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 

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.

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

www.transparantieregister.nl

www.transparantieregister.nl

www.transparantieregister.nl

www.transparantieregister.nl

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