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SA Code of Practice for the Marketing of Health ProductsMarketing Ethics and what does this mean for an HCP?

Dr Haseena GaniExecutive OfficerSept 2013Health products: medicines (as per MCC), medical devices and in-vitro laboratory diagnostics1Pharmaceutical Advertising Down But Definitely Not Out

Dr H Gani, Exec Officer, Sept 20132

AgendaEthical 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 201333Marketing EthicsEthics refers to the study of moral principles, or right and wrongMarketing 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 privacyDr H Gani, Exec Officer, Sept 20134Special ethics risks in marketing health productsVulnerability of the target market safeguard the interests esp elderly & youngKnowledge gap between marketer & client technical informationAbility to manipulate informationWhat is saidWhat is not said

Dr H Gani, Exec Officer, Sept 20135Why 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 20136Business Actions Toward Socially Responsible MarketingCorporate marketing ethics policiesDistributor relations, advertising standards, customer service, pricing, product development and general ethical standards.Guiding principle in policy determination Free market and legal systemInternational ethical policies and Codes of PracticeGoal 4: Learn the role of ethics in marketingDr H Gani, Exec Officer, Sept 20137Healthcare 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 environmentThe Marketing Code of Practice exists to help ensure that pharmaceutical companies operate in a responsible, ethical and professional manner when promoting medicines

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Dr H Gani, Exec Officer, Sept 20139It is important for the industry to make a success of the implementation and enforcement of the code in order to ensure that we are respected by stakeholders and can retain the privilege of self-regulation.9What is the MCA?Marketing Code AuthorityIndependent self regulatory enforcement organisation for the CodeSet up as legal entity (juristic body)Members of the MCA are the companies, not the trade associationsTrade associations are key stakeholders

Dr H Gani, Exec Officer, Sept 201310Ethics underpins the CodeAll that you do is values-basedImpacts on stakeholder interestsTherefore you have ethical responsibilitiesAs individualsAs communities / fraternitiesAs organisationsIn respect of ALL business activities including the marketing of health productsCode = expression of the underlying values & collective ethical responsibilities

Dr H Gani, Exec Officer, Sept 201311Principles of the CodeDr H Gani, Exec Officer, Sept 201312Scope of the CodeDr H Gani, Exec Officer, Sept 201313Complementary medicinesCode JourneyDr H Gani, Exec Officer, Sept 201314

A world first...Dr H Gani, Exec Officer, Sept 201315Mar 2012 - ConstitutionWhat do we have to date:A code that has been agreed by all associations mentioned in the following slideAn MoU signed by all the industry associations representing manufacturers with support from wholesalers and the pharmaceutical societyThe MoU relates to the:Forming of a self-regulatory marketing code authority funded by the industryThe appointment of an executive office to manage the authority. Interviews are currently taking placeThe commencement of a 6-12 month roll-out period. The first four months will be focussed on training and capacity building of company staffThe next two months will see a commencement of a trial period of self-regulation, which will continue until the MCA is formalised.The code will not be enforced i.e. no sanctions until such time as the MCA is formalised and members have signed the Constitution unless legislation intervenes. This must happen no later than 12 months from the signing of the MoU.

A guideline on implementation of the code has also been provisionally agreed by the Interim Board. These will be finally agreed and published by the Authority and the Board.

There is a also a guideline on sanctions.

What have we not have at this stage:

It is the desire of the associations to have the code enforced by law. The Medicines and Related Substances Act is the vehicle that should give effect to this Regulation 18C. We have the tacit agreement of the Department of Health that they support this vision. We will work with the Department of Health to make it happen.

15Recap - Legal context of the CodeDr H Gani, Exec Officer, Sept 201316Legal gaps identifiedCode will not resolve or eliminate issues around perversities in the marketMakes provision for a Marketing CodeCode and guidelinesDr H Gani, Exec Officer, Sept 201317GuidelinesThe Code is a collaborative effort and builds on the experiences and principles endorsed by the various sub-sectors in the marketing of health products.It is believed to be a world first to have generics and innovative medicines combining with veterinary, OTC medicines, medical devices and laboratory diagnostics.17Principles of the CodeDr H Gani, Exec Officer, Sept 201318The Healthcare Representative roleA 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 201319Not 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 881-884Scientific versus commercial sources of influence on the prescribing behavior of physicians American Journal of Medicine, The Vol. 73, Issue 1, Pages 4-8Changes 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 201320Prescribing under the influence?HC Representatives do influence physician behaviour

Sndergaard et al.: assess the impact of pharmaceutical representatives on prescribing behaviour for a new fixed dose combination inhaled corticosteroid and long-acting 2-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 201321At 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 interactionsImprovement was seen in web-based physician education and outreach60% of physicians surveyed said that pharma-sponsored physician education was useful to themOnly 30% found corporate reputation to be critical, although those who found it important said it was one of the most important factorsDr H Gani, Exec Officer, Sept 201322HC Representatives do influence physician behaviour & add value

Interactions with HCPsCompliance whose responsibility is it?

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Compliance whose responsibility?24

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

Dr H Gani, Exec Officer, Sept 2013What does the Code of Practice state on interactions with HCPs?Dr H Gani, Exec Officer, Sept 201326Healthcare representatives what to doTraining of Healthcare Sales Representatives is the companys 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 201327CPD meetings Companies, organisations or individuals are permitted to organise or sponsor meetings and events including Continuing Professional Development (CPD).

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CPD meetings points to considerHospitality/Venues of meetings and events (clause 17)The merit and focus of the meeting should be clearly scientific and/or educational. No standalone entertainmentThe venue and hospitality should be secondary to the meeting both in time allocation and focusThe venue should be appropriate and conducive to the scientific or educational objectives Hospitality, meals and entertainment should be modestInvitationsHonorariaProduct promotion and using INN name of the productReimbursement of acceptable costs eg travelTransparency and sponsorship declaration

Dr H Gani, Exec Officer, Sept 201329Advertising & promotional materialPost-registration by the MCC

All advertising and/or promotional material must be based on the current approved South African package insert Information, claims and comparisonsAccuracy, balance, fairness of claims. Exaggerated or misleading claims References & data on fileDisparaging references safety, quality and efficacyHigh standards suitability and tasteDisguised promotion

Dr H Gani, Exec Officer, Sept 201330Endorsements and testimonials by an HCPThe 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 201331Consultancy 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 201332GiftsInexpensive and of minimal intrinsic value i.e. within the cost limit set from time to time per annum by the MCANot for personal use e.g. no entertainment CDs/DVDs, 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 201333Other Competitions & prizesDonations to charityCorporate social responsibility

Dr H Gani, Exec Officer, Sept 201334Principles of the CodeDr H Gani, Exec Officer, Sept 201335Declaration of HCP independenceUnique 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 approachMoral compass

Dr H Gani, Exec Officer, Sept 201336Sources to sharpen HCPs skillsOnline resources, certification by professional bodies ConferencesAcademic meetingsRepresentative academic detailing vs salesMedical Science LiaisonsAwareness of the Code, company policies, international codes & regulations Professional Bodies Code of Conduct

Dr H Gani, Exec Officer, Sept 201337We need your help - teamworkOur 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 201338Majority of complaints are from HCPs PMCPA (UK)Dr H Gani, Exec Officer, Sept 201339

Code EnforcementDr H Gani, Exec Officer, Sept 201340

PrinciplesTransparencyFairnessDefined timelinesOpportunity for recourse

41Dr H Gani, Exec Officer, Sept 2013Enforcement Structure42Appointed by BoardAppointed by EO for specific complaintDr H Gani, Exec Officer, Sept 2013PanelsPROCESSAdjudication and Appeals = 34Legal=8 Expertise in marketing, medical & regulatory affairsGood representation from the different sectors & independentsBriefing sessionsIndemnitySLA Formal relationshipNDA/conflict of interest prior to each matter43Dr H Gani, Exec Officer, Sept 2013PANELSProcess flow for complaintsDr H Gani, Exec Officer, Sept 201344no resolutionno resolutionLegal Panel

HCP/ Public lodge a complaintSanctionsDr H Gani, Exec Officer, Sept 201345Can HCPs be held to account for not acting ethically?

The Code only covers the industrys 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 201346Four Key ActionsDr H Gani, Exec Officer, Sept 201347Dr H Gani, Exec Officer, Sept 201348

Thank you kindly...Any QuestionsDr H Gani, Exec Officer, Sept 201349