Medicines Regulation

Justin Madders Excerpts

Tuesday 21st November 2017 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Mr Davies. I congratulate my hon. Friend the Member for Bishop Auckland (Helen Goodman) on securing this extremely important debate. It is sad there are not more Members here, but—as always—there are competing interests. She has been assiduous in asserting the rights of Parliament to scrutinise the terms of our exit from the European Union, and today’s debate is no exception to that.

In common with the vast majority of Members—whatever our views on the European Union—my hon. Friend spoke with a genuine desire to ensure that our departure happens on the best possible terms. I am sure we can all see that one priority is to ensure that our economy is able to thrive and that patients are able to access all the medical treatments that they need, as every hon. Member has said. Most of them also mentioned the decision to relocate the European Medicines Agency from London to Amsterdam. I do not know whether the debate was timed with that in mind, but it is certainly apposite.

When my hon. Friend began her speech, she said there had been no explanation, no policy statement, no impact assessment and no opportunity to debate the many issues we have discussed today. Of course, she has a considerable constituency interest in this subject area, but, as we have heard from most Members, the issue affects every single person in this country. The importance of it cannot be downplayed.

My hon. Friend said that regulation is one of the major costs to the industry. I share her frustration that we do not have a clear steer from the Government on what the future of that vital component of the industry will be. As she said, investment decisions are being made now and we are already beginning to lose out. I totally agree with her that the Minister should make it clear that we are putting patients and public safety first.

My hon. Friend the Member for Lewisham East (Heidi Alexander) gave a passionate and well-informed speech on the merits of the EMA. She summed it up very well when she said that the EMA’s leaving us is bad, but our leaving the EMA will be far worse. She was right to highlight the risk of delays for patients accessing new medicines. She said that business and patients need clarity, which is something that has come through clearly from all the Members who spoke today.

My hon. Friend the Member for Barrow and Furness (John Woodcock) spoke with great sincerity about the important business in his constituency. He is a fervent advocate of other businesses and sectors there, so we know that he will not let the matter lie. The announcement in the summer must have come as a real blow, given that Ulverston, and his constituency, are quite isolated from other populations, and in the light of the potential for damage to the local economy when so many high-skilled jobs are at risk. My hon. Friend will obviously want to ask the Minister to be clear about the assistance necessary to get the best from a pretty bad situation. The conversations that he will want to have with Ministers will be similar to those that every Member will have about industries in their constituencies affected by the Brexit decision.

The hon. Member for Central Ayrshire (Dr Whitford) spoke, as always, with great authority on health matters. She highlighted the fact that we are already slipping down the pecking order, and spoke from personal knowledge. In addition to the certainty that patients and businesses need, she highlighted the fact that universities, as well as EU nationals, need certainty. We should not forget, either, the 61 people working for the EMA who may be transferring to Amsterdam. They, too, need certainty about their future. The hon. Lady noted the risk of tariffs being introduced on drugs that have come into the market in the past seven years, if we crash out of the EU on WTO terms. It would be useful to hear from the Minister whether any assessment has been made of the potential cost of the tariffs, and whether he envisages that that cost would be dealt with by the Department of Health, or that individual patients would be expected to pay more for the inevitable additional cost of the drugs.

I doubt whether, when our constituents cast their votes in the referendum, the many issues that we have discussed today would have been at the forefront of their minds. Regulation of medicine is an integral part of our relationship with the EU, but it was not mentioned on any buses. The closest that we got to any debate on the impact of Brexit on the health sector was the £350 million a week that would be spent in addition to existing expenditure. It is sad to see that no advocates of leave are here today to explain how the situation fits into the big picture that they were so keen to propound at the time. Of course it has become apparent since June 2016 and from today’s debate that there is a threat to jobs and investment in the science and research sector. As my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) succinctly pointed out at the start of the debate there is also a threat to access to new medicines; that is a serious unintended consequence. I certainly have not heard any Brexiteers suggesting that our current system is not advantageous to us as well as the other 27 EU member states. It is therefore difficult to overstate how critical the future of medicines regulation is to the economy and, more importantly, to the millions of patients in the UK who will need the medicines whether we leave the EU or not.

It might seem a long time ago now, but in July last year, just after she was appointed to her present role, the Prime Minister said:

“It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”.

That of course remains very much the case. As my hon. Friend the Member for Bishop Auckland said, we have been exceptionally successful in that sector. The industry has a turnover of more than £60 billion per year, generates exports worth £30 billion and gives us a trade surplus of £3 billion. It employs 220,000 people in this country, and 25% of the world’s top prescription medicines were discovered and developed in the United Kingdom. It is of huge economic importance, and it says something about the sorry state of affairs we are in that Members feel the only way to get any clarity on the future of that vital industry is to have Ministers come to Westminster Hall to debate the issues.

Together with the direct economic impact is the effect on millions of patients, who rely on our co-operation with the rest of the EU to get access to safe, effective and affordable medicines. As we have heard, 45 million patient packs of medicine a year move out of the UK to the EU and 37 million move in the opposite direction. That is an awful lot of movement on which we need the Government to provide clarity. Those benefits, and others that hon. Members have spoken about today, are under threat not only from the relocation of the EMA, but from our exit from the EU if that is not handled more carefully.

Losing the EMA from London is of course a huge blow, not just to the economy of London but to our pharmaceutical sector more widely, for the reasons we have heard. The benefit that it brings to any national economy is evident from the fact that 19 other cities across Europe were in the running to become its new host. In addition to the loss that we will experience from the agency’s physical removal, it also poses a number of challenges and threats to medicines regulation across the EU. Indeed, The Pharmaceutical Journal recently warned that

“a worst-case scenario could permanently damage the medicines regulatory system, leading to a public health crisis”.

Although the EU27 decided not to relocate the EMA in eastern Europe, after a survey of staff found that an alarming 70% to 94% of them would not be willing to relocate there, the move to Amsterdam could still present a risk, in the sense that the survey found that up to 40% of those currently employed at the agency would not be prepared to move.

As my hon. Friend the Member for Lewisham East said, it is not an easy process to move an office wholesale. Some things will stop, and there will be a loss of some highly skilled specialist staff, who will be difficult to replace. An EMA spokesperson said that

“while some job losses can be absorbed within the business continuity plan...beyond a critical threshold, the Agency will no longer be able to fulfil its mandate to protect the health of European citizens.”

I am sure that no one voted for that on 23 June 2016. Good staff will inevitably leave the EMA rather than relocate their homes, their children’s schools and the careers of their partners. That will be an important factor. As the journalist Dr Ben Goldacre put it,

“these highly specialist staff are like trees: they take a long time to grow, and they put down roots.”

In the short term we may benefit from some of those specialist staff staying in the UK, possibly at the expense of the EMA and the future success of European regulation; but let us be in no doubt that in the long term it will be to our detriment, because we will struggle to attract the best.

Before the Brexit talks even move on to the future of medicines regulation, the Government have a duty to act now to protect our vibrant life sciences sector. One of the key reasons why so many countries were competing to host the EMA is that its presence makes pharmaceutical companies far more likely to locate in the host city. Many of those companies will have a UK base, and, as has been mentioned, will be beginning to think about future plans; so what steps are the Government taking today to persuade those companies to stay in this country, and not just to retain their staff but to make investment decisions that will benefit the economy? As my hon. Friend the Member for Bishop Auckland said, the industry is international and highly mobile, and we cannot afford to lose investment through the big hole of current Government policy. When we leave the EU, we will potentially face a divergence from the current medicines regulation system across Europe. The challenge for the Government is to keep that divergence to a minimum or eliminate it altogether.

One of the first issues, which we have already discussed, is the likelihood that the Medicines and Healthcare Products Regulatory Agency will lose up to a third of its income, as that comes from its work as a rapporteur body for the EMA. Can the Minister confirm that that funding gap will not have to be bridged from the existing, already insufficient Department of Health budget? What estimate has been made of additional resources that may be required in the worst-case scenario?

We have already heard that in July a letter from the Health and Business Secretaries in the Financial Times confirmed that the Government will prioritise achieving regulatory co-operation in the article 50 negotiations, and that was welcome, although, as the Financial Times is not a party to the negotiations, it could be argued, from a cynical point of view, that it was merely window dressing. We take it at face value, however, and as a clear commitment to try to achieve as much co-operation as possible. Perhaps when the Minister responds he will say what progress has been made since that time. Will he also say whether Ministers or officials from the Department of Health form part of UK representations in negotiations with the EU? I appreciate that he will not be able to go into some of the details, but given the shared desire across the House to make progress and achieve as much harmony as possible in that area, can he put some flesh on the bones and say what exactly the Government will seek to achieve as we move forward? The Minister will understand that the big pharma companies are looking for a clear indication of the likely shape of the future relationship as soon as possible, and as we have heard, decisions are being made now. I hope that he can shed some light and provide clarity on that when he responds.

Will the Minister address Members on the jurisdiction of the European Court of Justice? If it cannot be used to adjudicate on licensing appeals, as appears to be the Government’s position at the moment, how will the two systems closely interact? Is there any possibility of a joint adjudication process? Operating alone in our own separate market would be not only extremely costly, but inevitably disastrous for patients. If pharmaceutical companies are forced to go through a separate regulatory system, as well as the NICE process, just to access what will be, in the big scheme of things, a fairly small market, we could find ourselves at the bottom of the list when new medicines are released. Pharmaceutical companies might view the UK as a lower priority than getting drugs into the bigger markets of the US, the EU or Japan. That might be a particular concern where the potential market for medicines is naturally small, such as with those for rare diseases. As already stated, we are already becoming a less attractive market for the life sciences sector, both for companies in the UK and for future investment decisions.

That is a very serious and bleak picture, and I hope that when the Minister responds he can reassure the House that ideology will not trump the best interests of our economy and our health service. My hon. Friend the Member for Bishop Auckland had seven questions—I lost count of the number asked by my hon. Friend the Member for Lewisham East, but there were many. I have a few of my own, and hopefully they will be a little more straightforward to answer—yes or no will probably do for most of them. In particular, I would like the Minister to guarantee today that after 1 April 2019 patients will have the same access to medicines as they do now, and that they will not face longer waits to access new treatments. Can he also guarantee that another part of the Department of Health’s budget will not be used to make up any shortfall in MHRA’s finance?

The Minister may not be aware that we held a debate on this subject just over a year ago, and many of the concerns raised then have been raised again today. All Members today have spoken with one voice about the need for clarity and certainty, and I hope that the Minister can provide us with that now.

[Geraint Davies (in the Chair)]

A lot of questions have been asked, and fortunately we have the time for a lot of answers.

--- Later in debate ---

[Steve Brine]

I share the hon. Lady’s concern. As I said, so much about this is still subject to negotiation. I cannot give her the exact assurance that she wants at this time.

The hon. Lady also asked about the EU exit transition. The Government are clear that we want to continue collaborating with the EU in the interest of protecting patient safety. The detail of any future relationship is, of course, subject to that negotiation. That is nothing new. We recognise completely that new arrangements can take time to implement, and we will work closely with the industry and key health system partners to ensure smooth implementation. The European Union (Withdrawal) Bill, which is going through the House at the moment, will ensure that a known legal framework is in place immediately after we leave the EU.

The hon. Lady talked about the Secretary of State “flirting” with leaving the EMA for the FDA. Earlier this year, the Secretaries of State for Health and for BEIS published a letter in the Financial Times setting out our aim to retain a close relationship in respect of medicines regulation. The FDA has been clear that it would not let another country “join” FDA processes even if we wanted to, but if we are outside EU processes, we will certainly look at how we can co-operate more closely with other global regulators.

The hon. Member for Lewisham East (Heidi Alexander) asked whether we had had contact with Australia and New Zealand. The chief executive of the MHRA chairs the International Coalition of Medicines Regulatory Authorities, and we of course have had discussions through that group on a contingency basis with Canada, Australia and others about the potential for greater collaboration once we have left the EU.

The hon. Lady asked whether I can guarantee that the adverse effects of drugs will be detected quickly. She also asked about orphan drugs and clinical trials. Increasingly, information about the adverse effects of drugs is shared at a global level. The EMA collaborates with many third countries. There is no need for a broad deal to agree to share safety information. We want to continue collaboration with the EU on orphan drugs for rare diseases, which she rightly pointed out are a subset of the wider issue. If we are outside EU processes, we will need to consider incentives for orphan drug development, and we are doing that. Clinical trials all receive national approval today, and they will receive approval under the EU clinical trials regulation, which is due to come into force in late 2019. The UK will remain a leading centre for clinical trials. There is no reason why multi-country trials cannot include the UK after Brexit.

Several Members, including the shadow Minister, the hon. Member for Ellesmere Port and Neston (Justin Madders), asked about MHRA resources. Some 90% of medicines on the UK market already have a national licence from the MHRA; fewer than 10% come via work that we do for the EMA. We have world-renowned scientific assessors at the MHRA. Some work and workloads may change post-Brexit, but I do not think that claims of fundamental change are correct. MHRA has full contingency planning in place.

[Justin Madders]

On that point, can the Minister confirm that Department of Health budgets will not be used to fund any additional MHRA costs?