Access to Medical Treatments (Innovation) Bill

Heidi Alexander Excerpts

Friday 29th January 2016 Commons Chamber

[Anne Marie Morris]

I shall resume my comments on amendment 2, which would remove clause 3. The argument goes that innovation has fallen in recent years owing to the legal complexities and doctors fearing a negligence claim against them if something goes wrong. There is no evidence of this, according to the Medical Protection Society, the Medical Defence Union, the General Medical Council or various other medical bodies that have spoken out on the issue. They claim that the Bill needs to be completely rethought and that no amount of amendment would make it acceptable. I would like to think that the work that my hon. Friend the Member for Daventry (Chris Heaton-Harris) has done will go some way to meet the concerns expressed before Committee stage.

Those most likely to benefit from innovative medicine are likely to be those most in desperation. Those who have nowhere else to turn will often be allured by the carrot on the end of the proverbial stick, but we must make sure that the treatment is right for that particular person. The UK has a proud history of research through universities, research institutes, the private sector and, of course, the NHS. According to the UK Clinical Trials Gateway, there are currently 3,754 trials recruiting, and that does not include the innovation that goes on day to day in the NHS.

According to the Association of the British Pharmaceutical Industry, it can take over 12 years to develop a new medicine to the standards of quality, efficacy and safety that are laid down in legislation. It will typically cost £1.15 billion to do all the research and development necessary before a new medicine can be licensed for use. For every successful medicine, 25,000 compounds are tested, 25 of these in clinical trials, with five receiving approval for marketing. The pharmaceutical industry invests more in research and development than any other industry—£11.2 million is spent every day—and employs around 23,000 people in R and D. My hon. Friend the Minister for Life Sciences stated in September last year:

“Research and innovation in the NHS are critical for addressing ...challenges.”

I agree and therefore wholeheartedly support amendment 2.

Amendment 3, which would remove clause 4, was tabled by my hon. Friend the Member for Daventry, with the support of the hon. Member for Central Ayrshire (Dr Whitford) and my hon. Friend and neighbour the Member for Totnes (Dr Wollaston). It is important to address the legal aspects of the Bill and medical negligence. The common law test, which is the main test for medical negligence, has been around since 1957 and derives from the case of Bolam v Friern Hospital Management Committee. The Bolam test states that if a doctor reaches the standard of a responsible body of medical opinion, he is not negligent. This rule has served us well over the past 55 years and I believe it will continue to serve us well. However, if it needs to be amended, our judges are in a suitable position to do that. The 1997 case of Bolitho v City and Hackney Health Authority, where the courts refined the Bolam test, is a great example of our common law in action.

Although I am sure some will point out that the Bill does not explicitly change the Bolam test and clause 4(3) appears to address the concerns that were expressed about the Saatchi Bill, I worry that lawyers would still find a way around this. Why tempt fate to change something that is not broken? Judges and lawyers know where they stand with the common law, so maintaining the status quo will give both doctors and patients the protection they need from negligent treatment. If the removal of clause 3 is agreed to, it is right that clause 4 should also be removed as it would no longer be necessary, and the common law of negligence and the Bolam test can continue to operate effectively, as they have done for 55 years. I therefore support amendment 3.

[Heidi Alexander]

This group of amendments, and in particular those which leave out clauses 3 and 4, are very welcome and have my full support. I appreciate that making such extensive changes to a Bill at this stage is not easy, but the hon. Member for Daventry (Chris Heaton-Harris) has been true to his word, and has rightly decided not to proceed with these clauses in the face of strong opposition.

Members who were present on Second Reading will have heard some of the grave concerns expressed by medical royal colleges, research charities and patient groups. I think it would be fair to the hon. Gentleman if I say that those concerns, which I shared, were more about the unintended consequences of clauses 3 and 4, than about the stated aim of his Bill. However, the effect of these amendments, if they are passed, is that the sole purpose of this Bill is now to give the Secretary of State the power to establish a database. The hon. Gentleman knows that on Second Reading, along with many other hon. Members, I said that I believed the Secretary of State already had this power.

The Association of Medical Research Charities has said that primary legislation is not required to set up a database of innovative medical treatments. According to the House of Commons Library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information. Indeed, in Committee, the Minister signalled his intention to introduce such a database, regardless of whether this Bill becomes law. He said at that time:

“If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database”.––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22.]

With that in mind, I have to question whether what is left of this Bill is needed at all.

There also seems to be some confusion, even in the Minister’s own mind, about the purpose of the Bill. The Daily Telegraph claimed on 22 January that the Minister had told it that changes in the reworked Bill could help to cut the length of time it took to bring a new drug to market by a third, from 15 years to 10 years. Yet when my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders) received a written answer to a question on this very subject on 28 January, the Minister’s reply was:

“The Bill is not specifically designed to reduce the length of time it takes to bring a new drug to market”.

I would be grateful if the Minister clarified the apparent contradiction in those remarks. Having said all that, I support all the amendments in this group. Indeed, they represent a positive step forward in terms of the overall Bill.

[George Freeman]

The amendments seek to remove the part of the Bill that sought to take forward the original proposals put forward by Lord Saatchi to provide reassurance to clinicians that fear of negligence should not be a barrier to innovation. I want to say something about the Government’s position on this point, which, as the hon. Member for Lewisham East (Heidi Alexander) has said, has been a point of some contention.

The Government share the ambition that fear of negligence should not be a barrier to innovation. Indeed, we have looked carefully at the provisions of the original Saatchi Bill and of this Bill, and taken legal advice in order to be sure that the proposed mechanism would in no way change medical negligence law, and that is indeed the case. Notwithstanding that, I have also repeatedly made it clear that if the Bill’s provisions were to create confusion, undermine patient, public and clinician trust and confidence and trigger a lawyer-fest of discussion about whether the mechanism did or did not have that effect, it would have had the opposite effect to that which it was seeking. In those circumstances, the Bill could trigger more confusion about medical negligence.

My hon. Friend the Member for Daventry (Chris Heaton-Harris) has done a sterling job in the past few months to get round all the various parties and reassure them that, in law, the proposed mechanism does not change the legal framework for medical negligence. However, as he himself has candidly said, such has been the level of opposition—and indeed some misunderstanding, not least because there are three Bills on this subject in the House—that this proposal has started to have the opposite effect. As I said on Second Reading and elsewhere, we would never be able to support a Bill which, despite its intentions, undermined public and patient trust and confidence in our world-class medical and clinical research landscape. The fact that a coalition of lawyers, clinicians, patients and charities was concerned about the clause meant that it would inevitably have to be removed if the Bill was to receive any support from the Government. I congratulate my hon. Friend on doing his very best to develop the debate and, in the end, deciding that it would be better to remove the clause and focus on the areas on which there is agreement.

In accepting the amendments that remove the provisions on medical negligence from the Bill, it is worth pointing out that I do not want the hon. Member for Lewisham East to misrepresent my position on this. Both the chief medical officer and the NHS medical director had advised us that they believed the proposal was safe, and we had no fear that it would in any way endanger patient safety. The point is that if it triggers legal, political or patient concern, it is self-defeating.

As I have said repeatedly at the Dispatch Box, fear of negligence is just one concern in a whole field of barriers to the adoption of innovation. I do not believe that it is the biggest barrier; I never have. The biggest is the difficulty of getting information to clinicians on the busy frontline of our national health service on the pace, scale and volume of innovative medicines that are coming through the system. That is why I believe that my hon. Friend’s refocusing the Bill on that, and on the introduction of a new mechanism for getting information on off-label drugs and innovative medicines in development, is very helpful and powerful.

In the consultation on the previous Bill on this subject, we received some evidence from clinicians that there was an issue about fear of negligence. Indeed, some Members have talked about the scale of the negligence bill that now confronts the NHS every year. I want to put on record, notwithstanding my earlier comments, that it is absolutely right to remove this mechanism from the Bill because it is having the opposite effect. There is an issue in our system, and we need to ensure that doctors and clinicians are not operating under the sword of Damocles because of the fear of negligence. It is equally important that patients should know that the system is there to protect them, and we do not want them to fear that medical negligence provisions are being undermined in any way. I strongly welcome the removal of this clause, but in so doing I do not want the hon. Member for Lewisham East to misrepresent our position by saying that we accepted that the mechanisms were in any way dangerous. Patient safety has always been our No. 1 concern.

[Heidi Alexander]

Will the Minister tell us why it is taken him so long to reach this conclusion? Will he also be clear about the contact that his officials at the Department of Health might have had with the hon. Member for Daventry (Chris Heaton-Harris) or Lord Saatchi on previous incarnations of this Bill? It strikes me that the Department has supported this Bill for a number of months and years in its different incarnations.

[George Freeman]

I am absolutely delighted that the hon. Lady has asked me that question, because it gives me the chance to deal with this matter directly. I am surprised at her question, in an age in which people want the Government to work in a cross-party way and to support private Members’ Bills and enable Back Benchers to get business through, and I have gone out on a limb to work in a cross-party vein. Sadly, however, the hon. Lady seems stuck. I thought this morning might have been a day on which to celebrate that joined-up work. Let me deal with the specific points that she has raised.

Right at the beginning, I said that I supported the aim of Lord Saatchi’s Bill to tackle the issue, such as it is, of medical fear of negligence if it is getting in the way of innovation. Indeed, we made it clear that we supported the aims of the Off-patent Drugs Bill, but not the mechanism involved. We also made it clear that we supported the aim of the Bill introduced by my hon. Friend the Member for Daventry to promote access to information about innovative medicines. I am surprised that the hon. Lady cannot get away from wanting to criticise that attempt. I believe that it is a good thing that we have reached joined-up consensus today on a package of amendments.

The hon. Lady should not believe everything that she reads in the papers. The article in The Daily Telegraph to which she referred talked about the accelerated access review, which I am leading and which I would like to think she welcomes and supports. My comments on speeding up the pace at which we can get innovative medicines to patients were in connection with that. I read the piece too, and it was misleading because it gave the impression that I thought this Bill would have the effect that I want the accelerated access review to have. I was merely making the point that the Bill in its current form could support the wider accelerated access review and the landscape that I am trying to put in place.

[Heidi Alexander]

I should like to state for the record that it has never been the Opposition’s desire to play political games with this Bill. We have always been concerned about what is in the best interest of patients, and I would like to make that point clear to the Minister and place it on record.

[George Freeman]

I am grateful to the hon. Lady for that clarification; it is most welcome.

I want to deal with the point that the hon. Lady and one or two others have made about the necessity of the Bill, given the powers that Ministers already have in relation to data. The Health and Social Care Information Centre, created under section 254 of the 2012 Act, can collect data, but there are restrictions on who it can disclose those data to. The Bill will enable disclosure to doctors, which could be limited by using just section 254. The 2012 Act also contains specific provisions relating to the HSCIC having a role in establishing other databases, so this approach is more in keeping with the general approach in the legislation.

The Bill might not pass in its current form, as it still has to go to the House of Lords. However, the point I made in Committee was that although I support the intention of that database provision, the law regarding the use of data in the NHS is complex and difficult, as Members know well. If the House wants the database to be created, having a Bill that makes very clear what it wants the database to do and requires Ministers to come back with proposals for it would be extremely helpful. In conclusion, I support these amendments.

Amendment 1 agreed to.

Clause 2

Database of innovative treatments

Amendment made: 11, page 1, line 18, leave out from beginning to “involves” in line 19 and insert

“In this section, “innovative medical treatment” means medical treatment for a condition that”.—(Chris Heaton-Harris.)

[Heidi Alexander (Lewisham East) (Lab)]

I beg to move amendment 8, 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,

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

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

[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.

[Anne Marie Morris]

I will speak first to amendments 8 and 9 and then turn my attention to amendment 15. As the hon. Member for Lewisham East (Heidi Alexander) explained, amendments 8 and 9 would add a whole host of bodies—I think that I counted eight—that the Secretary of State must consult before making regulations under subsection (1). This relates to the conferring of functions on the Health and Social Care Information Centre in connection with the establishment, maintenance and operation of a database. The hon. Lady has talked articulately about why the two amendments should be made, but I have some concerns.

My main concern, despite everything the hon. Lady said, is that adding all these organisations that the Secretary of State must consult will just add to the complication of the database. The amendments not only ask the Secretary of State to consult, but ask that all these organisations approve the regulations. Adding these extra organisations will just add to the confusion about who is policing the system. Is the consent of all those organisations needed before a treatment can be removed, or can it be removed just by the Health and Social Care Information Centre? If a complaint is made about what is on the database, does it go to the Secretary of State, the NHS or the Health and Social Care Information Centre, or does it have to be put in front of all those organisations again?

I understand that the hon. Lady might not have all the answers to my questions and that these issues go deeper than just her amendments, but I do not think that adding extra layers of consultation will help to simplify the Bill or make it any easier to implement the database, which, if put together correctly, could do much good and help many people across the country and, potentially, the world. I do not support amendments 8 and 9, because I believe that they will add unnecessary complications to the database and impede the good work that it could well achieve.

Amendment 15 has been tabled by the Minister, who has spoken eloquently throughout these debates. Including references to treatments carried out for the purposes of medical research will enhance the database, because it will allow the inclusion of clinical trials and other forms of medical research. Including medical research in the Bill will hopefully help to address the UK DUETS database. Mr Deputy Speaker, you will be glad to hear that that is not a database of UK singers who perform together; it is the database of uncertainties about the effects of treatment. It publishes treatment uncertainties from a wide range of people, including patients, clinicians and research recommendations, among others. By including medical research on the database, hopefully we can remove a few more treatment uncertainties from the database or, on the flip side, identify treatment uncertainties with greater ease and therefore tackle them head-on.

Clinical trials are vital if we are to put our NHS resources into the right treatments. They can help find out how to prevent illnesses, detect and diagnose illnesses or treat illnesses. The earlier we can do that, the more lives we can save, so I support any move to increase clinical trials, which I believe this amendment will do. It is my belief—I am sure that my hon. Friend the Minister will correct me if I am wrong—that his amendment will also increase knowledge of clinical trials among clinicians by adding them to the database. Sir Francis Bacon said that “knowledge is power”, and I do not believe that is any less true when it comes to medicine and saving lives. I fully support the Minister’s amendment.

--- Later in debate ---

[Chris Heaton-Harris]

I thank the hon. Lady for her explanation to my hon. and gallant Friend the Member for Beckenham (Bob Stewart).

It is important that doctors are aware of the changing methods by which care is being delivered. Innovation in the delivery of care must be recognised in the tapestry that is our wonderful national health service. I fully welcome the Minister’s amendment to my Bill. It makes it more worth while. The improvements we are making to the Bill today are dramatic, but they have not come out of thin air; they have come from a great deal of work. A great deal of thought has gone into them, which I very much appreciate.

Finally, and briefly, let me turn to amendments 8 and 9, in the name of the right hon. Member for Lewisham East (Heidi Alexander).

[Heidi Alexander]

Honourable.

[Chris Heaton-Harris]

Soon to be right honourable—I shall try to get her promoted to that position. I am sure there are some Privy Council positions awaiting on the Labour Benches.

I completely understand where the hon. Lady is coming from in trying to ensure the widest range of consultation on, actually, pretty much anything. Forget this Bill; when the NHS does something, it should try to interact with stakeholders who have direct and indirect concerns. As it stands, the list in her amendments looks like a preferred list of consultees, although I have a range of concerns about the listing, the order and so on. Given the way we have gone about this Bill—there has been a great deal of understanding and working together—I would like to think that when my hon. Friend the Minister answers this point and indicates what the Secretary of State would do with the power, how he would consult and which groups he would consult with, the hon. Lady will perhaps consider not pressing her amendments, in the full knowledge that there will be the widest possible consultation, should this Bill become law.

--- Later in debate ---

I hope that, with the reassurances about consultation, the House will support the hon. Lady in not pressing amendments 8 and 9. I will happily follow up on the commitments that I have made to make sure that all her suggested consultees are included and others too. I hope the House will support amendment 15, which seeks to remove the exemption for clinical research so that clinicians will have access under the Bill to drugs in clinical research that their patients may be eligible for.

[Heidi Alexander]

I have listened carefully to the debate on this group of amendments. Although I know that the hon. Members for Bury St Edmunds (Jo Churchill) and for Newton Abbot (Anne Marie Morris) have concerns about creating excessive bureaucracy, I think those concerns are somewhat overstated. The Bill already requires consultation before regulations are made. I am seeking to ensure that the appropriate organisations are able to have their input into the process. However, in the spirit of cross-party working for which the Minister has developed a fondness this morning, I beg to ask leave to withdraw my amendment 8 and not to press amendment 9.

Amendment, by leave, withdrawn.

Clause 3

Responsible Innovation

Amendment made: 2, page 2, line 26, leave out clause 3 —(Chris Heaton-Harris.)

Clause 4

Effect on Existing Law

Amendment made: 3, page 3, line 19, leave out clause 4 —(Chris Heaton-Harris.)

Clause 5

Interpretation

Amendments made: 4, page 3, line 40, leave out “this Act” and insert “section 2”.

Amendment 12, page 3, line 42, leave out paragraph (b).

Amendment 13, page 3, line 44, at end insert—

‘(1A) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—

(a) the off-label use of an authorised medicinal product, and

(b) the use of a medicinal product in respect of which no marketing authorisation is in force.

(1B) In subsection (1A)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—

(a) for a purpose other than one for which its use is specified,

(b) in relation to a person who is not within a description of persons for whom its use is specified, or

(c) in any other way in which its use is not specified.

(1C) In this section—

(a) “authorised medicinal product” means a medicinal product in respect of which a marketing authorisation is in force;

(b) “marketing authorisation” and “medicinal product” have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);

(c) “specified”, in relation to a medicinal product, means specified in its marketing authorisation.”’—(Chris Heaton-Harris.)

Amendment 15, 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).”—(George Freeman.)

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).

[Madam Deputy Speaker (Natascha Engel)]

We now come to amendment 5. With the leave of the House I will put the questions on amendment 5, 6 and 14 together.

--- Later in debate ---

[Heidi Alexander]

It is a pleasure to follow the hon. Member for Newton Abbot (Anne Marie Morris) and my hon. Friend the Member for Torfaen (Nick Thomas-Symonds).

In opening this debate on Third Reading, the hon. Member for Daventry (Chris Heaton-Harris) said that it was something of a relief to get to this stage. I have to say that I agree with him. I congratulate him on getting his private Member’s Bill through to its Third Reading. His commitment to the Bill has ensured that the crucial issue of improving access to innovative treatments and medicines has been debated in detail on the Floor of the House, which is a good thing.

I am conscious that we have already spent considerable time today debating a Bill that is now relatively straightforward, so I will keep my remarks brief. In short, the amendments that have been made today have made the Bill safer and have focused it on the area that the hon. Gentleman feels most passionately about—namely, the power to create a database.

Although I still question whether legislation is needed to give the Secretary of State this new power, the Bill is a vast improvement on what it was previously, and I will not oppose its Third Reading. I am sure that the other place will take a keen interest in scrutinising the Bill, as it has had extensive debates on this subject in the past and, indeed, on similar private Members’ Bills.

I urge the Minister to think very carefully about the design of the database. Even if he does not wish to broaden the list of statutory consultees, I hope that he will engage with the medical profession and other stakeholders to ensure that he gets the database right.

I congratulate the hon. Member for Daventry once more on navigating the Bill to this stage and on taking account of the very real concerns that I and many others have expressed to him.