European Union (Withdrawal) Bill

Lord Sharkey Excerpts

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

In responding to the amendment, the Government need to put on record that they fully intend to adopt the CTR when it comes into force and that they clearly understand the implications of it for the UK’s ability to lead on clinical trials. I beg to move.

[Lord Sharkey (LD)]

My Lords, my noble friend Lady Jolly has added her name to this amendment, but unfortunately she cannot be in her place today. She has asked me to speak in her stead, and I am delighted to do that. I declare an interest as chair of the Association of Medical Research Charities and of the Specialised Healthcare Alliance, which campaigns on behalf of people with rare diseases. Both these organisations have a direct interest in this amendment.

As the noble Lord, Lord Patel, made clear, the UK has a tremendous record in medical research, in both basic blue-sky research and in translation into treatments. We live in a golden age for medical research, and this golden age is driven very largely by the UK, by efforts in our universities and in our hospitals. There are many reasons for this pre-eminence: world-class university research, world-class medical institutions, the unique NHS system and a funding structure unlike anywhere else in the world, where medical research charities contribute £1.6 billion each year to research, sitting alongside public and private funding.

All this makes our medical research achievement one of the undoubted successes of the United Kingdom. This success has a simple and direct consequence: it produces very significant improvements in health and well-being and very significant improvements in our ability to cure and to treat disease. The chief mechanism by which research turns into cures or treatments is the mechanism of clinical trials.

The UK has long been, and remains, attractive to the pharmaceutical industry, for example, because of the NHS’s ability to run extensive clinical trials. The UK has been able to recruit the very best researchers—again partly because of the NHS. Another reason why clinical trials in the UK are important to researchers, as the noble Lord, Lord Patel, made clear, is our alignment with the other 27 EU states under the existing EU clinical trials directive of 2004.

This alignment is absolutely critical. It allows wide and varied datasets, it creates standard procedures and protocols, and it makes research into rare diseases possible. This last point is of huge importance. Some diseases, very often serious diseases, are so rare that there is not available in any one country a sufficient number of patients for research to take place. But because we are aligned across the EU by the 2004 directive, we can and do find sufficient numbers across 28 countries to carry out effective research.

Pancreatic cancer is a case in point. This is one of the hardest cancers to treat and has an appallingly low survival rate. Just 1% of people diagnosed with pancreatic cancer in England and Wales survive for 10 years or more. The European Study Group for Pancreatic Cancer recruited more than 700 patients from the UK, Germany, Sweden and France to a large-scale clinical trial. The results showed that an extra 13% of the patients on the trial lived for five years when given the tested combinations of chemotherapy and drugs. This is a huge result for patients and for the future of pancreatic cancer treatment, all made possible by, and only because of, the ability to run trials across 28 countries under a common regime. I should add here that the European Study Group for Pancreatic Cancer is led by an outstanding team at Liverpool University.

The 2004 clinical trials directive has proved invaluable. But it has also proved to have many deep and fairly obvious flaws, which we in the UK have been instrumental in trying to correct. After the introduction of the directive, the number of applications for clinical trials fell by 25% between 2007 and 2011, administration costs rose by 98% and delays in actually launching a clinical trial rose by 98%. All this was recognised in 2012 when, with a great deal of UK lobbying, work began on a revision to the directive.

This revision became, in 2014, the new EU clinical trials regulation, referred to in the amendment before us. As the noble Lord, Lord Patel, said, the benefits of the new regulation are straightforward: it speeds up the process for launching new clinical trials; it establishes a more proportionate regulatory regime, with much less red tape; it recognises the concept of co-sponsorship of trials; it simplifies the rules for critical multicountry trials; and it streamlines reporting requirements. This means faster and cheaper trials, faster results and faster delivery of any benefits to patients. All these are of course very good things.

Although the new regulation was agreed in 2014, it was estimated that it would apply only from 2017-18. That was to allow time to get in place the mechanisms needed to make it work properly. But this application date, as has been mentioned, has been delayed yet again, and the EU now says that the regulation will come into force in the second half of 2019. This presents the problem that the amendment addresses. The Bill assumes that we will have left the EU on 29 March 2019, so the new regulation will not be incorporated by this Bill into UK law. Without the amendment, though, the old directive will be, or could be, incorporated. Either way, that means we will not be aligned to the new regulation when it comes into force in the second half of 2019. We will not be part of a group of 28 member states when it comes to conducting clinical trials; we will be a group of one outside a group of 27. The consequences of that for clinical trials in the UK would be disastrous, as they would for UK medical research, for research in the NHS and for our attraction as a research base for pharmaceutical companies.

The amendment of the noble Lord, Lord Patel, takes no political stance and no view about the merits or otherwise of Brexit. It simply says that the Government must not incorporate the old, defective clinical-trials-directive-derived legislation into UK law before the Government have reported to both Houses about the costs and benefits of adopting the new EU clinical trials regulation.

I entirely support the amendment and believe it to be necessary, but I also believe it does not go far enough in ensuring that we are compliant with the new regulation from the day that it applies. That is what we need, not just to protect existing trials but to make certain that we are part of the new regime, which after all we were instrumental in creating. I very much hope that the Minister will take the amendment as the beginnings of a conversation about how to adopt or realign with the new regulation on day one of applicability, and I hope that he will be able—on Report if not today—to make a firm commitment to aligning the UK with the new regulation from the day that it becomes applicable.

[Viscount Ridley (Con)]

My Lords, I have added my name to this amendment. Unlike many amendments to the Bill, this one really is intended to be helpful to the Government and the Bill. Unlike many, it has a genuine point to make and is not merely an excuse to filibuster. Unlike some speeches in support of the amendments, when I say I shall be brief I shall mean it.

As the noble Lord, Lord Patel, says, the Prime Minister’s speech 10 days ago removed the need for lots of amendments to the Bill. In saying that we intend to join or align with the European Medicines Agency if possible, I think she has effectively indicated that the amendment is welcome. However, it is worth pressing the point briefly to get clarity. The background, as the noble Lord, Lord Sharkey, has said, is that the EU passed a disastrous clinical trials directive in 2004, destroying much of a thriving British clinical trial industry almost overnight—a crown jewel of our world-leading biomedical sector. It was not one of Brussels’ finest hours. None the less, the UK remains the leader in Europe and one of the leaders in the world in discovering, developing and testing new treatments for diseases, thanks to our strong pharmaceutical industry and our superb academic sector.

The UK’s MHRA—I shall not spell it out; we know what it stands for—in particular has been instrumental in designing and delivering a robust regulatory environment across the EU, providing an attractive and harmonised framework for clinical trials. It is the senior agency relating to the EMA. This includes reviewing the shortfalls of the clinical trials directive and putting its considerable expertise towards drafting the new clinical trials regulation that is coming along to undo some of the harm done by the 2004 directive.

We have already agreed to the CTR in full but, as the noble Lord, Lord Patel, says, due to a minor delay we risk not only failing to adopt its vastly improved principles in data sharing and expedience but, in the process, losing alignment with our European partners on vital shared research. The CTR will be applied in late 2019, as opposed to this year as originally planned. It will therefore not be covered by the EU withdrawal Bill as it stands. The resulting uncertainty is already having an effect. Clinical trials can run over many years and require significant planning. Uncertainty is already having consequences.

The Government have sent out strong signals that the UK should be a leading centre for the life sciences through the life sciences industrial strategy and associated sector deal. Aligning with the CTR and allowing collaboration to continue to underpin the UK’s thriving research sector will help the Government to achieve that ambition. I and many others are rightly concerned about new regulations that could come in during the implementation period that the UK will have no say in. The clinical trials regulation is categorically not one of those. It was devised with enormous input from British research expertise, was fully agreed to by British representatives in the EU and is regarded as a significant step forward for the governance of cross-national clinical trials. So I hope the Minister will be able to reassure us and the vital biomedical sector in this country by clarifying that we will align with the CTR, as implied by the Prime Minister 10 days ago.