Access to Medical Treatments (Innovation) Bill

Lindsay Hoyle Excerpts

Friday 29th January 2016 Commons Chamber

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

With this it will be convenient to discuss the following: amendment 9,  page 2, line 20, at end insert—

“(6A) Regulations under subsection (1) may not be made unless the Secretary of State is satisfied that the regulations have the approval in principle of—

(a) the HSCIC,

(b) the General Medical Council,

(c) the British Medical Association,

(d) the Association of Medical Research Charities,

(e) the Royal Colleges,

(f) the Academy of Medical Sciences,

(g) the Medical Research Council,

(h) the National Institute for Health and Care Excellence,

(i) the Medicines and Health Products Regulatory Agency, and

(j) any other body or individual that the Secretary of State considers it appropriate.”

Amendment 15, in clause 5, page 4, line 1, leave out subsection (2) and insert—

“( ) References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research).”

This amendment makes it clear that the database for which clause 2 provides may contain information about treatments carried out for the purposes of medical research (including, for example, in the context of a clinical trial).

[Heidi Alexander]

Setting aside the fact that I question whether what is left of the Bill is necessary, if the database is to be created, it is important that we get its design right. The Association of Medical Research Charities has expressed concern that the database might adversely impact patients and medical research. For such a database to be effective, it will need to be appropriately regulated and quality controlled. I believe that it can command the confidence of the medical profession only if it is developed in consultation with it. With that in mind, amendments 8 and 9 deal with the bodies that the Secretary of State must consult and get approval from before introducing regulations establishing a database of innovative treatments.

As the Bill stands—this is set out in clause 2(1)—to make those regulations the Secretary of State need only consult the Health and Social Care Information Centre. Restricting the statutory consultees to only one organisation seems highly restrictive and is inconsistent with the Bill’s explanatory notes, which state:

“The detailed design of the database would be consulted upon with professional bodies and organisations.”

Amendments 8 and 9 would make the legislation clearer on which bodies should be consulted.

I note that the Minister was unable to support similar amendments tabled in Committee because he felt that the list was “not exhaustive”. Indeed, he went on to say:

“Although it represents a helpful list of consultees, such a provision would need to include many more organisations. While I understand the intention behind the amendment, restricting the process would not be helpful”.

The hon. Member for Daventry (Chris Heaton-Harris) then said:

“I know from my consultation on the Bill with stakeholders that we would need longer lists than those in the amendments.”––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22-23.]

With those constructive comments in mind, I have included in the list a provision allowing the Secretary of State to consult

“any other body or individual that the Secretary of State considers it appropriate to consult.”

I know that there were concerns that the list of specified organisations could become out of date. However, given that these regulation-making powers would likely be used only once—to create the database—I do not believe that concern is wholly justified. Indeed, if the Minister, or any hon. Member, believes that an inappropriate organisation is on the list set out in my amendments, I would be keen to know which organisation they feel should not have a say in the creation of the database.

I hope that these important amendments will address the concerns raised in Committee and that hon. Members will now be able to support them, because they will ensure that we get the design of the database right.

--- Later in debate ---

My great-grandfather, a rural vicar, said that he did not mind his congregation looking at their watches, but got very concerned when they started shaking them. I notice that my hon. Friend the Member for Daventry is just about to start shaking his watch. He is champing at the bit to ensure that he gets the Bill on to the statute book, and I will therefore conclude my remarks.

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

The hon. Member for Daventry (Chris Heaton-Harris) may have to shake his watch a little longer. I call Jo Churchill.

[Jo Churchill]

I spoke earlier about the new clauses we tabled, but I did not emphasise my own need for us not to paralyse the database. It is vastly important, given the wider horizon of genomics and informatics, and we have not even touched on how it could accelerate the whole system and improve patient outcomes significantly. We need to put patients at the front and centre of the process, and allow enough flex for the system to be the best and the database to be the finest in the world. We have the finest scientists, the greatest charities and some of the best academic minds at our disposal.

The database may also revolutionise the life sciences industry, to which my hon. Friend the Member for Newton Abbot (Anne Marie Morris) has just referred. That industry generates 1% of our export market from one drug. The power for this billion-pound industry to grow and to improve health—not only in our own country, but across the world—has to be seen to be believed. It costs upwards of £1 million to take a drug to market. What on earth would incentivise a company to do that if it could not get some sort of payback? We must not tie the hands of the people who can find the answers. Many such companies start as micro-companies, spun off from the great universities of our country, but many of them fail in what they call “death valley”. Our health system needs to modernise, digitise and reform to collect, collate and use our health data in the right way.

I believe that clinical trials are vital. I would take part in one, as a dear friend of mine recently did, to give other people a better chance of beating their disease. That is why we must not constrain the database in a way that, like a straitjacket, would completely constrict the industry and academia. At the same time, we must maintain the rigour in dealing with science for which our country is so famed. I believe that the power behind that science is patient data, and every patient holds an answer. With the support of clinicians and charities, and with a strong sense of purpose from the Government, I want data to be used for the benefit of patients. I will stand here and make my point over and again for these five years if we wreck the ability for a database to be a power for good in this Chamber today.