2021 GUIDELINES ON COMPANY PROCEDURES RELATING TO THE ABPI CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY

It is important for companies to have policies and standard operating procedures (SOPs) to communicate corporate standards, expectations and behaviour. These might be a mixture of global, regional and local SOPs. Company documents should support compliance, ensure consistency, manage risk and provide a platform for continuous improvement. It should be clear and apparent to all staff which requirements are relevant to their role. These policies and SOPs are minimum requirements which should be adapted to fit the arrangements at a particular company. The introduction of the new ABPI Principles should also be reflected where appropriate. The PMCPA will not adjudicate on the ABPI Principles.

Companies’ Code related policies and procedures should be in line with the ABPI Code requirements, but of course, companies are fully entitled to have policies and procedures that impose higher standards than the ABPI Code. The ABPI Code reflects and extends beyond relevant UK legislation and ensures that the ABPI meets its commitments to implement other codes, such as the IFPMA and EFPIA Codes.

The guidelines, which are published on the PMCPA website, are regarded as best practice and should be adapted to fit in with the arrangements at any particular company. Paragraphs 10.4, 11.4 and 12.2 of the Constitution and Procedure for the Prescription Medicines Code of Practice Authority (PMCPA) variously authorise the Code of Practice Appeal Board or the ABPI Board to require an audit of a company’s procedures in relation to the ABPI Code to be carried out by the PMCPA. During such audits, the PMCPA will review a company’s policies and SOPs and their implementation, including but not limited to those relating to the Code. A company’s website may also be reviewed and should be up-to-date and accurate at all times. It is likely that an audit would also include a discussion about the company’s implementation of the ABPI Principles.

The guidelines do not cover all aspects of the Code and are thus no substitute for a detailed study of the Code as a whole, including the supplementary information.