Response to interpellation 2025/26:321 on access to orphan drugs
Translated from Swedish by AI; the translation may contain errors. The Swedish text is the original.
Summary AI, written in advance
KD considers access to orphan drugs to be a high priority 1. KD argues that it is too early to draw far-reaching conclusions about the model's effects 1 2, but that the government is following the developments and does not rule out further measures 1 2. KD wants to appoint a new pharmaceutical investigation 1 2, criticize the fragmented system with 21 regions 2 and has formed a working group to increase access to new effective medicines 3. KD is prepared to do things to change the situation for vulnerable patients 4 and argues that changes must occur in a sustainable way 4. C considers that the government says different things before and after the election 5. C argues that the current model does not work for rare diagnoses 5 and proposes a disaster commission 5.
Written by AI in advance and may contain errors. The numbers lead to the speech a statement builds on; check against the text below.
Socialministern Jakob Forssmed (KD)
Mr. Speaker! Anders W Jonsson has asked me when I will present proposals that could make a life-altering difference for a severely affected group, people with rare health conditions, and what initiatives I am prepared to take in light of what has been put forward.
Access to appropriate treatment for people with rare and often very serious diseases is an issue that the government prioritizes highly. For these patients, a new medicine can mean a decisive difference in quality of life.
During 2025, changes were made to the system for orphan drugs, and these are still being implemented. The Dental and Pharmaceutical Benefits Agency, TLV, has in its report assessed that the developed methods and criteria, including a higher accepted cost in relation to the benefit when it concerns the rarest and most serious conditions, will be able to lead to more medicines being covered by pharmaceutical benefits. It is therefore still too early to draw far-reaching conclusions about the model's overall effects. The Government is following the development closely and does not rule out further measures if it proves necessary.
At the same time, I want to be clear that TLV cannot alone solve all the challenges regarding access to orphan drugs. The pharmaceutical companies have a responsibility through their pricing and through the clinical documentation that forms the basis for the authority's assessments. The regions' cooperation is also crucial for equal access, not least through the management of clinical medicines via the Council for New Therapies, the NT-council, and through price and contract negotiations with the companies.
The government has already taken and announced several important measures to strengthen the availability of medicines. As a way to reduce the administrative burden for the regions when it comes to the management and follow-up of agreements, which are often a prerequisite for access to specialty medicines, the government has tasked the E-hälsomyndigheten to carry out a preliminary study on national management of cost reductions and exemptions within the pharmaceutical area (S2025/02173).
In the budget bill for 2025 (prop. 2024/25:1), the government announced its intention to appoint a new pharmaceutical investigation, with the aim of reviewing how Sweden can improve the model for financing, subsidizing, and access to medicines, including medicines for rare diseases. The government has also, in the regulatory letter for TLV, tasked the authority with following developments in other countries and analyzing how changes in the global environment can affect Swedish pricing systems and the availability of medicines in Sweden.
The government's goal is that Sweden should have a system that both safeguards equal access to treatment and is long-term sustainable, and the government follows the development closely and does not rule out further measures if it proves necessary.
Anders W Jonsson (C)
Mr. Speaker! I am surprised by the answer. There is also a very great disappointment among all the patients around Sweden who are now once again being told that the Christian Democrats and the current government are not doing more to solve the current situation.
What is this about then? In DN Debatt on November 25, Anna Furbeck writes: ”To receive an ALS diagnosis is not just a death sentence – it is a prolonged process where the body slowly stops obeying you. For every lost function, we are forced to experience the diagnosis anew. Now there is a medicine that can change this. Yet Swedish patients are denied access.” These are words, not mere sentiments.
Many are affected by fatal diseases. Here, it is about a disease that is potentially fatal, but there is a medicine that benefits patients in 20 other EU countries. But the medicine is not available here in Sweden. What is the reason for that? Well, it is connected to the model we have chosen for how we price medicines. We calculate based on the number of treated patients. That means if you have a disease that 10,000 or 20,000 suffer from, the price for the medicines provided becomes lower. But if you have the misfortune of being affected by a rare diagnosis that quite few suffer from and there is a specific medicine, the pricing has completely unreasonable consequences.
My example concerned a patient with ALS. Now, for some years, there has been a drug, Tofersen, which is available in other countries but not in Sweden.
I am surprised by the actions of the Christian Democrats here. During the previous parliamentary term, we succeeded here in the chamber in creating a broad majority. The Centre Party joined forces with representatives of the Christian Democrats, and we received a clear statement from the chamber that the government must act. One must act quickly, because it concerns people who suffer every day. It is people who even die. At that time, much of the discussion concerned the diagnosis cystic fibrosis.
Then we succeeded in pressing the Social Democratic government to give TLV a mandate to review the whole thing and see if, within existing economic frameworks, another way of calculating can be found. We were seven of eight parties who said that the current order is not sufficient. We believed then that it would become a quick change.
But after that, nothing has happened from the Social Affairs Department and the government's side. They have leaned back and proceeded based on the old mandate from a Social Democratic government, which means that from January 1, 2025, there is a new way of calculating.
I had a debate here with the then Minister Acko Ankarberg Johansson and said that we can already see, based on how the rules look, that the outcome will not be what we expected. 14 applications have been submitted so far, and only two of them have been granted.
There are 20 countries in the EU that have better access to orphan drugs than Sweden. Nothing is happening from the government's side. They lean back and say that they will wait for another period and see if that TLV mandate that the Social Democrats gave doesn't have an effect, despite everything. It surprises me that no other announcements come from the government. Here, one could do a number of different things, both in the short term and more long-term, but nothing is happening.
It would be interesting to know what the Minister has to say to Anna Furbeck, who has two small children and a fatal disease, ALS. There is a medicine, Tofersen, which is available in other countries, but here she is not granted access to it, due to, I would say, the government's sluggishness.
Socialministern Jakob Forssmed (KD)
Mr. Speaker! I maintain that it is too early to evaluate the changes that have occurred. They are urgent. It is urgent that we make changes so that more people can gain access to medicines, not least specialty medicines. I therefore think that we should see if we do not get more effect from this. But we will also take other measures.
We will appoint an inquiry to review the Swedish pharmaceutical system. It does not function well enough. It is far too fragmented. It also results in insufficient access to medicines for Swedish patients. The Productivity Commission has pointed out the deficiencies in this system. The Care Responsibility Committee has pointed them out. It is not least about the fragmented situation that we have and which the Center Party is a general advocate of – with 21 independent regions that are to negotiate separately with pharmaceutical companies and an NT Council that is not a particularly transparent operation. It also does not favor the introduction of specialty medicines.
There, I believe we need to make changes to achieve a system that provides better access and that provides greater opportunities to negotiate more actively with pharmaceutical companies in different ways so that one can press down the prices and thereby be able to introduce significantly more medicines in Sweden.
There is, therefore, a great deal to be done. We will not sit idly by in this area. We will appoint an inquiry to review how we can achieve a better and more purposeful system. Anders W Jonsson is right that there are deficiencies that mean Swedish patients do not have sufficient access to medicines. Of course, we need to do this in a responsible manner as well when it comes to the total cost and the economy, which we will always do. But that we would not do anything, I think is completely wrong.
Furthermore, we have given a special assignment to the E-health Authority to carry out a preliminary study. It concerns reviewing the conditions for how they could take over a part of the contract management and the cost reductions. This is currently something each region has to handle itself – with insufficient effects in this system.
One needs to conduct a broad analysis of what is required. Then, of course, one needs to carry out those things. And this is what we are in the full process of doing.
Anders W Jonsson (C)
Mr. Speaker! I know that many with rare diagnoses and who are affected by this hopeless situation are following this debate. I hope that one hears how falsely it sounds when the Minister and representatives for the government now say that they will wait and see the outcome of this, which has been in force since 1 January 2025.
Centerpartiet, Kristdemokraterna and five other parties were already in agreement when the Socialdemokraterna delivered the proposal to give a mandate to TLV and report back. We said: That is not enough. More was needed. Money needs to be added. A new system must be introduced.
Then we agreed on this. Now we have had this system for over a year. And one could see already in January and February, by doing test runs, that it was far from going to solve the problem. Regarding oncological drugs, the situation is different. But precisely when it comes to the rare diagnoses and orphan drugs, one can see in advance that it will not yield the required results.
Then the Minister says that it is because we have 21 regions. There are other countries with many regions that manage this in a good way. Furthermore, which I think one should listen to very carefully, he points out that the government is to appoint a new large pharmaceutical investigation and that it should be able to solve even this problem. Yes, but then we are years into the future. Anna Furbeck has her ALS diagnosis today. She gets worse every day because she does not get access to this medicine.
A large pharmaceutical investigation can certainly be good. But now we have had a number of them, and they often do not lead to such large changes. This applies especially when the government has previously said that the cost for this shall be taken over entirely by the regions.
I do not understand this. This is a party that, before the election, was extremely clear towards people with rare diagnoses in need of orphan drugs: This is what we are going to solve. Fast solutions are required here. People are being harmed, and people are dying. And as soon as one entered a position of government, one said in practice: What the Social Democrats and Lena Hallengren did before the election is completely sufficient. That is the new system, which TLV is now sitting and calculating. Now we are going to lean back and see what the result of that will be.
We already see the result today. There are 14 applications. 2 have been granted. 1 is possibly on hold. Patients suffer in the meantime.
It is the government and no one else who is responsible for this. Everyone points out that it is a national responsibility to ensure that the very rare patient groups actually get access to medicines.
I cannot understand why the Christian Democrats are doing this. They pushed this issue hard. But as soon as they entered government, it was no longer relevant.
This can be solved. A large-scale pharmaceutical investigation is a long-term solution – then we are four, five, six, seven years ahead. One could solve it by providing special funds directly to the regions and saying: Those who are approved by the NT Council regarding economics, we will take care of financially.
It is not about large sums of money in the state budget, but for the few people it concerns, this is extremely important. There is only one party that can do this better. It is the minister and the government who are responsible for these issues, but nothing is happening from there. Speak of disappointment for the people who are actually affected, including Anna Furbeck who has an ALS diagnosis. She knows that in other countries there is access to medicines, but in Sweden, for economic reasons, she does not get the medicine she needs.
Socialministern Jakob Forssmed (KD)
Mr. Speaker! I do not think Anders W Jonsson is really listening to what I am saying. We are not saying that what TLV is doing now will be sufficient for us to get increased access to medicines and specialty medicines. It will not be. That is why we want to do more and other things.
However, one cannot yet say that it has no effect, as the way of working is currently being implemented. Other considerations and other assessments are being made regarding orphan drugs than those that have been made previously, and in another area, it is being changed so that orphan drugs are prioritized up compared to some other medicines within the framework of the current system. It is good, and it will be able to bring about changes.
Will they be sufficient? I do not think so. That is why I also point out the problems that exist, not least regarding the NT Council and the regions' responsibilities. Specialty medicines are often clinic medicines, and there are also other changes required for it to be possible for more people to receive them.
It is clear that we are not satisfied with the situation we see now. I believe there are many major deficiencies in the Swedish pharmaceutical system that we need to address so that patients can get increased access to medicines.
We are developing a specific strategy for rare health conditions, where this will, of course, be an important part. It is clear that different types of measures need to be taken. We have formed a working group with participants from the regions, SKR, and the Government Offices with the aim of working together for increased access to new effective medicines with a long-term sustainable pricing, of course. Within the framework of the agreement, we are conducting these dialogues to increase the pressure on these issues and, of course, to be able to press the pharmaceutical companies further so that more medicines can be introduced.
It is incredibly urgent matters, where it is a matter of working to achieve an effect from what one does.
Anders W Jonsson (C)
Mr. Speaker! I would fully accept Minister Jakob Forssmed's answer if it were a newly appointed government and it were his first month on the job with responsibility for these issues. But now he comes with this when the mandate period is practically over.
Centerpartiet and Kristdemokraterna were completely in agreement before the election on what should be done. This was an acute problem that had to be solved here and now. It becomes obvious that one says one thing before the election and something completely different after the election.
It is interesting that the Minister is raising this: Now we are almost there. Now we are going to get a strategy for rare diagnoses. Yes, it is very good to have a strategy for rare diagnoses. But already when the government gave Socialstyrelsen the assignment to develop it, they said: You shall develop a strategy for the rare diagnoses, but you must absolutely not enter into the issue of orphan drugs. That was to be set aside. It turned out then that one should wait and see what Lena Hallengrens initiative from 2022 yielded, that is, the assignment to TLV and so on.
It is not rocket science what needs to be done. Here, it is about the fact that the model we have in Sweden for developing new medicines and paying for them works well, except when it comes to the rare diagnoses, because there are so few patients there.
We have in Sweden a healthcare system that in most areas is absolutely fantastic, but this is a stain of shame for us in Sweden. The Christian Democrats have now, after having been responsible for healthcare for four years, concluded that a catastrophe commission should be appointed to find out what is wrong.
My proposal to the Minister is: Start with this! This is a real disaster for Swedish healthcare. Severely ill people do not get access to medicines that patients in other countries get. Let the catastrophe commission for Swedish healthcare start by looking at this, because there are proposals for solutions here.
Socialministern Jakob Forssmed (KD)
Mr. Speaker! Anders W Jonsson points out a number of things that he believes would change things. I am prepared to do things to change the situation for vulnerable patients who do not get access to medicines.
Centerpartiet proposes in its budget motion that we should allocate 100 million for orphan drugs, but that could sometimes be enough for a single orphan drug, as they can cost that amount. What will happen then when the money is gone? Will patients have to wait until next year to receive their treatment and their medication? It is not an unthinkable scenario, when the drugs are high-priced.
We need to do this in a good way that really has an effect and that provides increased access to medicines for patients who have rare diagnoses and a great need for medicines. I believe we are in complete agreement that the current situation is not good enough.
Patients need medicines that work, and at the same time, we need a medicine system that delivers medicines and does so in such a way that we manage costs and challenges and achieve sustainability in what we do. We are determined to make changes, because I am not satisfied with how it works today.
Source: The Swedish Parliament. The speeches come from the open data of the Riksdag, translated into English by AI, which may contain errors.