Pharmacy Bill 2007 a complete overhaul of regulation of pharmacy for the first time in 130 years – new standards of governance, fitness to practise and registration for pharmacy – lifts restriction on qualified EU pharmacists setting up in Ireland
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The Minister for Health and Children, Mary Harney T.D., today (9 March 2007) 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.
The Minister said, “The publication of this Bill is a significant step in our drive towards assuring standards of patient safety. The Government have approved this Bill as a major reform to support and increase public confidence in pharmacy practice in a structured and sustained way for decades ahead.”
“The existing Pharmacy Acts date from 1875 to 1962 and it is clear, that in the interests of pharmacists and the public alike, a modern, accountable and efficient system of regulation is required. At this stage, incremental change to Pharmacy Acts is not enough. A whole new Bill is needed.”
“It is also necessary to put in place a modern regulatory regime, including fitness to practise provisions to allow 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 to be removed. This is achieved by the repeal of the Pharmacy Act 1962.”
“As with other legislation the Government has proposed, the public interest comes first here. It is stipulated in this Bill that the purpose of the Pharmaceutical Society of Ireland Council is to regulate the pharmacy profession having regard to the need to protect, maintain and promote the health and safety of the public. The Bill contains many practical new measures towards this goal. For example, for the first time both pharmacists and retail pharmacy businesses will be subject to a fitness to practice regime”.
“Consistent with its public interest role, and in keeping with other recent legislation in the health area, elected pharmacists will no longer be in a majority on the 21 member Council of the Society. Pharmacists will work with other people of standing and expertise on the Council to advance the interests of patients and the public.”
“I am also extending, as I have done with the Medical Council, the introduction of a lay majority to the Disciplinary Committees being introduced in this Bill.”
“Similarly, in order to meet today’s standards of openness, fitness to practice hearings will normally be held in public unless the Disciplinary Committee itself decides that the public interest is best served otherwise.”
“The Government accepted the view of the Pharmacy Review Group on the issue of conflicts of interest between those who prescribe and those who dispense drugs, particularly having regard to recent developments. I intend to introduce an amendment to the Bill at Committee Stage to deal with this.”
“Alongside the Health Bill 2006 and the Medical Practitoners Bill 2007, I am reinforcing standards and enforcement, this Bill demonstrates once more the Government’s commitment to ensuring patient safety in legislation, in regulation and in enforcement action.”
“I look forward to its passage through the Oireachtas and enactment at an early date.”
Details of the Bill
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.
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 3 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 3 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.
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 practice 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 Practice 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. Secondly, 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.