SA Code of Practice for the Marketing of Health Products

1. SA Code of Practice for the Marketing of Health Products Marketing Ethics and what does this mean for an HCP? Dr Haseena Gani Executive Officer Sept 2013

2. Pharmaceutical Advertising Down But Definitely Not Out Dr H Gani, Exec Officer, Sept 2013

3. Agenda • Ethical Marketing & the Marketing Code of Practice? • Prescribing under the influence • Compliance – whose responsibility? • What is ‘kosher’ in the Representative – HCP relationship? • HCPs independence • Enforcement structure & how can an HCP lodge a complaint? • The future Dr H Gani, Exec Officer, Sept 2013

4. Marketing Ethics • Ethics refers to the study of moral principles, or “right and wrong” • Marketing Ethics is all about marketers doing the “right thing”. Exactly what the right thing is, is not always completely clear-cut • Principles involved in ethical marketing : • Responsibilityfor their products and their decisions. • Honest and fair in their dealings with all stakeholders. This means that products must be fit for use and accurately described, and contracts (both formal and implicit) should be drawn up in good faith and honoured; • Respecting consumer (patient) rights -including the right of redress, the right to information and the right to privacy Dr H Gani, Exec Officer, Sept 2013

5. Special ethics risks in marketing health products • Vulnerability of the target market – safeguard the interests esp elderly & young • Knowledge gap between marketer & client – technical information • Ability to manipulate information • What is said • What is not said Dr H Gani, Exec Officer, Sept 2013

6. Why does the healthcare industry need to promote medicines to HCPs? • The industry has a legitimate right to promote medicines to health professionals to ensure that they are up-to-date on the latest treatments available for patients. The availability of accurate, up-to-date information is vital to the appropriate use of medicines. • There must be a balance between the needs of patients, health professionals and the public, bearing in mind the political and social environment within which the industry operates and the statutory controls governing medicines. Dr H Gani, Exec Officer, Sept 2013

7. Business Actions Toward Socially Responsible Marketing • Corporate marketing ethics policies • Distributor relations, advertising standards, customer service, pricing, product development and general ethical standards. • Guiding principle in policy determination • Free market and legal system • International ethical policies and Codes of Practice Dr H Gani, Exec Officer, Sept 2013 Goal 4: Learn the role of ethics in marketing

8. Healthcare industry actions towards Ethical Marketing? • In practice many companies and organisations have attempted to deal with issues of marketing ethics by developing codes of conducts. • Legislative gaps globally to regulate this environment • The Marketing Code of Practice exists to help ensure that pharmaceutical companies operate in a responsible, ethical and professional manner when promoting medicines Dr H Gani, Exec Officer, Sept 2013

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10. What is the MCA? • Marketing Code Authority • Independent self regulatory enforcement organisation for the Code • Set up as legal entity (‘juristic body’) • Members of the MCA are the companies, not the trade associations • Trade associations are key stakeholders Dr H Gani, Exec Officer, Sept 2013

11. Ethics underpins the Code • All that you do is values-based • Impacts on stakeholder interests • Therefore you have ethical responsibilities • As individuals • As communities / fraternities • As organisations • In respect of ALL business activities including the marketing of health products • Code = expression of the underlying values & collective ethical responsibilities Dr H Gani, Exec Officer, Sept 2013

12. Principles of the Code Dr H Gani, Exec Officer, Sept 2013

13. Scope of the Code Complementary medicines Dr H Gani, Exec Officer, Sept 2013

14. Code Journey Dr H Gani, Exec Officer, Sept 2013

15. A world first... Mar 2012 - Constitution Dr H Gani, Exec Officer, Sept 2013

16. Recap - Legal context of the Code Makes provision for a Marketing Code Legal gaps identified Code will not resolve or eliminate issues around perversities in the market Dr H Gani, Exec Officer, Sept 2013

17. Code and guidelines • Guidelines Dr H Gani, Exec Officer, Sept 2013

18. Principles of the Code Dr H Gani, Exec Officer, Sept 2013

19. The Healthcare Representative role • A pharmaceutical sales representative is a key factor within the sales of all drugs. • They are responsible to ensure the healthcare profession is informed of the benefits of the drug along with the safety and the side effects to assist a healthcare profession as the correct information and choices to prescribe medication. • The term used is ethical promotion, which can be described as communication of ethical values to promote their product to the physician. (Wright & Lundstrom, 2004) Dr H Gani, Exec Officer, Sept 2013

20. Prescribing under the influence? • Not a truth universally acknowledged • Wealth of anecdotal evidence - paucity of studies • Do drug samples influence resident prescribing behavior? A randomized trial American Journal of Medicine, The Vol. 118, Issue 8, Pages 881-884 • Scientific versus commercial sources of influence on the prescribing behavior of physicians American Journal of Medicine, The Vol. 73, Issue 1, Pages 4-8 • Changes in drug prescribing patterns related to commercial company funding of continuing medical education. Journal of Continuing Education Health Professions, 8(1), 13-20. Bowman, M. A., & Pearle, D. L. (1988). Dr H Gani, Exec Officer, Sept 2013

21. HC Representatives do influence physician behaviour • Søndergaardet al.: assess the impact of pharmaceutical representatives on prescribing behaviour for a new fixed dose combination inhaled corticosteroid and long-acting β2-agonist (LABA) in Denmark. • Greater increase in the market share of the promoted fixed dose combination in those practices that received a visit in comparison to those that did not receive a visit. • It did not show an increase in the proportion of patients with asthma receiving inhaled steroids. • Principally about increasing market share. • And not about increases in disease awareness and appropriate prescribing; in this case, the supposition is that increased steroid prescriptions would represent such an effect. Dr H Gani, Exec Officer, Sept 2013

22. HC Representatives do influence physician behaviour & add value At a time when many doctors are barring access to pharma reps, an August TNS Healthcare survey of 286 physicians: • 40% of doctors surveyed see an improvement in pharma sales interactions • Improvement was seen in web-based physician education and outreach • 60% of physicians surveyed said that pharma-sponsored physician education was useful to them • Only 30% found corporate reputation to be critical, although those who found it important said it was one of the most important factors Dr H Gani, Exec Officer, Sept 2013

23. Interactions with HCPs Compliance – whose responsibility is it? Dr H Gani, Exec Officer, Sept 2013

24. Compliance – whose responsibility? Dr H Gani, Exec Officer, Sept 2013

25. Compliance – whose responsibility? Dr H Gani, Exec Officer, Sept 2013

26. What does the Code of Practice state on interactions with HCPs? Dr H Gani, Exec Officer, Sept 2013

27. Healthcare representatives – what to do • Training of Healthcare Sales Representatives is the company’s responsibility • Compliance with codes and laws by Healthcare Sales Representatives • Gaining interviews : No inducement or subterfuge to gain an interview. Sales Representatives must not mislead as to their identity or the company that they represent. • Consideration for healthcare professionals and others • Information to scientific service of company (Adverse events) Dr H Gani, Exec Officer, Sept 2013

28. CPD meetings • Companies, organisations or individuals are permitted to organise or sponsor meetings and events including Continuing Professional Development (CPD). Dr H Gani, Exec Officer, Sept 2013

29. CPD meetings – points to consider • Hospitality/Venues of meetings and events (clause 17) • The merit and focus of the meeting should be clearly scientific and/or educational. No standalone entertainment • The venue and hospitality should be secondary to the meeting both in time allocation and focus • The venue should be appropriate and conducive to the scientific or educational objectives • Hospitality, meals and entertainment should be modest • Invitations • Honoraria • Product promotion and using INN name of the product • Reimbursement of acceptable costs eg travel • Transparency and sponsorship declaration Dr H Gani, Exec Officer, Sept 2013

30. Advertising & promotional material • Post-registration by the MCC • All advertising and/or promotional material must be based on the current approved South African package insert • Information, claims and comparisons • Accuracy, balance, fairness of claims. • Exaggerated or misleading claims • References & “data on file” • Disparaging references – safety, quality and efficacy • High standards – suitability and taste • Disguised promotion Dr H Gani, Exec Officer, Sept 2013

31. Endorsements and testimonials by an HCP • The name or photograph or film of a member of a health profession must not be used in any way that is contrary to the applicable professional codes for that profession and all endorsements, where permitted by professional codes, have to be done within the scope of such codes • Testimonials shall comply with the approved package insert and with the other principles of this Code. • Testimonials should be less than three years old and be the genuine views of the user • Active ingredient not trade name has been prescribed (evidence to substantiate) Dr H Gani, Exec Officer, Sept 2013

32. Consultancy • Genuine consultancy underpinned by a formal agreement • Declaration by the HCP • No direct payments to healthcare professionals for any other services Dr H Gani, Exec Officer, Sept 2013

33. Gifts • Inexpensive and of minimal intrinsic value i.e. within the cost limit set from time to time per annum by the MCA • Not for personal use e.g. no entertainment CD’s/DVD’s, electronic items for entertainment, tickets to attend sporting events or other forms of entertainment. • Educationaland/or of scientific value, benefit the patient and/or be relevant to the practice. • No cash or cash equivalents is allowed. • Cultural courtesy gifts Dr H Gani, Exec Officer, Sept 2013

34. Other • Competitions & prizes • Donations to charity • Corporate social responsibility Dr H Gani, Exec Officer, Sept 2013

35. Principles of the Code Dr H Gani, Exec Officer, Sept 2013

36. Declaration of HCP independence • Unique role = able to bring the value of the big hospital, the big pharmaceutical company, the big imaging device maker, and the big insurer all together at a single point for a particular person, the patient.  • Rational and appropriate prescription – best interest of the patient • Critical thinking to analyse the source and content of information • Patient-centric approach • Moral compass Dr H Gani, Exec Officer, Sept 2013

37. Sources to sharpen HCPs skills • Online resources, certification by professional bodies • Conferences • Academic meetings • Representative academic detailing vs sales • Medical Science Liaisons • Awareness of the Code, company policies, international codes & regulations • Professional Bodies’ Code of Conduct Dr H Gani, Exec Officer, Sept 2013

38. We need your help - teamwork • Our commitment to you = All companies that comply with the Code are required to conduct themselves with honesty and integrity in all their dealings with you and to respect the spirit, as well as the letter, of the Code. • Your assistance in leveling the playing fields & achieving compliance Dr H Gani, Exec Officer, Sept 2013

39. Majority of complaints are from HCPs… PMCPA (UK) Dr H Gani, Exec Officer, Sept 2013

40. Code Enforcement Dr H Gani, Exec Officer, Sept 2013

41. Principles • Transparency • Fairness • Defined timelines • Opportunity for recourse Dr H Gani, Exec Officer, Sept 2013

42. Enforcement Structure Appointed by Board Appointed by EO for specific complaint Dr H Gani, Exec Officer, Sept 2013

43. PROCESS Panels PANELS Adjudication and Appeals = 34 Legal=8 Expertise in marketing, medical & regulatory affairs Good representation from the different sectors & independents Briefing sessions Indemnity SLA – Formal relationship NDA/conflict of interest prior to each matter Dr H Gani, Exec Officer, Sept 2013

44. Process flow for complaints no resolution no resolution HCP/ Public lodge a complaint Legal Panel Dr H Gani, Exec Officer, Sept 2013

45. Sanctions Dr H Gani, Exec Officer, Sept 2013

46. Can HCPs be held to account for not acting ethically? The Code only covers the industry’s activities. However, those interacting with industry as individuals or organisations also have a responsibility to ensure that their interactions comply with relevant legal & professional requirements. Dr H Gani, Exec Officer, Sept 2013

47. Four Key Actions    Dr H Gani, Exec Officer, Sept 2013

48. Dr H Gani, Exec Officer, Sept 2013

49. Thank you kindly... Any Questions Dr H Gani, Exec Officer, Sept 2013