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Life sciences industry welcomes UK's ratification of Unified Patent Court Agreement
On World Intellectual Property Day (26 April 2018), the UK government confirmed that it had taken the positive step of ratifying the Unified Patent Court Agreement. This latest development, which underlines the UK's commitment to robust intellectual property protection, has been welcomed by several bodies, including the BioIndustry Association and the Chartered Institute of Patent Attorneys.
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Select Committee report on medicines, medical devices and substances of human origins
Last week the House of Commons Select Committee published its report on the impact Brexit may have on medicines, medical devices and substances of human origins, advocating very close regulatory alignment. You can read more on the report, its conclusions, and what life sciences companies need to do to prepare, on our Brexit blog.
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The impact of Brexit on access to medicines
The Department for Health and Social Care (DHSC) has commissioned Ernst and Young to conduct a study into the potential impact of Brexit on the supply of medicines, radioisotopes, vaccines and public health countermeasures in the UK.
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Update on E-health – drug prescription assistance software is classed as a medical device - Snitem (C 329/16)
An article considering the impact of the Snitem case on E-health applications
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Viagra to go over-the-counter: but how will you know it's real?
An article outlining the safety checks that consumers should follow when buying medicines over the internet.
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Chapter 2 in the Tale of Brexit, Medical Devices and MDR / IVDR: Suggestions for coping with the regulatory uncertainty
The UK is facing a perfect regulatory storm with the timing for Brexit and the staggered application of the various provisions of MDR and IVDR, with most of the provisions of the latter not being brought onto the UK statute book by the current draft of the EU (Withdrawal) Bill. Without clear guidance from the UK government on this point, it is difficult for medical device companies to know what to do to ensure that they might be able to continue to sell their devices on the market in the UK and the EU27 after Brexit. This post provides some ideas for how to cope with the uncertainty, ensuring you might prepare for the most favourable position in readiness for Brexit (scroll to section 4. at the bottom if you want the advice without the theory).
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Fieldfisher Life Sciences Team Recognised in Legal 500
The extensive Fieldfisher life sciences team has been ranked once again by the Legal 500 and many team members recognised for the specialist client advice.
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Generation Genome: the future is here – IP, regulatory and data protection challenges
First published in Digital Health Legal this article considers the IP, Regulatory and Data Protection challenges that need to be considered as the Government looks to move forward with personalised and genomic medicine.
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Energising Medical Devices
In this article published in the October 2017 issue of PharmaTimes, we explore how medical device companies can strategically use their IP to achieve their commercial goals and maximise the rewards flowing from their products.
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UK and overseas companies in the frame: two new corporate criminal offences in force as of 30 September 2017. What is the Criminal Finances Act 2017 and how should Life Science companies react?
Guidance for Life Science companies on the Criminal Finances Act, outlining various risk situations that might arise in business activities and noting items to think about in preparing to be compliant with the Act.