Effective March 31, 2012, the members of Canada's Research-Based Pharmaceutical Companies ("Rx&D") will be subject to a new Code of Ethical Practices (the "New Code").
Rx&D has had a Code of Ethical Practices since 1988 (the "Rx&D Code") which is mandatory for all members of Rx&D. The New Code follows an extensive review process that began in early 2010. This advisory is a brief summary of certain elements of the New Code that represent material changes of, or additions to, the Rx&D Code.
SCOPE OF THE CODE
Currently, the Rx&D Code largely applies to relationships between sales representatives of members and health care professionals ("HCPs"). The New Code addresses interactions between all member employees and HCPs, governments and other stakeholders. The term stakeholder is broadly defined and includes any individual or organization involved in the supply or purchase of prescription medicines.
GUIDING PRINCIPLES
The Guiding Principles have been substantially updated to reflect the expanded scope. Members are directed to be cognisant of potential conflicts of interest in interactions with stakeholders and to manage them appropriately. In addition, the principles indicate that all interactions are required to be in accordance with applicable laws and regulations.
Members are required to ensure that all relevant personnel and agents are appropriately trained in the requirements of the New Code and abide by it. Further, the principles include an obligation that Members not give or offer any payments or inducements that are either unlawful or improper, directly or indirectly, to any individual stakeholder.
SCIENTIFIC EXCHANGES
The New Code includes an express prohibition with respect to pro-active or solicited discussions of off-label indications, uses, dosages or populations. There is an express obligation to send requests for information on authorized products or uses to the member's medical department.
BUSINESS MEETINGS AND DISCUSSIONS
The New Code clarifies the number of stakeholders which may be invited per interaction (other than promotional or learning programs) by member employees. In addition, the New Code clarifies the responsibilities of the members in ensuring that the selection of venues is appropriate and conducive to the business purpose of the events being organized.
RETAINING THE SERVICES OF STAKEHOLDER
The New Code adds a section that sets out principles and standards with respect to the retention of stakeholders, including HCPs, to allow members to obtain information and/or advice from experts.
LEARNING PROGRAMS FOR HEALTH CARE PROFESSIONALS
This New Code section draws a distinction between accredited and unaccredited programs delivered by HCPs for HCPs and other relevant collaborators to facilitate their learning. The section considers separately accredited programs, unaccredited programs, preceptorships and speaker training (faculty training) and workshops.
CONFERENCES AND CONGRESSES
The New Code adds a part to address international conferences and congresses held in Canada. The New Code requires members to ensure compliance with the New Code by their international affiliates. There is a provision in
this section of the New Code that prohibits sponsorships of Canadian professional association conferences or congresses outside of Canada. In addition, provision is made for stand-alone scientific exchange meetings, organized by the international head offices of international members of Rx&D.
PROVISION OF FUNDING
The New Code provides members with additional guidance with respect to the circumstances in which donations, grants and financial support is acceptable. The New Code requires that funding be documented in contractual agreements outlining the nature of the funding provided.
LOANS OF MEDICAL INFORMATION
The New Code provides a new section on equipment loans to HCPs, reflecting current industry practice.
PATIENT PROGRAMS
The New Code adds a section on patient programs, reflecting current industry practice.
ENFORCEMENT
The New Code imposes an obligation on members to monitor compliance. On an annual basis, members must confirm to Rx&D that they have policies and procedures in place to facilitate ongoing compliance with the New Code. Penalties for non-compliance during a 12-month period have been increased to the following levels: First infraction – $25,000; second infraction – $50,000, and third infraction – $75,000.
FINAL COMMENTS
The members of Rx&D are to be congratulated for their efforts to proactively establish meaningful guidance and direction with respect to conduct in Canada. Members of Rx&D as well as non-members who have adopted, in whole or in part, prior versions of the Rx&D Code, will want to ensure that their internal codes are at least as stringent as the 2012 Code prior to March 31, 2012.
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