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Julia Gillert

Julia joined Baker McKenzie's London office as a trainee in 2005, qualifying in 2007, with a secondment to the Singapore office, and has shaped her practice to focus exclusively on regulatory matters affecting the Healthcare & Life Sciences industry.

On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation. The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorization and supervision of medicines.

On 26 April 2023, the European Commission finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical Strategy for Europe, and its aim is to make medicines more available, accessible and affordable whilst at the same time supporting innovation and boosting the competitiveness of the EU pharmaceutical industry.

In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in stark contrast to the more static and prescriptive approach of the EU AI Act. Instead of assigning responsibility for AI governance to a new single regulator, the UK Government is empowering existing regulators to come up with tailored approaches for specific sectors. The aim is to ensure that the UK remains a flexible and innovation-friendly jurisdiction for AI developers. The flipside is that the UK approach may leave gaps between regulators, by failing to take a more holistic approach along the lines of the EU.

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.

A new EU-level recommendation paper sets out wide-ranging recommendations for sponsors of decentralized clinical trials (DCTs). The Paper is great news for sponsors facing an array of grey areas and gaps in regulatory guidance around DCTs. It provides guidance on common issues in designing and implementing DCTs: from documenting the delegation of tasks to digital service providers, to obtaining e-consents and how investigators should manage new streams of incoming data. The recommendations are not legally binding, but the Paper nevertheless represents a vital step towards a common basis for implementing DCTs across the EU.

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).

The UK government has announced that the implementation of the future UK Medical Device Regulations will be pushed back from 1 July 2023 to 1 July 2024. The MHRA’s announcement means that CE-marked products will continue to be accepted in Great Britain and manufacturers will only be required to obtain a UK Conformity Assessed mark from July 2024. As a result, this extension will provide manufacturers an extra year to ensure that their products are compliant with the new UK regime.

The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the basis of the upcoming UK Medical Device Regulation reforms in 2024. In light of the operational difficulties faced by the NHS, AIaMD and SaMD are attractive solutions to alleviate pressures on the UK health system. Yet these products are complex and require a high level of regulatory scrutiny to ensure effectiveness and protect the safety of patients.