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.

SA Code of Practice for the Marketing of Health Products

Marketing Ethics and what does this mean for an HCP?

Dr Haseena GaniExecutive OfficerSept 2013

Dr H Gani, Exec Officer, Sept 2013

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Pharmaceutical Advertising Down But Definitely Not Out


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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


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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


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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


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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.


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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


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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


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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


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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


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Principles of the Code

Ethical marketing and promotion of

health products

Industry

image

Legal, regulatory

& professiona

l requiremen

ts

Independence of HCPs

Access to

products & info

Fair Competiti

on

Accurate informatio

n


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Scope of the Code

Marketing Code• Innovative medicines

• Generic Medicines• Rx and OTC• Veterinary• Devices• In vitro diagnostics

Complementar

y medicines


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Code Journey


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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

Mar 2012 - Constitution


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Recap - Legal context of the Code

Act 101 of 1965

Section 22G

Section 18C

Section 18B

Section 18A

Legal gaps identifiedCode will not resolve or eliminate issues around perversities in

the market

Makes provision for a Marketing

Code


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Code and guidelines

• Marketing & promotion of health products to healthcare professionals

Part A

• Marketing & promotion of health products to consumersPart B

• Medical Devices & DiagnosticsPart C

• Code EnforcementPart D

Guidelines


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health products

Industry

image

Legal, regulatory

& professiona

l requiremen

ts


Access to

products & info

Fair Competiti

on

Accurate informatio

n


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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)


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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).

Prescribing under the influence?


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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.


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At a time when many doctors are barring access to pharma reps, an August TNS Healthcare survey of 286 physicians: 40% ofÂ 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

HC Representatives do influence physician behaviour & add value


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Interactions with HCPsCompliance – whose responsibility is it?


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Compliance – whose responsibility?


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Compliance – whose responsibility?


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What does the Code of Practice state on interactions with HCPs?


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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)


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CPD 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 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


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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


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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)


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Consultancy Genuine consultancy underpinned by a

formal agreement

Declaration by the HCP

No direct payments to healthcare professionals for any other services


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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


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Other Competitions & prizes Donations to charity Corporate social responsibility


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health products

Industry

image

Legal, regulatory

& professiona

l requiremen

ts


Access to

products & info

Fair Competiti

on

Accurate informatio

n


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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


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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


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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


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Majority of complaints are from HCPs… PMCPA (UK)


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Code Enforcement


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Principles

Transparency Fairness Defined timelines Opportunity for recourse


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Enforcement Structure

MCA

Adjudicating Panel

Adjudicating

Committee

Appeal Panel

Appeal Committee

Legal Panel

Executive Officer

Appointed by

Board

Appointed by EO

for specific

complaint

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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


PANELS


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Process flow for complaints

Company to company

Refer to MCA

Adjudication panel

Refer to MCA

Appeals panel

Final Sanction

no resolution no resolution

Legal Panel HCP/ Public lodge a complaint


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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


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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.


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Four Key Actions

Complaints Process2nd May

New edition of the Code

& GuidelinesMid - July

WebsiteQ3

CertificationEnd Q3


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Thank you kindly...Any Questions

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.

Documents

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