9. Learning Programs for Health Care Professionals

The term “Continuing Health Education” (CHE) includes programs for all Health Care Professionals. The term “Continuing Professional Development” (CPD) is included within the definition of CHE. Members are committed to separating CHE from promotional activities and any other activities in which Health Care Professionals receive a fee for service.

The purpose of CHE is to provide programs for Health Care Professionals which follow the content development, ethical guidelines, and have received accreditation from a professional organization such as:5

• The Royal College of Physicians and Surgeons of Canada;
• The College of Family Physicians of Canada;
• The Federation of General Practitioners of Québec (FMOQ);
• The Federation of Medical Specialists of Québec (FMSQ);
• The Canadian Council on Continuing Education in Pharmacy (CCCEP); and
• Other Canadian organizations that provide credits that are recognized by CHE accrediting
  bodies.

[[5]]It is important to note that “endorsement” does not mean “accreditation.” Members should note that programs may only be called “accredited” once accreditation has been granted for the activity. As a further example, some professional organizations will validate the program, but accreditation is not granted until the activity involving the program has passed an ethical review by the region or province.[[5]]

All CHE programs and all CHE program-related materials must clearly identify the fact that final accreditation has been obtained.

To ensure professional standards for the industry, Member employees whose job functions include responsibility for CHE support must take a certified course in CHE training prior to or within one year of attaining responsibility for CHE activity (“CHE Professionals”).6

[[6]]The certified training referred to here would be a course issued by a learned society or educational organization. The intent is to ensure that the CHE Professional is trained in how to develop CHE programs so that the program is not disguised promotion. The intent is to have separate people in the roles of sales representatives and CHE. [[6]]

Member employees other than the CHE Professionals described in Section 9.3.2.2 may only be involved in program logistics in accordance with the National Standards for Support of Accredited CPD Activities7 or the standards and guidelines of other Canadian organizations that provided credits that are recognized by CHE accrediting bodies.

[[7]]The National Standard for Support of Accredited CPD Activities issued January 1, 2018, by the Royal College of Physicians and Surgeons of Canada; in collaboration with the College of Family Physicians of Canada (CFPC), the Committee on Accreditation of Continuing Medical Education (CACME), The Conseil québécois de développement professionnel continu des médecins (CQDPCM), and the Fédération des médecins spécialistes du Québec (FMSQ). 8 Where there may be a desire to combine CHE and OLA programs, the Member must validate with the accrediting organization that this is acceptable.[[7]]

“Other Learning Activities” are defined as unaccredited programs, events or activities, including self-directed learning programs that do not meet the accreditation criteria set out by the professional organizations listed above in Section 9.3.1.2. They are considered non-promotional in nature. Members must ensure that these activities aspire to high ethical standards, and are balanced.

Exchange of information on related scientific and clinical issues must be the primary focus of and reason for supporting an OLA program.

OLA topics and learning objectives must be informed by the results of a documented needs assessment conducted to determine the legitimate unmet learning needs of the intended target audience. The documented needs assessment must be reviewed and approved by the function within the organization that is responsible for learning activities.9 Such personnel may review and approve the needs assessment for a series of OLA programs related to specific learning objectives.

[[9]]This typically would exclude sales. 10 Engaging a speaker or moderator must be done in accordance with Section 7 – Retaining the Services of a Stakeholder.[[9]]

Member sales representatives can only be involved in logistical activities associated with learning programs such as:

• Distribution of approved invitations;
• Execution of agreements;
• Propose a potential speaker or moderator;10
• Making arrangements for venue, online platforms, incidental meals and refreshments in
  keeping with Section 6 of this Code;
• Confirmation of attendees;
• Collection of evaluations; and
• Distribution of learning program material (acceptable to attendees only).

[[10]]Engaging a speaker or moderator must be done in accordance with Section 7 – Retaining the Services of a Stakeholder.[[10]

While sales representatives can be involved in the distribution of an invitation and can propose a speaker or moderator, members must ensure there is appropriate oversight by nonsales personnel in the final approval of invitations, speakers and moderators. Final decisions on invitations, speakers and moderators, must be made by non-sales personnel.

Health Care Professionals’ preceptorships are unique programs that should facilitate learning and transfer of skills and knowledge from one Health Care Professional to another. Preceptorships allow a Health Care Professional to spend time with a trainer (the “Preceptor”) who is a recognized expert in their field that can withstand external scrutiny, to gain a better understanding and insight into a therapeutic area or disease state.

To facilitate the transfer of knowledge and skills among qualified Health Care Professionals, Members may support the number of preceptorships deemed necessary. Payment of honoraria calculated at fair market value reflective of usual rates of compensation for the services provided and reimbursement for the Preceptor’s reasonable travel and accommodation expenses are permitted.

A maximum of five (5) Health Care Professional “preceptees” (or “trainees”), per calendar year, per brand, per specialty by indication, where specific indications call for interactions with Health Care Professionals from different specialties, may be sponsored to participate in a preceptorship program in an appropriate teaching center, being a teaching hospital, a teaching clinic or a university, in or outside Canada. Sponsorship is limited to reasonable travel and accommodations.12

[[12]]This is recognized an as exception to 9.5.2, i.e. for the type of preceptorships where travel needs to take place to attend at, for example, a centre of excellence – travel and reasonable hospitality may be reimbursed/covered as an exception.[[12]]

For learning programs, irrespective of the format, on new products, new indications or disease state or significant label changes (i.e. patient safety), a need may arise to train an appropriate number of Health Care Professionals who are recognized experts on this information so as that they may disseminate this information to their colleagues for the benefit of Canadian patients. A product or indication is considered “new” up to one year after its initial marketing.13

[[13]]“Appropriate number of Health Care Professionals” means a justifiable number, proportional to the entire medical community or specialty. It would be unacceptable to train the entire membership of a specialty.[[13]]

An appropriate number of Health Care Professionals may be trained on legitimate learning programs, new products, new indications or disease states or significant label changes (i.e.patient safety) for the sole purpose of disseminating this information at subsequent events. These training meetings are referred to as “Speaker Training” or “Faculty Training.”

When Speaker training meetings should involve the selected group of recognized experts in the related field to meet at an appropriate venue within Canada, reasonable travel and related expenses including honoraria at fair market value for services may be paid to the trainer and trainees. Appropriate meals and refreshments may be provided in accordance with Section 6 of this Code; however, entertainment is prohibited. These Health Care Professionals must have a written agreement with the Member to participate in the meeting with the requirement to deliver subsequent training to other Health Care Professionals.14

[[14]]It is recommended that speaker trainings be interactive so as to ensure a comprehensive understanding of material and content by the future speakers. These sessions may be in a face-to-face environment or may occur through virtual channels.[[14]]

A Member’s decision regarding the selection or retention of Health Care Professionals as speakers should be made based on defined criteria such as general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills.

The total number of trained speakers must be reasonable relative to the size of the relevant audience of Health Care Professionals.

Should the need arise for Canadian recognized experts to be trained by an International recognized expert from a country where the new product or new indication is available, Members have the following options:

• Invite the International recognized expert to Canada to conduct the training; or
• Send a maximum of five (5) Canadian recognized experts per new product or new indication to an appropriate teaching center, such as a teaching hospital, a teaching clinic or a university, to receive this training. Reasonable travel and accommodation may be reimbursed.

Speaker training by an internationally recognized expert can only occur after a Health Canada filing for a new product or new indication and within a reasonable timeline before the expected date of launch of the new product or indication.