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.
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.
In this opinion, the EESC is calling for a European flagship initiative for health, based on the principles of universality, quality, accessibility, solidarity and inclusivity. The strategic pillars of this roadmap are outlined, and a more institutionalised involvement of civil society in defining, evaluating and monitoring health priorities is asked.
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 — EESK:s yttrande: Communication on availability of medicines
In this opinion, the European Economic and Social Committee (EESC) highlights the challenges hindering efficient cross-border access to social security services, including bureaucratic complexity and uneven progress in digitalisation across Member States. While supportive of the European Commission's efforts to simplify processes and enhance digitalisation, the EESC emphasises the need for accelerated progress and urges developing comprehensive action plans considering diverse stakeholder needs. Recognising the overall need for digitalisation, the EESC stresses the importance of inclusive solutions for digitally excluded individuals as well as robust IT systems to ensure data protection and cybersecurity. Additionally, the EESC calls for the finalisation of the revision of Regulation 883/2004 to address obstacles to free movement more effectively.
Download — EESK:s yttrande: Digitalisation in social security
The Belgian presidency of the Council of the European Union asked the EESC to provide their insights on the rethinking of the internal market in light of the acceleration of the Union’s twin transitions towards a green and digital economy and on crafting a European Industrial Strategy that positions industries as the backbone of Europe's economy.
Download — EESK:s yttrande: Developing a new European strategy for the Internal Market: helping our businesses to meet technological, social, environmental and competition challenges
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 — EESK:s yttrande: Securing Europe’s medicine supply: envisioning a Critical Medicines Act
The Commission is proposing an ambitious revision of the EU pharmaceutical legislation (including a Directive and a Regulation), in order to, inter alia, create a Single Market for medicines, ensure an innovation-friendly framework for research and production and reduce the administrative burden.
recognises that need to pay particular attention to the situation of smaller EU Member States, Cyprus, Ireland and Malta in particula;
stresses in particular the central role of a functioning, fair and efficient internal market;
welcomes the packaging requirements for UK products included in the package;
draws attention to the need for a timely and sustainable solution, which should be developed within the framework of the European Pharmaceutical Strategy.
Download — EESK:s yttrande: Medicinal products for human and investigational use / Derogations
Through this Own-Initiative Opinion proposed by its Fundamental Rights and Rule of Law Group, the EESC expresses its deep concern regarding the way COVID-19 has impacted the life, safety, welfare and dignity of all of the people living in the EU and worldwide. The EESC recalls that the EU is based on common European values which are non-negotiable under any circumstances. Therefore, special measures to address the COVID-19 crisis should remain exceptional and time-limited and should not go against the rule of law or endanger democracy, the separation of powers and the fundamental rights of European inhabitants. The EESC insists on the importance of checks and balances like parliaments, independent judiciaries, and civil society in ensuring balances responses. It calls for an inclusive recovery process leaving no one behind and fostering participation, democracy and the implementation of the European Pillar of Social Rights.
Download — EESK:s yttrande: The impact of COVID-19 on fundamental rights and the rule of law across the EU and the future of democracy (own-initiative opinion – FRRL)
During the COVID-19 crisis, the EU developed a wide range of health policy responses and initiatives, while also tackling the economic fallout of the pandemic. Many difficulties were encountered, but while some of them have been addressed, longer-term solutions are needed for mitigating future health crises.
In this opinion, the EESC comments on the Commission's evaluation of the measures taken so far to fight the pandemic and on the ten lessons learnt and proposes various recommendations in the field of crisis management, health protection, social and societal aspects, economy and finance, society and technology, international relations and democratic standards.
Download — EESK:s yttrande: Emerging stronger from the pandemic: acting on the early lessons learnt
The opinion, presenting EESC's position on the four proposals of the Health package published by the European Commission in November 2020, supports and welcomes these initiatives but draws the attention on some elements.
The EU and Member States should ensure that everyone has equal access to quality, well staffed, well equipped health and social services. This is particularly important in the context of the COVID-19 pandemic which has deepened existing inequalities.
Special attention in future EU policies should be given to healthcare workers and the need to improve working conditions, including pay, recruitment and retention, as well as their health and safety.
The new EU health package should be combined with the roll-out of the European Pillar of Social Rights (EPSR), particularly its principles 12, 16, 17 and 18 and the Action Plan on the EPSR. It should also be part of achieving Sustainable Development Goal (SDG) 3.
Download — EESK:s yttrande: Building a European Health Union
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.
The medical technological industry – focus of the opinion – plays a major role in the current transformation of the health sector to the benefit of patients and a value-based health care in Europe.
A major issue is highly personalised health care that ensures equal and better access and quality. Technology and large sources of anonymous data will greatly facilitate new treatments and operations as well benefit all phases of prevention and recovery. Recovery increasingly takes place outside hospitals, using eHealth technology.
Download — EESK:s yttrande: Industrial changes in the health sector (own-initiative opinion)
