Thursday, 18 December 2008

European Union: Public health

Global and continental health threats have hardly diminished, although media attention has turned to the financial meltdown and the economic recession.

Originally, the European Economic Community (EEC) had no specific policy, but little by little common concerns have led to joint action within the European Union. The Treaty of Lisbon would confer some shared competence on the EU and clarify areas where the union supports, coordinates or supplements member states’ health policies.


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Article 152 TEC

Global and continental health concerns are precariously balanced with traditional member states’ powers in the Title on public health.

The current Article 152 (ex Article 129) of the Treaty establishing the European Community (TEC), as published in the latest consolidated version of the treaties, OJ 29.12.2006 C 321 E/114–115:

TITLE XIII
PUBLIC HEALTH

Article 152 TEC

1. A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities.

Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education.

The Community shall complement the Member States' action in reducing drugs-related health damage, including information and prevention.

2. The Community shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action.

Member States shall, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas referred to in paragraph 1. The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination.

3. The Community and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health.

4. The Council, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting:

(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures;

(b) by way of derogation from Article 37, measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;

(c) incentive measures designed to protect and improve human health, excluding any harmonisation of the laws and regulations of the Member States.

The Council, acting by a qualified majority on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article.

5. Community action in the field of public health shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care. In particular, measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.

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Original Lisbon Treaty (ToL)

Although the Treaty of Lisbon is unreadable on its own, it spells out how the current treaties are amended.

Article 2, point 127 of the original Treaty of Lisbon (ToL) shows that Article 152 TEC underwent several specific amendments (OJ 17.12.2007 C 306/83–84):

PUBLIC HEALTH

127) Article 152 shall be amended as follows:

(a) in paragraph 1, second subparagraph, the word ‘human’ shall be replaced by ‘physical and
mental’ and, at the end of that subparagraph, the following shall be added: ‘, and monitoring, early warning of and combating serious cross-border threats to health’;

(b) in paragraph 2, at the end of the first subparagraph, the following sentence shall be added:

‘It shall in particular encourage cooperation between the Member States to improve the complementarity of their health services in cross-border areas.’;

(c) In paragraph 2, the following shall be added at the end of the second subparagraph: ‘, in particular initiatives aiming at the establishment of guidelines and indicators, the organisation of exchange of best practice, and the preparation of the necessary elements for periodic monitoring and evaluation. The European Parliament shall be kept fully informed.’;

(d) paragraph 4 shall be amended as follows:

(i) in the introductory wording to the first subparagraph, the following words shall be inserted at the beginning: ‘By way of derogation from Article 2 A(5) and Article 2 E(a) and in accordance with Article 2 C(2)(k)’ and the following shall be added at the end: ‘in order to meet common safety concerns:’;

(ii) in point (b), the words ‘by way of derogation from Article 37,’ shall be deleted;

(iii) the following new point (c) shall be inserted:

‘(c) measures setting high standards of quality and safety for medicinal products and devices for medical use.’;

(iv) the current point (c) shall be renumbered paragraph 5 and replaced by the following:

‘5. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, may also 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, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, xcluding any harmonisation of the laws and regulations of the Member States.’;

(e) the second subparagraph of the current paragraph 4 shall become paragraph 6 and paragraph 5, renumbered 7, shall be replaced by the following:

‘7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.’.


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Renumbering ToL

The Table of equivalences of the original Treaty of Lisbon tells us that Title XIII first became Title XIII in the TFEU (ToL), but renumbered Title XIV Public helath in the consolidated version.

Article 152 TEC initially became Article 152 TFEU (ToL) before the renumbering of the treaty made it into Article 168 TFEU in the consolidated version (OJ 17.12.2007 C 306/217).


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Lisbon Treaty consolidated

After the explicit amendments, horizontal amendments and renumbering, Article 168 of the Treaty on the Functioning of the European Union (TFEU) appears as follows in the consolidated TFEU, published in the Official Journal of the European Union, OJ 9.5.2008 C 115/122–124:

TITLE XIV
PUBLIC HEALTH

Article 168 TFEU
(ex Article 152 TEC)

1. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.

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

The Union shall complement the Member States' action in reducing drugs-related health damage, including information and prevention.

2. The Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. It shall in particular encourage cooperation between the Member States to improve the complementarity of their health services in cross-border areas.

Member States shall, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas referred to in paragraph 1. The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination, in particular initiatives aiming at the establishment of guidelines and indicators, the organisation of exchange of best practice, and the preparation of the necessary elements for periodic monitoring and evaluation. The European Parliament shall be kept fully informed.

3. The Union and the Member States shall foster cooperation with third countries and the competent international organisations in the sphere of public health.

4. By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:

(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures;

(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;

(c) measures setting high standards of quality and safety for medicinal products and devices for medical use.

5. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, may also 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, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, excluding any harmonisation of the laws and regulations of the Member States.

6. The Council, on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article.

7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.


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Amendments

There has been a growing awareness of the cross-border nature and even global character of health threats, so in general the treaty reform stages point in the direction of more effective means to combat common threats. But this movement has not been straightforward, partly due to concerns about handing the European Union powers.

Interested readers are invited to track Article III-179 of the draft constitution, Article III-278 of the Constitutional Treaty, the IGC 2007 Mandate and the final TFEU.

Supplementing information is offered by:

Klemens H. Fischer: Der Vertrag von Lissabon (pages 302 to 305)

François-Xavier Priollaud & David Siritzky: Le traité de Lisbonne (pages 279 to 281)

If your main focus is the change between the current TEC and the TFEU, you may find the following comment by professor Steve Peers helpful:

The amendments: add a reference to ‘physical and mental’ health; refer to action on monitoring, etc. public health; encourage cooperation on cross-border health services; make the Commission’s role clearer; create a specific legal base for legislation on medical products and medical devices; set out in more detail the power to adopt incentive measures; and clarify further the boundary between EU and Member State competences in this area.

In accordance with the Reform Treaty mandate, the new express EU competence concerning serious cross-border health threats has been moved from a shared power (ie a power for the EU to harmonise national law) to a supporting power only. Also, a declaration clarifying the internal market aspects of the new express power to harmonise law concerning medical devices, etc. is attached to the draft Reform Treaty. In fact, Article 95 EC is used at present to adopt legislation on this issue, so the ‘new’ legal base on this issue is not new in practice.

The draft Reform Treaty has also added a reference to the financing of health services.


(Source: Steve Peers: Statewatch Analysis, EU Reform Treaty Analysis no. 3.4: Revised text of Part Three, Titles VII to XVII of the Treaty establishing the European Community (TEC): Other internal EC policies; Version 2, October 2007)

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Declaration No 32

The member states agreed on a declaration concerning measures setting high standards of quality and safety for medicinal products and devices for medical use, mentioned in Article 168(4)(c) TFEU (OJ 9.5.2008 C 115/348):

32. Declaration on Article 168(4)(c) of the Treaty on the Functioning of the European Union

The Conference declares that the measures to be adopted pursuant to Article 168(4)(c) must meet common safety concerns and aim to set high standards of quality and safety where national standards affecting the internal market would otherwise prevent a high level of human health protection being achieved.

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EU powers

The powers of the European Union are attributed or conferred by the member states through the treaties. The Treaty of Lisbon makes an effort to present the different categories of competence in a systematic manner.

The categories of EU competence (the taxonomy) are set out in Article 2 TFEU. The three main or general categories are exclusive competence in 2(1), shared competence in 2(2) as well as supporting, coordinating or supplementing competences in 2(5), although the exact scope and arrangements are laid out in the various treaty provisions as stated in 2(6):

Article 2 TFEU

1. When the Treaties confer on the Union exclusive competence in a specific area, only the Union may legislate and adopt legally binding acts, the Member States being able to do so themselves only if so empowered by the Union or for the implementation of Union acts.

2. When the Treaties confer on the Union a competence shared with the Member States in a specific area, the Union and the Member States may legislate and adopt legally binding acts in that area. The Member States shall exercise their competence to the extent that the Union has not exercised its competence. The Member States shall again exercise their competence to the extent that the Union has decided to cease exercising its competence.

3. The Member States shall coordinate their economic and employment policies within arrangements as determined by this Treaty, which the Union shall have competence to provide.

4. The Union shall have competence, in accordance with the provisions of the Treaty on European Union, to define and implement a common foreign and security policy, including the progressive framing of a common defence policy.

5. In certain areas and under the conditions laid down in the Treaties, the Union shall have competence to carry out actions to support, coordinate or supplement the actions of the Member States, without thereby superseding their competence in these areas.

Legally binding acts of the Union adopted on the basis of the provisions of the Treaties relating to these areas shall not entail harmonisation of Member States' laws or regulations.

6. The scope of and arrangements for exercising the Union's competences shall be determined by the provisions of the Treaties relating to each area.



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Article 4 TFEU

As an area of shared competence between the EU and the member states, Article 4(2)(k) mentions common safety concerns in public health matters for the aspects defined in this Treaty.

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Article 6 TFEU

The European Union has competence to carry out actions to support, coordinate or supplement the actions of the Member States. Among the areas of such action, at European level, Article 6(1)(a) mentions the protection and improvement of human health.


In other words, different aspects of public health are subject to shared competence, supporting, coordinating or supplementing action or remain wholly with the member states.

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Summary of legislation: Public health

On the Commission’s Scadplus web pages with summaries of legislation, there is several dedicated to public health issues.

A new strategic approach to health for the EU (2008–2013) (last update 19 February 2008):

http://europa.eu/scadplus/leg/en/cha/c11579.htm


New Community health strategy (last update 26 July 2006):

http://europa.eu/scadplus/leg/en/cha/c11563.htm

Scientific Committees for consumer safety, public health and the environment (last update 2 May 2007):

http://europa.eu/scadplus/leg/en/lvb/l28153.htm

The precautionary principle (last update 2 November 2005):

http://europa.eu/scadplus/leg/en/lvb/l32042.htm

Programme of Community action in the field of health and consumer protection (2008–2013) (last update 8 April 2008):

http://europa.eu/scadplus/leg/en/cha/c11503c.htm


e-Health: improving health and healthcare through the use of information and communication technologies (last update 20 May 2005):

http://europa.eu/scadplus/leg/en/lvb/l24226f.htm

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News and links

General Commission news and links on Public Health can be found here:

http://ec.europa.eu/health/index_en.htm



Ralf Grahn