(7 years, 1 month ago)
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I beg to move,
That this House has considered the future of medicines regulation.
What a pleasure it is to see you in the Chair, Mr Davies. I am very pleased that you have been elevated to the Panel of Chairs. Yesterday, the European Parliament agreed to move the European Medicines Agency from London to Amsterdam. Today, we are asking the Minister to tell the British Parliament what will happen to medicines regulation in this country after we have left the European Union. My concern arises from the fact that I have a GlaxoSmithKline plant in Barnard Castle in my constituency that employs 1,200 people. Winston Churchill decided that production should take place in the middle of the Durham countryside, so it would not be hit by Hitler’s bombs; I certainly hope that it will also survive the Government’s Brexit.
I congratulate my hon. Friend on securing this timely and important debate, and declare an interest as the chair of the all-party parliamentary group on off-patent drugs. Does she agree that, irrespective of what happens with the Brexit negotiations, the Government should guarantee that any patient who needs access to drugs will not wait any longer as a result of Brexit?
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.