Clause 2 - Database of innovative treatments

Access to Medical Treatments (Innovation) Bill – in a Public Bill Committee at 3:15 pm on 16th December 2015.

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Photo of Justin Madders Justin Madders Shadow Minister (Health) 3:15 pm, 16th December 2015

I beg to move amendment 5, in clause 2, page 2, line 20, at end insert—

‘(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, and

(i) the Medicines and Health Products Regulatory Agency.’

Photo of Gary Streeter Gary Streeter Conservative, South West Devon

With this it will be convenient to discuss amendment 6, in clause 2, 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, and

(i) the Medicines and Health Products Regulatory Agency.’

Photo of Justin Madders Justin Madders Shadow Minister (Health)

I will be briefer on these amendments.

The clause deals with the creation of the database, which we consider unnecessary, because the Secretary of State already has the relevant power under section 254 of the Health and Social Care Act 2012. Even if there is a difference of opinion and the clause remains in the Bill, we want to broaden the number of bodies that the Secretary of State must consult. We think the list in the amendment is comprehensive, whereas, as the Bill stands, to make regulations under clause 2, the Secretary of State need consult only the Health and Social Care Information Centre. The explanatory notes to the Bill state:

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

from which we take some comfort, but we feel that it is better to be clear in the Bill about the wider range of bodies to be consulted.

Amendment 6 would insert a proposed new subsection (6A) requiring the Secretary of State to seek approval for regulations from the bodies on the same list, in essence, as in amendment 5, but with the addition of the HSCIC. It is about having approval in principle, as well as the details and mechanics of the database.

We are not making a complicated point, but we are putting on record our wish for a broader selection of groups to be consulted.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

I will be brief. Following our earlier conversation about the database provisions, I emphasise that they are the part of the Bill that the Government most strongly support. The database is not envisaged as it was in the predecessor Bill—if I may call it that—as a registry for recording ad hoc innovations by clinicians, but as a fundamental database to give all clinicians access to information on innovative medicines, including off-label uses of medicines and medicines that are either unlicensed but in use, as in the early access to medicines scheme, or in clinical trials, in which a patient might be eligible to enrol. The clause gives the Secretary of State the power to make regulations conferring functions on the HSCIC, the body that develops and puts into place databases such as the one we are discussing, in connection with the establishment, maintenance and operation of the database for innovative medical treatments.

I am pleased that my hon. Friend the Member for Daventry proposed the database for recording such treatments and for getting information on them out to clinicians. The measure is important in the promotion of innovation. Crucially, the measure would give doctors the ability to search the database for innovations, so the position is very different from that under the Bill introduced in the House of Lords last year, which proposed a database as a registry on which innovative doctors could log what they had done. The database proposed in this Bill is completely different, which is why I strongly support it.

The database could result in better care and health outcomes for patients and a faster uptake of new treatments, and it could support our work to make Britain a world-leading centre for innovative medicines. The pace of progress in genomics and informatics is profoundly changing the way in which new drugs are developed, but our databases and systems information have not kept up, so that is among the things that are being considered under the accelerated access review. While the Secretary of State might already have the legal power to create a database, the Bill helpfully sets out that provision may be made to give instructions to HSCIC to create a specific database, which I would welcome. If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database, but it would be helpful if the provision were set out clearly in legislation.

The Government do not support amendment 5 because it is not exhaustive. 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, but I would be happy to write to members of the Committee about our approach. I undertake to write to all the relevant organisations and to ensure that they are consulted, but I am old enough and ugly enough to know that well-intentioned lists of statutory consultees can quickly become out of date. They can create weird anomalies whereby parties that really have nothing to say are statutory consultees, yet those who have a lot to say are not. I am happy to discuss what other steps we can take to ensure that those who, rightly, need to be informed about the Bill and the mechanisms it proposes are properly informed.

The Government do not support amendment 6 for the same reason—because the list is not exhaustive—but I will be happy to put in a place an alternative mechanism to ensure that those parties listed the amendment and others are properly informed. I would not want to put in law a list of consultees that we might well need to amend quite quickly. I, for one, do not want to find myself back in Committee considering a statutory instrument to amend a list of statutory consultees established by a well-intentioned proposal, so I hope that the hon. Member for Ellesmere Port and Neston will withdraw the amendment.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

Obviously, I agree with the Minister, and I have discussed the matter with the shadow Minister. I know from my consultation on the Bill with stakeholders that we would need longer lists than those in the amendments. I hope that the hon. Member for Ellesmere Port and Neston will agree to the Minister’s generous offer and therefore withdraw the amendment.

Photo of Justin Madders Justin Madders Shadow Minister (Health)

Our debate has shown that a well-intentioned proposal might have unintended consequences, so I accept what the Minister and the hon. Member for Daventry say about the need for comprehensive lists. I think that the lists in the amendments are pretty comprehensive, but I accept that other bodies might emerge or feel that they should be included. I am happy to work with the hon. Gentlemen to ensure that we reflect the intention behind the amendments, yet do not create additional work a few years down the line because we have to amend the legislation. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 2 ordered to stand part of the Bill.

Clauses 3 to 5 ordered to stand part of the Bill.