Written answers

Thursday, 5 July 2007

Department of Health and Children

Pharmacy Regulations

5:00 pm

Photo of Ned O'KeeffeNed O'Keeffe (Cork East, Fianna Fail)
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Question 92: To ask the Minister for Health and Children when the new Pharmacy Act, 2007 will be enacted and put into law; the regulation governing pharmacists from outside this jurisdiction setting up here; and if she will outline the position. [19506/07]

Photo of Mary HarneyMary Harney (Dublin Mid West, Progressive Democrats)
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The 2007 Pharmacy Act was passed by the Oireachtas earlier this year. The Pharmacy Act will be commenced in 3 stages. The first stage is to put in place the Council of the new Pharmaceutical Society of Ireland. The second stage is registration, offences, powers of investigation etc. The third stage regards complaints, inquires and discipline (fitness to practice provisions).

A three stage process allows flexibility in implementation dates, given the complexity and number of new policies and procedures that the new PSI Council must have in place to accommodate each stage.

The 2007 Pharmacy Act allows for the removal of the restriction on pharmacists educated in other EU or EEA countries owning, managing or supervising a pharmacy in Ireland that is less than three years old — the derogation under Article 2.2 of Council Directive 85/433/EEC. My motivation in removing this derogation was to facilitate the many Irish pharmacy graduates who, because of the shortage of pharmacy undergraduate places available in the State, went abroad to train. On their return these graduates found that they were at a disadvantage to their Irish trained colleagues in not being able to establish a new pharmacy business, having instead to confine themselves to ones which had already been in operation for at least 3 years, a situation that was clearly unfair and unsustainable.

In relation to the removal of the derogation, new policies and procedures must be in place before the second stage of implementation of the Act, including the removal of the derogation, can proceed. Under section 17 of the 2005 Interpretation Act, the Council can complete drawing up these policies and procedures prior to commencement of the relevant parts and sections of the Act and this will be done in stage one.

The second stage of the implementation of the Act will deal with the new procedures for registration of pharmacists and pharmacy businesses under Part 4 of the Act, the conditions for conduct of a retail pharmacy business, including 3 years post-registration experience for supervising pharmacists, Part 7 of the Act on the investigation of alleged offences, breaches of codes or professional misconduct, regulations for supervision of the sale and supply of medicinal products and, in the interest of public safety, new conditions for registration of pharmacists in terms of forensic and linguistic competency. Once these new policies and procedures and the new regulatory regime for pharmacists and pharmacy businesses, are put in place by the Council, it will be possible to revoke the 1962 Pharmacy Act and remove the derogation.

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