EU Law includes Primary Legislation (such as the Treaties established by the European Council) and Secondary Legislation (such as Directives, Regulations). In these FEMWiki chapters we will describe what primary and secondary legislation exists relating to disease prevention and control.

It is important to be aware that the Union can only act "within the limits of competence conferred upon it by the Member States in the Treaties". This means that situations that are not described in EU primary (Treaties) or secondary law (regulations, directives), will per definition be matters to be acted upon only by the Member States. All EU Member States have national legislation dealing with Public Health issues, which will cover most situations for disease prevention and control. However, EU Law is of a higher order than National Law and hence will determine how certain situations in the areas of disease prevention and control will have to be dealt with, even at Member State levels.

It may occur to the reader that the articles related to public health in the Treaty seem generic, and somewhat vague. However it is important to understand that such texts will pave the way for more specific secondary legislations (directives and regulations) that will be quite specific. In the first part of this chapter the relevant areas of the Treaty are described. After that, an overview of all related directives and regulations will be given in the sub-chapters.

Public Health in the Lisbon Treaty

The Treaty on the Functioning of the European Union, in the amendment that was signed in Lisbon, 2007, Public Health is defined as a shared competence between the Union and the Member States.

Article 6a states that the Union shall carry out Public Health actions "to support, coordinate or supplement the actions of the Member States".

Article 9 states that in defining and implementing its policies, the Union "shall take into account requirements linked to a high level of education, training and protection of human health".

Restrictions to free movement of goods and people

Articles 34 and 35 deal with the free movement of goods within the internal market of the Union and state that quantitative restrictions on imports and exports of goods are prohibited. However, article 36 states inter alia that public health reasons may form an exception to justify such restrictions.

In article 45, that basically deals with the right of free movement of people in the Union, yet again mentions public health as a possible justification to restrict the freedom of movement.

Likewise in the chapter that deals with the freedom to establish a business in anywhere in the Union, article 52 mentions public health as one of the possible justifications for restriction of this right.

Adopting specific measures related to public health

To a large extend, the Treaty of Lisbon focuses on establishing and regulating an internal market within the Union, without internal borders and with full freedom of movement of persons and goods. However the Treaty recognized that public health issues can seriously disturb an internal market and hence describes areas where the European Parliament and Council may adopt specific measures in that area.

Article 114.3 states that the European Commission will take as a base for the area of public health "a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective." Basically this means that the Parliament and Council are empowered to develop secondary legislation (directives, decisions and regulations), within the evidence base of public health.

Article 114.8 states "When a Member State raises a specific problem on public health in a field which has been the subject of prior harmonisation measures, it shall bring it to the attention of the Commission which shall immediately examine whether to propose appropriate measures to the Council.".

Article 168: Public Health This article mentions Public Health more extensively and states:

(1) "Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health."

This is to be done through:

• fight against the major health scourges, by promoting research into their causes, their transmission and their prevention
• health information and education
• monitoring, early warning of and combating serious cross-border threats to health.

(2) Cooperation between Member States in this area needs to be encouraged and if needed supported by the Union. In particular to ensure that the health services of Member States are complementary and working well together in case of cross-border health threats.

The Commission is given mandate to take initiative for coordinating policies, in particular providing guidelines, indicators, exchange of best practice and periodic monitoring and evaluation.

(3) Coordination with countries outside the Union and competent international organisations should be fostered.

(4) The European Parliament and Council are assigned to create legislation in the areas of:

• safety of organs and substances of human origin, blood and blood derivatives.
• measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;
• measures setting high standards of quality and safety for medicinal products and devices for medical use.

(5) The European Parliament and the Council also get the room to:

adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges measures concerning monitoring, early warning of and combating serious cross-border threats to health measures aiming at protection of public health regarding tobacco and the abuse of alcohol (excluding any harmonisation of the laws and regulations of the Member States) Article 169: Consumer Protection Article 169 states that "In order to promote the interests of consumers and to ensure a high level of consumer protection, the Union shall contribute to protecting the health, safety and economic interests of consumers, as well as to promoting their right to information, education and to organise themselves in order to safeguard their interests."

It then describes how the Parliament and Council may adopt measures to this effect.

Secondary Legislation

All these activities relating to Public Health referred to in the Treaty are still to respect the subsidiarity and the proportionality principles, meaning that only situations that can not reasonably be dealt with by single member states are to be regulated and that the measures proposed should be proportional to the situation.

Still, these provisions give the basis for much detailed secondary legislation, which will be discussed in the following sub chapters. The overview of legislation can be found below:

Between 1998 and 2014, one of the cornerstones of the current EU legislation on communicable diseases has been European Commission decision 2119/98/EC, put in force in 1998. This decision required setting up a network for the epidemiological surveillance and control of communicable diseases in the Community. Later amendments to this decision included the list of communicable diseases and case definitions.

Then by the end of 1999 decision 2000/96/EC was made on the communicable diseases to be progressively covered by the Community network and at the same time decision 2000/57/EC was added on Early Warning and Response system for prevention and control in the EU.

At that time, most of these activities were performed by the member states that worked together in 'EU Networks'. In 2003 the European Parliament and Council put Regulation 1882/2003 in force, related to committees which assist the Commission in the exercise of its implementing powers.

Increasing number of health threats, such as SARS in 2003, have contributed to REGULATION (EC) No 851/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (21 April 2004), establishing a European Centre for Disease Prevention and Control.

Below is a selection of current EU regulations linked to disease prevention and control.

This framework changed significantly with the advent of the new 'serious cross border health threat initiative' which was proposed on 8 december 2011 by the European Commission and that has led to the so-called 'Decision 1082/2013/EU', repealing decision 2119/98/EC.

Food safety Legislation

The area of food safety falls under responsibility of the Consumer Protection tasks of the European Commission. A specific agency is committed to ensuring that Europe's food is safe: the European Food Safety Agency EFSA. In addition a significant body of EU legislations on food safety has been created to allow the EU to achieve this task.

Potable Water Safety

EU Directive 98/83/EC Quality of water intended for human consumption (Amendment: Directive 2002/27/EC, entry into force 05/04/2002)

Waste

Regulation (EC) No 1774/2002 Laying down health rules concerning animal by-products not intended for human consumption (Eight amendments (Regulation), last amendment: Regulation (EC) No 2007/2006, entry into force 17/01/2007)

EU Directive 2000/59/EC Port reception facilities for ship-generated waste and cargo residues

Communicable Diseases Surveillance

Surveillance is the collection of activities that allow society to detect threats in an early stage in order to respond in an effective and timely manner. As such, surveillance is part of the larger area of epidemic intelligence. The European Centre for Disease Prevention and Control ECDC has been created to detect and analyse threats to public health in the EU. In addition significant body of EU legislations on surveillance has been created to allow the EU to achieve this task.

Border measures for Public Health Purposes

Directive 2004/38/EC of the EP and Council, on the right of EU citizens and family members to move and reside freely in the EU

Regulation (EC) No 562/2006 of the EP and Council, on the Schengen Borders Code.

Occupational Health

Occupational health can be considered as part of the domain of public health, as the population perspective on health (in this case the population of employees) is an important element of this area.

EU Directive 89/391/EEC Introduction of measures to encourage improvements in the safety and health of workers at work (Amendments: one Regulation and one Directive, last amendment Directive 2007/30/EC, entry into force 28/06/2007).

EU Directive 93/103/EEC concerning the minimum safety and health requirements for work on board fishing vessels (Amendment: Directive 2007/30/EC, entry into force 28/06/2007).

EU Directive 98/24/EC on the protection of the health and safety of workers from the risk related to chemical agents at work (Amendment: Directive 2007/30/EC, entry into force 28/06/2007).

Safety rules and standards for passenger ships

For the area of global transport, specific attention may be given to sea transport, both of goods and of people. SHIPSAN TRAINET is a European project funded by the General Directorate for Health and Consumers of the European Commission. It involves 12 associated partners in 11 European countries and 24 collaborating partners including international organisations, professional associations and passenger shipping companies. In addition, safety rules and standards for passenger ships have been set up as EU legislation:

EU Directive 98/18/EC on safety rules and standards for passenger ships (Six amendments (Directives), last amendment: Directive 2002/25/EC). Directive 2001/106/EC the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control).

Welfare of animals in transit

EU Directive 95/29/EC Protection of animals during transport

Regulation (EC) No 1/2005 on the protection of animals during transport and related operations

FEM PAGE CONTRIBUTORS 2007

Editor

Arnold Bosman