News from the EU

ladies and gentlemen,

All of us around the table today acknowledged that the combination of the high transmissibility of the Delta variant in parallel with the large vaccination gap and the easing of non-pharmaceutical interventions and personal behaviours has led us to where we are today.

Today, the Commission published a study on medicines shortages in the EU, which has been requested by stakeholders, the European Parliament and the Council. Shortages present a significant problem for the quality and continuity of patient care, and can also have economic consequences. Though a number of actions have been launched in recent years to address shortages at EU-level, the COVID-19 pandemic has further highlighted the issue of availability of medicines and the vulnerabilities of supply chains. The study published today provides an overview of medicines shortages in the EU, on the basis of available data, as well as an analysis of their roots causes. It also presents an evidence-based assessment of the current legal framework, as well as potential solutions to address shortages through a series of 16 policy measures. The report will feed into the Commission’s on-going work on the Pharmaceutical Strategy, an ambitious, long-term project in the area of health, intended to make the European pharmaceutical system patient-centred, future-proof and crisis-resistant. The Commission aims at presenting a legislative proposal at the end of 2022, including measures to address shortages.

• Health: Commission publishes study on shortages of medicines

The State of Health in the EU’s Country Health Profiles provide a concise and policy-relevant overview of health and health systems in the EU/European Economic area, emphasizing the particular characteristics and challenges in each country. The 2021 edition has a special focus on the impact and responses of European health systems to the COVID-19 pandemic. Each Country Health Profile provides a short synthesis of:

• health status (including mortality from COVID-19)
• risk factors to health (including behavioural and environmental risks)
• the organisation of the health system and health spending
• the effectiveness, accessibility and resilience of the health system to the pandemic

Today, the Regulation on Health Technology Assessment (HTA), a deliverable of the EU Pharmaceutical Strategy, has been adopted. The new rules will allow vital and innovative health technologies - such as innovative medicines, certain medical devices, medical equipment and prevention and treatment methods - to be more widely available. The Regulation will also ensure the efficient use of resources, strengthen the quality of HTA across the EU, and save national HTA bodies and industry from duplicating their efforts, reassure business and ensure the long-term sustainability of EU HTA cooperation.

• Health: Commission welcomes the adoption of the Regulation on Health Technology Assessment