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  • Consultation on legislative changes to support the rollout of COVID-19 vaccines in the UK

    On 28 August 2020, the UK Department of Health & Social Care published a consultation on proposed changes to the Human Medicines Regulations 2012 (HMRs) to support the rollout of COVID-19 vaccines. The UK government states that although it is preferable that a new vaccine for COVID-19 is deployed through the usual marketing authorisation (product...

  • UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients

    The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims...

  • Guidance from the EU EMA and UK MHRA on clinical trials during the COVID-19 Pandemic

    The EMA and the competent authorities of the EU Member States have issued guidance to manage the conduct of clinical trials and the supply of medicinal products during the COVID-19 pandemic. This Guidance is particularly important for all sponsors conducting studies in the EU and for pharmaceutical companies supplying medicines in the EU. We discuss...

  • UK government publishes new draft legislation on medicines and medical devices

    The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period...

  • Paroxetine: AG Rules on Reverse Payment Settlement Referral

    Advocate General Kokott issued her opinion last week in the preliminary ruling referral from the UK Competition Appeal Tribunal (CAT). The CAT proceeding is itself an appeal against an infringement finding against a number of companies (except one, IVAX, which is now part of TEVA, which received a ‘No Grounds for Action’ letter). AG Kokott...

  • Join the Next Future Pharma Forum: Competition/Antitrust Seminar, 13 June

    Arnold & Porter’s Future Pharma Forum invites you to a complimentary competition/antitrust seminar aimed at junior lawyers and professionals new to the UK/EU life sciences industry. This seminar will provide a refresher of key EU and UK competition law topics, cover some key issues from an in-house practitioner’s perspective and touch on the implications of Brexit....

  • Impact of UK’s Temporary Tariff Regime on Life Sciences

    The UK Government published today details of the temporary tariff regime that will apply from 11pm on 29 March 2019 if the UK leaves the European Union (EU) without a deal (see here). This is being published ahead of the vote in Parliament on no deal to ensure that the members of parliament are well...

  • Frustrated by Brexit?

    On 20 February 2019, the English High Court delivered its eagerly awaited judgment in Canary Wharf v EMA [2019] EWHC 334 (Ch), rejecting the EMA’s argument that the United Kingdom’s withdrawal from the European Union would amount to a frustrating event allowing it to terminate its lease of premises in London. What is frustration Under...

  • Amendments to UK Human Medicines Regulations 2012

    On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012,  was laid before Parliament.  These regulations will come into force on 9 February 2019. The principal purpose of the amendments is to transpose into UK legislation the remaining provisions of Directive 2011/62/EU...

  • MHRA’s updated guidance on a hard-Brexit

    As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 without a deal, known as a “hard Brexit”. Following publication of the technical notice in...

  • Join us on 31 January for the 2019 Regulatory Boot Camp!

    Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit. Topics Overview of the EU...

  • Brexhaustion: IP Rights and Exhaustion Post-Brexit

    On 28 November 2018, the UK Government published draft secondary legislation changing UK intellectual property law relating to exhaustion of IP rights to deal with Brexit. The aim is to ensure that the doctrine of EEA-wide exhaustion continues to apply in the UK post-Brexit, irrespective of whether there is a deal or a no-deal Brexit. What...

  • Battle for access to information underlying the UK CMA dawn raid of Concordia

    On 5 December 2018, the High Court rejected Concordia’s application to obtain full access to the information underpinning the Competition and Markets Authority’s (CMA) application for a warrant for a dawn raid, over which the CMA had claimed public interest immunity (PII). The judge did, however, allow Concordia access to some information. This ruling is...

  • The UK 2019 Voluntary Scheme

    The UK Government (Department of Health and Social Care, DHSC) and the ABPI have announced today that they have agreed the Heads of Agreement for what will now be called a Voluntary Scheme for Branded Medicines Pricing and Access, expected to become effective from 1st January 2019 following the end of the current 2014 Pharmaceutical Pricing...

  • UK Supreme Court rules on validity and infringement of second medical use patents

    On 14 November, the Supreme Court handed down its judgment on the validity and infringement of the second medical use patent that protected Pfizer’s Lyrica® (pregabalin) for the treatment of various types of pain. In Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Anor [2018] UKSC 56, the Court decided that the patent...

  • MHRA guidance on no-deal Brexit

    In July, we considered the implications of the UK Government’s Brexit White paper, setting out its proposals for the UK’s ongoing relationship with the EU post-Brexit and how this would apply to the supply and manufacture of medicinal products and medical devices. Acknowledging the need for a contingency plan if no agreement can be reached,...

  • UK guidance for developers of health care software and technologies

    Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way. In response to early issues with the deployment of...

  • UK guidance for developers of health care software and technologies

    Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way. In response to early issues with the deployment of...

  • CJEU rules on SPCs for combination products

    On the morning of 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down judgment in Case C-121/17 Teva UK and Others v Gilead concerning the validity of Supplementary Protection Certificate (SPC) protection for Gilead’s combination HIV treatment TRUVADA (tenofovir disoproxil and emtricitabine). The CJEU held that an SPC can only...

  • UK Government’s Brexit White Paper

    Yesterday, the UK Government finally published its White Paper setting out its position on the UK’s continued relationship with the EU post-Brexit. Theresa May has said it “delivers on the Brexit people voted for”, although others in Parliament disagree. While at a very early stage of the negotiations, and with no real indication of how...

  • UK Supreme Court: rights-holders must pay costs of blocking IP-infringing websites

    In today’s judgment, the UK Supreme Court held that rights-holders should bear the costs of implementing website blocking injunctions to prevent IP infringement. The judgment overturns the practice adopted by the English courts since 2011 of requiring internet service providers, as innocent intermediaries, to bear these costs. A website-blocking injunction requires an internet service provider...

  • Revised model Clinical Trial Agreements applicable across the UK

    In February 2018, the Integrated Research Application System (IRAS) issued revised versions of the template model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA, used where clinical research organisations undertake site management responsibilities on behalf of the sponsor). The new mCTAs are designed to be used without modification for...

  • The UK’s Human Medicines Regulations 2012: MHRA issues its post-implementation review

    On 5 December 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a Post-implementation Review of the Human Medicines Regulations 2012 (the Review). The Review assesses the effectiveness and impact of the Human Medicines Regulation 2012 (the 2012 Regulations), which were introduced in the UK with a view to implementing a series of...

  • ECJ confirms rights holders can stop cloud-based television recording services

    On 29 November 2017, the Court of Justice of the European Union (ECJ) confirmed that, under the Copyright Directive (the Directive), the making available of copies of television programmes saved in the cloud must be authorised by the holder of the copyright or related rights. VCAST Limited, a UK incorporated company, made a video recording system...

  • Meaning of defect? Court of Appeal clarifies s3 Consumer Protection Act 1987

    What does “defect” mean? Rarely has the Court of Appeal been required to examine the meaning of “defect” within Section 3(1) of the Consumer Protection Act 1987 (the Act). In Baker v KTM Sportmotorcycle UK Ltd and another [2017] EWCA Civ 378, the Claimant, a maxillofacial surgeon, had suffered severe personal injuries when the front...

  • MHRA guidance on human factors for medical devices

    Last month, the UK MHRA published new guidance on human factors and usability engineering for medical devices to be taken into account when designing medical devices in accordance with the regulatory framework. ‘Human factors’ refer to how a person interacts with a product, and will depend on, among other things, the design of the product,...

  • What is the impact of the new Ofcom penalty guidelines?

    On 14 September 2017 Ofcom, the UK communications industry regulator, adopted new statutory guidelines (Penalty Guidelines) on how it would assess and determine the penalties (fines) payable by regulated communications companies who breach their obligations under the Communications Act 2003 (Act). The revised guidelines follow Ofcom’s June 2017 adoption of new guidelines for enforcement in...

  • UK Government seeks EU equivalency for UK data protection law post-Brexit

    The UK Government has released a “Future Partnership” paper setting out its vision for UK-EU data flows post-Brexit. In particular, the paper anticipates seeking an early UK-EU agreement that each area’s data protection laws provide equivalent protection, which would allow data to continue to flow between the EU, the UK and other third countries post-Brexit. ...

  • UK’s Digital Minister announces changes to UK data protection law

    With holiday season upon us, earlier this week Matt Hancock, the UK Government’s Digital Minister, announced proposals for a new UK data protection law. Previously covered on this blog here and here, little new of substance was announced, but in a slow news week, the announcement garnered significant UK media coverage and attention.  In his press release, Mr Hancock said: The new...

  • A nation of binge-watchers: Ofcom reveals the UK’s TV and online habits in its annual report

    Ofcom published its annual Communications Market Report this week. This report provides a reference for industry, stakeholders and consumers across the sectors Ofcom regulates.  A handy bite-size version of the report is available here. What has the 2017 report revealed? The increased take-up of fixed and mobile data services is extending people’s choice over how, where and...

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