Barry Andrews (Dún Laoghaire, Fianna Fail)

I am responding to the Deputy on behalf of my colleague, the Minister for Health and Children, Deputy Harney.

The profession of pharmacy has undergone a dynamic change since the Pharmacy Act 2007 was passed by the Oireachtas in May 2007. The latest stage of this transformation, which began with the commencement of additional sections of the Act on 28 November, includes the new registration regime for retail pharmacy businesses.

Registered pharmacists and pharmacies have a privileged position of responsibility in the sale and supply of medicinal products to the public. However, with this position of responsibility comes an obligation to maintain the trust that the public places in the profession. It is important that the public have confidence in the compliance of the pharmacy sector with the laws governing the provision of medicinal products and the operation of the premises used to provide this service. The registration sections of the Pharmacy Act 2007 set out to achieve this by putting in place a modern and robust regulatory regime for the pharmacists and their retail pharmacy businesses. Under this new regime, the Pharmaceutical Society of Ireland, which will have increased powers of inspection and, where necessary, enforcement, will be in an enhanced position to monitor the application of the laws regarding the storage, sale and supply of medicinal products in retail pharmacy businesses.

The Pharmaceutical Society of Ireland has been, and continues to be, a self-financing body. In arriving at a fee for the provision of the new registration regime for retail pharmacy businesses, the society engaged PricewaterhouseCoopers, PWC, to develop an evidence-based methodology for the determination of registration fees. In engaging in this exercise, the society sought to put in place a viable and sustainable self-financing structure for the provision of the regulatory regime required under the legislation. The process undertaken by PWC included a comparative analysis and benchmarking of the provision of pharmacy business registration services against comparable international pharmacy regulators. The aim was to identify the appropriate costs of the registration process to the society and allow for the allocation of these costs in a proportionate manner.

The PWC study found that regulators in very few other jurisdictions have such a comprehensive scope as the Pharmaceutical Society of Ireland in terms of its statutory obligations and role in public safety. With respect to our closest neighbours, the Royal Pharmaceutical Society of Great Britain, RPSGB, and the Pharmaceutical Society of Northern Ireland, PSNI, are primarily representative bodies, with little statutory responsibility. The arrangements for registration in Northern Ireland and Britain are also substantially different. The primary inspection and enforcement functions of pharmacy and medicine law are carried out by Government agencies such as the Department of Health, Social Services and Public Safety in Northern Ireland. The pharmacy registration fee in England, Scotland and Wales in 2007 was €683, with all statutory inspection and enforcement and the regulation function resting with other statutory agencies. The United Kingdom is currently establishing an independent regulator similar to the Pharmaceutical Society of Ireland. It is likely, therefore, that once this regulator — the general pharmaceutical council — is established in 2010, the position in the United Kingdom in terms of regulation and the funding of such regulation may change.

The Pharmaceutical Society of Ireland undertook the PWC process in order to estimate as accurately as possible the cost of the new services. It has also undertaken to keep the fees for the registration of retail pharmacy businesses under review throughout 2009 and to update the position regarding their appropriateness when preparing its 2010 fee submission. The Minister is satisfied that every effort has been taken to determine a fee for the registration of retail pharmacy businesses that is proportionate to the level of service required by the general public and the pharmacy profession in respect of the supervision of retail pharmacy businesses. The registration fees for individual pharmacists and pharmaceutical assistants have not increased for 2009.