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Directive 2011/24/EU of the European Parliament and of the CouncilShow full title

Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare

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CHAPTER V IMPLEMENTING AND FINAL PROVISIONS

Article 16Committee

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 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 3 months.

Article 17Exercise of the delegation

1.The powers to adopt delegated acts referred to in Articles 11(5) and 12(5) shall be conferred on the Commission for a period of 5 years from 24 April 2011. The Commission shall make a report in respect of the delegated powers not later than 6 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 18.

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 18 and 19.

Article 18Revocation of the delegation

1.The delegation of power referred to in Articles 11(5) and 12(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.

Article 19Objections to delegated acts

1.The European Parliament or the Council may object to the delegated act within a period of 2 months from the date of notification.

At the initiative of the European Parliament or the Council this period shall be extended by 2 months.

2.If, on expiry of the period referred to in paragraph 1, 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.

3.If the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

Article 20Reports

1.The Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of this Directive and submit it to the European Parliament and to the Council.

2.The report shall in particular include information on patient flows, financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, 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 all available information for carrying out the assessment and preparing the reports.

3.Member States and the Commission shall have recourse to the Administrative Commission established pursuant to 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)(i) and Article 8 of this Directive. A first report shall be presented by 25 October 2013. On the basis of these reports, the Commission shall, where appropriate, make proposals to alleviate any disproportionalities.

Article 21Transposition

1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 25 October 2013. 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.

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.

Article 22Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 23Addressees

This Directive is addressed to the Member States.

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