Mr. David Delaney:

It is a great honour for us to be invited to appear before the committee today, and we are delighted to take part in the meeting. I will briefly introduce myself, our organisation and the vice chairperson, Mr. Padraic O'Brien. I am the chairperson of Medicines for Ireland, a pharmaceutical trade association in Ireland whose members supply, on average, the majority of medicines every day across Ireland to the HSE, to pharmacists in the retail and hospital settings and to patients. Our medicines typically cover generic medicines, excellent value medicines to the Irish Exchequer that have saved billions of euro and driven up access over many years to key therapeutic areas. We also supply biosimilar medicines and over-the-counter medicines. It is a range of medicines, many of which are household names which we will not go into today. Some of our members include companies that are familiar to the committee, such as Pinewood Healthcare, Clonmel Healthcare and Accord Healthcare. My company is Viatris. It is a large American healthcare company. We have approximately 2,000 staff in Ireland, with production and research and development facilities in Galway, Cork and Dublin.

Rather than reading my opening statement, which I am sure the members of the committee have read, I will start by saying that the industry in Ireland has been in constant contact with all the authorities across Europe, particularly in Britain and Ireland and especially the regulators, preparing for Brexit. As Mr. Muiris O'Connor from the Department of Health said earlier, we are very happy to see that there have been no significant shortages of medicines in Ireland as Brexit became a reality. Our industry has been preparing for Brexit for at least three years.

We have invested millions and millions of euro, not only in Ireland but also in our production facilities in India, Hungary, France and Germany, to change the production lines, to change the packs and to change the coding on the packs. As Mr. O'Connor mentioned, we have invested significantly in the shipping routes and the logistical efforts. Millions and millions of euro have been invested by our industry to ensure that in Ireland, hopefully everybody on the call today, and all of our friends and family, generally speaking, have experienced no shortages. We have come hell of a long way.

At this stage, in relation to Northern Ireland our companies are the companies that supply the majority of medicines in Northern Ireland. In general. we are represented through our UK trade association but we work closely with that trade association and we share our members. On the Northern Ireland piece, while it has been a success in the Republic of Ireland with no shortages due to Brexit, I am optimistic but a bit concerned that there is a job of work left to be done to give us some sort of certainty for the supply of medicines into Northern Ireland for our families, friends and communities. I am concerned and our organisation is concerned. We have had a massive investment to get ready for Brexit and a massive investment to prepare for Covid and to see Ireland through Covid with no shortages but at such a time of uncertainty there is one remaining uncertainty, which is Northern Ireland. While it is only 3% of the UK market, and it seems like a very small market, I am aware that it is a place that is very close to the heart of all committee members. I see the amazing work this committee has done by providing a platform for civil society to talk about these issues related to the UK's withdrawal from the EU and I am aware that the whole committee is very much focused on this issue.

We are optimistic but we are a little bit concerned. We welcome the EU's latest announcement last week from Commissioner Šefovi. We continue to work hard with the European Medicines Agency, EMA, the Health Products Regulatory Authority, HPRA, and with the Department of Health but there are a number of challenges left to overcome. Mr. Padraic O’Brien and I will outline those to members shortly. We would love to hear the committee's views, and we want to give members a sense of where we are at and potentially some solutions to try to take away the uncertainty. Uncertainty is extremely unhelpful to patients in Northern Ireland, and certainly to my friends and family in Northern Ireland. Uncertainty is also quite disastrous for the industry. If one can picture it figuratively speaking, Mr. O'Brien and the rest of the leadership of the pharmaceutical companies in Ireland and those in our trade association, are asked daily if not weekly "How many packs for Northern Ireland and how many for various small places across Europe?". The questions then quite quickly drill down into "What is the regulatory framework like, what is the price, how are you shipping?". When we cannot really answer those questions for Northern Ireland it poses a risk and an uncertainty, which is no good for pharmaceutical companies that need to plan in advance and it is certainly no good for patients who could begin to feel anxious and worried.