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.
Medical device companies anticipating new rules post-Brexit may be feeling somewhat overlooked to hear the BEIS’s recent announcement regarding UKCA marking. From this announcement, it transpired that the UKCA marking announcement did not include medical devices and in-vitro medical devices.
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.
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The Medicines & Healthcare products Regulatory Agency launched a consultation in early 2022 as part of its post-Brexit efforts to develop a world-class and flexible regulatory environment for clinical trials. The consultation closed in March 2022, but continues to offer insights into what the future holds for the UK regime for clinical trials.
On 4 January 2022, the new UK foreign investment review regime under the National Security and Investment Act 2021 came into force. The new rules require businesses and investors to submit mandatory notifications for certain acquisitions of, and investments in, companies active in 17 key sectors of the economy. They also grant the Government extensive powers to investigate and impose conditions on a wide range of transactions (including both corporate investments and asset transactions) on national security grounds.