Looking Ahead

  • 26 November 2019 - Flynn Pharma v CMA - Appeal

  • 10 December 2019 - Teva UK Limited and ors v Gilead Sciences Inc – Appeal

  • 15 January 2020 – Glaxo v Vectura – Appeal

Ireland

  • 3 December 2019 - Anthropharm (Europe) Limited v Health Products Regulatory Authority Court of Appeal 2018 1080 JR – hearing

Decisions expected

Ireland

  • Merck Sharp & Dohme Corp -v- Clonmel Healthcare Ltd (McDonald, J) Ezetimibe & Impastation combination

Decisions

Court of Appeal considers approach to the assessment of safety under the CPA

Bailey and others v GlaxoSmithKline (UK) Ltd [2019] EWCA Civ 1924

This appeal considers how a defect should be analysed under s3 of the Consumer Protection Act and in particular what circumstances should be taken into account when determining what the public were generally entitled to expect in terms of safety. The defendant took the position that the approach should be holistic and that the court should look at risk and benefits whilst the claimants suggested a comparative risk approach. Ultimately the claimants sought to rely on the wider holistic approach. The appeal refers to guidance given in Wilkes v DePuy International Limited which supported the risk/benefit analysis as the appropriate one noting that “an assessment of safety will necessarily require the risks involved in use of that product to be balanced against the potential benefits including its potential utility” and that “risk benefit may lie at the heart of the question of appropriate level of safety of medicinal product for the purposes of the Act.” Whilst the decision is that the claimants were not entitled to rely on the holistic approach this does not represent any push back against the guidance in Wilkes v DePuy but instead is based solely on procedural issues. Although the Appeal judge did not comment explicitly on whether the guidance in Wilkes is the correct approach or not, the mention of the guidance suggests some implicit approval at least in terms of medicinal products, which should therefore be borne in mind by parties involved in cases under the Consumer Protection Act. The case is also interesting from a procedural perspective and may provide useful support where a party to proceedings seeks to stop the other party from the late bringing in of new issues. Decision

Brexit and UK Election 2019

What's new?

Businesses should study UK election manifestos closely

While it would be understandable to view next month's UK general election almost entirely through a Brexit lens, elections are rarely defined by a single issue. Brexit will provide the frame within which the December election will play out. But amid the Leave/Remain cacophony and the distraction of political soap opera, we shouldn't lose sign of the fact that whoever gains the keys to No 10 Downing Street will be elected to steer the direction of a huge swathe of domestic policy - much of which will be of direct and significant impact to business. In fact the Labour manifesto published on 21 November includes a commitment to "establish a generic drug company. If fair prices are rejected for patented drugs we will use the Patents Act provisions, compulsory licences and research exemptions to secure access to generic versions, and we will aim to increase the number of pharmaceutical jobs in the UK.” This was originally outlined in a Labour party paper 'Medicines for the Many' which we discussed previously here. More

UK UPC participation post-Brexit explored in EU paper

The policy department for citizens' rights and constitutional affairs has suggested that it will not be legally impossible for the UK to participate in the Unified Patent Court (UPC) system after Brexit; however, this outcome will only be possible with "innovative legal solutions". The policy unit said the UK government would have to accept patent law in the UK being shaped by the CJEU if it wants the UK to participate in the UPC system after Brexit. The question, the UK has to ask itself is therefore: can we participate in a UPC which relies on and refers to the CJEU? Worth noting is our update on the German constitutional case in the Other news section below. Details EU Patent and Brexit Research paper

Brexit resources

Withdrawal Agreement Briefing

This Briefing contains details of the key changes made to the Protocol on Ireland/Northern Ireland, the process for ratification, a summary of the key areas of consensus, and where appropriate suggests actions that businesses can take to manage risk now and to gain advantage. More

The life sciences sector and preparing for Brexit

This resource created by the Department for Business, Energy & Industrial Strategy (BEIS) collates guidance for preparing for a no deal EU Exit and can be viewed here.

Continuity of supply

The NHS England's website page regarding the continuity of supply of medical products can be viewed here.

No-deal handbook: A practical guide to preparing for a possible no-deal Brexit

Pinsent Masons' Brexit Advisory team have created a handbook to help businesses planning for a no-deal Brexit to understand what essential steps they should take to prepare for Exit Day, and how to mitigate the potential risks. Specific advice is available for sectors including Life Sciences. The handbook can be viewed here.

Report: How are the EU institutions and European countries preparing for Brexit?

Pinsent Masons' Brexit Advisory team have created a briefing to support businesses seeking to understand what specific changes to the law are currently being considered in light of Brexit. Insights have been gathered from our network of EU offices as well as from Belgium, France, Ireland, Italy, Germany, Spain and Switzerland. The briefing can be viewed here.

Pinsent Masons Brexit Hotline

Pinsent Masons has set up a Brexit Hotline to support clients to prepare their business for Brexit. GCs, in-house legal and operational teams can use this service to seek advice on specific Brexit-related issues or to identify the steps they could be taking now to prepare. The service can be accessed by email or phone:

E: Brexit Hotline T: +44 20 7490 6279

More information about our Brexit services can be found on our Brexit hub.

Other news

Spanish competition authority opens new pharma case

The Spanish Competition Authority (CNMC) has officially opened a competition law case against Merck Sharpe Dome, S.A. and parent company MSD Human Health Holdings, B.V. The details are patchy at this early stage although the CNMC have confirmed that it relates to a potential abuse of a dominant position, specifically the strategic misuse of intellectual property rights designed to delay entry into the Spanish market for combined hormonal contraceptives. The CNMC had previously carried out a dawn raid in May 2019. It has been ten years since the publication of the European Commission’s Pharma sector Inquiry and there is no indication that competition authorities are taking their foot off the pedal when it comes to active enforcement of competition law in the pharmaceutical sector. Press release

German ruling in Unified Patent Court case expected early 2020

The ruling on whether Germany's plans to ratify the Unified Patent Court (UPC) Agreement are in line with the country's constitution is expected to be issued in early 2020, the judge in charge of the case has said. Justice Peter Huber confirmed the likely timeframe for the eagerly anticipated decision of the Federal Constitutional Court for the first time in an interview with the publication Managing IP. More

OECD driving AI policy

The OECD plans to launch its AI Policy Observatory in early 2020. The aim of the observatory is to assist policymakers implement AI Principles. The OECD adopted its Principles on Artificial Intelligence in May this year, the first international standards agreed by governments for the responsible stewardship of trustworthy AI. The European Commission is expected to publish a new AI policy in March 2020. The OECD has recently published, with the Joint Research Centre of the European Commission, a report "Shaping the future of technologies and artificial intelligence". The report brings together data on patents, trademarks and scientific publications of the world’s top corporate R&D investors to shed light on the role of these key players in shaping the future of technologies, and of AI in particular. Interestingly the reports findings include that 54% of all AI patents are owned by 50 of the top 2000 R&D companies. Trade marks and scientific publications are far less concentrated. Principles on Artificial Intelligence OECD AI resources Report

Scrapping entrepreneurs' relief 'would be short-sighted'

The use of a report by the Institute for Fiscal Studies (IFS) as a justification for scrapping entrepreneurs' relief "is potentially a short-sighted view of the benefits of the relief". Ensuring that entrepreneurial business owners and investors maintain the view that the UK is an attractive place to live and do business is essential to the UK economy and a competitive tax rate on capital gains is part of this. More

ICO publishes new guidance on protecting special category data

The Information Commissioner's Office has published new guidance on how organisations should approach processing special category data which included genetic, biometric and health data. Guidance

GDPR cloud guidance issued in Ireland

New guidance provides "useful insight into how Ireland's data protection regulator will assess the way in which organisations engage cloud computing providers". Guidance issued by Ireland’s Data Protection Commission (DPC) highlights that organisations engaging cloud providers (‘data controllers’) must ensure that they have a written contract with the cloud provider (‘data processor’) to comply with the GDPR. The guidance provides a checklist of what a cloud service contract should contain. More

BEIS on future frameworks for international collaboration on research and innovation

Independent advice on a framework for future UK funding schemes for international collaboration, innovation and research was recently provided by Professor Sir Adrian Smith). Report Press release

IP and regulatory strategies can help drugs reach the market faster

As new technology shapes the drug discovery process, life sciences companies are urged to have a plan for protecting and commercialising their intellectual property (IP), and engaging with regulators. In understanding how their IP can be used to attract investment and how open dialogue can help overcome regulatory hurdles to obtaining marketing authorisation for new products, life sciences companies can obtain a potentially lucrative commercial advantage. Without a strategy, companies risk missing out on the investment needed, or rivals getting their products to market first. Details

Regulatory

New report on medicines subject to additional monitoring in the EU

This new report considers the experience gained on additional monitoring, a specific aspect of EU pharmacovigilance activities and whether its primary aim, to enhance side effects (ADR) reporting, has been achieved. The concept and scope of additional monitoring was introduced in Article 23 of Regulation (EC) No 726/2004 through Regulation (EU) No 1235/2010 and amended by Regulation (EU) No 1027/2012. During the 2012 revision of the pharmacovigilance legislation, the mandatory scope of the additional monitoring list was extended to certain medicines with specific post-authorisation obligations, namely:·products for which a post authorisation safety study (PASS) was requested at the time of marketing authorisation or following the granting of an authorisation; products which were granted a conditional marketing authorisation (CMA); products authorised under exceptional circumstances; and products authorised with obligations for stricter recording/monitoring of suspected ADRs. Additional monitoring aims to enhance adverse drug reaction (ADR) reporting for medicines for which the clinical evidence base is less well developed. Medicines that are subject to additional monitoring are identified by the inclusion of a black inverted triangle in the product information. Report

Some highlights of the EU Pharmaceutical Committee meeting on 7 November 2019

The Pharmaceutical Committee’s role as a consultative Committee to the EU Commission is to discuss policy matters and questions in the field of medicinal products covered by EU Regulation (EC) No 726/2004 and EU Directive/2001/83/EC. Policy areas recently identified as requiring attention include: identifying ways to help ensure Europe has a supply of affordable medicines and support the European pharmaceutical industry to ensure that it remains an innovator and world leader; achieve full implementation of the European One Health Action Plan against Antimicrobial Resistance; a communication on vaccination; and Europe’s Beating Cancer Plan. Areas of previous Committee discussions and elements of ongoing work are outlined in Section 4 on page 3 of this policy needs paper which include: drug repurposing; policy around security of supply chain, in particular APIs; regulation of innovative borderline products; and product information and digitalisation. The summary record of the meeting is not yet available but the following topics on the agenda are also worth noting:

  • Possible revision of the Commission note on the handling of duplicate marketing authorisation applications for biological products under CAP

    A paper was presented on this at the EU Pharmaceutical Committee on 7 November 2019. A targeted stakeholder consultation took place from 18 May to 10 September 2018. The objective of the consultation was to seek stakeholder views on the issue of granting duplicate marketing authorisations for biological medicinal products. The 2011 EU Commission note on the Handling of Duplicate Marketing Authorisation Applications did not include specific considerations for biological products and/or biosimilar medicines. The generic industry has raised concerns about the granting of duplicate marketing authorisations for generics in the case of biological medicinal products as only originator companies can request a duplicate of their own biological medicinal product as a generic. The main concerns are outlined in Section 2 of the paper. The results of the consultation are annexed to the paper. The main conclusion is that the introduction by an originator of a generic of its own biologic medicine cannot be assumed to have an automatic positive effect on availability and it would be for the applicant to demonstrate that this is the case. The vast majority of stakeholders consulted are of the opinion that more clarity is required as to how the legal provision of Article 82(1) of Regulation (EC) 726/2004 is to be applied and specifically what will “properly substantiated” and “sound evidence” actually entail. As a consequence the EU Commission is considering amending the Annex 1.1. of the 2011 Commission note on duplicates. The paper at section 4 sets out the EU Commission's proposed approach and member states are invited to comment. Duplicate Marketing Authorisation paper

  • EU strategic Approach on pharmaceuticals in the environment

    The EU Commission adopted the Communication on an EU strategic approach to pharmaceuticals in the environment in March 2019. The measures foreseen in the EU Strategic approach are to be discussed and further implemented by the Commission, Member States, the relevant Agencies and stakeholders. The Committee has proposed setting up an ad-hoc focused group for this area. Presentation

  • Reflection paper on the 'sunset clause' (Article 14, paragraphs 4, 5 and 6 of Regulation (EC) No 726/2004)

    This reflection paper considers the background to the legislation implementing the 'sunset clause' and how it is being applied. And while the "sunset clause" itself has so far not been subject to an authoritative interpretation by the EU Courts, many of the terms used in the wording of the provision, have been subject to court rulings and court interpretation. These include notions such as "placing on the market" and "Union market", which are key to understand the scope of the provision. The paper reviews the interpretation of these terms. Reflection paper

Medical devices: Latest notified body designations

The European Commission (EC) has announced Netherlands-based DARE!! Services B.V. and BSI Group the Netherlands B.V as the latest Notified Bodies (NB) to be designated under the EU's Medical Devices Regulation (MDR). BSI is now able to provide conformity assessments to the full scope of the MDR from both its UK and Netherlands notified bodies. Updates on NB's can be viewed on the EC's New Approach Notified and Designated Organisations (Nando) Information System. Nando

NICE International relaunch

Following an increasing number of enquiries from overseas health and social care bodies, the National Institute for Health and Care Excellence (NICE) has announced that it will relaunch its not-for-profit international division (NICE International). The Division will offer advisory services to international organisations, ministries and government agencies, helping "other international health and care systems optimise their use of evidence-based practice.” Details

Expert panels for medical devices and in vitro diagnostics

The European Commission (EC) has extended the deadline for experts to apply to be included in panels evaluating high-risk medical devices and in vitro diagnostics under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The panels will cover 11 areas and the deadline to apply is 24 November 2019. Details

EMA's Clinical Trials Information System

Following the European Medicine Agency's (EMA) update on its Clinical Trials Information System (CTIS), the European Parliament’s public health committee has raised concerns about its delayed rollout. It was originally anticipated that the CTIS would be ready for audit in July 2017, however after repeated delays the EMA reported that it was gearing up for an audit in June 2019. Its latest update states that following an operational assessment of the system, the EMA's Management Board will "consider the timing of the audit of the system". EMA Update Committee concerns

Regulatory harmonisation to combination products

The Swiss Agency for Therapeutic Products (Swissmedic) has outlined plans to align its approach to drug-device combination products with the specifications in development in the EU. While the European Medicines Agency (EMA) is still finalising its specifications, Swissmedic will ensure regulatory harmonisation once the new medical device regulations take effect. Press release

EMA, FDA and PMDA meeting update

Significant progress was made in discussions between the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) at the fourth tripartite meeting. Discussions involved further alignment on clinical trial designs for key indications for antibacterial drugs and also extended to methods to facilitate obtaining paediatric clinical data, clinical trial considerations for new treatment modalities and antifungal agents, which is an area affected by growing antimicrobial resistance. The agencies will meet again in 2020 to continue discussions. EMA update

New UK PharmaScan database

The new UK PharmaScan database has been released, which will provide information on medicines in clinical development from up to three years before UK launch or the start of phase III clinical development (whichever is earlier). The aim of database is to enable NHS forward planning for the introduction and faster uptake of new medicines. Press release

NICE guidance on cannabis-based treatments for NHS use

The National Institute for Health and Care Excellence (NICE) has issued guidance on cannabis-based treatments, following its approval of the first three cannabis-based medicines for prescription by the NHS in England and Wales. The cannabis-based medicines are intended to treat epilepsy, multiple sclerosis and chemotherapy-induced vomiting and nausea. NICE decided that, based on the current evidence, no treatments should be prescribed for chronic pain. Guidance

Clinical trials regulation Q&A

The European Commission (EC) has released an updated draft questions and answers (Q&A) document to provide further clarification on the implementation of the Clinical Trials Regulation. The Q&A now addresses requests for information (RFIs), how assessment reports will be made public, and the sponsor’s responsibilities concerning changes to a clinical trial that are not substantial modifications but are relevant for supervising the trial. Q&A document

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019

At its most recent meeting, the European Medicine Agency’s (EMA) human medicines committee (CHMP) recommended seven medicines for approval. Amongst these was an orphan drug, Isturisa (osilodrostat), for the treatment of Cushing’s syndrome. CHMP meeting highlights

ARM calls for Europe to streamline approval of clinical trials of ATMPs

A recent report by the Alliance for Regenerative Medicine (ARM) suggests that Europe should improve timelines for approval of clinical trials in some countries and streamline approval of multinational trials in order to increase its attractiveness for the development of Advanced Therapy Medicinal Products (ATMPs). Trends highlighted in the report appear to show flatlining of clinical development activity in Europe between 2014 and 2018, while activity has risen in North America and Asia over the same time period. ARM report

EMA advice to enable patient's faster access to treatments

The European Medicines Agency (EMA) has recently highlighted in a commentary how frequent interactions between a medicines developer, regulators, Health Technology Assessment (HTA) bodies, and patients can enable patient's faster access to highly innovative therapies. The interactions are described through the example of the recent authorisation of Zynteglo (lentiglobin). EMA press release

IMDRF clinical guidelines

The International Medical Device Regulators Forum (IMDRF) has released 3 final clinical guidelines to replace earlier guidelines by the Global Harmonization Task Force (GHTF). The guidelines cover clinical evaluations, clinical investigations and clinical evidence for medical devices. Guidelines

Events and webinars

  • 28 Nov 2019: How to make data pay: the exploitation of intangible assets - Register

  • 12 Dec 2019: Competition Law Issues in Digital Markets - Register

Consultations

New consultations

No new consultations

Open consultations

Strategic Agenda for Innovation in Healthcare under Horizon Europe

In line with the proposed European Health Innovation Public-Private Partnership (PPP) under Horizon Europe, five industry associations are working closely to create a Strategic Agenda for Innovation in Healthcare. The associations (COCIR, EFPIA, MedTech Europe, EuropaBio and Vaccines Europe) are seeking comments from the public and stakeholders to contribute to the Strategic Agenda, which intends to guide research and innovation and address key European healthcare challenges. The consultation closes on 24 November 2019. Press release Consultation

Cybersecurity in medical device regulation

A consultation launched by the International Medical Device Regulators Forum (IMDRF) aims to strengthen cybersecurity in medical device regulation. The IMDRF invites responses to its draft guidance on the general principles and best practices of cybersecurity in regulation of medical devices, which includes recommendations for pre-market and post-market management of medical device cybersecurity. The consultation closes on 2 December 2019. Consultation

Consultation on revised draft guide on the manufacture of ATMPs and Biological Medicinal Substances

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) seeks comments from stakeholders on its revised draft Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use). Both annexes form part of the guide to good manufacturing practice (GMP) for medicinal products. The consultation closes on 20 December 2019. Consultation

NHS England seeks views on draft NHS Commercial Framework for Medicines

The 2019 Voluntary Scheme for Branded Medicines Pricing and Access committed NHS England to publishing a commercial framework, giving additional detail on the commercial arrangements it has with industry. The Voluntary Scheme outlined an increasing role for NHS England working alongside the National Institute for Health and Care Excellence (NICE) and industry to support the introduction of clinically and cost-effective medicines. The NHS Commercial Framework for Medicines (“the Framework”) aims to set out the NHS’ approach for commercial activity for branded medicines. The Framework, and the activity it will potentially enable, aims to support both NHS England and NICE’s ambition to deliver patient access to proven, affordable and transformative medicines in a financially sustainable way. For the pharmaceutical industry, it aims to encourage faster market entry for new treatments and support uptake and adoption where these medicines are priced fairly and responsibly. The draft Framework makes clear that confidential complex commercial arrangements are expected to be considered only for products which represent value at or below the lower end of the standard NICE threshold or other applicable thresholds. Engagement is a key element of the Framework and the schematic on page 14 outlines the opportunities for engagement with NICE and NHS England. Examples of the commercial options available to companies are set out in Section 5. NHS expects that the Framework will be expanded in the future to include, for example, information on the commercial approach for biosimilar and generic medicines. Section 3 will be of interest to all companies. There will be stakeholder engagement and two workshops (dates to be confirmed) over the next 10 weeks (to take account of UK purdah, closing on 10th January 2020 and NHS England expects to publish a first edition in early 2020. Draft framework Overview