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On 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”).  With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products.  The Commission intends to build on the experience from the EU vaccines strategy.  In particular, the aim is to have three new therapeutics available by October 2021 and possibly two further products by the end of the year.

The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space:
Continue Reading European Commission outlines Strategy on COVID-19 Therapeutics

On 11 November 2020, the European Commission has announced a range of proposals to build a European Health Union.  The proposed measures reflect on the learnings from the current COVID-19 and previous influenza pandemics and seek to enhance Member States’ preparedness for future health crises, which also includes a greater involvement of the EU.  As part of its set of measures, the Commission is proposing to revise the current EU joint procurement framework.

  1. Current Joint Procurement Framework

In 2010, as part of its “lessons learnt from the A/H1N1 pandemic”, the European Council called for the development of a joint procurement framework for vaccines and antiviral medication.  Subsequently, the European Parliament and Council adopted Decision 1082/2013/EU (the “Decision”) on serious cross-border threats to health, which, among others, provides that the EU and any interested Member States may conduct a joint procurement procedure.  The detailed procedure was then agreed between the Commission and the Member States in the Joint Procurement Agreement (the “JPA”).
Continue Reading European Health Union: European Commission proposes Changes to the Joint Procurement Agreement

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”).  It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement.  In summary:

  • From 1 January 2021, different rules

The European Commission has recently issued Guidance on using the public procurement framework in the emergency situation related to the COVID-19 crisis.  The Guidance is intended to highlight to Member State authorities the flexibilities available to them under the EU public procurement framework and in particular the Public Procurement Directive 2014/24/EU.  The Guidance highlights

On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers.

The Department of Education and Cabinet Office has published guidance on key workers for COVID-19.  The guidance

The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications.  After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other

Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists.

In Case C-524/18, Dr.

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001.

PTC Therapeutics International Limited (“PTC”) had argued before the General Court that

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance).  This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being passed by UK Parliament. This latest Guidance follows on from the MHRA’s previous ‘no deal’ scenario further guidance note in January regarding medicines, medical devices and clinical trials regulation (available here).

  1. Legislative Background

The Medical Devices Regulations 2002 (UK MDR 2002) implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs), respectively (EU Directives) into UK law.  Pursuant to the European Union (Withdrawal) Act 2018, the UK MDR 2002 will continue to apply.


Continue Reading UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here).  The letter seeks to address concerns that a number of pharmaceutical companies will not have been