The Corona crisis has exposed a major flaw in the European system for approving personal protective equipment and medical devices, among other things.
Imposing high requirements on products that are not made in the EU has proven to be effectively impossible. As a result, many inferior products enter the Union in large quantities.
In the European Union, a high level of health and safety requirements has been agreed, combined with a system of admission to the internal market, control and enforcement. Worldwide, the EU is even one of the trading blocks with the highest possible standards. Doing business with the EU means that manufacturers from all over the world have to meet our high standards and follow legal procedures.
In normal times, this provides a good assurance of health and safety and fair competition.
Rules temporarily out of play
The corona crisis shows a clear weakness in this system. In times of great scarcity of face masks, gloves and insulation jackets, the high standards no longer applied. The market was happy to accept products that did not comply with any European standards and for which no legal approval had even been granted by the Notified bodies. Suddenly KN95 was adequate and a surgical mask appeared to offer sufficient protection in a high-risk environment. Purchasers who tried to follow the European standards and regulations were left empty-handed.
And even for inferior products, high prices are still paid.
Also, well-intentioned manufacturers and importers who wanted to have their products assessed on the basis of European standards were left behind because the tests and procedures took a very long time.
The reason for all this is basically that there is hardly any meaningful production within the EU. Everything has to be imported. The Chinese standards and the Chinese quality assurance system have actually become the measure of all things.
It is therefore completely pointless to set high health and safety requirements if you, as Europe, have little or no influence on this because you are dependent on third countries. In times of scarcity, you have nothing to demand, only to pay.
Meanwhile, it has been agreed within the EU to build up strategic stocks. In order not to be confronted with the same problems again during a subsequent pandemic. But does this mean we will be using non-European manufacturers again? And will compliance with the rules now be monitored and enforced?
And what do you do if the scarcity has another cause than a pandemic?
It seems to us reasonable to take a good look at the way in which we have organised all this here in Europe. There is certainly room for improvement.