The UK’s Information Commissioner’s Office (ICO) has launched a public consultation on its draft guidance on transparency in the health and social care sector. The proposed guidance emphasises the importance of going beyond the legal requirements of the GDPR in order to build trust with patients, and builds on themes of openness, honesty and patient engagement. The consultation is open until 7 January 2024. We’ve set out our top six takeaways on the proposed guidance…
The EU has published its draft Standard Contractual Clauses for the procurement of AI (AI SCCs). These are drafted for public organisations (such as public hospitals) wishing to procure AI systems developed by an external supplier, and are based on the requirements for high-risk AI systems in the EU AI Act. The AI SCCs might be a good starting point, but dig a little deeper, and you’ll find that the clauses are based on some…
The UK government has issued proposals for a new licensing regime for currently unregulated cosmetic procedures whilst also intending to classify and regulate certain cosmetic products such as dermal fillers as medical devices. The government has brought forward an amendment to the Health and Care Act 2022 that gives the Secretary of State for Health and Social Care the power to bring into force a licensing scheme in England for non-surgical cosmetic procedures. The purpose…
On 25 July 2023, the EU Commission published its response to the European Citizens’ Initiative’s petition on “Save Cruelty-free Cosmetics – Commit to a Europe without Animal Testing”. The petition received 1.2 million signatures from EU citizens and the EU Commission must respond to petitions gathering 1 million signatures or more. The EU Commission has confirmed the following in response to the requests of the petition: Protect and strengthen the cosmetics animal testing ban The…
On 27 April 2023, the MHRA announced that the UK government intends to introduce legislation this spring that will extend the acceptance period of CE marked devices onto the Great Britain market. The MHRA’s announcement has provided much needed. This statement made by the MHRA is an update to their announcement made on 28 March 2023, on which we previously blogged. This is a very welcome step from the MHRA after what has been a…
On 15 March 2023 (Regulation (EU) 2023/607), the EU extended both the transition period for the EU Medical Device Regulations (EU MDR) and the validity of CE mark certificates. The new arrangements give manufacturers more time than previously anticipated to get their medical devices certified and they recognise the capacity challenges faced by notified bodies. Higher-risk devices now have until 31 December 2027 to ensure that they comply with EU MDR requirements and medium to…
In brief The amendment to the Medical Device Regulation 2017/745 (MDR) and the In Vitro Medical Device Regulation 2017/746 (IVDR) has been published and enters into force immediately (20 March 2023). What does this mean for your organisation? The amendment extends transitional periods under the MDR for legacy devices (if manufacturers act now) and removes the “sell-off” date under the MDR and IVDR. We’ve set out our top four takeaways below: 1. New extended transitional…
In brief 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 (MHRA), the ABPI, and pharmaceutical companies. It includes advice for companies to help them use…
In brief 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 (CHMP) positive opinion has been received, applicants can continue to submit their ECDRP Marketing Authorisation Application (MAA) or…
The UK’s Department of Health and Social Care has announced that the voluntary scheme payment percentage (VPAS) 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). VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and…