EU jargon can be baffling for those not familiar with the processes and instruments. Here EPHA profiles the different instruments which form part of the policy making process. This article focuses on treaties and is part of a series articles on : regulations, directives, decisions, recommendations and opinions.
The European Union functions on the basis of Treaties that serve as the constitutions of the union. The latest one is the Treaty of Lisbon adopted in Lisbon in December 2007 that entered into force on 1st December 2009. It amends the Treaty on European Union (TEU; also known as the Maastricht Treaty) and the Treaty establishing the European Community (TEC; also known as the Treaty of Rome). In this process, the Rome Treaty was renamed to the Treaty on the Functioning of the European Union (TFEU).
The Treaty streamlines decision-making, slims down the institutions and creates the new posts of a permanent EU President and a foreign representative. The treaties give power-giving treaties, set broad policy goals and establish institutions that, amongst other things, can enact legislation in order to achieve those goals.
Public health will now be addressed by Article 168, replacing the current Article 152. Even though the general idea stays the same, there are changes both in terms of content and process which EPHA describes in more detail here.
The new treaty strongly reasserts the principle of subsidiary in public health. The Union shall fully respect Member States’ responsibilities for the definition of health policies; for providing and delivering health services and medical care, and for the management of health services and medical care and the allocation of the resources assigned to them. The European Union generally acts as a coordination engine, rather than a regulator.
However, EU observers are noting important innovations that broaden the EU’s remit in health, which is perceived as a sensitive area.
1. “’Wellbeing” becomes a new objective of the EU (Art. 3, Treaty on the Functioning of the European Union, TFEU).
This is a major development, as wellbeing is intrinsically linked to health. Indeed, ‘wellbeing’ translates into horizontal clauses of “health mainstreaming” (Art. 9 and art 168, TFEU), both of which assert that European Commission proposals should always take into account their possible adverse effects on health and that proposals should be changed if found problematic.
2. The treaty (Art. 168, TFEU) strengthens cooperation and coordination between Member States.
It encourages EU countries to establish guidelines, share best practices, set benchmarks and monitor. This new tool is designed to improve the complementarity of Member States’ health services in cross-border areas.
3. The EU now shares competence with Member States where common safety concerns in public health are identified. In such cases, it can introduce legally-binding legislation.
For example, this may concern standards of quality and safety relating to organs and substances of human origin, blood, blood derivatives, veterinary and phyto-sanitary standards, standards of quality and safety for medicinal products and devices for medical use, analysts say.
4. The Lisbon Treaty will allow the EU to adopt incentives to safeguard human health.
Even if not legally binding, this option might help cooperation in the fight against major cross-border health scourges and in the protection of public health regarding tobacco and the abuse of alcohol, according to top-level experts.
However, the clear nature and scope of these incentive measures are not defined in the Treaty. Will they be a totally new form of legislation or a reference to existing forms? Nonetheless, it seems obvious that they would not be legally binding – like the Council Recommendations.
5. Finally, the Lisbon Treaty will make the Charter of Fundamental Rights legally binding on those Member States that have not opted out of it, including the UK, Poland and the Czech Republic.
This implies that the right to preventive health care and to medical treatment is from now on clearly recognised as a fundamental right of EU citizens, albeit only under the conditions established by national laws and practices.
The process
Decisions on public health will still be adopted by ordinary legislative procedure* including those on safety and quality of organs and blood, veterinary and phyto-sanitary fields, quality and safety of medicinal products and devices
The reassertion of the subsidiarity principle and the ability of the Union to take action encouraging cooperation and coordination totally exclude any enforced harmonisation of public health laws or Member State regulations.
* The ordinary legislative procedure (formerly referred to as co-decision) is the legislative procedure based on the principle of parity and which means that neither European Parliament nor Council may adopt legislation without the other’s assent.