Medicines and Medical Devices Bill

Lord Sharkey Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Sharkey (LD)]

My Lords, I declare my interests as chair of the Association of Medical Research Charities, whose members contributed £1.9 billion to medical research last year, and of the Specialised Healthcare Alliance, which campaigns for those with rare conditions and those needing specialised care.

I will make three broad points. The first is to do with the Bill’s structure. I welcome the Bill, in that it could create opportunities for improved regulatory regimes. We cannot, however, tell whether it will. It is a skeleton Bill with a whole array of delegated powers and no detail of how the powers will actually be used. This makes effective, proper scrutiny very difficult, if not entirely impossible. The DPRRC report is especially damning on this point, as many noble Lords have noted. It is worth quoting its conclusion:

“We are deeply concerned not only by the Government’s failure to provide sufficient justification for the adoption of a ‘skeleton bill’ approach—which would give Ministers sweeping powers to almost completely re-write the existing regulatory regimes for medicines and medical devices—but also by their failure to acknowledge the breadth of the powers that the Bill would confer.”


The Minister wrote to me on 2 August, saying:

“You expressed some concern that this way of regulating the sector meant that Parliament would not be able to scrutinise the powers in the Bill if we did not provide further clarity about the policy changes we intended to make through the delegated powers. I have asked my officials to think further about the extent to which we can provide Parliament greater information to aid its scrutiny.”


That was a month ago. Can the Minister say what progress has been made in his thinking and whether we will see the fruits of it before Committee? For our part, in Committee we will want to explore means to improve scrutiny mechanisms, including the use of the made affirmative procedure mentioned by the DPRRC, and the use of a sunset provision, as discussed in the Commons.

My second point is to do with clinical trials, which are an absolutely critical part of UK life sciences and of what makes the UK a global leader in medical research. Anything that reduces the number of clinical trials will weaken that leadership and could delay access to new drugs and treatments. The Government understand this, which is why I was surprised by the weakness of their approach. The Bill simply requires the Minister, in making regulation, to “have regard to” the attractiveness of the UK as a place to carry out these trials or to supply human medicines. “Attractiveness” is not defined, and in any case this is a very weak and perhaps meaningless obligation that also entirely omits to mention manufacturing. We will want to return to all that in Committee.

We will also want to ask again which aspects of the CTR the Government believe to be in the best interests of UK patients, industry and non-commercial researchers, and which they will regulate for. We will also ask how the Government will assess these best interests and what they may be.

My final point is about consultation. We welcome the commitment to consultation and to a possible early start for it. Such consultation is necessary, but is not, as the DPRRC points out, a substitute for parliamentary scrutiny. The Bill and the Explanatory Memorandum contain no detail about the form of consultation, who is to be consulted and when, or when the consultation results will be available to Parliament. Will the Minister provide answers to these questions ahead of Committee, and could he confirm that patient groups, medical research charities and academic researchers will be among the consultees?