Oireachtas Joint and Select Committees

Tuesday, 19 October 2021

Seanad Committee on the Withdrawal of the United Kingdom from the European Union

Cross-Border Healthcare Directive: Discussion (Resumed)

Mr. David Delaney:

I will take the question on the medicines reserve and ask Mr. O'Brien to respond to the question on the logistics.

As I mentioned earlier, we have come through the brunt of Covid quite well in Ireland in terms of medicine supply and no shortages. That is down to the extremely flexible forward-thinking regulators that we have in Ireland, the policymakers in the Department of Health and the civil and public servants around the system, in particular in the HSE on the procurement side in the corporate pharmaceutical unit. They have been helpful and visionary. We did not sit on our laurels, move licences around and panic and worry behind the scenes in terms of trying to get the medicines, in particular ICU medicines, to the right countries in Europe. Last March 12 months, when we were on various calls throughout the weekends and late at night to make sure medicines were moving around Europe sufficiently to help people in ICU, we also commissioned an independent think-tank in Europe through a trade association in Europe, Medicines for Europe, to look at what longer-term solutions we need such that if we are hit by a large external shock we will not have try to reinvent the wheel, assess where the licences are in Europe, where the medicines are and who is manufacturing what and when. We took the step to invest heavily in this piece of data. At the same time as we were moving the medicines around we worked with DG Competition in Brussels to try to get clearance for them, in respect of which we were successful and are grateful for. We engaged with DG Competition on whether, at an Irish and European level, we could share among our members the data around the, generally speaking,15 ICU medicines used for the treatment of Covid patients, the information on supply and commercial availability of the medicines and the APIs to try to ensure that we have enough of these medicines in every European country. Traditionally speaking, that could have been a breach of competition law or it could have been a commercial problem for our members, but DG Competition very quickly came back to us with the legal opinion that we could share all of that information, to try to map out where the barriers are and which country has particular medicines. There is no point in one company making a huge amount of the top 13 ICU medicines when we might not have the other two in Italy or Ireland. We did all of that. We also fed all of that into a survey of our members to identify the potential policy options to make sure that we are not scrambling again in the face of an unprecedented external shock.

One of the polices, thoughts and potential interventions we came to via the independent economist in Brussels was a national medicines reserve. When Europe went through the oil shocks of the 1970s, one of the good policy choices made by a number of countries at a policy level and at a commercial level was to build an oil reserve in each country. We have shared with the committee the full paper around what a national medicines reserve would look like for Ireland, for other countries in Europe and how we would mitigate some of the potential challenges. The big challenges that come to mind include what price the NHS or the HSE would pay. Let us come up with a system for a fair and reasonable price. If the HSE is buying in bulk, obviously it should get a more competitive price.

On what happens to the medicines if they are not used after a year or two, we need to come up with a risk-sharing option whereby the industry might pay up anything from 10% to 50% of the cost to dispose of medicines in an environmentally-friendly way, with the state bearing the rest of the cost. There are other issues around where and how they would be warehoused. The Chairman raised an interesting point. The concept of a national medicines reserve could be something that is worthwhile, particularly for small countries like Ireland. It could work. We discussed this with some policymakers in Ireland as Covid was evolving over a year ago. We were alerting the policymakers to the fact that a lot of the generic medicines might take six to ten months to make, but the biological medicines take two years to make. While we could decide in the morning to establish a national medicines reserve, in terms of Covid a year ago, we really needed to try to make quick decisions because a lot of the HSE-type organisations across Europe were instigating huge tendering processes, essentially creating their own mini-medicines reserves, in particular in the UK, although it is not called a medicines reserve. The UK engaged in innovative and aggressive procurement policies. I take my hat off to the policymakers in the UK. They did this to protect patients across Great Britain. To be fair to them, the size, scale and rapidity with which they went at this problem hoovered up a huge amount of medicine supply for the British population, which it is, of course, the duty of the British authorities to do. We need everybody to work aggressively towards a medicines reserve or super procurement. If other external shocks like Covid were to hit, small countries like Ireland could be in some difficulty. We believe a medicines reserve is a great idea. We are happy to have a further engagement with the committee on that. I will hand over to Mr. O'Brien to respond to the question around the logistics and supply chains.

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