A new ABPI Code for 2021

The 2021 version of the ABPI Code will come into effect on 1 July. This brings in important changes to the self-regulatory system for the UK pharma industry. It amounts to the most substantial refresh of the Code since the 1990s.

The Prescription Medicines Code of Practice Authority (PMCPA) has published the updated Code alongside other materials to aid understanding of the changes.

The Code has been updated to reflect the structure of the 2019 EFPIA Code of Practice. (The EFPIA Code recently underwent a consolidation process to simplify, clarify and harmonise it and remove repetition.) The new Code also addresses three themes identified by a working group: to develop the underlying principles, ensure the Code is accessible and future-proof it where possible.

ABPI Principles

A new section sets out four ABPI Principles. These are: benefiting patients, acting with integrity, ensuring transparency, and treating everyone with respect. These are to be championed by leaders, and built into business practices and culture at every level.

Collaborative working

A new section addressing collaborative working has been added. This includes the existing joint working concept but extends more broadly to encompass additional types of activity. Collaborative Working is defined as follows:

Collaborative Working’ refers to pharmaceutical companies working with other organisations to deliver initiatives which either enhance patient care or are for the benefit of patients or alternatively benefit the National Health Service (NHS) and, as a minimum, maintain patient care.

Additional information and examples are given in Clause 20 and the associated supplementary information. 

Transition period for MEGS

A transition period extending to the end of 2021 will apply for ongoing medical and educational goods and services (MEGS), as explained in the supplementary information to Clause 23. The additional six months is permitted before these need to be reclassified as donations or grants, or as collaborative working.

Ongoing work

Further changes may be required to address the different marketing authorisation categories following Brexit and to reflect ongoing work on virtual ways of working, information for patients, and the industry approach to homecare. The PMCPA has been providing briefings to industry participants to help with the transition to the new Code. It emphasises that there is flexibility to be innovative, noting that businesses will not be penalised for over-reporting.

Top ten questions

The PMCPA’s back to basics list of top ten questions is a good starting point for analysis. These are:

  1. Is the medicine/indication licensed?
  2. Why is it not promotional?
  3. What is the role of the company/agency staff?
  4. Are the overarching and disclosure requirements met?
  5. How would the company respond if there were a complaint?
  6. What would you think if a competitor did it?
  7. What is the purpose of the activity / material?
  8. Who is the audience?  Are you sure you are not advertising a POM to the public?
  9. Are all the arrangements documented and in line with company policies?
  10. Has the necessary certification/examination taken place?

It will take some time for the revised Code to bed in and we expect there to be a degree of uncertainty around the changes for a while. Users should check in with the PMCPA for additional briefings and guidance as they get used to applying it.

Learn more about our life sciences and health and care expertise.

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