Public Petitions Committee

Meeting date: Tuesday, June 25, 2013

Official Report 497KB pdf

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Current Petition

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Thyroid and Adrenal Testing and Treatment (PE1463)

Agenda item 2 is on PE1463, on effective thyroid and adrenal testing, diagnosis and treatment. I welcome the Cabinet Secretary for Health and Wellbeing and Ms Metcalfe and Ms Mair, who are here to give evidence.

I ask the cabinet secretary to say something briefly; we will then get into brief—I hope—questions. I will try to close down the discussion in half an hour.

Thank you, convener. I will be brief.

Thank you for inviting me to give evidence on the concerns over thyroid and adrenal disorder patients’ access to medication.

The committee will be aware that there has been a recent interruption in the supply of liothyronine, which is one of the medicines that are used to treat thyroid conditions. I understand that the supply has now returned to normal and that new stock is now available. I also understand that such interruptions to the supply chain can be very distressing for patients, particularly when no alternative licensed source for the medicine is available in the United Kingdom. Unfortunately, such medicine shortages arise from time to time.

The Department of Health in England has responsibility for UK medicine shortages and acts on behalf of all UK health departments on those matters. Scottish Government officials keep in regular contact with it to consider any UK-wide implications, and will continue to do so. The Scottish Government is also in regular dialogue with the pharmaceutical industry, pharmaceutical wholesalers and pharmacists to minimise the impact of any supply-chain problems both on patients and on the national health service.

I am happy to answer questions.

Thank you, cabinet secretary.

Is there any evidence that drug companies are restricting supplies on the basis that that might help to force up prices?

No—certainly not in this case. One issue is that the number of patients in Scotland who are prescribed the drug in question is of the order of 420 to 450. The number for the UK is probably around the 5,000 mark. We need to bear in mind the relatively small size of the market, the very expensive raw material and the expensive and complicated manufacturing process for the drug. I believe that the source of the recent problems and shortage was the shortage of raw material for the drug. There was no sign or evidence at all of profiteering or deliberate manipulation of the market by any of the people in the supply chain.

How soon were you made aware of the problem?

Such things tend to percolate through the system reasonably quickly. We are in regular contact with the Department of Health and have discussed with it different ways of addressing the problem. Obviously, the priority was to get the supply reconnected as quickly as possible, so every action was taken to do that.

We also considered what alternative medicines could be supplied. In this case, the only real alternatives for some patients were medicines that are licensed in continental Europe but have not been licensed by the Medicines and Healthcare products Regulatory Agency in the UK. However, I believe that the MHRA issued guidance allowing interim use of those medicines until the supply of the original medicine was reconnected.

Thank you.

Those comments have been very useful. I have actually written to you about another medicine that is currently not available, and your reply to the previous question will be relevant to your reply on my query.

I am, of course, coming a bit late to this petition, but I understand that the petitioner has also highlighted the issue of single licensed drugs. That raises an interesting question. Does a single licensed drug come up through a conscious decision of the MHRA, because manufacturers have not applied for a licence for an alternative drug or because they have applied but have been turned down? I suppose that there is no general answer to that question, but I wonder whether you can reply with reference to thyroid deficiency drugs.

To be quite blunt about it, because of the small number of patients who benefit from these drugs, the number of suppliers is very small indeed; it is simply not a big part of the market, and pharmaceutical companies concentrate their efforts where they think the greatest need for supply will be. In this case, only a small cohort of patients require and benefit from the drug, and I think that I am right in saying that there is only one supplier of this particular drug in the UK.

One of the petitioners, I believe, has provided a note to say that she uses a different drug that she finds to be more effective. I do not know, but I imagine that she pays for that herself. Her situation reminds me of a constituent of mine who came to me about Armour Thyroid, which has also figured in the committee’s debates, and it raises a lot of interesting questions. That drug is the only one that works for my constituent, but because it is not licensed she has to pay for it. What is the position for general practitioners who prescribe unlicensed drugs? In the case in question, I do not think that the GP said that the drug was not effective for her, but I understand that there is a lot of risk in a GP taking such an approach. I can see it from the petitioner’s point of view—after all, she knows that a drug that she has to pay for works for her—and I imagine that the situation will be the same for other patients in other circumstances.

The MHRA has issued very clear guidance to clinicians about what is and is not licensed. Prescribing an unlicensed drug might have implications with regard to liabilities if anything goes wrong, and the MHRA guidance in all such areas is quite detailed.

On the wider issue that the petitioners have raised, my understanding is that there are related issues about the effectiveness of some people’s overall treatment for thyroid and related conditions. I believe that the committee is planning to hold a round-table meeting on some of the wider issues after the recess. Michael Matheson and our officials will certainly offer to participate in that meeting because we want to get to the bottom of the petitioners’ concerns—not just about the supply of drugs but about the wider question whether the treatment that is prescribed for them, particularly by GPs, is what it should be. We want to get evidence on that, find out what the problem appears to be and see whether we can address it.

Good morning, cabinet secretary. Your evidence has been helpful in painting a picture of where we are, but I want a fuller understanding of the situation. You said, if I heard you correctly, that during the period of disruption to the supply chain a medicine that is not licensed in the UK was made available on an interim basis. Do you have any understanding, from discussions with the MHRA, why only one such medicine has been licensed in the UK and why only one manufacturer has applied for a marketing authorisation for it?

Alpana Mair will give you more detail on that.

The cabinet secretary alluded earlier to the fact that not many patients are affected, so it is up to the pharmaceutical company to decide whether to manufacture the medicine. At the moment, only one is doing so. It is a complicated process to manufacture that particular product, so it would not be in many companies’ interests to go into what is very much a niche market. That is really why—

Is the medicine that is not licensed in the UK but was made available on an interim basis licensed in other countries?

It is. It is liothyronine, which is manufactured for supply in various countries. For example, a company in Germany has the licence for production in Germany. However, it is not licensed for—

So, for commercial reasons that company has decided not to apply for a licence in the UK.

Yes.

Okay. Thank you.

Good morning, cabinet secretary. What part did you play in the work that was undertaken by MHRA and the Department of Health to try to rectify this situation?

The work was done mainly at official level; such matters do not necessarily always involve ministers, north or south of the border. My job is to ensure that the necessary action has been taken. Certainly, when I was alerted to the issue, my job was to ensure that we were doing everything that we could in co-operation with our colleagues and friends down south to reconnect the supply as quickly as possible and, in the meantime, to ensure with the MHRA that our clinicians in Scotland were aware of the interim arrangements. That was the role of the Scottish Government.

Thanks.

Good morning, cabinet secretary. The bulk of the question that I was going to ask has been covered by Malcolm Chisholm. However, there is an issue about security of supply. We welcome the decision that was made to bring in an unlicensed medicine when there was a shortage. What can be done to increase security of supply? Have there been any discussions at Scotland or UK level about licensing in the UK of drugs that are licensed on the continent? We have heard from witnesses and in written evidence that some people feel that the drugs that are available on the continent are better than the drugs that are available in the UK and Scotland.

I think that there are two questions there. First, on contingency arrangements, we are working with our colleagues south of the border and in the other devolved Administrations to get more robust contingency arrangements in place so that any future disruption to supply can be dealt with differently and more speedily than perhaps has been the case in the past. I do not want to go into too much detail about that, because it involves commercial negotiations with the companies involved. You will understand that I would not want to disclose too much that might be to their advantage, and that we would rather keep certain bargaining chips up our sleeve.

We and our colleagues in London are very conscious of the need to have more robust contingency arrangements in place for shortages, not just in relation to liothyronine but more generally, although it has tended to be the worst in terms of shortages—in recent times, anyway. The general principle of contingency arrangements is absolutely agreed and we are working on that.

09:45

On the second point about encouraging companies that have products that are available on the continent to apply for licences in the United Kingdom, that has to be done through London, at the moment. It is a reserved matter.

I would have thought that, compared to the likes of Germany, the UK is not an insubstantial market. The German population is just over 80 million and the UK population is more than 60 million, so from a commercial point of view, those companies should be looking at the UK market as an area for expansion. We cannot, however, force them to apply for licences. If they were to do so and thereby make alternative medicines available, that would be all to the good, as far as I can see.

The petitioners have raised with the committee the cost of some of the medicines that are being made available and have done a price comparison. I have not analysed it fully, but they seem to be saying that the drugs that are available on the continent are a lot cheaper than those that are available in the UK. I know that you will not be able to comment too much on that, but could you inquire, with your department, into pricing regimes? That might, as you said, involve discussions with UK officials, but we should check out the pricing regimes. If the price of a licensed drug is based on some of the prices that we have in front of us, there is a major issue because some of the drugs are being charged at 10 times what health authorities on the continent are being charged.

Pricing is also a reserved matter, but we are very keen to reduce the price of drugs when we can. This year, the national health service will spend on prescription drugs just short of £1.4 billion out of our total £12 billion budget. That is a lot of money, so when we can identify savings, which we are doing in a number of ways, we are delighted to do so. Again, it is an issue that we are discussing with our colleagues in London.

I am certainly pleased to hear that the supply of liothyronine has returned to normal. Part of the point that I was going to raise has been covered, but I am keen to hear what the Scottish Government does routinely to monitor potential problems with supplies of medicines. Are there supply problems in respect of any other medicines at the moment?

I think that, at the moment, we do not have any shortages. Is that right?

Some products are affected, but the Department of Health monitors shortages that might cause problems and tries to avert them by suggesting alternative products or advising pharmacists how they can access alternative products. It also advises clinicians on how they can deal with potential shortages. From time to time shortages arise, but there is usually a mechanism in place to pick them up before they affect patients, and to put in place contingency arrangements to avert them, or to provide guidance when they cannot be avoided.

Clearly we would have an issue if there was a similar situation to that with liothyronine, when an alternative is not available.

There could be an issue, but in most cases there are alternatives. In recent shortages alternatives have been available for prescribers. Shortages tend to be formulation issues; one formulation might be out of stock, but clinicians could supply an alternative formulation instead.

Would clinicians recommend an unlicensed product?

The MHRA has issued guidance to allow on an interim basis the use of products that are licensed elsewhere but not licensed in the UK.

Good morning, cabinet secretary. Can I take you back to something that you said earlier in relation to the general point about diagnosis? I am concerned when we talk about a “niche market”. It has been established that 3.7 per cent of patients—103,000 people—have been diagnosed, which in many people’s minds elevates it above a niche market. Part of the concern is about the ability of GPs properly to diagnose the disorder. You said that you would try to investigate that deeper part of the petition. How will that investigation proceed?

First, on the niche market, I was referring specifically to that particular drug. We reckon that no more than about 450 patients in Scotland receive the drug. Of course, there is an argument about whether it should be prescribed to more patients. However, even in the general scheme of things, it is still a very small part of the overall pharmaceutical dispensary market in Scotland and the UK.

On the wider issues, we have already been looking at what the petitioners have said. As I said earlier, we hope also to participate in the round-table discussion with the committee. We want to get to the bottom of why some people, such as the petitioners, believe that the service that they are getting in primary care is not always what they should expect. The petitioners have made it clear that the care falls short of the service that they would anticipate receiving. Although we have not found evidence of that, we want to find out from the petitioners and others what their evidence is. We can then investigate that. Our clinical priorities team is trying to gather evidence of whether there is an issue that we need to address by way of future guidance or other means. Lesley Metcalfe will give the committee more detail on the work that we have already done.

We are undertaking three main streams of work at the moment, one of which is to consult the British Thyroid Association. We have asked for its views on the petition, and on the points that were made and so on. We have asked Health Improvement Scotland, through its Scottish health technologies group, to provide an evidence note on all the available published clinical evidence.

I understand from previous meetings that the petitioners do not feel that the research to date has been particularly supportive of their position or that enough clinical trials have been undertaken to prove their position. Again, by looking at all the published clinical evidence it may be that the conclusion is that further research needs to be done, potentially in liaison with the chief scientist office and so on.

We are also liaising with the diagnostic steering group at the Scottish Government to reach the diagnostic managed clinical networks in order to deal with issues around testing, and around the idea that the thyroid stimulating hormone test is not sufficient on its own and further testing is required. We have tried to consider what has perhaps not been raised around the committee table and will gather evidence from the MCNs. We are also very interested in what the petitioners have to say; we want to take all that into account in the round when we report back to the committee.

I stress that we are taking the petition and what the petitioners are saying very seriously. We want to get to the bottom of the problem, and to try to ensure that we go forward in a way that is acceptable to everybody, and that people are getting the health service that they wish for.

I was interested in Ms Mair’s comments about clinicians and primary services being made aware if there are going to be drug shortages. One of the issues that was raised by the petitioners is that the individual patients were not aware, so it was not until they went to fill a prescription that they found out from the pharmacist that the drug was not being manufactured at the time and no supplies were available.

The petitioner described a trawl around pharmacies around Scotland trying to get the prescription filled. Can we expect more consultation of patients on the lack of, or shortages of, particular drugs that they are used to taking? One of the issues that was raised by the petitioners is that they are confident about a particular drug and if that drug is not available, they feel less confident about the alternatives.

There is no doubt that we need to look at the communications in such cases. We have no direct contact with patients—that takes place through the GPs and the pharmacies. We will consider how to ensure that the information not only gets to patients, but tells them what to do in the event of a shortage. We try our best to ensure that such information is passed on. Clearly, the process has not been robust enough in some cases, so we will seek to improve that. We want to notify patients as early as possible when or if there may be a problem and, more important, what they should do in the event of a problem.

I have a constituency inquiry. I will not go into the details other than to say that a pharmacy has said that there is a shortage and, consequently, has given only half a prescription to my constituent. How should I advise that person?

It may be that the other half of the prescription is expected fairly soon. I do not know the circumstances, but if you want to write to me with the details I will have the matter investigated.

Thank you.

John Wilson alluded to the pricing mechanism. We have an example in which the price of the product from one source is double the price from another. What influence does the Government have with regard to MHRA licensing and contracts and, consequently, pricing?

Our influence is whatever can be exerted collectively on the Department of Health in London by the devolved Administrations. One reason why I am in favour of a yes vote is that we would have substantially more influence in such situations.

We have recommendations, which include—the cabinet secretary alluded to this—the possibility of a round-table meeting shortly after the summer recess. Paper PPC/S4/13/13/1 includes a list of the organisations that could be invited. Are there any other bodies that we could invite? Is there any other action that the committee wants to take?

Given that the cabinet secretary volunteered the Minister for Public Health to attend, I suggest that we invite him to the round-table discussion.

With officials.

With relevant officials.

Do members agree to hold a round-table discussion shortly after summer recess to include the Minister for Public Health and officials?

Members indicated agreement.

I thank the cabinet secretary, Ms Metcalfe and Ms Mair for attending and for giving clear answers.

09:58 Meeting suspended.

09:59 On resuming—