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 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

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 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 15SA Marketing Code ( )

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

ACTIVITIES TO HCP’S: APPLICABLE TO ALL HEALTH PRODUCTS 17SA Marketing Code ( )

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 incl of VAT/year For training or academic institutions, < R 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 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 MCA Adjudicating Panel Adjudicating Committee Appeal Panel Appeal Committee Legal Panel Executive Officer 23 Appointed by Board Appointed by EO for specific complaint 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 Company to Company MCASanctionDoH 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