Ethical Marketing Practices in the Healthcare Industry

 
Steve Speller
 
 
 
          
Substances that have the potential to:-
 
                                   do good
 
                                   do harm
 
 
        
Why is it needed in South Africa ?
 
                  To Protect Consumers
 
 
 
       
The complexity of three types of consumers
 
 
      
People
      Animals
 
      Healthcare Professionals
 
 
Direct
Indirect
Indirect
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 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.....
 
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
 
 
                      
Fundamental Principle
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
self regulation
 
A long journey
 
March 12 constitution signed
 
AGM
 
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
 
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?
 
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
 
14
 
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
 
15
 
SA Marketing Code (27-09-2011)
 
Scope of the Code
- 
Replace ASA appendix A & H
- Guidelines
 
ACTIVITIES TO HCP’S:
APPLICABLE TO ALL HEALTH
PRODUCTS
 
17
 
SA Marketing Code (27-09-2011)
 
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
 
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 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
 
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
 
(*)
 
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
 
                MCA Structure
 
23
Code Technical Advisory
Committee
 
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
 
No resolution
 
No resolution
Breach of Act
101, legal
mechanisms
 
25
 
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,  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
 
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
 
12
th
 September
 
9am – 11.45am
 
Cedar Park Hotel
                       120 Western Service Road Woodmead
 
Guest Speaker – Dr Anban Pillay
 
 
 
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This content delves into the complexities of ethical marketing practices in the healthcare industry, focusing on the responsibilities of suppliers, the interactions with different types of consumers, and the need for regulatory frameworks to protect consumers. It highlights instances of incentive schemes, off-label promotions, and the importance of reliable scientific information. The content discusses the industry's obligation to maintain ethical standards, enhance consumer awareness, and ensure fair competition while preserving the independence of healthcare professionals' decisions.

  • Ethical marketing
  • Healthcare industry
  • Consumer protection
  • Regulatory frameworks
  • Supplier responsibilities

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  1. Steve Speller

  2. Substances that have the potential to:- do good do harm

  3. Why is it needed in South Africa ? To Protect Consumers

  4. The complexity of three types of consumers Direct People Indirect Animals Indirect Direct Healthcare Professionals

  5. As suppliers of health care products what do we try to do to customers ? Inform Them? Influence Them?

  6. What is our intent?

  7. Incentive schemes Off label promotion ... Selective use of clinical trial information... Hospitality practices....

  8. 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.

  9. 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

  10. Code of Marketing Practice Fundamental Principle self regulation

  11. A long journey AGM March 12 constitution signed May 2011 Agreed MoU Oct 2010 Agreed version of the Code Feb 2010 Interim Board of the MCA 2009 SAMED & SALDA join July 2007 Marketing Steering Committee

  12. 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

  13. 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

  14. 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 14

  15. 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) 15

  16. Scope of the Code Marketing & promotion of medicines to healthcare professionals Part A - Replace ASA appendix A & H - Guidelines Marketing & promotion of medicines to consumers Part B Part C Devices Part D Enforcement

  17. ACTIVITIES TO HCPS: APPLICABLE TO ALL HEALTH PRODUCTS SA Marketing Code (27-09-2011) 17

  18. 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 18

  19. 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

  20. 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

  21. 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 21

  22. 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

  23. MCA Structure MCA Code Technical Advisory Committee Executive Officer Adjudicating Panel Appeal Panel Appointed by Board Legal Panel Appointed by EO for specific complaint Adjudicating Committee Appeal Committee 23

  24. 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

  25. Complaint Process No resolution No resolution Company to Company MCA Sanction DoH Breach of Act 101, legal mechanisms 25

  26. 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

  27. 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

  28. 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

  29. Annual General Meeting 12th September 9am 11.45am Cedar Park Hotel 120 Western Service Road Woodmead Guest Speaker Dr Anban Pillay

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