[ParlTrack]

Proposal for a directive
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 need 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 s~~tate of need. It~~ervices as are considered necessary in order to provide the person in need of care with as full and independent a life as possible. This Directive 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 professionals.

2008/12/16
Committee: ITRE

Angelika NIEBLER

Proposal for a directive
Recital 39

(39) Where medicinal products are authorised within the patient’s Member State in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and have been prescribed in another Member State for an individual named patient, it should be in principle possible for such prescriptions to be medically recognised and used in the patient’s own Member State. The removal of regulatory and administrative barriers to such recognition is without prejudice to the need for appropriate agreement of the patients’ treating physician or pharmacist in every individual case, if this is warranted by protection of human health and is necessary and proportionate to that objective. Such medical recognition should also be without prejudice to the decision of the Member State of affiliation regarding the inclusion of such medicinal products within the benefits covered by the social security system of affiliation. The implementation of the principle of recognition will be facilitated by the adoption of measures necessary for safeguarding the safety of a patient, and avoiding the misuse or confusion of medicinal products.deleted

2008/12/16
Committee: ITRE

Angelika NIEBLER

Proposal for a directive
Recital 44

(44) Measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission.deleted

2008/12/16
Committee: ITRE

Angelika NIEBLER

Proposal for a directive
Article 2 – paragraph 1 a (new)

This Directive shall not apply to services mainly geared to long-term care. These include in particular services provided over an extended period that are designed to assist people in need of help with the general running of their day-to-day lives.

2008/12/16
Committee: ITRE

Angelika NIEBLER

Proposal for a directive
Article 14

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 by an authorised person in another Member State for a named patient can be used in their 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. 2. For facilitating the implementation of paragraph 1, the Commission shall adopt: (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 an authorised person through developing a Community prescription template, and supporting interoperability of ePrescriptions; (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; (c) measures to exclude specific categories of medicinal products from the recognition of prescriptions provided for under this article where necessary in order to safeguard public health. 3. The measures referred to in points (a) and (b) of paragraph 2 shall be adopted in accordance with the regulatory procedure referred to in Article 19(2). The measures referred to in point (c) of paragraph 2, designed to amend non-essential elements of this Directive, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 19(3). 4. Paragraph 1 shall not apply to medicinal products subject to special medical prescription as provided for in Article 71(2) of Directive 2001/83/EC.deleted

2008/12/16
Committee: ITRE

Angelika NIEBLER

Proposal for a directive
Article 19

1. The Commission shall be assisted by a Committee, consisting of representatives of the Member States and chaired by the Commission representative. 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 of that Decision. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months. 3. Where reference is made to this paragraph, Article 5a (1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.deleted

2008/12/16
Committee: ITRE

6 Amendments of Angelika NIEBLER related to 2008/0142(COD)

ParlTrack - 2011-2024