On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) published an updated Code of Practice for the pharmaceutical industry. Following an extensive consultation with over 3,000 comments, ABPI has announced that the new “orange” 2024 Code amends the previous 2021 Code in three key areas: the PMCPA constitution and procedure; the provision of prescribing information; and certain elements of the Code moving from guidance to mandatory requirements. However, there are also interesting amendments to the requirement to maintain high standards and obligation to seek a lawful basis for disclosure of transfers of value to an individual.

ABPI has said that the new Code seeks to “raise the high standards expected of pharmaceutical companies even further while also ensuring that complaints can be resolved quicker”.Continue Reading A New 2024 Code for the British Pharmaceutical Industry  – “The Future is Orange”

In a judgment handed down today, 10 July 2023, Mr Justice Turner refused permission for an application by the British Generic Manufacturers Association (BGMA) for judicial review of the refusal of the Secretary of State for Health and Social Care (SoS) to appoint it as a second “industry body” (in addition to the Association of the British Pharmaceutical Industry (ABPI)) for the purposes of negotiation of the next voluntary scheme controlling the prices of branded health service medicines. The result of this decision is that negotiation will involve only the SoS and the ABPI, albeit taking into account submissions from other industry bodies (including the BGMA) and other stakeholders.Continue Reading BGMA refused permission for judicial review in relation to negotiation of the voluntary scheme

On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published by PMCPA in 2016, the large number of complaints since that time is evidence of continued uncertainty regarding permitted activity in this area.    

However, while the Guidance acknowledges the challenges introduced by the “open and transitory” nature of social media, it broadly reflects recent PMCPA decisions and rejects the more permissive approach that some stakeholders had advocated was appropriate.  Nevertheless, the additional clarity provided by the Guidance is welcome and, by defining general principles applicable to use of social media and issuing more detailed guidance in certain areas, PMCPA has provided a framework to assist companies in managing their social media activity going forward. Continue Reading UK PMCPA publishes long-awaited guidance on use of social media

The VPAS Payment Percentage for 2023, including the adjustments for accumulated Under Payments, is expected to be in excess of 26%.  As such, a number of VPAS Members have indicated that they are considering moving from VPAS to the Statutory Scheme. We explore how the situation arose and the implications below.
Continue Reading Concern over high Scheme Payments under the UK VPAS

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.
Continue Reading New 2021 Code of Practice for the British Pharmaceutical Industry