Canada Compliance Issues - Pharmaceutical …

1 4/30/2012 1 Canada Compliance Issues We re different, 1 PCF March 2012 Meeting Moderators: Derek Khan Eli Lilly Canada Litsa Kouroumalis Bristol-Myers Squibb Canada 2 Population 34,482, 800 North West Territories / NUNUVIK 77,000 YUKON 34,700 BRITISH COLUMBIA 4,573,300 3,779,400 ALBERTA SASK. 1,057,900 MANITOBA 1,250,600 ONTARIO 13,373,000 QUEBEC 7,979,700 NFLD 510,600 NOVA SCOTIA 945,400 PEI 145,900 NEW BRUNSWICK 755,500 Canada 4/30/2012 2 Some Canadian Pharma Stats* Pharma sales have 3% of global market making Canada 8th largest market globally. 7% annual growth between 2005-2009 making Canada 3rd fastest growing market globally (after Brazil and China) Brand-names (Research-based) make up 78% of sales and 52% of volume (generics account for the rest) Industry employees 27,000 people and provides 35,000 indirect jobs Industry clustered mainly in Montreal and Toronto and influenced by location of major biosciences clusters and supportive government policies of the two provinces Source: Industry Canada 3 4 Source: Industry Canada 4/30/2012 3 5 Source: Industry Canada 6 Canada USA Source: 4/30/2012 4 Canadian Compliance 7 Nurses Government officials Doctors Pharmacists Hospital Administrators Regulatory and Legal environment: What do we comply to in Canada ?

2 Industry Codes Rx&D* Code of Ethical Practices *Research-Based Pharmaceutical Companies (IFPMA code of Pharma Marketing Practices) PAAB Code of Advertising Acceptance Canadian Code of Advertising Standards Laws and Regulator Policies Health Canada policy statements Food and Drugs Act and Regulations Competition Act Patented Medicines Regulations and PMPRB Compendium Criminal Code PIPEDA (Personal Information Protection and Electronic Documents Act) National and provincial statutes, regulations, codes, policies, and guidelines governing physician conduct FCPA 8 4/30/2012 5 Comparison Self Regulation Enforcement: not material $ DTC ONLY Name, Price, Quantity CHE / CME: Industry involvement in content development and dissemination (rep logistics) Similar OIG/CIAs in Billions $ DTC Permitted IME Grants: No Industry involvement 9 Comparison Medical Practice Activities Loan of Medical Equipment Sponsorships to International Congresses permitted Reps business meals permitted for HCPs & Other Stakeholders RX&D code governs interactions not only with HCPs but gov t & other stakeholders On-line training provided by RX&D High risk of gov t scrutiny High risk of gov t scrutiny ?

3 ? Not industry practice for US HCPs Not permitted outside of speaker programs PhRMA: HCP interactions only PhRMA training requirements but no provision of course 10 4/30/2012 6 Comparison Preceptorships permitted for HCP/HCP, employee/HCP Charity events: employees, HCPs Displays: no food, snacks Payment for access within medical building permitted Patient Support Programs Not covered by PhRMA No specific guidance by PhRMA Permitted Not permitted (anti-kick back analysis) ?? 11 Links RX&D Code: PAAB Code: ASC Code: CMA PIPEDA 12 4/30/2012 7 Back-up slides 13 RX&D RX&D is the association of research based pharma companies whose mission is to advocate for policies that will bring the best innovative medicines to Canadians Underlying their commitment is their assurance for ethical practices and thus, members adhere to a strict code of ethical practices that govern all interactions with stakeholders Sections of the code include guidance on.

4 Samples, Education for HCPs, CHE, Sponsorships, Donations or Financial support, Gifts, Hospitality, Representatives, Post-Registrational trials, Service oriented items, market research, advisory boards, privacy, enforcement of the code Revised code effective March 31, 2012 14 4/30/2012 8 Learning Programs for HCPs CHE (Continuing Health Education) Accredited, Educational CHE certified professionals must only be involved in creation of program Reps logistics only OLAs (Other Learning Activities) Non-Accredited, cannot be referred as promotional Involves presentation of medical/scientific information Materials provided to speakers must follow the guidance framework provided by HC, PAAB, ASC etc. Reps logistics only 15 Role of Sales Representatives in Educational Programs with HCPs Sales representatives are involved in the implementation and logistics of CHE programs and Other learning Activities.

5 Role is limited to: Execution of agreements, where applicable Distribution invitations and collection of evaluations Making arrangements for venues, incidental meals & refreshments Distribution of accredited or learning program material to attendees only 16 4/30/2012 9 Enforcement of Code A statement of Compliance A requirement for companies to monitor Compliance An Increase in fines 17 Infraction published on the Rx&D website $ 25 000 $50 000 $75 000 $100 000 Pharmaceutical Advertising Advisory Board (PAAB) PAAB is an independent, multidisciplinary body that provides review and pre-clearance of drug advertising and promotional materials. Use of this pre-clearance regime is not mandatory but is strongly encouraged by Health Canada and required by some industry associations (such as Rx&D.)

6 PAAB applies to advertising directed at HCPs (physicians, nurses and pharmacists). The PAAB code applies to all communications in which claims, quotations and references are made for healthcare products and provides specific rules for the various defined advertising/promotion systems . Unless exempt from PAAB review ( reprints), all promotional material is pre-cleared by PAAB 18 4/30/2012 10 Direct to Consumer Advertising According to the Food and Drugs Act ( Canada ) prescription drugs may not be advertised to the general public other than with respect to the brand name, proper name, common name, price and quantity of the drug. 19 Canadian Medical Association Ethical Guidelines Peer Selling - The CMA Code of Ethics prohibits Peer Selling This occurs when a pharma manufacturer directly or through a third party sponsors a seminar that focuses on its own products and is designed to enhance the sale of those products and they engage a physician to conduct the session.

7 - This form of participation contravenes the Code of Ethics, which prohibits endorsement of a specific product. Peer Selling differs from CHE events because control and structure of CHE events are in the hands of the CHE organizers, removing such events from the realm of advertising. Physicians are not considered agents of Pharmaceutical companies when speaking even if paid by a Pharmaceutical company and constantly voice concerns about presenting slide decks created by Pharmaceutical companies as is they frequently add their own slides. 20 4/30/2012 11 Canadian Physicians Canada has single payer health care which provides universal health care. Canada s system is not socialized medicine under a system of socialized medicine physicians are salaried public employees In Canada the vast majority (95%) of physicians are private practitioners and bill on a fee-for-services basis.

8 Physicians are independent contractors even though their income derives from publicly-funded and provincially administered healthcare plans. Physicians who are salaried public employees are those employed in a department or ministry of health. 21