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The Commission introduced recently a double strategy in approaching to EU-wide public health integration, i.e. concerning supply of medicines to citizens in the member states “at all times and at affordable prices”; the strategy included both the regulatory and industrial dimensions. Besides, the Critical Medicines Alliance announced last October is aimed at stimulating and boosting the medicines’ manufacturing capacities and mobilizing national and the EU-wide institutional funding.
Background
The European Commission has been taking numerous efforts to create a strong EU-wide health union, in which all member states would be prepared to respond together to health crises provided that available medical supplies at affordable prices go together with the innovative activities in the pharmaceutical industry.
The EU states’ authorities are supposed to join the Commission’s efforts in improving prevention, treatment and aftercare for most dangerous and chronic diseases such as cancer and/or dementia, etc.
The European Health Union’s task presently is formulated in three goals: a) better protecting the citizens’ health, in general; b) equipping the member states with facilities for better preventive measures and addressing future possible pandemics, and c) improving the resilience of the EU-wide health systems.
More in: https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
European Health Data Space
The newly-launched European Health Data Space, EHDS represents one of the central building blocks of the European “health union” and, at the same time, is a milestone in the EU-wide digital transformation. The EHDS main aims are:
= improving healthcare services’ delivery in the member states by empowering people to control their health data in their home country or in other EU countries;
= offerring a consistent, secure, trustworthy and efficient framework for the use of health data; in this way researchers, innovators, public institutions and industry – under strict conditions – will have access to large amounts of high-quality health data, crucial to developing life-saving treatments, vaccines or medical devices;
= fostering a genuine EU-wide single market for digital health services and products.
The European Health Data Space builds on rigorous data privacy, interoperability and security requirements, including cybersecurity, which is a key for the trust of citizens and the robustness of the medical industry.
Trust is a fundamental enabler for the success of the European Health Data Space, which provides a reliable “setting” for secure access to and processing a wide range of health data. It is based on the following legal parameters: = General Data Protection Regulation, GDPR; = Data Governance Act; = Data Act; and = Network and Information Systems Directive.
As soon as these are the so-called horizontal legal and executive frameworks, they provide rules that apply to the health sector in general; however, the EHDS would also provide specific sectoral rules, considering the sensitivity of health data.
Source: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
More on EHDS in: https://ec.europa.eu/commission/presscorner/detail/en/FS_24_1347
Double strategy
The EU intends to create a robust supply of medicines in the member states: i.e. accessible to all, at all times and at affordable prices. Hence, the Commission has pursued a double strategy: looking at both the regulatory and industrial dimension.
= On the regulatory side, Commission has proposed an ambitious EU-wide reform of pharmaceutical legislation with the aim of encourage manufacturers to better address shortages. As soon as medicines are specific products and different from all others, the medical manufacturers should have some legal obligation: i.e. first, to ensure appropriate and continued supplies across the continent; secondly, to notify any interruption of supply. Besides, the cross border solidarity among the EU member states must also contribute to the optimal solutions.
With this in mind, the Commission has obliged the European Medicines Agency to create a “solidarity mechanism” among the EU-27 states.
However, regulatory measures alone are not enough: shortages have a significant industrial dimension; thus, the Commission announced in October 2023 the EU-wide industrial response to medicines shortages by establishing the Critical Medicines Alliance. Presently, over 250 stakeholders have pledged their commitment to the Alliance, including representatives from biotechnology and pharmaceutical companies, civil society organizations uniting patients, consumers, health professionals, the member states authorities, etc.
Critical Medicines Alliance
The Critical Medicines Alliance will draw upon the lessons of other successful alliances in boosting the economic security of medicines industry through first, manufacturing capacities and mobilizing national and EU funding; the EU will make best use of the newly created European Platform for Strategic Technologies. Besides, the market incentives would assist to scale up production by joint procurement and capacity reservation contracts.
Secondly, the Commission will diversify the supply chains of critical medicines and seek strategic partnerships with third countries, including prospective EU member states like those in the Western Balkans and Ukraine. By the end of 2024, the Alliance will deliver its initial recommendations.
Reference and source: https://ec.europa.eu/commission/presscorner/detail/en/speech_24_2287
Our comments. The European integration proceeds along two concentrated efforts in socio-economic integration, i.e. the Common Market (often called single or internal), and “common policies”. The latter include such specific spheres requiring the EU-wide efforts like common commercial policy (e.g. trade with countries outside the EU), customs union, common agricultural, transport and fisheries policies, and several newly emerging sectoral “unions”, such as energy union, capital markets union, innovation and banking unions, etc. (some “unions” are in the making, e.g. education and digital unions, energy and defense, as well as the health union, etc.).
Integration efforts within the new “health union” have been instigated by the recent pandemic, which required concentrated and specifically oriented EU-wide solutions and measures. However, on the way to “complete” integration, i.e. on par with other “union-wide” approaches, there are some stumbling legal blocks. Depending on the socio-economic sector under integration, the division of competence between the EU institutions and the member states suggests one of the following three “schemes” – exclusive, shared and supplementary; the health issues are within the last two, i.e. shared and supplementary.
As to the former, the EU law defines the integrative approach as common safety measures concerning “public health matters” (art. 4, TFEU); however, in the latter (supplementary one) it is “only” protection and improvement of human health (art.6, TFEU). And it is not just a “playing with words” in a legal puzzle: in fact, there two distinct and different approaches to health: in shared competences as “public health” (i.e. “common safety concerns in public health matters”), in the supplementary one as “protection and improvement of human health”.
Hence, such “cautious” approaches and measures from the EU institutions to a vital issue for all European citizens, being “divided” by the EU efforts and that of the member states: the EU law doesn’t suggest so far a “unified” approach.