Current regulations

These tragic cases led to more rigorous testing of medicines before granting a Marketing Authorisation and tighter regulations for promoting medicines. The aim was to protect patients. Your role as a nominated signatory is to protect patients by making sure we only promote our medicines within the marketing authorisation and that that marketing is not misleading.

Nowadays laws governing medicines promotion usually include two key criteria for the information provided in 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 and that we need to respect the serious nature of medicine in the way we operate. All four principles are to protect patients.

Here is more information about some of the codes governing medicines promotion:

EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA) was founded in 1978 and its first Code covering the promotion of prescription only medicines came into effect in January 1992. It forms the basis of a large number of national country codes in Europe, including the ABPI Code for the UK. As AstraZeneca’s global company is based in the UK, this Code is one of the ‘benchmark’ codes used in this training.

IFPMA

The International Federation of Pharmaceutical Manufacturers & Association was founded in 1968 and its Code was first created in 1981. Promotion of any medicinal product, anywhere in the world, by any company that is a member of the IFPMA or a member of an IFPMA member association, must be in line with the IFPMA Code.

FDA

In the United States the Federal Food and Drugs Act 1906 was the starting point for the creation of Food and Drug Administration (FDA). It regulates the US pharmaceutical industry through various Laws, Regulations, Guidance documents, and Enforcement Actions, which are available from the FDA website.

Medicines Australia

Medicines Australia’s Code of Conduct, established in 1960, sets the standards for the ethical marketing and promotion of prescription pharmaceutical products in Australia. Quarterly reports on breaches of the Code and sanctions applied are available from their website.