Josée hansen igz

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Josée hansen igz

  1. 1. Selling sickness: supervision and law enforcement in the Netherlands <ul><li>Josee Hansen </li></ul>
  2. 2. Regulatory framework, EU considerations <ul><li>internal market </li></ul><ul><li>public health </li></ul><ul><li>quality of information </li></ul><ul><li>(EU: Directive 2001/83/EC) </li></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  3. 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. 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. 5. The Dutch approach <ul><li>1994 - 1999 self-regulatory system </li></ul><ul><li>1999 - 2003 Inspectorate in the lead </li></ul><ul><li>2003 - today mixed approach: self-regulatory and Inspectorate </li></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  6. 6. Regulatory framework, Dutch considerations <ul><li>prescription only medicines (POM) </li></ul><ul><ul><li>no direct to consumer advertising </li></ul></ul><ul><ul><li>inducements </li></ul></ul><ul><ul><ul><li>€500 - €1500 for continuous training </li></ul></ul></ul><ul><ul><ul><li>€50 for events </li></ul></ul></ul><ul><li>non-prescription (OTC) </li></ul><ul><ul><li>quality of information </li></ul></ul><ul><li>health products </li></ul><ul><ul><li>medical claim </li></ul></ul><ul><ul><li>quality of information </li></ul></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  7. 7. The Dutch approach <ul><li>Self regulatory system: </li></ul><ul><ul><li>code of conduct </li></ul></ul><ul><ul><li>dependant on commitment of participants </li></ul></ul><ul><ul><li>partcipants: industry, professional bodies </li></ul></ul><ul><ul><li>POM: mainly advising upon request CGR </li></ul></ul><ul><ul><li>OTC: pre clearance of information KOAG </li></ul></ul><ul><ul><li>supervised by Health Care Inspectorate </li></ul></ul><ul><ul><li>agreement to upscale to Health Care Inspectorate </li></ul></ul><ul><li>CGR: focus on health care professionals and prescription only medicines (POM) </li></ul><ul><li>KOAG: focus on general public and non prescription medicines (OTC) </li></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  8. 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. 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. 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. 11. An example: assessment of websites <ul><li>Healthy Scepticism assessed 24 websites and reported to the Health Care Inspectorate </li></ul><ul><ul><li>2 cases: measures by Health Care Inspectorate </li></ul></ul><ul><ul><li>6 cases: measures by KOAG </li></ul></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  12. 12. Enforcement options <ul><li>Competent authorities / legal basis </li></ul><ul><ul><li>Dutch Medicines Act, based on Directive 2001/83/EC </li></ul></ul><ul><ul><li>Guidelines on inducements </li></ul></ul><ul><ul><li>Guidelines on administrative fines 2007 </li></ul></ul><ul><li>Methods of investigation Health Care Inspectorate </li></ul><ul><ul><li>General administrative law </li></ul></ul><ul><ul><ul><li>requiring information </li></ul></ul></ul><ul><ul><ul><li>investigating samples </li></ul></ul></ul><ul><ul><li>Obligation to cooperate </li></ul></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  13. 13. Enforcement options <ul><li>Minor violations: self-regulatory measures </li></ul><ul><ul><li>responsibility CGR </li></ul></ul><ul><li>Intermediate violations and repeated minor violations: warning by the Health Care Inspectorate </li></ul><ul><ul><li>letter </li></ul></ul><ul><ul><li>enforcement. A second violation of the same kind is to be answered with the last option </li></ul></ul><ul><li>Serious violations and repeated intermediate violations: fines by the Health Care Inspectorate </li></ul><ul><ul><li>€30,000, €50,000 or €150,000; to be doubled or tripled on second or third occasion </li></ul></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  14. 14. Complications regarding enforcement <ul><li>Disease mongering and selling sickness </li></ul><ul><li>Medical opinion leaders who do have interests </li></ul><ul><li>Clinical guidelines committees-members who have interests </li></ul><ul><li>Phase IV trials: paid to include patients </li></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  15. 15. Wishful thinking <ul><li>Stakeholders taking responsibility: pharmaceutical industry, health care professionals, patient organizations </li></ul><ul><li>Self regulation bodies: representing all stakeholders, independent, pro active and effective </li></ul><ul><li>Turning ‘letter and spirit’ into legislation </li></ul>Supervision and law enforcement in the Netherlands | 7 October 2010
  16. 16. Statements <ul><li>Eroding confidence of the patient in their own health, their doctor and the health care system is the real threat of selling sickness and advertising drugs. </li></ul><ul><li>  </li></ul><ul><li>Transparancy is more effective than rules and regulations to control influencing in research, and development and prescription of medicines </li></ul>Supervision and law enforcement in the Netherlands | 7 October 2010

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