The upcoming Cyprus Presidency of the Council of the EU has asked the EESC to draw up an exploratory opinion aimed at providing insight and recommendation on the establishment of the European centre of clinical excellence for pharmaceuticals, with the view to serve as a unified, evidence-based authority issuing pharmacotherapy recommendations, guidelines, and protocols for a wide range of diseases.
This exploratory opinion, requested by the Danish Presidency, outlines how AI and Big Data can improve rare disease patient pathways and support the development of personalised treatments. It highlights the main challenges linked to their use, such as data privacy, algorithmic bias, affordability, and geographical accessibility. In the text, the EESC puts forward recommendations to ensure that these technologies are applied in an ethical, inclusive, and patient-centred way.
Since the COVID-19 pandemic, health has become a central topic on the geopolitical stage. The EU Global Health Strategy, launched at the end of 2022, shows the political path forward, guiding the EU’s role in advancing health for all beyond 2023. This own-initiative opinion will examine four key dimensions: strategic autonomy in health; structural trends in health and related sectors; health coordination; and security, defence and the mitigation of major shocks.
On 24 October 2023 the European Commission adopted a set of actions to better prevent and mitigate critical medicine shortages in the EU. Recent critical shortages, including of certain antibiotics last winter, show that continued coordinated action is needed to address supply challenges and to make Europe's medicine supply chains more resilient in the long run. The main objective of the Communication is to prevent and mitigate critical shortages at EU level, focusing in particular on the most critical medicines, for which security of supply in the EU must be ensured at all times.
Download — Stellungnahme des Ausschusses: Communication on availability of medicines
The Covid 19-pandemic has drawn attention to the role of the pharmaceutical industry and to production, availability and affordability of medicines and medicinal products on the European market.
Dependency on critical ingredients, such as active pharmaceutical ingredients (APIs), became obvious when China and India limited exports. According to current data, up to 80% of APIs used in Europe and about 40% of finished medicines sold in Europe come from China or India. The European Union's increasing dependence on API supplies has led to a partial loss of capability to manufacture active substances independently, which poses a potential threat to public health in the countries of the European Union.
Download — Stellungnahme des Ausschusses: Securing Europe’s medicine supply: envisioning a Critical Medicines Act
The Commission proposes a new pharmaceutical strategy for Europe. It is a patient-centred strategy that aims to ensure the quality and safety of medicines, while boosting the sector’s global competitiveness. The EU needs to make sure that patients have access to high-quality, effective and safe medicines. It will foster patient access to innovative and affordable medicines. It will support the competitiveness and innovative capacity of the EU’s pharmaceutical industry.
Download — Stellungnahme des Ausschusses: Pharmaceutical strategy
