Draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) (EU Exit) Order 2018

Justin Madders Excerpts

Thursday 11th October 2018 General Committees

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Bailey. As the Minister said, there is little in the draft order that is controversial; the changes it makes are of a technical nature and are necessary as we approach Brexit.

Of course, there is much wider controversy about Brexit as a whole, and—in the context of this debate—particularly about its impact on the British pharmaceutical industry. I do not believe that anyone voted to make the national health service worse off; indeed, the bus advertisements would have led people to think that they were voting for the contrary. However, the decision to leave the European Medicines Agency could have far-reaching consequences, which is why the head of the Association of the British Pharmaceutical Industry recently stated that we are seeing a British success story being broken up. Until the decision was taken, the EMA headquarters in London had approximately 900 high-quality jobs. The MHRA also played a leading role in the EMA authorisations process.

In 2016, the UK was the rapporteur on 22 applications for new medicines and co-rapporteur on a further 19. That represented 36% of the total number of applications. This year, with a much different environment envisaged, the MHRA bid for 36 contracts, but was awarded only two. Of course, there will be no more contracts in the future.

Will the Minister explain what impact the loss of contracts will have on the MHRA? Will there be any shortfall, and can the Minister confirm that any shortfall will not be made up from existing NHS budgets? As we know, the life sciences sector in our country has a turnover of more than £60 billion a year, generates exports worth £30 billion and has a trade surplus of over £3 billion per annum. It employs 220,000 people, and 25% of the world’s top prescription medicines were discovered and developed in the United Kingdom.

The north-west, where my constituency is based, is one of the leading regions of the country for pharmaceuticals, employing about 18% of the total national workforce. Projects such as the proposed Cheshire science corridor are a really important factor in that. Can the Minister indicate what he thinks the likely impact of the decision to leave the EMA will be on the sector as a whole, and what steps he is taking to minimise that? There are also potential effects on patients’ access to new medicines and treatments.

The Office of Health Economics has warned that the average likely submission for marketing authorisation in the UK could take up to three months, that up to 15% of applications could be submitted more than a year after an European economic area submission, and that some products may not be tested or marketed in the UK at all. The OHE also found that 45% of applications were not submitted to Australia, Canada or Switzerland following submission to the EMA. Can the Minister give us assurances on the risks to the general availability of prescriptions and medicines for patients?

We do not oppose these regulations, but there are much wider and more profound questions about the Government’s attitude towards medicine regulation in this country. I hope the Minister can reassure us that the Department is stepping up to that particular challenge.

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[Steve Brine]

I am not giving the hon. Lady that guarantee. I am saying that it is a live consultation and it would not be appropriate for me to pre-empt it. I do not share the hon. Lady’s half-full view of our ambition for the future, which the Prime Minister set out in terms of our relationship with the EMA. The EU does not have a relationship with the UK as a third country at the moment. That is why we have set out an ambitious proposal for our new relationship with the EU and its agencies, including the EMA. I am hopeful, as are the Prime Minister and the Government whom I speak on behalf of, that we will secure a good deal. We still think that that is the most likely outcome. That includes a new relationship with the EMA. We should remember that the expertise that we have in this country, and the work we do with the EMA, will not suddenly change because it is based in Amsterdam. It will still need that expertise and that relationship. I am ambitious about the future, which is why I say what I say.

The matter before the Committee today is technical, to make changes to enable the agency to function after exit day.

[Justin Madders]

The Minister is speaking with great confidence, without any basis in fact, in saying that the MHRA will not need any state handouts in the future. Will he commit to report back to Parliament, if it turns out that it is not, in future, self-financing?

[Steve Brine]

Of course, if there is any change to any arm’s length agency that the Department works with, we will come back to Parliament for that discussion. That is partly what the consultation is about at the moment. So if the hon. Gentleman wants a blank cheque to say that we would come back to the House to have discussions around any future changes, the answer is self-evidently yes.

Question put and agreed to.