Dáil Éireann Debate, Tuesday - 7 November 2023
1294. Deputy Pádraig O'Sullivan asked the Minister for Health if he is concerned about medicine shortages this winter; what steps are being taken to ensure that a serious shortage is avoided; and if he will make a statement on the matter. [48491/23]
View answerThe causes of medicine shortages are multifactorial, including shortages of raw materials, manufacturing difficulties, increased demand and product recalls due to potential quality defects. Shortages of medicines are not unique to Ireland and there is no evidence that shortages disproportionately impact patients in Ireland compared to other countries.
At a National level, my Department is currently progressing several work streams to enhance the national system for the management of shortages, for example:
• Medicines Shortage Framework
• Pharma Package
• Medicines Substitution Protocol (MSP)
• Exempt Medicinal Product (EMP)
Ireland has medicines shortage framework in place which is operated by the Health Products Regulatory Authority (HPRA) on behalf of the Minister for Health. The Medicines Shortages Framework’s aim is to help avert potential shortages from occurring and to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise. The multi-stakeholder framework includes representation from the Department of Health, pharmaceutical industry, healthcare professionals, the HSE, and patients.
In the case of medicines that are used most often in Ireland, when there is a shortage, there are typically multiple forms, strengths, brands and generic medicines available from a range of sources. In the event that there are some supply issues for individual medicines, alternative options such as alternative strengths, brands and generic medicines may be available to ensure continuity of treatment. My Department maintains regular contact with the HPRA regarding medicines shortages.
Department staff are working on the proposed pharmaceutical legislation revision being delivered under the European Pharmaceutical Strategy. This aims to enhance the security of supply of medicines and to ensure medicines are available to patients, regardless of where they live in the EU.
The introduction of a Medicines Substitution Protocol (MSP) would allow Pharmacists to supply a specified medicinal product under the strict direction of a protocol drafted by clinical experts and approved by the Minister and without the need to seek authorisation from the prescriber. It would only be used when other existing measures are likely to be ineffective and in certain, defined serious shortages. It should be noted that unlike the UK’s Serious Shortage Protocol framework, implementation of a framework for MSPs is not necessary in Ireland for generic substitution as this mechanism was introduced under the Health (Pricing and Supply of Medical Goods) Act 2013 and already allows pharmacists to substitute prescribed medicines from a list of interchangeable medicines, which is published and maintained by the HPRA. Work is ongoing in the Department to progress the implementation of this protocol.
There is also a mechanism in Ireland that allows for the supply of unauthorised medicines: the Exempt Medicinal Product (EMP) route. Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations includes an exemption which enables practitioners to prescribe a medicine as an exempt medicinal product (EMP) under that practitioner’s direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.
As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country carried out by the respective competent authority for medicines in that state.
At a European Level, there are several work programmes ongoing in which Ireland is heavily involved, aimed at preventing and mitigating the impact of shortages. A Task Force on the Availability of Authorised Medicines and the European Commission’s Joint Action on Shortages was initiated in January 2023. This work is aimed at tackling the root causes of shortages as well as preventative and mitigation measures for the EU.
On 24th October the European Commission published a statement on “Addressing Medicines Shortages”. This details the wide range of measures underway or being proposed at EU level to work collectively to improve medicines availability. One measure is The European Voluntary Solidarity Mechanism, an EU wide initiative aimed at optimising medicines availability for all European residents.
