The document summarizes guidelines for providing information about diseases and prescription medicines to the public in the Netherlands. It outlines the Dutch regulatory system for pharmaceutical advertising and promotion. The guidelines were developed in response to increased disease awareness campaigns and public demand for prescription medicine information. They establish standards for balanced, complete information about diseases and technical information about prescription medicines. The guidelines apply to all parties providing such information and include conditions like not misleading the public or leading to unnecessary medical treatment. A transitional period was provided for adjusting existing information to the new guidelines.

1. Selling Sickness Guidelines in the Netherlands Dr Lode Wigersma, MD, PhD Director of policy, KNMG (Royal Dutch Medical Association) Vice Chair, CGR (Foundation for the Code of Pharmaceutical Advertising)

2. Outline Overview of Dutch regulatory system Background Guidelines Content of the Guidelines Conclusion and questions

3. Overview of the Dutch regulatory system Dutch Medicines Act Supervision IGZ (Inspectorate of Health Care) Self regulation Codes: Code of Pharmaceutical Advertising Supervision CGR (Foundation for the Code of Pharmaceutical Advertising Code of Public Promotion of Medicines Supervision KOAG (Inspection Board for the Public Promotion of Medicines)

6. Guidelines for:

8. Non-interventionals studies

9. Sponsoring

10. Focus on general public

11. Guidelines for advertisement of:

12. OTC/Selfcare medicines

13. Food supplements

14. Medical (selfcare) devices

15. Guidelines for information of:

17. Partiesbehind the selfregulation

18. Guidelines in the NetherlandsBackground Increase disease awareness campaigns Need/call for information on prescription-only-medicines from consumers/patients Report “Gezonde Scepsis” (Healthy Skepticism) Public and political attention in the Netherlands Consulation meetings organised by CGR/KOAG

19. Content of the guidelines Standards for information on disease and prescription-only-medicines to general public Basic principle: Information is not forbidden Applicable to all parties concerned

20. Scope of the guidelines Information on diseases General public No reference (direct nor indirect) to POM Information on diseases Technical information General public Reference (direct or indirect to POM) Information on diseases Technical information Individual questions Users of medicines Not public

21. Most important conditions I Balanced and complete All relevant treatments Same manner Categorising Not withhold or neglect information on purpose or without justifiable cause

22. Most important conditions II Applies to all linked media Not misleading No frightening pictures Not lead to wrong self-diagnoses or unnecessary medical treatment No guarantees of state that use of medicines is safe

23. Most important conditions III Self tests – validated and verified Testimonials – true reproduction – no before and after situation Children - prudently Visual materials – difference health care professionals / public

24. Corporate websites – www.pom.nl Not all relevant treatments Only technical user information Minor disease information – necessary for good understanding of treatment with specific prescription-only-medicine

25. Transitional period Effective October, 1st 2010 Transitional period six months April 1, 2011 Adjusting existing information Evaluation of practical effects of Guidelines

26. THANK YOU