UK – The Association of the British Pharmaceutical Industry (ABPI) 2021 Code of Practice comes into force from 1 July, alongside new ABPI Principles to help companies operate to high ethical standards.
The ABPI Code of Practice is the industry’s commitment to operate in a professional, ethical, and transparent manner, for the benefit of patients and the public.
The 2021 Code has been updated to make the Code easier for companies to use in their day-to-day activities, to reflect changes in the environment companies operate in and to reflect updates to the European Code.
Some new elements increase transparency and others will help companies work together with the NHS within an ethical framework to improve patient care.
All the changes are intended to help the industry continue to uphold high standards. The requirements in the existing Code already go above and beyond the law.
The ABPI is also putting increased emphasis on the ABPI Principles, which sit alongside the Code and they include benefitting patients, acting with integrity, promoting transparency and treating everyone with respect.
Changes done to the 2021 code
Layout: The new Code is arranged in six themed sections currently with the first section having the overarching requirements then follows promotion to health professionals and other relevant decision makers in the second section.
The third section will have interactions with health professionals, other relevant decision makers and healthcare organizations.
Section four takes in interactions with health professionals, other relevant decision makers, healthcare organisations, patient organisations and the public including patients and journalists.
Five adds in specific requirements for interactions with the public, including patients and journalists and patient organizations & six will have annual disclosure requirements.
The second change is working with the NHS that will have introduction of the concept of ‘collaborative working’ with healthcare organizations.
This is intended to reflect the scope of projects on which healthcare organizations and industry can work together for the joint development of patient and/ or healthcare centered projects.
Companies can continue to take part in ‘joint working’ with the NHS for the benefit of patients.
Our third change is contracted services which has a new requirement to disclose payments in aggregate for contracted services paid to members of the public, including patients and journalists from 2022, to be disclosed in 2023 and will be done on company websites.
Fourth is changes to Medical and Educational Goods and Services (MEGS) are now replaced and can be provided as either donations or collaborative working.
The final one is impact of the pandemic code that recognizes that in public health emergencies, temporary supply authorizations for medicines may be given.
There are various references to temporary supply authorizations in the Code including a new clause that a medicine with a temporary supply authorization must not be promoted unless it is part of a campaign that has been approved by health ministers.
Most requirements of the new Code come into force on 1 July, with the exception of an additional grace period until December 31 for companies transitioning ongoing MEGS to donations or collaborative working.