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In Digital Health

Key Legal Trends in The United States For Healthcare And Life Sciences In 2024

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In brief As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life sciences and healthcare industries in the US. These developments include the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act; the rise of artificial intelligence in drug development and manufacturing; the evolving landscape of US Food and Drug Administration regulation and enforcement of laboratory-developed tests; and the…

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In Healthcare Services

France’s 2024 Social Security Financing Bill: Balance Between Hopes and Disappointments

by , , and 3 Mins Read

26 December 2023 marked the enactment of the annual French Social Security Financing Bill for 2024 (LFSS). As every year, the LFSS introduces a number of changes which could have a significant impact on companies in the life sciences sector. This year’s LFSS includes amongst other, new measures to fight shortages, a reduction of the maximum contribution payable under the safeguard clause for certain medicines and a new clawback mechanism for manufacturers of medical devices…

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In Healthcare Services

European Commission’s Actions to Prevent Medicine Shortages in the EU

by and 4 Mins Read

On 24 October 2023, the European Commission issued a communication setting out short-term and medium/longer-term actions to prevent or mitigate critical shortages at EU level, with a particular focus on the most critical medicines for which supply needs to always be assured in the EU. Actions to be taken in the short term include the following: The immediate deployment of a voluntary solidarity mechanism to support member states experiencing shortages. This scheme will allow member…

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In Healthcare Services

UK Aesthetics Sector Regulatory Shake Up

by and 5 Mins Read

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…

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In Healthcare Services

Kick Start your Healthcare Reorganisation: Post-Implementation Phase (Post 4 of 4)

by , and 4 Mins Read

In the third and final post of our ‘Kick Start your Healthcare Reorganisation’ series, we focus on the post-implementation matters often encountered on healthcare and life sciences reorganisations. These range from the many regulatory requirements through to ensuring steps are taken to realise the maximum value from the reorganisation. These post-implementation matters often bring us back to, and illustrate the importance of, careful early planning and seamless implementation. The significant consequences of any change of…

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In Healthcare Services

What of Significance did we get on Tax Legislation Day?

by , and 2 Mins Read

Following a consultation earlier in the year, the UK government has published draft legislation on the proposed design of a merged R&D tax relief scheme. The draft proposes that the existing schemes – the R&D expenditure credit (RDEC) and the SME R&D relief – be merged into a single scheme that would operate as an above-the-line expenditure credit (in line with the current RDEC). Given the value of R&D tax relief to the life sciences…

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In Healthcare Services

Kick Start your Healthcare Reorganisation: Implementation Phase (Post 3 of 4)

by , and 4 Mins Read

In the second post of our ‘Kick Start your Healthcare Reorganisation’ series we focus on the implementation phase of a healthcare and life sciences reorganisation and specifically the following three areas: document execution; funds flow; and operational go-live. Whilst each area is individually significant, and is likely to have its own dedicated workstream, it is important to recognise that they each go hand in hand when looking to achieve smooth (and successful) implementation. Document execution…

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In Healthcare Services

Termination of Hungary’s OGYÉI as an Independent Authority – A Look Back at OGYÉI Case law

by and 6 Mins Read

OGYÉI’s integration into the new authority As of 1 August 2023, the National Institute of Pharmacy and Nutrition (OGYÉI) shall be merged into the National Public Health Center. The new authority will be called the National Center for Public Health and Pharmacy (NNGYK). The new authority will be headed by the Chief Medical Officer, and in terms of administrative hierarchy, the NNGYK will be under the supervision of the Minister of the Interior, acting in the…

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In Healthcare Services

Animal Testing: EU Accelerates Phase Out of Animal Testing in Europe

by , , and 2 Mins Read

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…

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In Healthcare Services

The Tide is Turning for Psychedelics-based Therapies in the UK

by , and 6 Mins Read

Last month, the UK House of Commons debated the current state of regulatory and legal hurdles negatively affecting the development of psilocybin-based (the psychedelic compound most commonly found in ‘magic mushrooms’) therapies for mental and physical health disorders in the UK. The debate resulted from an e-petition, which garnered 11,824 votes in February this year. The debate saw a consensus among Members of Parliament across party lines, collectively supporting the proposal for rescheduling psilocybin from…

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