Official Report: Minutes of Evidence

The Chairperson (Ms Ferguson): I warmly welcome Sean Curley, who is principal pharmaceutical officer with the Department of Health. Happy new year, Sean. When you are ready, I ask you to brief the Committee.

Mr Sean Curley (Department of Health): Happy new year, Chair. Thanks for being ahead of schedule. I got my new year's resolution up and running: I had to run up that hill. [Laughter.]

Good morning, members. Thank you for the opportunity to provide the Committee with the Department of Health's current understanding of regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management, which also amends regulation (EC) No 816/2006. My name is Sean Curley. I am a senior principal pharmaceutical officer in the Department of Health. My role today is to provide the Committee with information regarding any anticipated impacts of the regulation in Northern Ireland from a Health perspective.

As members will be aware, regulation EU 2025/2645 on compulsory licensing for crisis management, amending regulation (EC) No 816/2006, was adopted on 16 December and published in the Official Journal of the European Union on 30 December 2025. The Department of Health has an interest only in the amendment to regulation (EC) No 816/2006 on the compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, which applies in Northern Ireland via the Windsor framework's annex 2 section 7 entitled "Others". Although intellectual property (IP) rights — patents — is a reserved matter, the Department wanted to ensure that any amendments to regulation (EC) No 816/2006 would not have any negative impact on the availability of medicines in NI. As a consequence, the Department has been working closely with the Department of Health and Social Care (DHSC) and the Intellectual Property Office to understand the application of the legislation in NI.

By way of background, a patent owner can stop others copying their innovation without their permission. Patent owners can also choose to enter into voluntary agreements with other businesses to allow them to use their innovation; for example, they can allow them to manufacture their patented medicine.

However, Governments can issue a compulsory licence that permits third parties to manufacture or use patented technology without the consent of the patent owner in certain circumstances.

When it was published in 2006, regulation (EC) 816/2006 established the procedure for granting national compulsory licences within the EU in relation to patents concerning the manufacture and sale of pharmaceutical products intended for export to eligible countries. The legislation brought into force a decision made by the World Trade Organization on trade-related aspects of IP, known as "TRIPS", which sets out the requirements that must be met to allow countries to produce medicines for export to countries with health problems, where those countries do not have the manufacturing capacity to produce the medicines that they need.

The amendment to regulation (EC) 816/2006 set out in regulation (EU) 2025/2645 introduces an EU compulsory licensing system for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. At the time of the UK's explanatory memorandum (EM) in June 2023, an assessment considered the impact of the amending regulation if it were to apply in NI. The impact was expected to be limited, but, following the regulation's publication, there is now clarity that the EU system for compulsory licences will not apply in NI, as article 24 of (EU) 2025/2645 introduces an exemption for NI via new article 18c. That means that only a national compulsory licence granted by a UK competent authority can apply across the UK. As the new EU-wide compulsory licence will not apply in NI and as a national compulsory licence can continue to be granted and apply across the UK, the Department's current understanding is that the regulation should not have a significant impact on the everyday life of communities in NI. Through collaboration with the Department of Health and Social Care, we are aware that the UK Government plan to provide a refreshed EM on the adopted legislation in due course.

Members have discussed medicines and vaccines previously. It is important to clarify that a medicines marketing authorisation — the product licence — is granted and authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for the whole of the UK under Windsor framework arrangements that came into force on 1 January 2025. The authorisation of a medicine differs from a compulsory licence under IP rules, and a medicines authorisation was never in the scope of the regulation. That means that all medicines, including vaccines and medicines that are required during a pandemic or health emergency, will continue to be licensed UK-wide by the MHRA, regardless of amendments that are made to regulation (EC) 816/2006. Therefore, the Department's current understanding is that EU-wide compulsory licences granted under regulation (EU) 2025/2645 will not change NI's access to medicines and vaccines that are available in the UK, nor will the regulation change the UK's current national compulsory licensing regime on the manufacture of pharmaceutical products for export to countries with public health problems.

The Chairperson (Ms Ferguson): Thank you, Sean.

Mr Buckley: Thank you, Sean. Obviously, article 24 makes your life a lot easier before the Committee today, with the exemption for Northern Ireland.

I asked this question earlier, and you may not know the answer: it may come forward with the UK explanatory memorandum. However, the regulation has a requirement for the UK Government to take steps to ensure that products manufactured under the EU compulsory licence do not enter Northern Ireland. Does the Department understand what enforcement or protective measures will look like to ensure that that happens?

Mr Curley: I do not know too much about that, to be honest with you. However, products that are manufactured under an EU licence, if one is granted, are for countries that do not have the capacity to make those medicines. Thankfully, we are within the UK, and we have capacity, generally speaking. We hope that, if there is a health emergency or a pandemic, we will have the capacity to make such medicines, so the need for us to re-export products should be minimal. I would be surprised if it had any impact. I will leave the UK's EM to look into that, possibly.

Mr Buckley: OK. Thank you very much.

The Chairperson (Ms Ferguson): There are no further questions, Sean, so thank you very much.

Mr Curley: Thank you very much. I will not be running down the hill this time. [Laughter.]

The Chairperson (Ms Ferguson): Enjoy your wee walk down again.