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María Mercedes Vinuesa Sebastián

In decades past, public health development included increased detection, assessment, response, management and evaluation of illnesses at country level. Some risks were controlled or even eliminated and populations’ health improved. But socio-economic changes have now modified the risk landscape, and transnational health threats are becoming the major focus of public health (PH). Countries have begun to adapt their PH

systems and capacities to this new scenario and have identified the need for an international approach to PH.

The International Health Regulations (IHR 2005) at the global level and different EU decisions, including the creation of the European Centre for Disease Prevention and Control (ECDC), are the results of this new approach to confront PH threats.

Spain is adapting its national legislation to improve the response to PH threats and to comply with international and EU requirements. Further modifications are still needed and the Health Security Package (HSP) may foster these changes.

The aim of the measures proposed by the Commission is to streamline and strengthen EU capacities and structures for an effective response to serious cross-border threats to improve Europe’s resilience to crises in an “all-hazard approach”.

However, the scope of the proposal excludes radiation and nuclear energy, which are covered by the European Atomic Energy Treaty. There is a need to have a clear link among this “lex specialis”, regulated hazards and the HSP.

The Decision should assure coordination with existing legally binding instruments (pharmaceuticals products, medical devices and food stuffs).

María Mercedes Vinuesa Sebastián has been the Director General of Public Health, Quality and Innovation at the

Spanish Ministry of Health, Social Services and Equity since January 2012.

Prior to that, she was Coordinator of the National Plan of Hemotherapy and Medical Director and Specialist in preventive medicine at the University Hospital of Móstoles, Spain. Vinuesa Sebastián specialises in management and

methodology for a high-quality care, health care and business management as well as preventive medicine and public health.

SECURITY & DEFENCE AGENDA

Member states retain responsibility for PH crisis management at the national level.

Nevertheless, PH emergencies are increasing their transnational impact. The enlarged movement of travellers and goods requires coordinated international responses and cooperation to control associated PH threats.

Article 168 of the Lisbon Treaty reinforced PH action at the EU level by establishing a legal basis for combating serious cross-border threats to health. This article calls for action by the EU, which will complement national policies. The European Parliament and the Council should adopt incentive measures to protect and improve human health. According to the principle of subsidiary in Article 5, the Union action shall respect member states’ national policy definitions. Consultations within the formalised Health Security Committee (HSC) would be the appropriate procedure when facing an event of international concern.

The Commission’s impact assessment report states that IHR requirements are not fully cov-ered by current EU structures and legislation. The EU and its member states will have to assure the provisions needed, guided by the HSP.

Events such as the 2011 E. coli outbreak, associated with sprouted seeds, showed the need to learn from past experiences in the health threats communication process. Lives were lost and the food industry, trade and travel were affected; there were numerous transnational implications. Evidence-based decision making should be ensured. Adopted measures and effective communication should have balanced the risks and damages in terms of the population’s health but also on other sectors’ impact.

Emergencies should be controlled, minimising adverse consequences and applying proportionate measures at member states’ discretion. Accurate and up-to-date information is crucial and messages should be adapted to target audiences. Coordination

between affected countries and EU institutions should be intensified through the HSC. The reputations of countries and the EU institutions are at stake.

The HSP will foster improved cooperation. It highlights the EU added value for coordination. EU institutions have a key role in helping countries to manage events, facilitating the exchange of information and improving decision making. Situations experienced during the H1N1 influenza pandemic led to a popular mistrust in vaccination

and a lack of credibility of health authorities. Clear, strategic and evidence-based communication is the target.

EU institutions should provide pools of specialised resources (professionals, systems, knowledge) and assistance to improve member states’ capacity building, maintaining and strengthening current structures. The EU should ensure the independence of Scientific Committees and their reports should be discussed at the Health Security Committee. EU specialised agencies (EFSA, ECDC, EMA, etc) should also play a key role.

The HSP will require member states to adapt national legislation to comply with all requirements. This is not a new process since efficient PH action implies a non-stop development approach and international commitments are actively promoted by national authorities to respond to local needs.

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Response planning

Since 1986, the Spanish Health Authorities have developed several acts, in order to improve detection and response capacities at local, regional and national level and to comply with international commitments.

Further steps are needed. The multi-sectoral approach of PH including detection, warning and response to health threats proposed by national authorities, IHR and the EU HSP still lacks a strong legal backing in Spain. Our main challenge would be to achieve inclusive regu-lation and structures for all health threats independent of the source, coordinated at the national and European levels.

The HSP, once it is adapted to countries’ needs, may become a powerful and efficient tool for improving Europe’s capacity for responding to serious cross-border threats to health.

The commitment of national authorities to comply with all requirements included in the package will make the difference.