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
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.
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.
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
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
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
LOANS OF MEDICAL INFORMATION
The New Code provides a new section on equipment loans to HCPs,
reflecting current industry practice.
The New Code adds a section on patient programs, reflecting
current industry practice.
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.
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,
On June 30, 2016, the Minister of Justice and Attorney General of Canada, the Minister of Public Safety and Emergency Preparedness, and the Minister of Health announced the creation of a nine-member Task Force on Cannabis Legalization and Regulation (the "Task Force").
Pharma in Brief reported on many legal and regulatory developments of interest to the pharmaceutical industry in 2016. Looking back on 2016 as the new year begins, we have compiled our list of the past year's top headlines below. These include, in no particular order, key developments that affect the pharmaceutical industry and we will continue to monitor in 2017.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).