The European Commission today (Friday) adopted a proposal to postpone the date of application of the medical devices regulation by one year to 26 May 2021. MEP Peter Liese, EPP spokesperson for health expects a broad majority in favour of the proposal within an urgency procedure in the European Parliament.
"I fully support the proposal presented by the Commission today. Doctors and medical staff are fighting for the lives of patients all over Europe. To do this, they urgently need medical devices, for example ventilators. The companies that manufacture these devices simply do not have time for long, bureaucratic procedures. It is therefore right that the European Commission has now proposed to postpone the more complicated rules of the new Medical Devices Regulation by one year. What we don´t need now is bureaucracy and paperwork, but fast procedures and as much help as possible for patients fighting for their lives," Liese said.
"We urgently need more joint European action to overcome the corona crisis. Showing solidarity and acting together will make a huge difference in the fight against the corona crisis. If we fail to do so, the corona virus could destroy the EU", declared the German Member of European Parliament (MEP) and health policy spokesperson of the largest group in the European Parliament (EPP, Christian Democrats) and doctor Peter Liese. Liese called for massive extensions of cross-border aid measures. “So far, hardly any medical professionals from other EU countries have come to Italy. It is a bad sign for the Italians when they see that Albania, Cuba, China and Russia are helping out in their country, but other European member states are not. Moreover, only two Member States, namely the rather small country Luxembourg, which should explicitly being mentioned in this context, and Germany have accepted patients from other Member States. During the Ebola crisis, we helped patients from West Africa and flew them in. Why the hell is it not possible for patients from Madrid, who can no longer find a place in the completely overcrowded hospitals, to be treated in the Scandinavian countries, Ireland or Eastern Europe?” According to Liese, the European Commission is currently extensively working on finding a solution to this matter. Already tomorrow, Friday, a proposal shall be presented on how the work of the Member States in this area can be coordinated, as well as how free intensive care capacities can be reported as quickly as possible in order to help as many patients as possible, as quickly as possible.
The corona crisis has the EU firmly in its grip. The European Commission has therefore today adopted a paper on emergency assistance. Among other things, this involves providing financial support to Member States for transporting intensive care patients to other Member States or coordinating free hospital bed capacity. The aim is to save as many lives as possible in the current crisis. So far, only Luxembourg and Germany have taken over patients from other Member States on a large scale. MEP Peter Liese, EPP spokesperson for health praised this concrete form of support by the Commission.
"In my view, it is urgently necessary for all Member States to report their free bed capacities and to help those regions, such as Northern Italy, Madrid and Eastern France, where doctors and nurses are desperately fighting for people's lives but simply have no capacity left. The crisis hits Member States at different times and those who help today will certainly be grateful for help from others tomorrow," said the doctor and MEP. Liese himself had repeatedly called for this kind of support, as this also affects the core of the European Union.
Read more: Commission presents paper on emergency assistance
The current coronavirus crisis is of high concern to all of us, but we should not lose sight of people suffering from chronic, previously untreatable diseases. For one of these patient groups, MEP Peter Liese, EPP health spokesperson of the largest group in the European Parliament Dr. med. Peter Liese (Christian Democrats), now has good news.
The novel gene therapy drug Zolgensma from Novartis currently costs around two million US dollars (1.9 million euros) in the USA. It is used as a single-use therapy for children with spinal muscular atrophy. However, the drug has not yet been approved in Europe. This will change quickly as an approval is close. "I assume that the approval of Zolgensma will be granted soon. This week, the expert committees at the European Medicines Agency (EMA), which is responsible for Europe-wide approval, issued a final positive assessment. The European Commission will officially issue the approval in a timely manner. It can now take place quickly."
Read more: Zolgensma - Most expensive drug in the world close to marketing approval in Europe