Dáil Éireann Debate, Tuesday - 11 June 2013
989. Deputy Andrew Doyle asked the Minister for Health the work his Department is currently undertaking on various pieces of upcoming legislation, through a potential Bill to go through the Houses of the Oireachtas or through statutory instrument, to ensure Ireland is in compliance with the upcoming deadlines of Directives from the European Union; the deadline in each case; and if he will make a statement on the matter. [27476/13]
View answerThree Directives fall due for transposition by my Department during the remainder of 2013 as follows:
1. 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 health care – due 25/10/13
The purpose of the EU Directive on the Application of Patients' Rights in Cross Border Health care is to establish a clear legal framework to facilitate cross border health care with a focus on patient rights, information for patients on entitlements and patient choice. The Directive deals with complex issues, both nationally and between Member States, and work continues on the preparation of proposals for legislation. At this time it is not possible to be specific regarding dates for such legislation but details will be announced in due course.
2. Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State – due 25/10/13
It is anticipated that this Directive will be transposed by the due date.
3. Directive 2012/26/EU of the European Parliament and of the Council of 25 October, 2012 amending Directive 2001/83/EC as regards pharmacovigilance - due 28/10/13
It is anticipated that this Directive will be transposed by the due date.
In addition to the above, one article of Directive 2011/62/EU amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products - the "Falsified Medicines Directive" - remains to be transposed by my Department.
This Directive constitutes a major revision of the EU legislative framework regulating medicines. The Directive, other than Article 85c, was transposed into Irish law by means of four Statutory Instruments on 22 May, 2013.
Article 85c of the Falsified Medicines Directive relates to regulation of the internet supply of medicines. Article 85c will come into effect one year after the Commission adopts an Implementing Act regarding a common logo for internet sites. This Implementing Act has not as yet been adopted by the Commission. Drafting of a Statutory Instrument to transpose Article 85c into Irish law is at an advanced stage.
My Department continues to monitor the transposition of EU Directives on an ongoing basis and makes every effort to transpose Directives by their deadline.
