The ABPI have commenced their public consultation on changes to the ABPI Code of Practice. These incorporate amends that are required from the recent consolidation of three EFPIA Codes to one single EFPIA Code, but also respond to the needs within the UK industry, specifically ensuring the Code is accessible, and future-proofing the Code where relevant and possible.
There are very obvious changes to the layout of the Code with the adoption of "Chapters", and a restructuring of clauses (and associated clause
numbers). Clause 2 remains as the clause which addresses the reputation of the industry. There are four clear principles that sit above the requirements of the Code which echo those adopted by EFPIA; they outline the industry's commitment to patients, that we act with integrity, ensure transparency, and act with respect .
The supplementary information remains as a guide to support the application of the requirements of the Code, however some of the previous content has been extracted and will be incorporated into new Q&A or Guidance documents to be made available in early 2021.
The new 2021 Code will be published by 1st January 2021, however the 2019 Code will remain applicable until 30th June, allowing companies six months to incorporate and train staff on the changes and new requirements.
The consultation closes on 8th September 2020. Full details on the proposals can be accessed here. A new online tool has been developed by the ABPI that allows for responses to be submitted directly online; access to the submission portal can be found at the bottom of this page.
What you should do now:
Companies should review the proposals and provide ONE response representing the views of their organisation.
As this is a public consultation, individuals and other organisations are invited to provide comment on the proposals also. In doing so, this allows for people working in the industry to share their personal views which may not necessarily reflect those of their employer.
Responsible individuals should block time in their 2021 calendar to work on updating their company's Code-related policies and procedures. It can be assumed that everything will require an update; some changes will be minor, others will be more significant, so there will be an extensive amount of work in doing this.
Input into corporate calendars as soon as they become available for 2021 to secure training time with staff.
If you are interested in securing external support to review your existing processes in light of the changes, update your quality documents, provide training to all staff or focused training to key groups, e.g. marketers and signatories, Pharma Integrity will be happy to help you. You can contact us at Info@PharmaIntegrity.com.
Note: We know that there will also be a revised IPHA Code in 2021 but details on what will be incorporated have not yet been announced. It is likely that the consultation on the IPHA Code will be restricted to members of IPHA only, and there won't be a public consultation on the changes.