Press Release

Minister for Health & Children removes the “derogation” which prevented non-Irish qualified pharmacists from owning, operating or managing pharmacies which are less than 3 years old.

Mary Harney TD, Minister for Health & Children today (28th November, 2008) commenced sections of the Pharmacy Act 2007 dealing with the registration of pharmacists and retail pharmacy businesses and removed the “derogation” which prevented non-Irish qualified pharmacists from owning, operating or managing pharmacies which are less than 3 years old.

The removal of the “derogation” has been facilitated by newly commenced provisions of the Pharmacy Act 2007 relating to the registration of pharmacists and retail pharmacy businesses. These provisions provide a modern and robust regulatory regime, including new registration requirements relating to the linguistic and forensic competence of pharmacists, and new requirements relating to the personal control and supervision of the activities of pharmacists within retail pharmacy businesses.

The Commencement Order, signed by the Minister today enables these provisions to commence immediately and also includes the repeal of previous Pharmacy legislation dating from 1875 to 1962. The repeal of this old legislation has the effect of removing the “3 year rule” or “derogation” whereby a pharmacist who qualified in another EU/EEA state could not own, operate or manage a pharmacy that is less than three years old.

Background

In May 2007, the Minister for Health and Children commenced the first stage of this process when she dissolved the old Pharmaceutical Society of Ireland (established in 1875), established the new Pharmaceutical Society of Ireland and appointed its Council. The new Council and staff of the Society have worked closely with the Department of Health & Children to update and review its rules and regulations so that the sections of the Act concerning registration of pharmacists and pharmacy businesses, the operation of such businesses (in respect of the sourcing, sale, supply, storage and keeping of records in respect of medicinal products), and inspection and investigation powers, can be commenced. The Minister acknowledges the very strong support of the Society for reform in this area and, in particular, the substantial work carried out by the Society to enable this stage to commence.

The Pharmacy Act 2007 is an essential piece of legislation that provides for the health, safety and welfare of patients and the public and is being commenced on a staged basis. The Act enables pharmacists to practise in a regulated, controlled and safe environment and in a manner which will ensure the provision of high-quality service, in the context of increasingly complex and evolving care and therapeutic regimens for patients. It also provides a system whereby pharmacy owners will be required to demonstrate responsible and accountable practices, whilst providing the highest level of patient care and service. When fully enacted in 2009, the Act will put in place a modern fitness to practice structure aimed at safeguarding the public, and members of the profession in respect of their professional conduct.

Under Article 2.2 of 85/433/EEC, Member States were given the option of not recognising the qualification of any EU/EEA-qualified pharmacist in relation to the ownership, management or supervision of a pharmacy that is less than three years old or for the establishment of a new pharmacy. This meant that a pharmacist who qualified in another EU/EEA state could not own operate or manage a pharmacy that is less than three years old.

The third, and remaining, stage of the Commencement process will deal with the remaining sections of the Pharmacy Act. These sections concern the introduction of a fitness to practice regime for pharmacists and pharmacy businesses, its operation and the prohibition of certain economic, and businesses, relationships between pharmacists or pharmacies and doctors. It is hoped this final stage can be commenced in the first half of 2009.

Links

Pharmacy Act 2007 (Commencement) Order 2008

Regulation of Retail Pharmacy Businesses Regulations 2008

European Communities (Recognition of Professional Qualifications relating to the Profession of Pharmacist) (No. 2) Regulations 2008