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:

  • Research and development: The Commission plans to set up a COVID-19 ‘therapeutics innovation booster’ by July 2021 to develop a clear overview of the COVID-19 therapeutics projects under development. This platform will bring together relevant actors, including the European Medicines Agency (“EMA”), national authorities, and the private sector, to identify promising research projects and technologies, their stages of development and provide guidance on where to best focus investments, in order to accelerate innovation.  The Commission intends to mobilise certain financial instruments (including Horizon Europe, InvestEU and EU4Health) to aid development.
  • Clinical Trials: The Commission proposes that €5 million are earmarked under the EU4Health programme to support coordination in safety assessment and improve quality of safety data generated in clinical trials.  The Commission also intends to offer €2 million to support national competent authorities in carrying out expedited and coordinated assessments of clinical trial authorisation applications for COVID-19 therapeutics.
  • Horizon Scanning: The EMA has already established an Emergency Task Force to identify the development of promising COVID-19 therapeutics.  The Commission seeks to establish a portfolio of ten potential treatments and identify the five most promising ones by June 2021.  As part of the upcoming proposal for a European Health Emergency Preparedness and Response Authority (“HERA”), the Commission intends to provide for an interactive mapping platform across all Member States for upcoming therapeutics to assess their development, manufacturing capacities and supply chains.  This is envisaged for Q2 of 2022.
  • Supply chain: Building on the experience of the EU Task Force for Industrial Scale-up of COVID-19 vaccines, the Commission intends to facilitate cooperation between actors in the supply chain to ensure that available therapeutics are produced in sufficient quantity as soon as possible. It will organise “matchmaking” events (starting in Q3 2021) for all supply chain actors, so that they can find solutions for bottlenecks.
  • Regulatory process: The Commission intends to maximize use of the “rolling review,” allowing the EMA to check data from ongoing studies as they become available, before a formal application for the (conditional) marketing authorisation is submitted.  The EMA is currently conducting rolling reviews of three COVID-19 therapeutics building on monoclonal antibodies and seven rolling reviews for promising COVID-19 therapeutics are expected to start by the end of 2021.  The Commission is working towards granting conditional marketing authorisation for three new COVID-19 therapeutics by October 2021.  Building on national emergency use procedures, the Commission is considering a legislative proposal for an EU emergency-use authorisation of medicinal products.  The timing for the publication of this proposal is currently unclear.
  • Procurement: Since late October 2020, the Commission has signed joint procurement contracts (under the Joint Procurement Agreement for medical countermeasures (“JPA”)) for 19 medicines (analgesics, antibiotics, muscle relaxers, anaesthetics, resuscitation, including dexamethasone, etc.)  The Commission is currently discussing three new joint procurements for COVID-19 therapeutics.

The Commission recognizes that the JPA has limitations and is considering new streamlined solutions. This will involve increasing speed and flexibility in the current legal framework.  In this regard, participating Member States and other joint procurement agreement signatories would need to:

    • “adhere to shorter administrative deadlines;
    • use a distribution key where the resources being procured prove to be scarce;
    • place a certain percentage of orders in the first few months of the contract; and
    • refrain from engaging in parallel procurement processes for the same products or services.”

The Commission is also looking at using advance purchase agreements or the ‘innovation partnership’ procurement procedure to procure supplies.  The innovation partnership is a relatively new type of public procurement procedure.  It allows for an innovative solution to be developed during the performance of the contract.

In addition, the Commission is considering the emergency stockpiling of therapeutics under rescEU, as part of the Union Civil Protection Mechanism.

  • International Perspective: The Commission intends to expand the engagement with international partners on the development and fair distribution of COVID-19 treatments. The Commission also intends to increase the EU’s support through the Civil Protection Mechanism.

 

Tags: COVID-19, EMA, European Commission, European Medicines Agency, Medicinal Products, Pharmaceutical Companies, Pharmaceuticals
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Photo of Katharina Ewert Katharina Ewert

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing…

Katharina Ewert helps major national and multinational companies in the food, medical device, pharmaceutical and cosmetics sectors to navigate regulatory, litigation and procurement risks. With a strong background in general EU law and procedure, Katharina provides strategic advice to clients in a changing regulatory environment. Katharina is a member of Covington’s Diversity and Inclusion Committee.

In her work with a broad range of life sciences companies, Katharina regularly:

  • advises clients on all aspects of food development and marketing, including the regulation of ingredients, labelling and advertising;
  • helps companies in evaluating health and nutrition claims for foods and food supplements, as well as marketing claims for cosmetics;
  • provides strategic advice to major companies in the medicines and device space on national and EU public procurement considerations;
  • assists clients in navigating the implications of Brexit; and
  • represents clients in administrative proceedings in the national and EU courts.

Katharina’s pro bono work includes advising charities on corporate, commercial and public procurement matters.

Katharina gained valuable experience during a secondment the in-house legal team of a global pharmaceutical company.

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Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Sarah regularly advises on:

  • obligations under the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, including associated transition issues, and UK-specific considerations caused by Brexit;
  • medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • borderline classification determinations for software medical devices;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah is also Graduate Recruitment Partner for Covington’s London office.

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