Since February 2020, the pandemic has shown a new and, unfortunately, dangerous way of living and facing everyday life. Since then, EU government is working to grant to all Member States the adequate instruments to fight against this terrible pandemic.
As it is explained in the European Commission’s report dated 11.11.2020 “Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats”, these months have been very difficult to overcome and the need for a stronger EU Health security framework is becoming relevant. The collective effort to fight the ongoing COVID-19 pandemic, as well as other future health emergencies, call for strengthened coordination at EU level.
Moreover, in some specific therapeutical areas, such as the paediatrics, the pandemic has settled in an already difficult healthcare context due to the chronic shortage of paediatric medicines. This constant issue, in fact, has proven to increase the risk of undercured paediatric patients affected by COVID-19 and its complications. What do we, as EU, have to do right now?
We need absolutely to reinforce ECDC (European Centre for Disease Prevention and Control) ‘s role in EU’s health system and EMA’s system “to monitor and mitigate shortages of critical medicines”. It is necessary “to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry”. To this aim, some steps forward has been made by the European Commission with the launch of the Pharmaceutical Strategy that will try to find concrete solutions to stop medicines shortage. Covid-19 has shown a huge amount of medicines shortage in many scientific fields, especially in paediatrics where the situation was, and still is, very severe. The chronic shortage of paediatric medicines, available for less than 50% of cases when compared to medicines for adults in Europe, has proven to increase the risk of undercured paediatric patients affected by COVID-19 and its complications. Children are, indeed, orphan of appropriate and innovative treatments, while the majority of the products used in childhood have been produced for adults use and are prescribed and administered based on physicians’ own experience rather than on the results of ad hoc paediatric research. Moreover, medicines are often not available in a pharmaceutical form suitable for all the children’s age groups.
In order to organise and to obtain an efficient system to continue fighting against COVID-19, the EU Commission had made advances, such as recommendations on response measures by ECDC as part of rapid risk assessments
Concretely, this Communication is accompanied by three legislative proposals: an upgrading of Decision 1082/2013/EU on serious cross-border health threats, a strengthening of the mandate of ECDC and an extension of the mandate of EMA.