Mr. David Delaney:

I thank the Senator, there are some very interesting questions there, three of which I took a note of. I will go through them and then I will ask Mr. O'Brien to contribute to the other questions.

On the work by Commissioner Šefovi last week, it is very much welcome. It is steady progress from the initial non-papers that the Commission had discussed with industry about a month ago. The industry has been heavily involved in discussions with Commissioner Šefovi and with regulators. By industry, I mean ourselves, the wholesalers, pharmacists, parallel importers and distributors. It is very clear that Commissioner Šefovi and team have listened acutely to the concerns of industry and not just the concerns; they also listened to the solutions. When we pointed out the various regulatory challenges that exist, including the fact that current temporary derogations and waivers expire at the end of this year, it is clear that the Commissioner and his colleagues in DG SANTE and around the Commission have really listened. I wish to thank the Commission and a number of the key actors in the Commission, such as Commissioner McGuinness, as well as a number of MEPs who have been extremely open to the evidence from industry to try to help Commissioner Šefovi to craft a better set of policies.

We welcome the latest iteration of the Commissioner's policies but I again caution that while this is a large step down the road, there remain a number of uncertainties that revolve around what I would broadly call licensing issues. A lot of the checks on many goods and services have diminished, or will diminish should the Commissioner's proposals be followed through in their entirety. That will mean a lot of checks will be reduced and that is to be welcomed. However, the questions that I, Mr. O'Brien and the leaders in our trade association think about at the moment relate to what is really going to happen with licensing. It would appear that the Commissioner's proposals will call on almost every professional person receiving medicine in Northern Ireland to have what is called a wholesale distributor's authority licence. That is quite impractical. Perhaps it is an unintended consequence of the Commissioner's proposals but we would like some clarity on that.

Without getting into the minutiae, the main regulatory issues remaining relate to whether the same box of medicine currently for sale in Birmingham will be available in Belfast on 1 January. That is somewhat unclear because we do not know if the licensing and supervisory authorities in the UK will be authorised to move that medicine to Northern Ireland. We do not know if that medicine will still be dispensable in Northern Ireland.

Some regulatory challenges come to my mind. Commissioner Šefovi's proposals refer to another authorisation number being affixed to a box of medicine when it comes into the UK to show that it will go to Northern Ireland. Who will supervise that activity? Will it be the UK authorities? It would make sense for the UK authorities to supervise this new authorisation number. It would be politically challenging for the UK to foresee a circumstance where the European Medicines Agency, EMA, or another European regulatory authority, would have to attach an authorisation number to a box of medicines moving from the UK to Northern Ireland. There are a number of regulatory challenges which Commissioner Šefovi's proposal has addressed. Before his proposal, it was inevitable that medicines that were licensed in Europe and not England, Scotland or Wales would not be available for sale and use in Northern Ireland. That appears to have been clarified but a number of outstanding questions remain. The solution is more discussion and detail. Let us hear the response from the UK authorities. The nub of the challenge for the UK is that a number of Commissioner Šefovi's proposals revolve around European authorities having a supervisory or regulatory role within Britain which I think is a challenge that must be overcome because, obviously, Britain leaving the EU was a clear sign of its intention to step away from EU regulatory authorities.

The Senator also asked about the pharmaceutical sector, opioids and the TRIPS waiver. Mr. O'Brien may wish to come in on some of those questions. I will take the questions about the pharmaceutical sector, if that suits Mr. O'Brien.