Brexit

Following the United Kingdom’s (UK) decision to leave the European Union (EU), the PSI has been engaging with government departments, regulatory counterparts in the UK, 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 continuing to work to address the changes that will arise, including in a no-deal scenario, for 1 November 2019.

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 Great Britain and 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. In addition to a general review of the routes of recognition/ registration that the PSI Council has been undertaking, the Council approved a policy position and proposed 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 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 of the EU Directive (2005/36/EC). The PSI consulted on this change in September and updates on this contingency arrangement will be shared in October. 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 before the withdrawal date will not be affected by Brexit, meaning a pharmacist who qualified in the UK 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, the HSE, and many others 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.

It has been clearly stated by the Department of Health that hospitals, pharmacists or patients should not 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 patients and wider society where challenges may arise. Pharmacists and other health professionals have an important role to play in providing accurate information to people to avoid disruption and aid understanding of Ireland’s medicines supply arrangements.

Shortages exist already in the market, without any relation to Brexit, and the existing Medicine Shortages Framework in place by the HPRA will continue to be used to manage shortages and seek to reduce the impact on patients and healthcare professionals.

Access to cross-border health services and validity of UK prescriptions are all part of Government contingency planning with the latest information available on www.gov.ie/Brexit

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.

Pharmacies and health services must also consider what additional protections they need to put in place if they share personal data between Ireland and the UK. If personal data is transferred, for any reason, Irish entities need to continue to maintain compliance with our GDPR obligations. 

Visit 'Brexit and Business' on the www.gov.ie/Brexit website for more information.

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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