosure Platform

    • Technical and Functional Details

  • Management 


    ‐By hand‐Webservice 



    ‐Search function‐Max. 3 years


    HCP / Inst.‐By hand‐Control 

    FarmaOutput ‐Overview‐XML output




    Code of Conduct CGR

    Transparantieregister Foundation

  • Database. Table types


    Services Consultancy. General advice, for example writing an 


    scientific paper;12 

    Services Advisory Board. Meeting of HCP’s

    in which the company is 


    Services Speaker. Speaking/presenting;14 

    Services Non‐interventional Study;15 

    Services other.


    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


    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.

  • Conclusion and looking forward

  • 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.

  • Search function

    • Principle applied:• HCP;• HCO;• Year.

    • NOT: pharmaceutical company

  • Communication

    Communication is KEY• Newletters;• Q&A pre-launch• Q&A post launch• Website

    • General info• Presentations• Standard clauses

  • Governance

  • Governance

    • Stichting CGR:• Board• Policy making• Strategy

    • Stichting TRZ• Board• Supervisory Board• Focus on implementation

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