The PMCPA have published the approved wording of the 2021 ABPI Code of Practice, along with some supporting documents on their website (https://www.pmcpa.org.uk/the-code/forthcoming-2021-abpi-code-of-practice/).
What do you need to know?
- This is a “technical release” to support implementation by companies. The full final document in the format that we’re accustomed to is not yet available as changes are still to be approved to the Constitution & Procedure of the PMCPA, and the Guidelines on Company Procedures Relating to the Code (the two sections between the end of the clauses and the index at the rear of your booklet that you may or may not have consulted before but are important!).
- The new Code comes into operation on 1st July 2021. There will not be a transition period other than for MEGS where a further six months is available before the changes must be implemented (see Clauses 23 and 20).
- The revised principles allow companies to reinforce the importance and privilege of self-regulation both internally within their organisations, and externally.
- The PMCPA are planning to run topic-led webinars and are interested to receive feedback on the topics that companies are most interested in discussing.
- Topics still being worked on to be incorporated into future updates to the Code: legislative requirements surrounding prescribing information (in conjunction with the MHRA); Risk Minimisation Material; Early Access to Medicines Schemes; information for patients.
- No, we don’t know what colour it’s going to be yet! 🙂
What do you need to do?
- Review the new documents provided on the website.
- Establish a project plan for updating your internal company policies and procedures (which ones need to be updated, what company decisions need to be made, are there other updates that should be incorporated at the same time based on internal need and feedback, who will be part of the project plan for development, review and approval of documents).
- Determine how you will train employees and third party contractors on your updated policies and procedures (which roles are in scope, appropriate training methods, validation requirements).
- Develop your updated policies and procedures.
- Create training material.
- Execute your plans.
- Monitor and revise as appropriate.
