What is compliant medical education?

MEDICAL EDUCATION?

By Rina Newton

The term ‘Medical Education’ is a term that is often misunderstood within the pharmaceutical industry, which then leaves companies exposed to potential breaches of the ABPI Code of Practice. The Code doesn’t specifically mention the term ‘Medical Education’ but it does refer in Clause 1.2 to ‘information relating to human health or diseases provided there is no reference, either direct or indirect, to specific medicines’ as a non-promotional activity. Importantly, this means that genuine non-promotional medical education cannot mention a specific medicine or class – otherwise this will be seen to be promotional. Of course, there are many other types of non-promotion (such as advisory boards) which do allow the mention of a specific medicine or class.

For health professionals, medical education means keeping up to date with rapidly evolving clinical practice and technology so they are well-equipped with future skills and knowledge. It also allows them to complete their mandatory Continuing Professional Development (CPD), so represents a vital aspect of their professional lives. For them, medical education may cover any aspect of healthcare – from novel therapies and pathways to learning about guidelines and digital technologies.

What can we do as an industry to ensure that we meet the medical education needs of individual health professionals and the wider NHS whilst always adhering to the Code? This is best addressed by first considering the risks and then their mitigation.

What are the potential risks?

We know there is a very clear definition for promotion in the Code: any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.

Conversely, there is no single definition for non-promotion as there are many types, ranging from medical education and advisory boards to legitimate exchange of medical and scientific information during the development of a medicine. Each non-promotional activity has its own set of criteria that must be strictly adhered to in order for that activity to then be considered non-promotional. It therefore follows that if medical education discusses medicines (even if only at a class level) AND the activity does not meet all the criteria for any other acceptable category of non-promotion, then it will be considered as promotion. This will be a breach of the Code if the medicine/indication is not licensed, or the material is

not certified, or the content does not include obligatory information for promotional material etc.

When Roche 1 organised a non-promotional medical education symposia at a congress, they engaged a speaker to discuss an area of unmet educational need. Although the speaker brief stated that no proactive mention of rituximab was to be made, two slides mentioned the product and the speaker referred delegates to a subsequent session, where rituximab data would be discussed. Thus, the Panel ruled that the symposia did not meet the criteria for medical education and it was therefore actually promotional (and in breach).

The industry sometimes has a hard time defining compliant medical education for a number of different reasons. Sometimes this boils down to just one thing – allowing compliance to be defined by external drivers rather than observing Code requirements.

When approving or auditing medical education meetings, we often see justifications for the appropriateness of planned activities. Examples of the language used are listed below: • “Medical have organised this so it’s ‘educational’ not ‘promotional’”

• “The speaker is an international expert so it’s credible content”

• “We can’t put prescribing information on as it’s a medical meeting”

Therefore, our observations suggest there is more than just “comply with the Code” that needs to be advocated here.

In terms of how risk can be mitigated, there is a very clear solution. It is a common misconception that by mentioning other companies’ medicines or even the entire class, this will in some way ‘balance’ the content so that it is not promotional. In fact, any mention of the company’s medicine would be viewed as promotion (or worse, pre-licence or off-label promotion) – plus the company has in part ‘promoted’ the medicines of other companies… In conclusion, compliant medical education should not mention a specific product or class of product. Whilst some may regard this as limiting, arguably this nonpromotional activity still has an important part to play in educating NHS health professionals and other relevant decision makers on health policy, research areas, patient perspectives and needs, healthcare systems, trial design, diseases, symptoms, markers, prevalence, prognosis, diagnostic techniques, digital health technology and so on.

1. CASE AUTH/2598/4/13 CONSULTANT RHEUMATOLOGIST v ROCHE

Rina Newton Managing Director CompliMed