23 March 2020
Product Protection – 18 of 17 Insights
The COVID-19 crisis has led to an increase demand for certain products: personal protective equipment (PPE) and medical devices. The European Commission has now taken urgent measures to restrict the export of particular products outside of the European Union, except where an export authorisation has been granted. The European Commission has also recommended that economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities take steps to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand.
Implementing Regulation (EU) 2020/402 restricts the export of specific personal protective equipment set out in Annex I to the Regulation outside of the European Union. These products are used to protect the spread of infectious materials and though these fall into the following categories, the measures relate specifically to the product with the CN codes shown in Annex I:
The export restrictions do not apply where the exporter has obtained authorisation from the competent authority where they are established.
The European Commission published guidance on 19 March 2020 and have amended Regulation (EU) 2020/402 through a further Implementing Regulation of 19 March 2020. The amendments clarify that the export restrictions do not apply to exports to Norway, Iceland, Liechtenstein, Switzerland, as well as the overseas countries and territories listed in Annex II of the Treaty and the Faeroe Islands, Andorra, San Marino and the Vatican City.
The Guidance confirms that the UK should be considered as a Member State for the purpose of Regulation 2020/402, not a third country. It also clarifies the obligations around applying for an authorisation and further explains that the details of the application process will be determined by the Member States. Member States must notify the European Commission with the details of the National Competent Authority that will issue export authorisations.
The restrictions apply from 15 March 2020 for a period of six weeks in light of the rapidly developing COVID-19 crisis.
Commission Recommendation (EU) 2020/403, published on 16 March 2020, invites economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand. Those measures should not have a detrimental effect on the overall level of health and safety.
The recommendations include:
The laws and guidance around PPEs, medical devices, medicines and other healthcare products in response to COVID-19 is dynamic and further changes are likely to be seen as the situation develops.
Please contact Katie Chandler or Tasmina Goraya if you would like to discuss any of the issues raised in this article.
by Multiple authors
by Multiple authors
Wilson v Beko  EWHC 3362 (QB)