Medicines and Medical Devices Bill

Baroness Finlay of Llandaff Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Wheeler (Lab)]

My Lords, I support this amendment from the noble Lord, Lord Patel. It is very much the ambition to ensure access for UK patients to the latest and most innovative treatments. This is reflected in many of our amendments to this Bill, relating to attractiveness, clinical trials and regulatory alignment with the European Medicines Agency.

We fully support the Government’s commitment to extend the Cancer Drugs Fund into a £0.5 billion innovative medicines fund to be used for

“the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases”.

If, at last, the principle of using the rebates from the pharmaceutical rebates scheme could be achieved so that they are used for the benefit of the NHS and patients, then this will represent progress indeed, particularly ensuring that the money is used as an additional source of income and revenue for the NHS and is not part of expected and planned funding.

Like other noble Lords, we are very much looking forward to hearing from the Government the detail of their proposals, when they intend to commence the promised consultation and the proposed timetable for implementation.

We heard in previous debates important questions as to how the new fund will relate to the current NICE process for reviewing new cancer drugs, particularly those to treat rare cancers, and, more broadly, around what drugs will qualify, outside of cancer, to be covered by the new fund. For example, there may be candidates from medicines selected for the early access to medicines fund, the MHRA’s pre-licensing indicator of promising innovation, allowing them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, a prerequisite for any drug to get a full, positive EAMS designation, what consideration have the Government given to this?

Detail, too, is needed, as we have heard, on the criteria that will apply to any prospective drug for the fund. I certainly endorse the comments of the noble Lord, Lord O’Shaughnessy, on needing to have an ambitious definition of innovation. Will the criteria mirror the current processes that the NICE committee considers for funding under the CDF, or will it be widened to reflect and include some of the criteria for highly specialised technologies, where NICE takes a different approach to treatments for some of the rarest conditions?

One of the key concerns in earlier discussions in Committee was the need for reassurances about NICE’s work to support innovation and to ensure that the current NICE review of its methods and processes is open and transparent and delivers real and effective change. As was made clear, it is important that we learn lessons from both the strengths and criticisms of the CDF, and that we ensure speedy access to new medicines going forward. I look forward to the Minister’s response.

[Baroness Finlay of Llandaff (CB) [V]]

I thank the Committee for allowing me to come in a bit late; I apologise for that.

Noble Lords have made the main points that I would have made but I simply add this. A large number of molecules are held by pharma, often with a good scientific rationale, for use in a rare condition, and we have drugs that are licensed for other uses that could be reused or repurposed. If we can speed up all these processes, and provide an incentive for medicines development, those with rare conditions—who are often absolutely desperate to try something new and very keen to be part of a monitored development—could access medicines. That would put the UK in a stronger position in the long term.

In addition, the concept of this seems so sensible that I have also put down an amendment, later in the Bill, to try to replicate it for innovative devices. We have complex situations where medical engineers may come with up a device, but we will deal with that the next time round.

In the meantime, I am most grateful to all noble Lords for the important points they have made. I await the Minister’s reply with interest.

[Baroness Penn (Con)]

My Lords, this debate has once again focused the Committee’s mind on the importance of innovation and the way in which it can have a transformative impact on patients’ lives.

As noble Lords have spoken of, the success of the Cancer Drugs Fund in providing interim funding means faster access to cancer drugs, saving valuable time—up to eight months in some cases—for patients accessing those drugs. Patients are now able to access cancer drugs that have received a draft NICE recommendation from the point of marketing authorisation. As noble Lords have noted, this provides the template for the innovative medicines fund.

The success over the lifetime of the Cancer Drugs Fund to date did not need legislation. It was a response to the immediate need to target access to cancer drugs. In expanding the fund to become the innovative medicines fund, I do not think legislation would advance the fund’s purpose, capacity or delivery in any material way. It will be a managed access scheme delivered by NHSEI and NICE to expand the range of medicines that could be supported by that funding.

I understand that my noble friend Lord O’Shaughnessy and other noble Lords would like this debate to cover an update on progress towards delivering that fund. I assure noble Lords that proposals for the innovative medicines fund are in development as we speak. We know that patients will be keen to understand the impact on them, as well as pharmaceutical companies and the NHS. It is our intention that NHSEI and NICE will lead an engagement exercise in the first quarter of 2021 to get the fund established.