The first ever guidance on social media has been issued by the Prescription Medicines Code of Practice Authority (PMCPA) to help pharmaceutical companies apply the high standards demanded by the industry’s ABPI Code of Practice to all their online communications channels. The PMCPA Social Media Guidance 2023 has been produced in consultation with the Medicines and Healthcare Products Regulatory Agency, the ABPI, and pharmaceutical companies. It includes advice for companies to help them use social media in line with these rules and the rest of the Code, following a huge increase in PMCPA complaint cases during the COVID pandemic, and a consensus from the industry that the previous 2016 guidance on digital communications, which did not cover social media platforms, was outdated and unhelpful given today’s online climate.
The MHRA lifted some extra burden from the industry by extending the European Commission Decision Reliance Procedure (ECDRP) by 12 months until 31 December 2023. The ECDRP was introduced following Brexit and is available to medicines approved via the EU centralized procedure.
Before 31 December 2023, in situations where a Committee for Medicinal Products for Human Use positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or variations to MHRA, and MHRA will continue to review these applications via the current ECDRP process.
The MHRA also announced that from 1 January 2024, a new international recognition framework will be in place, which will have regard to decisions already made by the European Medicines Agency/European Commission and certain other regulators.
The UK’s Department of Health and Social Care has announced that the voluntary scheme payment percentage for 2023 will be set at 26.5% of sales for 2023 (representing almost GBP 3.3 billion). This is a further major increase to last year’s VPAS significant rate rise to 15% (around GBP 1.8 billion, rising from GBP 0.6 billion in 2021).