Canada’s Research-Based Pharmaceutical Companies (“Rx&D”) is the national association of Canadians employed by Canada’s 50 research based pharmaceutical companies, such as Abbott Laboratories, AstraZeneca, Bayer, Roche, Merck, Novartis and Pfizer, just to name a few.
Rx&D first adopted a Code of Ethical Practices (the “Code”) for its members in 1988. Since then the Code has evolved to respond to the changes in the Canadian pharmaceutical industry.
The Code provides guidance to its members on key ethical issues such as how to promote members products and services in a socially responsible manner. Much of the Code is devoted to issues pertaining to the interaction between the pharmaceutical industry and health care professionals (HCPs). HCPs are defined by the Code to include anyone who by education, training, certification or licensure is engaged in providing health care, while Stakeholders include any individual or organization other than HCPs and government, who may be involved in activities such as the supply and/or purchase of prescription medicines.
The new Code of Ethical Practices (“New Code”) takes effect on March 31, 2012. The Guiding Principles in the New Code remind members to be cognizant of potential conflicts of interest in interactions with stakeholders and to manage them appropriately. The Guiding 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.
Limits to Trips and Entertainment
The New Code provides that any material pertaining to prescription drugs and their uses, whether promotional in nature or not, must clearly indicate the nature of the Member’s involvement. Members may provide “occasional reasonable meals/refreshments” to HCPs but those promotional activities may not involve any off-label discussions. Member employees are not to participate in activities such as golf, hockey, theatre and spa with Stakeholders outside of a few limited exceptions. Members must avoid venues for business meetings/events that are “excessive or extravagant in nature” and under no circumstances are members permitted to pay a clinic room rental fee, clean up fee or any other type of “fee” that could be construed as a direct or indirect payment to gain access to a HCP. Meals and refreshments for spouses/companions of HCP are also prohibited. Sponsorship of Canadian Professional Association conferences or congresses hosted outside of Canada are also prohibited. Members are still permitted to sponsor stakeholder attendance at international events where there is a legitimate educational purpose being fulfilled in exchange for the HCP undertaking to submit a report or paper or presentation.
Members can provide accredited and unaccredited programs to HCPs, provided that the topics are not promotional-orientated and give a balanced view of all relevant therapeutic options.
No more goody bags?
Members can also loan medical equipment to HCPs, subject to a written agreement that specifies the program’s objectives, duration of the loan and confirms that the HCP will not invoice any payer for the use of the equipment. While members may provide “acceptable service-orientated items” to stakeholders, they may not offer any stakeholder or any member of the stakeholder’s clinical/administrative staff and/or family, any gift – in cash, or in kind or any promotional aid, prize, reward, or any other incentive or reward for prescribing, administering, recommending, purchasing, paying for, reimbursing, authorizing, approving, supplying any product or service sold or provided by the member or to obtain any other improper advantage for the member.
Donations and Financial Support
The New Code provides members with additional guidance with respect to the circumstances in which donations, grants and financial support is acceptable and provides that funding must be documented in contractual agreements outlining the nature of the funding provided.
Finally, the penalties for non-compliance during a 12-month period have been increased in the New Code to $25,000 for the first infraction; $50,000 for the second infraction and $75,000 for the third infraction.