Overview

Necessity is the mother of invention, wrote Benjamin Franklin. Of course, Franklin was Ambassador to France and beloved in Europe in the late 18th century. So perhaps that is why it appears the European Union is heeding this maxim as they approach regulatory issues surrounding coronavirus.

The team at the Atlantic Council Global Business and Economics Program (GBE) has done a new analysis of what has been happening with EU regulations in the midst of coronavirus.

This information is preliminary, and we plan to update this tracker. Here are the most important changes over the past two weeks:

European standards for medical supplies made freely available to spur production:

According to EU guidelines, medical supply standards must typically be purchased and used in line with intellectual property rules as well as all the relevant copyright protocols. But there is no time to go through this process at the moment, and the Commission requested an urgent change:

As Commissioner for the Internal Market Thierry Breton said: “We need to act collectively with urgency, solidarity, and audacity. I am encouraging manufacturers to increase and diversify production, building on positive examples such as textile and shoe manufacturers starting to produce masks and gowns. I will do everything possible to support their efforts. I am pleased to announce that following contacts with the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) has agreed to make freely available the standards needed for such companies to be able to produce masks and other protective equipment.”

In fact, the new guidance also encourages the delivery of new medical equipment and tools, including 3D printing capabilities as soon as possible. This could be a game changer for the European medical community and have far lasting consequences on supply chains in the region. It also shows the ability of the Commission to push the standard setting authorities when needed.

Export and Import authorization changes for Personal Protective Equipment (PPE):

While the Commission is understandably restricting the shipment of PPE to those outside the EU, it is making it easier to transfer equipment within the EU.

As a result, almost all member states have lifted national export restrictions and the protective equipment can be delivered seamlessly across the EU to where it is needed. This is a good example of one of the positive upsides of the common market.

The Commission is also making it clear how this should work by publishing detailed guidance, which can be found here. The rapid pace of action should be applauded and continued in the difficult days ahead.

The Commission has approved requests received from all Member States to waive customs duties and value-added taxes (VAT) on the import of medical devices, and protective equipment, from third countries in order to help in the fight against coronavirus.

The Commission is working to postpone entry into force of the new Medical Devices Regulation (MDR) for one year.         

          

The EU’s Medical Devices Regulation (MDR) is due to take effect in May 2020. The MDR was intended to regulate the market approval for new devices. But the Commission is showing much needed flexibility in this moment—despite having prepared members for the May implementation since 2017. Instead, the MDR is on hold, and the European Medicines Agency (EMS) has activated a plan for accelerating assessment and streamlining marketing procedures.

This is in line with what the medical industry has been requesting. MedTech Europe (the largest trade association) has said Europe’s MedTech industry won’t be able to comply with regulations as it responds to the pandemic. The Commission has responded, and these changes will be welcome.

However, over the long-term the MDR will still likely come into force. According to Marty Zuzulo, risk director at Grant Thornton, changes under the Medical Device Regulation adds more robust requirements which will demonstrate clinical safety and efficacy. The changes will also more closely align EU and US standards.

Next steps

These changes are just the beginning of what we can expect to see in the weeks ahead. The EU is moving rapidly within its current rules and adjusting rules where needed. This is the type of flexibility not only needed in a crisis, but also worth considering once the storm has passed. GBE will continue to monitor developments in this space.

Sources

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