Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020

Baroness Bowles of Berkhamsted Excerpts

Friday 27th November 2020 Lords Chamber

[Baroness Bowles of Berkhamsted (LD) [V]]

My Lords, it is not that long ago that, in the context of the internal market Bill, we discussed the unitary nature of patent protection in the United Kingdom. Now we find that it is not quite so for the time extensions gained through supplementary protection certificates that can be given to effectively extend patent terms when initial market approvals have eaten up the time available under the original patent term. I want to continue probing in the areas that have been opened up by the noble Lord, Lord Lansley, and the noble Baroness, Lady Wheatcroft.

For some time before us there may still be UK-wide authorisations, but as a kind of legacy, which will in future be split into Northern Ireland and Great Britain authorisations. If they started together and protection certificates exist, then they will continue. But at some point we will get to the position where authorisations come separately for Great Britain and Northern Ireland, depending on whether they are from the EU side or the Great Britain side. Applications for supplementary protection certificates will be made based on the first one that is achieved. If the other part of the jurisdiction also has a marketing authorisation before the end of the patent term, then that can be added in and it all proceeds.

In practical terms, I guess that pharmaceutical companies will try to ensure that they have both sets of marketing authorisations in place by the end of the patent term. However, it is possible that that will not happen. This can come about without the supplementary protection certificate if you have marketing authorisations in one part of the UK and not in the other. That raises the question of what happens to the goods: will they actually flow freely from one part of the United Kingdom to the other under the non-discrimination principle for goods in the internal market Bill, or will there be some kind of restriction? I understand fully that there are restrictions on what you can do between a place that is patented and a place that is not, but I am interested in how this interacts with the internal market Bill.

If we have that position, whether it comes about during the extended term or not, what happens to the licensing of drugs for use by the NHS under NICE? They will have different prices in different places, at least in theory. How will that operate, and how will it come about that you can get even treatment across the United Kingdom under the NHS?

This will not be the only instance when we will have such situations; they will happen in REACH. Can the Minister advise whether it is necessary, for example, always to have authorisations in both parts of the United Kingdom in this instance to enable marketing throughout the United Kingdom? I do not see how this is clear at all, unless you are going to say that there is no possibility of that trade between Northern Ireland and Great Britain.

I confess to also being confused about why the paediatric extension was not in the Northern Ireland protocol. As far as it appears from the explanations, that is at risk of being lost if the original market authorisation is not obtained in time to come under the supplementary protection certificate. That seems to potentially remove it. It is for only six months, but it has a valuable use.

That is all I need to say on the matter, as most of the other questions have been asked. I know that this debate is primarily about the supplementary protection certificates, which are probably the simple part of this—it is just a recording of where you got the authorisations and therefore where the extension can apply. The complexity comes with what is happening to the United Kingdom internal market. If the Minister does not feel he can give an answer to that right now, could he please write to lay out clearly the interaction between marketing authorisations, the internal market Bill and, taking into account costs, what may or may not be licensed by NICE?