After consultation with members and stakeholders, the Code of Practice 2021 has been agreed. The current version from 2019 will be replaced by the 2021 version with effect from 1 July 2021.
The ABPI Code of Practice, administered by the Prescription Medicines Code of Practice Authority on behalf of the ABPI, has regulated the promotion of medicines by pharmaceutical companies to health professionals since 1958. Since the writer’s first involvement in the life science and pharmaceutical industry in 1988, the Code has been amended more than a dozen times.
The objectives behind the latest revisions are to reflect the structure of the latest version of the Code for the European Federation of Pharmaceutical Industry Associations (EFPIA) and to “simplify, clarify, harmonise and remove repetition” and, more generally, to make it accessible for its intended audiences and be future-proofed, where possible.
As a reminder, amongst the guiding tenets of the ABPI are the following key principles:
“Patients are at the heart of our industry. We aspire to ensure that everything we do will ultimately benefit patients. Our primary contribution to society is to research and develop high quality medicines and to encourage their appropriate and rational use. Patient safety is paramount.
Ethical relationships with stakeholders are critical to our mission of helping patients, guiding the appropriate use of our medicines and ensuring the appropriate and timely exchange of scientific information”.
The new code contains a thematic colour-coded approach to the required standards relevant to particular stakeholders:
- Overarching Requirements – Grey
- Promotion to Health Professionals – Blue
- Interactions with Health Professionals and Healthcare Organisations – Green
- Interactions with Health Professionals and Healthcare Organisations, Patient Organisations, the Public and Journalists – Yellow
- Specific Requirements for Interactions with the Public, including Patients, Journalists and Patient Organisations – Pink
- Annual Disclosure Requirements – Teal
Some of the key changes include:
Clause 2 of the 2019 version states that “Activities or materials associated with promotion must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry”.
Clause 2 of the 2021 version removes the words “associated with promotion” so that it now reads:
“Activities or materials must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry”. This important overarching obligation therefore applies across the board to all activities of pharmaceutical companies.
Clause 20 of the 2021 Code introduces the concept of “collaborative working”. This covers “working with other parties to deliver initiatives which either enhance patient care or are for the benefit of patients or alternatively benefit the NHS and as a minimum, maintain patient care”. This definition goes further than “joint working” under the 2019 code which covered only activities involving direct benefit to patients.
This term replaces “use of consultants”. There is also an additional requirement from 2022 to disclose payments for contracted services paid to members of the public not representing patient organisations.
Donations and Grants
The term “Medical and Educational Goods and Services” from the 2019 version is no longer to be used, but these goods and services will now be covered by donations and grants. “Donations” will cover physical items and services whereas “Grants” now just covers the provision of funds.
The new code expressly refers to digital communications throughout.
Covid 19 Amendments
A number of amendments have been made, including to Clause 26, Relations with the Public, to reflect the impact of the coronavirus. These include the temporary supply of medicines for public health emergencies; promotions of such medicines to health professionals can only be made with the consent of health ministers. Finally, the usual prohibition of advertising prescription-only medicines to members of the public does not apply to vaccination campaigns carried out by pharmaceutical companies and approved by health ministers. For full details click here.
For those readers who are very familiar with the 2019 Code, changes from the 2019 version are shown in the tracked changes version shown here.
Following publication of the agreed Code for 2021 the PMCPA is consulting on two further amendments that it wishes to make before the Code takes effect on 1 July 2021. Once these proposed amendments have been considered and published by the PMCPA, Prospect Law will publish a short summary.
About the Author
David McIntosh was admitted as a Solicitor in 1988 and is a highly experienced commercial projects lawyer who has advised clients in a number of different fields including intellectual property, data privacy, procurement law (both public and private), manufacturing, distribution, information governance and general regulatory matters covering both the nuclear and pharmaceutical sectors.
Prospect Law is a multi-disciplinary practice with specialist expertise in the energy, infrastructure and natural resources sectors with particular experience in the low carbon energy sector. The firm is made up of lawyers, engineers, surveyors and other technical experts.
This article remains the copyright property of Prospect Law Ltd and Prospect Advisory Ltd and neither the article nor any part of it may be published or copied without the prior written permission of the directors of Prospect Law and Prospect Advisory.
This article is not intended to constitute legal or other professional advice and it should not be relied on in any way.
For more information or advice on your company’s promotional arrangements to healthcare professionals, or any issue arising from the 2021 Code, please contact David McIntosh on email@example.com or +44 (0)7940 204 948.