Healthcare

Recent Articles

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  16/04/2024

  APAC region

  Top developments and predictions in the Life Sciences & Healthcare sector in Asia-Pacific

  In this round-up, we look back at the top developments over the last 12 months in the life sciences & healthcare (LSHC) sector, and we look to the future with our top predictions for the coming year for businesses operating in the Asia-Pacific region.In 2023, China enhanced rules for the management of human genetic resources. It also intensified regulatory oversight in the sales of pharmaceuticals, medical devices, and cosmetics, particularly in the realm of online sales. Meanwhile, the Hong Kong government is actively working on unlocking the city’s potential in the Life Sciences &...

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  15/04/2024

  United Kingdom

  New and improved, or is it? – The CQC’s Single Assessment Framework

  The new Care Quality Commission (CQC) single assessment framework is now in force for health and social care providers across England. As background, the new framework aims to provide a single vision of quality for the whole health and care system – you can read more about the changes in our previous article titled “Out with the old, in with the new – what do healthcare and social care service providers need to know about the CQC’s new single assessment framework?” – (here)[1]. So now that the framework has been fully rolled out to providers, how is it going...

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  12/04/2024

  Europe

  Navigating clinical trial disclosures: No reasonable expectation of success in a patient sub-population in view of prior art reporting phase III clinical trial (T 1437/21)

  Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial. At a time when the European Medicines Agency (EMA) is requiring increased transparency for EU clinical trials, this case law is of increasing importance to those operating in the pharmaceutical space.In brief, this decision further supports the position that the disclosure of a clinical trial protocol does not always mean there is a reasonable expectation of success of achieving treatment. The...

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  08/04/2024

  Hungary

  Hungary proposes ex-ante competition tool to regulate essential companies

  On 2 April 2024, the Hungarian Ministry of Justice submitted an omnibus act to the Hungarian parliament proposing the amendment of several Hungarian laws, including the Competition Act. This Proposal’s most noteworthy element is – based on the German example – expanding the Hungarian Competition Authority’s (HCA) toolbox by introducing a new ex-ante regime enabling the HCA to impose obligations on certain companies without first having to demonstrate a violation of the law.This following article summarises the Proposal’s new rules, potential consequences and next steps.PROPOSED...

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  04/04/2024

  England and Wales

  Supreme Court ruling on the correct approach for assessing PSLA in “mixed injury” claims

  In a judgment welcomed by claimants, the Supreme Court has upheld the Court of Appeal’s decision in the case of Hassam & Anor v Rabot & Anor [2023] EWCA Civ 19 in respect of the correct approach to take when assessing damages in mixed injury cases.Mixed injury cases are those where a claimant suffers a whiplash injury which falls within the scope of the fixed tariff system contained within the Whiplash Injury Regulations 2021 (made under the Civil Liability Act 2018) but also suffers additional injury which does not fall within the tariff system and is subject to a common law assessment...

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  03/04/2024

  Ukraine

  Register of Damage for Ukraine is open for claims submission

  On 2 April 2024, the Register of Damage for Ukraine opened the claims submission process for compensation for damage, loss or injury caused by Russian aggression against Ukraine. The launch took place as part of the Ministerial Conference "Restoring Justice for Ukraine" co-hosted by the Netherlands, Ukraine and the European Commission at the World Forum in The Hague.As a reminder, the official website of the Register of Damage for Ukraine was launched on 4 March 2024. The website contains the following:documents governing the work of the Register;answers to frequently asked questions on the Register’s...

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