Response to interpellation 2024/25:592 on orphan drugs

Statsrådet Acko Ankarberg Johansson (KD)

Mr. Speaker! Anders W Jonsson has asked me, now that TLV's report has arrived and several assessors agree that the difference will be small, what measures I will take so that people in need of orphan drugs also in Sweden will get access to treatment.

I want to begin by saying that access to appropriate treatment for people with rare health conditions is an issue that the government prioritizes highly. Fair and equal access to effective medicines is crucial for all patients.

I have previously stated to Anders W Jonsson in response to interpellation 2024/25:159 that TLV 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 NT-rådet, and partly by conducting negotiations on agreements with the companies when needed.

It is however too early to draw conclusions about what concrete effects the changes will yield, as several parts of the proposed way of working have not yet been implemented or had time to be evaluated. TLV makes the assessment in its report that the developed methods and criteria will lead to more medicines for rare and severe conditions being covered by the pharmaceutical benefits.

Among other things, TLV emphasizes that they now accept a significantly higher cost in relation to the benefit for medicines for the rarest and most serious conditions. The authority has also reviewed its working methods to enable and facilitate price negotiations and discount agreements between regions and pharmaceutical companies, which can be a threshold for access.

At the same time, I want to emphasize the importance of that medicines covered by the benefits have a well-documented value for patients, where the benefit is in reasonable proportion to the cost. This is a fundamental principle to ensure a long-term sustainable and equitable pharmaceutical financing. This means that not all new medicines can automatically be granted subsidies – especially not if the clinical effect is uncertain or if the pricing is not in a reasonable relation to the value the medicine is expected to provide. At the same time, it is important that the system remains open to innovation and that new treatments with the potential to make a real difference for patients can also receive support.

The Government is closely following how TLV's new model is developed and what results it yields in practice. In the budget bill for 2025, the Government also announced its intention to appoint a new pharmaceutical investigation. The purpose is, among other things, to review how Sweden can improve its model for financing, subsidizing, and access to medicines.

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

Anders W Jonsson (C)

Mr. Speaker! A month ago, a debate article was published signed by representatives of Riksförbundet Sällsynta diagnoser, Föreningen för Kortväxta, and Neuroförbundet. They had a question for the Minister: How many more investigations are required before there is a difference in Sweden? Furthermore, they wrote that it is very difficult for patients, members, and families to understand why one does not get access to these medicines in Sweden when one gets them in other countries.

This is about sick people. A few weeks ago, I received an email from a grandmother who wrote that she has the most wonderful grandchild – a little girl – who suffers from achondroplasia. Achondroplasia means dwarfism; one becomes 110–120 centimeters tall. For this little girl, every single centimeter is important, the grandmother wrote.

There is a medicine for this, but one cannot get access to it in Sweden. The reason is that we have a model which implies that if you suffer from a severe disease that thousands of patients are affected by, you get a different treatment than if you have a severe disease that only affects 50. But the price of the medicine does not become lower just because it is a small patient group, and not a large group, that is to have the medicine.

That it has been this way led to the Riksdag during the previous mandate period unanimously – only the Socialdemokraterna were against it – demanding that the government come forward with a proposal that reverses the development. The then-government asked TLV to look at a system that could enable this.

TLV had however already said this before: ”But our previous report shows that today's structures for pricing and negotiation of medicines limit the possibilities for good access to medicines at long-term sustainable costs.” They had already urged the government to give them a mandate that would allow them to look outside the framework.

Now TLV has come forward with its proposal, and the Minister leans back and says that we can now calmly see what happens. But the proposal can be evaluated already now! Of the 20 non-oncological medicines that are most relevant in Sweden, with these rules, 2 of them, 10 percent, would become available, according to the Commission for Innovative Orphan Medicines. If one adds to that those administered by the NT Council, that is to say the regions, it could possibly be a matter of an additional 3. Interpreted positively, 5 of 20 would become available. That is what the result of TLV's method will be.

The Minister now says that we should wait and see in calm and that it must be another few years before we see what TLV has decided. But we already have the answer today! We know, and that is why the concern arises among the organizations, the parents, the siblings, and the patients. The days just pass without them getting access to medicines.

What worries me most is that the only thing the Minister points to in his answer is a new pharmaceutical inquiry. We all know that if an inquiry is commissioned this year, it will take several more years before the proposals are submitted. They are then to be referred. Many previous pharmaceutical inquiries, though not all, have otherwise ended up in the wastebasket.

The answer from the Minister to these organizations and to all affected patients is: We have to wait and see. Let the years pass. We shall appoint a new pharmaceutical investigation.

Mr. Speaker! This is not enough for me to be satisfied. Above all, it is not enough for the affected patients to be satisfied.

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Statsrådet Acko Ankarberg Johansson (KD)

Mr. Speaker! We share the disappointment that people are not receiving the medicines they need. This applies always. When one becomes ill or feels unwell, one should have access to both medicines and treatment – what one needs to feel better.

If you belong to a group that is very small, you are met with many difficulties today. When you seek care, you can sometimes be told that the healthcare staff are not familiar with the disease, and you may not even receive help. It is one of the reasons why we are working with a national strategy for rare diseases and health conditions.

We need to change the view on rare diseases across the board. They are very many and affect very many people. In Sweden, 500,000 or more are affected by a rare disease. This is, therefore, no small group, even though it consists of many different small groups.

We also have the question of medicines. If you take note of what is stated in the WAIT report, one realizes that it looks bad for Sweden. But we also have different systems. Other countries say that the medicines are available to patients when they have been approved, but they are not included in any subsidy. In Sweden, we say that it is not enough that they are approved, there must also be a subsidy for them to be counted as available to patients.

I will continue to stand by this position. Private financing is not a solution for the government; instead, the medicine must first enter the subsidy system before it can be accessed.

It differs, therefore, between different countries, which makes it partly difficult to compare us in a European perspective. We report it all in slightly different ways.

There are, however, problems with introducing new innovative therapies into healthcare. Often it is the individual clinic that has budget responsibility, which means that due to budget restrictions, one does not apply what, for example, a doctor assesses to be best for the patient.

What can the government do? I am very pleased that the previous government gave this assignment to TLV. We chose to change it in a final round by letting TLV think outside all frameworks. They did not have to follow the rules they usually follow, instead we said: How would you do it? At the beginning of the year, they concluded that Sweden can accept a higher price, even when we cannot make it pay off, just because there are reasons to do so. Now TLV has started work that means one can accept a higher price for smaller patient groups.

I note that the member was already at the beginning of the year completely certain that this will not work. So I cannot be that certain when this has barely had time to begin. But how much time will pass before I can say that it is not working, I do not know. First, medicines tested according to the new method must be introduced. Then we can follow up on whether it becomes better or worse.

Just as I pointed out in my initial response, it is not only about TLV's assessment of the medicines but also about the possibility of tripartite negotiations, that is to say, negotiations. In Sweden, we negotiate too little about medicines. There are too many medicines where one goes for list prices. Instead, all parties could negotiate so that we reach a different level.

This is also an argument that the research-based pharmaceutical industry raises in its meetings with the government. We need more negotiations so that we do not only go after list prices.

It may sound as if they are speaking against their own interests, since prices do indeed become lower after a negotiation. But they also see the value in that the products they have researched can be put into clinical use so that they can then draw further conclusions on how they function.

There is, therefore, a reason why we need to increase access to negotiations but also other methods to move forward. We will also return, in the relatively near future, with an investigation in that part to be able to go into depth regarding methods and what we need to do to facilitate this with the regions and the regulatory authorities we have. It is, in fact, a way to provide more medicines in clinical practice.

Then I would still like to send the question back to the member. Which model would the member use if the member themselves sat in the government and could decide everything? I am happy to listen.

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

Anders W Jonsson (C)

Mr. Speaker! The Minister says that she shares the disappointment. Yes, but the difference is that the Minister has responsibility. The Minister has responsibility for this development and that Swedish patients are not getting access to these important medicines.

It is not as the Minister says, that is to say that all countries have a system where a medicine is considered available when it is approved. Most countries define availability as when it is actually permitted and discounted, and there Sweden ends up in a real bottom position. Germany, which is a good country to compare with, has approximately the same rules as Sweden. There, 85 percent of patients get access to orphan drugs. The corresponding figure for Sweden is 24 percent. We land at ranking position 21 out of 36 comparable countries.

Now that we have the TLV report in front of us, one can actually perform an analysis of it. One simply takes medication after medication and looks at the points that are assessed. That is how the Commission for Innovative Specialty Medicines has arrived at these figures. Probably 2 out of 20 medications that TLV handles will be approved, and that is not good enough.

This is not about waiting either. I met patients who have the disease alpha1-antitrypsin deficiency. It is a hereditary disease that, in the worst cases, leads to a fairly significant premature death from lung disease. Those affected lack an enzyme, which means they cannot handle lung problems. It leads to early death.

The patients said: "We sit and wonder: In other countries, one has access to this, but in Sweden there is not a single patient who gets access to the effective treatment." It is not high-technology that is at issue here, but rather it is about administering the enzyme, primarily via medicines such as Prolastina and Respreeza. In Sweden, however, one does not get access to it. "Should we move to Spain or Germany?", was the question I received.

This is the responsibility of the government. I hear the government saying that one must wait until TLV has made a large number of decisions so that one can see if the figure 2 out of 20 is correct or if it is perhaps 4 medicines out of 20. That answer satisfies neither me nor the affected patients, because it is about days, weeks, and months of illness when people do not have access to medicines.

I think there are many different things one could do. One important thing is, of course, to appoint a large pharmaceutical inquiry, because there are a number of problems within the Swedish handling, financing, and approval of medicines. It is therefore important, and it must be done. But then one must know that the time perspective is three, four, or five years – with the risk that the entire inquiry, as it was last time, ends up in the wastebasket.

What can be done sooner is to give TLV a new assignment, which they have actually requested, to find a system that allows us to get access to these medicines faster. In Germany, it takes 45 days to get access to a new orphan drug – this applies to those that are actually approved – while in Sweden it takes 312 days. Every day counts.

What could have been done additionally is to say: We have money for a special government grant to SKR. When it comes to what the NT-council disposes of, the problem is that, just as the minister said, there is then a shortage of money in the clinic and a shortage of money in the region. One could make an agreement with SKR and say: For a limited period, that which is approved by TLV can also be used in the regions, and it is financed by the state via a special government grant to SKR.

So, there are opportunities here. One sits in government to effect change when one sees a problem, not just to share the disappointment.

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Statsrådet Acko Ankarberg Johansson (KD)

Mr. Speaker! One can always speculate on what it is like to sit in government and have all the power, and it is interesting that the member then proposes exactly the same thing as the government does – exactly the same thing.

It is not political decisions that should determine which medicine is to be approved, but we need principles that are upheld regardless of who applies.

Now, TLV has stated that when it comes to rare conditions, they intend to use a different model, which differs from the one we have previously codified. We have approved this from the government's side. Now, it is to be worked in a different way, which enables more to be approved for subsidy. If I were to say after just a couple of months that this is not working, I think the member should pose a question about that, that is, how one can draw such a conclusion after very few months. Some time needs to pass.

I note that the member repeatedly claims that I say things that I do not. That is a poor debating style. I do not claim that all countries have a different method. Nor have I said that it should apply to many medicines.

We need to let some time pass in order to be able to see, not least, TLV's assessment. How many medicines have been submitted for assessment, and what has happened with them? Are the times being shortened? Can one make the assessments one believes are appropriate? We therefore need some more time before we draw the conclusion that this system does not work. But that is not enough, and that is why we are doing the other things.

We need more negotiations between the parties to arrive at a reasonable pricing more quickly, because fundamentally, it is the pricing that determines how one views the value. It will not be the case that we approve everything at that first price that is submitted; no authority will consider it reasonable. One must always discuss what the price should be in relation to the value that is obtained from the medicine.

We do not have procurement as a method in Sweden, even though we in the government intend to return to it and look at the issue. I believe, in fact, that it is interesting. But it is about achieving negotiation, not least regarding rare medicines which are quite few and where one wants to find another arrangement.

The Chairman, however, raises a question that may recur – we will have to see what the investigation concludes – namely that one begins to decide that a part of the pharmaceutical budget is allocated for different areas. We have never had it that way in Sweden, except when it concerns hepatitis C and when we purchased vaccines, but we have a pharmaceutical budget where we pay what doctors prescribe. We do not, therefore, decide how much money should go to diabetes medication and so on, but doctors', and sometimes others', prescriptions are what determine what cost we incur.

Then we have TLV, which assesses what is subsidized. In some cases, one can even be prescribed something else that is not subsidized, but it is important that it enters the benefit system and the subsidy system so that it is not only those who have their own money who can get the medicines they need. In that regard, I think we have a good arrangement, in that TLV continues to make those assessments. I have also noted that the member wants it to be so.

I will gladly follow up in the future, once we have seen some assessments after the pharmaceutical companies have submitted their applications. We want to see what this yields: Will there be any change? Will it get better? To say right now that a certain sum of money should be set aside for rare medicines would not be particularly difficult to do technically; there is a possibility to do it in the budget. But on what grounds would the money be distributed, and which ones would be included? Then it becomes the same discussion that the TLV has today.

Therefore, TLV's mission, that is to look at which principles and what order we should have for this, is completely central. Even though the member's proposal to start dividing the pharmaceutical budget into different diagnoses or disease groups is interesting and I do not in any way want to exclude it, it would mean considerably more work.

Neither the member's proposals nor my proposals will give people access to new medicines immediately. It takes time. The important thing is that we do exactly what the member says and what the government does – both larger investigations and assignments to authorities. We adjust the assignments when we see that they are not sufficient. We will continue to do so to ensure the medicines that are needed, also for rare conditions.

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

Anders W Jonsson (C)

Mr. Speaker! No, I have never thought that it is politicians who decide which medicines should be subsidized and which not. On the other hand, it is politicians, above all the government but also the Riksdag, who allocate budget space and furthermore establish the regulatory framework that the authorities shall use when they evaluate.

We have today a situation in Sweden where we have quite good access to other medicines. We are well comparable with other countries. But when it comes to specialty medicines, we therefore land in place 21 out of 36 countries in a comparison. That should be an alarm bell for the Minister that measures must be taken here.

The Minister says that the only measure to be taken regarding the TLV report is to wait for TLV to make a number of decisions. If it then turns out that perhaps it is only 2 or 3 out of 20, it is only then, if at all, that the Minister is prepared to take measures.

I have pointed out various possibilities to move faster. One problem is that TLV makes good assessments based on the regulatory framework one has, but when the NT Council is to apply them, there are a number of regions that are short of money and cannot afford to use the medicines. It is a concrete Swedish problem, and one could solve it, for example, by having a specially designated state grant. I am no fan of them, but it would solve just this concrete problem while waiting for better systems.

Certain issues, Mr. Speaker, can be put on the back burner for many years. But here, it is actually about patients. It is about lives. It is about survival. In that case, one cannot simply lean back and refer to a larger pharmaceutical investigation that will be appointed and to the fact that TLV will hopefully make wise decisions.

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

Statsrådet Acko Ankarberg Johansson (KD)

Mr. Speaker! Leaning back is the last thing the government does in both this and other healthcare issues.

Last month, I attended the inauguration of the Nordic Conference on Precision Medicine. We are leaders in that field, and the government has declared that rare conditions shall also be included in the work with precision medicine. Traditionally, when we started, it was very cancer-related, and through the decisions we have made and the money we have allocated in the budget, we have ensured that rare conditions are also included in the work. It is extremely essential.

But it is not enough to get the right diagnosis if one does not get access to the right treatment. What we are discussing today is that one should get access to it and that it should be available.

I cannot rule out specific earmarked state grants, even though most of those have been granted with exactly the same argument as the member has: This is exactly what is needed. Then they happen to amount to hundreds, and suddenly everyone is very angry about them.

When it comes to the pharmaceutical budget, I believe we rather need to look at other parts. To start splitting it and dividing it into different diagnoses can be difficult, but I do not want to rule it out. If a medicine is approved for subsidy, it is however more important that the region cannot let it be, that is, say no to, using it. We cannot have double assessments so that TLV makes an assessment of subsidy and the NT-council then makes another assessment. I think it should be in a way and at a level where an assessment is made, and then it must be usable in the whole country.

The upcoming investigation will look at how we should clarify and simplify so that it actually becomes accessible throughout the country. I do not believe that giving money to those who prioritize something else is good. We must ensure that everyone prioritizes rare diseases and health conditions, and we do that, among other things, through the strategy we develop from the government side. It will be finalized by Socialstyrelsen within a month or so. In parallel, we are working on the issue of medicines and access to medicines, as it is just as essential as the strategy otherwise and a prioritized issue for this government.

The interpellations debate was hereby concluded.

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