Response to interpellation 2024/25:159 on access to orphan drugs

Statsrådet Acko Ankarberg Johansson (KD)

Madam Speaker! [The member] has asked me why I and the government let time pass instead of presenting proposals that involve a life-altering difference for a severely affected group, and what initiatives I am prepared to take in light of what has been put forward.

I want to begin by saying that I understand the deep concern and frustration that many patients and their relatives feel while waiting for better access to orphan drugs and medicines for rare and serious diseases. To know that there are medicines that can make a decisive difference for one's own or a loved one's health but not have access to them is a situation that no one should have to experience.

The government's goal is to work towards a system with long-term sustainable costs, where effective medicines are available for patients with both common and rare health conditions, as needed. It is, however, important to ensure that our systems are long-term sustainable and that the relevant actors can together ensure that important medicines reach those who need them most.

In October 2023, the government received the final report from the Dental and Pharmaceutical Benefits Agency, TLV, regarding the assignment on strengthened access to medicines for rare health conditions (S2022/03077). The report clearly states that the agency assesses that further investigation is needed for the proposals to be implemented in practice. TLV itself notes that the agency needs to deepen its work, among other things regarding how the proposals on patient size and sales volume can affect the accepted cost for a medicine and how it should function in practice. The government therefore decided to task TLV with continuing the analysis and developing tools to strengthen access to medicines for rare health conditions (S2024/00481). The claim that nothing has happened is therefore not correct.

TLV also emphasizes in its report that the authority cannot alone achieve all the changes required to strengthen the accessibility of essential medicines. The companies have a great responsibility through their pricing and the documentation that, according to today's system, forms the basis for TLV's assessments. The regions' cooperation is also of crucial importance for equal access to medicines, partly through the management of clinic medicines, which many medicines for rare health conditions fall under, via the council for new therapies—the so-called NT-council—partly by conducting negotiations on agreements with the companies when needed.

Against this background, SKR and the government agreed that, within the framework of the state grant to the regions for pharmaceutical costs 2024, they would analyze how the parties can strengthen access to new effective medicines as well as ensure sustainable pricing and cost-effective use. It is specifically stated that the parties shall investigate how the state grant can be used to strengthen the regions' incentives and opportunities to negotiate and conclude agreements for medicines.

I look forward to receiving TLV's final report in December.

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Anders W Jonsson (C)

Mr. Speaker! Three years ago, this issue was relevant here in the Riksdag. At that time, we succeeded in obtaining a majority for the decision, which all parties except one supported.

I remember the debate we had then. The Christian Democrat MP said she was glad that "a majority has given support to a proposal [.] which, when it becomes a reality, can be life-saving for people living with a rare disease".

I continue with a quote: "Today's position from the Social Affairs Committee is long-awaited for many families and for parents who today do not have access to medicines that literally can extend their children's lives."

Furthermore, she said: "We Christian Democrats believe that it is not sufficient for the Social Democrats to refer to the fact that they do not want to anticipate the work and the preparation taking place in the Government Offices."

Mr. Speaker! Six weeks ago, I made contact with a young family in southern Östergötland. They had had their first child, a little girl. The girl was four months old when I contacted the family, and they told me that it had been four very difficult months. There were major problems with the upbringing and the food, and the little girl was not gaining weight as she should.

Finally, they in Linköping had received the diagnosis familial infantile hypophosphatasia, an extremely serious disease. It begins with rearing difficulties, but I asked if she had had any fractures yet; that is what one usually gets when one has this condition. No, was the answer, she has not started walking and moving yet, but we know that when she starts with that, the legs will break - then she will get fracture after fracture.

What is so terrible for this family is that they know there is a medicine available. It is a medicine that is used in many other countries, and there are also some children in Sweden who have received it. It is an almost curative medicine that makes the fractures stop, and the children can almost live a normal life. But this girl does not get access to this medicine, instead she will get fractures when she starts to move.

I believe that neither the Minister for Health nor I can imagine the situation of seeing one's child with such a severe illness and at the same time knowing that there is a medicine in other countries and also in Sweden that our little girl will not have access to.

That is why I wrote in my interpellation that nothing has happened. Here we stood in the chamber and had a debate in which the Kristdemokraterna participated and said that this problem must be solved, that we cannot wait until the election. The government must do something immediately.

The Social Democratic government immediately gave a mandate to TLV, which was then supposed to be rolled out. It has been more than two years now, and I still receive those types of calls. I still read about and meet families who are in this dreadful situation.

Why is nothing happening? Here, if nothing else, one should be able to take a temporary measure while waiting for a system to be built. I respect that it takes time, but this is a matter of children dying and being harmed when the help is actually even available in the country. What does the Minister for Health and Social Affairs intend to do so that this girl and other children in corresponding situations do not have to wait for further measures and processes, perhaps all the way until the next election, before anything happens? That is the background to the matter in my question.

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Statsrådet Acko Ankarberg Johansson (KD)

Mr. Speaker! I thank the member for the question.

What can be done now lies entirely with the regions themselves. If one wants to achieve the change that I believe both the member and I desire, more national governance is required, where the state has a completely different influence over which medicines may be used, how they are financed, and how they are managed.

Today, it is only the regions themselves, primarily through the NT-council, that make decisions on this. The government cannot intervene in this in any way. Regardless of what I say or think, I cannot influence it in any way. I can also find that frustrating sometimes, but that is the order we have. Those who can achieve a change in the respective regions today are the NT-council, which has this in its hands. They are responsible for themselves, not I.

The assignment that the previous government gave TLV was good, and I am glad they did it as a result of an almost unanimous parliamentary announcement. But the assignment contained some limitations, which meant that when TLV came back, they said that their proposal would not work fully with the limitations regarding groups and prices that were included. That was why, when we gave the renewed and extended assignment, we wrote that TLV did not need to feel bound by them but could think more freely based on the goal that if one has a rare disease, one must be able to access the medicines one needs. In the scope we gave for the assignment to TLV, we gave them the opportunity to think broader and further.

Then I cannot interfere in what an authority does, and the member knows that very well. But I look forward to receiving their final report, which will be presented soon, in December. An important part will be which paths they point out for how we should work forward. I believe, just like the member, that something long-term and sustainable needs to be done.

What we have already supplemented with is that it states in the financial plan that we want to investigate the entire financing of pharmaceuticals. The starting point is to take a firmer national grip. We are not using the tools that exist to get better prices and ensure that one gets the medicines one needs. That is why we have initiated, and hope to soon be able to return with, a larger investigation regarding the entire pharmaceutical side. We make a distinction between prescription and benefit medicines, something that is starting to become obsolete given the developments, and how we handle medicines.

Even in that question, just as in the question we just debated, I think there is reason to look towards Denmark, which has a better system than what we have in Sweden, so that we can manage pharmaceuticals jointly. Denmark is better at clinical trials, and they are better at pharmaceuticals through the unified national system the country has.

Each region and the NT-council decides the handling. It is a function that has very little transparency, and it is difficult for both me and the member to determine how it works and what assessments are de facto made. But when TLV makes its assessments, it is transparent, and we know how they have made decisions. There is an order for how it works. Therefore, it is essential that it is authorities that hold the assessments from now on so that they function well.

We hope that TLV's assignment has become easier to report on this time. Now they are not as bound by different things, but they can submit more proposals that the government can work further with.

With all certainty, I hope that the member returns during the spring when we have had time to read the investigation and can assess what can be done further based on TLV's report.

The speech at riksdagen.se, in Swedish (opens in a new tab)

Anders W Jonsson (C)

Mr. Speaker! I cannot say that the Minister for Health's answer makes me any calmer.

Malin Johansson has written the following: I have two daughters with the same serious disease. The serious disease is called spinal muscular atrophy. It means that the motor neurons in the brainstem, the elongated spinal cord, and the spinal cord are relentlessly broken down. There are 300 Swedes living with SMA. Of them, there are 72 individuals who receive neither medication nor access to the gene therapy that is necessary. One of my daughters receives the treatment, but not the other. She would have turned 18 by the time the medicine became available, and she is now being left without treatment. Any parent can imagine how anxiety-ridden and cruel our family situation is. Just as grateful as we are that we receive care for one of our children, just as terrible does the injustice and irrationality toward the other child appear.

This is, therefore, yet another story about what is happening day after day, week after week, and month after month. When I hear the Minister for Health and Social Affairs say that a new large-scale pharmaceutical investigation must be appointed to look at the system that already exists, yes, then we are talking about two three four years into the future before that investigation will have an effect. There was an old pharmaceutical investigation that had a proposed solution to this very specific problem.

I am equally concerned when the Minister for Health and Care says that this is not something she can do anything about, but that it is the regions that make those decisions. But this is not a problem that exists in just one region, it is a problem in the whole country. And it is fundamentally the financing that is the problem.

I agree with the Minister for Health and Social Affairs that we must have a long-term solution, but while waiting for the long-term solution, one cannot just sit and wait. In that case, one must find another temporary solution.

There are a number of other areas where the government has been very good at finding acute solutions and funding in the blink of an eye. I would say that this is one of the most acute problems, where one should find a temporary solution that applies until the new system is in place so that Sweden does not stand out from all other countries. Treatment of SMA is something that exists in most European countries. It is standard, and all patients get access to treatment. There, the solution could be the one that the old pharmaceutical investigation proposed, namely that for expensive orphan drugs for a small patient group, the state steps in temporarily and finances it while awaiting another solution.

But the Minister for Health points out that a major pharmaceutical investigation is to look at the entire system. That the regions are to resolve the situation for the two medical conditions that I have raised, I do not believe makes any of the families happy and satisfied. They do not know if their children will live as long.

It is burning in the joints, and here the government must ensure that there is a rapid preparation and secure the money and a temporary solution. I and the families have full respect for the fact that one can then investigate in peace and try to produce a good and long-term system for specialty medicines and medicine financing in total.

Right now, children are being harmed because this government has made no changes at all during the two years they have been in power, despite the high-flown rhetoric we heard from the Christian Democrats before the 2022 election.

The speech at riksdagen.se, in Swedish (opens in a new tab)

Statsrådet Acko Ankarberg Johansson (KD)

Mr. Speaker! I thank the members for the additions.

I answered exactly as the member wants it to be. What can be done today can be done by every region and the NT-rådet, depending on which decisions they themselves make. Neither the member nor I can review it. As a member of Parliament, however, one is free to have opinions on what the NT-rådet does and what authorities do. I do not have that possibility. But it is they who can achieve change today.

We hope to be able to do something with the new report that TLV is to submit in December this year, where we have removed things that previously prevented TLV from fully being able to submit proposals that they themselves thought were good. When we were informed that TLV did not think the previous investigation became sufficiently good due to too many limitations, we gave them a renewed and extended assignment. We told them that the limitations do not have to be included without thinking about what is best for the group.

I look forward to TLV's proposal which is to come in December, and then we will do what we can based on the proposals TLV puts forward. It is not to sit and wait for several years, but it is to do what one can from the government's perspective.

I regret that the member obviously did not appreciate this, but I pointed out that we must conduct a new major investigation into the entire pharmaceutical area. What was reported in 2019 is unfortunately not usable in a bill today, and it is necessary to have a new investigation. Developments in healthcare are moving fast, so we must find another way to approach the whole of healthcare and when it comes to pharmaceuticals.

That is why we are commissioning the investigation, but I did not say that it is the solution to today's problems. There, we hope that TLV will come up with good proposals so that the government can come up with better proposals - in the near term, unlike a government investigation - and that the authority itself makes decisions on them, because for medicines that are effective and allow one to live their life, one must be able to get access to them.

The possibilities today lie with the regions and the NT-council, but we hope to be able to assist via TLV in the future.

The speech at riksdagen.se, in Swedish (opens in a new tab)

Anders W Jonsson (C)

Mr. Speaker! I am not saying no to reviewing the entire pharmaceutical system. But I realize that it is a process over a number of years before we are finished, and these families - I have told you about two families now; I could stand here for hours describing the situation for these people - do not want to wait for a number of years. They want a solution here and now for their children, who suffer every day they do not have access to these medicines.

I do not want to stand in the chamber time and again and have interpellation debates with the Minister for Health and Social Affairs, but I want these families – many of whom I know are following this discussion – to receive a statement from the Minister for Health and Social Affairs as soon as possible: Yes, we see your difficult situation. We will solve this temporarily while we investigate the large pharmaceutical system and while TLV continues its analysis. We will ensure that over the coming years there is a temporary system in place that ensures your children get access to medicines that are life-saving and, above all, make a very big difference in their daily lives. That is the statement I want from the Minister for Health and Social Affairs. I do not want to be forced, for two years until the election, to repeatedly raise this issue and see these families suffer and fare poorly because the policy cannot handle this quickly enough.

The government that the Minister for Health and Social Affairs represents has time and again shown that if one wants to, yes, then one can very quickly solve various problems. One can find new money, and one can quickly push through various legislative changes. And if there is any group for which one should use that ability, it is precisely these children with rare diagnoses; there are medicines that can actually make a difference. It is my plea to the Minister for Health and Social Affairs: Ensure that this problem is solved as quickly as it can possibly be!

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Statsrådet Acko Ankarberg Johansson (KD)

Mr. Speaker! The reason why the government is appointing an inquiry to develop a strategy for rare diseases and diagnoses is that we see that this is a group that has been overlooked for a long time. One often comes to healthcare and is told: I am not familiar with your disease. One does not even get adequate help for what one is seeking. That is the reason why we are developing a strategy. But it is a supplement to the work we have already started at TLV so that people can get the medicines they need.

I am happy to repeat it: Those who can now achieve changes and have all the power in their hands are the regions and the NT-council. The government does not have the power to make decisions regarding medicines and access for patients. That is the regions and the NT-council, respectively, and TLV.

The part that we control with TLV is benefit medicines, where decisions are made on subsidies. We have commissioned an investigation there. The one that came from the previous government was not good enough in our view, as it had limitations. TLV themselves said that they would like to deepen this. In our supplementary directive, we said: Do not feel bound by previous limitations but think broader, because we must succeed with this issue.

That investigation will be reported in December this year. I hope to get back to you as soon as possible, once we have read and reviewed its proposals. But I am not aware of these proposals today, and I cannot provide any timetable for something I know nothing about.

A larger investigation will also be needed. I would not have mentioned it, because the member is now trying to pretend that it was my only answer. It is quite bad style, I think.

What is necessary for this group is, above all, that they receive the medicines they need, and it is not money that is the problem. We are adding 6 billion more to the budget now in order to be able to finance medicines next year. The costs have increased by 20 percent over the last two years, and we have provided those funds.

I am pleased that the member's party, Centerpartiet, just like the Socialdemokraterna, agrees with the government that we need to raise the high-cost protection and the patient fees to some extent. We will need to do that. But it will be the case that medicines cost more and more, and we are prepared to take those costs because we add those funds. Money, therefore, should not stand in the way, but we must have a regulatory framework that ensures patients receive the medicines they need.

The interpellations debate was hereby concluded.

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