Canadian Lawyer InHouse

By Jennifer McKenzie and Tamarah Luk A look at Rx&D's code of ethical practices Clarification provided on interactions with health-care professionals. O and on regulating member-developed patient-support programs. tion on the lending of medical equip- ment to health-care professionals, Expansion and clarifications The amendments require all members' employees to be trained in the laws and regulations governing their interactions with health-care professionals, govern- ments, and others, as well as the code. Code of Ethical Practices came into effect, binding its member companies. The new code is an overhaul of the previous one to reflect current industry practices. Some of the more significant changes are discussed below. New additions For the first time, the new code express- ly prohibits the promotion of off-label uses of drugs. With this change, new code reflects long-standing prohi- bitions on off-label marketing under the Food and Drugs Act and Regulations. Unsolicited requests for the on off-label uses by health-care profes- sionals are considered non-promotion- al and thus are not prohibited under the new code. However, members must forward such requests to their medical department and clearly indicate that their response to the request relates to an unauthorized use. Other new additions include a sec- information n March 31, 2012, Canada's Research- Based Pharmaceutical Companies' (commonly known as Rx&D) new Previously, only sales representatives had to be trained on the code. The new code also makes substantial changes to Rx&D's position on advi- sory boards and consultant meetings. First, the code has been broadened to allow members to retain stakeholders (i.e., health-care professionals, govern- ment, and any other stakeholder with an interest in or impacted by mem- bers' activities) as advisers/consultants. it must be clear that hiring the stake- holder as an adviser/consultant is not an inducement for prescribing, supplying, recommending, etc., members' products. The new code also clarifies section on hospitality. This previously set out members' respon- sibilities when wining and dining stakeholders for "[facilitating] greater interaction." The new code gives this sec- tion the clearer title "Business Meetings and Discussions" and delineates mem- bers' responsibilities in connection with: (1) selecting venues, and (2) providing meals and refreshments. New provi- sions have been added to assist members on permissible hospitality activities. For example, the new code prohibits mem- bers from conducting business meetings section Other new additions include a section on the lending of medical equipment to health-care professionals, and on regulating member- developed patient-support programs. Previously, only health-care profession- als could be retained. Second, advisory boards and consul- tant meetings appear to be redefined. Previously, both were defined based on subject matter: advisory boards were convened to advise on drug develop- ment (from discovery to maturity) and consultant meetings were convened to advise on specific product Now, advisory boards will be defined based on their continuous relation- ship of advising members on different aspects of their business. Consultant meetings will be defined as ad hoc meetings on specific aspects of their business. Finally, agreements between members and advisers memorializing the retainer must satisfy expanded cri- teria under the new code. For example, issues. or events at personal residences. It also prohibits members from paying a clinic room rental fee, cleanup fee, or any similar fee that could be construed as a payment to gain access to a health-care professional. Enforcement Fines for violating the code are also increased under the new code: $25,000 for a first violation, $50,000 for a sec- ond violation, $75,000 for a third viola- tion, and $100,000 for each subsequent violation. posted on the Rx&D web site. IH Jennifer McKenzie is a partner Infractions are still being with Bereskin & Parr LLP and head of the firm's Regulatory, Advertising & Marketing practice group and Tamarah Luk is an associate in the group. INHOUSE WWW.CANADIANLAWYERMAG.COM/INHOUSE AUGUST/SEPTEMBER 2012 • 11 the

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