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Sundhedsudvalget 2009-10
KOM (2008) 0414
Offentligt

COUNCIL OF

THE EUROPEAN UNION

Brussels, 31 July 2009

12532/09

Interinstitutional File:

2008/0142 (COD)

LIMITE

SAN 206

SOC 465

MI 292

CODEC 1025

NOTE

from :

to :

No prev. doc.

No. Cion prop. :

Subject :

General Secretariat of the Council

Working Party on Public Health

10231/09 SAN 151 SOC 365 MI 222 CODEC 759

11307/08 SAN 136 SOC 389 MI 234 CODEC 904

Proposal for a Directive of the European Parliament and of the Council on

the application of patients' rights in cross-border healthcare

- Presidency compromise proposal

Delegations will find in the Annex the Presidency's compromise proposal concerning the above

draft directive.

Please note that changes with respect to document 10231/09 are marked by strikethrough for

deletions and

bold underlined

for additions.

________________

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ANNEX

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the application of patients' rights in cross-border healthcare

(2)

For the majority of the provisions in this Directive, Articles 47(2), 55 and 95 of the

Treaty is the appropriate legal base since the provisions have the aim of improving the

functioning of the internal market and the free movement of goods, services and persons.

Given that that the conditions for recourse to Article 95 of the Treaty as a legal basis are

fulfilled, the Community legislature shall rely on this legal basis even when public health

protection is a decisive factor in the choices made; in this respect Article 95(3) of the Treaty

explicitly requires that, in achieving harmonisation, a high level of protection of human health

should be guaranteed taking account in particular of any new development based on scientific

facts.

However, Articles 13 and 15 of this Directive have the aim of providing incentive

measures for cooperation between the Member States in the area of healthcare. For

these Articles, Article 152(4)(c) of the Treaty is therefore the appropriate legal base.

(9)

This Directive on the application of patients’ rights in cross-border healthcare applies 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 freedom to provide services.

However, if there are legitimate concerns over the

safety and quality of care provided by a healthcare provider outside of the social security

system in the Member State of treatment, this Directive provides the Member State of

affiliation with the possibility of excluding this healthcare provider from the scope of the

relevant provisions.

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This Directive shall apply to the provision of healthcare regardless of whether it is provided

by healthcare provider who is or is not in a contractual relation to the social security system.

However, if there is, in an individual case, a serious risk to the public policy, public security

or public health caused by the fact, that the concrete health provider is not bound by any

contract to the social security system, so that the quality or safety of healthcare is threatened,

the Member States may take measures in accordance with Articles 46 and 55 of the EC

Treaty.

(9a) In this Directive, healthcare means all health services and goods provided or prescribed by

health professionals to patients to assess, maintain or restore their state of health. However, it

is clear that the obligation to reimburse costs of cross-border healthcare shall be limited to

healthcare for which the insured person is entitled to according to the legislation of his/her

Member State of affiliation.

(9b)

This

As regards long-term care, the Directive does not apply to the social care part of long-

term care and to the services whose primary purpose is to support people in need of assistance

in carrying out routine, everyday tasks. More specifically this refers 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 life as possible. These include, in particular, basic hands-on care services (like

bathing, dressing, eating, getting in and out of bed or chair, moving around and using the

bathroom), domestic work/home help (like housework, meals, shopping, transport and social

activities). Thus, this Directive should not apply, for example, to long-term care services

provided in residential homes or housing

(“nursing homes”),

or assistance provided to

elderly people or children to long-term care services provided in residential facilities ("nursing

homes") by home care services or in assisted living facilities.

(9c) The access to and allocation of organs for the purpose of organ transplants fall outside

the scope of this Directive. However, the medical treatment of transplanting organs fall

within the scope of this Directive.

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(10) For the purpose of this Directive, the concept of “cross-border healthcare” means:

−

a situation in which the patient physically receives healthcare provided in a Member

State other than that where

he or she is an

the insured person has social security

affiliation; this is what is referred to as “patients mobility”;

−

provision of healthcare services, through use of Information and Communication

Technologies (ICT), in situations where the health professional (or

several

more health

professionals) and the patient are not in the same

Member State.

location. It involves

secure transmission of medical data and information, through text, sound, images or

other forms needed for the prevention, diagnosis, treatment and follow-up of patients;

this is what is referred to as “telemedicine”;

−

the purchase of goods connected with healthcare, such as medicinal products and

medical devices, in a Member State other than that where the insured person has social

security affiliation or in

the

case when the medicinal product or medical device is

purchased in another Member State than that where the prescription was issued.

(10a) This Directive does not give any person an entitlement to enter, stay or reside in a Member

State in order to receive healthcare in that State. In case that 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 is not regarded as an insured

person according to the definition of the insured person set in this Directive.

(12) In order to enable patients to make an informed choice when they seek to receive healthcare

in another Member State, the Member State of treatment shall ensure that patients

from other

Member States

receive on request the relevant information on health and quality standards

enforced on its territory as well as on the characteristics of healthcare provided by a specific

healthcare providers

subject to these standards.

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(12aa) In order to further enable patients to make an informed choice, healthcare providers

should provide patients on request with information on several aspects of the healthcare

services they offer. 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. Furthermore, the Member State of

treatment may oblige other actors than the healthcare providers, such as insurance

providers or public authorities, to provide this information if this is more suitable with

regard to the organisation of its healthcare system.

(12a) Members States

should

have to ensure that all patients are treated equitably on the basis of

their healthcare need rather than their Member State of social security affiliation. In doing so,

Member States

should

must 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

requires healthcare providers to accept for planned treatment or to prioritise patients from

other Member States to the detriment of other patients, such as through increasing waiting

time for treatment. Inflows of patients may create a demand exceeding the capacities existing

in a Member State for a given healthcare. 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 46 and 55 of the EC Treaty. However this limitation is without prejudice to the

Member States obligations under Regulation No (EC) 883/2004.

(12b) In the light of the case-law of the Court of Justice (judgment of 11 March 2004, Commission

v France, C-496/01), in the absence of harmonisation measures, Community law does not

preclude a Member State from imposing, in context of an authorisation scheme, its level of

public health protection on healthcare providers established in another Member State which

wish to offer services to patients insured in the first Member State. However, the conditions to

be satisfied in order to obtain such authorisation may not duplicate the equivalent statutory

conditions, which have already been satisfied in the Member State of establishment.

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(25) This Directive does not aim to create entitlement for reimbursement of cost 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 does not prevent the Member States from extending their benefits in kind scheme to

healthcare provided in another Member State according to its provisions. This Directive

recognises that Member States are free to organise their own healthcare and social security

systems in such a way as to determine entitlement for treatment at a regional or local level.

(26a) Member States should be free to set up voluntary systems or prior notification whereby

patients can get written confirmation in advance whether they will be reimbursed after

receiving a certain treatment, and if applicable with what amount, and to provide for

the assumption of costs through other means than reimbursement ex-post, such as

through advance payment or direct payment between institutions, as long as these

arrangements comply with Community law. Likewise, Member States should be free to

reimburse patients with a higher amount than the level of costs that would have been

assumed had the healthcare been provided on its territory.

(27) This Directive provides also 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 obliges a Member State of

affiliation to reimburse an insured person for a medicinal product prescribed in the Member

State of treatment, which is not among the benefits provided to that insured person by the

social security system in the Member State of affiliation.

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(28) 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 and are

not discretionary and discriminatory. It is thus appropriate to require that these general

conditions and formalities are being applied in an objective, transparent and non-

discriminatory way and are known in advance, based primarily on medical considerations and

that they do 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 are made as quickly as possible.

This is without prejudice to the rights of

the Member States to provide for criteria or conditions of prior authorisation in the case

of patients seeking healthcare in their Member State of affiliation. Since conditions,

criteria and formalities relating to entitlements to healthcare, such as determining the

cost-effectiveness of a specific treatment for a specific patient, is a matter for the

Member State of affiliation, such conditions, criteria and formalities cannot be required

in the Member State of treatment as well as this would constitute an obstacle to the free

movement of persons, goods and services. However, the Member State of treatment may

impose conditions, criteria and formalities relating to clinical circumstances, such as

assessing patient safety risks in performing a specific procedure on a specific patient.

the administrative formalities for assumption of costs are required in the Member State of

treatment as well as in the Member State of affiliation, under the principle of equal treatment,

such double requirement would be an obstacle to free movement.

Furthermore, these conditions, criteria and formalities could include a procedure that

ensures that a person seeking healthcare in another Member State has been provided

with all technical, professional and medical support required for making an informed

choice of healthcare provider, if this procedure is neither discriminatory nor an obstacle

to the free movement of persons, services or goods.

This is without prejudice to the rights

of the Member States to provide for criteria or conditions of prior authorisation in the case of

patients seeking healthcare in their Member State of affiliation.

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(29) In the light of the case-law of the Court of Justice, making the assumption by the national

social security system of costs of healthcare provided in another Member State subject to

prior authorisation is a restriction to 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 paid for by its social security system.

(30) deleted

(31) 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 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 provided, 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 has found that for

one thing, 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. For another

thing, 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, 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

which may be made available for healthcare are not unlimited, whatever the mode of funding

applied.

(31a) 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. With regard to the progress of technology, the

development of new methods of treatment and the different policies of Member States

regarding the roles of hospitals in their healthcare systems, 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.

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(31b) Given that the Member States are responsible for laying down rules as far as the management,

the requirements, the quality and safety standards

and

in the organisation and delivery of

healthcare and that the planning necessities differ from one Member State to another, it is

therefore for the Member States to decide whether there is a need to introduce the 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 care shall be

made publicly available for all the patients.

(31c) The criteria attached to the grant of prior authorisation

should

must be justified in the light of

the overriding reasons in the general interest capable of justifying obstacles to the free

movement of healthcare. 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 or the objective of maintaining treatment capacity or medical competence on

national territory, essential for the public health, and even the survival of the population.

Conversely, the refusal to grant prior authorisation may not be based solely 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 of the patient’s medical condition, the history

and probable course of his illness, the degree of pain he/she is in and/ or the nature of his

disability at the time when the request for authorisation was made or renewed.

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(31d) According to the constant case-law of the Court of Justice, the criteria for granting or

refusing prior authorisation shall 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/or healthcare budget. Therefore it should be for every

Member State to set up such criteria for refusing prior authorisation that are necessary

and proportionate in that specific context, also taking into account which healthcare

that fall 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. Therefore, Member States might 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 is made public in advance.

(33)

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 applies also to the actual reimbursement of costs of healthcare incurred in another

Member State after the patient's return.

It is appropriate that patients should normally have

a decision regarding the cross-border healthcare within fifteen calendar days. However, that

period should be shorter where warranted by the urgency of the treatment in question. In any

event, recognition procedures and rules on the provision of services as provided for by

Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on

the recognition of professional qualifications should not be affected by these general rules.

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(34) 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 have to be provided

compulsorily to patients are specified, however the national contact points may provide more

information voluntarily and also with the support of the European Commission. Information

shall be provided for 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, but does not have

to, be provided also in languages other than in the official languages of the Member State in

which the national contact points are situated.

(39)

Where medicinal products are authorised within the patient's Member State in accordance

with 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

and

have been prescribed in another Member State for an individual named patient, it should be in

principle possible for such prescriptions to be medically recognised and used in the patient's

own Member State. The removal of regulatory and administrative barriers to such recognition

is without prejudice to the need for appropriate agreement of the patients' 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 shall not affect national rules governing dispensing, including any

professional or ethical duty that would require the pharmacist 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 within 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 will be facilitated by the adoption of measures necessary for

safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal

products.

OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006

of the European Parliament and of the Council (OJ L 378, 27.12.2006, p. 1).

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(45a) In accordance with point 34 of the Interinstitutional Agreement on better law-making,

Member States are encouraged to draw up, for themselves and in the interests of the

Community, their own tables illustrating, as far as possible, the correlation between this

Directive and the transposition measures, and to make them public.

CHAPTER I

GENERAL PROVISIONS

Article 1

Aim

This Directive provides for rules for the access to safe and high-quality cross-border healthcare and

establishes cooperation mechanisms on healthcare between Member States, in full respect of

national competencies in organising and delivering healthcare.

Article 2

Scope

This Directive shall apply to the provision of healthcare to patients, regardless of how it is

organised, delivered and financed.

This Directive shall not apply to services in the field of long-term care whose purpose is to

support people in need of assistance in carrying out routine, everyday tasks.

This Directive shall not apply to allocation and access to organs for the purpose of organ

transplants.

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Article 3

Relationship with other Community provisions

This Directive shall apply without prejudice to:

(a)

(b)

Directive 2005/36/EC on the recognition of professional qualifications;

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;

(c)

Directive 95/46/EC on the protection of individuals with regard to the processing of

personal data and on the free movement of such data and Directive 2002/58/EC

concerning the processing of personal data and the protection of privacy in the

electronic communications sector;

(d)

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;

(da) Directive 2001/83/EC on the Community code relating to medicinal products for human

use;

(e)

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;

(ea) Directive 89/105 Council Directive 89/105/EEC of 21 December 1988 relating to the

transparency of measures regulating the prices of medicinal products for human use and

their inclusion in the scope of national health insurance systems;

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(f)

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;

(g)

Directive 2000/43/EC of the Council of 29 June 2000 implementing the principle of

equal treatment between persons irrespective of racial or ethnic origin;

(h)

Regulation (EC) No 883/2004 of the European Parliament and of the Council of

29 April 2004 on the coordination of social security systems and its implementing

Regulation;

(i)

Regulation (EC) No 1338/2008 of the European Parliament and of the Council on

Community statistics on public health and health and safety at work;

(j)

Regulation (EC) 1082/2006 of 5 July 2006 on a European Grouping of territorial

cooperation (EGTC);

(k)

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 and

amending Directive 2001/83/EC;

(l)

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;

(m) "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".

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Article 4

Definitions

For the purposes of this Directive, the following definitions shall apply:

(a)

"healthcare" means health services

provided

and goods, in particular medicinal

products and medical devices, provided or prescribed

or dispensed

by health

professionals to patients to assess, maintain or restore their state of health;

(b)

"Member State of affiliation" means the Member State where the patient is an insured

person; if, due to the application of Article 20(4) or Article 27(5) of the Regulation (EC)

No 883/2004, the institution of the place of residence is considered to be the competent

institution, the state of residence shall be considered as a Member State of affiliation;

Where, due to the application of Regulation (EC) No 883/2004, the health

insurance body in the Member State of residence of the patient is responsible for

the provision of benefits in accordance with the legislation of that state, then that

Member State is regarded as the Member State of affiliation for the purposes of

this Directive;

(c)

"Member State of treatment" means the Member State on whose territory healthcare is

actually provided to the patient;

(d)

"cross-border healthcare" means healthcare provided or prescribed in a Member State

other than the Member State of affiliation;

(e)

"health professional" means a doctor of medicine or a nurse responsible for general care

or a dental practitioner or 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;

(f)

"healthcare provider" means any natural or legal person or any other entity legally

providing healthcare on the territory of a Member State;

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(g)

"patient" means any natural person who seeks to receive or receives healthcare in a

Member State;

(h)

"insured person" means a person who is eligible for the assumption of costs of

healthcare by a statutory social security system according to the legislation of

the

Member State of affiliation;

(i)

(j)

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

"medical device" means a medical device as defined by Council Directive 93/42/EEC of

14 June 1993 concerning medical devices or by 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 or by Directive 98/79/EC of the European Parliament and

of the Council of 27 October 1998 on in vitro diagnostic medical devices;

(k)

"prescription" means a prescription for a medicinal product or a prescription for a

medical device issued by a health professional legally entitled to do so in the Member

State in which the prescription is issued;

(l)

"health technology" means a medicinal product or 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.

(n)

“social security system” means the statutory social security system or the statutory

healthcare system of a Member State.

(o)

“planned cross-border healthcare” means such cross-border healthcare that falls

outside the scope of Article 19 in Regulation (EC) No 883/2004.

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CHAPTER II

RESPONSIBILITIES OF MEMBER STATES WITH REGARDS TO CROSS-BORDER

HEALTH CARE

Article 5

Responsibilities of the Member State of treatment

Cross-border healthcare shall be provided in accordance with the legislation of the Member

State of treatment and according to standards and guidelines on quality and safety defined by

that Member State.

The Member State of treatment shall ensure that:

(a)

patients receive upon request relevant information on standards and guidelines referred

to in paragraph 1, including provisions on supervision and assessment

of healthcare

providers, and information on healthcare providers that are subject to these

standards and guidelines;

(b)

healthcare providers provide individual patients with relevant information on

availability, prices and quality and safety of the healthcare they provide in the Member

State of treatment, as well as on the healthcare providers’ authorisation

or registration

status,

their insurance cover or other means of personal or collective protection with

regard to professional liability. This information shall be provided to the same extent as

to the nationals of the Member State of treatment;

(ba) prices charged for healthcare to patients from other Member States are calculated

according to objective, non-discriminatory criteria known in advance, without

affecting the prerogative of private providers to set prices freely, as long as they do

not discriminate against patients from other Member States;

(c)

there are systems in place of making complaints and mechanisms in place for patients to

seek remedies in accordance with the legislation of the Member State of treatment if

they suffer harm arising from the healthcare they receive;

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(d)

systems of professional liability insurance or a guarantee or similar arrangement, which

are equivalent or essentially comparable as regards their purpose and which are

appropriate to the nature and the extent of the risk, are in place for treatment provided

on its territory;

(e)

patients have access to at least a copy of their medical records, with regards to the

healthcare received in the Member State of treatment and in compliance with its

legislation, and that the fundamental right to privacy with respect to the processing of

personal data is protected in conformity with national measures implementing

Community provisions on the protection of personal data, in particular Directives

95/46/EC and 2002/58/EC;

(f)

patients who have received treatment are entitled to a written or electronic medical

record of such treatment, and access to this record or a copy thereof in conformity

with and subject to national measures implementing Community provisions on the

protection of personal data, in particular Directives 95/46/EC and 2002/58/EC.

Patients from other Member States shall enjoy equal treatment with

patients affiliated to the

social security system of the

nationals of the Member State of treatment.

This shall be without prejudice to the possibility for the Member State of treatment, where it

is justified by overriding reasons of general interest, such as management of national or multi

national waiting lists in the context of organ shortage, to adopt measures

regarding the

access to treatment

aimed at fulfilling its fundamental responsibility to ensure sufficient and

permanent access to healthcare on its territory.

Such measures shall be limited to what is necessary and proportionate and shall not constitute

a means of arbitrary discrimination.

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Article 6

Responsibilities of the Member State of affiliation

The Member State of affiliation shall ensure that cost of cross-border healthcare is reimbursed

in accordance with Chapter III.

The Member State of affiliation shall ensure that there are mechanisms in place to provide

patients on request with information on their rights and entitlements in this Member State

related to receiving cross-border healthcare, in particular as regards procedures for accessing

and determining those entitlements, conditions for reimbursement of costs and systems of

appeal and redress if the patient considers that his/her rights have not been respected.

The Member State of affiliation shall ensure that patients

that seek to receive or receives

cross-border healthcare

have access to at least a copy of their medical records,

or a copy

thereof,

with regards to the healthcare received in the Member State of affiliation and in

compliance with its legislation, when they seek to receive or receive cross-border healthcare,

and that the fundamental right to privacy with respect to the processing of personal data is

protected in conformity with

and subject to

national measures implementing Community

provisions on the protection of personal data, in particular Directives 95/46/EC and

2002/58/EC

Article 7

National contact points for cross-border healthcare

Each Member State shall designate one or more national contact points for cross-border

healthcare and communicate their names and contact details to the Commission.

National contact points shall cooperate with each other and with the Commission. National

contact point(s) shall provide patients on request with contact details of national contact

point(s) in other Member States.

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National contact point(s) in the Member State of treatment shall provide patients with

information concerning healthcare providers,

including on request information on a

specific providers’ right to provide services or any restrictions on its practice,

information on existing quality and safety standards and guidelines, patients’ rights,

procedures for complaints and for seeking remedies, according to legislation of the Member

State.

National contact point(s) in the Member State of affiliation shall provide patients with

information referred to in Article 6(2).

The information shall be easily accessible, including by electronic means.

CHAPTER III

REIMBURSEMENTOF COSTS OF PLANNED CROSS-BORDER HEALTHCARE

Article 8

General principles for reimbursement of costs

Subject to the provisions of Articles 9 and 10, the Member State of affiliation shall ensure

reimbursement of costs incurred by an insured person who received planned cross-border

healthcare, if the healthcare in question is among the benefits to which the insured person is

entitled in the Member State of affiliation.

It is for the Member State of affiliation to determine, whether at a local, regional or national

level healthcare for which an insured person is entitled to assumption of costs and the level of

assumption of those costs, regardless of where it is provided.

The costs of

planned

cross-border healthcare shall be reimbursed by the Member State of

affiliation up to the level of costs that would have been assumed by the Member State of

affiliation, had this healthcare been provided in its territory without exceeding the actual costs

of healthcare received.

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For the purposes of the provisions of paragraph 3, Member States shall have a mechanism for

calculation of costs of

planned

cross-border healthcare that are to be reimbursed to the

insured person by the statutory social security system. This mechanism shall be based on

objective, non-discriminatory criteria known in advance.

The mechanism shall be applied at

the relevant administrative level in cases where the Member State of affiliation has a

decentralised healthcare system.

The Member State of affiliation may impose on an insured person seeking reimbursement of

costs of

planned

cross-border healthcare the same conditions, criteria of eligibility and

regulatory and administrative formalities, whether set at a local, regional or national level,

including any assessment by a health professional or healthcare administrator, providing

services for the statutory social security system of the Member State of affiliation as it would

impose if this healthcare was provided in its territory, in so far as they are neither

discriminatory nor an obstacle to free movement of persons, services and goods.

This may

include an assessment by a health professional or healthcare administrator providing

services for the social security system of the Member State of affiliation if this is

necessary for determining the individual patient’s entitlement to healthcare. However,

no conditions, criteria of eligibility and regulatory and administrative formalities

imposed according to this paragraph may be discriminatory or constitute an unjustified

obstacle to the free movement of persons, services or goods.

Member States shall ensure that requests regarding of cross-border healthcare are dealt with

objectively and impartially within reasonable maximum time limits set out and made publicly

available in advance by the Member States.

Member States shall ensure that any administrative decisions regarding of cross-border

healthcare are subject to administrative review and also capable of being challenged in

judicial proceedings, which include provision for interim measures.

8. The Member State of affiliation shall not make the reimbursement of costs of

planned

cross-border healthcare subject to prior authorisation with the exception of Article 9.

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For the purposes of reimbursing cross-border healthcare according to this Article, the

Member State of affiliation may exclude healthcare providers that are not, by contract,

accreditation or otherwise, part of the social security system of the Member State of

treatment if:

the provider is not subject to at least the same or equivalent standards and

guidelines on quality and safety, including provisions on supervision, as providers

that are part of the social security system in the Member State of treatment, and

the decision to exclude a healthcare provider according to this paragraph is based

on legitimate concerns over the quality and safety of the healthcare provided by

the healthcare providers in question and does not constitute a means of arbitrary

discrimination.

Article 9

Healthcare that may be subject to prior authorisation

The Member State of affiliation may make the reimbursement of costs of planned cross-

border healthcare subject to prior authorisation, in accordance with the provisions of

this Article and Article 10.

1. For the purposes of reimbursement of costs of cross-border healthcare in accordance with

this Directive, h

Healthcare

that may be subject to prior authorisation shall be limited to

healthcare as defined by the legislation of the Member State of affiliation which

is made

subject to planning in so far as it:

(a)

is made subject to planning in so far as it involves overnight accommodation of the

patient in question for at least one night or

(b)

requires use of highly specialised and cost-intensive medical infrastructure or medical

equipment or

(c)

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

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The Member State of affiliation may make the reimbursement of costs of cross-border

healthcare as defined in paragraph 1 subject to prior authorisation by introducing a system of

prior authorisation.

The system of prior authorisation shall be limited to what is necessary and proportionate and

shall not constitute a means of arbitrary discrimination.

The criteria for refusing prior authorisation to patients shall be limited to what is

necessary and proportionate with regard to overriding reasons in the general interest.

The Member State of affiliation may refuse to grant a prior authorisation for reasons

including, but not limited to the following:

(a)

the patient is not entitled to the treatment in question, in accordance with Article 8

of this Directive;

(b)

if 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 the person concerned;

(c)

if the patient according to a clinical evaluation with reasonable certainty will be

exposed to a safety hazard that cannot be considered to be normal, taking into

account the potential benefit for the patient of the sought cross-border healthcare;

(d)

if the general public with reasonable certainty will be exposed to a substantial

safety hazard as a result of the cross-border healthcare in question;

4. The Member State of affiliation shall make publicly available which

cross-border

healthcare

is subject to prior authorisation as well as all relevant information on the system of prior

authorisation.

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Article 10

Procedures regarding crossborder healthcare requests for granting prior authorisation

The Member State of affiliation shall ensure that administrative procedures regarding the use

of crossborder healthcare and reimbursement of costs of healthcare incurred in another

Member State are based on objective, non-discriminatory criteria which are made publicly

available in advance, and which are necessary and proportionate to the objective to be

achieved.

Any such procedural systems shall be easily accessible and capable of ensuring that

requests are dealt with objectively and impartially within reasonable time limits set out

and made public in advance by the Member States. Urgency and individual

circumstances shall be taken into account when dealing with such requests.

When

dealing with a request for prior authorisation by an insured person, the Member State of

affiliation shall take into account urgency and all the individual circumstances

The Member State of affiliation shall check whether the conditions of Regulation (EC)

No 883/2004 are met. If that is the case, the prior authorisation shall be granted pursuant to

that Regulation unless otherwise requested by the insured person.

Member States shall ensure that administrative decisions regarding the use of cross-

border healthcare and reimbursement of costs of healthcare incurred in another

Member State are subject to administrative review and also capable of being challenged

in judicial proceedings, which include provision for interrim measures.

In any event, the Member State of affiliation may refuse to grant a prior authorisation for

reasons including, but not limited to the following:

(a)

if this healthcare which is among the benefits provided for by the legislation of the

Member State of affiliation and can be provided on its territory within a time-limit

which is medically justifiable, taking into account of the current state of health and the

probable course of the disease of the person concerned;

(b)

if there is a clinical risk for the patient or the population if the patient receives cross-

border healthcare.

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CHAPTER IV

COOPERATION ON HEALTHCARE

Article 11

Mutual assistance and cooperation

Member States shall render such mutual assistance as is necessary for the implementation of

this Directive,

including the exchange of information about standards and guidelines on

quality and safety, including provisions on supervision, in order to facilitate the

implementation of Article 8.7.

Member States shall facilitate cooperation in cross-border healthcare provision at regional and

local level.

Article 12

Recognition of prescriptions issued in another Member State

If a medicinal product or a medical device is authorised to be marketed on their

territory,

Member States shall ensure that prescriptions issued for an authorised medicinal

product or a medical device in another Member State for a named patient can be

executed

used in their territory in compliance with their national legislation in force and that any

restrictions on recognition of individual prescriptions are prohibited unless they:

(a)

are limited to what is necessary and proportionate to safeguard human health and are

non-discriminatory, or

(b)

are based on legitimate and justified doubts about the authenticity, content or

comprehensibility of an individual prescription.

The recognition of prescriptions shall not affect national rules governing dispensing,

including generic substitution.

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In order to facilitate implementation of paragraph 1, the Commission shall adopt:

(a)

before x months prior to the transposition date measures enabling a health professional

to verify the authenticity of the prescription and whether the prescription was issued in

another Member State by a health professional qualified and legally entitled to do so

through developing a list of elements to be included in the prescriptions; and

(b)

guidelines

supporting the Member States in developing the interoperability of

ePrescriptions;

(c)

before x months prior to the transposition date measures to

facilitate

ensure that

medicinal products

or medical devices

prescribed in one Member State and dispensed

in another are correctly identified; and

(d)

measures to facilitate

that the information to patients concerning the product is

comprehensible including specific measures for products not available in all Member

States;

(e)

if appropriate, measures to exclude specific categories of medicinal products

or medical

devices

from the recognition of prescriptions provided for under this article where

necessary in order to safeguard public health.

The measures

and guidelines

referred to in points (a), and(b),

of paragraph 2 shall

be adopted in accordance with the regulatory procedure referred to in Article 16(2). The

measures referred to in point

(e)

of paragraph 2, designed to amend non-essential elements of

this Directive, by supplementing it, shall be adopted in accordance with the regulatory

procedure with scrutiny referred to in Article 16(3).

Paragraph 1 shall not apply to medicinal products subject to special medical prescription as

provided for in Article 71(2) of Directive 2001/83/EC.

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Article 13

European reference networks

The Commission shall support Member States

by facilitating the development of European

reference networks

between healthcare providers and expertise in the Member States.

The networks shall be based on voluntary participation by its members, which shall

participate and contribute to the networks activities according to the legislation of the

Member State where they are established.

The

aim

objective of European reference networks shall be to help to:

(a)

realise the potential of European cooperation regarding highly specialised healthcare for

patients and for healthcare systems from innovations in medical science and health

technologies;

(b)

facilitate access to diagnosis and to high quality and cost-effective healthcare for all

patients with a medical condition requiring a particular concentration of expertise;

(c)

(d)

maximise cost-effective use of resources;

reinforce research, epidemiological surveillance like registries and provide training for

health professionals;

(e)

facilitate mobility of expertise, virtually or physically and to develop, share and spread

information, knowledge and best practice within and outside the networks;

(f)

Member States with an insufficient number of patients with a particular medical

condition or lacking technology or expertise to provide highly specialised services.

Member States are encouraged to facilitate the development of the European reference

networks:

(a)

(b)

by identifying appropriate expertise throughout their national territory;

by fostering the participation of expertise in the European reference networks.

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For the purposes of paragraph 1, the Commission shall adopt guidelines on:

(a)

develop and publish

criteria and conditions that the European reference networks

should fulfil;

(b)

develop and publish

the procedure for establishing, developing and

criteria for

evaluating European reference networks respecting the Member States competences and

rules in regard of the authorisation or recognition of their own expertise

(c)

facilitate the exchange of information and expertise in relation to the establishment

of networks and their evaluation.

The criteria and conditions referred to in paragraph 3 (a) and (b).These

guidelines shall

be adopted in accordance with the procedure referred to in Article 16(2).

Measures adopted according to this Article shall not harmonize any laws or regulations

of the Member States and shall fully respect the responsibilities of the Member States

for the organisation and delivery of health services and medical care.

Article 14

Cooperation on eHealth , including telemedicine

Member States shall,

supported by the Commission,

aim at interoperability of information

and communication technology systems, through in particular

through

specifying the

necessary standards and terminologies for interoperability. applicable whenever a Member

State decides to introduce them.

In order to facilitate cooperation between Member States, the Commission shall, in

accordance with the procedure referred to in Article 16(2) adopt guidelines concerning, in

particular, interoperability of information and communication technology systems.

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Article 15

Cooperation on health technology assessment

The

Community

Commission shall

support and

facilitate cooperation and the exchange of

scientific information among Member States within a network connecting national authorities

or bodies responsible for health technology assessment

designated by the Member States.

The members of the network shall participate and contribute to the network’s activities

according to the legislation of the Member State where they are established.

The objective of the

Community support

network referred to in paragraph 1 shall be:

(a)

to support Member States in their cooperation between

the

national authorities or bodies

referred to in paragraph 1

(b)

and

to support Member States in the provision of objective, reliable, timely, transparent

and transferable scientific information on the short- and long-term effectiveness of

health technologies and enable an effective exchange of this information between

the

national authorities or bodies without interfering in the Member States' competence to

decide on the impact of the cost-benefit analysis for their own healthcare system.

In order to implement paragraph 2, the network on health technology assessment may

receive Community aid. Aid may be given in order to:

(a)

(b)

contribute to the financing of administrative and technical support;

support Member States in developing and sharing methodologies for health

technology assessment and relative effectiveness assessment;

(c)

contribute to the financing of the provision of transferable scientific information to

be used in national reporting and case studies commissioned by the network;

(d)

facilitate cooperation between the network and other relevant institutions and

bodies of the Community;

(e)

facilitate the consultation of stakeholders.

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Member States shall designate the authorities or bodies participating in the network referred to

in paragraph 1 and communicate to the Commission names and contact details of those

authorities or bodies.

Arrangements for granting the aid, the conditions to which it may be subject and its

amount, shall be adopted

For the purposes of paragraph 1 the Commission shall in

accordance with the procedure referred to in Article 16(2). adopt guidelines concerning, in

particular, the exchange of information within the network, including the nature and type of

the information to be exchanged.

Those authorities and bodies in the network designated

as beneficiaries by the participating Member States shall be eligible for Community aid.

The appropriations required for measures provided for in this Article shall be decided

each year as part of the budgetary procedure.

Measures adopted according to this Article shall not harmonize any laws or regulations

of the Member States and shall fully respect the responsibilities of the Member States for

the organisation and delivery of health services and medical care.

CHAPTER V

IMPLEMENTING AND FINAL PROVISIONS

Article 16

Committee

The Commission shall be assisted by a Committee, consisting of representatives of the

Member States and chaired by the Commission representative.

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall

apply, having regard to the provisions of Article 8 of that Decision. The period laid down in

Article 5(6) of Decision 1999/468/EC shall be set at 3 months.

Where reference is made to this paragraph, Article 5a (1) to (4), and Article 7 of Decision

1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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Article 17

Reports

The Commission shall within five years after the date referred to in Article 19, and

subsequently every three years, draw up a report on the operation of this Directive and submit

it to the European Parliament and to the Council.

The report shall in particular include information on patients' flows, financial dimensions of

patients' mobility,

the implementation of Article 8(7)

and on the functioning of the

European reference networks and national contact points. To this end, the Commission shall

conduct assessment of the systems and practices put in place in the Member States, in the

light of the requirements of this Directive and the other Community legislation relating to

patients' mobility.

The Member States shall provide the Commission with all the necessary assistance and

information for carrying out the assessment and preparing the reports.

Article 18

Transposition

Member States shall bring into force the laws, regulations and administrative provisions

necessary to comply with this Directive by … [three years after its entry into force].

They shall forthwith communicate to the Commission the text of those provisions.

When Member States adopt those provisions, they shall contain a reference to this Directive

or be accompanied by such a reference on the occasion of their official publication. Member

States shall determine how such reference is to be made.

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Article 19

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union.

Article 20

Addressees

This Directive is addressed to the Member States.

Done at Brussels, […]

For the European Parliament

The President

[…]

For the Council

The President

[…]

__________________

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