Mr. Padraic O'Brien:

Before we move on from the Brexit issue, it is worth pointing out, as Mr. Delaney noted, the enormous time, effort, energy and cost that MFI members have expended in preparing for continuing the supply to Irish patients post Brexit. Every industry has experienced logistical risks and delays because of Brexit. Given that the supply of medicines is such a regulated industry, as it should be, the impact of Brexit for our members in Ireland was profound. The decentralised procedure, DCP, is at the centre of the discussion for Northern Ireland and it had equal effect for MFI members who accessed the procedure known as share packs. For all intents and purposes, we could pool our demand with the UK in order to supply Irish patients. A share pack contained all the regulatory information to satisfy both the UK regulator, then the Health Research Authority, HRA, and the Irish regulator, the Health Products Regulatory Authority, HPRA. The required content was stated on the pack. That situation can no longer continue post Brexit, which means we had to perform all the regulatory tasks to make that happen, which was expensive and required a lot of effort. It also means compartmentalising the market. Demand could previously be pooled and one batch of products could be run off for both markets but, going forward, that can no longer happen. Efficiencies are therefore lost. Economies of scale could be triggered in the past, which meant that generics could be launched in markets because that demand was shared. Now, however, Ireland must access an Ireland-only pack and must stand alone and satisfy minimum order quantities, etc., which it did not have to do in the past.

Thankfully, MFI members have been very successful in ensuring we can avoid delays and continue to launch generic products. Not only do generic products provide savings for the State, which is the ultimate payer for the majority of our drugs, but those savings are reinvested in future novel medicines that are on patent. It provides the affordability for Irish patients to be able to access those products, as the committee knows. While MFI members have so far been very successful, it should be noted that the removal of the economies of scale that existed in the share-pack system under the DCP, which served the Irish market very well over a number of years, means the reduction of the viability of the supply of some products into the Republic of Ireland. Supply should never be taken for granted. We are in a good place and the evidence so far is that we will continue to supply in a controlled manner. However, at the same time, supply of medicines should never be taken for granted. The global supply of medicines is interconnected to supply in a small market like ours. Markets in Ireland are affected by dynamics in other countries across Europe. We are in a good place and that is because of the hard work, effort, energy and expense of members of MFI.