Zolgensma - Most expensive drug in the world close to marketing approval in Europe
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Hope for little patients and their families / Appeal to Novartis to significantly reduce the price in the EU
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."
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Europe’s answer to the corona crisis: more solidarity, less bureaucracy
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“More solidarity and less bureaucracy. This is the answer that the European Union should and will give to the corona crisis”, this is the assessment of the health spokesperson of the biggest group in the European Parliament (EPP, Christian democrats) Dr. Peter Liese. Liese expressed his gratitude to all the people that fight against the corona crisis and treat patients. He explained that patients from the most affected countries, for example France and Italy, are now finally also treated abroad, for example in Germany. “When my group approved a resolution two weeks ago, and even last week when this resolution became public, many people did not believe that member states would really be ready to help, but I am very happy that it is now really working. Also material such as ventilation machines are sent from other European countries to the most affected ones and the European Commission is establishing a crisis mechanism so that the ventilation machines can be used always where the largest need is”, explained Liese. He also expressed confidence that many obstacles which unfortunately hinder the fight against the crisis will be abolished already this week. “All the funds that are available should be focused on fighting the crisis now. This will be approved by the European Parliament in an extraordinary meeting already on Thursday. Most of us are not meeting physically, but we are doing a remote session and also remote voting. We want to be a good example because a strong advice from scientists is that meetings should be avoided whenever possible”, expressed Liese.
Read more: Europe’s answer to the corona crisis: more solidarity, less bureaucracy
Covid-19 and new medical device rules
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Vital to allow the industry deal with the unprecedented demand
The EU Commission has today agreed to temporarily suspend the introduction of new Medical Device rules amid the Covid-19 crisis “With all our systems under enormous pressure, especially our medical devices industry, it is time to press the pause button on implementation of the Medical Devices Regulation, due to come into force in two months, until such time as things return to normal said Mairead McGuinness MEP and Vice President of the Parliament "It's the right move. I will do my utmost to ensure that the European Parliament adopts the proposal as soon as possible. We must now ensure that all those who can manufacture ventilators, masks, tests and other medical devices do so and focus on addressing the current crisis", said EPP MEP Peter Liese, health spokesperson of the largest group in the European Parliament (EPP- Christian Democrats) and supported the announcement of the European Commission to postpone the implementation of the new medical devices regulation for one year.
Corona crisis in Europe
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Finally European solidarity is working - We Europeans stand together
The corona crisis continues to have Europe firmly in its grip. Now European solidarity starts to work. Various Member States are, for example, supplying ventilators to Italy, which has been hardest hit by the crisis. Germany is even taking over patients from France, where the crisis is coming to a head. MEP Dr. Peter Liese, EPP spokesperson for health explained. "I am glad that European solidarity is now also working and that our group's proposal is being put into practice. The peak of the crisis will hit the Member States with a time lag and when other countries reach the peak of the crisis, these countries will be grateful if they too can feel the effects of European solidarity. That is what distinguishes us Europeans. We stand together in difficult times and help each other", said Liese.