(1)

Since the outbreak of the epidemiological crisis caused by the coronavirus SARS-CoV-2, the disease associated with it, the COVID-19, has been spreading fast across the world, reaching also the Union’s territory. According to the European Centre for Disease Prevention and Control, the risk associated with COVID-19 infections for people in the Union is currently considered to be moderate to high, based on the probability of transmission and the impact of the disease. The virus spreads rapidly within the Union, and might have an enormous public health impact with substantial fatal outcomes in high-risk groups and significant economic and societal disruption.

(2)

In this context, the need for personal protective equipment, as detailed in Annex 1, has already increased significantly. Given its nature and the prevailing circumstances, such type of equipment is an essential product since it is necessary to prevent the further spreading of the disease, and safeguard the health of medical staff treating infected patients.

(3)

In line with Council Conclusions of the Health Ministers Council on 13 February 2020, a procurement procedure for personal protective equipment has been launched under the Joint Procurement Agreement for medical countermeasures. According to an indicative time-line and depending on the market situation, it might be finalized as of beginning of April.

(4)

The demand for medical protective equipment has been exacerbated in the last days and is expected to continue increasing significantly in the imminent future with accompanying shortages developing in several Member States. Constraints exist throughout the EU single market to meet customers demand for the relevant Personal Protective Equipment, in particular mouth protection masks. At this moment in time, there are on-going efforts to increase manufacturing capabilities. This may feed into review of the measure as necessary and as situation evolves.

(5)

Production of personal protective equipment such as mouth protection masks in the Union is currently concentrated in a limited number of Member States, namely the Czech Republic, France, Germany, and Poland. Despite the fact that increased production has been encouraged, the current level of Union production and existing stocks will not be sufficient to meet the demand within the Union. This is particularly the case as this demand rises as a result of the epidemic situation and the personal protective equipment can be exported without restriction to other parts of the world.

(6)

Some third countries have already officially decided to restrict exports of protective equipment. Others seems to have taken similar actions on a more informal basis. Some of these countries are also traditional suppliers to the Union market and this is further exerting pressure on the Union market.

(7)

In order to remedy and prevent a critical situation, it is in the Union interest that the Commission takes an immediate action of a limited duration in order to ensure that exports of personal protective equipment are subject to an authorisation in order to ensure adequacy of supply in the Union in order to meet the vital demand.

(8)

Exports of certain quantities of specific products may be authorised under specific circumstances such as to ensure assistance provided to third countries, and depending on the needs of the Member States. The administrative modalities for these authorisations should be left to the discretion of the Member States during the time of these temporary measures.

(9)

There are vital needs of protective equipment within the Union with regard to hospitals, patients, field workers, civil protection authorities. Such vital needs are constantly monitored through the Union civil protection mechanism.

(10)

Whereas this measure at present applies to personal protective equipment, as detailed in Annex 1, a need may arise to review the scope of the Annex and products covered by this Regulation.

(11)

Due to the urgency of the situation, justified by the fast spreading of the COVID-19 infection, the measures provided for in this Regulation should be taken in accordance with Article 3(3) of Regulation (EU) 2015/479.

(12)

In order to prevent speculative depletion of stocks, this implementing Regulation should enter into force on the day of its publication. In accordance with Article 5(5) of Regulation (EU) 2015/479, these measures should have a duration of six weeks,