Overview of activities relevant to public health - Hoofdinhoud

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COUNCIL OF THE EUROPEAN UNION

Brussels, 11 December 2009

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SAN 347

General Secretariat of the Council

Working Party on Public Health at Senior Level

Overview of activities relevant to public health

In view of the meeting on 16 December 2009, delegations will find attached a document on the above mentioned subject. The document reflects the main developments that took place since the meeting of the Working Party on Public Health at Senior level on 9 December 2008 and covers the period from 1 December 2008 to 1 December 2009.

This overview contains the following parts:

• 1. 

  Introductory summary;
• 2. 

  Overview of recent and current Council activities related to public health in areas covered by Council preparatory bodies (Annex I);
• 3. 

  New developments with respect to cases submitted to the Court of Justice of the EU (Annex II).

The document is primarily submitted for information of delegations. Comments on the content and structure are welcomed and should be sent to secretariat.dgi2a@consilium.europa.eu.

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INTRODUCTORY SUMMARY

With respect to legislative work, the year 2009 was influenced by the elections to the European Parliament that took place on 4 -7 June 2009. The discussions between the European Parliament and the Council on different co-decision legislative proposals were intensified in the period January -April 2009 with the objective to agree before the end of the sixth parliamentary term with a special focus on proposals that were at the second reading stage. After the European elections, the co-decision legislative work restarted in September 2009. For the above reason, the overview does not contain a specific report about the own initiatives of the European Parliament.

Public Health

In the area of the public health three Member States holding the Presidency of the Council from 1 July 2008 to 31 December 2009 (France, Czech Republic and Sweden) took forward the EU Health Strategy in line with the Council conclusions of December 2007 and June 2008.

During this period, the following topics were discussed:

• - 

  Patients' mobility and safety;
• - 

  Availability and safety of organs;
• - 

  Quality of healthcare;
• - 

  e-Health and healthcare information;
• - 

  Reduction of alcohol related harm and tobacco control;
• - 

  Communicable diseases (Influenza H1N1);
• - 

  Antibiotic resistance;
• - 

  Alzheimer's disease;
• - 

  Rare diseases.

Major attention has been paid to the Commission's proposal for a Directive on the application of patients´ rights in cross-border health care. The European Parliament adopted its first reading opinion on 23 April 2009 putting forward 122 amendments to the Commission's proposal. In spite of intensive discussions in the Working Party, during which the Commission proposal was substantially modified, the Council (EPSCO) did not reach a political agreement at its meeting on 1 December 2009. The discussions will thus continue under the Spanish Presidency.

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Influenza H1N1 pandemic has been another topic of major importance. The Council (EPSCO) held special meetings on 30 April and 12 October 2009 to discuss the situation and exchange views on best practices to cope with the pandemic. Council conclusions have been adopted at both meetings. The H1N1 pandemic has also been discussed at the Council (EPSCO) meeting on 1 December 2009. The Swedish Presidency convened 3 meetings of the Friends of the Presidency Group on Pandemic Influenza.

Social security

Regulation (EC) No 883/2004 on the coordination of social security systems will become applicable on 1 May 2010 and will replace the current Regulation No 1408/71 EEC. This is a result of the second reading agreement between the Council and the European Parliament on the amendment to the regulation (EC) No 883/2004 and on the regulation on its implementation approved by the Council in July 2009

The Council (EPSCO) adopted the Joint Report on Social Protection and Social Inclusion 2009 and the Conclusions on healthy and dignified ageing on 9 March and 30 November 2009 respectively. On 20 October 2009, the Commission adopted the Communication on Solidarity in Health: reducing health inequalities in the EU.

Pharmaceuticals

The "Pharmaceuticals package", submitted by the Commission in December 2008, was the main subject of discussion in 2009. This package consists of five legislative proposals, one on falsified medicinal products, two on pharmacovigilance and two on information to the general public on prescription-only medicines. While good progress has been made on the proposals relating to pharmacovigilance and falsified medicines, almost all delegations have substantial problems with proposals on information to the general public, on which very little progress has been made so far.

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Food and feed safety

In line with the EU "farm to fork" approach announced by the Commission in its White Paper on Food Safety in 2000 to tackle weaknesses in the food legislation within the EU, the legislative work continued . The Regulation (EC) No 767/2009 on the placing on the market and use of feed and the "Pesticide package" have been agreed by the European Parliament and the Council and subsequently adopted.

In June 2009, the Council reached a political agreement on the Regulation on novel foods. The common position should be formally adopted in January 2010 and transmitted to the European Parliament for a second reading. The main problem for the European Parliament remains the inclusion of the food production from animals obtained by non-traditional breading techniques (e.g. cloning) and their offspring in the scope of the regulation.

Discussion continued on the proposal for a Regulation on the provision of food information to consumers (labelling). In spite of the substantial progress achieved in clarifying different provisions during the Swedish Presidency, there is no agreement for the time being and discussion will continue under the Spanish Presidency. The European Parliament should adopt its opinion in the first reading in June 2010.

Environment

In June 2009, the Council (Environment) reached political agreement on a proposed Directive on Industrial Emissions (Recast). Directive 2009/126/EC on Stage II petrol vapour recovery during refuelling of motor vehicles at service stations has been adopted by the Council in October 2009.

Three other proposals - recast of Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) , recast of Directive on waste electrical and electronic equipment (WEEE) and Regulation on Biocidal Products have been submitted by the Commission and are currently under discussion.

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Research

On 3 December 2009, the Council adopted the conclusions concerning Joint programming of research in Europe, launching the pilot joint programming initiative on combating neurodegenerative diseases, in particular Alzheimer's.

The Commission submitted a mid-term progress report on the Lead Market Initiative for Europe in September 2009. With respect to eHealth, it has been identified as one of the six lead market areas, the foreseen activities have been initiated and there is no need to change or adapt the action plan. It is still too early to notice any market growth as a result of the LMI activities. However, the Commission's efforts to adopt a market-focused approach to eHealth development have been widely welcomed by industry and user stakeholder groups, and by the Member State Contact Group (i2010 sub-group on eHealth).

Agriculture

The Regulation (EC) 470/2009 on of residue limits of pharmacologically active substances in foodstuffs of animal origin entered into force on 6 July 2009 and has been applicable since the same day.

The Regulation (EC) No 1069/2009 on animal by-products has been adopted in the first reading. It entered into force on 4 December 2009 and will apply from 4 March 2011.

Civil Protection

The EU CBRN Action Plan as well as a set of corresponding Council conclusions were adopted by

the Council (JHA) on 30 November 2009.

Court of Justice of the EU (ECJ)

As to the cases before the Court of Justice of the EU that concern provision of healthcare, five new cases have been lodged in areas of patient mobility (1), free provision of services (1), competition (1) and medicinal products (2). The ECJ ruled in thirteen pending cases. In four cases, the Advocate general gave his/her opinion and we can expect rulings in the course of 2010.

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ANNEX I

Overview of recent and current Council activities related to public health in areas covered by

Council preparatory bodies

PUBLIC HEALTH

Working Party on Public Health

As the main objective of this document is to give the information about the health related activities of other Council preparatory bodies than the Working Party on Public Health, the activities of the latter are outlined here without further details.

The implementation of the 18-month programme of the French, Czech and Swedish Presidencies led to the adoption or to the negotiation by the Council of the following documents:

EU legislation Adoption:

• - 

  Regulation (EC) No 1338/2008 of 16 December 2008 on Community statistics on public health and health and safety at work¹

Proposals in negotiation:

• - 

  Directive on the application of patients' rights in cross-border healthcare²;
• - 

  Directive on standards of quality and safety of human organs intended for transplantation³.

OJ L 354, 31.12.2008, p. 70. Doc. 11307/08 (COM(2008)414). Doc. 16521/08 (COM(2008) 818 final)

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1

Council Recommendations: Adoption:

• - 

  Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections (OJ C 151, 3.7.2009, p. 1–6);
• - 

  Council Recommendation of 9 June 2009 on an action in the field of rare diseases (OJ C 151, 3.7.2009, p. 7–10);
• - 

  Council Recommendation of 1 December 2009 on smoke-free environments (doc. 15937/1/09 REV 1);

To be adopted:

• - 

  Council Recommendation on seasonal influenza vaccination (possible day of adoption, 22 December 2009).

Council conclusions:

• - 

  Neurodegenerative diseases associated with ageing and in particular Alzheimer's disease (16 December 2008, doc. 16825/08);
• - 

  Health Security

(16 December 2008, doc. 16825/08);

• - 

  Influenza A/H1N1 infection (30 April 2009, doc. 9347/09);
• - 

  Special Report No. 2/2009 concerning the European Union's Public Health Programme (2003-2007): an effective way to improve health?

(12 October 2009, doc. 13737/09);

• - 

  Pandemic (H1N1) 2009 - a strategic approach (12 October 2009, doc. 14311/09);
• - 

  Promoting universal prevention programmes and interventions by EU Member States to prevent or delay first use of drugs, including poly-drug use

(12 October 2009, doc. 13405/09);

• - 

  Alcohol and health

(1 December 2009, doc 16611/09);

• - 

  Innovative incentives for effective antibiotics (1 December 2009, doc. 16611/09);
• - 

  Safe and efficient healthcare through eHealth (1 December 2009, doc. 16611/09);

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• - 

  Joint programming of research in Europe:
• a) 

  The launch of the pilot joint programming initiative on combating neurodegenerative diseases, in particular Alzheimer's;
• b) 

  Progress in joint programming and the way ahead (3 December 2009, doc. 16129/1/09);
• - 

  Security of Supply of Radioisotopes for Medical Use (17 or 22 December 2009, doc. 17034/09).

SOCIAL PROTECTION

Working Party on Social Questions Social Protection Committee

Following the adoption of common position by the Council on 17 December 2008 and second reading negotiations with the European Parliament, the Regulation No 988/2009 amending Regulation (EC) No 883/2004 on the coordination of social security systems and determining the content of its Annexes as well as the Regulation (EC) 987/2009 laying down procedures for implementing the Regulation (EC) No 883/2004 (have been published) in the Official Journal⁴ on 30 October 2009. As a result, Regulation No (EC) 883/2004, as amended, shall apply as of 1 May 2010 and will replace the current Regulation No 1408/71 EEC.

The new rules aim to protect the social security rights of insured persons moving within the Community, with a view to removing obstacles to the free movement of persons.

The fact that Regulation (EC) No 883/2004 now concerns all European citizens, since it also covers the non-working population, means modernising the methods and procedures for cooperation between Member States’ social security institutions. Specifically, it is a question of facilitating the procedures for insured persons and reducing the time needed for institutions in the various branches of social security (sickness, accidents at work, occupational diseases, invalidity, old age, unemployment, family benefits) to respond and to process cross-border cases.

⁴ OJ L 284, 30.10.2009, p.1.

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Furthermore, electronic exchange of data between social security institutions through the EESSI system (Electronic Exchange of Social Security Information) will play an essential role in facilitating the transfer of the information needed for coordinating and, in particular, for ascertaining and calculating the rights of insured persons.

On 9 March 2009, the Council (EPSCO) adopted the Joint Report on Social Protection and Social Inclusion 2009⁵ prepared by the Social Protection Committee. The Joint Report was also noted by the European Council at its meeting on 19-20 March 2009. With regard to healthcare, the Joint Report stresses that:

"Member States strive to improve the value for money of healthcare and reduce health inequalities by increased attention to primary care, prevention, health promotion, better coordination and rational use of resources. These strategies need to be more vigorously pursued, in particular where healthcare systems are under-resourced. This also implies addressing potential staff shortages in health care by measures to recruit, train, retain and develop health care professionals at all levels. Member States are also striving to establish and strengthen systems for quality long-term care, to create a solid financing basis, to improve care coordination and to ensure sufficient human resources as well as support for informal carers."

On 30 November 2009, the Council (EPSCO) adopted Conclusions on healthy and dignified ageing⁶. These conclusions stress that frailty in old age should be recognized in terms of a combination of medical, psychological and social factors. Health and social services should actively strengthen dignity and coordination between health and social sectors and integrated policies should be improved. Member States have a lot to learn from each other and an enhanced cooperation between the health and social sectors is needed at the EU-level, as well as between and within the Member States, in order to promote a healthy and dignified ageing in the European Union.

On 20 October 2009, the Commission adopted the communication on Solidarity in Health: reducing health inequalities in the EU⁷. It is envisaged that the Social Protection Committee will prepare an Opinion for endorsement by the Council (EPSCO) in March 2010.

⁵   Doc. 7503/09.

⁶   Doc. 15955/09.

⁷   Doc. 14848 (COM(2009) 567 final).

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PHARMACEUTICALS AND MEDICAL DEVICES

Working Party on Pharmaceuticals and Medical Devices

Following the review of the Pharmaceuticals legislation in 2004, its two basic instruments Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation (EC) 726/2004 have been complemented by the introduction of Community rules on paediatric medicines and on advanced therapy medicinal products. In 2007, the Medical device directives were also subject to substantive amendments.

The work on improving the Community legal framework for medicinal products has continued during 2008 and 2009. The Directive 2009/53/EC amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products⁸ was agreed and adopted in the first reading. It entered into force on 20 July 2009 and shall be transposed by Member States by 20 January 2011.

The "Pharmaceuticals package" has been submitted by the Commission to the Council and the European Parliament on 10 December 2008. The package contains five legislative proposals, one on the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source⁹, two on pharmacovigilance¹⁰ and two on information to the general public on prescription-only medicines ¹¹. It also contains a Commission Communication

on "Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector"¹².

The Working Party has made good progress on the proposals relating to pharmacovigilance and falsified medicines. As regards the proposals on information to the General Public, almost all delegations have substantial problems and very little progress has been made in the Council examination. The Council (EPSCO) on an progress achieved¹³. The Rapporteurs of the European Parliament has started their work and the ENVI Committee is expected to vote in April 2010.

8

9

10

11

12

13

OJ L 168, 30.6.2009, p.33.

Doc. 17504/08.

Doc. 17501/08 (COM(2008) 664 final) and 17502/08 (COM(2008) 665 final).

Doc. 17498/08 (COM(2008) 662 final) and 17499/08 (COM(2008) 663 final).

Doc. 17503/08.

Doc. 16055/09.

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FOOD SAFETY

I.      Feed: placing on the market and use of feed Working Party on Agricultural Questions (Feedingstuff)

The Regulation (EC) No 767/2009 on the placing on the market and use of feed¹⁴ was adopted by the Council on 22 June 2009 after an agreement in first reading with the European Parliament. It entered into force on 21 September 2009 and shall be applicable from 1 September 2010.

The Regulation simplifies the authorisation procedures by adopting a risk-oriented approach based on market surveillance and renouncing the use of pre-defined feed groups, with a view to ensuring that the feed industry will be able to exploit new sources of bio-protein from within the EU. It establishes general rules for the labelling of feed, such as the need to identify the type of feed, the name and address of the operator, the list of additives and the net weight. Specific labelling requirements are proposed for compound feed, feed intended for nutritional purposes and pet food. The initiative of updating the EU's list of feed materials was transferred to stakeholders as it requires the creation of a feed materials Community catalogue to improve the labelling of feed materials and of EU codes for good labelling practices regarding voluntary labelling provisions.

II.     Pesticide package

Working Party on Agricultural Questions (Pesticides/Plant protection products)

The "pesticides package" should be seen in the context of the Thematic Strategy on the sustainable use of pesticides, which overall purpose is to minimize the impact of pesticides on human health and the environment. The Commission made its proposal in July 2006. The "package", consisting of two Regulations and one Directive, has been agreed by the European Parliament and the Council.

¹⁴ OJ L. 229, 01.09.2009, p. 1.

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The Regulation (EC) No 1107/2009 concerning placing of plant protection products on the market¹⁵ and Directive 2009/127/EC establishing a framework for Community action to achieve a sustainable use of pesticides¹⁶ were formally adopted by the Council on 24 September 2009 following a second reading agreement reached on 18 December 2008. The Regulation entered into force on 14 December 2009 and shall apply from 14 June 2011. The Directive entered into force on 25 November 2009 and shall be transposed by Member States before 25 November 2011.

The application of this new Regulation on placing on the market of plant protection products will exclude from the market the most dangerous substances (i.e. carcinogenic, mutagenic or toxic for reproduction substances) used nowadays to protect the European crops. Other substances with neurotoxic, immunotoxic or endocrine-disrupting effects will be banned if they are deemed to pose a significant risk. This should be achieved by a very thorough approval procedure based on exclusion criteria set out at EU level. In addition, other active ingredients presenting a particular danger will have to be replaced with safer alternatives within 5 years. The Regulation also provides for incentives for the use of products with a low-risk profile. It will gradually replace the existing legislation in this domain (Council Directive 91/414/EEC).

The Directive on sustainable use of pesticides follows the decision adopting the 6th Environment Action Programme, in which the European Parliament and the Council recognised that the impact of pesticides on human health and the environment needed to be further reduced. The Directive fills a gap in the present legal framework, which is that of the use phase of pesticides. Although, at the moment, it only affects plant protection products, the Commission foresees to broaden its scope to biocidal products in the future. In particular, the Directive:

• - 

  provides for the adoption of national action plans to set up quantitative targets to reduce the risk of pesticides use;
• - 

  promotes low pesticide-input farming and the use of non-chemical alternatives wherever possible;
• - 

  obliges Member States to ensure that the general standards of integrated pest management are implemented;
• - 

  bans aerial spraying subject to exceptions authorised by the national authorities.

15 16

OJ L 309, 24.11.2009, p. 1. OJ L 309, 24.11.2009, p. 1.

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The third part of the package, the Regulation (EC) 1185/2009 on statistics on plant protection products¹⁷ has been agreed in conciliation (the Conciliation Committee met on 4 November 2009) and approved by the Council on 16 November 2009¹⁸. It will enter into force on 30 December 2009 and will be directly applicable. The principal objective of the Regulation is to guarantee that comparable data are collected in all the Member States thereby making it possible to calculate harmonised risk indicators.

III. Genetically modified organisms (GMOs) Working Party on Agricultural Questions (GMO)

In December 2008 the Council ("Environment") adopted conclusions concerning some aspects of the EU policy on GMOs¹⁹, in which it urges the Commission to consider the need to present new proposals covering, in particular, the improvements in procedures for evaluation of risk assessments and for the functioning of scientific expertises on GMOs, particularly as regards environment protection.

At March 2009 Council ("Agriculture and Fisheries") meeting some delegations expressed concerns on the process of approval of GMOs for cultivation and the Commission announced that an evaluation report on this matter will be issued in June 2010.

In June 2009 the Council ("Environment") held an exchange of views concerning the question of cultivation of GMOs in the EU. Many delegations urged the Commission to put forward proposals aimed at allowing individual Member States to adopt national measures leading to regulate and/or prohibit the cultivation of GMOs in certain sensitive areas.

In September 2009 the Agriculture and Fisheries Council held an exchange of views on the EU shortage of feed supply, whereby the importance of GM imported material was highlighted, in particular, the negative effects of the asynchronous approvals of GMOs between the EU and the rest of the world. In this context, a significant number of delegations and the Commission favoured a rapid authorisation procedure for GMOs within the EU, while other delegations called for caution on the related decision-making process.

¹⁷      Doc. 1112/08 (Council common position), doc. 8907/09 (EP's second reading amendment).

¹⁸      OJ L 324, 10.12.2009.

¹⁹      Doc. 16882/09.

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In November 2009 the Council took note of the intention expressed by the Commission representative that the new College will work on a proposal concerning the EU zero tolerance policy on unauthorised GMOs.

IV.    Food improvement agents package Working Party on Foodstuffs

The "food improvement agents package" consists of four regulations²⁰:

• a) 

  Regulation No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
• c) 

  Regulation No 1332/2008 on food enzymes
• b) 

  Regulation No 1333/2008 on food additives
• d) 

  Regulation No 1334/2008 on flavourings and certain food ingredients with flavouring properties.

The package was adopted by the Council on 18 November 2008 following the second reading agreement with the European Parliament. It entered into force on 20 January 2009. Three sectoral regulations will be applicable as of 20 January 2010. The application of the Common authorisation procedure to them depends on the adoption of implementing measures referred therein, but shall in any case be not later than 16 December 2010.

V.     Novel Foods

Working Party on Foodstuffs

The proposal for a Regulation on novel foods (COM(2007)872) was submitted by the Commission on 14 January 2008. Following the adoption of the first reading legislative resolution by the European Parliament on 25 March 2008, the Council reached a political agreement on 22 June 2008 (doc. 10754/09 + ADD1). The Council's common position at first reading will be adopted in January 2010. The negotiations with the European Parliament in the second reading should take place in the first semester 2010, subject to confirmation. The main problem for the European Parliament remains the inclusion of food production from animals obtained by non-traditional breading techniques (e.g. cloning) and their offspring in the scope of the regulation.

²⁰ OJ L 354, 31.12.2008, p. 1-50.

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VI. Food information to consumers Working Party on Foodstuffs

The proposal for a Regulation on the provision of food information to consumers (labelling), submitted by the Commission on 30 January 2008, has been intensively discussed at the level of the Working Party during the French, Czech and Swedish Presidencies. In spite of the progress achieved in clarifying different provisions, there is no agreement for the time being. Progress reports have been regularly submitted for the information of the Council at the end of each Presidency²¹, last being the information to the Council (AGRI) on 15 December 2009. The European Parliament should adopt its opinion in the first reading in June 2010.

With respect to the Regulation (EC) No 1924/2006 on nutrition and health claims made on foods²², the Commission submitted several proposals to the Council in the framework of comitology procedure with scrutiny. As neither the Council nor the European Parliament opposed the Commission's proposals, 9 health claims related to reduction of disease risk or children's development and health have been authorized²³. In addition, on 30 November 2009 the Commission amended the Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims²⁴.

ENVIRONMENT

EU environmental legislation

Working Party on the Environment (WPE)

In June 2009, the Council (Environment) reached political agreement on a proposed Directive on Industrial Emissions (Recast)²⁵. The Common position should be transmitted to the European Parliament in January 2010. When adopted, the directive will revise and merge seven separate existing directives concerning industrial emissions in order to achieve a high level of environmental protection while simplifying the legal framework and avoiding unnecessary administrative burdens.

²¹      Doc. 16519/08 (French Pres), 10641/09 (Czech Pres) and 16594/09 (Swedish Pres).

²²      OJ L 404, 30.12.2006, p. 9.

²³      Commission Regulations (EC) No 983/2009, No 1024/2009.

²⁴      Commission regulation (EC) No 1169/2009.

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It should make a major contribution to public health by reducing polluting emissions from industry, particularly sulfur and nitrous oxides and dust.

Following the first reading agreement, the Directive 2009/126/EC on Stage II petrol vapour recovery during refuelling of motor vehicles at service stations²⁶ has been adopted. Measures envisaged in this Directive will protect public health by requiring the installation of equipment in service stations for the recovery of petrol vapour during refuelling. Member states shall transpose the directive before 1 January 2012.

The proposal for the Regulation on Biocidal Products²⁷, proposal for a Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) (Recast)²⁸ and Proposal for a Directive on waste electrical and electronic equipment (WEEE) (Recast)²⁹ are currently examined by the Working Party on the Environment. The Biocides Regulation should prevent the placing on the market of biocidal products that are harmful to public health, but also ensure that biocidal products are available to control harmful organisms necessary to protect public health. Similarly, the RoHS Directive should ensure that electric and electronic equipment placed on the market does not contain certain substances very harmful to human health and the environment.

RoHS and WEEE directives have been in place for five years and have helped to reduce the environmental impact of electronic appliances. However, there are still substantial amounts of electronic waste that undergo substandard treatment and are illegally exported to third countries, causing environmental harm. This needs to be remedied. In addition, experience of the first few years of implementing the Directives has revealed a number of technical, legal and administrative difficulties that need to be addressed.

25 26 27 28 29

Doc. 11962/09 + ADD1.

OJ L 285, 31.10.2009, p.36.

Doc. 11063/09 (COM 2009/267 final).

Doc. 17333/09 (COM(2008) 809 final).

Doc. 17367/09 (COM(2008)810 final).

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ANNEX I                                    DG I                        LIMITE EN

In order to address the environmental problem caused by the “leakage” of electronic waste to substandard treatment and to illegal exports, the Commission has proposed a new waste collection rate in the WEEE Directive. It is proposed that the enforcement of both Directives should be strengthened. For the RoHS Directive, national market surveillance mechanisms have been introduced for assessing product conformity . In the case of the WEEE Directive, minimum inspection requirements for Member States are proposed, as well as minimum monitoring requirements for shipments of WEEE.

Council Conclusions on the "combination effects of chemicals", are being prepared by the Swedish Presidency with a view to their adoption by the (Environment) Council on 22 December 2009. The objective is to encourage the Commission to take action on this subject with particular attention to endocrine disruptors.

International processes

Working Party on the International Environmental issues (WPIEI)

In preparation of the 25th session of the UNEP Governing Council (UNEP GC), the Council (Environment) adopted on 4 December 2008 conclusions affirming its commitment to the overall objective of protecting human health and the environment from the release of mercury and its compounds and considering that a multilateral environmental agreement would be the most appropriate instrument for mercury control at global level. The conclusions also emphasized that such an agreement should cover the whole life cycle of mercury and affirmed support for a comprehensive structure of the agreement. In 2009 the Working Party on International Environmental Issues (WPIEI) has been preparing for the international negotiation process (Intergovernmental Negotiating Committee - INC) as laid down in UNEP GC Decision 25/5. The work in WPIEI will be further intensified in 2010 in view of the first INC meeting scheduled for June 2010.

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In March 2009 the Council adopted a Decision establishing the position concerning proposals for mending Annexes A, B and C to the Stockholm Convention on Persistent Organic Pollutants at the fourth meeting of the Conference of Parties on 4 - 8 May 2009. The Conference took a decision to add nine new chemicals to the Annexes to the Convention and so extend the scope of the Convention from the original "dirty dozen" to 21 substances, many of which, e.g. lindane and polybrominated diphenyl ethers and PFOS, are still widely used as pesticides, flame retardants and for a number of other commercial purposes. The EU fully achieved its ambitious goal of listing all the nominated substances.

In the first half of 2009 WPIEI also intensively dealt with EU preparation for the second meeting of the International Conference on Chemicals Management (ICCM2) on 11-15 May 2009, which undertook a review of the Strategic Approach to International Chemicals Management (SAICM). The Conference's priority was to accomplish the remaining tasks from ICCM1, to allow effective functioning of the ICCM in the future. ICCM2 also provided an opportunity to see progress which had been made on SAICM implementation in the three years since ICCM1.

EU positions has been prepared in the framework of UNECE Convention on Transboundary Air Pollution (CLRTAP) and its additional Protocols on a number of matters relevant to public health. More specifically, seven new substances are to be added to the Protocol on POPs; the revision of the Protocol on Heavy Metals and of the Gothenburg Protocol to Abate Acidification, Eutrofication and Ground-level Ozone is the subject of intensifying discussions, that include further regulation of Particulate Matter or the inclusion of new pollutants, such as black carbon and carbon monoxide. The Executive Body of the CLRTAP, at its 27th session in December, is expected to mandate the Working Group on Strategies and Reviews on particular aspects of this revision. On a more general level, discussions have been initiated on a Long Term Strategy that will have an impact on the future policy directions of the Convention.

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ANNEX I                                    DG I                        LIMITE EN

RESEARCH

On 3 December 2009, the Council adopted the Conclusions concerning Joint programming of research in Europe³⁰. These conclusions include the launching of the pilot joint programming initiative (JPI) on combating neurodegenerative diseases, in particular Alzheimer's, and welcome the progress made in the High Level Group on Joint Programming (GPC) by identifying and substantiating the first wave of themes for JPIs to be adopted by the Council in due time. These themes include two health related ones, namely "Agriculture, food security and climate change" and "Health, food and prevention of diet related diseases".

As reported in December 2008, the health is one of the 10 thematic areas for support from 7th Research Framework Programme under its sub-programme "Cooperation" with a budget of € 6 billion for 2007-13. The sub-programmes of food, agriculture and biotechnology, nanotechnologies and security also address health-related issues.

The objective of the health research programme is to improve the health of European citizens, and increase and strengthen the competitiveness and innovative capacity of European health-related industries and businesses. Global health issues, like emerging epidemics, are also addressed. European collaboration with developing countries will allow those countries to develop research capacities.

The Innovative Medicines Initiative is one of Joint Technology Initiatives, a public-private partnership between the European Community represented by the European Commission and the pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) to boost investment in European bio-pharmaceutical R&D and to overcome bottlenecks in the development of innovative medicines.

³⁰ Doc.17226/09.

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ANNEX I                                    DG I                        LIMITE EN

COMPETIVENESS AND GROWTH

The Communication from the Commission on the regulatory aspects of nano-materials³¹ was submitted in June 2008. It follows-up on the Commission's commitment for a regulatory review of EU legislation in relevant sectors announced in its Communication “Nanosciences and nanotechnologies: an action plan for Europe 2005 – 2009”³², which specified that all applications and use of nano-sciences and nanotechnologies must comply with the high level of public health, safety, consumers and workers protection, and environmental protection chosen by the Community.

The Communication concludes that current EU legislation covers in principle the potential health, safety and environmental risks in relation to nanomaterials. The protection of health, safety and the environment needs mostly to be enhanced by improving implementation of current legislation. The Commission intends to report on progress of its work in the field of nanotechnology and nano-science in 2011. The Council has not so far reacted to this communication.

eHealth is one of the six lead market areas identified by the Commission in the Lead Market Initiative for Europe³³. The Commission submitted a mid-term progress report on the initiative on in September 2009³⁴. With respect to eHealth, the Commission states that most of the foreseen activities have been initiated and deadlines have been respected, with no particular need to change or adapt the action plan. It is still too early to notice any market growth as a result of the LMI activities. However, the Commission's efforts to adopt a market-focused approach to eHealth development have been widely welcomed by industry and user stakeholder groups, and by the Member State Contact Group (i2010 sub-group on eHealth).

31 32 33 34

Doc. 110110/08.

COM(2005) 243 final of 7.6.2005.

Doc.5181/08.

Doc. 12959/09 (COM/2008/0366 final).

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Overall it can be concluded that the LMI has significantly helped with the creation of a favourable political environment for the efficient implementation of eHealth actions. Most of the actions for eHealth had their seed in the eHealth Action Plan (2004), but the LMI has contributed to the continuity of the eHealth activities and has in some cases played a decisive role in supporting actions. The LMI also contributed to strengthening the focus of the activities in eHealth deployment to the market prospective, which was less visible in the eHealth action plan. It is hoped that the remaining 2 years' activity under the LMI action plan can significantly contribute to market growth and increased employment in the field, despite the difficult economic climate.

AGRICULTURE

Commission Communication on Agricultural Product Quality: product standards, farming

requirements and quality schemes

Working Party on Agricultural Product Quality/Special Committee on Agriculture

Following its Green Paper³⁵, subsequent public consultation and a High Level Conference on Agricultural Product Quality organized in Prague on 12-13 March 2009, the Commission adopted its Communication on 28 May 2009³⁶.

The Communication lays down strategic orientations to improve the EU agricultural product quality policy. Aims at identifying ways to improve communication about the qualities of agricultural products in order to help reconnect farmers with consumers. It also aims, among others, to identify ways to ensure that quality labelling schemes are easy to use and understand, while ensuring the coherence of the EU quality policy.

In response to this Communication, the Council hold a debate and Council Conclusions³⁷ were adopted on 22-23 June 2009. The Commission is expected to present legislative proposals in 2011, e.g. recast of legislation on geographical indications and marketing standards.

³⁵      Doc.14358/08 (COM(2008) 641).

³⁶      Doc. 10359/09 + ADD 1 to ADD10.

³⁷      Doc. 10722/09 + ADD1.

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Veterinary aspects

Working Party of Veterinary Experts (Public Health)/Working Party of Chief Veterinary Officers

The Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human (Animal by-products Regulation)³⁸ has been adopted in the first reading. It entered into force on 4 December 2009 and will apply from 4 March 2011.

The new Regulation will replace current Regulation (EC) No 1774/2002, while keeping its main principles in force. It introduces more risk-proportionate rules and clarifies the rules on animal byproducts, as well as their interaction with other EU legislation (for instance the legislation on food hygiene and waste).

The most important innovations are :

• - 

  the introduction of the concept of an "end point" in the manufacturing of animal by-products, after which the processed products are no longer subject to the animal by-products regulation, as some potential risks have been eliminated for example by heat or chemical substances; instead, the general rules on product safety apply. Under the current rules, almost all material from animals which does not enter the food chain, is subject to the rules on animal byproducts.
• - 

  The distinction between foodstuffs and animal by-products is clarified by confirming that operators need to make an irreversible decision, if products are destined for purposes other than human consumption. This means that once a product has become an animal by-product, it must not re-enter the food chain.
• - 

  A registration obligation is introduced for operators who transport animal by-products, in order to strengthen traceability.

38

OJ L 300, 14.11.2009, p. 1.

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The Regulation 470/2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin ³⁹, proposal for which was submitted by the Commission under Article 152(4)(b) (public health) of the EC Treaty, entered into force on 6 July 2009 and has been applicable since the same day. Following the adoption of the European Parliament's first reading opinion in June 2008, the Council adopted its Common position on 18 December 2008. The European Parliament approved the Council's common position on 2 April 2009.

The new regulation repealed Regulation (EEC) No 2377/90 and introduced a new procedures for the establishment of maximum residue limits (MRLs) in order to respond to shortcomings identified with the former procedures (e.g. decreasing availability of veterinary medicines, absence of points of reference for control services in the Member States for substances detected in food from third countries).

CIVIL PROTECTION

Working Party on Civil Protection

The basis for the cooperation is the Council Decision of 8 November 2007 establishing a Community Civil Protection Mechanism (Recast) and the Council Decision of 5 March 2007 establishing a Civil Protection Financial Instrument laying down the rules for the provision of financial assistance in the area of civil protection. When it comes to health related questions, the possible preparatory measures include pooling of information related to necessary medical resources and stimulation of the use of new technologies. That kind of information can be made available by Member States on a voluntary basis for the protection of public health following a request for intervention under the above Mechanism.

Since December 2008, the Member States have further developed their civil protection capabilities, inter alia through the registration of additional civil protection assistance intervention modules (e.g. by March 2009 11 advanced medical post modules, 2 advanced medical post surgery modules, 1 field hospital module and 2 medical aerial evacuation of disaster victims modules have been

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registered. In addition 3 search and rescue in CBRN conditions and 11 CBRN detection and sampling modules are registered).

Following a set of Council conclusions addressing chemical, biological and radiological and nuclear risks and on bio-preparedness (doc. 16589/07), the Commission adopted on 24 June 2009 a communication on strengthening chemical, biological, radiological and nuclear (CBRN) security in the European Union - an EU CBRN Action Plan⁴⁰, which was based on the findings of a CBRN Task Force, established by the Commission in February 2008.

The overall goal of the above policy package is an all-hazard approach to reduce the threat of and damage from CBRN incidents of accidental, natural or intentional origin, including acts of terrorism. The EU CBRN Action Plan as well as a set of corresponding Council conclusions⁴¹ were adopted by the Council (JHA) on 30 November 2009.

According to the EU CBRN Action Plan each Member State should i.a:

• - 

  assess the required amounts and types of medical countermeasures in case of a incident involving high-risk CBRN materials;
• - 

  assess the availability of medical resources for the decontamination of victims, transport and of required countermeasures in the form of technical CBRN equipment;
• - 

  assess the possibility of sharing medical counter-measures across borders in case of an incident;

The Commission should collect and disseminate good practices among the Member States concerning the ways in which medical staff and other first responders can receive guidance on dealing with large scale CBRN emergencies and a rapid increase of the number of victims.

39 40 41

OJ L 152, 16.6.2009, p. 11.

Doc. 11480/09 (COM(2009) 273 final).

Doc. ST 15505/1/09 REV 1.

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HEALTH AND DEVELOPMENT

In reaction to the Commission's communication Commission Communication⁴², the Council (GAERC) adopted on 18 May 2009 Conclusions on supporting developing countries in coping with the crisis⁴³. The conclusions encourage, inter alia, all donors to participate in existing initiatives in the field of health which have shown their ability to provide stable and predictable resources in a coordinated manner.⁴⁴

As every year, the Council adopted the EU Statement on the occasion of World's AIDS Day (1 December)⁴⁵.

There are number of ongoing health-related development policy work and activities under EU external assistance:

• • 

  Implementation of the European Programme for Action to confront HIV/AIDS, malaria and tuberculosis through external action (2005-2011)⁴⁶
• • 

  Implementation of the European Programme for Action to tackle the critical shortage of health workers in developing countries (2007-2013)⁴⁷
• • 

  Promotion and protection of the rights of the child in the EU's external action - the development and humanitarian dimensions⁴⁸

42 43 44 45 46

47 48

Doc. 8695/09 + ADD1 to ADD4.

Council conclusions of 18 May 2009 (doc. 10018/09 + COR 1).

Council Conclusions of 11 November 2008 (doc. 15480/08).

16083/09 + ADD 1.

Council conclusions of 24 May 2005 (doc. 9278/05) + Commission progress report

(doc10776/09) + Council conclusions (doc. 16076/09).

Council conclusions of 14 May 2007 (doc. 7189/07).

Council conclusions of 26 May 2008 (doc. 9739/08).

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49

50

51

Mainstreaming gender equality and women's empowerment in development cooperation⁴⁹, in

particular the health aspects: health protection, reversion of the feminization trend of

HIV/AIDS, sexual and reproductive health and rights (SRHRs), etc.

EU Agenda for Action on the MDGs, which includes specific objectives in the area of Health⁵⁰

Strengthening health systems in developing countries⁵¹.

Council conclusions of 14 May 2007 (doc. 9561/07).

EU contribution to the MDGs Summit held in New York on 25 September 2008 (doc.

11096/08).

Council conclusions of 10 November 2008 (doc. 15391/08).

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ANNEX II

New developments in ECJ - CFI case law concerning health (period 1/12/2008 - 30/11/2009)

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LIMITE EN

Free Movement of Goods and Services (not medicinal products)

• 1) 

  C-512/08 - Commission v France (supported by Finland) (Prior authorisation for non-hospital care in other Member State), Action brought on 25.11.2008, NEW CASE

The Commission raises two complaints in support of its action.

• 1) 

  The Commission contests the requirement imposed by the French law of obtaining prior authorisation in order to receive reimbursement of expenses for certain non-hospital treatment provided in another Member State. This concerns the Article R-332-4 of the French Social Security Code, which makes the reimbursement for medical services available at a general practitioner's surgery requiring the use of the extensive material supplies in part II of Article R-712-2 of the Public Health Code subject to the grant of prior authorisation;
• 2) 

  The Commission objects to the absence, in French law, of a provision allowing the patient - insured under the French social security system - to be granted additional reimbursement in the circumstances set out in paragraph 53 of the judgment of 12 July 2001 in Vanbraekel and Others, that is to say, a reimbursement covering the difference in relation to the amount to which that patient would have been entitled if the hospital treatment had been provided in his own Member State. Consequently, those patients, insured under the French social security system, do not benefit fully from the rights which they are granted under Article 49 EC, as interpreted by the Court of Justice.
• 2) 

  C-208/07 -Von Chamier-Glisczinski, 16.7.2009 (Care received in a specialized establishment in other Member State)

Regional Social Court of the Land of bavaria (Bayerische LandessocialGericht) referred to the ECJ a reference for preliminary ruling concerning the interpretation of Article 19 of the Council Regulation (EEC) No1408/71of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community.

The reference has been made in the context of proceedings between Mrs von Chamier-Glisczinski and the Deutsche Angestellten-Krankenkasse (German employee sickness insurance fund, ‘DAK’), with regard to its refusal to pay certain costs relating to care received in a specialised establishment in Austria.

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Questions referred to the ECJ:

Should Article 19(1)(a) - in conjunction, as the case may be, with Article 19(2) - of Regulation (EEC) No 1408/71 be interpreted in the light of Article 18 EC and Articles 39 EC and 49 EC, in conjunction with Article 10 of Regulation (EEC) No 1612/68, as meaning that an employed or self-employed person, or a member of that person's family, may not receive any cash benefits or reimbursement provided on behalf of the competent institution by the institution of the place of residence, if there is provision under the law applicable to the institution of the place of residence for persons insured by that institution to receive only cash benefits, and not benefits in kind?

If there is no such entitlement to benefits in kind, is there, in the light of Article 18 EC, or Articles 39 EC and 49 EC, any entitlement to payment -subject to prior approval - by the competent institution of the costs of in-patient care in a care home situated in another Member State, in the amount of the benefits payable in the competent Member State?

The Advocate General has advised the Court to find that where a person obtains care in a care home in another Member State, Article 18 EC prohibits any national legislation which prevents reimbursement of the costs of such care if it would have been provided in a care home under the home social security system and located in the Member State where the person was insured.

The Court ruled that:

• 1. 

  Where, unlike the social security system of the competent State, that of the Member State of residence of a person reliant on care, insured as a member of the family of an employed or self-employed person within the meaning of Council Regulation (EEC) No 1408/71 of 14 June 1971, does not provide for the provision of benefits in kind in situations of reliance on care, Articles 19 or 22(1)(b) of that regulation do not of themselves require the provision of such benefits outside the competent State by or on behalf of the competent institution.
• 2. 

  Where, unlike the social security system of the competent State, that of the Member State of residence of a person reliant on care, insured as a member of the family of an employed or self-employed person within the meaning of Regulation No 1408/71, does not provide for the provision of benefits in kind in given situations of reliance on care, Article 18 EC does not preclude, in circumstances such as those of the main proceedings, legislation such as that introduced by Paragraph 34 of Book XI of the Social Security Code (Sozialgesetzbuch), on the basis of which a competent institution refuses in such circumstances to pay, independently of the mechanisms introduced by Article 19 or, as the case may be, Article 22(1)(b) of that regulation and for an unlimited period, the costs linked to a stay in a care home situated in the Member State of residence up to an amount equal to the benefits to which that person would have been entitled if he had received the same care in a care home - party to a service agreement - situated in the competent State.

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• 3) 

  C-211/08 -Commission v Spain (Reimbursement of hospital treatment during a temporary stay in another Member State) -PENDING

The Commission brought the case against Spain to the ECJ for infringement of Article 49. The Commission claims that the Spanish authorities’ refusal to grant additional reimbursement of the costs incurred for hospital care required during a temporary stay in another Member State, arguing that this refusal deprived European citizens of a right granted to them by the Court under Article 49 of the Treaty as interpreted in the Vanbraeckel case (Case C-368/98).

The Spanish legislation on social security matters provides that hospital benefits covered by the Sistema Nacional de Salud must be provided by its own system, except in very exceptional cases of 'urgent, immediate health assistance which is essential'. As a result, when a person entitled under the Spanish Sistema Nacional de Salud moves temporarily to another Member State and, during that stay, receives assistance in hospital which is necessary from the medical point of view in accordance with Article 22(1)(a)(i) of Regulation 1408/71, the costs incurred by him are not reimbursed by the Spanish authorities.

The Commission takes the view that the judgment in the Vanbraeckel case (relating to planned treatment with a Form E112, where the ECJ held that reimbursement should be at least the same as that which would have been granted to the patient if he had received hospital treatment in the Member State in which he is insured) must also apply where a tourist, student or any other person temporarily residing in the territory of another Member State requires hospital treatment. It considers that European citizens must enjoy the same rights whether they are authorised to undergo hospital treatment in another Member State or are hospitalised during a temporary stay in another Member State.

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• 4) 

  C-336/08 -Reinke (Reimbursement of the cost of emergency treatment in a private hospital in another Member State) - PENDING

Regional Social Court of the Berlin-Brandenburg referred to the ECJ a reference for preliminary ruling concerning application of Regulation (EEC) No 574/72 laying down procedure for implementing Regulation (EEC) No 1408/71.

Questions submitted:

Does the entitlement to reimbursement under Article 34(4) and (5) of Regulation (EEC) No 574/72 cover the costs of emergency treatment incurred by a pensioner entitled to benefits under Article 31 of Regulation (EEC) No 1408/71 in a private clinic in the place of stay if the competent hospital has refused to provide the treatment by way of benefit in kind on the ground of overcrowding?

May reimbursement be limited to the reimbursement rates provided for in Article 34(4) of Regulation (EEC) No 574/72 where the competent institution pays hospitals for benefits in kind, not on the basis of abstract and general rates, but on the basis of individual contracts, and where national law does not limit the benefit in kind to treatment in certain hospitals?

Is a national provision according to which reimbursement of the cost of treatment in a private hospital in another Member State is excluded, even in the case of emergency treatment, compatible with Articles 49 EC and 50 EC and 18 EC?

State Aid No new case.

Procurement

• 5) 

  C-300/07 -Hans & Christophorus Oymanns (Status of statutory sickness insurance fund as contracting authority),

The reference for a preliminary ruling has been made in the course of proceedings between Hans & Christophorus Oymanns GbR, Orthopädie Schuhtechnik and AOK Rheinland/Hamburg relating to: 1. whether statutory sickness insurance funds (such as the German statutory sickness insurance funds) constitute contracting authorities for the purposes of the application of the rules in Directive 2004/18 on the coordination of procedures for the award of public works contracts public supply contracts and public service contracts,

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• 2. 

  whether the supply of orthopaedic shoes, made and tailored individually in accordance with the patient’s needs by specialist shoe manufacturers under an agreement with the statutory sickness insurance fund, together with detailed advice given to the patients before and after such supply is to be regarded as a supply contract or a service contract,
• 3. 

  thirdly, if the supply of orthopaedic shoes is to be regarded as a service, whether, in the present case, it is to be regarded as a ‘service concession’ or a ‘framework agreement’ within the meaning of the provisions of Directive 2004/18 ?

The Court ruled:

• 1. 

  The first alternative of letter (c) of the second subparagraph of Article 1(9) of Directive 2004/18/EC must be interpreted as meaning that there is financing, for the most part, by the State when the activities of statutory sickness insurance funds are chiefly financed by contributions payable by members, which are imposed, calculated and collected according to rules of public law such as those in the main proceedings. Such sickness insurance funds Statutory insurance funds thus constitute contracting authorities are to be regarded as bodies governed by public law and therefore as contracting authorities for the purposes of the application the rules in the Directive 2004/17.
• 2. 

  When a mixed public contract concerns both products and services, the criterion to be applied in order to determine whether the contract in question is a supply contract or a service contract is the respective value of the products and services covered by the contract. Where the products supplied are individually manufactured and tailored to the needs of each customer and where each customer must receive individual advice on the use of the products, the manufacture of those products must be classified in the ‘supply’ part of the said contract for the purposes of calculating the value of each part thereof.
• 3. 

  If the provision of services is regarded as being more important than the supply of products in the contract in question, an agreement such as the one at issue in the main proceedings, concluded between a statutory sickness insurance fund and a trader, in which payment for the various types of service to be provided by the trader and the duration of the agreement are determined, with the trader undertaking an obligation to implement the agreement in regard to insured persons who ask him to do so and the abovementioned fund alone paying that trader for its services, must be regarded as a framework agreement within the meaning of Article 1(5) of Directive 2004/18.

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Competition

• 6) 

  C-217/09 Maurizio Polisseni v A.S.L. No 14 V.C.O.Omegna (Establishment of pharmacies), NEW CASE lodged on 5 June 2009

Questions referred

Does Article 43 EC and, in any event, Community law on competition, preclude a national rule such as that laid down in Article 1 of Law No 475 of 2 April 1968 and Article 13 of Presidential Decree No 1275 of 21 August 1971, in so far as it makes authorisation to transfer a pharmacy from one set of premises to another, even though it remains within the authorised area, subject to the requirement that it must be located at a distance of at least 200 metres from other similar establishments, measured by the shortest route on foot from door to door; in particular, are the restrictions on freedom of establishment imposed in that rule at odds with the reasons of public interest which could justify such restrictions and are they not in any event inappropriate for the purpose of meeting those interests?

Does the principle of proportionality, which must be observed by any legitimate restriction on freedom of establishment and competition, in any event preclude a restriction on a pharmacist's right to engage in free enterprise such as that resulting from the rules on minimum distance referred to in the first question?

Do Articles 152 EC and 153 EC, which impose a high level of protection on human health and consumer interests as a matter of priority, preclude a national rule such as that laid down in Article 1 of Law No 475 of 2 April 1968 and Article 13 of Presidential Decree No 1275 of 21 August 1971, in so far as it makes authorisation to transfer a pharmacy from one set of premises to another, even though it remains within the authorised area, subject to the requirement that it be located at a distance of at least 200 metres from other similar establishments, measured by the shortest route on foot from door to door, without any further consideration being given to the customers' interests or to the requirement of efficient local distribution of services relating to the protection of health?'

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Non-Discrimination

• 7) 

  C-341/08- Petersen (Age limit for exercising the profession of panel dentist) -PENDING

The Regional Social Court of Dortmund (Germany) referred to the ECJ a question whether the statutory regulation of a maximum age limit for admission to practice a profession (in this case, to work as a panel dentist and age limit of 68 years) can be an ‘objective and reasonable measure to protect a legitimate aim’ (in this case the health of patients treated by panel practitioners) and an ‘appropriate and necessary means of achieving that aim’ within the meaning of Article 6 Directive 2000/78/EC, if it is based solely on the assumption (itself based on ‘general experience’) that a general drop in performance occurs from a certain age, without considering the individual performance of the doctor in question.

The Advocate General proposes that Article 2, par.2. letter a) in conjunction with Article 6, par. 1 of the Directive 2000/78/EC establishing a general framework for equal treatment in employment and occupation shall be interpreted as not precluding the national legislation, as the measure in the main proceeding, according to which the authorisation to work as panel dentist ends at the end of the quarter of the year in which the panel dentist reached the age of 68 years.

Freedom of Establishment

• 8) 

  C-89/09 - Commission v France (joined by Denmark) (Ownership of medical laboratories), NEW CASE

The Commission maintains that, by limiting to a maximum of 25% of one-quarter the shares and therefore the voting rights in a Société d'Exercice Libéral à Responsabilité Limitée (limited liability company formed by persons carrying on a professional activity) operating medical laboratories which can be held by persons who are not biologists and by prohibiting holdings of capital in more than two companies established in order jointly to operate one or more medical laboratories, the French Republic has failed to fulfil its obligations under Article 43 of the EC Treaty.

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The French legislation in question restricts unduly the freedom of establishment guaranteed by the Treaty. The objective of protection of public health, referred to by the defendant as a justification, could be achieved by less restrictive measures. The Commission claims in that regard that, while it seems justified to require that medical analyses be carried out by competent staff with the appropriate professional qualifications, to require such qualifications for the mere holding of shares in or right to operate medical laboratories seems on the other hand disproportionate with regard to the objective pursued.

• 9) 

  C-393/08 -Sbarigia (Imposition of holiday closure for pharmacies) - PENDING

This case concerns the imposition of holiday closure periods on pharmacies in the city of Rome. Lazio regional law provides that pharmacies have limited opening times, weekly rest periods and specific annual holiday periods, and that derogations from these limitations are subject to a discretionary assessment by the administration. The referring court asks whether such practice is compatible with freedom of competition and freedom to provide services in Articles 49 EC and 81 to 86 EC. It also ask whether imposing conditions on the public pharmacy service limiting or precluding the possibility of extending the possibility of extending the daily, weekly or annual opening times of individual pharmacies is compatible with Article 152 EC, on ensuring a high level of human health protection, and Article 153 EC, on ensuring a high level of consumer protection.

• 10) 

  C-356/08 -Commission v Austria (Mandatory opening of bank account by medical doctor), 25.6.2009

This is an action against Austria seeking a declaration that by imposing an obligation on every medical doctor becoming established in Oberösterreich (Land of Upper Austria) to open a bank account with the Oberösterreichische Landesbank to which fees for benefits in kind are to be transferred by the health insurance funds, the Republic of Austria has failed to comply with its obligations under Articles 43 EC, 49 EC and 56 EC. The Commission alleges that the requirement is disproportionate to the need to ensure the proper calculation and levying of the contributions payable to the medical councils by medical doctors established in Oberösterreich. Accordingly the Commission maintains that the disputed rules amount to unjustified restrictions of the freedom of establishment of medical doctors established in other Member States and that of banks, their freedom to provide services and the free movement of capital.

The Court ruled that the measure in question is not consistent with Article 49 (free movement of services) and that Austria failed to comply with its obligations according to this Article.

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• 11) 

  C-315/08 -Grisoli (Limitations on opening of new pharmacies) -PENDING The Italian Council of State has referred the following questions to the ECJ:
• • 

  Is it compatible with Articles 152 and 153 EC that there is a single pharmacy in communes with a population of less than 4 000 inhabitants?
• • 

  Is it compatible with Articles 152 and 153 EC to make the establishment of the second pharmacy in communes with a population of over 4 000 inhabitants subject to conditions such as population over that amount of at least 50 per cent of the levels, distance of at least 3 000 metres from the existing pharmacy, and existence of particular requirements of the pharmacy service in relation to the topographical and road conditions, to be assessed by both the health units (local health companies) and the local association of pharmacists or in any event by the authorities competent for matters of organisation and review of the pharmacy service?

This case has been stayed pending the judgment in case C-570/07: Blanco Perez and Chao Gomez.

• 12) 

  C-570/07 and C-571/07 Blanco Perez and Chao Gomez (Establishment of pharmacies), PENDING

The plaintiffs, two Spanish citizens, who are qualified pharmacists but are not accredited to open a pharmacy. They have practised their profession for several years in veterinary pharmacies. As they aim to operate their own pharmacy, they wish to obtain permission to open a new pharmacy within the Autonomous Community of Asturias in Spain. The relevant permit was denied to the plaintiffs by a decision of the Ministry of Health and Public Health Services of the Principality of Asturias on 14 June 2002. This decision was confirmed by the Asturian Governing Council on 10 October 2002. The plaintiffs have mounted a legal challenge to this decision before the Tribunal Superior de Justicia de Asturias.

The decisions of the Asturian authorities are based on Decree 72/2001 of 19 July 2001 regulating pharmacies and pharmaceutical dispensaries in the Principality of Asturias which establishes a system of licensing including certain restrictions on the establishment of pharmacies within the Autonomous Community as well as a system governing the award of licences between competing candidates. The plaintiffs claim that this decree violates their right to freedom of establishment under Article 43 EC. In view of the doubts surrounding the legality of the decree in the light of Community law, the national court has referred the following two questions to the Court of Justice:

‘Should Articles 2, 3 and 4 of Decree 72/2001 dated 19 July of the Principality of Asturias regulating pharmacies and pharmaceutical dispensaries, and Sections 4, 6 and 7 of the Annex thereto, be considered to be in breach of Article 43 of the EC Treaty? (Case C-570/07)’

and

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‘Does Article 43 [EC] preclude the legislation of the Autonomous Community of the Principality of Asturias concerning authorisation for the establishment of pharmacies? (Case C-571/07)’

In his opinion of 30 September 2009, the Advocate General proposes that the Court answers the questions as follows:

– Article 43 EC precludes national under which authorisation is necessary for the setting-up of a new pharmacy and priority is given to those who have practised within a part of that Member State’s territory;

– Article 43 EC precludes legislation under which the authorisation for the setting-up of a new pharmacy is subject to a population requirement with the purpose of promoting the setting-up of pharmacies in less-populated areas if such purpose is not pursued in a coherent and consistent manner, notably if the same legislation does not clearly benefit those who open pharmacies in underserved areas over those who simply wait for an opening in a lucrative area and grants a proprietary interest in the pharmaceutical licence in such a way as to undermine the effectiveness of the incentive scheme;

– as to the requirement imposing a minimum distance between pharmacies, it is for the national court to determine whether the specific distance imposed is justified, bearing in mind the degree of interference with the right of establishment, the nature of the public interest invoked and the degree to which, in the light of the number and distribution of pharmacies within the region and the distribution and density of the population, universal coverage could be achieved through less restrictive means.

• 13) 

  C-171/07 & C-172/07 - Apotherkammer Des Saarlandes & Others v Ministerium für Justiz, Gesundheit und Soziales (Ministry of Justice, Health and Social Affairs) (Right to operate pharmacies by pharmacist) , 19.5.2009

DocMorris NV (‘DocMorris’) is a public limited company established in the Netherlands whose business includes the selling of medicinal products by mail order. By decision of 29 June 2006, the Ministry granted it, with effect from 1 July 2006, a licence to operate a branch pharmacy in Saarbrücken (Germany), subject to a condition requiring it to recruit a pharmacist who would be entrusted with managing the pharmacy in question personally and on his own responsibility (‘the decision of 29 June 2006’).

The claimants (Saarland Pharmacists’ Association and German Pharmacists’ Association), submitted that the decision of 29 June 2006 is contrary to the Law on Pharmacies because it infringes the ‘Fremdbesitzverbot’, that is to say the principle, as resulting from subparagraph 3 of Paragraph 2(1) in conjunction with Paragraphs 7 and 8 of the Law on Pharmacies, under which the right to own and operate a pharmacy is restricted to pharmacists alone (‘the rule excluding non-pharmacists’).

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Verwaltungsgericht des Saarlandes (Administrative Court, Saarland) referred the following questions to the ECJ for a preliminary ruling:

Are the provisions concerning freedom of establishment for capital companies (Articles 43 and 48 EC) to be interpreted as precluding a national

regulation according to which only pharmacist can own and run a pharmacy?

If the first question is answered in the affirmative: is a national authority entitled and obliged to abrogate national provisions it regards as contrary to Community law even if there is no clear breach of Community law and it has not been established by the Court of Justice of the European Communities that the relevant provisions are incompatible with Community law?

The Court ruled:

Articles 43 EC and 48 EC do not preclude national legislation which prevents persons not having the status of pharmacist from owning and operating pharmacies. Given its reply to the first question, the Court did not reply to the second question.

In its reasoning, the Court underlined that the judgment in Case C-140/03 Commission v Greece upon which Saarland, the Ministry, DocMorris and the Commission rely, where the Court ruled that the Hellenic Republic had failed to fulfil its obligations under Articles 43 EC and 48 EC by enacting and maintaining in force national provisions under which the establishment by a legal person of an optician’s shop was subject inter alia to the condition that authorisation for the establishment and operation of that shop had to have been granted to a recognised optician who was a natural person and the person holding the authorisation to operate the shop had to hold at least 50% of the company’s share capital and participate at least to that extent in the profits and losses of the company.

Given the particular nature of medicinal products and of the medicinal-product market, and as Community law currently stands, the Court’s findings in Commission v Greece cannot be transposed to the field of the retail supply of medicinal products. Unlike optical products, medicinal products prescribed or used for therapeutic reasons may none the less prove seriously harmful to health if they are consumed unnecessarily or incorrectly, without the consumer being in a position to realise that when they are administered. Furthermore, a medically unjustified sale of medicinal products leads to a waste of public financial resources which is not comparable to that resulting from unjustified sales of optical products.

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• 14) 

  C-169/07 - Hartlauer Handelsgesellschaft mbH vs. Wiener Landesregierung (Government of the Province of Vienna) and Oberösterreichische Landesregierung (Government of the Province of Upper Austria)

By decision of 29 August 2001 the Wiener Landesregierung rejected the application by Hartlauer, a company established in Germany, for authorisation to set up a private health institution in the form of a outpatient dental clinic in the 21st District of Vienna on the ground that dental care was adequately ensured in Vienna by public and private non-profit-making health institutions and other contractual practitioners offering comparable services. That assessment had been carried out on the basis of the ratio of the number of inhabitants to the number of dental practitioners, which was 2 207 inhabitants per practitioner. On the basis of the expert’s findings, the Wiener Landesregierung concluded that the health institution whose establishment was sought would not have the effect of substantially accelerating, intensifying or improving the provision of dental medical care for patients resident in Vienna, so that there was no need for the institution.

On similar grounds, the Oberösterreichische Landesregierung by decision of 20 September 2006 rejected Hartlauer’s application for authorisation to set up a outpatient dental clinic in Wels. Hartlauer brought proceedings against those decisions before the Verwaltungsgerichtshof (Administrative Court), which joined the two cases.

Administrative Court referred the following question to the ECJ for a preliminary ruling:

Does Article 43 EC (in conjunction with Article 48 EC) preclude the application of national legislation under which authorization is required for

setting up a private hospital in the form of an independent outpatient clinic for dental medicine (dental clinic) and that authorization is to be

refused if, according to the stated purpose of the institution and the range of services envisaged, there is no need for the planned outpatient dental

clinic having regard to the existing provision of care by established doctors working on a contractual basis with sickness funds, institutions

owned by sickness funds and institutions contracted to sickness funds and by established dentists working on a contractual basis with sickness

funds?

The Court concluded that the system of prior administrative authorisation at issue in the main proceedings is not based on a condition capable of adequately circumscribing the exercise by the national authorities of their discretion. The national legislation at issue in the main proceedings is not appropriate for ensuring attainment of the objectives of maintaining a balanced high-quality medical service open to all and preventing the risk of serious harm to the financial balance of the social security system.

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The Court ruled:

Articles 43 EC and 48 EC preclude national legislation under which authorisation is necessary for the setting up of a private health institution in the form of an independent outpatient dental clinic, where that legislation does not also subject group practices to such a system and is not based on a condition capable of adequately circumscribing the exercise by the national authorities of their discretion.

• 15) 

  C-568/07-Commission v Greece (Non respect of judgment of 21 April 2005 in case C-140/03), 4.6.2009

In the original case, the Court ruled that the requirement in law preventing an optician as a natural person to operate more than one optician’s shop (Law No 971/79 on the exercise of the profession of optician and on shops for the sale of optical articles) is against Article 43 EC.

Furthermore, by enacting and maintaining in force Law No 971/79 and Law No 2646/98 on the development of a national social security system and other provisions, under which the establishment by a legal person of an optician’s shop in Greece is subject to the following conditions:

– authorisation for the establishment and operation of the optician’s shop must have been granted to a recognised optician who is a natural person, the person holding the authorisation to operate the shop must hold at least 50% of the company’s share capital and must participate at least to that extent in the profits and losses of the company, and the company must be in the form of a collective or limited partnership, and

– the optician in question may participate at most in one other company owning an optician’s shop, subject to the condition that the

authorisation for the establishment and operation of that shop is in the name of another authorised optician,the Hellenic Republic has failed to fulfil its obligations under Articles 43 EC and 48 EC.

In the present case, the Court ruled that Greece failed to comply with the judgment and ordered Greece to pay into the ‘European Community own resources’ account of the Commission of the European Communities a lump sum of EUR 1 million.

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• 16) 

  C-531/06- Commission v Italy, 19.5.2009 (Right to operate pharmacies by pharmacist)

This action is brought by the European Commission who claim that the Court should declare that:

• • 

  by keeping in force legislation which restricts the right to operate private pharmacies to natural persons who have graduated in pharmacy and to companies composed exclusively of members who are pharmacists; and
• • 

  by keeping in force legislative provisions which make it impossible for undertakings engaged in the distribution of pharmaceutical products to acquire shareholdings in the companies which manage municipal pharmacies, the Italian Republic has failed to fulfill its obligations under Articles 43 and 56 of the EC Treaty.

The Court followed the opinion of the Advocate General that the Commission’s first complaint is unfounded. This complaint is closely related to the first question referred for a preliminary ruling in Joined Cases C-171/07 and 172/07, in which the Court ruled that that Articles 43 EC and 48 EC do not preclude national legislation under which only pharmacists may own and operate a pharmacy, since such legislation is justified by the objective of ensuring proper provision of medicinal products to the public.

The Court found also the Commission's second complaint unfounded. According to the Court, the Italian Republic was able, without infringing the principle of proportionality, to retain the prohibition preventing undertakings engaged in the distribution of pharmaceutical products from acquiring stakes in companies which manage municipal pharmacies.

The Court dismissed the action. Medicinal Products

• 17) 

  C-198/09 - IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (Regulation of prices of medicinal products), NEW CASE lodged on 4 June 2009

Reference for preliminary ruling submitted by the Regional administrative tribunal in Lazio (Italy) concern the interpretation of Article 4 (1) of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems.

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More specifically, questions concern:

• 1. 

  Does interpretation of "decreases in prices are being made, if any' in Article 4(1) means that the prices may be decreased exclusively for medicinal products which are already subject to the price freeze or to any category of medicinal products?
• 2. 

  May the Article 4(1) be interpreted as meaning that it is possible to have recourse to prize freeze even more than once in the course of a single year, and to do that again for many years (from 2002 until 2010)?
• 3. 

  Is it compatible with the Community rules to adopt measures which refer to economic values attributed to expenditures on the basis of 'predictions' rather than values which have been 'ascertained' (this question relates to both situations)?
• 4. 

  Must the requirements relating to compliance with the ceilings for pharmaceutical expenditure which each Member State is competent to determine be linked, point by point, to pharmaceutical expenditure alone, or is it within the powers of the Member States to take account also of data relating to other health expenditure?
• 5. 

  Must the principles of transparency and of shared participation on the part of the undertakings with an interest in measures freezing the prices of pharmaceutical products or reducing them across the board be interpreted as requiring provision to be made, always and in any circumstances, for the possibility of derogation from the price imposed (Article 4(2) [of Directive 89/105/EC]) and for genuine participation by the applicant company, with the consequent need for the administrative authorities to state the reasons for any refusal?
• 18) 

  C-350/08- Commission v Lithuania- PENDING

The Commission is seeking a declaration that Lithuania has failed to meet its obligations under Article 6(1) of and Section 4 of Part II of Annex I to Directive 2001/83/EC (on the Community code relating to medicinal products for human use), as amended, by retaining in force the national authorisation for the marketing of the medicinal product ‘Grasalva’ without having ensured that it complied with all Community law requirements in force for similar biological medicinal products with regard to quality, safety and efficacy.

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• 19) 

  C-62/09 - Association of the British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency - PENDING

High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court) referred to the Court the following question for preliminary ruling:

Does Article 94(1) of Directive 2001/83/EC on the Community code relating to medicinal products for human use preclude a public body forming part of a national public health service, in order to seek to reduce its overall expenditure on medicines, from implementing a scheme which offers financial incentives to medical practices (which may in turn provide a financial benefit to the prescribing doctor) to prescribe a specific named medicine supported by the incentive scheme that is either:

(a)     a different prescription medicine to the medicine previously prescribed by the doctor to the patient; or

(b)    a different prescription medicine to that which otherwise might have been prescribed to the patient but for the incentive scheme, where such a different prescription medicine is from the same therapeutic class of medicines used for treatment of the patient's particular condition ?

• 20) 

  C-421/07 - Damgaard, 2.4.2009

Reference for a preliminary ruling concerns the interpretation of Article 86 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34).

The reference was made in the context of criminal proceedings brought by the Anklagemyndigheden (Public Prosecutor) against Mr Damgaard, a journalist, who has been charged with having publicly disseminated information about the properties and availability of a medicinal product the marketing of which is not authorised in Denmark.

This reference from a Danish court asks whether Article 86 of Directive 2001/83/EC, on the Community code relating to medicinal products for human use, is to be interpreted as meaning that dissemination by a third party of information about a medicinal product, including in particular information about the medicinal product's therapeutic or prophylactic properties, is to be understood as constituting advertising, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller.

16805/08                                                                                                                                                 JS/mm                                               47

ANNEX II                                                                     DG I                                       LIMITE EN

The Court ruled:

Article 86 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, is to be interpreted as meaning that dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising within the meaning of that article, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product. It is for the national court to determine whether that dissemination constitutes a form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.

• 21) 

  Cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07- Menarini Industrie Farmaceutiche Riunite Srl and Others v Ministero della Salute, Agenzia Italiana del Farmaco Joined (Regulation of prices for medicinal products)

These references for a preliminary ruling concern the interpretation of Article 4 of Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems.

The Court ruled that Article 4(1) of Council Directive 89/105/EEC is to be interpreted as meaning that:

• 1. 

  provided the requirements laid down by that provision are met, the competent authorities of a Member State may adopt general measures reducing the prices of all, or of certain categories of, medicinal products, even if the adoption of those measures is not preceded by a freeze on those prices.
• 2. 

  provided the requirements laid down by that provision are met, the adoption of measures reducing the prices of all, or of certain categories of, medicinal products is possible more than once a year and for several years.
• 3. 

  it does not preclude measures controlling the prices of all, or of certain categories of, medicinal products from being adopted on the basis of predicted expenditure, provided that the requirements laid down by that provision are met and that the predictions are based on objective and verifiable data.
• 4. 

  it is for the Member States to determine, in compliance with the objective of transparency pursued by that directive and the requirements laid down by that provision, the criteria on the basis of which the review of the macro-economic conditions referred to in that provision is to be conducted and that those criteria may consist in pharmaceutical expenditure alone, in health expenditure overall or even in other types of expenditure.

5.

Article 4(2) of Directive 89/105 is to be interpreted as meaning:

16805/08 ANNEX II

JS/mm

48

DG I

LIMITE EN

that the Member States must, in all cases, provide for the possibility for an undertaking, which is concerned by a measure freezing or

reducing the prices of all, or of certain categories of, medicinal products, of applying for a derogation from the price imposed

pursuant to such measure;

that they are to ensure that a reasoned decision on any such application is adopted, and

that the genuine participation of the undertaking concerned consists, first, in the submission of an adequate statement of the particular

reasons justifying its application for derogation and, second, in the provision of detailed additional information if the information

supporting the application is inadequate.

• 22) 

  C-489/06- Commission v Greece -PENDING

The Commission is seeking a declaration that by rejecting tenders in respect of medical devices bearing the CE certification marking, without, in any event, the competent contracting authorities of Greek hospitals having followed the procedure set out in Directive 93/42/EEC, Greece has failed to fulfil its obligations under Article 8(2) of Directive 93/36/EEC, coordinating procedures for the award of public supply contracts, and Articles 17 and 18 of Council Directive 93/42/EEC concerning medical devices.

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ANNEX II                                                                     DG I                                       LIMITE EN

Working Time Directive and Employment

No new cases.

Free Movement of Persons & Mutual Recognition of Professional Qualifications (MRPQ)

• 23) 

  C-73/08- Bressol & Chaverot- PENDING

This case concerns a decree adopted by the Parliament of the French Community of Belgium which limits the number of non-residents able to enroll in certain programmes in the first two years of undergraduate studies in higher education. The decree was adopted in response to a restrictive policy practised by a neighbouring Member State, France, which led to an influx of students from that Member State in a number of programmes of study of a medical nature. By its first question the referring court asks whether such a restriction is incompatible with Articles 12 EC, 18(1) EC, 149 EC and 150(2) EC or whether it can be justified. The referring court then asks if the answer to the first question would be different if the French Community of Belgium could show that the effect of the situation is that too few students residing in that Community obtain diplomas for there to be, over a long period, a sufficient number of qualified medical personnel to ensure the quality of the public health system in that Community.

Failure by a Member State to fulfill the obligation

• 24) 

  Cases C-7/09 to C-13/09 (Tissues and Cells Directive)

The Commission lodged infringement cases against Belgium, Italy and Portugal concerning non-transposition of Directive 2004/23/EC of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells and the implementing Commission Directives 2006/17/EC of 8 February 2006 and 2006/86/EC of 24 October 2006. The Court already ruled in three cases declaring that Belgium and Italy failed to comply with their obligations.

• 25) 

  Cases C-197/08, C-198/08 and to C-221/08 (Tobacco taxes) The present actions for failure to fulfil obligations once more concern Member State rules fixing minimum prices for tobacco products. The

16805/08                                                                                                                                                 JS/mm                                               50

ANNEX II                                                                     DG I                                       LIMITE EN

Commission takes the view in the light of the Court’s previous case-law that those rules infringe Article 9(1) of Council Directive 95/59/EC of 27 November 1995 on taxes other than turnover taxes which affect the consumption of manufactured tobacco.

The defendant Member States argue essentially that, contrary to the Court’s previous case-law, the fixing of minimum prices does not infringe Directive 95/59 and is in any case justified on health protection grounds. In that regard they rely inter alia on a World Health Organisation Framework Convention on Tobacco Control. (3)

The Advocate General proposes to the Court to:

In Case C-197/08:

(1) declare that, by maintaining in force a system of minimum prices for cigarettes released for consumption in France and a prohibition on selling tobacco products at a promotional price which is contrary to public health objectives, the French Republic has failed to fulfil its obligations under Article 9(1) of Council Directive 95/59/EC of 27 November 1995 on taxes other than turnover taxes which affect the consumption of manufactured tobacco;

In Case C-198/08:

(1) declare that, by enacting and retaining legal provisions under which minimum selling prices for cigarettes and for fine-cut tobacco for the rolling of cigarettes are set by the State, the Republic of Austria has failed to fulfil its obligations under Article 9(1) of Council Directive 95/59/EC of 27 November 1995 on taxes other than turnover taxes which affect the consumption of manufactured tobacco;

In Case C-221/08:

(1)    declare that, by imposing minimum retail prices for cigarettes, Ireland has failed to fulfil its obligations under Article 9(1) of Council Directive 95/59/EC of 27 November 1995 on taxes other than turnover taxes which affect the consumption of manufactured tobacco;

(2)    declare that, by failing to provide the necessary information on the applicable Irish legislation in order to enable the Commission to fulfil its duty to monitor compliance with Directive 95/59, Ireland has failed to fulfil its obligations under Article 10 EC.

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ANNEX II                                                                     DG I                                       LIMITE EN

Miscellaneous

• 26) 

  C-288/08 Kemikalieinspektionen v. Nordiska Dental AB Judgment (Exportation of amalgam for dental uses), 19.11. 2009

Reference for a preliminary ruling submitted by a Swedish court (Svea hovrätt) concerning the interpretation of certain provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and, in the alternative, the interpretation of Articles 29 EC and 30 EC.

The reference has been made in proceedings between Kemikalieinspektionen (Swedish Chemicals Inspectorate) and Nordiska Dental AB (‘Nordiska Dental’) regarding the refusal of the application submitted by Nordiska Dental for a waiver of the prohibition on the exportation of mercury, or of chemical compounds containing mercury, in the course of marketing amalgam for dental use during the period from 1 January 2007 to 31 December 2009.

Nordiska Dental manufactures alloy for dental amalgams and, for that purpose, imports prepacked mercury. The European Union accounts for 72.5% of its sales. The products sold by Nordiska Dental bear the CE marking provided for in Article 17(1) of Directive 93/42.

With the intention of exporting dental amalgams, Nordiska Dental applied to the Kemikalieinspektionen in July 2005 for a waiver – to cover the period from 1 January 2007 to 31 December 2009 – from the prohibition, laid down in Article 8 of Ordinance (1998:944), on the commercial exportation of mercury or of chemical compounds containing mercury. Nordiska Dental had already been granted such a waiver twice, in respect of earlier periods.

By decision of 14 December 2005, the Kemikalieinspektionen refused the application. Nordiska Dental contested that decision before the Stockholms tingsrätt (Stockholm District Court), which partly upheld its action, holding by judgment of 20 June 2006 that a prohibition – such as that laid down in Swedish law – on the exportation of dental amalgams containing mercury to the other Member States of the European Union or to States belonging to the European Economic Area is contrary to Article 4(1) of Directive 93/42 or to Article 29 EC. However, that court held that such a prohibition is not contrary to Community law to the extent that it concerns exports to non-Member States.

The Kemikalieinspektionen appealed against that judgment to the referring court.

On the view that the dispute before it raises questions as to the conformity of the Swedish legislation at issue in the main proceedings with Directive 93/42 and, as the case may be, with Articles 29 EC and 30 EC, the Svea Hovrätt decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:

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ANNEX II                                                                     DG I                                       LIMITE EN

‘1a. Are the provisions of Directive [93/42] to be interpreted as precluding the application of a national prohibition on commercial exports from the country in question of dental amalgam containing mercury which is based on considerations of environmental and health protection?

1b. Does the fact that the product concerned bears the CE marking have any bearing on that interpretation?

• 2. 

  If the answer to the first question is negative, are Paragraphs 8 and 11 of [Ordinance (1998:944)], which are based on the considerations

mentioned above, compatible with Articles 29 EC and 30 EC where those provisions are applied to dental amalgam which contains mercury and which bears the CE marking?’

The Court ruled:

Article 4(1) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, must be interpreted as precluding legislation of a Member State under which the commercial exportation of dental amalgams containing mercury and bearing the ‘CE’ marking provided for in Article 17 of that directive is prohibited on grounds relating to protection of the environment and of health.

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ANNEX II                                                                     DG I                                       LIMITE EN

• 20 okt '09
  COM(2009)567 - Solidariteit in de gezondheidszorg: verkleining van de ongelijkheid op gezondheidsgebied in de EU
  
  
  
• 24 jun '09
  COM(2009)273 - Aanscherping van de chemische, biologische, radiologische en nucleaire beveiliging in de EU – een CBRN-actieplan voor de EU
  
  
  
• 10 dec '08
  COM(2008)664 - Wijziging, wat de geneesmiddelenbewaking van geneesmiddelen voor menselijk gebruik betreft, van Verordening (EG) nr. 726/2004 tot vaststelling van gemeenschappelijke procedures voor het verlenen van vergunningen en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Geneesmiddelenbureau
  
  
  
• 8 dec '08
  COM(2008)818 - Kwaliteits- en veiligheidsnormen voor menselijke organen, bestemd voor transplantatie
  
  
  
• 4 dec '08
  COM(2008)812 - Fase II-benzinedampterugwinning tijdens het bijtanken van personenauto’s in benzinestations
  
  
  
• 3 dec '08
  COM(2008)809 - Beperking van het gebruik van bepaalde gevaarlijke stoffen in elektrische en elektronische apparatuur
  
  
  
• 3 dec '08
  COM(2008)810 - Afgedankte elektrische en elektronische apparatuur (AEEA)
  
  
  
• 21 okt '08
  COM(2008)665 - Wijziging, wat de geneesmiddelenbewaking betreft, van richtlijn 2001/83/EG tot vaststelling van een gemeenschappelijk wetboek betreffende geneesmiddelen voor menselijk gebruik
  
  
  
• 21 okt '08
  COM(2008)662 - Wijziging van Verordening (EG) nr. 726/2004 tot vaststelling van gemeenschappelijke procedures voor het verlenen van vergunningen en het toezicht op geneesmiddelen voor menselijk en diergeneeskundig gebruik en tot oprichting van een Europees Geneesmiddelenbureau, wat publieksvoorlichting over receptplichtige geneesmiddelen voor menselijk gebruik betreft
  
  
  
• 21 okt '08
  COM(2008)663 - Wijziging van richtlijn 2001/83/EG tot vaststelling van een gemeenschappelijk wetboek betreffende geneesmiddelen voor menselijk gebruik, wat publieksvoorlichting over receptplichtige geneesmiddelen betreft