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Can I have an SPC for my drug-device combination?
Spoiler alert: No, you can’t, says the CJEU in its ruling on C-527/17 (Boston Scientific)
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PMCPA Code – can pharmaceutical companies be responsible for the actions of their corporate parent?
Pharmaceutical companies rarely operate in one country, and are normally supported by an international parent company and numerous subsidiary companies around the globe. However, a parent company in another country may not appreciate the regulatory responsibilities in the UK, and may cause problems for the UK subsidiary.
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Opaque CJEU ruling threatens future of gene editing in the EU: CRISPR-Cas9 organisms are subject to rigid controls of GMO Directive
The Court of Justice of the European Union (CJEU) has ruled that organisms created using modern gene editing tools – including CRISPR Cas-9 - should be subject to the same stiff regulation as genetically modified organisms (GMOs).
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MDR / IVDR Transitional Regime: Timing is All!
It is less than 2 years before MDR and 4 years before IVDR become fully applicable, and medical devices manufacturers requiring notified body certification for CE marking should assess their regulatory position urgently to avoid the situation of not being able to sell their devices in the EU.
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Brexit – How is it looking for Life Sciences Companies?
The UK government has this week published four reports indicating that market access for UK life sciences companies will not change during the Brexit implementation period of 29 March 2019 to 31 December 2020. So why are various pharmaceutical companies announcing plans to stockpile drugs in preparation for Brexit?
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Latest guidance from the CJEU on repacking/overstickering of medical devices
Under EU trade mark rules, a trade mark owner may be able to prevent the further commercialisation of its medical devices through parallel importation. What happens when the importer simply adds a small additional label? This question has recently been answered by the CJEU and we discuss the practical implications in this blog on our Intellectual Property blog, SnIPpets.
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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