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 the following flexibilities, which authorities may wish to rely on in procuring urgently needed equipment and medicines in response to COVID-19:

  • Authorities may choose to rely on digital tools to facilitate a more effective procurement process;
  • In case of urgency and extreme urgency, the timelines for the open and restricted procedures may be significantly shortened; and
  • Authorities may rely on the negotiated procedure without publication allowing them to negotiate directly with one or more potential suppliers.

The last point is particularly relevant.  The negotiated procedure without publication can ordinarily only be relied upon in certain very narrow circumstances.  One of these circumstances includes “reasons of extreme urgency brought about by events unforeseeable by the contracting authority”, which makes compliance with the deadlines for other procedures impossible.  In the Guidance, the Commission acknowledges:

“The specific needs for hospitals, and other health institutions to provide treatment, personal protection equipment, ventilators, additional beds, and additional intensive care and hospital infrastructure, including all the technical equipment could, certainly, not be foreseen and planned in advance, and thus constitute an unforeseeable event for the contracting authorities.”

Similarly, the Commission also accepts that the need has to be met as soon as possible, so that even the shorter timelines for the open or restricted procedures may be unsuitable.  However, the Commission also notes that this would need to be assessed on a case-by-case basis and that urgency could not be invoked in the procurement ultimately takes longer than if any of the other procedures were followed.  Finally, the Guidance also makes clear that this procedure should only be used to meet immediate needs and to “cover the gaps until more stable solutions can be found.

The Guidance addressed to Member State authorities follows after 25 Member States had participated in a joint procurement for personal protective equipment by the European Commission and for which bids were received by the end of March (see here).

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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;
  • provides strategic advice to major companies in the medicines and device space on national and EU public procurement considerations;
  • counsels clients on the protection of trade secrets and commercially confidential information, including in connection with freedom of information requests;
  • assists clients in navigating the implications of Brexit;
  • helps companies in evaluating marketing claims for cosmetics; and
  • represents clients in administrative proceedings in the national and EU courts.

Katharina’s pro bono work includes providing regulatory advice to charities and other non-profit organizations.

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

Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs. 

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts. 

Brian is an honorary lecturer at University College London.