Medicines Regulation

Debate between Heidi Alexander and Steve Brine

Tuesday 21st November 2017 Westminster Hall

[Steve Brine]

I thank the hon. Lady; she is always there when we need her.

As I was saying, those skills and expertise have allowed the MHRA heavily to influence global practice and regulations, which is why I say it is a world leader. A majority of medicines available in the UK—around 90%—already receive a national UK licence issued directly by the MHRA. It also leads the assessment of more than 20% of new medicines licensed by the EMA, with particular expertise and specialism in more complex new drugs that come to market. Similarly, on medical devices, five of the EU’s 55 notified bodies are in the UK, and they undertake a disproportionate amount of work. We estimate that they assess between 50% and 60% of the highest-risk devices on the EU market—a big player.

The strengths of our world-leading regulator are similarly reflected in the UK’s life sciences sector. The UK has one of the strongest and most productive life sciences industries in the world, with more than 5,000 companies, more than 233,000 employees, and an eye-watering turnover of more than £63.5 billion each year. It also provides products that the NHS and patients rely on every day—I know that the constituency of the hon. Member for Bishop Auckland has seen the benefits of that productive industry.

GlaxoSmithKline announced this year an investment at its Barnard Castle facility in Teesdale, as part of a wider £140 million investment in the expansion of manufacturing HIV and respiratory medicines. However, we cannot be, and are not, complacent, and we must continue to work hard to support the industry, and we have done just that. The industrial strategy Green Paper was launched in January this year, and it set an “open door” challenge to industry to come up with proposals to transform their sectors through various sector deals.

[Heidi Alexander]

I am grateful to the Minister for his exposition of the current state of life sciences in the UK, all of which we could probably find out if we typed a few words into Google. May I bring him to one of the first questions, which is of pressing importance? What will the regulatory environment be for pharmaceutical companies that wish to get a pan-European licence in April 2019, during the so-called transition period envisaged by the Prime Minister, following the conclusion of negotiations on article 50?

[Steve Brine]

I will come to that.

[Heidi Alexander]

Please, come on. Just get straight to it.

[Steve Brine]

We should always try to be courteous to one another in this House, if we can manage that. To refer to the previous point, DEFRA is responsible for animal medicines policy; EMA covers both human and animal medicines. The Department of Health and DEFRA work incredibly closely together; therefore, DEFRA Ministers answer on applications for animals. I can assist with that at any time.

We are working with Sir John Bell and others in the life sciences sector to consider the industrial strategy in more detail, and specifically what action can be taken by Government and industry in partnership through an ambitious sector deal. At the launch of “Life Sciences: Industrial Strategy”, the Secretary of State for Business, Energy and Industrial Strategy, who has been much spoken of already in this debate, reiterated the Government’s commitment to the sector by announcing the first phase of their investment—£146 million for leading-edge healthcare, which is expected to leverage more than £250 million of private funding from the industry.

Leaving the EU, with all its challenges, allows us to make fresh choices about how we shape our economy and presents an opportunity to deliver a bold industrial strategy that prepares us for the years ahead. Our approach to the EU exit negotiations for medicines regulation is focused on building on the strengths of the MHRA and the UK life sciences sector that I have just set out. As the UK leaves the EU, both parties will have the shared aim to protect the health of patients across Europe and to ensure the safe and timely access to medicines and medical devices that I know concerns hon. Members as it concerns me. It is in the interests of patients and the life sciences industry for us to find a way to continue UK-EU co-operation and to ensure continued sharing of data, even if our precise relationship with the EU will, by necessity, change.

Earlier this year, the Secretary of State for Health and the Secretary of State for Business, Energy and Industrial Strategy published an open letter in the Financial Times setting out Government’s aim to retain a close working partnership in respect of medicines regulation after the UK leaves the EU. Our approach is underpinned by three key principles, which are worth stating. First, patients should not be disadvantaged; secondly, innovators should be able to get their products into the UK market as quickly and simply as possible; and thirdly, the UK should continue to play a leading role in promoting public health.

Yesterday, obviously, the new location of the EMA was announced; in 2019 it will move to Amsterdam. Both the UK and the EU have a collective responsibility to make sure that the process is as seamless as possible, in order to minimise disruption to existing regulatory procedures and public health protection. There are no benefits to UK or EU patients in tearing up the sort of close working relationships that get crucial drugs on the market as fast as possible, share early alerts about problems with medicines or allow patients to benefit from new scientific discoveries earlier. As the Prime Minister has said, there is also no need to impose tariffs where we have none now, which is the case for medicines and medical technologies.

Continued collaboration is in the interests of public health and safety across the continent of Europe, and in the UK for our constituents, because we all know that health is different. Medicines and med tech are different from other consumer products. Patients who need an innovative treatment cannot simply pay more or consume less but otherwise carry on as they were, marginally worse off. We recognise that it could be the difference, as has been said, between life and death. We look forward to discussing these issues as early as possible with our EU counterparts as part of the negotiations.

[Steve Brine]

Yes, of course. I want to come on to the many different questions asked. The hon. Member for Central Ayrshire (Dr Whitford) said that Scotland would have bid for the EMA if it had voted yes a couple of years ago. I do not think that it would have done, because it would not have been a European Union member state.

[Heidi Alexander]

I am grateful to the Minister for giving way. Mr Davies, I hope that it is not out of order to say that the Minister does not quite seem himself. If he is poorly, and my earlier remarks were somewhat curt, I apologise for them.

It would help everyone here to understand the Government’s overriding objective for medicines regulations in a post-Brexit environment. Do we intend to automatically follow EU authorisations in future, or does the Minister foresee divergence from EU regulations?

[Steve Brine]

rose—

--- Later in debate ---

[Steve Brine]

There is a huge body of work going on in the Department about the impact of Brexit on every single area of every single Minister’s responsibility.

[Heidi Alexander]

What assessment has the Minister made of how staying in the European economic area might impact medicines regulation, were we to go down that route instead of the one the Government are currently pursuing?

[Steve Brine]

The hon. Lady asks me to visualise all the different scenarios for the current negotiations. We have been clear that we want a comprehensive deal. A number of Members mentioned that no deal is some sort of ideological obsession for some Government Members. That may be true, but they do not speak for Government policy. We are not looking for no deal; we are looking for a comprehensive deal.

The hon. Member for Barrow and Furness (John Woodcock) asked about meeting my colleague Lord O’Shaughnessy. I cannot speak for my colleague’s diary, but I will speak to him. If he cannot meet the hon. Gentleman and his taskforce, I will. The hon. Gentleman always speaks passionately for his constituency, and I am more than happy to try to sort that out for him.

The hon. Member for Central Ayrshire raised a concern about safety data. That absolutely should always be shared at a global level. The MHRA leads about a third of the EU’s pharmacovigilance work. The EMA already shares data with third countries. It is in all our interests for that to continue. If we are outside EU regulatory procedures, we will ensure that the UK remains an attractive market and that regulation does not delay patient access. A number of Members expressed concern about that, and it is a concern of mine, which is why it is a priority for us.