COVID-19: European Commission Authorises Exportation of Personal Protective Equipment

In order to prevent depletion of stock of protective equipment amidst the COVID-19 crisis due to the fast spreading nature of the virus and the enormous public health impact, the European Commission have taken immediate steps to protect the availability of supplies of personal protective equipment (“PPE”), by introducing measures provided for in the newly implemented Regulation (EU) 2020/402 of 14 March 2020 (the “Regulation”) which should be taken in accordance with Article 3(3) of Regulation (EU) 2015/479, requiring that exports of such PPE outside of the European Union are subject to an export authorisation by Member States.

The demand for PPE has risen significantly in recent days and is expected to continue increasing significantly with concerns that shortages of equipment are already developing. Given the global crisis, such type of equipment is an essential product which is necessary to prevent the further spread of the virus, to safeguard the health of medical staff treating infected patients and the health of the general population from coming into contact with the virus. However constraints existing in the EU market to meet the demand of production and export of PPE required additional measures to be adopted in an effort to increase manufacturing and export capacities as demand rises as a result of the global pandemic.

The European Commission have stated that the challenges presented by the rapidly spreading COVID-19 virus justifies the urgency of implementing additional regulations to protect citizens and to meet the PPE shortages so that equipment can be exported without restriction to other parts of the world. This in turn will help to remedy and prevent a critical situation.

PPE covers equipment such as masks, protective eyewear and face shields amongst many other protective articles. There are critical shortages and surging demands for this equipment within the EU and third countries in particular for hospitals, patients, field workers, and civil protection authorities.

The Regulation permits exports of certain quantities of specific PPE to be authorised under specific circumstances such as to ensure assistance provided to third countries depending on the needs of the Member States. The way in which the authorisation is to be implemented is be a matter for each individual Member State during the time the temporary measure is in place. It will be valid for a six week period and Member States will be consulted on the potential adaptations of the current measures in place and further measures that may need to be introduced.

Member States have already accepted the European Commissions requests to adopt national measures to ensure that PPE is available to those throughout the European Union and third countries who need it most. The European Commission is assisting Member States to put in place certain mechanisms to best implement the Regulation having regard to factors such as international engagements, the change of urgent needs within with European Union and third countries, and the integration of production and supply chains with such third countries.

How we can help

BHSM’s Healthcare and Life Sciences Department offer practical legal and regulatory compliance advice to a variety of clients across the medical devices sector.

If you have any queries or concerns, or would like to discuss the above in further detail or generally in relation to COVID-19, please feel free to contact Jennifer Watters (01 440 8300 / jwatters@bhsm.ie) or David Scott (01 440 8300 / dscott@bhsm.ie) in the Healthcare & Life Sciences Department of BHSM.

This article is for general information purposes.  Legal advice must be obtained for individual circumstances.  Whilst every effort has been made to ensure the accuracy of this article, no liability is accepted by the author for any inaccuracies.