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Selling sickness: supervision and law enforcement in the Netherlands ,[object Object]
Regulatory framework, EU considerations ,[object Object],[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Competing interests Supervision and law enforcement in the Netherlands | 7 October 2010 public health needs <–> market driven phase IV study <–> seeding trials information <–> promotion clinical support <–> gifts clinical guidelines <–> disease mongering training <–> influencing
The Dutch way Introductie stafmedewerkers | 27 september 2010 Minister SG DG DG DG IG Public health Health care Long term care Medical products CBG CCMO Lareb
The Dutch approach ,[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Regulatory framework, Dutch considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
The Dutch approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Regulators in the Netherlands Supervision and law enforcement in the Netherlands | 7 October 2010 health product Health Products (HP) Non-prescription Medicines (OTC) Prescription Only medicines (POM) Medical Devices (MD) regulator Inspection Board for the Public Promotion of Medicines (KOAG) - Minor  violations of  law All  violations of  Code of Conduct - - Code of conduct for pharmaceutical advertising (CGR) - - Minor  violations of  law All  violations of  Code of Conduct - Health care Inspectorate - Recurrent minor  violations of  law All major  violations of  law Recurrent minor  violations of  law All major  violations of  law -
Collaboration: how it could be done Supervision and law enforcement in the Netherlands | 7 October 2010 Suspected violation is reported to HCI / CGR / KOAG Case handled by HCI Case handled by CGR Case handled by KOAG Infringement is ceased Case closed
Real life: parallel tracks Supervision and law enforcement in the Netherlands | 7 October 2010 Suspected violation is reported to HCI / KOAG HCI / KOAG assesses case and decides on appropriate regulator Case handled by HCI Case handled by CGR Case handled by KOAG Infringement is ceased Infringement is continued / repeated Secondary handling by HCI Case closed Suspected violation is reported to CGR Case handled by CGR Infringement is ceased Infringement is continued / repeated Secondary handling by HCI Case closed All  cases regarding promotion directed at  health care professionals All  cases regarding promotion directed at  the public
An example: assessment of websites ,[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Enforcement options ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Enforcement options ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Complications regarding enforcement ,[object Object],[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Wishful thinking ,[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010
Statements ,[object Object],[object Object],[object Object],Supervision and law enforcement in the Netherlands | 7 October 2010

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Josée hansen igz

  • 1.
  • 2.
  • 3. Competing interests Supervision and law enforcement in the Netherlands | 7 October 2010 public health needs <–> market driven phase IV study <–> seeding trials information <–> promotion clinical support <–> gifts clinical guidelines <–> disease mongering training <–> influencing
  • 4. The Dutch way Introductie stafmedewerkers | 27 september 2010 Minister SG DG DG DG IG Public health Health care Long term care Medical products CBG CCMO Lareb
  • 5.
  • 6.
  • 7.
  • 8. Regulators in the Netherlands Supervision and law enforcement in the Netherlands | 7 October 2010 health product Health Products (HP) Non-prescription Medicines (OTC) Prescription Only medicines (POM) Medical Devices (MD) regulator Inspection Board for the Public Promotion of Medicines (KOAG) - Minor violations of law All violations of Code of Conduct - - Code of conduct for pharmaceutical advertising (CGR) - - Minor violations of law All violations of Code of Conduct - Health care Inspectorate - Recurrent minor violations of law All major violations of law Recurrent minor violations of law All major violations of law -
  • 9. Collaboration: how it could be done Supervision and law enforcement in the Netherlands | 7 October 2010 Suspected violation is reported to HCI / CGR / KOAG Case handled by HCI Case handled by CGR Case handled by KOAG Infringement is ceased Case closed
  • 10. Real life: parallel tracks Supervision and law enforcement in the Netherlands | 7 October 2010 Suspected violation is reported to HCI / KOAG HCI / KOAG assesses case and decides on appropriate regulator Case handled by HCI Case handled by CGR Case handled by KOAG Infringement is ceased Infringement is continued / repeated Secondary handling by HCI Case closed Suspected violation is reported to CGR Case handled by CGR Infringement is ceased Infringement is continued / repeated Secondary handling by HCI Case closed All cases regarding promotion directed at health care professionals All cases regarding promotion directed at the public
  • 11.
  • 12.
  • 13.
  • 14.
  • 15.
  • 16.