Many people have asked for a simple declaration that the ABPI, and its Code of Practice, support industry and patient organisations working together. The Introduction to the ABPI Code has always referred to this, and the 2019 edition, in the principles and overview of self-regulation, states that:
“Working with patients and patient organisations can bring significant public health benefits.”
While this new sourcebook provides informal guidance, following it does not guarantee compliance. Companies need to ensure they comply with the ABPI Code.
This document has been prepared in response to suggestions from industry and patient organisations. There is a great deal of useful and thoughtful guidance available already from national and international organisations, in addition to the ABPI Code, and we are not seeking to replicate or replace what already exists. Rather, our aim in this sourcebook is to collate practical tools and tips and to provide pointers to sources of information.
The ideas you will find here constitute a framework for thinking and deciding on how best to engage with patient organisations. One size does not fit all, so inevitably there is not one template that can be applied to every situation. But we hope that you will find enough advice to help guide your way.
In 2018 the ABPI researched how its Code of Practice should be developed to take account of the evolving needs of patients and industry.
We talked to compliance, health and business professionals across the pharmaceutical industry, as well as representatives of patient organisations.
We found there was a desire for some further guidance that could sit alongside the ABPI Code and help build alliances between industry and patient organisations.
We held workshops to define the topic areas and to look at some possible responses. We also carried out desk research to bring together available guides, and spoke to colleagues at the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
We have structured the sourcebook around these six areas.
The ABPI Code of Practice sets standards for the promotion of medicines to health professionals and other relevant decision makers in the UK.
It also covers interactions between the industry and health professionals. The ABPI Code sets standards relating to the provision of information about prescription-only medicines to the public and patients, and pharmaceutical companies’ relationships with patient organisations. The ABPI Code does not cover the promotion of over-the-counter medicines to the public.
The ABPI Code is a self-regulatory code, first established by the ABPI in 1958. It is regularly updated and reviewed in consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA), the British Medical Association (BMA), the Royal Pharmaceutical Society (RPS), the Royal College of Nursing (RCN), the Competition and Markets Authority (CMA) and the Serious Fraud Office (SFO).
ABPI member companies agree to comply with the Code as a condition of membership, and in addition, about 60 non-member companies are signed up. The ABPI Code is administered by the Prescription Medicines Code of Practice Authority (PMCPA), which operates independently of the ABPI itself.
The ABPI Code demonstrates the commitment of the pharmaceutical industry to benefiting patients by operating in a professional, ethical and transparent manner, to ensure the appropriate marketing of medicines and to support health professionals in the provision of high-quality healthcare.
The Introduction to the ABPI Code sets out the sanctions that may be applied if a company is found to have breached the ABPI Code.