Ireland - Pharmacy Bill 2007: a complete overhaul of regulation of pharmacy for the first time in 130 years
Keywords: Regulation, Ireland, Social care
The Minister for Health and Children, Mary Harney T.D. has announced the publication of the Pharmacy Bill 2007, which provides for an enhanced and modern system of regulation of the pharmacy profession in Ireland, and removes the derogation, whereby there was a restriction on pharmacists educated in other EU or EEA countries from owning, managing or supervising a pharmacy in Ireland that is less than three years old.
Details of the Bill include:
Membership, governance, and accountability. The Council of the Pharmaceutical Society will continue to consist of 21 members – however,the balance between pharmacist and non-pharmacist representation has been significantly altered to include a majority of persons who are not nominated by the pharmacy profession. Modern governance and accountability arrangements applicable to other statutory bodies, particularly in the health and social care area; will now apply to the Pharmaceutical Society.
Registration. The registration system for pharmacists will be reformed to bring it into line with the best practice in the regulatory field and current EU requirements. For the first time registration will be extended to retail pharmacy businesses. This is an important development as the retail pharmacy business is the last link in the chain from manufacture to sale of medicinal products and was lacking in regulation to ensure minimum standards.
Carrying-out of a retail pharmacy business. Part 5 of the Bill specifies what constitutes the carrying-out of a retail pharmacy business and creates offences for acting other than in accordance with these provisions. It requires that the sale and supply of medical products be under the control of a registered pharmacist. It further requires that an experienced (minimum three years post qualification), nominated pharmacist must be in personal and whole-time charge of each registered retail pharmacy premises. It also requires that corporate bodies should have an experienced (minimum three years post qualification) pharmacist in personal control of that part of the business that consists of the management and administration of the sale and supply of medicinal products.
Pharmaceutical assistants. Provision is made for the continuation of the situation where pharmaceutical assistants may act on behalf of a registered pharmacist in their temporary absence.
Holding oneself out to be a registered pharmacist. An offence is created for holding oneself out to be a registered pharmacist or using certain expressions/terms in this regard.
Fitness to practise provisions. Fitness to Practise provisions will be introduced for the first time and will extend to retail pharmacy businesses. In light of the interaction of the corporate ownership and professionals in running pharmacies, it is felt that the registration process and the Fitness to Practise regimes need to be linked so that remedies and sanctions can be applied evenly across those responsible for the provision of the service and not just the individual pharmacist.
A majority of persons on the Fitness to Practise committee will not be pharmacists and, in keeping with provisions introduced in the Medical Practitioners Bill 2007, Fitness to Practise inquiries will normally be held in public. However, the Fitness to Practise committee may decide, on application by the pharmacist or a witness, including the complainant, to hold some or all of an inquiry in private, depending on the circumstances.
Removal of the derogation. The derogation whereby there was a restriction on pharmacists educated in other EU or EEA countries from 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 –will be removed by the repeal of the Pharmacy Act 1962. In order to remove the derogation it was necessary to put in place certain provisions to protect the safety of the public. First among these was a fitness to practice regime for pharmacists. This was required to ensure that any issues in respect of the professional competence of a pharmacist registered in the State could be dealt with in a timely and proportionate manner. Second, it was necessary to deal with the issue of language competency. This has been done by linking the requirement to have linguistic competence, in the case of EU qualified pharmacists, to whether or not the pharmacist will be in direct contact with the public. In the case of non-EU pharmacists, they will be required to satisfy the PSI, at registration, that they have the linguistic competency required.
For further information: www.dohc.ie/
