2021 pharmaceutical industry Code of Practice launched

Publication comes alongside new ABPI Principles to help companies operate to high ethical standards.

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. It is independently administered by the Prescription Medicines Code of Practice Authority (PMCPA).

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. They are key to how the industry operates and essential in building trust. All companies are expected to embed them in their organisations. The principles are:

• Benefitting patients
• Acting with integrity
• Promoting transparency
• Treating everyone with respect.

Changes to the 2021 Code include:

• Layout – The new Code is arranged in six themed sections:

o overarching requirements
o promotion to health professionals and other relevant decision makers
o interactions with health professionals, other relevant decision makers and healthcare organisations
o interactions with health professionals, other relevant decision makers, healthcare organisations, patient organisations and the public including patients and journalists
o specific requirements for interactions with the public, including patients and journalists and patient organisations
o annual disclosure requirements

• Working with the NHS - introduction of the concept of ‘collaborative working’ with healthcare organisations. This is intended to reflect the scope of projects on which healthcare organisations and industry can work together for the joint development of patient and/ or healthcare centred projects. Companies can continue to take part in 'joint working' with the NHS for the benefit of patients.

• Contracted services - 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. This will be done on company websites.

• Changes to MEGS - Medical and Educational Goods and Services (MEGS) are now replaced and can be provided as either donations or collaborative working.

• Impact of the pandemic – The Code recognises that in public health emergencies, temporary supply authorisations for medicines may be given. There are various references to temporary supply authorisations in the Code including a new clause that a medicine with a temporary supply authorisation 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.

Welcoming the new Code, ABPI Chief Executive Richard Torbett said:

“We are proud of our Code which holds companies to standards which go above and beyond the law.

“The 2021 version of the Code has seen a substantial overhaul, and I’m confident that it will help companies keep to high standards and forge transparent and collaborative relationships for the benefit of patients."

ABPI President Ben Osborn said:

“From this year we are putting new emphasis on the ABPI’s Principles.

“We want everyone in pharmaceutical companies to live and breathe these from leadership teams and commercial leads to admin assistants and research scientists. It’s all of our responsibility to put the Code and its Principles into action.”