>>>Can a Member State in times of Corona crisis prohibit a pharmaceutical company to deliver certain products (such as testing kits or protective medical gear) to other EU countries? (Altius)

Can a Member State in times of Corona crisis prohibit a pharmaceutical company to deliver certain products (such as testing kits or protective medical gear) to other EU countries? (Altius)

Authors: Hanne Baeyens and Carmen Verdonck (Altius)

Publication date: march 2020

With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU?

This principle is one of the cornerstones of the European Union’s internal market which implies that national barriers to the free movement of goods within the EU need to be removed.

However, the principle is not an absolute value. In specific circumstances, restrictions or even prohibitions are acceptable when serving important purposes such as the protection of the environment or human health and if they respect the principle of proportionality and necessity.

In the European Commission’s paper of 25 May 2018  on the obligation of continuous supply to tackle the problem of shortages of medicines, the Commission indicates that Member States may take measures to prevent or address shortages of medicines by restricting the free movement of goods within the EU “as long as such restrictions are justifiable as appropriate, necessary and proportionate to protect the life and health of humans by preventing the occurrence of shortages of medicines”.

In parallel with what applies for medicines, EU countries seem thus entitled to impose temporary restrictions on exports of medical equipment in times of shortage to protect public health.

In exceptional circumstances, the imposition of limited export bans may be justified in respect of those medical devices where there is a demonstrated supply shortage and consequent risk to patient safety. Such measures are lawful under EU law free movement principles provided they are in response to a genuine public health risk, are appropriate to achieve the public health objective and are not more restrictive than is necessary to achieve their legitimate objective.

On the other hand, the question arises whether such export restrictions are still possible in the event of a global crisis such as the Corona virus? After all, the shortage is not only at home, but also in many other EU countries and isn’t this contrary to the principle of solidarity between EU member States?

Indeed, top European Union officials are urging members to put solidarity above national interests as the Corona virus spreads quickly across the continent.

Speaking on 6 March 2020 after an urgent meeting in Brussels of health ministers from the 27-country bloc, crisis management commissioner Janez Lenarcic said EU nations are entitled to restrict exports of medical equipment but warned that such decisions could compromise the EU’s ability to manage the growing coronavirus crisis. Public health experts are concerned that should more developed countries ban exports of masks and protective gear, poorer nations could be at risk of widening outbreaks, particularly among medical workers.

According to the Belgian health minister Maggie de Block, limiting exports of medical supplies is « not in the spirit of the EU ».

The just published EU’s coordinated economic response to the COVID-19 Outbreak of 13 March 2020 clearly wants to tackle this problem and underlines that export restrictions will only be possible in very exceptional circumstances:

The Treaty allows Member States under certain strict conditions to deviate from Single Market rules. Any national restrictive measure taken under Article 36 TFEU to protect health and life of humans must be justified, i.e. suitable, necessary and proportionate to such objectives by ensuring an adequate supply to the relevant persons while preventing any occurrence or aggravation of shortages of goods, considered as essential, such as personal protective equipment, medical devices or medicinal products. Any planned national measure restricting access to medical and protective equipment must be notified to the Commission, which is to inform the other Member States thereof.

The measures so far notified to the Commission have been assessed with regard to ensuring that essential goods reach those who need them the most. The Commission is treating those cases as a matter of priority and supports Member States to correct any such measure. In case Member States do not sufficiently adapt their rules, the Commission will take legal action.”

Annex 2 to this response provides guidance for Member States on how to put in place adequate control mechanisms to ensure security of supply across Europe and can be found at the following link:

https://ec.europa.eu/info/sites/info/files/communication-annex-coordinated-economic-response-covid19-march-2020_en.pdf

The Commission clarifies that “a simple export ban alone cannot meet the legal requirement of proportionality. Such a measure does not, in itself, ensure that the products will reach the persons who need them most. They would therefore prove unsuitable to reach the objective of protecting the health of people living in Europe”.

It emphasizes that “measures without a clearly identified scope restricted to actual needs, a solid rationale and/or a limited duration may increase the risk of scarcity and therefore are very likely to be disproportionate”.

It can be concluded from this recent communication that export restrictions in times of Corona will not be easy to justify and will have to be done in close cooperation with the European Commission.

Read the original article here

2020-03-19T10:07:16+00:00 19 mars, 2020|Categories: Pharma & lifesciences|Tags: , |