Selling Sickness Guidelines in the Netherlands<br />Dr Lode Wigersma, MD, PhD<br />Director of policy, KNMG (Royal Dutch M...
Outline<br />Overview of Dutch regulatory system<br />Background Guidelines<br />Content of the Guidelines<br />Conclusion...
Overview of the Dutch regulatory system<br />Dutch Medicines Act<br />Supervision IGZ (Inspectorate of Health Care)<br />S...
<ul><li>Legislation
 Penalties</li></ul>Working<br />Agreements<br /><ul><li> Focus on practitioners
 Guidelines for:
 Advertisement to health </li></ul>professionals<br /><ul><li> Hospitality and gifts
 Non-interventionals studies
 Sponsoring
 Focus on general public
 Guidelines for advertisement of:
 OTC/Selfcare medicines
 Food supplements
 Medical (selfcare) devices
 Guidelines for information of:
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Lode Wigersma - Selling Sickness 2010

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Lode Wigersma - Selling Sickness 2010

  1. 1. Selling Sickness Guidelines in the Netherlands<br />Dr Lode Wigersma, MD, PhD<br />Director of policy, KNMG (Royal Dutch Medical Association)<br />Vice Chair, CGR (Foundation for the Code of Pharmaceutical Advertising)<br />
  2. 2. Outline<br />Overview of Dutch regulatory system<br />Background Guidelines<br />Content of the Guidelines<br />Conclusion and questions<br />
  3. 3. Overview of the Dutch regulatory system<br />Dutch Medicines Act<br />Supervision IGZ (Inspectorate of Health Care)<br />Self regulation Codes:<br />Code of Pharmaceutical Advertising<br />Supervision CGR (Foundation for the Code of Pharmaceutical Advertising<br />Code of Public Promotion of Medicines<br />Supervision KOAG (Inspection Board for the Public Promotion of Medicines)<br />
  4. 4. <ul><li>Legislation
  5. 5. Penalties</li></ul>Working<br />Agreements<br /><ul><li> Focus on practitioners
  6. 6. Guidelines for:
  7. 7. Advertisement to health </li></ul>professionals<br /><ul><li> Hospitality and gifts
  8. 8. Non-interventionals studies
  9. 9. Sponsoring
  10. 10. Focus on general public
  11. 11. Guidelines for advertisement of:
  12. 12. OTC/Selfcare medicines
  13. 13. Food supplements
  14. 14. Medical (selfcare) devices
  15. 15. Guidelines for information of:
  16. 16. Prescription-only-medicines</li></li></ul><li>Self regulation in the Netherlands<br />CGR (Foundation for the Code of Pharmaceutical Advertising), since 1998<br />Advertising aimed at healthcare professionals<br />KOAG (Inspection Board for the Public Promotion of Medicines), since 1926<br />Advertising – if allowed - aimed at the public<br />
  17. 17. Partiesbehind the selfregulation<br />
  18. 18. Guidelines in the NetherlandsBackground <br />Increase disease awareness campaigns<br />Need/call for information on prescription-only-medicines from consumers/patients<br />Report “Gezonde Scepsis” (Healthy Skepticism)<br />Public and political attention in the Netherlands<br />Consulation meetings organised by CGR/KOAG<br />
  19. 19. Content of the guidelines<br />Standards for information on disease and prescription-only-medicines to general public<br />Basic principle: Information is not forbidden<br />Applicable to all parties concerned<br />
  20. 20. Scope of the guidelines<br />Information on diseases<br />General public<br />No reference (direct nor indirect) to POM <br />Information on diseases<br />Technical information<br />General public<br />Reference (direct or indirect to POM)<br />Information on diseases<br />Technical information <br />Individual questions <br />Users of medicines<br />Not public<br />
  21. 21. Most important conditions I <br />Balanced and complete<br />All relevant treatments <br />Same manner<br />Categorising <br />Not withhold or neglect information on purpose or without justifiable cause<br />
  22. 22. Most important conditions II<br />Applies to all linked media<br />Not misleading<br />No frightening pictures<br />Not lead to wrong self-diagnoses or unnecessary medical treatment<br />No guarantees of state that use of medicines is safe<br />
  23. 23. Most important conditions III<br />Self tests – validated and verified<br />Testimonials – true reproduction – no before and after situation<br />Children - prudently<br />Visual materials – difference health care professionals / public<br />
  24. 24. Corporate websites – www.pom.nl<br />Not all relevant treatments<br />Only technical user information<br />Minor disease information – necessary for good understanding of treatment with specific prescription-only-medicine<br />
  25. 25. Transitional period<br />Effective October, 1st 2010<br />Transitional period six months April 1, 2011<br />Adjusting existing information<br />Evaluation of practical effects of Guidelines<br />
  26. 26. THANK YOU<br />

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