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

Baroness Wheatcroft Excerpts

Friday 27th November 2020 Lords Chamber

[Baroness Wheatcroft (Non-Afl) [V]]

My Lords, I thank the Minister for introducing this SI. I am pleased to follow the noble Lord, Lord Lansley, with his endorsement of the great achievements of our pharmaceutical industry.

In one way this legislation is very straightforward but it is also a reflection of the drastic change now under way in what is still, for the time being, our United Kingdom. It encapsulates the fact that, once the transition period ends, Northern Ireland’s relationship with Great Britain will be dramatically changed. As someone who believes in the union and is clear that it has strengthened its component parts, it grieves me to see this rupture.

Supplementary protection certificates are not common. Apparently only about 70 are issued in a year. They are important; the need to get medicines to market can be huge, and the time taken can span many years. However, as we have seen with the development of Covid vaccines, it can be done remarkably quickly in some cases, which we should all be very grateful for. Nevertheless, given the usual investment, in money and in the time that it takes to develop drugs and some agrochemicals, it makes sense to provide a mechanism that allows the usual patent lengths to be extended. That is what the SPCs do. However, the SPC relates to the marketing authority that approves the product for market, and once the transition period has ended, no matter how often we say that there will be no hard border between the UK and Northern Ireland, products authorised in Northern Ireland will not be able to apply for an SPC that would be recognised on the mainland. Equally, a product approved by the relevant regulator will only be eligible for an SPC that protects it in Britain.

Therefore, to be covered in both territories, companies will need two marketing approvals. This is not a mere technicality. When this SI was debated, or waved through, in the other place—to call it a debate is something of an exaggeration, since there were only two speakers, one of whom was the Minister—the potential risks came to light. The Minister accepted that if a product from Northern Ireland secured an SPC on the basis of an EU marketing authority, it would be vulnerable to having the intellectual property unprotected in Great Britain. There would thus be the risk of the market being flooded with generic copies of something that it had invested huge amounts in developing.

The Minister assures us that the SPC remains a UK-wide intellectual property right, but the protection that it provides extends only to the territory in which the product has been authorised. This sounds like Alice in Wonderland reasoning. What use is a property right if it does not confer protection? Can the Minister tell the House how he would define an intellectual property right? No impact assessment has been conducted on this SI, so can he put a cost on the extra bureaucratic procedures that drug manufacturers will have to go through to get wide authorisation? Also, as the noble Lord, Lord Lansley, pointed out, it is possible to extend an SPC by six months in the case of paediatric medicines. Can the Minister explain why this exception, and say whether it would be sensible for us to have it secured for any drug in this category?