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 2

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 3

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 :  Responsibility for 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 4

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 5

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 6

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 Goal 4: Learn the role of ethics in marketing Dr H Gani, Exec Officer, Sept 2013 7

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 8

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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 10

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 11

12. Principles of the Code Dr H Gani, Exec Officer, Sept 2013 12 Ethical marketing and promotion of health products Industry image Legal, regulatory & professional requirements Independence of HCPs Access to products & info Fair Competition Accurate information

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

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

15. A world first... July 2007 – Marketing Steering Committee 2009 – SAMED & SALDA join Feb 2010 – Interim Board of the MCA Oct 2010 – Agreed version of the Code May 2011 – Agreed MoU Dr H Gani, Exec Officer, Sept 2013 15 Mar 2012 - Constitution

16. Recap - Legal context of the Code Act 101 of 1965 Section 22G Section 18C Section 18B Section 18A Dr H Gani, Exec Officer, Sept 2013 16 Legal gaps identified Code will not resolve or eliminate issues around perversities in the market Makes provision for a Marketing Code

17. Code and guidelines Marketing & promotion of health products to healthcare professionals Part A Marketing & promotion of health products to consumers Part B Medical Devices & Diagnostics Part C Code Enforcement Part D Dr H Gani, Exec Officer, Sept 2013 17 Guidelines

18. Principles of the Code Dr H Gani, Exec Officer, Sept 2013 18 Ethical marketing and promotion of health products Industry image Legal, regulatory & professional requirements Independence of HCPs Access to products & info Fair Competition Accurate information

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 19

20.  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 20 Prescribing under the influence?

21. HC Representatives do influence physician behaviour  Søndergaard et 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 21

22. 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 22 HC Representatives do influence physician behaviour & add value

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

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

25. Compliance – whose responsibility? 25 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 26

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 27

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 28

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 29

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 30

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 31

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 32

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.  Educational and/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 33

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

35. Principles of the Code Dr H Gani, Exec Officer, Sept 2013 35 Ethical marketing and promotion of health products Industry image Legal, regulatory & professional requirements Independence of HCPs Access to products & info Fair Competition Accurate information

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 36

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 37

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 38

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

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

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

42. Enforcement Structure MCA Adjudicating Panel Adjudicating Committee Appeal Panel Appeal Committee Legal Panel Executive Officer 42 Appointed by Board Appointed by EO for specific complaint Dr H Gani, Exec Officer, Sept 2013

43. Panels PROCESS  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 43 Dr H Gani, Exec Officer, Sept 2013 PANELS

44. Process flow for complaints Company to company Refer to MCA Adjudication panel Refer to MCA Appeals panel Final Sanction Dr H Gani, Exec Officer, Sept 2013 44 no resolution Legal Panel HCP/ Public lodge a complaint

45. Sanctions Minor Moderate Serious Severe Fines not paid Corrective Action not implemented Repeated Breaches Multiple breaches Invalid / unjustified / vexatious complaints Bringing the Code into disrepute Breaches Immediate withdrawal of material/activity Written reprimand Publication of corrective advertisement, Issue a corrective letter to healthcare professionals/public Corrective Action R 6 - R300K 30 -60 days Fines / Timelines Dr H Gani, Exec Officer, Sept 2013 45

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 46

47. Four Key Actions Complaints Process 2 nd May New edition of the Code & Guidelines Mid - July Website Q3 Certification End Q3 Dr H Gani, Exec Officer, Sept 2013 47

48. Dr H Gani, Exec Officer, Sept 2013 48

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