Life Sciences - Healthcare

Recent Articles

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  14/05/2024

  Hungary

  EU introduces criminal offences and penalties for sanctions violations

  Criminal offencesUnder the Directive, the following conduct constitutes a criminal offence when committed intentionally and in violation of restrictive measures or a national provision implementing restrictive measures:making funds or economic resources available directly or indirectly to, or for the benefit of, a designated person, entity or body;failing to freeze funds or economic resources belonging to or owned, held or controlled by a designated person, entity or body;enabling designated natural persons to enter into, or transit through, the territory of a EU member state;entering into or continuing...

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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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  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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  25/03/2024

  Europe

  Patentability of inventions relating to diagnostic methods at the EPO

  Under Article 53(c) of the European Patent Convention (EPC), diagnostic methods practised on the human or animal body are excluded from patentability. The purpose behind this exclusion is to avoid patent infringement by medical and veterinary practitioners when carrying out a medical diagnosis. How Article 53(c) EPC should be applied was discussed in detail in the Enlarged Board of Appeal decision G 1/04.In this decision, the Board held that the exclusion of diagnostic methods from patentability should be interpreted narrowly and sets out specific criteria for the assessment of this exclusion.The...

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