Denis Naughten (Roscommon-South Leitrim, Fine Gael)
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Question 422: To ask the Minister for Health and Children her plans for the publication and enactment of the Pharmacy Bill No. 1 and No. 2; and if she will make a statement on the matter. [20878/07]

Mary Harney (Dublin Mid West, Progressive Democrats)
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The first Pharmacy Act was passed by the Oireachtas on 5th April this year and will be commenced in 3 stages.

Stage 1 of the Pharmacy Act implementation process has been completed and the Council of the new PSI has been established. The Society's Council has been working on reviewing current procedures, and on the preparation of new procedures to allow the commencement of those sections of the Act included in Stage 2 of the process.

Stage 2 will deal with the new procedures which will apply to the registration of pharmacists and pharmacy businesses as outlined in Part 4 of the Act. This stage will also set out the conditions which must be met for the conduct of a retail pharmacy business. It includes the conditions applying to the necessity of having an experienced (3 years post-registration) pharmacist in personal control of the sale and supply of medicinal products in that part of a pharmacy business which consists of the management and administration of such products. It will also put in place Part 7 of the Act dealing with the investigation, and related issues, of any offences, breaches of codes or professional misconduct which may be alleged to have occurred.

Once these new policies and procedures, and the changed regulatory regime for pharmacists and pharmacy businesses, are put in place by the Council it will be possible to revoke the Pharmacy Act, 1962 and affect the removal of the derogation. This new regime will include regulations relating to the supervision of the sale and supply of medicinal products, and new conditions relating to the registration of pharmacists in terms of their forensic and linguistic competency, both in the interest of public safety.

Stage 3 will deal with the Complaints, Inquires and Discipline (Fitness to Practice Provisions) regime — Part 6 of the Act. Part 6 includes the provisions concerning the regulation of the beneficial interest between pharmacists and doctors. As the matters dealt with in Part 6 are being introduced for the pharmacy sector for the first time, and there are many new procedures and policies to be put in place in other areas, it is considered prudent that the new Council of the PSI be permitted to establish all of the necessary registration and inspection functions procedures to enable the proper conduct of any fitness to practice procedures. This is particularly important as Part 6 includes, under sections 63, 64 and 65, the matter of conflict in beneficial interest between pharmacists and doctors. It should also be noted that the proper conduct of Part 6 requires that the other Parts of the Act are functioning efficiently.

The second Pharmacy Bill will follow on from the Pharmacy Act 2007 and will deal with other changes in the regulatory framework for pharmacy and pharmacy services, not addressed in the 2007 Act, and remaining recommendations of the Pharmacy Review Group. Preparation of a framework for, and the publication of, the second Bill, is dependent on the progress of the enactment of the first Pharmacy Act.