1. WHO Medicines Strategy Priorities: 2004-2007 Dr Guitelle Baghdadi Essential Drugs and Medicines Policy World Health Organization August 2004

2. 2 WHO Medicines 2004 – 2007: 4 objectives, 7 components and 44 expected outcomes OBJECTIVES n Policy n Access n Quality and safety n Rational use COMPONENTS 1. Implementation and monitoring of medicines policies 2. Traditional medicine and CAM 3. Fair financing and affordability 4. Medicines supply systems 5. Norms and standards 6. Regulations and QA systems 7. RU by health professionals and consumers

3. 3 Medicines Strategy 2004 – 2007: development process of 1 year with three main phases n Phase I: internal update with 5 working groups ä WHO staff: HQ, Regional offices and country offices ä 5 areas: policy, TRM/CAM, access, quality & safety, and RUM ä Means: telephone conferences and emails n Phase II: external review ä Sent to full range of partners (259): Member States, WHO collaborating centres, WHO expert committees, UN family, NGOs, etc. ä 71replies received n Phase III: finalization ä Telephone conferences with Member States ä Videoconference between WHO/HQ and Regional Offices

4. 4 WHO Medicines Strategy 2004-2007: 5 priorities Objectives: policy, access, quality & safety, rational use 1. National medicines policies that focus on human rights, need for innovation, health-oriented approach to trade agreements, stronger ethical dimension 2. Access to traditional medicine by protecting knowledge and access, expanding evidence base, ensuring safety, informing consumers 3. Access to essential medicines, with emphasis on HIV medicines for 3-by-5, medicines for malaria, tuberculosis, childhood illness, reproductive health 4. Safer medicines through expanded safety monitoring and continued strengthening of quality assurance 5. Rational use through continuing education, initiatives linked to health insurance

5. 5 Ethical Criteria for Promotion of Medicines Dr Guitelle Baghdadi Essential Drugs and Medicines Policy World Health Organization August 2004

6. 6

7. 7 WHO definition of promotion "all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs"

8. 8 Overview 2.WHO ethical criteria for drug promotion 1.Promotion of medicines: current challenges 3.Some countries practices…

9. 9 Overview 2.WHO ethical criteria for drug promotion 1.Promotion of medicines: current challenges 3.Some countries practices…

10. 10 Examples of promotional tools and target audiences n Prescribers n Discounts n Gifts n Educational events n Monitoring of prescriptions n Pharmacies n Direct to consumer advertising (DTCA) n Medicalisation or "illness promotion" n Support to patient-help organizations n Consumers n Sales Representatives n Education events n Journal advertisements n Gifts n Samples n Enter patients in clinical trials against payment n Physicians or opinion leaders paid as speakers

11. 11 "Imbalance between commercially produced and independent drug information" (1) n Large amount spent around the world for drug promotion: ä US: US$ 13 – 15 billion (2000) (1) ä Australia:US$ 1.3 – 2 billions per year (2) ä Italy:US$ 1.1 billion (1998) (1) ä Low-income countries: 20 – 30% of sales revenue (1) n Growth spending on DTCA for prescription drugs ä US: US$ 55 million (1991) to US $ 2.4 billion (2001) (3) n Others figures (US): ä currently 80,000 sales reps (1) ä 314,000 physician events in 2003 (sponsored industry) (1) ä free samples: $ 11 billion (retail value) or $ 2-3 billion (prod. cost) n Only 50% countries have drug information centres (1999) (1) (1) WHO Medicines Strategy 2004 – 2007 (2) www.healthyskepticism.orgwww.healthyskepticism.org (3) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001

12. 12 Increasing evidence that promotion techniques influence physicians' prescribing n Medical journals ads: information content generally poor (1) ä Headlines can be misleading (32%) ä Lead to improper prescribing if no additional information (44%) ä Little or no educational value (57%) ä Often minimize risks and harmful effects (50% to 60%) n Advertisement material: only 6% material supported by scientific evidence (2) ä 15% of brochures did not contain any citations ä 22% citations listed could not be found ä 63% info correctly referenced but articles did not reflect results n Sponsored medical conferences ä Attendance associated with increased prescribing of sponsored product (3) (1) Wilkes M. Pharmaceutical Advertisements in Leading Medical journals: Experts' Assessment. Ann Intern Med. 1992;116:912-9 (2) Tuffs A. Only 6% of drug advertising material is supported by evidence [news]. BMJ 2004; 328: 485 (3) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380

13. 13 Sales representatives too often only source of information for health professionals n Interactions start during medical school (2) n 80 – 95% doctors see sales reps regularly (1) ä average 4 times a month (2) ä US: 1 sales rep for 15 to 30 physicians (3) n Seen as important source of info (new drugs) (3) n 10% sales reps statements are inaccurate (3) n 25% doctors recognize inaccurate statements (3) n Impacts ä prescribing costs ä irrational prescribing ä preference of new drugs ä decreased prescription of generics (2) (1) Moynihan R. Who pays for the pizza? BMJ 2003; 326: 1189-1192 (2) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380 (3) Ziegler M. & al.. The accuracy of drug information from pharmaceutical sales representatives. JAMA 1995; 273: 1296-1298

14. 14 Gifts, trips, dinners influence prescribing habits & power needs to be acknowledged n Most doctors deny gifts influence their prescribing (1) n Recognized as conflict of interest and established "ceilings" (e.g. $ 100 in US) (2) n Small gifts play important role (2) ä Pens, note pads, etc. act as "reminder items" (2) ä Sole or among top reasons to see sales reps (1) n Psychological aspects: indebtedness, reciprocity (2) ä Food, flattery and friendships: powerful tools of persuasion (1) Wazana A. Physicians and the pharmaceutical industry. JAMA 2000; 283:373-380 (2) Katz D & al. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift giving. AM J Bioethics.2003;3:39-46

15. 15 DTCA of prescription-only medicines is legal only in US and New Zealand n US since 1980s ä FDA decision 1997: relax restrictions on radio and TV ä 2003: US$ 3 billion per year ä 8.5 m. people request & receive prescription after advertisement n New Zealand ä 2003: GPs launched campaign for ban n Rejected by EU health ministers in June 2003 and EU parliament in December 2003 n All other countries (internet, satellite, etc.) DTCA raises concerns, despite advocacy that it creates better informed patients: n Increases prescription costs (1) n Misleading statements lead to irrational use and undue risks 1) n Often breach regulation (1) n Strains on physicians-patient relation (1) n No evidence of health benefits (2) n Promotes medicalisation of normal life (1) (1) HAI, DTCA prescription drugs, the European Commission's proposal for legislative change, December 2001 (2) Mansfield P. & al. DTCA is more profitable if it is misleading. NZ Med J 2003; 116 (1182)

16. 16 Some DTCA examples

17. 17 Overview 2.WHO ethical criteria for drug promotion 1.Promotion of medicines: current challenges 3.Some countries practices…

18. 18 WHO ethical criteria (1988) still relevant today, more than ever n Objective to promote "proper behaviour" n Reliable, accurate, truthful, informative, balanced, up-to date, and in good taste n NOT misleading or unverifiable or omissions n Scientific data available in public domain n No financial/material benefit offered to health professional n Scientific and educational activities not used for promotional purposes

19. 19 WHO ethical criteria cover wide arrange of promotional activities n Advertising: ä Professionals: min. summary scientific information ä Consumers: help make rational decisions, no DTCA n Medical representatives ä Technical knowledge and ethical conduct ä Complete/unbiased information and no offer of inducement n Samples ä Modest quantities for prescription drugs ä Difficult to justify for non-prescription drugs n Symposia and scientific meetings ä Objective scientific content & independent scientists ä Sponsorship clearly stated, gifts secondary to main purpose n Post-marketing scientific studies ä Inform health authorities and validated relevant committees ä "… not be misused as a disguised form of promotion."

20. 20 Overview 2.WHO ethical criteria for drug promotion 1.Promotion of medicines: current challenges 3.Some countries practices…

21. 21 Examples of country practices include regulation, policy and training interventions n Increase awareness of physicians (e.g. "no free lunch") n Independent drug information centres (professionals and consumers) n Code of conduct (professional associations, pharmaceutical industry) n Publicly funded continuing education of staff n Training of medical students to critically assess pharmaceutical promotion ä successful experience in Indonesia with long-term impact (1) n Others… (1) Drug advertisements: a critical lesson for Indonesian students, WHO, Essential Drugs Monitor, 1997, Issue n° 23

22. 22 Questions for discussion in your countries: n What are drug promotion data in your countries? n Amount spent on drug promotion (vs. independent information)? n How many violations have been found in the last few years? Any sanctions? n Are students trained to analyse pharmaceutical promotion? n Are there codes of conduct for health professionals and/or industry? n Etc.

23. 23 For more information visit: http://www.drugpromo.info/ http://www.drugpromo.info/