Brexit

Following the United Kingdom’s (UK) decision in 2017 to leave the European Union (EU) on 29 March 2019, the PSI has been engaging with government departments, regulatory counterparts in the UK and Northern Ireland, and others in relation to changes that will impact on the PSI’s functions, and the wider health and pharmacy environment. Brexit of any kind means change, and in line with the whole-of-Government response to Brexit, the PSI has considered a broad array of challenges and assessed the risks that generally and particularly relate to our work and the wider health and pharmacy sector.

We are working to be ready to address these changes as best we can, and to support others where changes may impact pharmacists, pharmacies and the continuity of safe and effective patient care.

Recognition of qualifications

The PSI is responsible as the competent authority in Ireland for the recognition of pharmacist qualifications. To recognise a qualification, the PSI must be able to verify that pharmacists have attained the necessary standard of academic and practical training, amongst other requirements. Pharmacists must obtain recognition of a qualification appropriate for practice before being able to apply to register. The PSI operates three routes of recognition/registration to the pharmacist register: the national route, EU/EEA route and third country qualification recognition route.

The legal basis underpinning the recognition of qualifications between Ireland and the UK will change following Brexit. Subject to any transitional arrangements, this will have consequences for people holding a qualification obtained in UK/Northern Ireland who seek recognition of this qualification here.

The PSI has been engaged in reviewing and putting in place means of handling changes that will apply, mindful of those who will seek access to practice in Ireland. The Council is reviewing the routes of recognition/registration. One part of this, is the review of the third country route of recognition to streamline and reform the process for all applicants applying with qualifications from outside of the EU irrespective of nationality. In addition to that general review, at its March 2019 meeting the Council approved a policy position and technical amendment to the PSI (Registration) Rules so that the PSI will be able to operate an efficient and practical approach to qualification recognition under the third country recognition route in the case of a no-deal Brexit occurring. This will rely on the equivalence of a qualification, including UK and Northern Irish qualifications obtained before or in progress before the UK’s departure date from the EU, provided they are listed in Annex V and are compliant with the requirements of Article 44 (EU Directive (2005/36/EC). The Rule change must be approved by the Minister for Health.

The PSI has been engaging with regulatory counterparts in the General Pharmaceutical Council UK, the Pharmaceutical Society of Northern Ireland, and with the Department of Health and national health and social care regulators in relation to these matters, with a view to maintaining efficient and effective recognition and registration procedures post-Brexit.

Please note that decisions taken in Ireland on the recognition of professional qualifications that were obtained in the UK/Northern Ireland before the withdrawal date will not be affected by Brexit, meaning a pharmacist who qualified in the UK/Northern Ireland and is now registered in Ireland remains registered.

Also, the UK has published its draft European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2018 which it is intended to enact in the case of a no-deal Brexit. This legislation will enable Irish qualifications to be recognised in the UK.

National position on medicines

As part of the whole-of-Government response to Brexit, the Minister for Health has outlined a comprehensive set of preparations to ensure continuity of health services and supply of medicinal products in the event of a no-deal Brexit. The Department of Health has outlined that Ireland is unlikely to face an immediate impact on medicine supplies in the period immediately after 29 March. This is because there are already additional stocks of medicines routinely built into the Irish medicine supply chain.

The Department of Health, together with the HPRA and the HSE, has been working to protect the availability of medicines for Irish patients post-Brexit, acknowledging the extent of medicines moved through the UK to get to Ireland. A significant amount of contingency planning for both an orderly and a disorderly Brexit has been undertaken by the Department, HSE and HPRA in conjunction with the pharmaceutical industry and medicines wholesalers.

Therefore, there is no need for hospitals, pharmacists or patients to order extra quantities of medicines, or for doctors to issue multiple prescriptions for the same medication. The impact of doing so will have a knock-on effect on managing existing stock levels and hamper the supply of medicines for other patients. All involved must balance the interests of their patient and wider society where challenges may arise.

The existing Medicine Shortages Framework in place by the HPRA is, and will be, used to help prevent shortages from occurring and seek to reduce the impact of shortages on patients and healthcare professionals by co-ordinating the management of potential or actual shortages as they arise.

Other considerations

In the event of a no-deal Brexit, the UK will be treated as a third country for the purposes of processing personal data. The PSI is working to maintain robust data protection arrangements and to ensure the appropriate sharing of information, post Brexit, in accordance with the law, as it relates to the protection of the public and their safety.

The PSI is maintaining close engagement with all relevant parties in relation to these and other matters and will provide information as it arises to PSI registrants. We aim to keep this webpage updated with information as it is made available.

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