19 Amendments of Othmar KARAS related to 2008/0142(COD)
Amendment 101 #
Proposal for a directive
Recital 43
Recital 43
(43) 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 avoiding duplication of effort, and provide a better basis of evidence for optimal use of new technologies to ensure safe, high- quality and efficient healthcare. This willmay also contribute to the internal market by maximising the speed and scale of diffusion of innovations in medical science and health technologies. Such cooperation requires sustained structures involving all the relevant authorities of all the Member States, building on existing pilot projects. stakeholders, including healthcare professionals, patients’ representatives, researchers and producers as well as authorities of all the Member States, building on existing pilot projects. In addition, such cooperation must also be based on sound principles of good governance such as transparency, openness, inclusiveness, objectiveness and fairness of procedures, which are responsive to patients’ needs, preferences and expectations. The Commission should ensure that only Health Technology Assessment bodies which adhere to these principles can join the network.
Amendment 109 #
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safeprovides rules for access to safe and high-quality healthcare in other Member States and establishes cooperation mechanisms for healthcare between Member States, whigh quality and efficient cross-borderle fully respecting national responsibilities for organising and delivering healthcare.
Amendment 120 #
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of cross-border healthcare regardless of how it is organised, delivered and financed or whether it is public or private.
Amendment 136 #
Proposal for a directive
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
3a. This Directive shall take precedence over Directive .../.../EC of the European Parliament and of the Council of ... [on consumer rights]1 where contracts between healthcare professionals and patients are concerned. 1 OJ L ...
Amendment 170 #
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. TWhen healthcare is provided in a Member States of trether than that where the patmient shall be responsible for the organisation is an insured person, or in a Member State other thand the delivery of healthcare. In such a context and taking into account principles of universality, access to good quality care, equity and solidarity, they shall define clear quality and safety standards for healthcare providedat where the healthcare provider resides, is registered or established, such healthcare service is provided according to the legislation of the Member State of treatment in accordance with paragraph 2. The Member State onf their territory, andreatment shall ensure that:
Amendment 180 #
Proposal for a directive
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) the application of such standards by healthcare providers in practice is regularly monitored and corrective action is taken when appropriate standards are not met, taking into account progress in medical science and health technologhealthcare referred to in paragraph 1 is provided in accordance with the standards and guidelines on quality and safety defined by the Member State of treatment ensuring that: (i) patients and healthcare providers from other Member States are provided with information on such standards and guidelines, including provisions on supervision, inter alia by electronic means; (ii) patients and healthcare providers from other Member States are provided with information on treatment options, availability, prices and possible outcomes of the healthcare provided and details of the healthcare provider's insurance cover or other means of personal or collective protection with regard to their professional liability;
Amendment 181 #
Proposal for a directive
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) healthcare providers provide all relevant information to enable patients to make an informed choice, in particular on treatment options, availability, prices and possible outcomes of the healthcare provided and details of their insurance cover or other means of personal or collective protection with regard to professional liability;
Amendment 187 #
Proposal for a directive
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) patients have athe means of making complaints and are guaranteed remedies and compensation when they suffer harm arising from the healthcare they receive and are guaranteed remedies and the right to seek compensation;
Amendment 197 #
Proposal for a directive
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
(ga) patients who have received treatment are entitled to a written or electronic record of such treatment and of any medical advice for the continuity of their care.
Amendment 203 #
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 340 #
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) provide and disseminate information to patients in particular on their rights related to cross-border healthcare and the guarantees well as ofn 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;
Amendment 362 #
Proposal for a directive
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. For facilitating the implementation of paragraph 1, the Commission shall adopsuggest:
Amendment 379 #
Proposal for a directive
Article 15 – paragraph 3 – introductory part and point a
Article 15 – paragraph 3 – introductory part and point a
The Commission shall adoptpropose: (a) a list of specific criteria and conditions that the European reference networks must fulfil, including a list of rarer disease areas needing to be taken into account 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:
Amendment 384 #
Proposal for a directive
Article 16
Article 16
The Commission 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 accordancline with the applicable lawdata protection laws in each Member State. 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 387 #
Proposal for a directive
Article 17 – title
Article 17 – title
Cooperation on management of new health technologies
Amendment 389 #
Proposal for a directive
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1a. The European Commission shall, in consultation with the European Parliament, set up an operational framework for the network which is based on the principles of good governance including transparency, objectiveness, fairness of procedures, and broad and full stakeholder participation of all relevant societal groups including healthcare professionals, patients, researchers and industry.
Amendment 390 #
Proposal for a directive
Article 17 – paragraph 2 – point a a, b and c (new)
Article 17 – paragraph 2 – point a a, b and c (new)
(aa) to find sustainable ways to balance the objectives of access to medicines, reward for innovation and management of healthcare budgets; (ab) develop transparent, objective, inclusive and timely procedures and methodologies which are balancing all objectives; (ac) ensure full participation of all relevant societal groups, in particular patients, medical community, research and industry;
Amendment 392 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Member States shall designate the authorities or bodies participating in the network as referred to in paragraph 1 and communicate to the Commission names and contact details of those authorities or bodies.The Commission shall only allow authorities to join the network which fulfil the principles of good governance.
Amendment 393 #
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(2), adopt the necessary measures for the establishment and the management of this network according to the above objectives and specifying the nature and type of the information to be exchanged.