Medicines Regulation

Jim Shannon Excerpts

Tuesday 21st November 2017 Westminster Hall

[Helen Goodman]

In one sentence, my hon. Friend gets to the nub of the issue; I will probably take 20 minutes to reach it. He is absolutely right. The problem is that the Government did not make a plan, and as yet have not resolved how they will regulate medicines from 1 April 2019. I have been asking about that for a year. We have had no clear explanation, no policy statement, and no impact assessment. The Government refused to debate the matter in the course of the legislation for triggering article 50. We have not been able to debate it properly as part of the scrutiny of the European Union (Withdrawal) Bill, which is in Committee today, in parallel with our debate.

We are therefore extremely interested to hear what the Minister will say, especially as two months ago there were leaks from the Department of Health that the Secretary of State was flirting with the idea that we should leave the EMA and join the American Food and Drug Administration. I was particularly surprised that that was being floated, because the Association of the British Pharmaceutical Industry has said consistently that it thinks that we should be aligned with EMA standards. Alignment with Europe on regulation of medicine does not simply mean having the same rules on exit day; it means having a mutual recognition agreement with the EMA, and continued alignment of future regulations as they change, which they inevitably will.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Lady on what she is saying. Obviously, as a Brexiteer, I probably have a very different opinion about what will happen on 31 March, but that is by the bye. Does she agree that it is imperative that the phenomenal work done by the Medicines and Healthcare Products Regulatory Agency and the EMA, which she referred to, can continue? Ensuring that we are able to supply safe and effective medication not simply to the UK but to all nations worldwide must be high on the priority list of the Brexit team. That is something that she and I very much agree on.

[Helen Goodman]

The hon. Gentleman truly is a gentleman, and I agree with him entirely. We want to see continued UK participation in EU regulatory and medicine safety processes as well. The ABPI has also said, reasonably enough, that it wants to maintain trading terms equivalent to being a full member of the customs union, and to have a common system for VAT.

In May, the EMA and the European Commission issued a statement saying that if the United Kingdom does not stay in the single market, stick with the EMA, or join the EEA—the European economic area—but goes for a clean break, drugs made in the United Kingdom will no longer be authorised for use in the European Union, and drugs made in the European Union will no longer be authorised for use in the UK. Tackling that would involve costly and time-consuming checks. It could even mean that the availability of drugs would diminish dramatically.

What response have the Government made to that statement? What practical steps have Ministers taken? All we have seen is a letter from the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy to a newspaper, which said that they want a “close working relationship” with the EU, and that patient safety matters, as does certainty, long-term stability, and innovation. The letter said that Ministers will set up a regulatory system with competitive fee pricing. This afternoon, we would like the Minister to explain that.

Currently, the UK Medicines and Healthcare Products Regulatory Agency—MHRA—contributes to the EMA’s work, and the UK pays approximately a fifth of the overall costs. It is universally acknowledged that the MHRA could not take on the task of licensing all drugs without astronomical costs for the industry and the taxpayer.