*ulqf;d...brussels, 3 december 2010 interinstitutional file: 2008/0142 (cod) 17348/10 limite san 291...

PUBLIC

Conseil UE

17348/10 JS/ng 1

DG I LIMITE EN

COUNCIL OF

THE EUROPEAN UNION

Brussels, 3 December 2010

Interinstitutional File:

2008/0142 (COD)

17348/10

LIMITE

SAN 291

SOC 824

CODEC 1440

NOTE

from : General Secretariat

to : Working Party on Public Health

No. prev.doc.: 16441/10 SAN 251 SOC 768 CODEC 1281

Subject : Proposal for a Directive on the application of patients' rights in cross-border

healthcare

- Examination of the European Parliament’s second reading draft amendments

In view of the Working Party on Public Health (Attachés level) meeting on 6 December 2010,

delegations will find attached the modified four column table containing the European Parliament

draft second reading amendments.

The new Presidency’s proposals following the technical meeting with the EP on 2 December 2010

are in the third column, in particular for Articles 4 and 9 to 14.

_____________________

17348/10 JS/ng 2

ANNEX DG I LIMITE� EN

ANNEX

STATUS AS OF 2 DECEMBER 2010 (after the Technical meeting on 2 December 2010)

COUNCIL POSITION AT FIRST

READING

EP DRAFT SECOND READING

AMENDMENTS PRESIDENCY PROPOSAL EP POSITION

Chapter I – GENERAL PROVISIONS

Article 1 – Subject matter and scope

Amendment 37

1. This Directive provides rules for

facilitating the access to safe and

high-quality cross-border healthcare

and promotes cooperation on

healthcare between Member States, in

full respect of national competencies

in organising and delivering

healthcare.

1. This Directive provides rules for







healthcare and aims at

complementing the existing

framework on the coordination of

social security systems, Regulation

EC (No) 883/2004, with a view to

application of patients' rights. This

Directive establishes a general

framework for patients' rights

regarding cross-border mobility. In

the

application of this Directive, Member

States shall take into account the

principle of equity.

1. This Directive provides for rules for







healthcare. This Directive also aims

at clarifying the relation with the

existing framework on the

coordination of social security

systems, Regulation EC (No)

883/2004, with a view to application

of patients' rights.

The Council agrees to refer to the

Regulation in this Article but is of the

opinion that the word

“complementing” does not accurately

describe the situation.

OK, if principle of “equity” remains

in Article 4(1).

OK for the Council (outcome of

Coreper on 10/11/2010)

17348/10 JS/ng 3


Amendment 38

Article 1 Paragraph 2

2. This Directive shall apply to the

provision of healthcare to patients,

regardless of how it is organised,

delivered and financed.

2. This Directive shall apply to

provision of cross-border healthcare

to patients, regardless of how it is

organised, delivered and financed.

NOT ACCEPTABLE

OK

3. This Directive shall not apply to:

(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;

Amendment 39


(b) allocation of and access to organs

for the purpose of organ transplants;

(b) organ transplantation;

NOT ACCEPTABLE

OK, if reference to the Directive on

organs is inserted into Article 2.

OK for the Council

(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.

17348/10 JS/ng 4


Amendment 40

Article 1 Paragraph 3, ca (new)

(ca) sales of medicinal products and

medical devices over the Internet.

NOT ACCEPTABLE

OK

4. This Directive shall not affect laws

and regulations in Member States

relating to the organisation and

financing of healthcare in situations

not related to cross-border healthcare.

In particular, nothing in this Directive

obliges a Member State to reimburse

costs of healthcare provided by

healthcare providers established on its

own territory if those providers are

not part of the social security system

or public health system of that

Member State.

Article 2 - Relationship with other Union provisions

This Directive shall apply without

prejudice to:

(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;

17348/10 JS/ng 5


(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,

Council Directive 93/42/EEC of 14

June 1993 concerning medical devices

and Directive 98/79/EC of the

European Parliament and of the

Council of 27 October 1998 on in

vitro diagnostic medical devices;

(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;

(d) Directive 96/71/EC of the


Council of 16 December 1996

concerning the posting of workers in

the framework of the provision of

services;

(e) Directive 2000/31/EC of the


Council of 8 June 2000 on certain

legal aspects of information society

services, in particular electronic

commerce, in the Internal Market;

17348/10 JS/ng 6


(f) Council Directive 2000/43/EC of

29 June 2000 implementing the

principle of equal treatment between

persons irrespective of racial or ethnic

origin;

(g) Directive 2001/20/EC 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;

(h) Directive 2001/83/EC of the


Council of 6 November 2001 on the

Community code relating to medicinal

products for human use;

(i) Directive 2002/98/EC 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;

17348/10 JS/ng 7


(j) Council Regulation (EC) No

859/2003;

(k) Directive 2004/23/EC 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;

(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;

(m) Regulation (EC) No 883/2004 and

Regulation (EC) No 987/2009 of the


Council of 16 september 2009 laying

down the procedure for implementing

Regulation (EC) N° 883/2004 on the

coordination of social security

systems;

(n) Directive 2005/36/EC;

17348/10 JS/ng 8


(o) Regulation (EC) 1082/2006 of the


Council of 5 July 2006 on a European

grouping of territorial cooperation

(EGTC);

(p) Regulation (EC) No 1338/2008 of


Council of 16 December 2008 on

Community statistics on public health

and health and safety at work;

(q) Regulation (EC) No 593/2008 of


Council of 17 June 2008 on the law

applicable to contractual obligations

(Rome I), 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) 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


Council of 7 July 2010 on standards

of quality and safety of human

organs intended for

transplantation.

OK

17348/10 JS/ng 9


Article 3 – Definitions

For the purposes of this Directive, the

following definitions shall apply:

(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;

OK

(b) "insured person" means:

(i) persons, including members of

their families and their survivors, who

are covered by Article 2 of Regulation

(EC) No 883/2004 and who are

insured persons within the meaning of

Article 1 (c) of that Regulation, and

(ii) nationals of a third country who

are covered by Regulation (EC) No

859/2003, or who satisfy the

conditions of the legislation of the

Member State of affiliation for

entitlement to benefits.

17348/10 JS/ng 10


(c) "Member State of affiliation"

means:

(i) for persons referred to in point

(b)(i) the Member State that is

competent to grant to the insured

person a prior authorisation to receive

appropriate treatment outside the

Member State of residence according

to Regulation (EC) No 883/2004 and

Regulation (EC) N 987/2009

(ii) for persons referred to in point

(b)(ii), the Member State that is

competent to grant to the insured

person a prior authorisation to receive

appropriate treatment in another

Member State according to

Regulation (EC) No 859/2003. If no

Member State is competent according

to that Regulation, the Member State

of affiliation shall be the Member

State where the person is insured or

has the rights to sickness benefits

according to the legislation of that

Member State.

17348/10 JS/ng 11


(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;

17348/10 JS/ng 12


(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;

17348/10 JS/ng 13


(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.

17348/10 JS/ng 14


Chapter II – RESPONSIBILITIES OF MEMBER STATES WITH REGARD TO CROSS-BORDER HEALTH CARE

Article 4 – Responsibilities of the Member State of treatment

Amendment 41


1. Cross-border healthcare shall be

provided in accordance with the

legislation of the Member State of

treatment and with standards and

guidelines on quality and safety laid

down by that Member State.

1. The Member States of treatment

shall be responsible for the

organisation and the delivery of

cross-border healthcare, taking into

account principles of universality,

access to good quality care, equity

and solidarity. They shall define

clear quality standards for

healthcare provided on their

territory, and ensure compliance

with existing Union legislation on

safety standards, and that:

(a) cross-border healthcare is

provided in accordance with the


treatment;

(b) cross-border healthcare is

provided in accordance with standards and guidelines on quality

defined by the Member State of

treatment;

(c) cross-border healthcare shall

not lead to patients being

encouraged against their will to

SUBJECT TO THE OUTCOME OF

THE DISCUSSIONS ON QUALITY

AND SAFETY

Point (c) would be covered by Recital

3(a).

POLITICAL

17348/10 JS/ng 15


receive treatment outside of their

Member State of affiliation.

2. The Member State of treatment

shall ensure that:

Amendment 42

Article 4 Paragraph 1 points a-f

(a) patients receive upon request

relevant information on the

standards and guidelines referred to

in paragraph 1, including provisions

on supervision and assessment of

healthcare providers, and

information on which healthcare

providers are subject to these

standards and guidelines;

(a) patients receive from the

national contact point upon request

relevant information on the

standards and guidelines referred to

in point (b) of Paragraph 1,

including provisions on supervision

and assessment of healthcare

providers, and information on which

healthcare providers are subject to

these standards and guidelines and

clear information on costs in

accordance with article 7( 6), on

accessibility for persons with

disabilities as well as on the

healthcare provider's authorisation

or registration status and number,

and any restrictions on their

practice;

(a) patients receive from the national

contact point upon request relevant

information on the standards and

guidelines referred to in point (b) of

Paragraph 1, including provisions on

supervision and assessment of healthcare

providers, and information on which

healthcare providers are subject to these

standards and guidelines and on the

accessibility of hospitals for persons

with disabilities;

Proposal to have a clearer text in the

article itself on the issue of the

accessibility without a recital. The

reference to 7(6) on the mechanism to

calculate what is being reimbursed to

the patient is not appropriate here since

this concerns the obligations of the MS

of treatment and not the MS of

affiliation. Should be taken up in article

5 point (b).

(a) patients receive from the national

contact point upon request relevant

information on the standards and

guidelines referred to in point (b) of

Paragraph 1, including provisions on

supervision and assessment of

healthcare providers, and information

on which healthcare providers are

subject to these standards and

guidelines and clear information on

costs calculations in accordance with

article 7( 6), on accessibility for

persons with disabilities;

+ corresponding Recital

Member States should provide upon

request information on accessibility of

hospitals for persons with disabilities;

17348/10 JS/ng 16


(b) healthcare providers provide

individual patients with relevant

information on the availability,

quality and safety of the healthcare

they provide in the Member State of

treatment, clear invoices and clear

information on prices, 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. 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;

(b) healthcare providers provide all

relevant information to enable

patients to make an informed

choice, including on treatment

option, on the availability, clear

invoices and clear information on

prices, as well as on the healthcare

providers' 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;

(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


information on prices, as well as on the

healthcare providers' 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;

(b) healthcare providers provide all

relevant information to enable

individual patients to make an

informed choice, including on

treatment option, on the availability,

quality and safety of the healthcare they

provide in the Member State of


information on prices, as well as on the

healthcare providers' 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;

(ba) the information referred to in

points (a) and (b) is inter alia

remotely accessible by electronic

means and that such information is

also made available in formats

accessible to persons with disabilities.

NOT ACCEPTABLE

Would be covered by compromise

proposal for Article 6(5).

EP dropped point (ba) as the Council

accepted the new text in Article 6(5)

with the EP addition.

OK for the Council.

17348/10 JS/ng 17


(c) there are complaints procedures

and mechanisms for patients to seek

remedies in accordance with the


treatment if they suffer harm arising

from the healthcare they receive;

(c) there are transparent complaints

procedures and mechanisms in place

for

patients, in order to seek remedies

and compensation in accordance

with the



from

the healthcare they receive;

(c) there are transparent complaints

procedures and mechanisms in place for

patients, in order to seek remedies in

accordance with the



from

the healthcare they receive;

ACCEPTABLE, but without the words

"and compensation".

OK

(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;

(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;

(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;

17348/10 JS/ng 18


(f) 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.

(f) patients who have received

treatment

are entitled to a written or electronic

medical record of such treatment,

and of any medical advice for the

continuity of their care, and access

to at least a copy of

this record in conformity with and

subject to national measures




2002/58/EC, without prejudice to

the exceptions applicable in the

Member States.

(f) for the continuity of the 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

Directive 95/46/EC and 2002/58/EC.

OK

3. The principle of non-

discrimination with regard to

nationality shall be applied to

patients from other Member States.

17348/10 JS/ng 19


Amendment 43

Article 4 Paragraph 3 Sub-Paragraph 2

This shall be without prejudice to

the possibility for the Member State

of treatment, where it is justified by

overriding reasons of general

interest, to adopt measures

regarding access to treatment aimed

at fulfilling its fundamental

responsibility to ensure sufficient

and permanent access to healthcare

within its territory. Such measures

shall be limited to what is necessary

and proportionate and may not

constitute a means of arbitrary

discrimination.

This shall be without prejudice to

the possibility for the Member State

of treatment to adopt measures

regarding access to treatment aimed

at fulfilling its fundamental

responsibility to ensure sufficient

and permanent access to healthcare

within its territory. Such measures

shall be justified and limited to what

is necessary and proportionate and

may not constitute a means of

arbitrary discrimination or an

obstacle to the free movement of

patients, services or goods such as

medicinal products and medical

devices, and shall be made publicly

available in advance.

This shall be without prejudice to the

possibility for the Member State of

treatment, where it is justified by

overriding reasons of general interest,

to adopt measures regarding access to

treatment aimed at fulfilling its

fundamental responsibility to ensure

sufficient and permanent access to

healthcare within its territory. Such

measures shall be limited to what is

necessary and proportionate and may not

constitute a means of arbitrary

discrimination and shall be made

publicly available in advance.

No agreement yet. If Coreper would

decide on a specific formulation in

article 7, paragraph 9, this could

possibly be applied throughout the text.

This shall be without prejudice to the

possibility for the Member State of

treatment to adopt measures regarding

access to treatment, where these

measures are justified by justified by planning requirements 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, so far as possible, any

waste of financial, technical and

human resources. Such measures shall

be limited to what is necessary and

proportionate and may not constitute a

means of arbitrary discrimination and

shall be made publicly available in

advance.

(aligned to new wording on art 7.7

ECJ 5.10.10)

17348/10 JS/ng 20


Amendment 44

Article 4 Paragraph 3 Sub-Paragraph 2a (new)

However, this Directive shall not

oblige healthcare providers in a

Member State either to provide

healthcare to an insured person

from another Member State or to

prioritise the provision of

healthcare to an insured person

from another Member State to the

detriment of a person who has

similar health needs and is an

insured person of the Member State

of treatment;

NOT ACCEPTABLE

A Directive can not create obligations

on healthcare providers as it is always

addressed to the Member States.

However, the phrase could be put in a

recital. This is what the Council did in

its recital 19.

Could be OK for accepting only a

recital under POLITICAL POINT

(Related to quality and safety)

Amendment 45

Article 4 Paragraph 4 Sub-Paragraph 1

4. Member States shall ensure that

the healthcare providers on their

territory apply the same scale of fees

for healthcare for patients from other

Member States, as for domestic

patients in a comparable situation, or

that they charge a price calculated

according to objective, non

discriminatory criteria if there is no

comparable price for domestic

patients.

4. The Member State of treatment

shall ensure that the healthcare

providers on its territory apply the

same scale of fees for healthcare for

patients from other Member States,

as for domestic patients in a

comparable situation, whatever the

socioeconomic position of the

patient.

4. Member States shall ensure that the

healthcare providers on their territory

apply the same scale of fees for

healthcare for patients from other

Member States, as for domestic patients

in a comparable medical situation, or

that they charge a price calculated

according to objective, non

discriminatory criteria if there is no

comparable price for domestic patients.

OK

17348/10 JS/ng 21


This paragraph shall be without

prejudice to national legislation

which allows healthcare providers to

set their own prices, provided that

they do not discriminate against

patients from other Member States.

This paragraph shall be without

prejudice to national legislation

which allows healthcare providers to

set their own prices, provided that

they do not discriminate

against patients from other Member

States.

Amendment 46


5. This Directive shall not affect

laws and regulations in Member

States on the use of languages, nor

shall it imply any obligation to deliver information in other

languages than those which are

official languages in the Member

State concerned.

5. This Directive shall not affect

laws and regulations in Member

States on the use of languages. The

Member State of treatment may

deliver information in other

languages than those which are

official languages in the Member

State concerned.

5. This Directive shall not affect laws

and regulations in Member States on the

use of languages. Member States may

choose to deliver information in other

languages than those which are official

languages in the Member State

concerned.

OK

Amendment 47

Article 4 Paragraph 5a (new)

5a. In so far as it is necessary to

facilitate the provision of cross-

border healthcare and taking as a

basis a high level of protection of

health, the Commission, in

cooperation with the Member

States, may develop guidelines to

facilitate the implementation of

paragraph 1.


THE DISCUSSIONS ON QUALITY

AND SAFETY

POLITICAL cf new proposal on article

10(1)

17348/10 JS/ng 22


Article 5 – Responsibilities of the Member State of affiliation

The Member State of affiliation

shall ensure that:

(a) the cost of cross-border

healthcare is reimbursed in

accordance with Chapter III;

Amendment 48

Article 5 Points b-c

(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

procedures for accessing and

determining those entitlements,

conditions for reimbursement of

costs and systems of appeal and

redress if the patients considers that

their rights have not been respected;

(b) there are easily accessible

mechanisms in place to provide

patients on request with information,

inter alia remotely accessible by

electronic means, on their rights and





determining those entitlements,

conditions for reimbursement of

costs and systems of appeal and

redress if the patients considers that

their rights have not been respected

and the terms and conditions that

would apply, inter alia whenever

harm is caused as a result of

healthcare received in another

Member State. This information

shall be published in formats

accessible to persons with

disabilities. Member States shall

consult stakeholders, including

(b) there are mechanisms in place to

provide patients on request with

information on their rights and





determining those entitlements, the

terms and conditions for reimbursement

of costs, in accordance with Art. 7(6),

and for appeal and redress if the

patients considers that their rights have

not been respected.

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.

This addition would replace the

reference to “clear information on costs

in accordance with article 7(6) as

proposed initially by the EP in

OK

17348/10 JS/ng 23


patients' organizations, to ensure

information is clear and accessible.

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.

amendment 42.

(ba) in the event of complications

resulting from healthcare provided

abroad or if a particular medical

follow up proves necessary, it

guarantees to provide healthcare

equivalent to that received on its

territory;

(ba) where a patient has received

cross-border healthcare and where

medical follow-up proves necessary,

the same medical follow-up is

available as if this healthcare had been

provided on its territory;

OK

(c) patients who seek to receive or

do receive cross-border healthcare

have access to at least a copy of their

medical records, in conformity with,

and subject to, national measures




2002/58/EC.

(c) patients who seek to receive or

do receive cross-border healthcare

have access to at least a copy of their

medical records, in conformity with,

and subject to, national measures




2002/58/EC.

If the medical records are held in

electronic form, patients shall have

a guaranteed right to obtain a copy

of, or a right of remote access to,

(c) 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


protection of personal data, in particular

Directives 95/46/EC and 2002/58/EC.

OK

17348/10 JS/ng 24


those records. Data shall be

transmitted only with the express

written consent of the patient or the

patient's relatives.

Article 6 – National contact points for cross-border healthcare

Amendment 49


1. 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.

1. 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. Member States shall

ensure that independent patient

organisations, sickness funds and

healthcare providers are

encompassed by national contact

points. The national contact points

shall be established in an efficient

and transparent way.

Information about the existence of

the national contact points shall be

disseminated across Member States,

so that patients have easy access to

the information.

1. 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. The

Commission and the Member States

shall make this information publicly

available. Member States shall ensure

that the national contact points consult

with patient organisations, healthcare

providers and healthcare insurers.

The word "encompass" could entail that

healthcare providers and patient

organizations are part of the national

contact points, which is not the intended

objective.

OK

17348/10 JS/ng 25


Amendment 50


2. National contact points shall

cooperate with each other and with

the Commission. National contact

points shall provide patients on

request with contact details of

national contact points in other

Member States.

2. National contact points shall

facilitate the exchange of

information referred to in

paragraph 3 and cooperate closely

with each other and with the

Commission.

National contact points shall provide

patients on request with contact

details of national contact points in

other Member States.

ACCEPTABLE OK

Amendment 51


3. National contact points in the

Member State of treatment shall

provide patients with information

concerning healthcare providers,

including on request information on

a specific provider’s right to provide

services or any restrictions on its

practice, information referred to in

Article 4(2)(a), as well as

information on patients’ rights,

complaints procedures and

mechanisms for seeking remedies,


Member State.


Member State of treatment shall

support patients to protect their

rights by providing them with

information, inter alia remotely

accessible

by electronic means, concerning

healthcare providers, including on

request information on a specific

provider's right to provide services

or any restrictions on its practice,

information referred to in Article

4(2)(a), and on the protection of

personal data, the level of

accessibility to healthcare facilities

3. To enable patients to make use of

their rights in cross-border healthcare,

national contact points in the Member

State of treatment shall provide them

with information concerning healthcare

providers, including on request

information on a specific provider's right

to provide services or any restrictions on

its practice, information referred to in

Article 4(2)(a) as well as information on

patients' rights, complaints procedures

and mechanisms for seeking remedies,


Member State, as well as the legal and

administrative options available to settle

OK

17348/10 JS/ng 26


for people with disabilities, as well

as information on patients' rights,

complaints procedures and

mechanisms for seeking remedies,


Member State, as well as the

options available to settle any

dispute, and to identify the

appropriate out-of court

settlement scheme for the specific

case, including in the event of harm

arising from cross-border

healthcare.

disputes, including in the event of harm

arising from cross-border healthcare.

Amendment 52



Member State of affiliation shall

provide patients with the

information referred to in Article

5(b).



provide patients and healthcare

professionals with the information

referred to in Article 5(b).

ACCEPTABLE

OK

17348/10 JS/ng 27


Amendment 53


5. The information referred to in this

Article shall be easily accessible,

including by electronic means.

5. The information referred to in this

Article shall be in formats easily

accessible for people with

disabilities.

The information referred to in this

Article shall be easily accessible and be

made available by electronic means

and in formats accessible to people

with disabilities, as appropriate.

The new wording proposed to meet the

EP concern on Article 4(1), point

(ba)(new) in AM 42.

OK

Chapter III – REIMBURSEMENT OF COSTS OF CROSS-BORDER HEALTHCARE

Article 7 – General principles for reimbursement of costs

Amendment 54


1. Subject to the provisions of

Articles 8 and 9, the Member State

of affiliation shall ensure the costs

incurred by an insured person who

receives cross-border healthcare are

reimbursed, if the healthcare in

question is among the benefits to

which the insured person is entitled

in the Member State of affiliation.







question is among the benefits

provided for by the legislation, or

administrative regulations or

guidelines or codes of conduct of

the medical professions, to which

the insured person is entitled in the

Member State of affiliation or is

equally effective to healthcare that

is among those benefits. Member


THE DISCUSSION ON PRIOR

AUTHORISATION (ARTICLES 7

AND 8)

POLITICAL

17348/10 JS/ng 28


States may choose to only

reimburse such methods of

treatment that are sufficiently tried

and tested by international medical

science.

Without prejudice to Regulation

(EC) No 883/2004, the Member

State of affiliation shall reimburse

the costs to the Member State of

treatment or the insured person

which would have been paid for by

its statutory social security system

had equally effective healthcare

been provided in its territory. If a

Member State of affiliation rejects

the reimbursement of this

treatment, that Member State shall

have to give a medical justification

for its decision. In any event, it is

for the Member State of affiliation

to determine the healthcare that is

paid for regardless of where it is

provided.




AND 8)

Without prejudice to Regulation

(EC) No 883/2004, on the basis of a

prior objective clinical examination

subject to article 9 paragraph 3,

patients affected or suspected to be

affected by rare diseases shall have

the right to access healthcare in

another Member State and to

receive reimbursement even if the




AND 8)

17348/10 JS/ng 29


diagnosis and/or treatment in

question is not among the benefits

provided for by the legislation, or

administrative regulations,

or guidelines or codes of conduct of

the medical professions, of the

Member State of affiliation. Such

treatment shall be subject to prior

authorisation.

Amendment 55

Article 7 paragraph 1a (new)

1 a. Any costs incurred by the

insured person over and above the

level reimbursed by the Member

State of affiliation shall be borne

solely by the insured person, unless

the Member State of affiliation

decides also to reimburse the

insured person for the costs

incurred in excess of that level.




AND 8)

17348/10 JS/ng 30








question is among the benefits to

which the insured person is entitled

in the Member State of affiliation.

2. By way of derogation from

paragraph 1:

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

17348/10 JS/ng 31


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) N 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 Treaty.

3. It is for the Member State of

affiliation to determine, whether at a

local, regional or national level, the

healthcare for which an insured

person is entitled to assumption of

costs and the level of assumption of

those costs, regardless of where the

healthcare is provided.

17348/10 JS/ng 32


Amendment 56


4. The costs of 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.

4. The costs of cross-border

healthcare shall be reimbursed or

paid directly by the Member State of

affiliation in accordance with the

provisions of this Directive 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.

Member States may decide to cover

other related costs, such as

therapeutic treatment and

accommodation and travel costs.

The extra costs which persons with

disabilities might incur when

receiving cross-border healthcare

due to one or more disabilities shall

be reimbursed by the Member State

of affiliation in accordance with

national legislation and on the

condition that sufficient

documentation setting out these

costs exists.




AND 8)

17348/10 JS/ng 33


5. Member States may adopt

provisions in accordance with the

Treaty aimed at ensuring that

patients enjoy the same rights when

receiving cross-border healthcare as

they would have enjoyed if they had

received healthcare in a comparable

situation in the Member State of

affiliation.

Amendment 57


6. For the purposes of paragraph 4,

Member States shall have a

mechanism for calculation of costs

of cross-border healthcare that are

to be reimbursed to the insured

person by the Member State of

affiliation. 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.

6. For the purposes of this Article,

Member States shall have a

transparent mechanism for the

calculation of costs of cross-border

healthcare. This mechanism shall be



advance. The mechanism shall be



advance and applied at the relevant

(local, regional or national)

administrative level.




AND 8)

17348/10 JS/ng 34


Amendment 58


7. The Member State of affiliation

may impose on an insured person

seeking reimbursement of the costs

of cross-border healthcare, including

healthcare received through means

of telemedicine, the same

conditions, criteria of eligibility and


formalities, whether set at a local,

regional or national level, as it

would impose if this healthcare were

provided in its territory. 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. 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 goods, persons, or


may impose on a patient seeking

cross-border healthcare provided in

another Member State, the same

conditions, criteria of eligibility and


formalities, whether set at a local,

national or regional level, for

receiving healthcare and

reimbursement of healthcare costs as it would impose if that healthcare

was provided in its territory. This

may include an assessment by a

health professional or healthcare

administrators 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. However, no conditions,

criteria of eligibility and regulatory

and administrative formalities

imposed according to this paragraph

may be discriminatory or constitute

an obstacle to the free movement of

patients or goods, such as




AND 8)

17348/10 JS/ng 35


services.

medicinal products and medical

devices, and such conditions,

criteria and formalities shall be

made publicly available in advance.


shall not make the reimbursement of

costs of cross-border healthcare

subject to prior authorisation, except

in the cases set out in Article 8.

Amendment 59



may limit the application of the rules

on reimbursement for cross-border

healthcare according to this Article:

a) based on overriding reasons of

general interest such as the risk of

seriously undermining the financial

balance of a social security system,

or the objective of maintaining a

balanced hospital service open to all,

and

b) to providers that are affiliated to a

system of professional liability

insurance, a guarantee or a similar

arrangement as established by the

Member State of treatment

according to Article 4(2)(d).

deleted




AND 8)

17348/10 JS/ng 36


Amendment 60


10. The decision to limit the

application of this Article pursuant

to paragraph 9(a) and (b) shall be

restricted to what is necessary and

proportionate and may not constitute

a means of arbitrary discrimination

or an unjustified obstacle to the free

movement of goods, persons, or

services. Member States shall notify

the Commission of any decisions to

limit reimbursement on the grounds

stated in paragraph 9(a).

deleted SUBJECT TO THE OUTCOME OF



AND 8)

Amendment 61

Article 7 Point a (New)

Article 7a (New) - Prior notification

Member States may offer patients a

voluntary system of prior

notification whereby, in return for

such notification, the patient shall

receive a written confirmation of

the maximum amount that will be

paid. On presentation of that

written confirmation by the patient

at the hospital of treatment,

reimbursement

shall be made directly to that

hospital by the Member State of

affiliation.




AND 8)

To be seen in line with article 9.

17348/10 JS/ng 37


Article 8 – Healthcare that may be subject to prior authorisation

Amendment 62



may make the reimbursement of

costs of cross-border healthcare

subject to prior authorisation, in

accordance with this Article

and Article 9.

deleted


THE DISCUSSION PRIOR


AND 8)

POLITICAL

Amendment 63

Article 8, Paragraph 2

2. Healthcare that may be subject to

prior authorisation shall be limited

to healthcare which:

(a) is made subject to planning in so

far as it involves overnight hospital

accommodation of the patient in

question for at least one night;

(b) is made subject to planning in so

far as it requires the 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

2. Healthcare that may be subject to

prior authorisation shall be set out

in a list, by the Member State of

affiliation, to be transmitted to the

Commission. It shall be limited to

healthcare which:

(a) is made subject to planning in so

far as it involves overnight

hospital accommodation of the

patient in question for at least one

night;

(b) is made subject to planning in so

far as it requires use of highly

specialised and cost-intensive

medical infrastructure or medical

equipment; or




AND 8)

17348/10 JS/ng 38


population or which could raise

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.

(c) involves treatments presenting a

particular risk for the patient or the

population;

Amendment 64


2a. The Member State of affiliation

may provide for a system of prior

authorisation for reimbursement by

its social security system of the cost

of hospital care provided in another

Member State where the following

conditions are met:

(a) had the healthcare been

provided on its territory, it would

have been assumed by the Member

State's social security system; and

(b) the absence of prior

authorisation could seriously

undermine or be likely to

undermine:

(i) the financial balance of the

Member State's social security

system; and/or

(ii) the planning and rationalisation

carried out in the hospital sector to

avoid hospital overcapacity,




AND 8)

17348/10 JS/ng 39


imbalance in the supply of hospital

care and logistical and financial

wastage, the maintenance of a

balanced medical and hospital

service open to all, or the

maintenance of treatment capacity

or medical competence on the

territory of the concerned Member

State.

Amendment 65


3. The system of prior authorisation,

including the criteria for refusing

prior authorisation to patients, shall

be limited to what is necessary and

proportionate and may not constitute

a means of arbitrary discrimination.

3. The system of prior authorisation

shall apply without prejudice to

Regulation (EC) No 883/2004 and

shall be limited to what is necessary

and proportionate may not constitute

a means of arbitrary discrimination

or an obstacle to freedom of

movement of patients, services or

goods, such as medicinal products

and medical devices. Member

States shall notify the Commission

of any decisions to limit

reimbursement on justified grounds

as stated in this Article.




AND 8)

17348/10 JS/ng 40


Amendment 66


4. When a patient applies for prior

authorisation, the Member State of

affiliation shall check whether the

conditions of Regulation (EC) No

883/2004 are met. Where those

conditions are met the prior

authorisation shall be granted

pursuant to that Regulation unless

the patient requests otherwise.

4. With regard to any request for

authorisation made by an insured

person with a view to receiving

cross-border healthcare, the


ascertain whether the conditions

laid down in Regulation (EC) No

883/2004 have been met. Where

those conditions are met, the prior

authorisation shall be granted

pursuant to that Regulation.




AND 8)

Amendment 67



may refuse to grant prior

authorisation for reasons including,

but not limited to, the following:

(a) if the patient is not entitled to the

healthcare in question, in accordance

with Article 7;

(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

5. Without prejudice to paragraph

3, the Member State of affiliation

may refuse to grant prior

authorisation only for the following

reasons:

(a) the patient is not entitled to the

healthcare in question, in accordance

with Article 7;




AND 8)

17348/10 JS/ng 41


person concerned;

(c) if 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;

(d) if 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) if 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;

(c) if the general public will be

exposed with reasonable certainty to

a substantial safety hazard as a result

of the cross-border healthcare in

question;

Amendment 68

Article 8 Paragraph 5e

(e) if this healthcare is to be

provided by healthcare providers

that raise 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.

(e) if the healthcare provider in

question is not authorised,

registered, licensed, certified or

accredited, to provide or perform

the care or treatment for which the

authorisation has been sought,

according to the standards and

guidelines laid down by laws and

regulations or through accreditation

systems established by the Member

State of treatment.




AND 8)

17348/10 JS/ng 42


Amendment 69

Article 5a (new)

5a. Prior authorisation application

systems must be made available at a

local/regional level and must be

accessible and transparent to

patients. The rules for application

and refusal of prior authorisation

must be available in advance of an

application so that the application

can be made in a fair and

transparent way.


NEEDS TO BE CLEANED

TOGETHER WITH ARTICLE 9

TO BE DISCUSSED AT THE

TECHNICAL MEETING ON 8

DECEMBER

Amendment 70



shall make publicly available which

healthcare is subject to prior

authorisation for the purposes of this

Directive, as well as all relevant

information on the system of prior

authorisation.


shall make publicly available which

healthcare is subject to prior

authorisation, for the purposes of

this Directive, as well as all relevant

information on the system of prior

authorisation including appeal

procedures in the event of a refusal

to give authorisation.

NEEDS TO BE CLEANED




DECEMBER

17348/10 JS/ng 43


Amendment 71

Article 8, Paragraph 6a (new)

6a. Patients seeking to receive

healthcare provided in another

Member State shall be guaranteed

the right to apply for prior

authorisation in the Member State

of affiliation, inter alia by

electronic means where

appropriate;

NEEDS TO BE CLEANED




DECEMBER

Article 9 – Administrative procedures regarding cross-border healthcare


shall ensure that administrative

procedures regarding the use of


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.

17348/10 JS/ng 44


Amendment 72

Article 9 Paragraph 1a New

1a. Member States shall organize,

in all cases where and when

appropriate, transfer of funds of

corresponding costs of cross border

healthcare directly between the

competent institutions.

NOT ACCEPTABLE

Would fall if there is an agreement on

the new proposal on article 7a at Coreper

level.

To be seen in line with the 2nd part of

article 7a new (move prior notification

to article 9).

Amendment 73

Article 9 Paragraph 1b (new)

(1b). In the other cases, the


ensure that patients will receive

reimbursement without undue

delay.

(1b) The Member States of affiliation

shall ensure that patients receive

reimbursement without undue delay.

(1b) In the other cases, the Member

States of affiliation shall ensure that

patients receive reimbursement without

undue delay.

To be read in line with article 9(1a)

(new).


shall ensure that administrative

procedures regarding the use of




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.

17348/10 JS/ng 45


2. Any procedure referred to in

paragraph 1 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 each

Member State. Urgency and

individual circumstances shall be

taken into account when dealing

with such requests.


paragraph 1 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 each Member

State. Urgency and individual

circumstances shall be taken into

account when dealing with such

requests.


paragraph 1 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 each Member State.

Urgency and individual circumstances

shall be taken into account when

dealing with such requests.

Amendment 74


2a. Member States shall, when

setting out the time limits within

which requests for cross-border

healthcare must be dealt with and,

when considering these requests ,

take into account:

(a) the specific medical condition,

(b) individual circumstances,

(c) the patient's degree of pain,

(d) the nature of the patient's

disability, and

(e) the patient's ability to carry out

a professional activity.

2a. Member States shall, when setting

out the time limits within which

requests for cross-border healthcare

must be dealt with and, when

considering these requests , take into

account:


(b )urgency and individual

circumstances,

Time limits are made public in advance

by each Member state;

2a. Member States shall, when setting

out the time limits within which

requests for cross-border healthcare

must be dealt with and, when

considering these requests , take into

account:


(b )urgency and individual

circumstances,

Time limits are made public in advance

by each Member state;

17348/10 JS/ng 46


Amendment 75



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 are

capable of being challenged in

judicial proceedings, which include

provision for interim measures.


any administrative or medical

decisions regarding the use of cross-

border healthcare and



are subject, on a case-by-case basis,

to an appeal procedure, to an

additional medical opinion or an

administrative review and are

capable of being challenged in

judicial proceedings, which include

provision for interim measures.


administrative or medical decisions

regarding the use of cross-border

healthcare and reimbursement of costs of

healthcare incurred in another Member

State are subject to a review and are

capable of being challenged in judicial

proceedings, which include provision for

interim measures.

3. Member States shall ensure that any

administrative or medical decisions

regarding the use of cross-border

healthcare and reimbursement of costs

of healthcare incurred in another

Member State are subject, on a case-by-

case basis, to a review , to an

additional medical opinion or an

administrative review and are capable

of being challenged in judicial

proceedings, which include provision

for interim measures, in accordance

with the national legislation.

Chapter IV – COOPERATION IN HEALTHCARE

Article 10 – Mutual assistance and cooperation

Amendment 76


1. 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 7(9), and


mutual assistance as is necessary for

the implementation of this Directive,

including the exchange of

information, especially between

their national contact points in

accordance with Article 4, 5 and 6

and about standards and guidelines

on quality and safety, including

Coreper 24 November:


mutual assistance as is necessary for the

implementation of this Directive,

including cooperation on standards

and guidelines on quality and safety

and the exchange of information,

especially between their national contact

points in accordance with Article 6,

including on provisions on supervision,

POLITICAL to be read with art 4. 5a

17348/10 JS/ng 47


including mutual assistance to

clarify the content of invoices.

provisions on supervision, in order

to facilitate the implementation of

Article 7(9), and including mutual

assistance to clarify the content of

invoices.

in order to facilitate the implementation

of Article 7(9)*, and including mutual

assistance to clarify the content of

invoices.

* Reference should be deleted as a

result of deletion of para. (b) of Article

7(9).

Amendment 77


2. Member States shall facilitate

cooperation in cross-border

healthcare provision at regional and

local level.


cooperation in cross-border


local level as well as through

information and communication

technologies and other forms of

cross-border cooperation.


cooperation in cross-border healthcare

provision at regional and local level as

well as through information and

communication technologies and other

forms of cross-border cooperation

Keep EP amendment.

ACCEPTABLE for the Council

Amendment 78


2a. The Commission shall

encourage Member States,

particularly neighbouring

countries, to conclude agreements

among themselves and to develop

joint action programmes.

The Commission shall also

encourage the Member States to

cooperate to create areas in which

patients will have improved access

to health care, particularly in cross-

border areas.

2a. The Commission shall encourage

Member States, particularly

neighbouring countries, to conclude

agreements among themselves. The Commission shall also encourage

the Member States to in cross-border

healthcare provision in border regions.

(46) The Commission should encourage

2a. The Commission shall encourage

Member States, particularly

neighbouring countries, to conclude

agreements among themselves and to develop joint action programmes. The Commission shall also encourage

the Member States to cooperate to

create areas in which patients will

have improved access to health care,

particularly in cross-border areas.

+ Corresponding recital drafted by the

EC

(46) The Commission should encourage

17348/10 JS/ng 48


cooperation between the Member States in the

areas set out in Chapter IV of this Directive

and may, in accordance with Article 168.2

Treaty on the functioning of the European

Union, 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


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.

cooperation between the Member States in the

areas set out in Chapter IV of this Directive

and may, in accordance with Article 168.2

Treaty on the functioning of the European

Union, 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 cross-border areas, and by

making recommendations and

disseminating information and best

practices on how to overcome such

obstacles.

Amendment 79

Article 10 Paragraph 2b (new)

2b. Member States shall guarantee

that registers in which health

professionals are listed are

available to relevant authorities of

other Member States.

2b. The Member States of treatment

shall ensure that information on the

right to practice of health professionals

contained in national or local registers

established on its territory is, upon

request, made available to the

authorities of other Member States, for

the purpose of cross-border healthcare,

in accordance with chapters II and III

and with national measures


protection of personal data, in


2b. The Member States of treatment

shall ensure that information on the

right to practice of health professionals

contained in national or local registers

established on its territory is, upon


authorities of other Member States, for

the purpose of cross-border healthcare,

in accordance with chapters II and III

and with national measures


protection of personal data, in


17348/10 JS/ng 49


2002/58/EC, and the principle of

presumption of innocence. The

exchange of information shall take

place via Internal Market Information

system established pursuant to the

Decision 2008/49/EC of the

Commission of 12 December 2007

concerning the implementation of the

Internal Market Information System

(IMI) as regards the protection of

personal data.

2002/58/EC, and the principle of

presumption of innocence. The

exchange of information shall take

place via Internal Market Information

system established pursuant to the

Decision 2008/49/EC of the

Commission of 12 December 2007

concerning the implementation of the

Internal Market Information System

(IMI) as regards the protection of

personal data. This provision is applied

without prejudice to Directive

2005/36/EC.

Presidency comment: See text proposal

in the third column.

(Directive 2005/36/EC is already

covered by Article 2(n))

Recital corresponding to new EP proposal for AM 79

Member State of affiliation may need

to receive confirmation that the cross-

border health care will or has been

delivered by a legally practicing health

professional. It is therefore appropriate

to ensure that information on the right

to practice 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 States of affiliation.

Member State of affiliation may need

to receive confirmation that the cross-

border care will or has been delivered

by a legally practicing health

professional. It is therefore

appropriate to ensure that information

on the right to practice contained in

the national or local registers of health

professionals, if established in the

Member State of treatment, are, upon


authorities of the Member States of

affiliation.

ACCEPTABLE for the Council.

17348/10 JS/ng 50


Amendment 80

Article 10 Paragraph 2c (new)

2c. Member States shall

immediately and proactively

exchange information about

disciplinary and criminal findings

against health professionals where

they impact upon their registration

or their right to provide services.

SEE EP PROPOSAL ON AM 79.

OK. Covered by art 10(2) (b) +

corresponding recital

Article 11 – Recognition of prescriptions issued in another Member State

Amendment 81

Article 11 Paragraph 1 - Introductory part

1. If a medicinal product is

authorised to be marketed on their

territory, Member States shall ensure

that prescriptions issued for such a

product in another Member State for

a named patient can be dispensed on

their territory in compliance with

their national legislation in force,

and that any restrictions on

recognition of individual

prescriptions are prohibited unless

such restrictions are:

(a) limited to what is necessary and

proportionate to safeguard

1. If a medicinal product is

authorised to be marketed on their

territory in accordance with Article

6(1) of Directive 2001/83/EC,

Member States shall ensure that

prescriptions issued for such a

product in another Member State for

a named patient can be dispensed on

their territory in compliance with

their national legislation in force,

and that any restrictions on

recognition of individual

prescriptions are prohibited unless

such restrictions are:


proportionate to safeguard

1. If a medicinal product is authorised to

be marketed on their territory in

accordance with Directive 2001/83/EC or Regulation (EC) 726/2004, Member

States shall ensure that prescriptions

issued for such a product in another

Member State for a named patient can be

dispensed on their territory in

compliance with their national

legislation in force, and that any

restrictions on recognition of individual

prescriptions are prohibited unless such

restrictions are:


1. If a medicinal product is authorised to

be marketed on their territory in

accordance with Article 6(1) of

Directive 2001/83/EC or Regulation

(EC) 726/2004, Member States shall

ensure that prescriptions issued for such

a product in another Member State for a

named patient can be dispensed on their

territory in compliance with their

national legislation in force, and that

any restrictions on recognition of

individual prescriptions are prohibited

unless such restrictions are:


17348/10 JS/ng 51


human health, and

non-discriminatory, or

(b) based on legitimate and justified

doubts about the authenticity,

content or comprehensibility of

an individual prescription.

human health, and

non-discriminatory, or



content or comprehensibility of

an individual prescription.

proportionate to safeguard human

health, and non-discriminatory, or



content or comprehensibility of an

individual prescription.

proportionate to safeguard human

health, and non-discriminatory, or



content or comprehensibility of an

individual prescription.


Amendment 82

Article 11 Paragraph 1 Sub-Paragraph 2 and 3

The recognition of prescriptions

shall not affect national rules

governing dispensing, if those rules

are compatible with Union law, and

shall not affect rules governing generic or other substitution. The

recognition of prescriptions shall not

affect the rules on reimbursement of

medicinal products. Reimbursement

of costs of medicinal products is

covered by Chapter III of this

Directive.

The recognition of such prescription

shall not affect national rules

governing prescribing and

dispensing, including generic or

other substitution. The recognition

of prescriptions shall not affect the

rules on reimbursement of medicinal

products. Reimbursement of costs of

cross-border prescriptions of

medicinal products. Reimbursement

of costs of medicinal products is

covered by Chapter III of this

Directive.


shall not affect national rules governing

prescribing and dispensing, if those

rules are compatible with Union law,

including generic or other substitution.

The recognition of prescriptions shall

not affect the rules on reimbursement of

medicinal products. Reimbursement of

costs of medicinal products is covered

by Chapter III of this Directive.


shall not affect national rules governing

prescribing and dispensing, if those

rules are compatible with Union law,

including generic or other substitution.

The recognition of prescriptions shall

not affect the rules on reimbursement of

medicinal products. Reimbursement of

costs of cross-border prescriptions of

medicinal products is covered by

Chapter III of this Directive.


17348/10 JS/ng 52


The recognition of prescription

shall not affect any professional or

ethical duty that would require the

pharmacist to refuse to dispense

had the prescription been issued in

the Member State of affiliation.

In particular, the recognition of

prescription shall not affect any

national rules recognising for ethical

reasons the right of the pharmacist to

refuse to dispense, had the prescription

been issued in the Member State of

affiliation, if compatible with the

Union's law.

The recognition of prescription shall

not affect any national rules

recognising for ethical reasons the

right of the pharmacist to refuse to

dispense, had the prescription been

issued in the Member State of

affiliation, if compatible with the

Union's law.

This paragraph shall also apply to

medical devices that are legally

placed on the market in the

respective Member State.

This paragraph shall also apply to

medical devices that are legally

placed on the market in the

respective Member State.

These paragraphs shall also apply to

medical devices that are legally placed

on the market in the respective Member

State.

These paragraphs shall also apply to

medical devices that are legally placed

on the market in the respective Member

State.


Amendment 83


2. In order to facilitate

implementation of paragraph 1, the

Commission shall adopt:

(a) no later than …; 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

2. In order to facilitate the


Commission shall adopt no later

than …:

(a) measures enabling a pharmacist

or other health professional to

verify the authenticity of the

prescription and whether the

prescription was issued in another

Member State by a member of a



developing a EU prescription cross-




(a) measures enabling to verify the

authenticity of the prescription and

whether the prescription was issued in

another Member State by a member of a



developing a non-exhaustive list of

elements to be included in the

prescriptions, including elements to




(a) measures enabling a pharmacist or

other health professional to verify the






developing a EU prescription cross-

border template including a non-

17348/10 JS/ng 53


elements to be included in the

prescriptions;

border template, and supporting

interoperability of ePrescriptions;

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.







developing [a model] [a format] based

on a non-exhaustive list of [clearly

identifiable] elements to be included in

the prescriptions, including elements to

facilitate, if needed, contact between the

prescribing party and the dispensing

party in order to contribute to a



protection;

exhaustive list of elements to be

included in the prescription, and

supporting interoperability of

ePrescriptions; and measures to

facilitate, if needed, contact between

the prescribing party and the

dispensing party in order to ensure



protection.

Possible new EP's proposal :







developing an EU template based on a

non-exhaustive list of elements to be

included in the prescriptions, 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;

17348/10 JS/ng 54


(b) guidelines supporting the

Member States in developing the


(b) guidelines supporting the

Member States in developing the


OK OK

(c) no later than …; 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;

(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;

OK OK

(d) no later than …, measures to

facilitate the comprehensibility of

information to patients concerning

the prescription and the instructions

included therein, on the use of the

medicinal products or medical

devices.

(d) measures to facilitate the

comprehensibility of information to

patients concerning the prescription

and the instructions included therein

on the use of the use of the

medicinal product or medicinal

devices, including clarity as to

different names used for the same

medical product or medical device;

(d) measures to facilitate that the

information to patients concerning the

prescription and the instructions

included on the use of the product is

comprehensible, including indication on

active substance and dosage;

(d) measures to facilitate that the

information to patients concerning the

prescription and the instructions

included on the use of the product is

comprehensible, including indication

on active substance and dosage;


Possible new EP proposal

Measures referred in points (a) shall be

adopted by the Commission no later

17348/10 JS/ng 55


than....., and (c), and (d) shall be

adopted by the Commission no later

than.....


Amendment 84

Article 11 Paragraph 2, Point d a (new)

(da) measures to ensure, if needed,

contact between the prescribing

party and the dispensing party in

order to ensure complete

understanding of the treatment,

whilst maintaining confidentiality

of patient's data.

The amendment falls, see para 2a

becomes part of Amendment 83

Amendment 85


3. The measures and guidelines

referred to in points (a) to (d) of

paragraph 2 shall be adopted in

accordance with the regulatory

procedure referred to in Article

15(2).

3. The measures referred to in points

(a) to (da) of paragraph 2 shall be

adopted in accordance with the

regulatory procedure referred to in

Article 15(2).

3. The measures and guidelines referred

to in points (a) to (d) of paragraph 2

shall be adopted in accordance with the


Article 15(2).

See final paragraph of amendment 83.

4. In adopting measures or

guidelines under paragraph 2, the

Commission shall have regard to the

proportionality of any costs of

compliance with, as well as the

likely benefits of, the measures or

guidelines.

17348/10 JS/ng 56


5. For the purpose of paragraph 1,

the Commission shall also adopt, by

means of delegated acts in

accordance with Article 16 and

subject to the conditions of Articles

17 and 18 and no later than …

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.

Amendment 86

Article 11 Paragraph 5 Sub-Paragraph 1 a (New)

However, where a prescription is

issued in the Member State of

treatment for medicinal products or

medical devices which are not

normally available on prescription

in the Member State of affiliation,

it shall be for the latter to decide

whether to authorise exceptionally

or to provide an alternative

medicinal product deemed to have

the same therapeutic effect.

However, where a prescription is issued

in the Member State of treatment for

medicinal products or medical devices

which are not normally available on

ordinary prescription in the Member

State of affiliation and where the

dispensing of this prescription is

sought in the Member State of

affiliation, it shall be for the latter to

decide whether to authorise

exceptionally how to provide the

prescribed product to the patient or to

provide an alternative medicinal product

deemed to have the same therapeutic

effect.

17348/10 JS/ng 57


Where a prescription is issued in the

Member State of treatment for medicinal

products or medical devices available in

the Member State of affiliation and

where dispensing is sought in the latter

Member State, the Member State of

affiliation shall take all necessary

measures, in addition to the recognition

of the prescription, in order to ensure

continuity of treatment.

NOT ACCEPTABLE for the Council

Need to clarify with the EP

The Council understands the rationale

behind this amendment as it was

explained during the technical meeting

on 22 November, but the text doesn’t

reflect this according to the Council.

Possible new EPs proposal // wait for

new wording by the EC

However, where a prescription is issued

in the Member State of treatment for

medicinal products or medical devices

which are not normally available on

ordinary prescription in the Member

State of affiliation and where the

dispensing of this prescription is

sought in the Member State of

affiliation, it shall be for the latter to

decide whether to authorise

exceptionally how to provide the

prescribed product to the patient or to

provide an alternative medicinal product

deemed to have the same therapeutic

effect.

+ corresponding recital

Taking into consideration that

healthcare are more and more

personalised, Member State of

affiliation could decide how to provide

patients with medicinal products or

medical devices prescribed in another

17348/10 JS/ng 58


Member State and which are not

normally available on ordinary

prescription in the Member State of

affiliation;

6. Paragraph 1 shall not apply to

medicinal products subject to special

medical prescription provided for in

Article 71(2) of Directive

2001/83/EC.

Article 12 – European reference networks

Amendment 87


1. The Commission shall support

Member States in the development

of European reference networks

between healthcare providers and

centres of expertise in the Member

States. The networks shall be based

on the voluntary participation of

their members, which shall

participate and contribute to the

networks’ activities in accordance

with the legislation of the Member

State where the members are

established.


Member States in the development

of European reference networks

between healthcare providers and

centres of expertise in the Member

States, in particular in the area of

rare diseases, which shall draw on

the health cooperation experience

acquired within the European

groupings of territorial cooperation

(EGTCs). Those networks shall at

all times be open to new healthcare

providers which might wish to join

them, provided that such healthcare

providers fulfil all the required

conditions and criteria.


Member States in the development of

European reference networks between

healthcare providers and centres of

expertise in the Member States, in

particular in the area of rare diseases.

The networks shall be based on

voluntary participation by its members,

which shall participate and contribute

to the networks’ activities in

accordance with the legislation of the

Member State where the members are

established and shall at all times be

open to new healthcare providers which

might wish to join them, provided that

such healthcare providers fulfil all the

required conditions and criteria.


Member States in the development of

European reference networks between


expertise in the Member States, in

particular in the area of rare diseases.

The networks shall be based on

voluntary participation by its members,

which shall participate and contribute

to the networks’ activities in

accordance with the legislation of the

Member State where the members are

established and shall at all times be

open to new healthcare providers

which might wish to join them,

provided that such healthcare

providers fulfil all the required

conditions and criteria. ACCEPTABLE for the Council

17348/10 JS/ng 59


Amendment 88


2. The aim of European reference

networks shall be to help:

(a) 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;

2. The objective of European

reference networks shall be:

(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;

2. The European reference networks

shall have at least three of the following

objectives:

(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

2. The European reference networks

shall provide strong contribution in

medical domains where expertise is

rare and in particular they shall fulfill

several, at least three, of the following

objectives:

OK

(aa) to contribute to the pooling of

knowledge regarding sickness

prevention and the treatment of

major commonly occurring

disorders;



prevention;



prevention and the treatment of major

commonly occurring disorders;


(b) facilitate improvements in

diagnosis and the delivery of high

quality and cost-effective healthcare

for all patients with a medical

condition requiring a particular

concentration of expertise;

(b) to help to promote access and

facilitate improvement and the

delivery of high quality and cost-

effective healthcare for all patients

with a medical condition requiring a

particular concentration of resources

or expertise;

(b) 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 and in medical domains where

expertise is rare;

OK

17348/10 JS/ng 60


(c) maximise cost-effective use of

resources;

(c) to maximise cost-effective use of

resources by concentrating them

where appropriate;

ACCEPTABLE

OK

(d) reinforce research,

epidemiological surveillance like

registries and provide training for

health professionals;

(d) to reinforce research,

epidemiological surveillance like

registries and provide training for

health professionals;

ACCEPTABLE

OK

(e) facilitate mobility of expertise,

virtually or physically, and to

develop, share and spread

information, knowledge and best

practice within and outside the

networks;

(e) 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;

ACCEPTABLE

OK

(ea) to provide quality and safety

benchmarks and to help develop

and spread best practice within and

outside the network;

(ea) to encourage the development of

quality and safety benchmarks and to

help develop and spread best practice

within and outside the network;

(ea) to encourage the development of

quality and safety benchmarks and to

help develop and spread best practice

within and outside the network;


(f) Member States that have an

insufficient number of patients with

a particular medical condition or

that lack technology or expertise to

provide highly specialised services.

(f) to help Member States with an

insufficient number of patients with

a particular medical condition or

lacking technology or expertise to

provide a full range of highly

specialised services of the highest

quality;

(f) 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.

OK

17348/10 JS/ng 61


(fa) to implement instruments

which enable the best possible use

to be made of existing healthcare

resources in the event of serious

accidents, particularly in cross-

border areas.

NOT ACCEPTABLE OK

Amendment 89


3. Member States are encouraged to

facilitate the development of the

European reference networks:

(a) by identifying appropriate


expertise throughout their national

territory;

(b) by fostering the participation of


expertise in the European reference

networks.


development of the European

reference networks, the

Commission, in collaboration with

the Members States, shall:

(a) identify appropriate healthcare

providers and centres of expertise

throughout their national territory;

(b) foster the participation of



networks.




(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


territory;




networks.




(a) by connecting appropriate



territory and ensuring the dissemination of information towards appropriate healthcare providers and

centres of expertise throughout their

national territory;




networks.


17348/10 JS/ng 62


Amendment 90



the Commission shall:


the Commission, in collaboration

with relevant experts and

stakeholders, shall:

DEPENDS ON THE OUTCOME OF

THE DISCUSSION ON ARTICLE

12(5)

IF 12(3) and 12(5) accepted by the

Council:

4. For the purposes of paragraph 1, the

Commission, after consulting relevant

experts and stakeholders, shall:

New phrasing in the chapeau should be

acceptable to the Council.

(a) develop and publish criteria and

conditions that the European

reference networks should fulfil in

order to receive support from the

Commission;

(a) adopt a list of specific criteria

and conditions that the European

reference networks must fulfil,

including also a list of rarer disease

areas to be covered and the

conditions and criteria required

from healthcare providers wishing

to join the European reference

networks, in order to ensure, in

particular, that the European

reference networks:

(i) have appropriate capacities to

diagnose, to follow-up and manage

patients with evidence of good

outcomes so far as applicable;

(ii) have sufficient capacity and

activity to provide relevant services

and maintain quality of the services

provided;

(a) adopt a list of specific criteria and

conditions that the European reference

networks must fulfil, including inter

alia a list of rarer disease areas to be

covered and the conditions and criteria

required from healthcare providers

wishing to join the European reference

networks,

The concept of rarer diseases is not

acceptable to the Council.

17348/10 JS/ng 63


(iii) have capacity to provide expert

advice, diagnosis or confirmation

of diagnosis, to produce and adhere

to good practice guidelines and to

implement outcome measures and

quality control;

(iv) can demonstrate a multi-

disciplinary approach;

(v) provide high level of expertise

and experience documented

through publications, grants or

honorific positions, teaching and

training activities;

(vi) provide strong contribution to

research;

(vii) are involved in epidemiological

surveillance, such as registries;

(viii) have close links and

collaboration with other expert

centres and networks at national

and international level and capacity

to network;

(ix) have close links and

collaboration with patients

associations where such

associations exist;

(x) have appropriate and effective

relationships with technology

providers.

17348/10 JS/ng 64


(b) develop and publish criteria for

evaluating European reference

networks;

(b) develop, adopt and publish the

procedures for establishing and


networks.

(b) develop, adopt and publish the

procedures for establishing and


networks;

NOT ACCEPTABLE for the Council

(c) facilitate the exchange of

information and expertise in relation

to the establishment of European

reference networks and the

evaluation of them.

c) facilitate the exchange of

information and expertise in relation

to the establishment of European

reference networks and the

evaluation of them.

c) facilitate the exchange of information

and expertise in relation to the

establishment of networks and their

evaluation.

ca) part-finance the establishment

of the said networks.

NOT ACCEPTABLE OK

Amendment 91


5. The criteria and conditions

referred to in paragraph 4 shall be

adopted in accordance with the


Article 15(2).

5. The Commission shall adopt, by

means of delegated acts in

accordance with Article 16 and

subject to the conditions of Articles

17 and 18, the measures referred to

in paragraph 4.

TO BE DISCUSSED AT WP ON 6

DECEMBER

Keep EP amendment at this stage

17348/10 JS/ng 65


Amendment 92


6. Measures adopted pursuant to

this Article shall not harmonise

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.

deleted

NOT ACCEPTABLE Keep EP amendment at this stage

Article 12 b new

POLITICAL cf rare diseases package

Article 13 – eHealth

Amendment 93



the Member States towards

delivering sustainable economic

and social benefits of European e-

health 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 quality

healthcare.

1. The Commission shall, in

accordance with the procedure

referred to in Article 15(2), adopt

specific measures necessary for

achieving the interoperability of


technology systems in the

healthcare field, applicable

whenever Member States decide to

introduce them. Those measures

shall conform to the applicable data

protection laws in each Member

State and shall also reflect


THE DISCUSSIONS ON E-HEALTH

POLITICAL

17348/10 JS/ng 66


developments in health

technologies and medical science,

including telemedicine and

telepsychiatry, and respect the

fundamental right to the protection

of personal data. They shall specify

in particular the necessary

standards and terminologies for

inter-operability of relevant


technology systems to ensure safe,

high-quality and efficient provision

of cross-border health services.

The Member States shall ensure

that the use of e-Health and other

telemedicine services:

(a) adhere to the same professional

medical quality and safety

standards as those in use for non-

electronic healthcare provision;

(b) offer adequate protection to

patients, notably through the

introduction of appropriate

regulatory requirements for

practitioners similar to those in use

for non-electronic healthcare

provision.

17348/10 JS/ng 67


2. For the purpose of paragraph 1

and in due observance of the

principles of data protection as set

out in particular in Directives

95/46/EC and 2002/58/EC, the

Commission shall:


THE DISCUSSIONS ON E-HEALTH

2. The objectives of the eHealth

network shall be to 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 quality

healthcare.

In order to achieve the above

mentioned objectives,

(a) the network will:

(i) develop a non-exhaustive list of

data that are to be included in

patients’ summaries, and that can be

shared between health professionals to

enable continuity of care and patient

safety across borders, and

(ii) develop effective methods for

enabling the use of medical

information for public health and

research;

(b) support Member States in

developing common identification and

authentication measures to ensure

transferability of data in cross-border

17348/10 JS/ng 68


healthcare.

The objectives referred to in (a) and (b)

shall be pursued in due observance of

the principles of data protection as set

out in particular in Directives

95/46/EC and 2002/58/EC.



procedure referred to in Article 15 (2),

adopt the necessary measures for the

establishment, the management and

the transparent functioning of this

network.

Amendment 94

Article 13 Paragraph 2 Point ai

a) draw up guidelines in close

collaboration with the Member

States on:

(i) a non-exhaustive list of data that

are to be included in patients’

summaries and that can be shared

between health professionals to

enable continuity of care and patient

safety across borders, and

(ii) effective methods for enabling

the use of medical information for

public health and research;

(i) a non-exhaustive list of data that

are to be included in Electronic

Health Records and that can be

shared between health professionals

to enable continuity of care and

patient safety across borders, and

SEE PROPOSAL FOR AM 93 ABOVE.

17348/10 JS/ng 69


Amendment 95

Article13 Paragraph 2b

(b) support the Member States in

developing common identification

and authentication measures to

facilitate transferability of data in

cross-border healthcare.

(b) adopt identification and

authentication measures to ensure

transferability of data in cross-

border healthcare while

guaranteeing a high level of

security and the protection of

personal data. These measures

shall be adopted in accordance with

the procedure referred to in Article

15(2).

SEE PROPOSAL FOR AM 93 ABOVE

Amendment 96

Article 13 Paragraph 2, Sub-Paragraph 1a (new)

Work on the measures referred to

in points (a) and (b) shall start no

later than two years after entry into

force the Directive.

SEE PROPOSAL FOR AM 93 ABOVE

17348/10 JS/ng 70


Article 14 – Cooperation on health technology assessment

Amendment 97


1. The Union shall support and

facilitate cooperation and the

exchange of scientific information

among Member States within a

voluntary network connecting

national authorities or bodies

responsible for health technology

assessment designated by the

Member States. The members of the

network shall participate in, and

contribute to, the network's activities

in accordance with the legislation of

the Member State where they are

established.

1. The Union shall support and

facilitate cooperation and the

exchange of scientific information

among Member States For this

purpose, the Commission shall, in

consultation with the European

Parliament, facilitate the

establishment of a network

connecting national authorities or

bodies responsible for health

technology assessment designated

by the Member States. The members

of the network shall participate in,

and contribute to, the network's

activities in accordance with the

legislation of the Member State

where they are established. That

network shall be based on the

principles of good governance

including transparency, objectivity,

independence of expertise, fairness

of procedures, and broad

stakeholder participation from all

relevant groups, including - but not

limited to - health professionals,

patients' representatives, social

partners, scientists and industry,

1. The Union shall support and facilitate

cooperation and the exchange of

scientific information among Member

States within a voluntary network

connecting national authorities or bodies

responsible for health technology

assessment designated by the Member

States. The members of the network

shall participate in, and contribute to, the

network's activities in accordance with

the legislation of the Member State

where they are established. That

network shall be based on the principles

of good governance including

transparency, objectivity, independence

of expertise, fairness of procedures and

appropriate stakeholder consultations.

To be looked at more in detail.

+corresponding Presidency recital

(50) 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 basis of evidence

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.

The addition in recital 50 should be

acceptable to he Council since the only

new element concerns the words “and

consultation of a wide range of

17348/10 JS/ng 71


whilst respecting Member States'

competence in the area of health

technology assessment. Names of

experts and individuals

participating to the network's

activities should be publicly

available, together with their

declaration of interest.

stakeholders”.

Amendment 98


2. The objectives of the Union

support referred to in paragraph 1 shall be to:

2. The objectives of the health

technology assessment network

shall be to:

2. The objectives of the health

technology assessment network shall be

to:

ACCEPTABLE

OK

(a) support Member States in their

cooperation through the national

authorities or bodies referred to in

paragraph 1; and

(a) support cooperation between

national authorities or bodies;

(a) support cooperation between national

authorities or bodies;

ACCEPTABLE

OK

(aa) to find sustainable ways to

balance the objectives of access to

medicines, reward for innovation

and management of healthcare

budgets;

NOT ACCEPTABLE To be looked at more in detail

17348/10 JS/ng 72


(b) 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 to enable an

effective exchange of this

information between the national

authorities or bodies.


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 enable an effective

exchange of this information

between national authorities or

bodies;


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

enable an effective exchange of this

information between national authorities

or bodies;

ACCEPTABLE

OK

(ba) analyse the nature and type of

information that can be exchanged.

(ba) support the analysis of the nature

and type of information that can be

exchanged.

It is for Member States to define what

data should be exchanged.

OK

(bb) avoid duplications of

assessments made by the European

regulatory bodies, particularly in so

far as these bodies take decisions

with regards to safety, efficacy,

quality and eligible patient

populations;

(bb) avoid duplications of assessments;

This should be acceptable to the

Council.

17348/10 JS/ng 73


3. In order to fulfil the objectives set

out in paragraph 2, the network on

health technology assessment may

receive Union aid. Aid may be

granted in order to:

(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.

17348/10 JS/ng 74


Amendment 99


3a. Member States shall designate

the authorities or bodies

participating in the network as

referred to in paragraph 1 and

communicate to the Commission

the names and contact details of

those authorities or bodies.

ACCEPTABLE IN PRINCIPLE, BUT

NEEDS TO BE COMBINED WITH

ARTICLE 14(1) AS THERE IS AN

OVERLAP

OK to put it in article 14(1)

Amendment 100

Article 14, Paragraph 3b (new)

3b. The Commission shall, in



15(2), adopt the necessary

measures for the establishment, the

management and the transparent

functioning of this network.

NOT ACCEPTABLE

Amendment 101

Article 14, Paragraph 3c (new)

3c. The Commission shall only

allow such authorities to join the

network which fulfil the principles

of good governance as defined in

paragraph 1.

NOT ACCEPTABLE OK to put it in article 14(1)

Needs rewording.

17348/10 JS/ng 75


4. Arrangements for granting the

aid, the conditions to which it may

be subject and the amount of the aid,

shall be adopted in accordance with

the regulatory procedure referred to

in Article 15(2). Only those

authorities and bodies in the network

designated as beneficiaries by the

participating Member States shall be

eligible for Union aid.

5. The appropriations required for

measures provided for in this Article

shall be decided each year as part of

the budgetary procedure.

Amendment 102


6. Measures adopted pursuant to

this Article shall not interfere with

Member States' competences in

deciding on the implementation of

health technology assessment

conclusions and shall not

harmonise 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.

Deleted

NOT ACCEPTABLE

17348/10 JS/ng 76


Chapter V – IMPLEMENTING AND FINAL PROVISIONS

Article 15 – Committee

Amendment 103


1. The Commission shall be assisted

by a Committee, consisting of

representatives of the Member States

and chaired by the Commission

representative.

1. The Commission shall be assisted

by a Committee, consisting of

representatives of the Member States

and chaired by the Commission

representative.

In that process, the Commission

shall ensure the consultation of

experts from the relevant patient

and professional groups, as well as

the social partners, in an

appropriate manner, especially in

the context of the implementation

of this Directive, and shall provide

a report on those consultations.

NOT ACCEPTABLE

2. 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 thereof.

The period laid down in Article 5(6)

of Decision 1999/468/EC shall be

set at three months.

17348/10 JS/ng 77


Article 16 – Exercise of the delegation

Amendment 104


1. The powers to adopt delegated

acts referred to in Article 11(5) shall

be conferred on the Commission for

a period of five years from ... * The

Commission shall make a report in

respect of the delegated powers not

later than six months before the end

of the five-year period. The

delegation of powers shall be

automatically extended for periods

of an identical duration, unless the

European Parliament or the Council

revokes it in accordance with Article

17.

The powers to adopt delegated acts

referred to in Article 11(5) and

Article 12(5) shall be conferred on

the Commission for a period of five

years from ...*. The Commission

shall make a report in respect of the

delegated powers not later than six

months before the end of the five

year period. The delegation of

powers shall be automatically

extended for periods of an identical

duration, unless the European

Parliament or the Council revokes it

in accordance with Article 17.

NOT ACCEPTABLE

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 powers to adopt delegated

acts are conferred on the

Commission subject to the

conditions laid down in Articles 17

and 18.

17348/10 JS/ng 78


Article 17 – Revocation of the delegation

1. The delegation of power referred

to in Article 11(5) 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

powers 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

powers 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.

17348/10 JS/ng 79


Article 18 – Objection to delegated acts

1. The European Parliament or the

Council may object to the delegated

act within a period of two months

from the date of notification.

At the initiative of the European

Parliament or the Council this period

shall be extended by two months.

2. If, on expiry of that period,

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.

17348/10 JS/ng 80


3. If the European Parliament or the

Council objects to a delegated act, it

shall not enter into force. The

institution which objects shall state

the reasons for objecting to the

delegated act.

Article 19 – Reports

1. The Commission shall by…* and

subsequently every three years

thereafter, draw up a report on the

operation of this Directive and

submit it to the European Parliament

and to the Council.

* 5 years from the date of entry into

force of this Directive.

17348/10 JS/ng 81


The report shall in particular include

information on patient flows,

financial dimensions of patient

mobility, the implementation of

Article 7(9) and on the functioning

of the European reference networks

and national contact points. To this

end, the Commission shall conduct

an 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 Union legislation relating

to patient mobility.

The Member States shall provide the

Commission with assistance and

available information for carrying

out the assessment and preparing the

reports.

17348/10 JS/ng 82


3. Member States and the

Commission shall have recourse to

the Administrative Commission

established under Article 71 of

Regulation (EC) No 883/2004, in

order to address the financial

consequences of the application of

this Directive on the Member States

which have opted for reimbursement

on the basis of fixed amounts, in

cases covered by Articles 20(4) and

27(5) of that Regulation.

The Commission shall monitor and

regularly report on the effect of

Article 3(c) of this Directive. A first

report shall be presented by... **. On

the basis of these reports, the

Commission shall, where

appropriate, make proposals to

alleviate any disproportionalities.

** 2 years from the date of entry

into force of this Directive.

17348/10 JS/ng 83


Amendment 105

Article 19a (New)

Data collection

1. Member States shall collect

statistical data needed for

monitoring purposes on the

provision of cross-border

healthcare, the care provided, its

providers and patients, the cost and

the outcomes. They shall collect

such data as part of their general

systems for collecting healthcare

data, in accordance with national

and Community law for the

production of statistics and on the

protection of personal data, and

specifically Article 8(4) of Directive

95/46/EC.

NOT ACCEPTABLE (whole article).

2. Member States shall transmit the

data referred to in paragraph 1 to

the Commission at least annually,

except for data that are already

collected pursuant to Directive

2005/36/EC.

3. Without prejudice to the

measures adopted for the

implementation of the Community

Statistical Programme as well as to

those adopted for the

17348/10 JS/ng 84


implementation of Regulation (EC)

No 1338/2008, the Commission

shall, in accordance with the


Article 22(2), adopt measures for

the implementation of this Article.

4. In accordance with Article 4, the

public authorities in the Member

State of treatment shall monitor

regularly the accessibility, quality

and financial state of their

healthcare systems on the basis of

the data collected under paragraph

1.




15(2), adopt:

(a) measures necessary for the

management of the network of

national contact points provided for

in Article 6, the nature and type of

data to be collected and exchanged

within this network;

(b) guidelines on information to

patients provided for in Articles 5

and 6.




17348/10 JS/ng 85


15(2), adopt measures necessary for

achieving a common security level

of health data at national level,

taking into account existing

technical standards in this field.

Article 20 – Transposition

Amendments 106

Art. 20 Paragraph 1 Sub-Paragraph 1

1. Member States shall bring into

force the laws, regulations and

administrative provisions necessary

to comply with this Directive by….

***. They shall forthwith inform

the Commission thereof.

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. The methods of making

such reference shall be laid down by

the Member States.

1. Member States shall bring into

force the laws, regulations and

administrative provisions necessary

to comply with this Directive

by….***. They shall forthwith

inform the Commission thereof.

Member States shall communicate

the text of those provisions and a

correlation table between those

provisions and this Directive.

*** 3 years from the date of entry

into force of this Directive.

*** OJ: 1 year from the date of

entry into force of this Directive.

NOT ACCEPTABLE

2. Member States shall communicate

to the Commission the text of the

main provisions of national law

which they adopt in the field

covered by this Directive.

17348/10 JS/ng 86


Article 21

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 22

Addresses

This Directive is addressed to the

Member States.

______________________

*ulqf;d...brussels, 3 december 2010 interinstitutional file: 2008/0142 (cod) 17348/10 limite san 291...

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