The UK’s Association of the British Pharmaceutical Industry (ABPI) has, together with the Prescription Medicines Code of Practice Authority (PMCPA), published the new Code of Practice for the Pharmaceutical Industry (the 2021 Code). Publication of the 2021 Code follows a consultation conducted in 2020, with subsequent revisions prior to approval on 12 January 2021.
The 2021 Code will be implemented from 1 July 2021 and represents a significant structural revision of the current 2019 Code. It is described as the most extensive revision to the Code in over 30 years. There is no transition period for the new arrangements after 1 July 2021, other than for medical and educational goods and services (MEGS). The supplementary information to Clauses 20 and 23 sets out a 6 month period (until 31 December 2021) during which ongoing MEGS, provided under Clause 19 of the 2019 Code, may continue without the need to be reclassified as either a donation or collaborative working and comply with any new requirements as a result of this change.
Some of the key changes introduced through the 2021 Code are summarised below.
Structure of the 2021 Code
The structure, and several definitions, of the 2021 Code reflect those of the 2019 European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice. The clauses of the 2021 Code are allocated to six colour-coded sections, principally relating to activities of particular stakeholder groups. These sections are:
- Overarching Requirements (Grey Section)
- Promotion to Health Professionals (HCPs) and Other Relevant Decision Makers (Blue Section)
- Interactions with HCPs, Other Relevant Decision Makers and Healthcare Organisations (HCOs) (Green Section)
- Interactions with HCPs, Other Relevant Decision Makers, HCOs, Patient Organisations (POs) and The Public including Patients and Journalists (Yellow Section)
- Specific Requirements for Interactions with The Public including Patients and, Journalists, and POs (Pink Section)
- Annual Disclosure Requirements (Teal Section)
The new thematic approach has resulted in some clauses from the 2019 Code being split between several clauses in the 2021 Code, some provisions (e.g. Clauses 3.1, 12.1, 15.1, 24.1 and 26.1) being duplicated as they are required to be in more than one section and some elements being deleted on the basis that they are no longer required. The 2021 Code includes 31 clauses, compared to the 2019 Code’s 29 clauses.
Key Changes Introduced in the 2021 Code
Most of the substantive requirements of the 2019 Code are reflected in the 2021 Code. However, there are a number of significant changes, including:
- Clause 2: The limitation of Clause 2 to promotional activities and materials has been removed from the 2021 Code; this overarching provision now applies generally and states: “Activities or materials must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry.”
- Collaborative working: Clause 20 of the 2021 Code addresses ‘collaborative working’, defined as “pharmaceutical companies working with other parties to deliver initiatives which either enhance patient care or are for the benefit of patients or alternatively benefit the NHS and, as a minimum, maintain patient care”. Collaborative working is broader than – but includes – the concept of ‘joint working’ (used in the 2019 Code), which is limited to activities involving direct benefit to patients. This change recognises the fact that some projects cannot show a direct benefit to patients and therefore fall outside the definition of ”joint working” in the 2019 Code.
- Contracted services: This term replaces ‘use of consultants’ in the 2019 Code, and envisage members of the public (e.g., journalists and patients) being covered by some of the requirements of the 2021 Code in relation to fee-for service arrangements. Only certain services by journalists or patients will, however, be covered by the 2021 Code, generally where these relate to healthcare, disease or medicine. A distinction is made between providing advice on the design of a clinical trial (falling within the 2021 Code) and participating in a clinical trial (falling outside of the 2021 Code). There is also an additional requirement from 2022 to disclose payments for contracted services paid to members of the public (not representing a PO) to include patients and journalists (to be disclosed in 2023). This was added following the publication of the EFPIA guidance ‘Working together with patients – Principles for remunerating patients, patient organisation representatives and carers for work undertaken with the pharmaceutical industry’.
- Events: The 2021 Code proposes a new definition of ‘events’, and its requirements relating to events apply to all company-organised meetings, including those with POs and journalists.
- Donations and grants: The term ‘Medical and Educational Goods and Services’ (MEGS) will no longer be used, although the same arrangements may still be provided but will be classified as either donations or grants or possibly as collaborative working. Clause 19 of the 2019 Code has been replaced by Clause 23 of the 2021 Code, which refers to ‘donations and grants’ and covers the provision of such benefits to POs as well as to HCOs. Clause 23.1 of the 2021 Code clarifies ‘In general donations are physical items, services or benefits in-kind which can be offered or requested. Grants are the provision of funds’. In addition, the 2021 Code requires that written agreements are put in place for all donations and grants and must be certified.
- Patient Organisations: POs and/or individuals representing POs are now explicitly covered by the clauses of the 2021 Code addressing the following activities :
- Donations and Grants
- Sponsorship of organisations in relation to Events and Meetings and other activities
- Contracted Services
- Disclosure which includes a requirement for a note summarising the methodologies used in preparing the disclosure.
- Digital communications: The text throughout the 2021 Code has been amended to refer explicitly to digital communications.
- Coronavirus amendments: Specific provisions have been made to Clause 3 Obligations, Clause 11 Marketing Authorisation and the supplementary information to Clause 26 Relations with the Public including Patients and Journalists. These relate to the temporary supply of medicines for public health emergencies, the promotion of such medicines to the health professionals and other relevant decision makers may proceed only with the approval of health ministers. In addition, the general prohibition on advertising of prescription only medicines to members of the public does not apply in relation to vaccination and other campaigns carried out by companies and approved by health ministers.
Although the 2021 Code will not be effective until 1 July 2021, the next few months will see various briefings and information being made available to help companies and stakeholders implement the changes, including:
- Guidelines on company procedures relating to the Code
- Guidance documents and Q and A
- Amendments to the Constitution & Procedure (which will require consultation)
- Introduction to the Code to be updated
- Communications plan for 2021 Code launch (July 2021)
- Training materials
- Website update and 2021 Interactive Code development