The consultation documents on proposed changes to the 2016 ABPI Code of Practice for the Pharmaceutical Industry and PMCPA Constitution and Procedure are published today (29 August 2018). Respond to 2018Consultation@pmcpa.org.uk by 10 October 2018.
Background to the proposals to amend the ABPI Code and the PMCPA Constitution and Procedure
The proposals to amend the ABPI Code take into account the need to ensure that the ABPI Code reflects UK law and incorporates requirements from the IFPMA and EFPIA Codes.
The approach agreed by the ABPI Board was that, wherever possible, topics are covered in Q and As. If the topic cannot be addressed by Q and A then the PMCPA should issue or update existing guidance. The current topics for PMCPA guidance (available on this website) are Clause 3; Advisory Boards; Certification; Digital and Clause 18. New guidance on working with patient organisations has been requested and work is starting on that. The agreed approach keeps proposals to change the ABPI Code and the supplementary information to a minimum. There has been some discussion about setting out principles in the Code of Practice booklet. The plan is to include the principles in the introduction to the Code and then to consider developing them in subsequent codes. This should work well following the work done by IFPMA and EFPIA to develop principles. Work has started on changes to the PMCPA website including improvements to the search facility. The overall aim is to ensure that those in companies have improved support to make well informed compliance decisions.
EFPIA is currently reviewing and consolidating its three codes. This is likely to mean further changes will be necessary to the ABPI Code. EFPIA plans to complete its work by the end of 2018/early 2019. The EFPIA consolidation will mean we will have to look again at the ABPI Code when we will also take the opportunity to reconsider relevant feedback.
There will be another version of the ABPI Code for 2020. IFPMA has recently agreed changes to its Code of Practice and this will be published shortly.
The documents below set out proposals to amend the 2016 ABPI Code and the PMCPA Constitution and Procedure:
Responses to 2018Consultation@pmcpa.org.uk by 10 October 2018. The ABPI press release is here.
The timetable is as follows:
Wednesday, 29 August
Proposals sent to ABPI members, non members that have agreed to comply with the Code and those organisations cited in the PMCPA Constitution and Procedure. Proposals put on the PMCPA website for public consultation.
Wednesday 10 October
Consultation closes. Responses to be sent to 2018Consultation@pmcpa.org.uk. Responses assessed.
Tuesday, 6 November
Final proposals for changes to the ABPI Code and to the PMCPA Constitution and Procedure to be agreed by the ABPI Board.
Proposals for changes to the Code and to the PMCPA Constitution and Procedure to be before the ABPI Half-Yearly General Meeting.
Ongoing/Finalise in December
Updating of guidance, developing new guidance, developing Q and A, work on PMCPA website.
Tuesday 1 January 2019
New Code to come into operation with a transition period.
Assess impact of new EFPIA Code, review ABPI Code and if needed.
Autumn Consult on further changes to ABPI Code.
1 January 2020 New ABPI Code.
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The ABPI Code sets standards for pharmaceutical companies which govern the promotion of medicines. The ABPI Code also includes requirements for pharmaceutical companies when working with healthcare professionals and patient organisations. It is administered independently of the ABPI by the Prescription Medicines Code of Practice Authority (PMCPA). The detailed provisions in the Code aim to ensure that pharmaceutical companies operate in a responsible, ethical and professional manner.