Life-Lines Life Sciences through a legal lens

2019-04-10

Looking Ahead 

  • 9 April 2019 - Allergan v Aspire Pharma Ltd – Trial to commence
  • 11 April 2019 – Bayer Pharma (C-688/17) – AG Opinion expected
  • 7 May 2019 - Dr Reddy’s Labs and others v Napp Pharmaceuticals – Trial floating
  • 13 May 2019 - Illumina & Ors v Premaitha Health PLC – Trial floating
  • 20 May 2019 - Eli Lilly v Genentech – Appeal
  • 19 July 2019 - (1) Samsung Bioepis UK Limited (2) Biogen IDEC Limited – Fresenius Kabi Deutschland GmbH – Trial floating

Outstanding Decisions

  • Pfizer v Hoffman La Roche (HP 2017 000064)
  • Ranbaxy Laboratories & Ors v Commission (C-586/16)

Decisions 

No new decisions

Brexit

Latest news

No changes to UK right to work checks for EU citizens until 2021

There will be no changes to the way in which individuals from the EU, EEA or Switzerland prove their right to work in the UK until 1 January 2021, even if the UK leaves the EU without a formal withdrawal agreement in place, the UK government has said. More

DHSC guidance on prescriptions issued in the EEA and Switzerland

The Department of Health and Social Care (DHSC) has issued guidance for pharmacists on prescriptions issued in the EEA and Switzerland, which is expected to take effect on 12 April 2019 in the event that the UK leaves the EU with no deal. It will mean that prescriptions issued in an EEA member state or Switzerland can only be dispensed in the UK if the prescriber is from a profession outlined in this guidance that is legally entitled to issue such a prescription in the country in which it is issued. Guidance

New guidance page on substantial amendments to a clinical trial if the UK leaves the EU with no deal

New guidance published by the MHRA covers significant amendments to a clinical trial including changes to the trial sponsor/legal representative, IMP certification and importation and amendments to Research Ethics Committee (REC). The Health Research Authority (HRA) has also produced guidance on when amendments are required to be submitted for REC review. Guidance

Conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice in a no deal scenario

The MHRA has issued guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and the national scientific advice service in the event that the UK leaves the EU without a deal. Guidance

Export of medicines: certificate of a pharmaceutical product in no deal scenario

The MHRA has published guidance on the process for applying for a Certificate of Pharmaceutical Product (CPP) if the UK leaves the EU without a deal. The MHRA has said that it will be able to issue a CPP for a grandfathered centrally authorised product (CAP), however the expedited service (2 days) will not be available for the first CPP request relating to a grandfathered CAP. Mandatory baseline data required for a grandfathered CAP should also be submitted at least 2 days prior to the CPP request. CPP applicants are requested to alert the MHRA Certificates team by email at [email protected] when an application is the first CPP request for a grandfathered CAP. Guidance

UK government updates plans for no-deal Brexit carbon tax

The UK government has confirmed plans to introduce a carbon tax on heavy energy users should the UK exit the EU without a negotiated withdrawal agreement in place; they will need to pay a carbon tax instead of participate in the EU Emissions Trading Scheme (EU ETS). More

Our Brexit resources

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.

Brexit - preparing for a No Deal Brexit: Videos and Webinar

The UK Parliament has now voted to allow the British Prime Minister to reopen negotiations on the Withdrawal Agreement to secure changes to the Irish backstop. Given the continuing uncertainty businesses should now take steps to ensure that they are prepared in time for a possible 'No Deal' Brexit. We have created a series of videos to support businesses to prepare for such a scenario. These videos cover four key areas of risk where our clients have expressed concern: contracts and supply chain, data, IP and workforce issues. The videos can be viewed here. Also in this series of videos, experts from our core global sectors discuss how Brexit is affecting businesses and suggest some steps that clients can take to manage the relevant risks.

Webinar recording: Preparing your business for a ‘No Deal’ Brexit

In this webinar, Pinsent Masons' Brexit Advisory Group discuss how businesses can prepare for a possible Brexit No Deal scenario, in the wake of the UK Parliament's rejection of the Withdrawal Agreement negotiated with the EU on 15 January 2019. Webinar 
More information about our Brexit services can be found on our Brexit hub.

Pinsent Masons Brexit Hotline

The UK Parliament has again voted to reject the Withdrawal Agreement which the UK government negotiated with the European Union. Given the continuing uncertainty, 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

Other news

Proposed cap on R&D tax credits may adversely affect life sciences SMEs

The UK government has proposed reintroducing a pay as you earn (PAYE) and national insurance contribution (NIC) cap on the amount of payable tax credit that a qualifying loss-making business can receive in any one accounting period. The government is currently consulting on such proposals, which are expected to take effect on or after 1 April 2020, so as to minimise any impact on genuine businesses. Life sciences small or medium enterprises (SMEs) are amongst those likely to be affected by the cap, and are urged to respond to the government consultation to help ensure that genuine companies can continue to benefit from the payable tax credit. The consultation closes on 24 May 2019Consultation More

GDHP publishes a series of white papers to share country experiences in digital health

The Global Digital Health Partnership (GDHP) a collaboration of governments and territories, government agencies and the World Health Organization has published a set of white papers to share country experiences of digital health in key areas of challenge and debate and to aid in the presenting of persuasive positions for planning, prioritised investments, strategic approaches, and evaluation of digital health initiatives. GDHP was formed to support the effective implementation of digital health services and facilitates global collaboration and co-operation in the implementation of digital health services.  White papers

EU Commission takes forward its work on ethics guidelines for AI

The EU Commission has announced plans to take forward the work of the High-Level Expert Group on Artificial Intelligence (AI HLEG) set up to support the implementation of the European strategy on Artificial Intelligence. The Commission is taking a three-step approach: setting-out the key requirements for trustworthy AI, launching a large scale pilot phase for feedback from stakeholders, and working on international consensus building for human-centric AI. Press release

IPO's manual on Patent Practice updated

The Intellectual Property Office's (IPO's) manual of patent practice has been updated to reflect recent changes in the law and judicial decisions. The manual explains the IPO’s practice under the Patents Act 1997. The most recent update includes substantive changes to Sections 2, 3, 4A, 5, 14, 15A, 17, 18, 19, 20, 60, 73, 75 89A, 89B, 125 and the SPC section. Manual of Patent Practice

Regulatory

COCIR: advancing cybersecurity of health and digital technologies

A report published by the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) outlines the different requirements introduced by EU regulators, to address the increased cybersecurity risks of digital health technologies is increasing. The report also contains recommendations for ensuring that medical devices and services in Europe remain secure and calls for a cohesive approach to cybersecurity in the MedTech industry. The report outlines six recommendations for harmonising medical device standards to reflect changes to EU and national laws, such as the Medical Devices Regulation (MDR) and the General Data Protection Regulation (GDPR) and the forthcoming Cybersecurity Act. Report

US FDA announces new tailored review framework for artificial intelligence-based medical devices

The FDA is considering a total product lifecycle-based regulatory framework for medical devices that use advanced artificial intelligence algorithms. The framework would allow for modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained. The FDA has issued a discussion paper. The FDA predicts that under its existing guidance, many changes made to software as a medical device driven by artificial intelligence and machine learning would be subject to a premarket review and this has prompted the FDA to reimagine a regulatory approach for these devices. The proposed regulatory framework could enable the FDA and manufacturers to evaluate and monitor a software product from its premarket development to postmarket performance. This potential framework allows for the FDA’s regulatory oversight to embrace the iterative improvement power of artificial intelligence and machine learning-based software as a medical device, while assuring patient safety. The FDA consultation is open until 3 June.  FDA statement  Discussion paper

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019

At its first meeting in Amsterdam, the European Medicines Agency’s (EMA's) human medicines committee (CHMP) recommended a new treatment for beta-thalassaemia and three extensions of indication.EMA press release

Seminars and webinars

Fast-growth companies: their keys to success - Dublin Wednesday 1 May 2019

The panel will discuss how Europe’s fastest-growing companies keep ahead of the pack based on an exclusive survey in association with Mergermarket of 400 of Europe’s fastest-growing companies. We will hear the views and experience from the perspective of the CEO of Buymie, the COO of Initiafy, Deloitte Corporate Finance, the CEO of Livecosts.com, the founders of Spotlight Whitening and others. The seminar is hosted by Matt Cooper, Business Journalist, Broadcaster and Author. Register here

Consultations

New consultations

Proposed cap on R&D tax credits may adversely affect life sciences SMEs

The UK government has proposed reintroducing a pay as you earn (PAYE) and national insurance contribution (NIC) cap on the amount of payable tax credit that a qualifying loss-making business can receive in any one accounting period. The government is currently consulting on such proposals, which are expected to take effect on or after 1 April 2020, so as to minimise any impact on genuine businesses. Life sciences small or medium enterprises (SMEs) are amongst those likely to be affected by the cap, and are urged to respond to the government consultation to help ensure that genuine companies can continue to benefit from the payable tax credit. The consultation closes on 24 May 2019Consultation Our paper

IMDRF consultation on clinical evaluation documents

The International Medical Device Regulators Forums (IMDRF’s) medical devices clinical evidence working group (MDCE WG) has proposed updates to three Global Harmonization Task Force (GHTF) documents on clinical evidence key definitions and concepts as well as clinical investigations. The newly harmonised documents are intended to support the rapid market entry of medical devices across multiple jurisdictions, reflecting recently implemented and/or forthcoming regulatory requirements in the IMDRF member countries. The consultation closes on 5 June 2019. Consultation

Open consultations

Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man

The revision of the guideline on the evaluation of anticancer medicinal products in man proposes a review of the concepts related to biomarkers, which as the paper discusses are increasingly used to define malignant diseases and develop new treatment strategies, improve the description of the regulatory standards relevant for rare cancers and additional minor amendments to a number of other sections. The consultation closes on 14 April 2019Consultation

Big Data: how it can support the evaluation and supervision of medicines

Stakeholders' feedback is sought on the recently published European Medicines Agency and Heads of Medicines Agency (EMA-HMA) Joint Big Data task force summary report. The report outlines recommendations and associated actions which should be addressed in working towards understanding the acceptability of evidence derived from Big Data and how it can support the evaluation and supervision of medicines. The consultation closes on 15 April 2019More

Consultation on the revised guideline for designation as an orphan medicinal product

Stakeholders' views are being sought by the European Commission on the revised guidelines for applications for designation as an orphan medicinal product and the transfer of designations from one sponsor to another. The revised guidance follows the introduction of the European Medicines Agency's (EMA's) online portal for submittingapplications. The consultation closes on 28 April 2019Consultation

Vertical block exemption: businesses invited to share views

Businesses have been given an opportunity to shape potential changes to EU competition laws relevant to so-called 'vertical agreements'. The European Commission has opened a consultation aimed at collecting "evidence and views from stakeholders" on the Vertical Agreements Block Exemption (VABER) and relevant provisions under the Treaty on the Functioning of the EU (TFEU) that underpins it. The consultation is part of a broader evaluation exercise that the Commission is in the middle of to determine whether the VABER is "still effective, efficient, relevant, in line with other EU legislation and adds value". The Commission has said it will use the evaluation "to decide whether to let the Regulation lapse, to prolong or to revise it". The VABER is due to expire on 31 May 2022. The VABER is just one of the seven EU block exemptions that will carried across into UK domestic law as "retained exemptions" to account for Brexit. The exemption will apply in the UK until the expiry of the current VABER. The consultation closes on 27 May 2019Consultation

Use of patient disease registries for regulatory purposes

A discussion paper has been prepared by the Cross-Committee Task Force on Registries established by the EMA Patient Registries Initiative. The paper discusses methodological and operational aspects of the use of patient disease registries and registry studies for regulatory purposes. The EMA has requested comments and suggestions from any the interested parties. The EMA proposes to finalise of the document in Q4 2019. The consultation closes on 30 June 2019Consultation

Revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections

EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation. The revisions reflect discussions regulators in the European Union, the United States and Japan have had over the last few years to explore and agree how to align as much as possible their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. The consultation closes on 19 July 2019Revised guideline Press release

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

This revised guideline replaces the previous guideline on the evaluation of medicinal products indicated for treatment of bacterial infections and amendments to it. The revisions reflect scientific advice given on the development of antibacterial agents, decisions taken during regulatory procedures and alignments on clinical trial requirements that have resulted from discussions between regulators in the EU, United States and Japan, including revised recommendations for primary endpoints, primary analysis populations and non-inferiority margins in trials to support certain infection site-specific indications for use. The consultation closes on 31 July 2019Consultation

Consultation on draft key principles of electronic product information

A joint public consultation welcoming views on the proposed key principles of electronic product information (ePI) for human medicines has been launched by the European Medicines Agency (EMA), Heads of Medicines Agency (HMA) and the European Commission (EC). The draft principles are intended to form the basis of how the ePI system, which aims to provide available and up to date information to patients and healthcare professionals, will be developed and used in the EU. The consultation closes on 31 July 2019Press release Consultation

EMA consultation on ATMPs in clinical trials

The European Medicines Agency (EMA) has opened a consultation seeking comments on a new guideline for the quality, clinical and non-clinical requirements of investigational advanced therapy medicinal products in clinical trials. The consultation closes on 1 August 2019Consultation