My Lords, I shall speak in support of the amendment in the name of the noble Lord, Lord Lansley, to which I have added my name. Important arguments have been made with regard to the need to ensure that we can move away from the clinical trials directive which is currently the basis for such legislation in our country, and to adopt the
clinical trials regulation to which our regulatory authorities have made such an important contribution over recent years.
On previous occasions Her Majesty’s Government, with specific regard to the 2018 EU withdrawal agreement Bill and the 2018 Trade Bill, made clear commitments that we should implement the clinical trials regulation in full as part of a negotiated agreement incorporating its legislative and non-legislative provisions; or, in the event that no agreement can be reached, that an element of the regulation would be adopted to the greatest extent possible on a unilateral basis in domestic legislation. We have received further reassurances in terms of the withdrawal agreement Act that the Government would give priority to taking the necessary steps to bring into UK law without delay all the relevant parts of the EU clinical trials regulation that were within the control of the United Kingdom. With regard to the Trade Bill, in September 2018, the House was reassured in the strongest possible terms by Her Majesty’s Government that a commitment was being made to implementing the regulation. However, when the Bill before us was considered in the other place, no such commitment was made and therefore, this probing amendment is vital.
I know that arguments have been made that not all the elements of the regulation are within the power of Her Majesty’s Government to implement, but as we have heard from the noble Lord, Lord Lansley, there is the opportunity to deal with the clinical trials portal and information system in a different way and to design, as other amendments propose, a system that might be agreeable. Arguments have also been made that the clinical trials regulation itself, although a substantial improvement on the current directive, is not perfect, and that the GCP and ICH guidance to which the clinical trials regulation makes reference need themselves to be advanced. Work is being undertaken in that regard.
The European clinical trials regulation provides for referring to guidance on the operational delivery of clinical trials or other guidance, so that should not be seen as an impediment. The real concern here is that while, unfortunately, impediments and hurdles to the adoption of the clinical trials regulation may be identified, that would be the wrong thing to do. The regulation is important. The current clinical research legislation under which we labour in our country is not ideal, which is why we have this regulation. On many occasions, Her Majesty’s Government have committed to the adoption of the regulation, so can the Minister indicate why the opportunity provided by this Bill should not be taken to fulfil those undertakings and thus provide us with the greatest possible certainty regarding the conduct of clinical research in our country? This is vitally important to patients, to the economy and to sustaining a viable life sciences ecosystem.