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Julia Gillert

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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.

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.

In a draft compromise text obtained by Politico, the European Council has dropped a key provision seeking to harmonize telemedicine from the draft European Health Data Space. The (now-removed) Article 8 was aimed at encouraging the cross-border provision of telemedicine services across the EU. However, the reality is that there are vast national differences between Member States on telemedicine-related laws. It is going to require a far more concerted legislative effort to harmonize this area of law across the EU.

EFPIA, the European Federation of Pharmaceutical Industries and Associations and IFPMA, the International Federation of Pharmaceutical Manufacturers and Associations, published at the end of September 2022 a long-awaited Note for Guidance to assist their member companies with their use of social media and digital channels. The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code.

In 2020, the European Commission began a review of the EU’s rules on blood, tissues and cells used for medical treatments and therapies. Now the Commission has published a draft legislative proposal to amend the rules. The proposal does not recommend a complete overhaul: the EU will not change its definitions of blood, tissue and cell products. Yet it does promise a significant update to the two Directives published in the early 2000s that continue to govern the use of BTC components in the EU. Most importantly, the proposed legislation would be packaged as a Regulation rather than a Directive, meaning it would have a direct effect in the Member States.

In November 2018, the law surrounding the prescription of medical cannabis was changed by the British Home Office. Promising developments occurred in the year after this, including the approval of a cannabis based drug for childhood epilepsy and the opening of London’s first medical cannabis clinic with 150 patients on a waiting list. Nevertheless, almost four years on from the relaxation of barriers to access, it appears that minimal tangible progress has been made, particularly as it pertains to patient access which was the key motivation triggering government officials such as Home Secretary Sajid Javid to change the law in 2018.

A revision of EU pharmaceutical legislation by the European Commission will be published on 21 December. These revisions indicate the execution of the European Commission’s 2020 Pharmaceutical Strategy – a strategy that seeks to create a more resilient regulatory system in light of the COVID-19 pandemic.

The MHRA has been accepted as a full member of three groups: the International Medical Device Regulatory Forum (IMDRF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the US-based Medical Devices Innovation Consortium. These partnerships bolster the MHRA’s position as an influential international player in medicinal and medical device regulation and restore the MHRA’s ties with the IMDRF and ICH.