Medicines Regulation

Lord Walney Excerpts

Tuesday 21st November 2017 Westminster Hall

[John Woodcock (Barrow and Furness) (Lab/Co-op)]

It is a pleasure to serve under your chairmanship, Mr Davies. It is unfortunate that I am following two superb contributions. I congratulate my hon. Friend the Member for Bishop Auckland (Helen Goodman) on securing this important and timely debate. She and my hon. Friend the Member for Lewisham East (Heidi Alexander) spoke powerfully and persuasively about the risks that the UK pharmaceutical industry in its entirety faces. I am not going to attempt to add to what they said and the questions they asked. Rather, I am going to focus on the cephalosporins business, which is carried out on three sites, two of which are in the UK—in the constituency of my hon. Friend the Member for Bishop Auckland and in Ulverston in my constituency, where there is a genuinely world-class sterile facility where the drugs are created. They are then placed in a powder form in Barnard Castle and in vials in Verona.

As the Minister is surely aware, there was great celebration in Ulverston, and it was heralded by the then Prime Minister and Chancellor, David Cameron and George Osborne, when David Cameron visited the day after the 2012 Budget and made a Budget roll-out announcement that GSK was going to be investing at least £350 million in a new biopharm pharmaceutical facility, largely as a result of the patent-box tax legislation, which the Conservative Government continued from Labour’s innovative tax policy, introduced by Prime Minister Gordon Brown. In July, GSK announced—out of the blue, for all intents and purposes—that it is going to pull that investment and scrap the entire project, leaving our community devastated. Not only that, but it is launching a strategic review of the existing cephalosporins business, which has been running for decades across both sites and is growing in profitability and potential.

Although cephalosporins are not a new product, they are well established. British manufacturing of such products in Ulverston and Barnard Castle, and across into the EU in Verona, has enabled them to penetrate new markets and benefit many more critically ill patients in hospitals. They are the very strongest antibiotics, and are typically used in hospitals for people with very serious vulnerabilities and infections. That business had and has a great future, but GSK has clearly signalled at a corporate level that it wishes to divest. Officially, that is a review of the business, but the company at the highest level is clear that it wants to find a new buyer.

When the company dropped its bombshell in July, it was clear and categoric that the decision was not as a result of Brexit. The company took care to say that, and we have to take it at its word. We can detect the thinking of the new chief executive officer, Emma Walmsley—a Barrovian, by the way, which has made the decision all the more stinging—that GSK wants to focus on fewer products, completely cutting some and potentially divesting itself of others. Although Brexit may not have triggered that deeply worrying blow to pharmaceutical manufacturing in the north of England, however, it is certainly a significant factor in whether we will be successful in finding a new buyer for the plant who is prepared to invest and to take the business to new heights, sustaining the employment of people in my constituency and in Barnard Castle, as well as creating more jobs in the decades ahead.

Every business, in no matter what sector, operates on the basis of wanting certainty and stability and of not liking uncertainty or the potential risk in what is at the moment the complete lack of clarity that the Government can give on the future of the regulatory environment for medicines in this country. I therefore really hope that the Minister is listening to what we are saying.

In another sector that is enormously important to our regional economy, civil nuclear, we do get a sense that, at the ministerial level at least, the Government are working hard to overcome this—I absolutely agree with my hon. Friends—absolutely nonsensical decision to rule out anything based on ECJ jurisdiction, thereby creating all the problems. We need to hear from the Minister that he is prepared to do whatever it takes to ensure that the transition is seamless. He should not only produce something a year down the line but give a level of certainty now, ready for GSK in Ulverston to attract new buyers to the site.

The Minister might be aware that I have formed the GSK Ulverston taskforce—which brings together community stakeholders and the site directors, with input from the Department for Business, Energy and Industrial Strategy and the local authorities—to ensure that we all maximise the chances of attracting a new investor. The decision will principally be a commercial decision, of course, but the Government can help in many ways. I would say that they have a duty and a responsibility to help, given the level to which they heralded the new jobs that have now been cancelled.

Other important areas include infrastructure, but I do not expect the Minister to go into those today. He can, however, acknowledge the difficulty that uncertainty causes to attracting new investors. I hope he will give more certainty today, and he should certainly undertake to go away and come back in short order to inform Parliament of what the relationship will be, so that the Government and we as a taskforce can better communicate that to the stakeholders.

My final request is that the Minister or his counterpart in the other place, Lord Howe—

[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

Lord O’Shaughnessy.

[John Woodcock]

Lord O’Shaughnessy—apologies, the previous Minister in the Lords has moved on. I thank the Minister here for the correction. I hope that he or Lord O’Shaughnessy will meet with me, my hon. Friend the Member for Bishop Auckland and other members of the taskforce. Lord Prior was really helpful when he spoke to me on the day of the announcement but there has been significant progress since then and many more challenges need to be met. If the Minister undertakes to make that happen, it will be very helpful.

--- Later in debate ---

[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.

[John Woodcock]

Presumably the Minister recognises the need for cross-border manufacture with European nations to remain absolutely seamless. The issue of cephalosporins in GSK affects not only in Barnard Castle and Ulverston but Verona, which obviously is in Italy.

[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.

[Steve Brine]

rose—

[John Woodcock]

On a point of order, Mr Davies. If the Minister is struggling and feeling unwell, is there a way in which we could bring the debate to an earlier close and he could write to us in response to our questions? I am concerned by how he seems.

[Geraint Davies (in the Chair)]

The Minister is the last speaker. He can stop the debate at any time, at which point I will ask Helen Goodman to make her closing remarks for two minutes. Feel free to end whenever you feel is appropriate, Minister.