Activities of Thomas ULMER related to 2008/0142(COD)
Plenary speeches (2)
Explanations of vote
Explanations of vote
Amendments (48)
Amendment 60 #
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 35 of the Charter of Fundamental Rights of the European Union. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination, the fundamental ethical choices of Member States and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 65 #
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) This Directive respects and does not prejudice the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States, in particular as regards the protection of the right to life of every human being.
Amendment 73 #
Proposal for a directive
Recital 8
Recital 8
(8) This directive aims to establish a general framework for provision of safe, high quality and efficient cross-border healthcare in the Community and to ensure patients mobility and freedom to provide healthcare and high level of protection of health, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits related to health and the organisation and delivery of healthcare and medical care and social security benefits in particular for sickness.Does not affect English version.)
Amendment 74 #
Proposal for a directive
Recital 9
Recital 9
(9) This Directive on the application of patients’ rights in cross-border healthcare applies to all types of healthcare. As confirmed by the Court of Justice, neither their special nature nor the way in which they are organised or financed removes them from the ambit of the fundamental principle of freedom of movement. As regards long-term care, the Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in a particular state of need. It does not apply, for example, to residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionalneed of nursing, support or care in so far as this involves specific expert treatment or help provided by a social security system. This covers first and foremost such long term care services as are considered necessary in order to provide the person in need of care with as full and independent a life as possible. These include, in particular, services in the field of basic care (e.g. bathing/showering, dressing/undressing, cutting up food and feeding, assistance in getting up and going to bed, walking/standing, trips to the toilet for emptying the bladder or bowel), domestic care (such as cleaning, heating, washing dishes, cooking, shopping, administrative formalities and trips to social events) and medical treatment (such as help in changing dressings, pain relief, administering medication, etc). The Directive does not apply, for example, to care in long-term residential care establishments or in assisted-living facilities.
Amendment 77 #
Proposal for a directive
Recital 10
Recital 10
(10) For the purpose of this Directive, the concept of "cross-border healthcare" covers the following modes of supply of healthcare: – Use of healthcare abroad (i.e.: a patient moving to a healthcare provider in another Member State for treatment); this is what is referred to as 'patient mobility'; – Cross-border provision of healthcare (i.e.: delivery of service from the territory of one Member State into the territory of another); such as telemedicine services, remote diagnosis and prescription, laboratory services; – Permanent presenconly covers the use of a healthcare provider (i.e.: establishment of a healthcare provider in another Member State); and – Temporary presence of persons (i.e.: mobility of health professionals, for example moving temporarily to the Member State of the patient to provide services)abroad.
Amendment 87 #
Proposal for a directive
Recital 11
Recital 11
(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection. In view of these common values it is nevertheless accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions. This Directive is without prejudice to ethical diversity. It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed under national laws, regulations and codes of conduct of the medical professions.
Amendment 93 #
Proposal for a directive
Recital 12
Recital 12
(12) Given that it is impossible to know in advance whether a given healthcare provider will supply healthcare to a patient coming from another Member State or a patient from their own Member State, it is necessary that the requirements to ensure that healthcare is provided according to common principles and clear quality and safety standards are applicable to all type of healthcare in order to ensure the freedom to provide and obtain cross border healthcare which is the aim of the directive. Member States' authorities have to respect the shared overarching values of universality, access to good quality care, equity and solidarity, which have been already widely recognised by the Community institutions and by all the Member States as constituting a set of values that are shared by health systems across Europe. Members States also have to ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably (which also expressly means no discrimination against national patients and providers) on the basis of their healthcare need rather than their Member State of social security affiliation. In doing so, Member States must respect the principles of freedom of movement within the internal market, non- discrimination inter alia with regard to nationality (or in the case of legal persons, with regard to the Member State in which they are established), necessity and proportionality of any restrictions on free movement. However, nothing in this Directive requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, such as through increasing waiting time for treatment.
Amendment 103 #
Proposal for a directive
Recital 17
Recital 17
(17) The right to the protection of personal data is a fundamental right recognised by Article 8 of the Charter of Fundamental Rights of the European Union. Ensuring continuity of cross-border healthcare depends on transfer of personal data concerning patient's health. These personal data should be able to flow freely from one Member State to another, but in the same time the fundamental rights of the individuals should be safeguarded. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data establishes the right for individuals to have access to their personal data concerning their health, for example in the patient's medical records containing such matters as diagnosis, examination results, assessments by treating physicians and any treatment or interventions provided. These provisions also apply in the context of cross-border healthcare covered by this Directive. The patient should be able to stop the release of his data at any point and receive confirmation that his data have been deleted.
Amendment 135 #
Proposal for a directive
Recital 27
Recital 27
(27) This Directive provides also for the right for a patient to receive any medicinal product authorised for marketing in the Member State where healthcare is provided in that Member State, even if the medicinal product is not authorised for marketing in the Member State of affiliation, insofar as it is an indispensable part of obtaining effective treatment in another Member State.
Amendment 138 #
Council position
Article 1 – paragraph 3 – point c a (new)
Article 1 – paragraph 3 – point c a (new)
(ca) sales of medicinal products and medical devices over the Internet.
Amendment 139 #
Proposal for a directive
Recital 30
Recital 30
(30) There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certain other kindmust remain within Member States’ legal jurisdiction. This ensures that, in qualified competition, expert further developments can be integrated into the system (i.e. that the assumption of more and more complex tasks by advanced technology, e.g. operations in the non-hospital sphere, remains possible). The specific distinction between hospitalisation and non-hospital care will be made on the basis of thealthcare, if that healthcare requires use of highly specialised and cost-intensive medical infrastruct practice of patient treatment in the country of provision in the typical course or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for thef events. Should significant differences emerge between cross-border patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commisss, the Commission has a direct right to intervene and take corrective action, through the comitology procedurea body to be set up.
Amendment 140 #
Council position
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) "healthcare" means health services provided to patients by health professionals to patients to assess, maintain or restore theibelonging to the regulated health professions if these activities are performed in a Member sState of health, including the prescription, dispensation and provision of medicinal products and medical deviceswhere the services are provided by members of a regulated health profession under the appropriate professional title;
Amendment 150 #
Council position
Article 4 – paragraph 2 – point f
Article 4 – paragraph 2 – point f
(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, without prejudice to the exceptions applicable in the Member States.
Amendment 174 #
Proposal for a directive
Recital 40
Recital 40
(40) European reference networks should provide healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, in order to provide affordable, high quality and cost-effective care and could also be focal points for medical training and research, information dissemination and evaluation. The mechanism for identification and development of the European refMember States shall facilitate the development of the European reference networks of healthcare providers in the form of voluntary groupings with the aim of exchanging scientific experience networks should be established with the aim to organise at European level equal access to high level shared expertise in a given medical fieldin order to improve healthcare possibilities for all patients as well as for health professionalswith rarer illnesses, based on the open coordination method.
Amendment 199 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safe, high quality and efficient healthcare and the re- imbursement of cross-border healthcare.
Amendment 200 #
Council position
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
(2) In order to facilitate implementationFor the purposes of paragraph 1, the Commission shall adopsupport:
Amendment 201 #
Council position
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) no later than…. measuresprocesses at Member State level enabling a health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing a non-exhaustive list of elements to be included in the prescriptions; *Note to OJ: please insert the date - 18 months after the entry into force of this Directive.
Amendment 203 #
Council position
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(b) guidelines supporting the Member States in developing the interoperability of ePrescriptions; for this purpose it shall draw up guidelines in close collaboration with the Member States;
Amendment 205 #
Council position
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
(c) no later than… measuresprocesses at Member State level 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; *Note to OJ: please insert the date - 18 months after the entry into force of this Directive.
Amendment 206 #
Council position
Article 11 – paragraph 2 – point d
Article 11 – paragraph 2 – point d
(d) no later than…* measuresprocesses at Member State level to facilitate the comprehensibility of the information to patients concerning the prescription, and the instructions included therein, on the use of the medicinal products or medical devices. *Note to OJ: please insert the date - 18 months after the entry into force of this Directive.
Amendment 208 #
Council position
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 214 #
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private. This Directive shall not apply to services whose main focus is in the field of long-term care, especially including those services provided over an extended period of time whose purpose is to support people in need of assistance in carrying out routine, everyday tasks.
Amendment 251 #
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) "healthcare" means a health service provids or products, in particular medical or pharmaceutical services and medicinal products or medical devices, provided by, prescribed by or under the supervision of a health professional in the exercise of his profession, and regardless of the ways in which it isthey are organised, delivered and financed at national level or whether it isthey are public or private;
Amendment 281 #
Proposal for a directive
Article 4 - point (h)
Article 4 - point (h)
(h) "Member State of affiliation" means the Member State where the patient is an insured person; if the institution of the place of residence is the competent institution pursuant to the second subparagraph of Article 22(3) of Regulation (EEC) No 1408/71 or Article 20(4) or Article 27(5) of Regulation (EEC) No 883/2004, the State of residence shall be deemed to be the Member State of affiliation;
Amendment 298 #
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) "harm" means adverse health outcomes or injuries stemming from the provision of healthcare and which can only be related to the obligation of effort of the health professional.
Amendment 305 #
Proposal for a directive
Article 5
Article 5
Amendment 387 #
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system for treatment carried out generally and lege artis in the Member State of treatment on the basis of the given diagnosis at the level thadt the same or similar healthcare been provided in its territorycosts would have been reimbursed to the insured person for treatment carried out generally and lege artis in his Member State of affiliation. 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.
Amendment 413 #
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities including codes of conduct of the medical professions for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neitherot discriminatory nor an obstacle to freedom of movement of persons.
Amendment 455 #
Proposal for a directive
Article 8 – paragraph 1 – point (a)
Article 8 – paragraph 1 – point (a)
(a) healthcare which requires overnight accommodation of the patient in question for at least one night, or which is defined as such by the legislation of Member States of affiliation.
Amendment 457 #
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 518 #
Proposal for a directive
Article 9 – paragraph 3
Article 9 – paragraph 3
Amendment 528 #
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 572 #
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) provide and disseminate objective information of a general nature to patients in particular on their rights related to cross- border healthcare, and the guarantees ofinformation about quality and safety, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable. No recommendations concerning the service providers (rankings) should be supplied;
Amendment 596 #
Proposal for a directive
Article 12 – paragraph 3 – point c
Article 12 – paragraph 3 – point c
Amendment 615 #
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. If a medicinal product is authorised to be marketed on theirits territory in accordance with Article 6(1) of Directive 2001/83/EC, a Member States shall ensure that prescriptions for this medicinal product issued by an authorised person in another Member State for a named patient can after recognition by a doctor be used in theirits territory and that any restrictions on recognition of individual prescriptions are prohibited unless they: (a) are limited to what is necessary and proportionate to safeguard human health and are non-discriminatory or (b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription or about the authority of the prescriber. Costs will be reimbursed according to the conditions applying in the Member State of affiliation.
Amendment 620 #
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
The recognition of such a prescription shall not affect the application of the following national regulations: (i) rules governing the dispensing of medicinal products, including generic substitution, (ii) rules relating to pricing and reimbursement, (iii) professional or ethical rules which would require the pharmacist to refuse to dispense had the prescription been issued in his own Member State.
Amendment 633 #
Proposal for a directive
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) measures to ensure that medicinal products prescribed in one Member State and dispensed in another are correctly identified and that the information to patients concerning the product is comprehensible; prescriptions issued in accordance with this EU template shall be written in International Nonproprietary Names (INN).
Amendment 635 #
Proposal for a directive
Article 14 – paragraph 2 – point ba (new)
Article 14 – paragraph 2 – point ba (new)
(ba) measures to facilitate the establishment of contacts between the prescriber and the dispenser, so as to clarify any doubts concerning the prescription.
Amendment 639 #
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 646 #
Proposal for a directive
Article 15 - paragraph 1
Article 15 - paragraph 1
1. Reference networks are voluntary associations for the exchange of scientific experience with the aim of improving the possibilities for healthcare provision for patients with rare diseases and are based on the open coordination method. Reference networks present an opportunity to demonstrate Europe's excellence in medical research and treatment. Member States shall facilitate the development of the European reference networks of healthcare providers. Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria.
Amendment 651 #
Proposal for a directive
Article 15 - paragraph 2
Article 15 - paragraph 2
Amendment 656 #
Proposal for a directive
Article 15 - paragraph 3
Article 15 - paragraph 3
Amendment 672 #
Proposal for a directive
Article 15 - paragraph 4
Article 15 - paragraph 4
Amendment 680 #
Proposal for a directive
Article 16
Article 16
The CommissionMember States shall, in accordance with the procedure referred to in Article 19(2), adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce them. Those measures shall reflect developments in health technologies and medical science and respect the fundamental right to the protection of personal data in accordance with the applicable law. They shall specify in particular the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high- quality and efficient provision of cross- border health services.
Amendment 691 #
Proposal for a directive
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1a. The network shall act on the basis of an operational framework based on the principles of good governance. These principles include inter alia transparency of procedures, a formal right of appeal, objectiveness, impartiality and the full involvement of all relevant stakeholders.
Amendment 696 #
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Commission shall, in accordance with the procedure referred to in Article 19(23), adopt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged.
Amendment 698 #
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Member States shall transmit the data referred to in paragraph 1 to the Commission for statistical purposes at least annually, except for data that are already collected pursuant to Directive 2005/36/EC.
Amendment 701 #
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Commission shall be assisted by a Committee, consisting of representatives of and chaired by the Member States and chaired by the Commission . The Committee may be completed by representatives of patients, payer organisations and healthcare presentativeofessionals.