Speeches

Madam President, I welcome the proposal for a regulation on a strengthened role for the European Medicines Agency. The Covid-19 pandemic has clearly highlighted the need for a coordinated approach in the provision of medical devices and medicinal products in crisis situations. I also strongly support the call by rapporteur Nicolás González Casares for the need for an appropriate regulatory framework to ensure the provision of high-quality health services in emergency situations. It was the absence of a pan-European legal framework that proved to be the major problem in containing the pandemic. Key challenges highlighted the lack of a mechanism to collect and analyse data from Member States, as well as the absence of an assessment of the risk of shortages of medicinal products. The extension of the Agency’s mandate will enable the development of therapies and tailored strategies to combat public health emergencies. On the other hand, however, conferring wider powers without having an impact assessment carries some risk. To date, it is unclear what the impact will be on the health systems of individual Member States in terms of financial, administrative and human resources. The health crisis should not be a pretext to loosen the personal health data protection regime. The cyberattack on the Medicines Agency in November last year showed the vulnerability of the security systems. Protecting digital infrastructure is a top priority. Last but not least, the lack of transparency in the pricing of medicines undermines public trust. Patients are not banal consumers of the scales on the market, they are suffering people, people in need. Society has the right to demand socially responsible pricing principles from pharmaceutical companies.