Access To Medical Treatments (Innovation) Bill

Philippa Whitford Excerpts

Friday 29th January 2016 Commons Chamber

What we are discussing could be a new system. Finally, it speaks about, “Delivering change”. I look to the Minister to make those five commitments work with off-patent, repurposed drugs for everyone in the UK.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I rise to support new clauses 1 to 3, 5 and 6 and amendments 10 and 13. The only reason new clause 4 does not stand in my name is that it relates to NHS England, which is outwith my purview.

People are well aware of my objections to clauses 3 and 4. Many Members in this House and medical voices outside the House have real concerns about the danger to patients of doctors having to convince only one colleague before trying a completely unproven approach. As well as the danger to patients, I feel that there is a danger to our clinical trials system. Why would someone go through applications, a year of paperwork and phases 1, 2 and 3, when they could just cut to the chase?

I pay tribute to the hon. Member for Daventry (Chris Heaton-Harris) for being willing to sit around a table with the Members who were named by the hon. Member for Torfaen (Nick Thomas-Symonds) and the Minister, and to start with a blank sheet of paper and work out how we could do something useful. It has been a great procedure. I welcome the fact that later in the day the hon. Member for Daventry will propose the removal of the clauses on innovative practice and litigation.

Turning to the off-patent drugs proposals, 6 November was a very frustrating day in this House. Every single Member who spoke from the Back Benches spoke in favour of the Off-patent Drugs Bill, but the time ran away during the Minister’s response—not the Minister who is here today. That debate showed the appetite across the House to get something done on off-patent drugs.

The hon. Member for Bury St Edmunds (Jo Churchill) has explained most of what I was going to explain. There is still the issue that while specialists are steeped in the evidence and used to using drugs off label, those who are not are less sure. There is no automatic place where they can check a dose or an indication. Sometimes, it is the general practitioner who does not carry it through. We have had lots of discussions in this House about the changes in the NHS and the evolution to multidisciplinary teams out in the community. That means that there are far more non-medical prescribers. The further someone is from the expert prescriber, the less comfortable they are. They do not have easy access to somewhere they can check when they think, “Is that just my bad handwriting or is that really what I mean?” That is what new clause 6 on the BNF could achieve.

The BNF is used by everyone and is on every desk in the NHS. As the hon. Member for Bury St Edmunds said, people can either check a drug that they have had a letter about from the hospital or look something up when they think, “I don’t have anything for this. What exists?” We will also discuss that when we come to the database proposals. I welcome the fact that the database has been changed from being a registry of people doing their own thing to a place where information is shared.

On new clause 5, which I tabled, although the inclusion of off-patent drugs in the BNF will achieve the sharing of information and will, in a sense, give them a slightly informal kite mark, I feel that it is important to look eventually at providing a licence. The reason for my concern relates to the drug simvastatin, which is used all over the place to control people’s cholesterol and has been found to be useful in multiple sclerosis—a disease that plagues many people and causes a lot of suffering, and for which, frankly, we do not have a lot to offer. That drug is incredibly cheap, but if a company decides to tweak a little molecule of it, call it something else and put it out as a new wonder-drug for multiple sclerosis, we will be having debates in Westminster Hall about a drug that costs fifty grand and that the NHS cannot afford. Under General Medical Council rules, the cascade is still that a doctor must prescribe a licensed drug over an unlicensed or off-label one, regardless of cost. If a doctor was faced with fifty grand for simvastatin-new versus sixpence for the simvastatin we all know, they would have no choice, and we would be right back in the same position—relentlessly discussing the NHS’s access to drugs.

The drugs we are talking about are already safe. They have had a patent and been used for so long that they are now off patent, which means that they have been around for a decade. We know their side effects, the common dosages and what to look out for. They should not have to start at point zero of the licensing process. We need a short licensing system, so that patient groups, academics, charities and the British Generic Manufacturers Association can say, “We think there is something useful here.” We have put provisions in new clauses 2 and 3 for the NIHR and NICE to have capacity in their systems to provide a funnel for evidence on such drugs.

These drugs are not developed by big pharma, so there are not huge costs that have to be recouped. The purposes of them are usually found by academics and clinicians, so pharmaceutical companies should not make a massive profit out of them. The benefit should be that the NHS can afford them and patients can access them. We have many debates about access to medical treatments in the House, usually in Westminster Hall and usually about drugs that are eye-wateringly expensive. In this case we are talking about drugs that are proven and cheap. We need to come up with a system that makes them accessible to patients.

I commend the Minister for the time, that, as others have said, he has given the four of us around a few tables, hammering these provisions together. I hope that we will be supported in working them through and actually doing some good for the NHS and our patients.

[Anne Marie Morris (Newton Abbot) (Con)]

It is with great pleasure that I rise to speak in support of this important Bill, introduced by my hon. Friend the Member for Daventry (Chris Heaton-Harris), and the amendments he has tabled. Specifically, I rise to support amendment 13. I am sure that the hon. Member for Torfaen (Nick Thomas-Symonds) will be disappointed that his private Member’s Bill did not make it to Committee stage, but I hope that he is happy to see some of it included in this Bill.

I had my reservations about the Bill as it stood originally, and I have reservations about some of the amendments, but I believe that amendment 13 will increase the use of off-label drugs in a safe and secure way. Those drugs can often be a cheaper and quicker way to tackle a disease, as they do not have to go through the rigmarole of being developed and licensed, which can take many years and many billions of pounds. NICE states that an unlicensed medicine is one that

“does not have a UK marketing authorisation and is not expected to do so in the next 2 years”,

whereas an off-label medicine is one

“with an existing UK marketing authorisation that is…used outside the terms of its marketing authorisation”,

and for which

“it is not expected that the existing UK marketing authorisation will be extended to cover this use in the next 2 years.”

The inclusion of off-label use classes in the database as innovative medical treatments will allow the medical profession to see where off-label use has been effective, even if it is at the other end of the country. However, we must be careful not to place off-label uses on a pedestal and allow people to cling on to false hope. They are the most vulnerable people in our society, often looking for any treatment that may help them, but we must ensure that any drug that is prescribed off label is used responsibly and ethically. I believe that the database will help by allowing doctors to see what is effectively a large sample trial that gives them more information on a particular treatment. I therefore support amendments 13 and 10.

--- Later in debate ---

[George Freeman]

The hon. Gentleman makes two good points. This is, of course, UK-wide. One of the challenges, as a UK Minister, is to put in place a framework that will support this across the UK while respecting the different mechanisms in the devolved Administrations. I hope the Bill will provide a basis for a similar mechanism in areas where there are different formats. I believe that in Scotland, Northern Ireland and Wales, but particularly in Scotland and Northern Ireland, there is a hunger to do that. I believe the Bill will support those existing mechanisms.

[Dr Philippa Whitford]

We have moved on from talking about the BNF. I accept the comments about listing groups that would be considered in new clause 5. Does the Minister accept, however, that we still need to deal with the cascade of prescribing to ensure doctors are not forced to prescribe a licensed medicine, which is actually just a minimal moderation of an off-patent drug at a vastly expensive cost? That means we still need some kind of change to the licensing or short licensing process in the future.

[George Freeman]

The hon. Lady makes an important point about the classification of different drugs available to clinicians. Without detaining the House with too long a peroration on that classification, it is worth setting out that there is a clear cascade.

Clinicians can use unlicensed medicines in situations where, in their clinical judgment, and with patient consent, they believe it is the right thing to do. They are subject to all their usual professional undertakings. There are then off-label uses of drugs: drugs that do not have a licence for a particular indication but which the clinician, on the basis of evidence, is able to prescribe when they feel that evidence is compelling. The Bill now goes to the heart of that and will help to provide reassurance. For many clinicians, being able to click on a mouse with their patient and say, “For your condition there are one, two, three or no off-label medicines available for which NICE has looked at the evidence,” would be a powerful catalyst in helping to promote off-label use. There are generic drugs, which have been patented and brought to market, that are available at a heavily discounted open price.

There are then on-patent drugs, which have been brought to market and are still subject to a patent. The manufacturer has an exclusivity, which is the period in which their sunk costs in bringing the medicine to the system, can be reimbursed. That is an important protection to make sure we continue to have a thriving life science sector that can take the risks of investing in new drugs. Typically, new drugs take 15 years and £2 billion to develop. If there were no patenting mechanism, there would simply be no enthusiasm to do that research, which has a very high failure rate. In law, there is a key point of principle, which is that a licensed drug should be used first and that an unlicensed drug cannot be used purely on the basis of cost. That is a really important principle. An unlicensed drug can, however, be used on the basis of evidence. That is why the mechanism will allow NICE to look at the evidence and to signal to clinicians that they have the evidence basis on which to use the drug in an off-label indication.

One of the issues we have dealt with in discussions is the whole question of the European licensing of medicines. If we were to go down that route—I know the hon. Member for Central Ayrshire understands this—I can assure the House we would be here not just for weeks and months, but years. I am leading for the Government on reforming the European landscape of 21st medical research. The central role of protecting innovators’ sunk costs is really important to our life sciences sector, and the new clauses and amendments create a mechanism by which we can accelerate off-label use without running a coach and horses through that.

[Dr Whitford]

I accept the Minister’s points, but my concern remains that if in 10 years we have simvastatin in its current form versus a new name that is just a tweaked simvastatin at a thousand times the price, doctors will, under GMC rules, have to go for the one with the licence, as opposed to the off-patent one, even if it is in the BNF. I accept that the BNF mechanism will absolutely increase usage, but we still need to consider the longer term, given that in the future we might have huge numbers of off-patent drugs with new purposes.

[George Freeman]

The hon. Lady makes an interesting, important and useful point that I undertake to pick up in our consultation in response to the accelerated access review. The landscape will continue to change fast over the next few years. The Bill, as amended, will promote the greater use of off-label medicines. Crucially, the database mechanism, which, I reassure everybody, is very different from the original registry proposed in a precursor Bill—it is to make clinicians aware of what drugs are available—will generate data that will be incredibly powerful in helping the system to adapt and use the freedoms I hope to give it through the accelerated access review. That will ensure we are better and faster at getting these repurposed medicines into use.

I am delighted to say that the Government are happy to support amendments 10 and 13. Amendment 10 would set out in the Bill that its purpose specifically includes promoting access to the innovative use of licensed medicines outside their licence indications. It puts four square at the heart of the Bill the aims of the Off-patent Drugs Bill, which was promoted by the hon. Member for Torfaen (Nick Thomas-Symonds), and which, as hon. Members across the House have commented, had a lot of in-principle support. I am pleased, therefore, that we have found a form of words that moves it forward. At the heart of it, there is a clever protection for clinical sovereignty. We are not telling clinicians what they have to prescribe or putting in law a requirement that they prescribe in a particular way. We are giving them information on evidence-based off-label drugs. The feedback from clinicians so far is that it genuinely will help them to understand, promote and prescribe off-label uses.

Amendment 13 seeks to clarify the definition in the Bill of innovative medical treatments to make it clear that it includes off-label and unlicensed medicines. I mentioned earlier the pace at which genomics and informatics were uncovering new uses for drugs—some have referred to it as finding diamonds in the dustbin. There are extraordinary applications among the existing pharmacopoeia of tens of thousands of drugs. We now realise that many of them have particular impacts and effects. That is all to the good. It is thanks to the power of our life sciences sector that we are beginning to uncover those, and the Bill will support that.

With those comments in support of amendments 10 and 13, I hope I have given hon. Members enough reassurance and that they feel able to withdraw or not press the probing new clauses. I will be happy, following Third Reading, to put in place, through the accelerated access programme, a clear plan for keeping on top of the system’s implementation and tracking the use of repurposed medicines. We will continue with the work we did with charities through the winter and with the very helpful discussions we had with the charitable sector, and the Department will look annually at the data and whether the landscape is changing, and if it is, we will keep that under review.

--- Later in debate ---

[Chris Heaton-Harris]

I just thought I would check about amendment 13, Mr Deputy Speaker. This whole experience has been a steep learning curve when it comes to procedure in the House. Perhaps we have invented a few things on the side as well, given how we have gone about our business here. I do not want to speak too soon, but if we could conduct all our health debates in the positive and constructive tone that has characterised these debates and the process behind the Bill, we might improve our heath service in leaps and bounds, rather than getting caught up in unnecessary politics. But that is where we are.

My amendments 1, 2 and 3 would remove, among other provisions, two clauses on clinical negligence. I want to talk about the reasons for their removal and the original idea behind the clauses. As right. hon. and hon. Members who have been following the progress of my Bill will know, many of the ideas in it came from Lord Saatchi’s Medical Innovation Bill in another place. Those ideas have not had the smoothest of journeys in this place. I have been regularly reminded by hon. Members—I thank those here today—and others outside this place that these clauses have not enjoyed the support of stakeholders.

Such concerns have been around since before the Bill was even drafted. Unfortunately, the echoes of those concerns haunted the first mention of the word “innovation” in the clause, and I decided from conversations I have had that those concerns could not be quelled in time. Throughout the process, I was clear that I wanted to listen to everybody with something to say on this matter. I have met and read the briefings of everyone who has contacted me wishing to share their views, and I hope it has been evident that I have been up front, honest and very clear about my intentions. I tried to solve the concerns of Members and the medical community who believed the clause would have negative and unintended consequences. That is why I tabled these amendments.

I hope that this process reflects favourably on Parliament and shows how a piece of possible legislation can evolve with a huge amount of stakeholder engagement and with parliamentary opinion taken on board. Since the beginning, I have focused on the sharing of good practice and transparency—and, indeed, on the failures of treatments through a database. Those ideas are reflected in clause 2 and have received much support.

I wanted to maintain the camaraderie built up around the Bill and have been unable to find the support I needed for the more controversial clauses, 3 and 4. Clause 3 sets out the steps that a doctor would need to take to show that he or she had acted responsibly using the Bill. They were intended to reflect the steps that a responsible doctor could be expected to take under common law when innovating. In relation to a proposed treatment, clause 3 would require the innovating doctor to

“obtain the views of…appropriately qualified doctors”

with

“appropriate expertise and experience in dealing with patients with the condition in question.”

Clause 4 expressly preserves the common-law Bolam test, the key precedent for judging whether a doctor has acted negligently.

The two clauses received strong opposition, which I will not go into too much. However, I worked closely with many officials from the Department of Health, and I want to thank them, because I had read the briefings that were so adamant in saying how dangerous parts of the Bill would be, so it was nice to have some of the best and brightest legal and parliamentary counsel remind me again and again that they viewed them as perfectly safe and did not see them as a danger to patients.

[Dr Philippa Whitford]

Does the hon. Gentleman understand the danger of undermining our clinical trials systems, in that, using the Bill, a doctor would have to convince only one colleague before they could go ahead and try something completely new? The recent tragedy of the patient who died while taking part in a phase 1 trial shows the need for steps and procedures to reduce the risk.

[Chris Heaton-Harris]

The hon. Lady knows that I would obviously have preferred to retain clauses 3 and 4, but I have to agree with her: the body of opinion stands on her side of the argument, not mine, so the simple answer is yes.

I remind the House, though, that there was a decent and honourable purpose behind clauses 3 and 4. Dr John Hickey, the former head of a primary care trust, contacted me to say that,

“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 (last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill.”

He went on to say:

“Over the last 30 years I have seen how doctors have increasingly practised defensive medicine…because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests.”

In fact, it may interest Members to hear that, in reading the debates on the Bill introduced by the hon. Member for Torfaen (Nick Thomas-Symonds) and the recent debate on the Mesothelioma (Amendment) Bill, I have seen much stated that supports the action I wanted to take in clauses 3 and 4 to reassure doctors who fear litigation. For example, the British Medical Association’s parliamentary brief for the Second Reading of the Off-patent Drugs Bill stated that there were

“two barriers to the use of off-patent drugs in a new indication: 1) Clinicians’ confidence in prescribing: clinicians take on a personal and professional liability if they prescribe an off-patent drug in a new indication”,

and therefore they require reassurance. The brief goes on:

“GMC guidance also indicated a greater level of responsibility for the doctor prescribing off-label and therefore potential greater risk of liability which would be a disincentive for a doctor prescribing off-label drugs”.

That is a simple statement of the purpose of clauses 3 and 4: to give doctors a supplementary way to assure themselves that they are doing the right thing where they might want to do something they believe to be in their patients’ best interests, in a fully evidenced, responsible and honest way.

Similarly, the Multiple Sclerosis Society’s brief on the same subject states:

“Guidance from the General Medical Council is clear that a doctor takes on an extra level of personal liability when prescribing off-label, which would be a significant disincentive to prescribing”.

Breast Cancer Now says that, because of personal liability,

“doctors can be unwilling to prescribe drugs for new purposes, even where…clinical evidence is strong”.

As Lord Freyberg stated in the mesothelioma debate in the other place,

“The fastest way to save lives is to see if the drugs for common cancers work on the rarer ones as well, given the shared mechanism of disease across cancer. This is off-label research and until we fix the issue of liability, as advocated by the noble Lord, Lord Saatchi, we will continue to send thousands, like my sister, to an early grave.”—[Official Report, House of Lords, 20 November 2015; Vol. 767, c. 407.]

There was therefore plenty of reason and evidence to support clauses 3 and 4, but I guess politics is all about being pragmatic, and I believe that the provisions that we have already discussed are worthy in themselves of inclusion in a sensible Bill, because they will do some positive things. It is therefore with some reluctance, as I am sure the House will understand, that I have decided to table these amendments, which strike the elements relating to clinical negligence from my Bill.