The Regulations and protecting patients
These tragic cases led to more rigorous testing of medicines before granting a Marketing Authorisation and tighter regulations for promoting medicines. The ultimate aim was to protect patients. One of the roles of the signatory approval process is to protect patients by making sure we only promote our medicines within the terms of the marketing authorisation and that our marketing is not misleading. However it is also there to ensure that all communications about our products (whether on or off-label) and therapy areas, to all potential audiences, complies with the relevant regulations.
Nowadays laws governing medicines promotion usually include two key criteria for the information provided in marketing materials. It must:
- be consistent with approved product information; and
- not be deceptive or inaccurate.
Most countries also have many additional requirements governing promotion of medicines that are laid out in various codes and guidelines, however, most are details driving the above fundamental requirements and others support two other core principles;
- that clinicians should not be inappropriately influenced in their prescribing
- that we need to respect the serious nature of medicine in the way we operate
All four principles are there to protect patients. In your role within Medical, you may be much more focused on non promotional activities. However items 2-4 in the above list still apply.
