WHAT IS COMPLIANT 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 31
