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.
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This new opinion aims to show with concrete examples the potential of combining advanced robotics and virtual worlds of the metaverse in the service of the medical sector and to draw conclusions on the actions to be implemented for Europe to become a leader in these sectors.
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.
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.
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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.
In accordance with the EU-UK Withdrawal Agreement, Regulation (EC) No 726/2004 and Directive 2001/83/EC as well as the Commission acts based on them, apply to and in the UK in respect of Northern Ireland.
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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.
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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.
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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.
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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.
With this opinion the EESC welcomes the Commission's approach to leave SPC protection intact as regards placing products on the EU market, as well as the market exclusivity of EU SPC holders in the Member States during the full period of SPC protection. Furthermore the EESC deems it to be most important that, on those non-EU markets where protection does not exist or has expired, there be fair competition for EU-based manufacturers who bring generics and biosimilars to these markets. The EESC also supports the Commission's stance on SMEs, since they play an important role in manufacturing generics and developing biosimilars.
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