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”).

  1. Proposed Changes to the Joint Procurement Framework

As part of its announcement, the Commission has published a draft Regulation on serious cross-border threats to health, which would repeal Decision 1082/2013/EU.  The draft Regulation proposes a number of changes to the current joint procurement framework:

  • Participation in joint procurement activities would now also be open to EFTA and EU candidate countries. The Decision only envisaged participation of EU Member States.  However, in reality, this change only constitutes a clarification because since the beginning of the COVID-19 pandemic, several EEA, EFTA, candidate and potential candidate countries have joined the current JPA.  This includes countries, such as Norway, Iceland, Liechtenstein, Montenegro, North Macedonia, Albania, Serbia, as well as Bosnia and Herzegovina and Kosovo.
  • Consistent with the current JPA, the draft Regulation also provides that participation in any joint procurement initiative is voluntary. However, the draft Regulation introduces a new requirement that countries that choose to participate in a joint procurement must not procure the same goods “through other channels” or “run parallel negotiation processes”.  This is a significant change from the current JPA, which does not preclude participating countries from negotiating bilaterally in parallel to the joint initiative.  This change clearly reflects the frictions earlier this year where some Member States formed alliances placing national interests ahead of the common EU interest in the procurement of personal protective equipment and medicinal products to treat COVID-19.
  • The Commission and Member States are required to coordinate and exchange information, among others, in relation to joint procurement, stockpiling and donation of medical countermeasures under various EU instruments.

It is likely that the proposed Regulation will undergo further changes during the legislative process.  Once the Regulation is adopted, the Commission and participating countries will need to consider adjusting the terms of the current JPA to reflect the new framework.

Tags: European Commission, European Union, Public Procurement
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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Bart has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.

During his previous professional career, Bart was a professor of EU law at the University of Copenhagen and published a couple of books with Oxford and Cambridge University Press. His academic swan song was the (now leading) textbook republished in 2020 by his former academic colleagues in 2nd edition: EU External Relations Law, available from Hart Publishing.

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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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