SA Marketing Code of Practice

Steve Speller

What are health products?

Substances that have the potential to:-

do good

do harm

Code of Marketing Practice

Why is it needed in South Africa ?

To Protect Consumers

Code of Marketing Practice The complexity of three types of consumers

People Animals

Healthcare Professionals

Direct

IndirectIndirect

Direct

As suppliers of health care products what do we try to do to customers ?

Inform Them?

Influence Them?

What is our intent?

Off label promotion

...

Selective use of clinical trial information...

Incentive schemes

Hospitality practices....

Pharma industry in the newsPolish Newsweek:

Pharmaceutical corporations spend millions of dollars on presents for the doctors who prescribe their patented medicines. When buying medicines, we have to pay not only for our health, but also for costly gifts.

Milan (Reuters):Italian police are investigating a unit of a pharma company for allegedly offering illegal incentives to doctors and medical staff to prescribe its drugs

British Medical Journal May: Who pays for the pizza? Re-defining the relationships between doctors and drug companies.

Obligations for all.....A Code of Practice for the marketing of

healthcare products is required to provide a basis for the ethical marketing of health products

Requirement for reliable scientific information to be available to health care practitioners and patients/consumers

To enhance the rationale use of health products and fair competition in their marketing

Preserve the independence of the decisions taken by healthcare professionals

Code of Marketing Practice

Fundamental Principle

self regulation

A long journey

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

March 12 constitution signed

AGM

Scope of the Code

The Code is a collaborative effort by various sub-sectors in the marketing of health productsBuilds on the experiences and principles endorsed by these

sub-sectorsCode has been established after many years of

consultation: at first, only ethical products were regulated by the Code but now, many categories of products includedInnovative medicinesGenericsVeterinary medicinesOTC productsMedical devicesLaboratory diagnostics

Current Trade Associations subscribing to the Code

PIASA: Pharmaceutical Industry Association of South AfricaNAPM: National Association of Pharmaceutical manufacturersIMSA: Innovative Medicines South AfricaSMASA: Self-Medication Manufacturers Association of South AfricaPHARMISA: Pharmaceuticals made in South AfricaSAAHA: South African Animal Health AssociationSAMED: South African Medical Device Industry AssociationSALDA: South African Laboratory Diagnostics Association

Support for the initiative and enforcement:

Pharmaceutical Wholesalers and DistributersPharmaceutical Society of Southern Africa

Who is the Code Applicable to?licence holders, their agents, contractors, third party

distributors /marketers and/or contracted events organisersany member of medical, dental, pharmacy, nursing or allied

health professionsany seller of health products who may prescribe, purchase,

supply, administer, loan or lease a health product or recommend the use thereof

is not applicable to wholesalers, distributors (excluding distributors of medical devices) and logistics companies except to the extent that they may influence the demand for health products

Note: Logistics service providers forum and PSSA has

endorsed the Code 14

What the Code does not cover?

18A: “bonus system, rebate system or any other incentives scheme”

18B: Sampling22G: Pricing, dispensing fees,

logistics fee

Proposal to DoH: Gaps on legislation

15SA Marketing Code (27-09-2011)

Scope of the Code

•Marketing & promotion of medicines to healthcare professionals

Part A

•Marketing & promotion of medicines to consumersPart B

•DevicesPart C

•EnforcementPart D

- Replace ASA appendix A & H

- Guidelines

Part A:

ACTIVITIES TO HCP’S: APPLICABLE TO ALL HEALTH PRODUCTS

17SA Marketing Code (27-09-2011)

Healthcare Sales Reps(C15)TrainingInterviews / access to HCP:

No inducementsNo fees paidNo donations to charities or in lieu of hospitalityMislead as to company identityNo inconvenienceReport AE

PI provided for new products and then afterwards should be available on request

18

Interactions with HCP (C17)Hospitality, venue of meeting

Scientific and educational Hospitality secondary to meeting Appropriate venue* Modest – not more the HCP would pay for themself No spouse or other guest Reasonable honorarium for speaker Local CPD – reasonable travel to HCP outside major cities Overseas congress / speakers

Business class travel only for incoming and outgoing faculty members (i.e. HCPs presenting at congress, educational events or local CPD accredited events).

Selection of attendees should be transparent and open to scrutiny Payment to congress or organisers not HCP unless proof of payment No recreational or sporting activities allowed

19

Interactions with HCP (C17)Other matters:

No standalone social or sporting eventsConsultancy services

Genuine service Declaration by HCP Written agreements Honararium – fair market value and relate to activity performed

Can’t pay for room rentals

Inducements(*)C18No gifts, rebates to HCP to induce use of productsGifts / promotional items

Inexpensive and value of R 300 (medical devices cap of R 2500 / practise or institution) Educational and scientific benefit patient / practice No cash or equivalent No personal use Scientific medical reference books, journals, anatomical models :

For individual practising HCP or practises, < R 2 500 incl of VAT/year For training or academic institutions, < R 10 000 incl of VAT/year

The value of medical devices should not exceed R300 inclusive of VAT / per item with a cap of R 2500 / practise or institution

Promo items can be branded with company or product logoCultural gifts – not allowed by SAMED / SALDA

(*) Subject to company / corporate policies

21

Other activities (C18)Competition (C18.5)

Based on medical / product knowledge Prize relevant to practice The maximum is R 2 000 If prize is congress sponsorship – cover conference fees,

accommodation and travel for the winner only.Donations / grants to HCP (C18.6)

Supporting healthcare or research Documented Not inducement Not paid to HCP

Corporate Social Responsibility (C18.7) Support a charitable organizations charitable contributions are not for marketing Not an incentive to prescribe any health product

22

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MCA StructureMCA

Executive Officer

Adjudicating Panel

Adjudicating Committee

Appeal Panel

Appeal Committee

Legal Panel Appointed by

BoardAppointed by EO

for specific

complaint

Code Technical Advisory Committee

Overall: Key MCA objectives Awareness of the Code:

General roles and responsibilities of the MCAIndustry healthcare groupsGovernment: health and CPAASAHCPsAllied medical professionalsPatientsConsumers

Training of all Industry stakeholders on the content of the Code Internal and external providers: must get our certification Paper based E based Getting certification

Implementation of the Code: Self regulation Legislated environment

Enforcement and sanctions

25

Complaint Process

Company to Company

MCA

Sanction

DoH

No resolution No resolution

Breach of Act 101,

legal mechanisms

Is it having an impact?Yes BUT early days

Still lots to do re appointment of Executive Officer finalisation of training and certification process regulations influence healthcare professionals

Still required....

The Medicines and Related Substances Control Act 101, 1965 will be the vehicle for the Code enforcement

Via Regulation 18 C of Act 101, 1965Desire of the Associations to have the Code

enforced by lawWorking with the DoH to seek approval of

proposed wording for the update of the Regulations

ConclusionsYears of dedication of the Marketing Code Steering

Committee to develop a new CodeMarketing Code Authority is now established Procedures are defined to formalise the AuthorityWith new Associations being added to the existing

groups, the Constitution will be signed by all Associations

Essential to have fair and balanced promotion of medicines for both Healthcare professionals and patients

Essential to retain the self regulatory status of the Code in line with other highly functional international Codes

Annual General Meeting12th September

9am – 11.45am

Cedar Park Hotel 120 Western Service Road Woodmead

Guest Speaker – Dr Anban Pillay