Official Report: Minutes of Evidence

The Chairperson (Mr Gildernew): I welcome by video link Mr Canice Ward, senior principal pharmacist; Mr Chris Garland, senior principal pharmacist; and Ms Bernie Duffy, head of medicines policy branch. You are all very welcome to our meeting. Thank you for attending. I will now go to members' questions.

Mrs Cameron: Thank you, panel, for your attendance. Have the Executive received a reply to their request that the falsified medicines directive does not come into effect in NI from 1 January?

Mr Canice Ward (Department of Health): The discussions are ongoing. We hope to have some sort of resolution shortly but, as of yet, no.

Mrs Cameron: OK. What is the situation with current UK licences for products being sold in Northern Ireland? Is the Minister working with the industry to support continuity?

Mr Chris Garland (Department of Health): The current UK licences will still be eligible in Northern Ireland at the end of the transition period. As regards ensuring continuity of supply, we are working with the Department of Health and Social Care (DHSC) on a multilayered national contingency approach with a number of strands, including ensuring additional buffer stocks on UK supply and rerouting additional freight capacity away from the short straights. That work is ongoing. We are working very closely with DHSC and national colleagues on that.

Mrs Cameron: OK, thank you. My next question is on the next item. Do you want me to leave it?

The Chairperson (Mr Gildernew): Is it on the second SI?

Mrs Cameron: Yes. Will I just ask it?

The Chairperson (Mr Gildernew): Oh, yes. Go ahead now.

Mrs Cameron: How advanced are plans for a large-scale immunisation programme for COVID-19?

Mr Ward: Pam, it is separate colleagues in the Department who manage that. We are here to talk about the legislation, but we can get back to you with an update on that offline.

Mrs Cameron: Sorry, I could not quite make you out, Canice. Could you repeat that?

Mr Ward: Other colleagues in the Department are responsible for vaccination programme planning. We can ask for an update from them for the Committee.

Mrs Cameron: That would be appreciated; thank you.

Mr Ward: No problem.

The Chairperson (Mr Gildernew): Canice, on the Human Medicines (Amendment Etc.) (EU Exit) Regulations, has any assessment been done of the potential impact on the supply of medicines, or is the assessment that it is addressed sufficiently to ensure that there is no interruption to supply?

Mr Garland: Colin, the multilayered approach that I mentioned outlined a number of mitigations that are designed to ensure the continued availability of medicines to Northern Ireland. We continue to work very closely with the Department of Health and Social Care and the other UK countries on that. Our priority is to ensure the continued availability of medicines to Northern Ireland, certainly in the context of the protocol. We are part of a working group, led by the Department of Health and Social Care and working with industry, that is exploring what measures need to be put in place to maintain that in the longer term as well. However, a number of shorter-term mitigations have already been put in place, particularly around the continued availability of goods that are already on the market prior to the end of the transition period. The MHRA has released guidance on that for industry with a clear definition of what is meant by "goods on the market". These goods will continue to be able to circulate freely between GB, Northern Ireland and the EU from 1 January.

The Chairperson (Mr Gildernew): Thank you.

Mr Buckley: This follows neatly on from that point. With 98% of medicine supplies coming through GB to Northern Ireland, there is indeed a lot of concern as to the future of medicine supply in Northern Ireland if there were to be a divergence in rules and given the many unanswered questions in respect of the protocol. You briefly mentioned exploring options. Could you elaborate a wee bit on that in respect of ensuring that there is continuity of supply for patients, particularly those with oncoming illnesses and how they can be prioritised?

Mr Garland: A number of options are being worked through with industry. I cannot provide you with the full detail of those at the minute because some are linked to ongoing negotiations between the EU and the UK. However, a number of potential long-term mitigations are being explored with industry. Ultimately, the decision as to the particular mitigations will be a matter for commercial companies. Individual companies will consider their own supply chains and what works best for them. However, we are very clear, from the messaging that we are getting from industry, that they are very willing to work with us to maintain the continuity of supply of medicines to Northern Ireland.

The Chairperson (Mr Gildernew): OK. Thank you, Bernie, Chris and Canice for your written briefing and your answers to the Committee's questions. We appreciate your taking the time to join us. We will now give these SIs further consideration.

Are members content to note the SIs?

Ms Bradshaw: Sorry. Colm?

The Chairperson (Mr Gildernew): Go ahead, Paula.

Ms Bradshaw: I did not ask a question because I thought that the briefing that they supplied was very comprehensive. I would like to put on record my thanks for the additional information that the Committee received.

The Chairperson (Mr Gildernew): Thank you.