My Lords, Amendment 84 in my name and those of the noble Baronesses, Lady Thornton and Lady Jolly, and the noble Viscount, Lord Ridley, is a very simple amendment that seeks clarification about how the Government intend to deal with the clinical trials regulation when it comes into force. The amendment is not designed to be political, or to interfere with the aims of the Bill. It has been tabled to bring to the Government’s attention a very specific issue with the forthcoming clinical trials regulation as the UK withdraws from the EU and the implication that will have on clinical trials.
The CTR is a significant improvement on the existing regulations governing clinical trials that it will replace, the clinical trials directive. It has the potential to benefit both patients and the research environment in the UK, yet it is also in a somewhat unusual position with regard to the Bill. It will reform the governance of clinical trials across the European Union. The UK was central to its development, with both the MHRA—the Medicines and Healthcare products Regulatory Agency—and individual researchers contributing their expertise. It was adopted in 2014, with the UK’s full support. However, due to a minor technical delay with the set-up of the data-sharing portal it will not come into effect until late 2019, rather than this year as planned. As such, it will come into effect after exit day and will not be covered by Clause 3 and what it converts into UK law. It will be the existing clinical trials directive that is covered by the current Bill.
If we do not take steps to adopt the CTR, we will fall out of alignment when it comes into effect and our ability to undertake collaborative clinical trials with our EU partners will cease. To reduce the uncertainty that is of concern to the research community and pharma, the Government should commit to aligning with the CTR when it comes into effect, and provide details of how they will seek to do this.
The CTR is a major improvement upon the current clinical trials directive, harmonising the approach to conducting clinical trials across the EU. It will include a co-ordinated, centralised approval process and a portal which decreases the administrative burden for clinical trials and support. It is transparent and, since it is a regulation, it will immediately come into law across member states, ensuring clinical trials governance across the EU. The current divergence in how the clinical trials directive is applied in member states results in substantial delays in opening trials involving more than one country.
The CTR allows for a more risk-proportionate approach to trials and authorisation, extending them to investigational medicinal products and enabling the optimised use of medicines that already have marketing authorisation. Other benefits include quicker trial set-up, ambitious timelines for review, flexibility and the simple reporting of adverse reactions leading to improved patient safety. Patients also benefit from being involved in clinical studies, which are the gold standard for developing evidence to see whether a new intervention is suitable to become standard practice. They also provide patients with opportunities to access innovations at an early stage in their development. Through enhanced collaboration, the CTR would provide increased opportunities for UK patients to access clinical trials.
Collaboration is particularly important on rare diseases, where patient pools are smaller. Streamlined co-operation on trials looking at these diseases is crucial in making progress in research and improving outcomes.
The CTR also has implications for UK science and innovation. The Prime Minister said in her Statement last week that,
“our partnership will need to cover agreements in other areas, including … a far-reaching science and innovation pact”.—[Official Report, Commons, 5/3/18; col. 28.]
The UK’s life sciences are strong and the UK is a world leader in medical research. Looking at existing medicine, for instance, around 25% of the world’s top 100 prescription medicines were discovered and developed in the UK, while three of the five top-selling drugs to treat rheumatoid arthritis and other inflammatory conditions globally are innovations based on UK science. Unfortunately, we did not commercialise them so we do not get the billions with which they now benefit pharma.
The Government’s recent Life Sciences Industrial Strategy sets out the UK’s ambition to strengthen the environment for clinical trials. The strategy mentions opportunities to improve translational science and attract more clinical trials from industry. Alignment with the CTR will facilitate this ambition to come to fruition sooner.
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The MHRA’s efforts to streamline approvals for clinical trials have already been acknowledged by the life sciences sector deal. These efforts have been made under the impression that the CTR will be implemented. The CTR includes a mechanism for UK researchers to participate in and co-sponsor a clinical trial. Trial leadership is especially important for non-commercial trials, which are often run by academic institutions. UK academics have expressed concerns due to the inability to lead on clinical trials, including the impacts on reputation and funding prospects without alignment with the CTR.
UK research is also beneficial to the EU. The UK undertakes a huge amount of clinical trials activity, both in national and pan-EU trials. Currently, the UK conducts the third-largest number, after Germany and Spain, of cross-national clinical trials with EU partners. It has the highest number of phase 1 trials in the EU, where treatments are first tested on humans, and the second-highest number of phase 2 and 3 trials, where treatments are tested for efficacy against current options. For example, 28% of 200 clinical trials funded by Cancer Research UK involved patients from other EU countries.
The UK and EU also collaborate through the sharing of scientific ideas and expertise. The European Medicines Agency, the EMA, hitherto based in London but which will move to Amsterdam when we exit the EU, and the UK Medicines and Healthcare products Regulatory Agency, the MHRA, worked closely together on the regulation of clinical trials. The MHRA is respected by industry and other peer institutions across Europe as a good source of knowledge and scientific advice on conducting clinical trials. As well as authorising clinical trials and regulating medicines and medical devices, the MHRA shares knowledge and expertise
with the EMA. Maintaining this valuable working relationship is crucial to both the UK and Europe as we leave the EU.
In the UK, we are in the fortunate position of currently leading the world—I do not exaggerate—in several areas of biomedical science, such as genomic medicine, stem cell medicine, regenerative medicine, data science as it applies to health, health informatics and many others. Clinical trials are an important part of the discovery process of getting medicines to patients. The British scientific community has heavily contributed to the development of the CTR and has planned on its implementation. It is only because of a cruel quirk that it will not automatically apply here under the auspices of the Bill. The Government need to act to ensure that we can align with the regulation and maintain the cross-national collaboration which is crucial for patient outcomes, for supporting our vibrant research environment and, possibly, for our life sciences industry.
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.