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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 ?

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Presentation Transcript
what are health products
What are health products?

Substances that have the potential to:-

do good

do harm

code of marketing practice
Code of Marketing Practice

Why is it needed in South Africa?

To Protect Consumers

code of marketing practice1
Code of Marketing Practice

The complexity of three types of consumers

People

Animals

Healthcare Professionals

Direct

Indirect

Indirect

Direct

slide7

Off label promotion ...

Incentive schemes

Selective use of clinical trial information...

Hospitality practices....

pharma industry in the news
Pharma industry in the news
  • Polish 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
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
a long journey
A long journey

AGM

March 12 constitution signed

scope of the code
Scope of the Code
  • The Code is a collaborative effort by various sub-sectors in the marketing of health products
    • Builds on the experiences and principles endorsed by these sub-sectors
  • Code has been established after many years of consultation: at first, only ethical products were regulated by the Code but now, many categories of products included
    • Innovative medicines
    • Generics
    • Veterinary medicines
    • OTC products
    • Medical devices
    • Laboratory diagnostics
current trade associations subscribing to the code
Current Trade Associations subscribing to the Code
  • PIASA: Pharmaceutical Industry Association of South Africa
  • NAPM: National Association of Pharmaceutical manufacturers
  • IMSA: Innovative Medicines South Africa
  • SMASA: Self-Medication Manufacturers Association of South Africa
  • PHARMISA: Pharmaceuticals made in South Africa
  • SAAHA: South African Animal Health Association
  • SAMED: South African Medical Device Industry Association
  • SALDA: South African Laboratory Diagnostics Association

Support for the initiative and enforcement:

  • Pharmaceutical Wholesalers and Distributers
  • Pharmaceutical Society of Southern Africa
who is the code applicable to
Who is the Code Applicable to?
  • licence holders, their agents, contractors, third party distributors /marketers and/or contracted events organisers
  • any member of medical, dental, pharmacy, nursing or allied health professions
  • any 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

what the code does not cover
What the Code does not cover?
  • 18A: “bonus system, rebate system or any other incentives scheme”
  • 18B: Sampling
  • 22G: Pricing, dispensing fees, logistics fee

Proposal to DoH: Gaps on legislation

SA Marketing Code (27-09-2011)

scope of the code1
Scope of the Code

- Replace ASA appendix A & H

- Guidelines

part a
Part A:

ACTIVITIES TO HCP’S:

APPLICABLE TO ALL HEALTH PRODUCTS

SA Marketing Code (27-09-2011)

healthcare sales reps c15
Healthcare Sales Reps(C15)
  • Training
  • Interviews / access to HCP:
    • No inducements
    • No fees paid
    • No donations to charities or in lieu of hospitality
    • Mislead as to company identity
    • No inconvenience
    • Report AE
  • PI provided for new products and then afterwards should be available on request
interactions with hcp c17
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
interactions with hcp c171
Interactions with HCP (C17)

Other matters:

  • No standalone social or sporting events
  • Consultancy services
    • Genuine service
    • Declaration by HCP
    • Written agreements
    • Honararium – fair market value and relate to activity performed
  • Can’t pay for room rentals
inducements c18
Inducements(*)C18
  • No gifts, rebates to HCP to induce use of products
  • Gifts / 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 logo
  • Cultural gifts – not allowed by SAMED / SALDA

(*) Subjectto company / corporate policies

other activities c18
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
mca structure
MCA Structure

Code Technical Advisory Committee

Appointed by Board

Appointed by EO for specific complaint

overall key mca objectives
Overall: Key MCA objectives
  • Awareness of the Code:
    • General roles and responsibilities of the MCA

Industry healthcare groups

Government: health and CPA

ASA

HCPs

Allied medical professionals

Patients

Consumers

  • 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
complaint process
Complaint Process

No resolution

No resolution

Breach of Act 101, legal mechanisms

is it having an impact
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
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, 1965
    • Desire of the Associations to have the Code enforced by law
  • Working with the DoH to seek approval of proposed wording for the update of the Regulations
conclusions
Conclusions
  • Years of dedication of the Marketing Code Steering Committee to develop a new Code
  • Marketing Code Authority is now established
  • Procedures are defined to formalise the Authority
  • With 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 meeting
Annual General Meeting
  • 12th September
  • 9am – 11.45am
  • Cedar Park Hotel

120 Western Service Road Woodmead

  • Guest Speaker – Dr AnbanPillay