ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Chris Heaton-Harris Excerpts

Wednesday 16th December 2015 Public Bill Committees

[The Chair]

Before I call the Bill’s promoter, I have allowed quite a lot of latitude but it is important in Committee to focus specifically on the amendments that we are deliberating, which the hon. Lady did without referring to them. That is the way forward and that is our system.

[Chris Heaton-Harris (Daventry) (Con)]

It is a pleasure to serve under your chairmanship yet again, Mr Streeter. I hope you will be as gentle with me this time as you were last time.

[The Chair]

Unlikely.

[Chris Heaton-Harris]

It was worth a try. I welcome the speeches that we have just heard and I certainly welcome the engagement that I have had with the shadow spokesman and a whole range of people across the House on my Bill. I thank the Minister for his engaged help and that of his officials, who have been unbelievably helpful behind the scenes and have set me right on a whole host of issues as I have been through the process—a process that has been very enjoyable but that I never intend to undertake again.

In talking about amendments 1 and 2, we probably just had the stand part debate for clauses 3 and 4. I am sure there will be a better debate at that point but, essentially, that is the major area of controversy in the Bill. I know that the hon. Member for Central Ayrshire has some concerns about the database. She has been unbelievably constructive in her approach to the Bill and I know that we can sit down and get to a point where her concerns are listened to and taken on board. I am very happy to work with her on amendments for Report, if she has any then, to get the Bill to that position.

On the amendments, the Minister said—I will not repeat all the Minister’s words because they were wise, and wise words need to be heard only once by any parliamentary Committee—and parliamentary counsel gave me the same advice, that the Bill does not change medical negligence law. In fact, that is stated in the Bill. However, is there an actual need for it?

The Minister set out what happened in the consultation, as to whether there was a need and whether doctors were concerned about litigation. I want to put a couple of things on the record to show that I have not just made up the concern based on a casual hearing of what the Minister said about the consultation. On Second Reading, I read out a quote from Dr John Hickey. I will read it out again because I am not sure that many people heard it at the time. He said:

“As a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (the last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill. Over the last 30 years I have seen how doctors have increasingly practised defensive medicine both because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests. I believe that your Bill, if approved by Parliament, would assist in meeting the concerns of clinicians treating such patients . . . I believe there are adequate safeguards in your Bill, particularly with respect to consent, to prevent the potential ‘quackery’ about which some of the critics of your Bill and Lord Saatchi’s previous Bill have expressed concern.”

He was actually the chairman of my local NHS trust and I have a great deal of respect for him.

We all received a host of briefings; I know Committee members have enjoyed the briefings on the Bill they have received over the past few days. I apologise for any extra work I might have created.

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I hope that I have given the hon. Gentleman enough reassurance and explained the rationale. I strongly support his intentions and will happily talk to him about amendments we might table, but I cannot accept the mechanism proposed.

[Chris Heaton-Harris]

I will be brief. I have listened to the debate. The hon. Member for Torfaen put his case strongly, and there is a constructive and helpful offer on the table from the Minister. I simply ask the hon. Gentleman to withdraw his amendment and to take up the offer to return to this on Report, having worked on something with the Minister, the team from the Department of Health and me. Hopefully we can then get to a good place on the off-label use of drugs.

[The Chair]

Our timing is good. We might have a Division downstairs shortly, so we have plenty of time for Mr Thomas-Symonds to respond.

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[George Freeman]

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.

[Chris Heaton-Harris]

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.

[Justin Madders]

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.

Clause 6

Extent, commencement and short title

Question proposed, That the clause stand part of the Bill.

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[The Chair]

This debate is an opportunity for Mr Heaton-Harris to say something nice about the Chair.

[Chris Heaton-Harris]

Thank you, Mr Streeter. What a wise Chairman you are—one of the best Committee Chairmen ever.

I thank all members of the Committee for their forbearance, especially those who have distinct issues with parts of the Bill. The offers I made are real, and, if I cannot get the controversial parts in clauses 3 and 4 into the right place quickly, I intend to table amendments to delete them, as I said to the hon. Member for Torfaen, so that there is absolute clarity. I look forward to working with anybody who wants to work with me on getting all the other provisions in the Bill into the right place.

I thank you very much, Mr Streeter, and would like to wish a very merry Christmas to every member of the Committee and staff, especially the departmental staff. There is a gentleman called Mr Peter Knight who helped convene a workshop last week for me to explain to interested organisations what the database could look like and how the consultation on it might proceed, which shed a lot of light on this issue and clarified things.

[George Freeman]

I would like briefly to add my thanks to you, Mr Streeter, for chairing the Committee.

We have had a constructive discussion with all parties represented on the Committee, with some front-line advice from clinicians. I thank my hon. Friend the Member for Daventry for his clear offer. I pay tribute to him for the clarity of that offer. The Government are concerned that this Bill, with the noblest of intentions, is still not in a place where it has widespread support from all parties. A Bill that elicits concerns and opposition from both industry and charities, patient groups, lawyers and the General Medical Council is a Bill whose nobility of purpose is not yet reflected in unanimity of support.

I am grateful to my hon. Friend, and I know that he is keen to get the Bill to a point where it can be distinguished from a predecessor Bill that generated a lot of heat and some opposition. I genuinely believe he is trying to get to that point, particularly on the database provisions. I urge him to keep his foot to the pedal, particularly on the negligence provisions, on which we have a bit more work to do. I repeat that if a well-intentioned Bill has the inadvertent effect of undermining patient and public trust in the world-class status of our research medicine and clinical trials, it will be self-defeating and I would find it impossible to support. However, we have a chance to avoid that.

I thank you for your excellent chairmanship of the Committee, Mr Streeter, and add my thanks to the officials sitting on both sides of you, who have guided us through this process. I hope we can get to a point where we can go back to the House on Report and say that this Committee has managed to rescue a noble cause and, with the help of my hon. Friend the Member for Daventry, put forward a proposal we can all support.