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

Chi Onwurah Excerpts

Thursday 19th November 2020 General Committees

[Chi Onwurah (Newcastle upon Tyne Central) (Lab)]

It is a great pleasure to serve under your chairmanship for the first time, Ms Ghani, and to follow the Minister—not for the first time. I welcome her opening remarks and I share her support for the United Kingdom’s world-beating life sciences sector and the fantastic innovation that it shows, for which we are particularly grateful as we face the pandemic. I agree that patents must recognise the balance between rewarding innovation and ensuring the diffusion of the often life-saving treatments, medicines and products that they protect. I also welcome the levelling of the playing field for IP attorneys, about which we have corresponded.

The UK’s relationship with its closest neighbours following the end of the transition period is yet to be decided. The Government’s ongoing negotiations are causing confusion and uncertainty for businesses across the United Kingdom. The shadow Northern Ireland Secretary, my hon. Friend the Member for Sheffield, Heeley (Louise Haigh), set out yesterday the immense frustration in Northern Ireland at the Government squandering vital time to prepare for the biggest changes that it has ever known in its trading relationship.

The Opposition wish to do everything we can to ensure effective preparation, certainty and readiness, so we will not oppose the statutory instrument and we welcome the measure of certainty that it provides. I have some brief questions, however.

As the Minister set out, following the end of the transition period and the introduction of the Northern Ireland protocol, the way in which some patent medicines and agrochemicals are regulated will change. New marketing authorisation procedures will therefore be required for those products in certain parts of the United Kingdom. The European Union’s SPCs apply to specific pharmaceutical and plant-protection products. They are designed, as the Minister said, to offset the loss of patent protection by products that occur due to the compulsory and, rightly, often lengthy testing in clinical trial phases, and are valuable intellectual property rights, taking effect when a patent expires.

The draft statutory instrument will change the existing legislation on SPCs and the authority of marketing authorisations across the whole UK. At present, two marketing authorisations are valid in the UK: the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency. Post-Brexit, marketing authorisations from the EMA will need to be converted into the UK equivalent. However, under the Northern Ireland protocol, Northern Ireland will remain bound by the EU law for the authorisation of medicines and agrochemicals, meaning that there will be separate marketing authorities for Northern Ireland and Great Britain.

Will the Minister provide the Committee with examples of the companies and products that she envisages will take advantage of this situation? Having spoken to the IPO, I know that a limited number of SPCs are granted generally—there are only 70—but the Committee would benefit from some examples so that we can know how the legislation will be used. I note that an impact assessment has not been undertaken, because of the limited impact, but we would benefit from understanding how the Government envisage the SI being used.

The SI will allow an SPC to be granted based on whichever authorisation the applicant has at the point of application. If the SPC enters into force with a marketing authorisation covering only one of either Great Britain or Northern Ireland, the protection provided by the SPC extends only to that territory, as the Minister set out. An applicant may submit an additional marketing authorisation allowing protection to be extended to the whole of the UK.

Ensuring minimum friction between Northern Ireland and Great Britain is of the utmost importance. The Prime Minister promised exactly that just over 12 months ago. My understanding—this follows on from my first question, and I discussed it briefly with the Intellectual Property Office as well—is that the draft statutory instrument could lead to drugs and agricultural products being available in Northern Ireland under different conditions and circumstances from Great Britain, in terms of whether they can be reproduced or generic equivalents can be sold.

A general impact assessment has not been performed, so I would like to know whether the Government have looked at the implications. If drugs are available under different rules, in different circumstances or with the different extent of a patent in Northern Ireland and in Great Britain, is there a possibility of that causing issues, advantages or incentives for trade or movement between Great Britain and Northern Ireland? Will the Minister reassure us that that has been considered?

Finally, will the Minister, representing the Government, provide a commitment to firms that trade in medicines and agrochemicals between Great Britain, Northern Ireland and the Republic of Ireland that the rules and regulations will not change in how they evolve, in order to provide long-term security to British and Irish businesses? The Labour party will not oppose the draft SI, and we are happy to work with the Government in future to ensure the safety of agricultural and medicine products, as well as frictionless trade between all the nations in the United Kingdom.