SA Marketing Code of Practice Steve Speller What
Description: 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
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slide1. SA Marketing Code of Practice Steve Speller<br>
slide2. What are health products? Substances that have the potential to:-
do good
do harm<br>
slide3. Code of Marketing Practice Why is it needed in South Africa ?
To Protect Consumers<br>
slide4. Code of Marketing Practice The complexity of three types of consumers
People
Animals
Healthcare Professionals Direct Indirect Indirect Direct<br>
slide5. As suppliers of health care products what do we try to do to customers ?
Inform Them?
Influence Them?<br>
slide6. What is our intent?<br>
slide7. Off label promotion ... Selective use of clinical trial information... Incentive schemes Hospitality practices....<br>
slide8. 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.<br>
slide9. 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<br>
slide10. Code of Marketing Practice Fundamental Principle self regulation<br>
slide11. A long journey March 12 constitution signed AGM<br>
slide12. 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<br>
slide13. 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<br>
slide14. 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<br>
slide15. 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)<br>
slide16. Scope of the Code - Replace ASA appendix A & H
- Guidelines<br>
slide17. Part A: ACTIVITIES TO HCP’S:
APPLICABLE TO ALL HEALTH PRODUCTS 17 SA Marketing Code (27-09-2011)<br>
slide18. 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<br>
slide19. 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<br>
slide20. 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<br>
slide21. 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<br>
slide22. 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<br>
slide23. MCA Structure 23 Appointed by Board Appointed by EO for specific complaint Code Technical Advisory Committee<br>
slide24. 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<br>
slide25. Complaint Process No resolution No resolution Breach of Act 101, legal mechanisms 25<br>
slide26. 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<br>
slide27. 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<br>
slide28. 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<br>
slide29. Annual General Meeting 12th September
9am – 11.45am
Cedar Park Hotel
120 Western Service Road Woodmead
Guest Speaker – Dr Anban Pillay<br>
slide2. What are health products? Substances that have the potential to:-
do good
do harm<br>
slide3. Code of Marketing Practice Why is it needed in South Africa ?
To Protect Consumers<br>
slide4. Code of Marketing Practice The complexity of three types of consumers
People
Animals
Healthcare Professionals Direct Indirect Indirect Direct<br>
slide5. As suppliers of health care products what do we try to do to customers ?
Inform Them?
Influence Them?<br>
slide6. What is our intent?<br>
slide7. Off label promotion ... Selective use of clinical trial information... Incentive schemes Hospitality practices....<br>
slide8. 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.<br>
slide9. 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<br>
slide10. Code of Marketing Practice Fundamental Principle self regulation<br>
slide11. A long journey March 12 constitution signed AGM<br>
slide12. 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<br>
slide13. 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<br>
slide14. 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<br>
slide15. 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)<br>
slide16. Scope of the Code - Replace ASA appendix A & H
- Guidelines<br>
slide17. Part A: ACTIVITIES TO HCP’S:
APPLICABLE TO ALL HEALTH PRODUCTS 17 SA Marketing Code (27-09-2011)<br>
slide18. 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<br>
slide19. 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<br>
slide20. 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<br>
slide21. 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<br>
slide22. 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<br>
slide23. MCA Structure 23 Appointed by Board Appointed by EO for specific complaint Code Technical Advisory Committee<br>
slide24. 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<br>
slide25. Complaint Process No resolution No resolution Breach of Act 101, legal mechanisms 25<br>
slide26. 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<br>
slide27. 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<br>
slide28. 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<br>
slide29. Annual General Meeting 12th September
9am – 11.45am
Cedar Park Hotel
120 Western Service Road Woodmead
Guest Speaker – Dr Anban Pillay<br>