Product Safety and Medical Devices
Current stage – In Force
Who is in charge – European Parliament and Council of EU
The Covid-19 pandemic has highlighted the interconnectedness between human, animal, and ecosystem health and the risks posed by the loss of biodiversity on Earth. This pandemic has shed light onto the need to reinforce the application of a One Health Approach in the Union to achieve better well-rounded outcomes as mentioned within Regulation (EU) 2021/552 with actions to tackle threats to health.
Shortages of medicinal products and devices within the pandemic represent a growing threat to public health, with a serious impact on healthcare systems and on the right of patients to access appropriate medical treatments. Increased global demand for medicinal products, which was exacerbated by the COVID-19 pandemic, has led to further shortages of medicinal products, weakening the healthcare systems in Member States and posing significant risks to patients’ health and to the care of patients.
The rapid evolution of the COVID-19 pandemic and the spread of the virus led to uncertainty of the supply and demand and the risks of shortages of medicinal products and how this triggered export restrictions among Member States which seriously impacted the internal market.
Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be identified, developed, notably through joint efforts by public authorities, the private sector and academia, and made available to Union citizens as soon as possible during such emergencies.
The COVID-19 pandemic has also highlighted the need to coordinate assessments and conclusions on multinational clinical trials, in line with what was done on a voluntary basis by clinical trials experts of Member States prior to the date of application of Regulation (EU) No 536/2014 of the European Parliament and of the Council and the need for Union-level advice on the use of medicinal products in national compassionate use programmes in order to avoid delays in the implementation.
