4.4.2011   

EN

Official Journal of the European Union

L 88/1

(1)

Council Regulation (EC) No 708/2007 (3) establishes a framework governing aquaculture practices in relation to alien and locally absent species to assess and minimise the possible impact of those species and of associated non-target species on aquatic habitats. It provides that introductions and translocations for use in closed aquaculture facilities may at a future date be exempted from the permit requirement of Chapter III of that Regulation, based on new scientific information and advice.

(2)

The Community-funded concerted action, entitled ‘Environmental impacts of alien species in aquaculture’ (IMPASSE), has delivered a new operational definition of ‘closed aquaculture facilities’. For facilities according to that definition, the degree of risk associated with alien and locally absent species can be reduced to an acceptable level if the potential for escape of the organisms to be farmed and of non-target organisms is addressed during transportation and if well-defined protocols are applied at the receiving facility. Introductions and translocations for use in closed aquaculture facilities should only be exempted from the permit requirement if those conditions are met.

(3)

It is therefore necessary to amend the definition of ‘closed aquaculture facility’ in Regulation (EC) No 708/2007 by adding specific features intended to ensure the biosecurity of those facilities.

(4)

Member States should draw up a list of closed aquaculture facilities located in their territory. For reasons of transparency, that list should be published and regularly updated on a website set up in accordance with Commission Regulation (EC) No 535/2008 of 13 June 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 708/2007 concerning use of alien and locally absent species in aquaculture (4).

(5)

Following these amendments certain other adaptations are needed to Regulation (EC) No 708/2007, in particular, to remove the references to ‘closed aquaculture facilities’ in the definition of ‘routine movement’ and from Annex I.

(6)

The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in order to adapt Annexes I, II and III to technical and scientific progress, to amend Annex IV in order to add species to that Annex and to adopt specifications for the conditions necessary for adding species to Annex IV. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

(7)

The measures necessary for the implementation of this Regulation should be adopted by the Commission by means of implementing acts in accordance with Article 291 TFEU.

(8)

The term ‘Community’ used in the enacting terms of Regulation (EC) No 708/2007 should be changed, following the entry into force of the Treaty of Lisbon on 1 December 2009.

(9)

Regulation (EC) No 708/2007 should therefore be amended accordingly,

1.

in Article 2(1), in the title of Article 13, in Article 15(2) and in the title of Article 19, the noun ‘Community’, or the corresponding adjective, is replaced by the noun ‘Union’, or the corresponding adjective, and any grammatical adjustments needed as a consequence of this replacement shall be made;

2.

Article 2 is amended as follows:

3.

Article 3 is amended as follows:

4.

in Article 4, the existing paragraph is numbered as ‘1’ and the following paragraph is added:

‘2.   The competent authorities in the Member States shall monitor and supervise aquaculture activities so as to ensure that:

5.

Article 14 is replaced by the following:

‘Article 14

Release into aquaculture facilities in the case of routine introductions

In the case of routine introductions, the release of aquatic organisms into aquaculture facilities shall be allowed without quarantine or pilot release, unless, in exceptional cases, the competent authority decides otherwise on the basis of specific advice given by the advisory committee. Movements from a closed aquaculture facility to an open aquaculture facility shall be considered to be routine or non-routine movements in line with Articles 6 and 7.’;

6.

Article 24 is replaced by the following:

‘Article 24

Amendments of Annexes and detailed rules

1.   The Commission may, by means of delegated acts in accordance with Article 24a and subject to the conditions laid down in Articles 24b and 24c:

2.   When adopting delegated acts as referred to in paragraph 1, the Commission shall act in accordance with this Regulation.

3.   In order for its species to be added to Annex IV, an aquatic organism must have been used in aquaculture in certain parts of the Union for a long time (with reference to its life cycle) with no adverse effect, and its introduction and translocation must be possible without the coincident movement of potentially harmful non-target species.

4.   Member States may request the Commission to add species to Annex IV. Member States may provide scientific data to prove coherence with relevant criteria for adding species to Annex IV. The Commission shall decide on the suitability of a request within 5 months of its receipt, excluding the time for the Member State to provide additional information if the Commission so requests.

5.   Member States concerned may, in respect of their outermost regions as referred to in Article 349 of the Treaty on the Functioning of the European Union, propose the addition of species to be included in a separate part of Annex IV.

6.   The Commission may adopt detailed rules for the implementation of paragraphs 4 and 5, and in particular the formats, the contents and the particulars of Member States’ requests for the addition of species and the information to be provided in support of such requests, in accordance with the procedure referred to in Article 30(2) of Regulation (EC) No 2371/2002.’;

7.

the following Articles are inserted:

‘Article 24a

Exercise of the delegation

1.   The power to adopt the delegated acts referred to in Article 24 shall be conferred on the Commission for a period of 5 years from 24 April 2011. The Commission shall make a report in respect of the delegated power at the latest 6 months before the end of the 5-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 24b.

2.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

3.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 24b and 24c.

Article 24b

Revocation of the delegation

1.   The delegation of power referred to in Article 24 may be revoked at any time by the European Parliament or by the Council.

2.   The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation.

3.   The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.

Article 24c

Objections to delegated acts

1.   The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.

At the initiative of the European Parliament or the Council, that period shall be extended by 2 months.

2.   If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.

The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.

3.   If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.’;

8.

Annex I is amended as follows:

4.4.2011   

EN

Official Journal of the European Union

L 88/5

(1)

The rules of Member States require that construction works be designed and executed so as not to endanger the safety of persons, domestic animals or property nor damage the environment.

(2)

Those rules have a direct influence on the requirements of construction products. Those requirements are consequently reflected in national product standards, national technical approvals and other national technical specifications and provisions related to construction products. Due to their disparity, those requirements hinder trade within the Union.

(3)

This Regulation should not affect the right of Member States to specify the requirements they deem necessary to ensure the protection of health, the environment and workers when using construction products.

(4)

Member States have introduced provisions, including requirements, relating not only to safety of buildings and other construction works but also to health, durability, energy economy, protection of the environment, economic aspects, and other important aspects in the public interest. Laws, regulations, administrative measures or case-law, established either at Union or Member State level, concerning construction works may have an impact on the requirements of construction products. Since their effect on the functioning of the internal market is likely to be very similar, it is appropriate to consider such laws, regulations, administrative measures or case-law as ‘provisions’ for the purposes of this Regulation.

(5)

Where applicable, provisions for an intended use or uses of a construction product in a Member State, aimed at fulfilling basic requirements for construction works, determine the essential characteristics the performance of which should be declared. In order to avoid an empty declaration of performance, at least one of the essential characteristics of a construction product which are relevant for the declared use or uses should be declared.

(6)

Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (3) aimed to remove technical barriers to trade in the field of construction products in order to enhance their free movement in the internal market.

(7)

In order to achieve that objective, Directive 89/106/EEC provided for the establishment of harmonised standards for construction products and provided for the granting of European technical approvals.

(8)

Directive 89/106/EEC should be replaced in order to simplify and clarify the existing framework, and improve the transparency and the effectiveness of the existing measures.

(9)

This Regulation should take account of the horizontal legal framework for the marketing of products in the internal market, established by Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products (4) as well as by Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (5).

(10)

The removal of technical barriers in the field of construction may only be achieved by the establishment of harmonised technical specifications for the purposes of assessing the performance of construction products.

(11)

Those harmonised technical specifications should include testing, calculation and other means, defined within harmonised standards and European Assessment Documents for assessing performance in relation to the essential characteristics of construction products.

(12)

The methods used by the Member States in their requirements for construction works, as well as other national rules relating to the essential characteristics of construction products, should be in accordance with harmonised technical specifications.

(13)

Where appropriate, classes of performance in relation to the essential characteristics of construction products should be encouraged to be used in harmonised standards, so as to take account of different levels of basic requirements for construction works for certain construction works as well as of the differences in climate, geology and geography and other different conditions prevailing in the Member States. On the basis of a revised mandate, the European standardisation bodies should be entitled to establish such classes in cases where the Commission has not already established them.

(14)

Where an intended use requires threshold levels in relation to any essential characteristic to be fulfilled by construction products in Member States, those levels should be established in the harmonised technical specifications.

(15)

When assessing the performance of a construction product, account should also be taken of the health and safety aspects related to its use during its entire life cycle.

(16)

Threshold levels determined by the Commission pursuant to this Regulation should be generally recognised values for the essential characteristics of the construction product in question with regard to the provisions in Member States and should ensure a high level of protection within the meaning of Article 114 of the Treaty on the Functioning of the European Union (TFEU).

(17)

Threshold levels can be of a technical or regulatory nature, and may be applicable to a single characteristic or to a set of characteristics.

(18)

The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are recognised as the competent organisations for the adoption of harmonised standards in accordance with the general guidelines for cooperation between the Commission and those two organisations signed on 28 March 2003. Manufacturers should use those harmonised standards when the references to them have been published in the Official Journal of the European Union and in accordance with the criteria established under Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (6). Once a sufficient level of technical and scientific expertise on all the relevant aspects is attained, recourse to harmonised standards with regard to construction products should be increased, including, where appropriate, and after consultation of the Standing Committee on Construction, by requiring, by means of mandates, that those standards be developed on the basis of existing European Assessment Documents.

(19)

The procedures under Directive 89/106/EEC for assessing performance in relation to the essential characteristics of construction products not covered by a harmonised standard should be simplified in order to make them more transparent and to reduce costs to manufacturers of construction products.

(20)

In order to allow a manufacturer of a construction product to draw up a declaration of performance for a construction product which is not covered or not fully covered by a harmonised standard, it is necessary to provide for a European Technical Assessment.

(21)

Manufacturers of construction products should be allowed to request European Technical Assessments to be issued for their products on the basis of the guidelines for European technical approval established under Directive 89/106/EEC. The right to use those guidelines as European Assessment Documents should therefore be ensured.

(22)

The establishment of draft European Assessment Documents and the issuing of European Technical Assessments should be entrusted to Technical Assessment Bodies (hereinafter referred to as ‘TABs’) designated by Member States. In order to ensure that TABs have the necessary competence for carrying out those tasks, the requirements for their designation should be set out at Union level.

(23)

TABs should establish an organisation (hereinafter referred to as an ‘organisation of TABs’), supported, where applicable, through Union financing, to coordinate procedures for the establishment of draft European Assessment Documents and for the issuing of the European Technical Assessments, ensuring the transparency and the necessary confidentiality of those procedures.

(24)

Except in the cases laid down in this Regulation, the placing on the market of a construction product which is covered by a harmonised standard or for which a European Technical Assessment has been issued should be accompanied by a declaration of performance in relation to the essential characteristics of the construction product in accordance with the relevant harmonised technical specifications.

(25)

Where applicable, the declaration of performance should be accompanied by information on the content of hazardous substances in the construction product in order to improve the possibilities for sustainable construction and to facilitate the development of environment-friendly products. Such information should be provided without prejudice to the obligations, particularly with regard to labelling, laid down in other instruments of Union law applicable to hazardous substances and should be made available at the same time and in the same form as the declaration of performance so as to reach all potential users of construction products. Information on the content of hazardous substances should initially be limited to substances referred to in Articles 31 and 33 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (7). However, the specific need for information on the content of hazardous substances in construction products should be further investigated with a view to completing the range of substances covered so as to ensure a high level of protection of the health and safety of workers using construction products and of users of construction works, including with regard to recycling and/or reuse requirements of parts or materials. This Regulation is without prejudice to Member States’ rights and obligations pursuant to other instruments of Union law that may apply to hazardous substances, in particular, Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (8), Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (9), Regulation (EC) No 1907/2006, Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (10) and Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (11).

(26)

It should be possible for the declaration of performance to be numbered in accordance with the product-type reference number.

(27)

It is necessary to provide for simplified procedures for the drawing up of declarations of performance in order to alleviate the financial burden of enterprises, in particular small and medium-sized enterprises (SMEs).

(28)

In order to ensure that the declaration of performance is accurate and reliable, the performance of the construction product should be assessed and the production in the factory should be controlled in accordance with an appropriate system of assessment and verification of constancy of performance of the construction product. Several systems could be chosen to be applied for a given construction product, in order to take into account the specific relationship of some of its essential characteristics to the basic requirements for construction works.

(29)

Given the specificity of construction products and the particular focus of the system for their assessment, the procedures for the conformity assessment provided for in Decision No 768/2008/EC, and the modules set out therein, are not appropriate. Specific methods should therefore be established for the assessment and verification of constancy of performance in relation to the essential characteristics of construction products.

(30)

Due to the difference in the meaning of the CE marking for construction products, when compared to the general principles set out in Regulation (EC) No 765/2008, specific provisions should be put in place to ensure the clarity of the obligation to affix the CE marking to construction products and the consequences thereof.

(31)

By affixing the CE marking or having such marking affixed to a construction product, manufacturers should indicate that they take responsibility for the conformity of that product with its declared performance.

(32)

The CE marking should be affixed to all construction products for which the manufacturer has drawn up a declaration of performance in accordance with this Regulation. If a declaration of performance has not been drawn up, the CE marking should not be affixed.

(33)

The CE marking should be the only marking of conformity of the construction product with the declared performance and compliance with applicable requirements relating to Union harmonisation legislation. However, other markings may be used, provided that they help to improve the protection of users of construction products and are not covered by existing Union harmonisation legislation.

(34)

To avoid the unnecessary testing of construction products for which performance has already been sufficiently demonstrated by stable test results or other existing data, the manufacturer should be allowed, under conditions set up in the harmonised technical specifications or in a Commission decision, to declare a certain level or class of performance without testing or without further testing.

(35)

To avoid duplicating tests already carried out, a manufacturer of a construction product should be allowed to use the test results obtained by a third party.

(36)

Conditions should be defined for the use of simplified procedures for the assessment of the performance of construction products, in order to reduce as far as possible the cost of placing them on the market, without reducing the level of safety. The manufacturers using such simplified procedures should demonstrate appropriately the fulfilment of those conditions.

(37)

In order to enhance the impact of market surveillance measures, all simplified procedures provided for in this Regulation for the assessment of the performance of construction products should apply only to natural or legal persons which manufacture the products they place on the market.

(38)

To further decrease the cost to micro-enterprises of placing construction products, which they have manufactured, on the market, it is necessary to provide for simplified procedures for the assessment of performance when the products in question do not imply significant safety concerns while complying with the applicable requirements, whatever the origin of those requirements. Enterprises applying those simplified procedures should, in addition, demonstrate that they qualify as micro-enterprises. Moreover, they should follow the applicable procedures for verification of constancy of performance provided for in the harmonised technical specifications for their products.

(39)

For an individually designed and manufactured construction product, the manufacturer should be allowed to use simplified procedures for the assessment of performance, where it can be demonstrated that the product placed on the market complies with the applicable requirements.

(40)

The interpretative framework for the definition of ‘non-series process’, to be applied to different construction products covered by this Regulation, should be established by the Commission in consultation with the Standing Committee on Construction.

(41)

All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they place or make available on the market only construction products which are in compliance with the requirements of this Regulation, which aim to ensure the performance of construction products and fulfil basic requirements for construction works. In particular, importers and distributors of construction products should be aware of the essential characteristics for which there are provisions on the Union market, and of the specific requirements in Member States in relation to the basic requirements for construction works, and should use this knowledge in their commercial transactions.

(42)

It is important to ensure the accessibility of national technical rules so that enterprises, and in particular SMEs, can gather reliable and precise information about the law in force in the Member State where they intend to place or make available on the market their products. Member States should therefore designate Product Contact Points for Construction for this purpose. In addition to the tasks defined in Article 10(1) of Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State (12), Product Contact Points for Construction should also provide information on rules applicable to the incorporation, assembling or installation of a specific type of construction product.

(43)

In order to facilitate the free movement of goods, Product Contact Points for Construction should provide, free of charge, information about provisions aimed at fulfilling basic requirements for construction works applicable to the intended use of each construction product in the territory of each Member State. Product Contact Points for Construction may also provide economic operators with additional information or observations. For additional information, Product Contact Points for Construction should be allowed to charge fees that are proportionate to the costs of providing such information or observations. Member States should furthermore ensure that sufficient resources are allocated to the Product Contact Points for Construction.

(44)

Since the creation of Product Contact Points for Construction should not interfere with the allocation of functions among competent authorities within the regulatory systems of the Member States, it should be possible for Member States to set up Product Contact Points for Construction in accordance with regional or local competences. Member States should be able to entrust the role of Product Contact Points for Construction to existing contact points established in accordance with other Union instruments, in order to prevent the unnecessary proliferation of contact points and to simplify administrative procedures. In order not to increase administrative costs for enterprises and competent authorities, Member States should also be able to entrust the role of Product Contact Points for Construction not only to existing services within the public administration, but also to national SOLVIT centres, chambers of commerce, professional organisations and private bodies.

(45)

The Product Contact Points for Construction should be able to carry out their functions in a manner that avoids conflicts of interest, particularly in respect of the procedures for obtaining the CE marking.

(46)

For the purposes of ensuring an equivalent and consistent enforcement of Union harmonisation legislation, effective market surveillance should be operated by the Member States. Regulation (EC) No 765/2008 provides the basic conditions for the functioning of such market surveillance, notably for programmes, financing and penalties.

(47)

The responsibility of Member States for safety, health and other matters covered by the basic requirements for construction works on their territory should be recognised in a safeguard clause providing for appropriate protective measures.

(48)

Since it is necessary to ensure throughout the Union a uniform level of performance of bodies carrying out the assessment and verification of constancy of performance of construction products, and since all such bodies should perform their functions to the same level and under conditions of fair competition, requirements should be set for those bodies seeking to be notified for the purposes of this Regulation. Provision should also be made for the availability of adequate information about such bodies and for their monitoring.

(49)

In order to ensure a coherent level of quality in the assessment and verification of constancy of performance of construction products, it is also necessary to establish requirements applicable to the authorities responsible for notifying the bodies carrying out those tasks to the Commission and the other Member States.

(50)

In accordance with Article 291 TFEU, rules and general principles for the control by Member States of the Commission’s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (13) continues to apply, with the exception of the regulatory procedure with scrutiny, which is no longer applicable.

(51)

For the purposes of achieving the objectives of this Regulation, the Commission should be empowered to adopt certain delegated acts in accordance with Article 290 TFEU. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

(52)

In particular, the Commission should be empowered to adopt delegated acts outlining the conditions for the use of websites to make available the declaration of performance.

(53)

Since a period of time is required to ensure that the framework for the proper functioning of this Regulation is in place, its application should be deferred with the exception of the provisions concerning the designation of TABs, notifying authorities and notified bodies, the establishment of an organisation of TABs and the establishment of the Standing Committee on Construction.

(54)

The Commission and the Member States should, in collaboration with stakeholders, launch information campaigns to inform the construction sector, particularly economic operators and users of construction products, of the establishment of a common technical language, the distribution of responsibilities between individual economic operators and users, the affixing of the CE marking on construction products, the revision of the basic requirements for construction works and the systems of assessment and verification of constancy of performance.

(55)

The basic requirement for construction works on sustainable use of natural resources should notably take into account the recyclability of construction works, their materials and parts after demolition, the durability of construction works and the use of environmentally compatible raw and secondary materials in construction works.

(56)

For the assessment of the sustainable use of resources and of the impact of construction works on the environment Environmental Product Declarations should be used when available.

(57)

Wherever possible, uniform European methods should be laid down for establishing compliance with the basic requirements set out in Annex I.

(58)

Since the objective of this Regulation, namely to achieve the proper functioning of the internal market for construction products by means of harmonised technical specifications to express the performance of construction products, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

1.

‘construction product’ means any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works;

2.

‘kit’ means a construction product placed on the market by a single manufacturer as a set of at least two separate components that need to be put together to be incorporated in the construction works;

3.

‘construction works’ means buildings and civil engineering works;

4.

‘essential characteristics’ means those characteristics of the construction product which relate to the basic requirements for construction works;

5.

‘performance of a construction product’ means the performance related to the relevant essential characteristics, expressed by level or class, or in a description;

6.

‘level’ means the result of the assessment of the performance of a construction product in relation to its essential characteristics, expressed as a numerical value;

7.

‘class’ means a range of levels, delimited by a minimum and a maximum value, of performance of a construction product;

8.

‘threshold level’ means a minimum or maximum performance level of an essential characteristic of a construction product;

9.

‘product-type’ means the set of representative performance levels or classes of a construction product, in relation to its essential characteristics, produced using a given combination of raw materials or other elements in a specific production process;

10.

‘harmonised technical specifications’ means harmonised standards and European Assessment Documents;

11.

‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC, on the basis of a request issued by the Commission, in accordance with Article 6 of that Directive;

12.

‘European Assessment Document’ means a document adopted by the organisation of TABs for the purposes of issuing European Technical Assessments;

13.

‘European Technical Assessment’ means the documented assessment of the performance of a construction product, in relation to its essential characteristics, in accordance with the respective European Assessment Document;

14.

‘intended use’ means the intended use of the construction product as defined in the applicable harmonised technical specification;

15.

‘Specific Technical Documentation’ means documentation demonstrating that methods within the applicable system for assessment and verification of constancy of performance have been replaced by other methods, provided that the results obtained by those other methods are equivalent to the results obtained by the test methods of the corresponding harmonised standard;

16.

‘making available on the market’ means any supply of a construction product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

17.

‘placing on the market’ means the first making available of a construction product on the Union market;

18.

‘economic operator’ means the manufacturer, importer, distributor or authorised representative;

19.

‘manufacturer’ means any natural or legal person who manufactures a construction product or who has such a product designed or manufactured, and markets that product under his name or trademark;

20.

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a construction product available on the market;

21.

‘importer’ means any natural or legal person established within the Union, who places a construction product from a third country on the Union market;

22.

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

23.

‘withdrawal’ means any measure aimed at preventing a construction product in the supply chain from being made available on the market;

24.

‘recall’ means any measure aimed at achieving the return of a construction product that has already been made available to the end-user;

25.

‘accreditation’ has the meaning assigned to it by Regulation (EC) No 765/2008;

26.

‘factory production control’ means the documented, permanent and internal control of production in a factory, in accordance with the relevant harmonised technical specifications;

27.

‘micro-enterprise’ means a micro-enterprise as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (14);

28.

‘life cycle’ means the consecutive and interlinked stages of a construction product’s life, from raw material acquisition or generation from natural resources to final disposal.

(a)

the construction product is individually manufactured or custom-made in a non-series process in response to a specific order, and installed in a single identified construction work, by a manufacturer who is responsible for the safe incorporation of the product into the construction works, in compliance with the applicable national rules and under the responsibility of those responsible for the safe execution of the construction works designated under the applicable national rules;

(b)

the construction product is manufactured on the construction site for its incorporation in the respective construction works in compliance with the applicable national rules and under the responsibility of those responsible for the safe execution of the construction works designated under the applicable national rules; or

(c)

the construction product is manufactured in a traditional manner or in a manner appropriate to heritage conservation and in a non-industrial process for adequately renovating construction works officially protected as part of a designated environment or because of their special architectural or historic merit, in compliance with the applicable national rules.

(a)

the reference of the product-type for which the declaration of performance has been drawn up;

(b)

the system or systems of assessment and verification of constancy of performance of the construction product, as set out in Annex V;

(c)

the reference number and date of issue of the harmonised standard or the European Technical Assessment which has been used for the assessment of each essential characteristic;

(d)

where applicable, the reference number of the Specific Technical Documentation used and the requirements with which the manufacturer claims the product complies.

(a)

the intended use or uses for the construction product, in accordance with the applicable harmonised technical specification;

(b)

the list of essential characteristics, as determined in the harmonised technical specification for the declared intended use or uses;

(c)

the performance of at least one of the essential characteristics of the construction product, relevant for the declared intended use or uses;

(d)

where applicable, the performance of the construction product, by levels or classes, or in a description, if necessary based on a calculation in relation to its essential characteristics determined in accordance with Article 3(3);

(e)

the performance of those essential characteristics of the construction product which are related to the intended use or uses, taking into consideration the provisions in relation to the intended use or uses where the manufacturer intends the product to be made available on the market;

(f)

for the listed essential characteristics for which no performance is declared, the letters ‘NPD’ (No Performance Determined);

(g)

when a European Technical Assessment has been issued for that product, the performance, by levels or classes, or in a description, of the construction product in relation to all essential characteristics contained in the corresponding European Technical Assessment.

(a)

keep the declaration of performance and the technical documentation at the disposal of national surveillance authorities for the period referred to in Article 11(2);

(b)

further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the construction product with the declaration of performance and compliance with other applicable requirements in this Regulation;

(c)

cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by construction products covered by the mandate of the authorised representative.

(a)

any economic operator who has supplied them with a product;

(b)

any economic operator to whom they have supplied a product.

(a)

references of superseded harmonised technical specifications, if any;

(b)

date of the beginning of the coexistence period;

(c)

date of the end of the coexistence period.

(a)

the product does not fall within the scope of any existing harmonised standard;

(b)

for at least one essential characteristic of that product, the assessment method provided for in the harmonised standard is not appropriate; or

(c)

the harmonised standard does not provide for any assessment method in relation to at least one essential characteristic of that product.

(a)

be transparent to the manufacturer concerned;

(b)

define appropriate mandatory time limits in order to avoid unjustified delay;

(c)

take appropriately into account the protection of commercial secrecy and confidentiality;

(d)

allow for adequate participation by the Commission;

(e)

be cost-effective for the manufacturer; and

(f)

ensure sufficient collegiality and coordination amongst TABs designated for the product in question.

(a)

where the product is fully covered by a harmonised standard, the TAB shall inform the manufacturer that, in accordance with Article 19(1), a European Technical Assessment cannot be issued;

(b)

where the product is fully covered by a European Assessment Document, the TAB shall inform the manufacturer that such a document will be used as the basis for the European Technical Assessment to be issued;

(c)

where the product is not covered, or not fully covered, by any harmonised technical specification, the TAB shall apply the procedures set out in Annex II or those established in accordance with Article 19(3).

(a)

organise the coordination of the TABs and, if necessary, ensure cooperation and consultation with other stakeholders;

(b)

ensure that examples of best practice are shared between TABs to promote greater efficiency and provide a better service to industry;

(c)

coordinate the application of the procedures set out in Article 21 and in Annex II, as well as provide the support needed to that end;

(d)

develop and adopt European Assessment Documents;

(e)

inform the Commission of any question related to the preparation of European Assessment Documents and of any aspects related to the interpretation of the procedures set out in Article 21 and in Annex II and suggest improvements to the Commission based on experience gained;

(f)

communicate any observations concerning a TAB not fulfilling its tasks in accordance with the procedures set out in Article 21 and in Annex II to the Commission and the Member State which designated the TAB;

(g)

ensure that adopted European Assessment Documents and references to European Technical Assessments are kept publicly available.

(a)

for one or several essential characteristics of the construction product, which the manufacturer places on the market, that product is deemed to achieve a certain level or class of performance without testing or calculation, or without further testing or calculation, in accordance with the conditions set out in the relevant harmonised technical specification or a Commission decision;

(b)

the construction product, covered by a harmonised standard, which the manufacturer places on the market corresponds to the product-type of another construction product, manufactured by another manufacturer and already tested in accordance with the relevant harmonised standard. When these conditions are fulfilled, the manufacturer is entitled to declare performance corresponding to all or part of the test results of this other product. The manufacturer may use the test results obtained by another manufacturer only after having obtained an authorisation of that manufacturer, who remains responsible for the accuracy, reliability and stability of those test results; or

(c)

the construction product, covered by a harmonised technical specification, which the manufacturer places on the market is a system made of components, which the manufacturer assembles duly following precise instructions given by the provider of such a system or of a component thereof, who has already tested that system or that component for one or several of its essential characteristics in accordance with the relevant harmonised technical specification. When these conditions are fulfilled, the manufacturer is entitled to declare performance corresponding to all or part of the test results for the system or the component provided to him. The manufacturer may use the test results obtained by another manufacturer or system provider only after having obtained an authorisation of that manufacturer or system provider, who remains responsible for the accuracy, reliability and stability of those test results.

(a)

the necessary personnel with technical knowledge and sufficient and appropriate experience to perform the third party tasks in the process of assessment and verification of constancy of performance;

(b)

the necessary description of procedures according to which the assessment of performance is carried out, ensuring the transparency and the ability of reproduction of these procedures; it shall have appropriate policies and procedures in place that distinguish between the tasks it carries out as a notified body and other activities;

(c)

the necessary procedures to perform its activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

(a)

sound technical and vocational training covering all the third party tasks in the process of assessment and verification of constancy of performance within the relevant scope for which the body has been notified;

(b)

satisfactory knowledge of the requirements of the assessments and verifications they carry out and adequate authority to carry out such operations;

(c)

appropriate knowledge and understanding of the applicable harmonised standards and of the relevant provisions of the Regulation;

(d)

the ability required to draw up the certificates, records and reports to demonstrate that the assessments and the verifications have been carried out.

(a)

test equipment has an appropriate calibration system and the traceability of the measurements is guaranteed;

(b)

the quality of the test results is ensured.

(a)

any refusal, restriction, suspension or withdrawal of certificates;

(b)

any circumstances affecting the scope of, and conditions for, notification;

(c)

any request for information on assessment and/or verification of constancy of performance activities carried out which they have received from market surveillance authorities;

(d)

on request, third party tasks in accordance with the systems of assessment and verification of constancy of performance carried out within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

(a)

failure of the product to achieve the declared performance and/or to meet the requirements related to the fulfilment of basic requirements for construction works laid down in this Regulation;

(b)

shortcomings in the harmonised technical specifications or in the Specific Technical Documentation.

(a)

the CE marking has been affixed in breach of Article 8 or 9;

(b)

the CE marking has not been affixed, when required, in accordance with Article 8(2);

(c)

without prejudice to Article 5, the declaration of performance has not been drawn up, when required, in accordance with Article 4;

(d)

the declaration of performance has not been drawn up in accordance with Articles 4, 6 and 7;

(e)

the technical documentation is either not available or not complete.

(a)

the determination, where appropriate, of the essential characteristics or threshold levels within specific families of construction products, in relation to which, in accordance with Articles 3 to 6, the manufacturer shall declare, in relation to their intended use, by levels or classes, or in a description, the performance of the manufacturer’s product when it is placed on the market;

(b)

the conditions on which a declaration of performance may be electronically processed, in order to make it available on a web site in accordance with Article 7;

(c)

the amendment of the period for which the manufacturer shall keep the technical documentation and the declaration of performance after the construction product has been placed on the market, in accordance with Article 11, based on the expected life or the part played by the construction product in the construction works;

(d)

the amendment of Annex II and where necessary the adoption of supplementary procedural rules in accordance with Article 19(3) in order to ensure compliance with the principles in Article 20, or the application in practice of the procedures set out in Article 21;

(e)

the adaptation of Annex III, table 1 of Annex IV, and Annex V in response to technical progress;

(f)

the establishment and adaptation of classes of performance in response to technical progress in accordance with Article 27(1);

(g)

the conditions on which a construction product shall be deemed to satisfy a certain level or class of performance without testing or without further testing in accordance with Article 27(5), provided that the fulfilment of the basic requirements for construction works is not thereby jeopardised;

(h)

the adaptation, establishment and revision of the systems of assessment and verification of constancy of performance in accordance with Article 28, relating to a given product, a given product family or a given essential characteristic, and in accordance with:

4.4.2011   

EN

Official Journal of the European Union

L 88/44

(1)

Council Regulation (EC) No 1964/2005 (2) provides that, from 1 January 2006, the tariff rate for bananas of CN code 0803 00 19 is to be EUR 176/metric tonne.

(2)

On 31 May 2010, the Geneva Agreement on Trade in Bananas (3) between the European Union and Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Peru and Venezuela (‘the Agreement’) regarding the structure and operation of the Union’s trading regime for bananas of CN code 0803 00 19 was signed.

(3)

In accordance with the Agreement, the Union will gradually reduce its banana tariff from EUR 176/metric tonne to EUR 114/metric tonne. A first cut, which was applied retroactively from 15 December 2009, the date of initialling of the Agreement, reduced the tariff to EUR 148/metric tonne. The subsequent cuts are to apply in seven annual instalments with a possible delay of a maximum of two years if agreement on agriculture modalities in the Doha Round of the World Trade Organisation (WTO) is delayed. The final tariff of EUR 114/metric tonne is to be reached on 1 January 2019 at the latest. The tariff reductions will be bound in the WTO at the moment of the certification of the EU banana schedule.

(4)

After having been applied provisionally since its date of signature, the Agreement was approved by Council Decision 2011/194/EU (4).

(5)

In light of the new banana tariffs to be applied pursuant to the Agreement, it is appropriate to repeal Regulation (EC) No 1964/2005,

4.4.2011   

EN

Official Journal of the European Union

L 88/45

(1)

According to Article 168(1) of the Treaty on the Functioning of the European Union (TFEU), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. This implies that a high level of human health protection is to be ensured also when the Union adopts acts under other Treaty provisions.

(2)

Article 114 TFEU is the appropriate legal basis since the majority of the provisions of this Directive aim to improve the functioning of the internal market and the free movement of goods, persons and services. Given that the conditions for recourse to Article 114 TFEU as a legal basis are fulfilled, Union legislation has to rely on this legal basis even when public health protection is a decisive factor in the choices made. In this respect, Article 114(3) TFEU explicitly requires that, in achieving harmonisation, a high level of protection of human health is to be guaranteed taking account in particular of any new development based on scientific facts.

(3)

The health systems in the Union are a central component of the Union’s high levels of social protection, and contribute to social cohesion and social justice as well as to sustainable development. They are also part of the wider framework of services of general interest.

(4)

Notwithstanding the possibility for patients to receive cross-border healthcare under this Directive, Member States retain responsibility for providing safe, high quality, efficient and quantitatively adequate healthcare to citizens on their territory. Furthermore, the transposition of this Directive into national legislation and its application should not result in patients being encouraged to receive treatment outside their Member State of affiliation.

(5)

As recognised by the Council in its Conclusions of 1-2 June 2006 on Common values and principles in European Union Health Systems (4) (hereinafter the ‘Council Conclusions’) there is a set of operating principles that are shared by health systems throughout the Union. Those operating principles are necessary to ensure patients’ trust in cross-border healthcare, which is necessary for achieving patient mobility as well as a high level of health protection. In the same statement, the Council recognised that the practical ways in which these values and principles become a reality vary significantly between Member States. In particular, decisions about the basket of healthcare to which citizens are entitled and the mechanisms used to finance and deliver that healthcare, such as the extent to which it is appropriate to rely on market mechanisms and competitive pressures to manage health systems, must be taken in the national context.

(6)

As confirmed by the Court of Justice of the European Union (hereinafter the ‘Court of Justice’) on several occasions, while recognising their specific nature, all types of medical care fall within the scope of the TFEU.

(7)

This Directive respects and is without prejudice to the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States.

(8)

Some issues relating to cross-border healthcare, in particular reimbursement of healthcare provided in a Member State other than that in which the recipient of the care is resident, have already been addressed by the Court of Justice. This Directive is intended to achieve a more general, and also effective, application of principles developed by the Court of Justice on a case-by-case basis.

(9)

In the Council Conclusions, the Council recognised the particular value of an initiative on cross-border healthcare ensuring clarity for Union citizens about their rights and entitlements when they move from one Member State to another, in order to ensure legal certainty.

(10)

This Directive aims to establish rules for facilitating access to safe and high-quality cross-border healthcare in the Union and to ensure patient mobility in accordance with the principles established by the Court of Justice and to promote cooperation on healthcare between Member States, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits relating to health and for the organisation and delivery of healthcare and medical care and social security benefits, in particular for sickness.

(11)

This Directive should apply to individual patients who decide to seek healthcare in a Member State other than the Member State of affiliation. As confirmed by the Court of Justice, neither its special nature nor the way in which it is organised or financed removes healthcare from the ambit of the fundamental principle of the freedom to provide services. However, the Member State of affiliation may choose to limit the reimbursement of cross-border healthcare for reasons relating to the quality and safety of the healthcare provided, where this can be justified by overriding reasons of general interest relating to public health. The Member State of affiliation may also take further measures on other grounds where this can be justified by such overriding reasons of general interest. Indeed, the Court of Justice has laid down that public health protection is among the overriding reasons of general interest that can justify restrictions to the freedom of movement envisaged in the Treaties.

(12)

The concept of ‘overriding reasons of general interest’ to which reference is made in certain provisions of this Directive has been developed by the Court of Justice in its case-law in relation to Articles 49 and 56 TFEU and may continue to evolve. The Court of Justice has held on a number of occasions that overriding reasons of general interest are capable of justifying an obstacle to the freedom to provide services such as planning requirements relating to the aim of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources. The Court of Justice has likewise acknowledged that the objective of maintaining a balanced medical and hospital service open to all may also fall within one of the derogations, on grounds of public health, provided for in Article 52 TFEU, in so far as it contributes to the attainment of a high level of health protection. The Court of Justice has also held that such provision of the TFEU permits Member States to restrict the freedom to provide medical and hospital services in so far as the maintenance of treatment capacity or medical competence on national territory is essential for public health.

(13)

It is clear that the obligation to reimburse costs of cross-border healthcare should be limited to healthcare to which the insured person is entitled according to the legislation of the Member State of affiliation.

(14)

This Directive should not apply to services the primary purpose of which is to support people in need of assistance in carrying out routine, everyday tasks. More specifically, this Directive should not apply to those long-term care services deemed necessary in order to enable the person in need of care to live as full and self-determined a life as possible. Thus, this Directive should not apply, for example, to long-term care services provided by home care services, in assisted living facilities and in residential homes or housing (‘nursing homes’).

(15)

Given their specificity, access to and the allocation of organs for the purpose of organ transplants should fall outside the scope of this Directive.

(16)

For the purpose of reimbursing the costs of cross-border healthcare, this Directive should cover not only the situation where the patient is provided with healthcare in a Member State other than the Member State of affiliation, but also the prescription, dispensation and provision of medicinal products and medical devices where these are provided in the context of a health service. The definition of cross-border healthcare should cover both the situation in which a patient purchases such medicinal products and medical devices in a Member State other than the Member State of affiliation and the situation in which the patient purchases such medicinal products and medical devices in another Member State than that in which the prescription was issued.

(17)

This Directive should not affect Member States’ rules concerning the sale of medicinal products and medical devices over the Internet.

(18)

This Directive should not give any person an entitlement to enter, stay or reside in a Member State in order to receive healthcare in that State. Where the stay of a person on the territory of a Member State is not in accordance with the legislation of that Member State concerning the right to enter or stay on its territory, such person should not be regarded as an insured person according to the definition in this Directive. Member States should continue to be able to specify in their national legislation who is considered as an insured person for the purposes of their public healthcare scheme and social security legislation as long as the patients’ rights set out in this Directive are secured.

(19)

When a patient receives cross-border healthcare, it is essential for the patient to know in advance which rules will be applicable. The rules applicable to cross-border healthcare should be those set out in the legislation of the Member State of treatment, given that, in accordance with Article 168(7) TFEU, the organisation and delivery of health services and medical care is the responsibility of the Member States. This should help the patient in making an informed choice, and should avoid misapprehension and misunderstanding. It should also establish a high level of trust between the patient and the healthcare provider.

(20)

In order to help patients to make an informed choice when they seek to receive healthcare in another Member State, Member States of treatment should ensure that patients from other Member States receive on request the relevant information on safety and quality standards enforced on its territory as well as on which healthcare providers are subject to these standards. Furthermore, healthcare providers should provide patients on request with information on specific aspects of the healthcare services they offer and on the treatment options. To the extent that healthcare providers already provide patients resident in the Member State of treatment with relevant information on those specific aspects, this Directive should not oblige healthcare providers to provide more extensive information to patients from other Member States. Nothing should prevent the Member State of treatment from also obliging other actors than the healthcare providers, such as insurance providers or public authorities, to provide the information on specific aspects of the healthcare services offered, if that would be more appropriate with regard to the organisation of its healthcare system.

(21)

In its Conclusions the Council recognised that there is a set of common values and principles that are shared across the Union about how health systems respond to the needs of the population and patients that they serve. The overarching values of universality, access to good quality care, equity, and solidarity have been widely acknowledged in the work of various Union institutions. Therefore, Member States should also ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably on the basis of their healthcare needs rather than on the basis of their Member State of affiliation. In doing so, Member States should respect the principles of free movement of persons within the internal market, non-discrimination, inter alia, with regard to nationality and necessity and proportionality of any restrictions on free movement. However, nothing in this Directive should oblige healthcare providers to accept for planned treatment patients from other Member States or to prioritise them to the detriment of other patients, for instance by increasing the waiting time for treatment of other patients. Inflows of patients may create a demand exceeding the capacities existing in a Member State for a given treatment. In such exceptional cases, the Member State should retain the possibility to remedy the situation on the grounds of public health, in accordance with Articles 52 and 62 TFEU. However, this limitation should be without prejudice to Member States’ obligations under Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (5).

(22)

Systematic and continuous efforts should be made to ensure that quality and safety standards are improved in line with the Council Conclusions and taking into account advances in international medical science and generally recognised good medical practices as well as taking into account new health technologies.

(23)

Ensuring clear common obligations in respect of the provision of mechanisms for responding to harm arising from healthcare is essential to prevent lack of confidence in those mechanisms being an obstacle to taking up cross-border healthcare. Systems for addressing harm in the Member State of treatment should be without prejudice to the possibility for Member States to extend the coverage of their domestic systems to patients from their country seeking healthcare abroad, where this is more appropriate for the patient.

(24)

Member States should ensure that mechanisms for the protection of patients and for seeking remedies in the event of harm are in place for healthcare provided on their territory and that they are appropriate to the nature and extent of the risk. However, it should be for the Member State to determine the nature and modalities of such a mechanism.

(25)

The right to the protection of personal data is a fundamental right recognised by Article 8 of the Charter of Fundamental Rights of the European Union. Ensuring continuity of cross-border healthcare depends on transfer of personal data concerning patients’ health. These personal data should be able to flow from one Member State to another, but at the same time the fundamental rights of the individuals should be safeguarded. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (6) establishes the right for individuals to have access to their personal data concerning their health, for example the data in their medical records containing such information as diagnosis, examination results, assessments by treating physicians and any treatment or interventions provided. Those provisions should also apply in the context of cross-border healthcare covered by this Directive.

(26)

The right to reimbursement of the costs of healthcare provided in another Member State by the statutory social security system of patients as insured persons has been recognised by the Court of Justice in several judgements. The Court of Justice has held that the Treaty provisions on the freedom to provide services include the freedom for the recipients of healthcare, including persons in need of medical treatment, to go to another Member State in order to receive it there. The same should apply to recipients of healthcare seeking to receive healthcare provided in another Member State through other means, for example through eHealth services.

(27)

In accordance with the principles established by the Court of Justice, and without endangering the financial balance of Member States’ healthcare and social security systems, greater legal certainty as regards the reimbursement of healthcare costs should be provided for patients and for health professionals, healthcare providers and social security institutions.

(28)

This Directive should not affect an insured person’s rights in respect of the assumption of costs of healthcare which becomes necessary on medical grounds during a temporary stay in another Member State according to Regulation (EC) No 883/2004. In addition, this Directive should not affect an insured person’s right to be granted an authorisation for treatment in another Member State where the conditions provided for by Union regulations on the coordination of social security systems are met, in particular by Regulation (EC) No 883/2004 or Council Regulation (EEC) No 1408/71 of 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 (7), which are applicable by virtue of Regulation (EU) No 1231/2010 of the European Parliament and of the Council of 24 November 2010 extending Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 to nationals of third countries who are not already covered by these Regulations solely on the ground of their nationality (8) and Council Regulation (EC) No 859/2003 of 14 May 2003 extending the provisions of Regulation (EEC) No 1408/71 and Regulation (EEC) No 574/72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality (9).

(29)

It is appropriate to require that also patients who seek healthcare in another Member State in other circumstances than those provided for in Regulation (EC) No 883/2004 should be able to benefit from the principles of free movement of patients, services and goods in accordance with the TFEU and with this Directive. Patients should enjoy a guarantee of assumption of the costs of that healthcare at least at the level as would be provided for the same healthcare, had it been provided in the Member State of affiliation. This should fully respect the responsibility of the Member States to determine the extent of the sickness cover available to their citizens and prevent any significant effect on the financing of the national healthcare systems.

(30)

For patients, therefore, the two systems should be coherent; either this Directive applies or the Union regulations on the coordination of social security systems apply.

(31)

Patients should not be deprived of the more beneficial rights guaranteed by the Union Regulations on the coordination of social security systems when the conditions are met. Therefore, any patient who requests an authorisation to receive treatment appropriate to his condition in another Member State should always be granted this authorisation under the conditions provided for in the Unions regulations when the treatment in question is among the benefits provided for by the legislation in the Member State where the patient resides and when the patient cannot be given such treatment within a time limit that is medically justifiable, taking account of his current state of health and the probable course of the condition. However, if a patient instead explicitly requests to seek treatment under the terms of this Directive, the benefits which apply to reimbursement should be limited to those which apply under this Directive. Where the patient is entitled to cross-border healthcare under both this Directive and Regulation (EC) No 883/2004, and the application of that Regulation is more advantageous to the patient, the patient’s attention should be drawn to this by the Member State of affiliation.

(32)

Patients should, in any event, not derive a financial advantage from the healthcare provided in another Member State and the assumption of costs should be therefore limited only to the actual costs of healthcare received.

(33)

This Directive does not aim to create an entitlement to reimbursement of the costs of healthcare provided in another Member State, if such healthcare is not among the benefits provided for by the legislation of the Member State of affiliation of the insured person. Equally, this Directive should not prevent the Member States from extending their benefits-in-kind scheme to healthcare provided in another Member State. This Directive should recognise that Member States are free to organise their healthcare and social security systems in such a way as to determine entitlement for treatment at a regional or local level.

(34)

Member States of affiliation should give patients the right to receive at least the same benefits in another Member State as those provided for by the legislation of the Member State of affiliation. If the list of benefits does not specify precisely the treatment method applied but defines types of treatment, the Member State of affiliation should not refuse prior authorisation or reimbursement on the grounds that the treatment method is not available in its territory, but should assess if the cross-border treatment sought or received corresponds to benefits provided for in its legislation. The fact that the obligation to reimburse cross-border healthcare under this Directive is limited to such healthcare that is among the benefits to which the patient is entitled within its Member State of affiliation does not preclude Member States from reimbursing the cost of cross-border healthcare beyond those limits. Member States are free, for example, to reimburse extra costs, such as accommodation and travel costs, or extra costs incurred by persons with disabilities even where those costs are not reimbursed in the case of healthcare provided in their territory.

(35)

This Directive should not provide either for the transfer of social security entitlements between Member States or other coordination of social security systems. The sole objective of the provisions regarding prior authorisation and reimbursement of healthcare provided in another Member State should be to enable freedom to provide healthcare for patients and to remove unjustified obstacles to that fundamental freedom within the patient’s Member State of affiliation. Consequently this Directive should fully respect the differences in national healthcare systems and the Member States’ responsibilities for the organisation and delivery of health services and medical care.

(36)

This Directive should provide for the right for a patient to receive any medicinal product authorised for marketing in the Member State of treatment, even if the medicinal product is not authorised for marketing in the Member State of affiliation, as it is an indispensable part of obtaining effective treatment in another Member State. Nothing should oblige a Member State of affiliation to reimburse an insured person for a medicinal product prescribed in the Member State of treatment, where that medicinal product is not among the benefits provided to that insured person by the statutory social security system or national health system in the Member State of affiliation.

(37)

Member States may maintain general conditions, criteria for eligibility and regulatory and administrative formalities for receipt of healthcare and reimbursement of healthcare costs, such as the requirement to consult a general practitioner before consulting a specialist or before receiving hospital care, also in relation to patients seeking healthcare in another Member State, provided that such conditions are necessary, proportionate to the aim, not discretionary or discriminatory. This may include an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patient’s entitlement to healthcare. It is thus appropriate to require that these general conditions, criteria and formalities should be applied in an objective, transparent and non-discriminatory way and should be known in advance, based primarily on medical considerations, and that they should not impose any additional burden on patients seeking healthcare in another Member State in comparison with patients being treated in their Member State of affiliation, and that decisions should be made as quickly as possible. This should be without prejudice to the rights of the Member States to lay down criteria or conditions for prior authorisation in the case of patients seeking healthcare in their Member State of affiliation.

(38)

In the light of the case-law of the Court of Justice, making the assumption by the statutory social security system or national health system of costs of healthcare provided in another Member State subject to prior authorisation is a restriction to the free movement of services. Therefore, as a general rule, the Member State of affiliation should not make the assumption of the costs of healthcare provided in another Member State subject to prior authorisation, where the costs of that care, if it had been provided in its territory, would have been borne by its statutory social security system or national health system.

(39)

Patient flows between Member States are limited and expected to remain so, as the vast majority of patients in the Union receive healthcare in their own country and prefer to do so. However, in certain circumstances patients may seek some forms of healthcare in another Member State. Examples include highly specialised care or healthcare provided in frontier areas where the nearest appropriate facility is on the other side of the border. Furthermore, some patients wish to be treated abroad in order to be close to their family members who are residing in another Member State, or in order to have access to a different method of treatment than that provided in the Member State of affiliation or because they believe that they will receive better quality healthcare in another Member State.

(40)

According to the constant case-law of the Court of Justice, Member States may make the assumption of costs by the national system of hospital care provided in another Member State subject to prior authorisation. The Court of Justice has judged that this requirement is both necessary and reasonable, since the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are equipped, and even the nature of the medical services which they are able to offer, are all matters for which planning, generally designed to satisfy various needs, must be possible. The Court of Justice has found that such planning seeks to ensure that there is sufficient and permanent access to a balanced range of high-quality hospital treatment in the Member State concerned. In addition, it assists in meeting a desire to control costs and to prevent, as far as possible, any wastage of financial, technical and human resources. According to the Court of Justice, such wastage would be all the more damaging because it is generally recognised that the hospital care sector generates considerable costs and must satisfy increasing needs, while the financial resources made available for healthcare are not unlimited, whatever mode of funding is applied.

(41)

The same reasoning applies to healthcare not provided in a hospital but subjected to similar planning needs in the Member State of treatment. This may be healthcare which requires planning because it involves use of highly specialised and cost-intensive medical infrastructure or medical equipment. In light of technological progress, the development of new methods of treatment and the different policies of the Member States regarding the roles of hospitals in their healthcare systems, the question of whether this kind of healthcare is delivered within hospital or ambulatory care facilities is not the decisive factor for deciding whether it requires planning or not.

(42)

Given that the Member States are responsible for laying down rules as regards the management, requirements, quality and safety standards and organisation and delivery of healthcare and that the planning necessities differ from one Member State to another, it should therefore be for the Member States to decide whether there is a need to introduce a system of prior authorisation, and if so, to identify the healthcare requiring prior authorisation in the context of their system in accordance with the criteria defined by this Directive and in the light of the case-law of the Court of Justice. The information concerning this healthcare should be made publicly available in advance.

(43)

The criteria attached to the grant of prior authorisation should be justified in the light of the overriding reasons of general interest capable of justifying obstacles to the free movement of healthcare, such as planning requirements relating to the aim of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources. The Court of Justice has identified several potential considerations: the risk of seriously undermining the financial balance of a social security system, the objective of maintaining on grounds of public health a balanced medical and hospital service open to all and the objective of maintaining treatment capacity or medical competence on national territory, essential for the public health, and even the survival of the population. It is also important to take into consideration the general principle of ensuring the safety of the patient, in a sector well known for information asymmetry, when managing a prior authorisation system. Conversely, the refusal to grant prior authorisation may not be based on the ground that there are waiting lists on national territory intended to enable the supply of hospital care to be planned and managed on the basis of predetermined general clinical priorities, without carrying out an objective medical assessment.

(44)

According to the constant case-law of the Court of Justice, the criteria for granting or refusing prior authorisation should be limited to what is necessary and proportionate in the light of these overriding reasons in the general interest. It should be noted that the impact on national health systems caused by patient mobility might vary between Member States or between regions within a Member State, depending on factors such as geographical location, language barriers, location of hospitals in border regions or the size of the population and healthcare budget. It should therefore be for Member States to set such criteria for refusing prior authorisation that are necessary and proportionate in that specific context, also taking into account which healthcare falls within the scope of the prior authorisation system, since certain treatments of a highly specialised nature will be more easily affected even by a limited patient outflow than others. Consequently, Member States should be able to set up different criteria for different regions or other relevant administrative levels for the organisation of healthcare, or indeed for different treatments, as long as the system is transparent and easily accessible and the criteria are made public in advance.

(45)

Where the patient is entitled to healthcare and that healthcare cannot be provided within a time limit which is medically justifiable, the Member State of affiliation should in principle be obliged to grant prior authorisation. However, in certain circumstances, cross-border healthcare may expose the patient or the general public to a risk which overrides the interest of the patient to receive the cross-border healthcare sought. In such instances, the Member State of affiliation should be able to refuse the request for prior authorisation, in which case the Member State of affiliation should direct the patient towards alternative solutions.

(46)

In any event, if a Member State decides to establish a system of prior authorisation for assumption of costs of hospital or specialised care provided in another Member State in accordance with the provision of this Directive, the costs of such care provided in another Member State should also be reimbursed by the Member State of affiliation up to the level of costs that would have been assumed had the same healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received. However, when the conditions set out in Regulation (EEC) No 1408/71 or Regulation (EC) No 883/2004 are fulfilled, the authorisation should be granted and the benefits provided in accordance with Regulation (EC) No 883/2004 unless otherwise requested by the patient. This should apply in particular in instances where the authorisation is granted after an administrative or judicial review of the request and the person concerned has received the treatment in another Member State. In that event, Articles 7 and 8 of this Directive should not apply. This is in line with the case-law of the Court of Justice which has specified that patients who were refused prior authorisation on grounds that were subsequently held to be unfounded, are entitled to have the cost of the treatment obtained in another Member State reimbursed in full according to the provisions of the legislation in the Member State of treatment.

(47)

Procedures regarding cross-border healthcare established by the Member States should give patients guarantees of objectivity, non-discrimination and transparency, in such a way as to ensure that decisions by national authorities are made in a timely manner and with due care and regard for both those overall principles and the individual circumstances of each case. This should also apply to the actual reimbursement of costs of healthcare incurred in another Member State after the patient has received treatment. It is appropriate that, under normal circumstances, patients be entitled to receive decisions regarding cross-border healthcare within a reasonable period of time. However, that period should be shortened where warranted by the urgency of the treatment in question.

(48)

Appropriate information on all essential aspects of cross-border healthcare is necessary in order to enable patients to exercise their rights on cross-border healthcare in practice. For cross-border healthcare, one of the mechanisms for providing such information is to establish national contact points within each Member State. Information that has to be provided compulsorily to patients should be specified. However, the national contact points may provide more information voluntarily and also with the support of the Commission. Information should be provided by national contact points to patients in any of the official languages of the Member State in which the contact points are situated. Information may be provided in any other language.

(49)

The Member States should decide on the form and number of their national contact points. Such national contact points may also be incorporated in, or build on, activities of existing information centres provided that it is clearly indicated that they are also national contact points for cross-border healthcare. National contact points should be established in an efficient and transparent way and they should be able to consult with patient organisations, healthcare insurers and healthcare providers. The national contact points should have appropriate facilities to provide information on the main aspects of cross-border healthcare. The Commission should work together with the Member States in order to facilitate cooperation regarding national contact points for cross-border healthcare, including making relevant information available at Union level. The existence of national contact points should not preclude Member States from establishing other linked contact points at regional or local level, reflecting the specific organisation of their healthcare system.

(50)

Member States should facilitate cooperation between healthcare providers, purchasers and regulators of different Member States at national, regional or local level in order to ensure safe, high-quality and efficient cross-border healthcare. This could be of particular importance in border regions, where cross-border provision of services may be the most efficient way of organising health services for the local population, but where achieving such cross-border provision on a sustained basis requires cooperation between the health systems of different Member States. Such cooperation may concern joint planning, mutual recognition or adaptation of procedures or standards, interoperability of respective national information and communication technology (hereinafter ‘ICT’) systems, practical mechanisms to ensure continuity of care or practical facilitating of cross-border provision of healthcare by health professionals on a temporary or occasional basis. Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (10) stipulates that free provision of services of a temporary or occasional nature, including services provided by health professionals, in another Member State is not, subject to specific provisions of Union law, to be restricted for any reason relating to professional qualifications. This Directive should be without prejudice to Directive 2005/36/EC.

(51)

The Commission should encourage cooperation between Member States in the areas set out in Chapter IV of this Directive and may, in accordance with Article 168(2) TFEU, take, in close contact with the Member States, any useful initiative to facilitate and promote such cooperation. In that context, the Commission should encourage cooperation in cross-border healthcare provision at regional and local level, particularly by identifying major obstacles to collaboration between healthcare providers in border regions, and by making recommendations and disseminating information and best practices on how to overcome such obstacles.

(52)

The Member State of affiliation may need to receive confirmation that the cross-border healthcare will be, or has been, delivered by a legally practising health professional. It is therefore appropriate to ensure that information on the right to practise contained in the national or local registers of health professionals, if established in the Member State of treatment, are, upon request, made available to the authorities of the Member State of affiliation.

(53)

Where medicinal products are authorised within a Member State and have been prescribed in that Member State by a member of a regulated health profession within the meaning of Directive 2005/36/EC for an individual named patient, it should, in principle, be possible for such prescriptions to be medically recognised and for the medicinal products to be dispensed in another Member State in which the medicinal products are authorised. The removal of regulatory and administrative barriers to such recognition should be without prejudice to the need for appropriate agreement of the patient’s treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective. The recognition of prescriptions from other Member States should not affect any professional or ethical duty that would require pharmacists to refuse to dispense the prescription. Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products among the benefits covered by the social security system of affiliation. It should further be noted that the reimbursement of medicinal products is not affected by the rules on mutual recognition of prescriptions, but covered by the general rules on reimbursement of cross-border healthcare in Chapter III of this Directive. The implementation of the principle of recognition should be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products. These measures should include the adoption of a non-exhaustive list of elements to be included in prescriptions. Nothing should prevent Member States from having further elements in their prescriptions, as long as this does not prevent prescriptions from other Member States that contain the common list of elements from being recognised. The recognition of prescriptions should also apply for medical devices that are legally placed on the market in the Member State where the device will be dispensed.

(54)

The Commission should support the continued development of European reference networks between healthcare providers and centres of expertise in the Member States. European reference networks can improve the access to diagnosis and the provision of high-quality healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, and could also be focal points for medical training and research, information dissemination and evaluation, especially for rare diseases. This Directive should therefore give incentives to Member States to reinforce the continued development of European reference networks. European reference networks are based on the voluntary participation of their members, but the Commission should develop criteria and conditions that the networks should be required to fulfil in order to receive support from the Commission.

(55)

Rare diseases are those that meet a prevalence threshold of not more than five affected persons per 10 000, in line with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (11), and they are all serious, chronic and often life threatening. Some patients affected by rare diseases face difficulties in their quest for a diagnosis and treatment to improve their quality of life and to increase their life expectancy, difficulties which were also recognised by the Council Recommendation of 8 June 2009 on an action in the field of rare diseases (12).

(56)

Technological developments in cross-border provision of healthcare through the use of ICTs may result in the exercise of supervisory responsibilities by Member States being unclear, and can thus hinder the free movement of healthcare and give rise to possible additional risks to health protection. Widely different and incompatible formats and standards are used for provision of healthcare using ICTs throughout the Union, creating both obstacles to this mode of cross-border healthcare provision and possible risks to health protection. It is therefore necessary for Member States to aim at interoperability of ICT systems. The deployment of health ICT systems, however, is entirely a national competence. This Directive therefore should recognise the importance of the work on interoperability and respect the division of competences by providing for the Commission and Member States to work together on developing measures which are not legally binding but provide additional tools that are available to Member States to facilitate greater interoperability of ICT systems in the healthcare field and to support patient access to eHealth applications, whenever Member States decide to introduce them.

(57)

The interoperability of eHealth solutions should be achieved whilst respecting national regulations on the provision of healthcare services adopted in order to protect the patient, including legislation on Internet pharmacies, in particular national bans on mail order of prescription-only medicinal products to the extent that they are compatible with the case-law of the Court of Justice and Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (13) and Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (14).

(58)

The constant progress of medical science and health technologies presents both opportunities and challenges to the health systems of the Member States. Cooperation in the evaluation of new health technologies can support Member States through economies of scale and avoid duplication of effort, and provide a better evidence base for optimal use of new technologies to ensure safe, high-quality and efficient healthcare. Such cooperation requires sustained structures involving all the relevant authorities of the Member States, building on existing pilot projects and consultation of a wide range of stakeholders. This Directive should therefore provide a basis for continued Union support for such cooperation.

(59)

According to Article 291 TFEU, rules and general principles concerning mechanisms for the control by Member States of the Commission’s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new Regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.

(60)

The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of measures that would exclude specific categories of medicinal products or medical devices from the recognition of prescriptions, as provided for in this Directive. In order to identify the reference networks which should benefit from support by the Commission, the Commission should also be empowered to adopt delegated acts in respect of the criteria and conditions that European reference networks have to fulfil.

(61)

It is of particular importance that, when empowered to adopt delegated acts in accordance with Article 290 TFEU, the Commission carry out appropriate consultations during its preparatory work, including at expert level.

(62)

In accordance with point 34 of the Interinstitutional Agreement on better law-making (16), Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(63)

The European Data Protection Supervisor has also delivered his opinion on the proposal for this Directive (17).

(64)

Since the objective of this Directive, namely providing rules for facilitating the access to safe and high quality cross-border healthcare in the Union, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective,

(a)

services in the field of long-term care the purpose of which is to support people in need of assistance in carrying out routine, everyday tasks;

(b)

allocation of and access to organs for the purpose of organ transplants;

(c)

with the exception of Chapter IV, public vaccination programmes against infectious diseases which are exclusively aimed at protecting the health of the population on the territory of a Member State and which are subject to specific planning and implementation measures.

(a)

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 (18);

(b)

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (19), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (20) and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (21);

(c)

Directive 95/46/EC and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (22);

(d)

Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services (23);

(e)

Directive 2000/31/EC;

(f)

Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin (24);

(g)

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (25);

(h)

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 (26);

(i)

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (27);

(j)

Regulation (EC) No 859/2003;

(k)

Directive 2004/23/EC of the European Parliament and of the Council 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 (28);

(l)

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (29);

(m)

Regulation (EC) No 883/2004 and Regulation (EC) No 987/2009 of the European Parliament and of the Council of 16 September 2009 laying down the procedure for implementing Regulation (EC) No 883/2004 on the coordination of social security systems (30);

(n)

Directive 2005/36/EC;

(o)

Regulation (EC) No 1082/2006 of the European Parliament and of the Council of 5 July 2006 on a European grouping of territorial cooperation (EGTC) (31);

(p)

Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (32);

(q)

Regulation (EC) No 593/2008 of the European Parliament and of the Council of 17 June 2008 on the law applicable to contractual obligations (Rome I) (33), Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to non-contractual obligations (Rome II) (34) and other Union rules on private international law, in particular rules related to court jurisdiction and the applicable law;

(r)

Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (35);

(s)

Regulation (EU) No 1231/2010.

(a)

‘healthcare’ means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices;

(b)

‘insured person’ means:

(c)

‘Member State of affiliation’ means:

(d)

‘Member State of treatment’ means the Member State on whose territory healthcare is actually provided to the patient. In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established;

(e)

‘cross-border healthcare’ means healthcare provided or prescribed in a Member State other than the Member State of affiliation;

(f)

‘health professional’ means a doctor of medicine, a nurse responsible for general care, a dental practitioner, a midwife or a pharmacist within the meaning of Directive 2005/36/EC, or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC, or a person considered to be a health professional according to the legislation of the Member State of treatment;

(g)

‘healthcare provider’ means any natural or legal person or any other entity legally providing healthcare on the territory of a Member State;

(h)

‘patient’ means any natural person who seeks to receive or receives healthcare in a Member State;

(i)

‘medicinal product’ means a medicinal product as defined by Directive 2001/83/EC;

(j)

‘medical device’ means a medical device as defined by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC;

(k)

‘prescription’ means a prescription for a medicinal product or for a medical device issued by a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC who is legally entitled to do so in the Member State in which the prescription is issued;

(l)

‘health technology’ means a medicinal product, a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare;

(m)

‘medical records’ means all the documents containing data, assessments and information of any kind on a patient’s situation and clinical development throughout the care process.

(a)

the legislation of the Member State of treatment;

(b)

standards and guidelines on quality and safety laid down by the Member State of treatment; and

(c)

Union legislation on safety standards.

(a)

patients receive from the national contact point referred to in Article 6, upon request, relevant information on the standards and guidelines referred to in paragraph 1(b) of this Article, including provisions on supervision and assessment of healthcare providers, information on which healthcare providers are subject to these standards and guidelines and information on the accessibility of hospitals for persons with disabilities;

(b)

healthcare providers provide relevant information to help individual patients to make an informed choice, including on treatment options, on the availability, quality and safety of the healthcare they provide in the Member State of treatment and that they also provide clear invoices and clear information on prices, as well as on their authorisation or registration status, their insurance cover or other means of personal or collective protection with regard to professional liability. To the extent that healthcare providers already provide patients resident in the Member State of treatment with relevant information on these subjects, this Directive does not oblige healthcare providers to provide more extensive information to patients from other Member States;

(c)

there are transparent complaints procedures and mechanisms in place for patients, in order for them to seek remedies in accordance with the legislation of the Member State of treatment if they suffer harm arising from the healthcare they receive;

(d)

systems of professional liability insurance, or a guarantee or similar arrangement that is equivalent or essentially comparable as regards its purpose and which is appropriate to the nature and the extent of the risk, are in place for treatment provided on its territory;

(e)

the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC;

(f)

in order to ensure continuity of care, patients who have received treatment are entitled to a written or electronic medical record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.

(a)

the cost of cross-border healthcare is reimbursed in accordance with Chapter III;

(b)

there are mechanisms in place to provide patients on request with information on their rights and entitlements in that Member State relating to receiving cross-border healthcare, in particular as regards the terms and conditions for reimbursement of costs in accordance with Article 7(6) and procedures for accessing and determining those entitlements and for appeal and redress if patients consider that their rights have not been respected, in accordance with Article 9. In information about cross-border healthcare, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from Regulation (EC) No 883/2004;

(c)

where a patient has received cross-border healthcare and where medical follow-up proves necessary, the same medical follow-up is available as would have been if that healthcare had been provided on its territory;

(d)

patients who seek to receive or do receive cross-border healthcare have remote access to or have at least a copy of their medical records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.

(a)

if a Member State is listed in Annex IV to Regulation (EC) No 883/2004 and in compliance with that Regulation has recognised the rights to sickness benefits for pensioners and the members of their families, being resident in a different Member State, it shall provide them healthcare under this Directive at its own expense when they stay on its territory, in accordance with its legislation, as though the persons concerned were residents in the Member State listed in that Annex;

(b)

if the healthcare provided in accordance with this Directive is not subject to prior authorisation, is not provided in accordance with Chapter 1 of Title III of the Regulation (EC) No 883/2004, and is provided in the territory of the Member State that according to that Regulation and Regulation (EC) No 987/2009 is, in the end, responsible for reimbursement of the costs, the costs shall be assumed by that Member State. That Member State may assume the costs of the healthcare in accordance with the terms, conditions, criteria for eligibility and regulatory and administrative formalities that it has established, provided that these are compatible with the TFEU.

(a)

is made subject to planning requirements relating to the object of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources and:

(b)

involves treatments presenting a particular risk for the patient or the population; or

(c)

is provided by a healthcare provider that, on a case-by-case basis, could give rise to serious and specific concerns relating to the quality or safety of the care, with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Union.

(a)

the patient will, according to a clinical evaluation, be exposed with reasonable certainty to a patient-safety risk that cannot be regarded as acceptable, taking into account the potential benefit for the patient of the sought cross-border healthcare;

(b)

the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the cross-border healthcare in question;

(c)

this healthcare is to be provided by a healthcare provider that raises serious and specific concerns relating to the respect of standards and guidelines on quality of care and patient safety, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment;

(d)

this healthcare can be provided on its territory within a time limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned.

(a)

the specific medical condition;

(b)

the urgency and individual circumstances.

(a)

limited to what is necessary and proportionate to safeguard human health, and non-discriminatory; or

(b)

based on legitimate and justified doubts about the authenticity, content or comprehensibility of an individual prescription.

(a)

measures enabling a health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing a non-exhaustive list of elements to be included in the prescriptions and which must be clearly identifiable in all prescription formats, including elements to facilitate, if needed, contact between the prescribing party and the dispensing party in order to contribute to a complete understanding of the treatment, in due respect of data protection;

(b)

guidelines supporting the Member States in developing the interoperability of ePrescriptions;

(c)

measures to facilitate the correct identification of medicinal products or medical devices prescribed in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross border healthcare where the legislation of the dispensing Member State permits such substitution. The Commission shall consider, inter alia, using the International Non-proprietary Name and the dosage of medicinal products;

(d)

measures to facilitate the comprehensibility of the information to patients concerning the prescription and the instructions included on the use of the product, including an indication of active substance and dosage.

(a)

to help realise the potential of European cooperation regarding highly specialised healthcare for patients and for healthcare systems by exploiting innovations in medical science and health technologies;

(b)

to contribute to the pooling of knowledge regarding sickness prevention;

(c)

to facilitate improvements in diagnosis and the delivery of high-quality, accessible and cost-effective healthcare for all patients with a medical condition requiring a particular concentration of expertise in medical domains where expertise is rare;

(d)

to maximise the cost-effective use of resources by concentrating them where appropriate;

(e)

to reinforce research, epidemiological surveillance like registries and provide training for health professionals;

(f)

to facilitate mobility of expertise, virtually or physically, and to develop, share and spread information, knowledge and best practice and to foster developments of the diagnosis and treatment of rare diseases, within and outside the networks;

(g)

to encourage the development of quality and safety benchmarks and to help develop and spread best practice within and outside the network;

(h)

to help Member States with an insufficient number of patients with a particular medical condition or lacking technology or expertise to provide highly specialised services of high quality.

(a)

by connecting appropriate healthcare providers and centres of expertise throughout their national territory and ensuring the dissemination of information towards appropriate healthcare providers and centres of expertise throughout their national territory;

(b)

by fostering the participation of healthcare providers and centres of expertise in the European reference networks.

(a)

adopt a list of specific criteria and conditions that the European reference networks must fulfil and the conditions and criteria required from healthcare providers wishing to join the European reference network. These criteria and conditions shall ensure, inter alia, that European reference networks:

(b)

develop and publish criteria for establishing and evaluating European reference networks;

(c)

facilitate the exchange of information and expertise in relation to the establishment of European reference networks and their evaluation.

(a)

make health professionals aware of the tools available to them at Union level to assist them in the correct diagnosis of rare diseases, in particular the Orphanet database, and the European reference networks;

(b)

make patients, health professionals and those bodies responsible for the funding of healthcare aware of the possibilities offered by Regulation (EC) No 883/2004 for referral of patients with rare diseases to other Member States even for diagnosis and treatments which are not available in the Member State of affiliation.

(a)

work towards delivering sustainable economic and social benefits of European eHealth systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare;

(b)

draw up guidelines on:

(c)

support Member States in developing common identification and authentication measures to facilitate transferability of data in cross-border healthcare.

(a)

support cooperation between national authorities or bodies;

(b)

support Member States in the provision of objective, reliable, timely, transparent, comparable and transferable information on the relative efficacy as well as on the short- and long-term effectiveness, when applicable, of health technologies and to enable an effective exchange of this information between the national authorities or bodies;

(c)

support the analysis of the nature and type of information that can be exchanged;

(d)

avoid duplication of assessments.

(a)

contribute to the financing of administrative and technical support;

(b)

support collaboration between Member States in developing and sharing methodologies for health technology assessment including relative effectiveness assessment;

(c)

contribute to the financing of the provision of transferable scientific information for use in national reporting and case studies commissioned by the network;

(d)

facilitate cooperation between the network and other relevant institutions and bodies of the Union;

(e)

facilitate the consultation of stakeholders on the work of the network.

4.4.2011   

EN

Official Journal of the European Union

L 88/66

(1)

In accordance with Council Decision 2010/314/EU (1), the Geneva Agreement on Trade in Bananas between the European Union and Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Peru and Venezuela and the Agreement on Trade in Bananas between the European Union and the United States of America were signed on behalf of the Union on 31 May 2010 and 8 June 2010, respectively, subject to their conclusion at a later date.

(2)

Those two Agreements should be approved,

(a)

the Geneva Agreement on Trade in Bananas between the European Union and Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Peru and Venezuela (2) (the ‘Geneva Agreement’);

(b)

the Agreement on Trade in Bananas between the European Union and the United States of America (3) (the ‘EU/US Agreement’).