Certain questions regarding the healthcare system's preparedness for supply and logistics
Translated from Swedish by AI; the translation may contain errors. The Swedish text is the original.
Summary AI, written in advance
KD supports the government's proposal on a statutory stockholding obligation for outpatient pharmacies and expanded delivery obligations to hospital pharmacies 1. KD advocates for proportionate sanction fees for pharmaceutical companies that do not report shortages in a timely manner 1 2 3. KD considers that personal protective equipment is already covered by current formulations 4 and sees it as positive that there is consensus on increasing the availability of equipment 5. C argues that the proposed sanction fees are too high and risk reducing the availability of medicines 6 7. S wants to legislate to protect the health and safety of healthcare personnel 8 9. S considers it good to clarify requirements for patient safety 9. S shares the government's view on sanction fees 9. S wants the government to present sharp proposals on the obligation of municipalities and regions to maintain stocks 9.
Written by AI in advance and may contain errors. The numbers lead to the speech a statement builds on; check against the text below.
Christian Carlsson (KD)
Madam Speaker! To provide health and medical care, it is not only necessary to have the right staff and suitable premises, but there must also be medical products - medicines, medical technology aids, and other types of equipment so that good care can be provided. This naturally sounds like a self-evident matter, and it is.
But the truth is that the basic stock of medicines and medical technology products is lacking in Sweden today. Patients who are to collect their medicine are all too often met with the message that just their medicine is not available because it is backordered. This naturally causes irritation and, in some cases, suffering and insecurity for these patients and also for their families. But it also affects patient safety itself. The healthcare system's supply preparedness therefore needs to be strengthened, and it needs to be strengthened on a broad front.
Against this background, the bourgeois government has now presented a bill with a long series of proposals to specifically strengthen the healthcare system's supply and crisis preparedness. It is very welcome.
The proposals range from clarifying the obligation to provide healthcare products in the law to something as specific as that we should be able to protect ourselves better in a radiological emergency. But common to all the measures proposed in the bill that today's report deals with is that they aim to strengthen both the crisis and supply preparedness within Swedish health and medical care.
As a Christian Democrat, I would like to mention some of the concrete measures we are now taking to increase the availability of medicines, so that those who are ill can receive the medicines they need when they need them.
Firstly, we are now introducing a statutory stock-holding obligation for outpatient pharmacies. The idea is that the pharmacies' stock should be adapted based on the needs of the patients where the pharmacy is located. This shall be one of the pharmacies' core missions, and the purpose is simply that more patients should be able to receive the medicine directly over the counter when they visit a pharmacy, so that they can take the medicine home with them.
Secondly, the obligation that wholesalers of medicines have to deliver medicines to outpatient pharmacies is expanded to henceforth also include deliveries to hospital pharmacies.
Third, and finally, provisions are introduced regarding a sanction fee for pharmaceutical companies that do not comply with the obligation to notify the Medical Products Agency at least two months in advance that the company's sale of a medicinal product is ceasing, either temporarily or permanently.
It is unfortunately a major problem that this obligation is not complied with to a greater extent in cases where the shortage could actually have been foreseen. The reporting obligation that exists for pharmaceutical companies is central from a preparedness perspective. Läkemedelsverket is responsible for producing situational pictures of critical shortage situations that may arise, and their conditions for doing that job naturally deteriorate if the reporting is missing or occurs far too late. Ultimately, this affects people's health.
Against this background, we in Kristdemokraterna support the proposal that Läkemedelsverket shall be allowed to issue a sanction fee as a measure to increase compliance. Of course, the sanction fees shall be reasonable and proportionately set, and they shall be determined with regard to the severity of the violation.
Against that background, it is also good that the bourgeois government intends to very closely monitor what the introduction of the possibility to levy a sanction fee has for consequences, so that we ensure that the sanction fee has the intended effect - i.e., increased availability of medicines. From the committee's side, we would like to emphasize the importance of such a follow-up.
With that, I move for approval of the Social Affairs Committee's proposal in the report.
Anders W Jonsson (C)
Madam Speaker! Christian Carlsson says from the rostrum that the ambition of the entire bill is to increase the availability of medicines. There is probably not a single person in this country who does not want to increase the availability of medicines; the pandemic has shown that there have been obvious concerns in a number of areas.
The problem is that the proposals being put forward risk having the exact opposite effect in a situation where sanction fees of between 25,000 and 100 million kronor are introduced. These are absurd amounts, which are even written into the laws. If we look at other countries that have implemented this, we see that it has had the exact opposite effect.
In the Netherlands, for example, which has sanction fees at a significantly lower level, this has had the effect that companies withdraw medicines. Some medicines in Sweden sell for perhaps 100,000 kronor, and if the company risks a sanction fee of millions of kronor, one naturally draws the conclusion that one should withdraw the medicine – or alternatively, one ends up at the other end, that is, sitting and reporting a risk that medicines will be missing not only for those medicines where one believes there is a risk but also for very many others.
Depending on that one set the bar too high in the Netherlands, this therefore led to the number of medicines decreasing by 5 percent. Despite that, Christian Carlsson does not mention a single word of the extremely heavy criticism from heavy actors in the field.
My question to Christian Carlsson is therefore: In view of the fact that this has been implemented in the Netherlands, with significantly lower sanction fees than the 100 million kronor the government proposes, and it has had the effect that the number of medicines has decreased by 5 percent – what is the government doing to assess how much this will reduce the availability of medicines in Sweden? It will not increase, as Christian Carlsson says.
Christian Carlsson (KD)
Madam Speaker! As a Christian Democrat and a conservative politician, I am naturally very keen that we ensure the availability of medicines so that there are medicines for sick people who are in need of exactly those medicines, and at the same time have a world-class business climate and reasonable conditions for the companies operating here.
I also have great respect for the concerns that are raised. That is why the government points out the importance of the Medical Products Agency having a close dialogue with the companies and firms concerned. What is stated here is also important, namely that the fees shall be proportionate. It must be so that they are reasonable and set based on the circumstances that exist, and there is a possibility for a reduction of the fee. It is extremely important that the implementation of the fee can gain confidence, quite simply.
It is also for that reason that the committee majority underlines what the government itself says, that is to say that the development shall be carefully monitored so that we actually get an increased access to medicines and do not get a lot of unwanted effects. I therefore do not share the description of reality that I would not have touched upon this in my speech, because the entire conclusion was about just that.
Anders W Jonsson (C)
Madam Speaker! Now, it is not only about increasing the availability of medicines, but also about creating a world-class business climate. These are big words that Christian Carlsson uses when there are clear indications that this both scares away the pharmaceutical industry from Sweden and will reduce the availability of medicines.
The specific question I had for Christian Carlsson concerns the fact that several other countries have introduced this system but with significantly lower sanction fees. In France, they are at a maximum of 10 million, and here they are therefore to be at a maximum of 100 million. In the Netherlands, they have had this for so long that they have conducted a follow-up, and there I believe they are at 1 million in sanction fees. There, this has led to the pharmaceutical industry withdrawing. A large number of medicines are being deregistered, because it is clear that the one who sells for 100,000 kronor in the Netherlands cannot risk million-fines.
My simple question, to which I have received no answer from Christian Carlsson, is: Now that there is a concrete example of a country in our immediate vicinity that has introduced this but at a significantly lower level, how has the government reasoned when introducing this with 100 million kronor in sanction fees? It risks having devastating consequences. It definitely does not lead to what Christian Carlsson is calling for, that is to say, an increased supply of medicines. In the Netherlands, the exact opposite happened.
Furthermore, in connection with this, with a world-class business climate, it occurs in a situation where the collective pharmaceutical industry is sounding the alarm. The alarm is not being sounded because one is forced to pay sanction fees, but because the fees are being set at a level that will have completely unreasonable consequences, primarily for the patients but also for the pharmaceutical industry in Sweden.
That was my specific question: How have you analyzed this based on what has actually happened in reality, Christian Carlsson? It has happened in the Netherlands, which is a country quite comparable to Sweden.
Christian Carlsson (KD)
Madam Speaker! It sounds almost as if Anders W Jonsson is saying that the Center Party would be completely against introducing a sanction fee. I have not perceived that previously, but it is possible that is the case. In that case, it is just as well to say it.
The assessment we have made is that we must increase the availability of medicines. The companies are not taking their responsibility to report expected shortages in the way they should and as they are obligated to do today. Therefore, we are simply prepared to introduce a sanction fee to increase compliance.
We make the assessment that this will have a positive effect, but at the same time, we are naturally humble in the face of the concerns that are raised. That is why there is a great consensus in the committee that we need to follow this closely, so that the sanction fee is not designed in a way that does not win confidence and legitimacy and that causes it to have unwanted effects.
In my world, it is fully possible to demand that companies report when they see they have a shortage and at the same time offer a world-class business climate. I do not believe there needs to be a contradiction; we can both set reasonable conditions for the companies and have a healthcare system where patients can receive care and medicines in a timely manner. These things can be together in the driver's seat and in the front room.
That is our assessment of this. We will, of course, ensure that we follow the issue moving forward.
Mikael Dahlqvist (S)
Madam Speaker! I thank Christian Carlsson for his speech from the rostrum.
The Social Democrats fundamentally agree with much of what is stated in the bill that the government is presenting and which we are to take a position on here in the chamber. Furthermore, it was the previous S-led government that commissioned this investigation via Åsa Kullgren. It is a very ambitious and thorough investigation.
What I intend to ask Christian Carlsson about, Madam Speaker, is something that we Social Democrats consider important to highlight and even legislate in the Health and Care Act. It concerns medical products and the part regarding personal protective equipment.
We know, unfortunately, how it looked during the pandemic. It was a complete catastrophe in terms of access to protective equipment, especially at the beginning of the crisis, both within healthcare, within elderly care, and within social care. I dare say it was most problematic within social care, because it was unfortunately very low priority. Despite the fact that the regions and municipalities have a responsibility to have certain emergency stocks, there was not enough.
Now these issues are being raised, and that is good. However, Madam Speaker, we believe that Arbetsmiljöverket, the state's own expert authority, has a point when the authority wants that this be clarified with personal protective equipment by adding "and protect the health and safety of healthcare personnel". One must, therefore, consider both the patient perspective and the employees.
Christian Carlsson (KD)
Madam Speaker! I would like to begin by agreeing with a great deal of the description that Member Dahlqvist gave here. The covid-19 pandemic we had showed the need for increased access to healthcare equipment, not only from the patient perspective but also from the worker perspective.
It is also very clear that there has been a failure in employer responsibility when it comes to preventing workplace environment risks in very many places around Sweden where one had not ensured that the personal protective equipment was on site.
We agree with the assessment. The Government has been clear that the law's requirements shall include personal protective equipment needed to ensure that good care can be provided. This is included in this concept, and therefore we do not consider such a clarification to be necessary. We have the same intention but simply think it is covered by the wording that exists. The Government has also been clear about this in its bill.
Mikael Dahlqvist (S)
Madam Speaker! Thank you, Christian Carlsson, for the answer!
Despite the fact that it is very clear in the legislation today – there are several laws that regulate the employer's responsibility regarding safe and secure workplaces and a good working environment – this was lacking, which our own expert agency, Arbetsmiljöverket, was very clear about in its evaluation. Riksrevisionen has also looked into this.
What Christian Carlsson says is correct: healthcare products and personal protective equipment are included. This is good; we share that view. But what is it that creates extra security here? The proposal from us Social Democrats means that we want to change the legislation and add the part concerning the staff's perspective.
I thank Christian Carlsson for the answer. I hear that Christian Carlsson's and the government's intention is to move forward with another sharp proposal. We will, however, have a reservation in that matter going forward.
Christian Carlsson (KD)
Madam Speaker! I note that there are different legal paths to achieve the same ambition, which is to increase the availability of personal protective equipment for staff within Swedish healthcare. It is positive that there is consensus regarding this.
Mikael Dahlqvist (S)
Madam Speaker! Today's report concerns the healthcare system's preparedness for serious incidents in peacetime and during high alert.
With the pandemic in fresh memory and the ongoing war in Ukraine, we all experience how vulnerable our society is. It is especially now that each one of us realizes how dependent we are on society's efforts and resources. Market economic phenomena such as just-in-time, or just in time, do not simplify the inventory management of healthcare products when crises break the logistics.
Sweden is an import-dependent country. A serious peacetime crisis, such as the pandemic, or a war entails significant or long-lasting needs to have stocks of products. If the crisis or the war affects many countries - perhaps even globally, as during the pandemic - it becomes difficult to purchase materials because all countries need, for example, protective equipment.
But even before the pandemic, the previous S-led government acted by appointing several inquiries that were to come forward with sustainable and sharp proposals to improve Sweden's capacity for resilience during extraordinary events. Already in 2018, Åsa Kullgren was given the responsibility to investigate the healthcare system's preparedness. The inquiry is extensive and consists of three reports. Some of these proposals are included in today's bill.
Madam Speaker! The Government proposes that healthcare products shall be included in the law where healthcare activities are conducted. It is good that it clarifies what requirements shall be set to increase, among other things, patient safety and quality.
Arbetsmiljöverket has expressed in its referral response that it supports the proposal but considers that the provision in Chapter 5, Section 2 of the Health and Medical Care Act should be supplemented with the addition "and protect the health and safety of healthcare personnel".
We Social Democrats share the Swedish Work Environment Authority's view. The outbreak of covid-19 demonstrated the need for increased access to healthcare equipment not only from a patient perspective but also from an employee perspective. We consider the Swedish Work Environment Authority's formulation to be a good and clear marking of the importance of the healthcare system's supply readiness also from an employee perspective. We believe that the Riksdag should stand behind what is stated in Chapter 5, Section 2 and add the Swedish Work Environment Authority's proposed text.
Madam Speaker! In recent years, the number of medicines on the shortage list has increased. The shortage of medicines is therefore not solely linked to the pandemic. If a medicine that is critical for the treatment of seriously ill patients is, for some reason, not available on the Swedish market, very large risks to people's lives and health arise quickly.
In the proposition, it is proposed that, on one hand, an obligation to hold stock is introduced for outpatient pharmacies, and on the other hand, an obligation to deliver is introduced for wholesalers towards hospital pharmacies. Before the deregulation of the pharmacy market, Apoteket AB had such a mandate, and it is now proposed that the company regains the requirement for the obligation to hold stock.
Today, there are requirements for pharmaceutical companies to notify the Medical Products Agency at least two months before the sale of a medicinal product ceases temporarily or permanently. Today, the Medical Products Agency does not receive sufficient information, which makes it more difficult for the agency to prevent shortages of medicines.
We share the government's view and therefore consider, in accordance with the investigation and the government's assessment, that the possibility of sanction fees should be introduced. At the same time, we want to flag that sanction fees involve risks.
It is important that the fees can be used in a flexible way in relation to the actors' size and economic situation, but at the same time that the fees are large enough to achieve the intended effect.
Medicines are sold in a market with strong economic actors and interests. A sanction system built around sanctions in the case of lack of information regarding individual items can affect the companies' actions and thus to what extent they choose to provide certain of these items and medicines. There is therefore an obvious risk that some companies try to protect themselves from the risk of being hit by sanctions by simply offering a smaller range.
The risk of over-reporting is also obvious, as one would rather report once too many than too few due to the risk of a fine.
The Pharmaceutical Industry Association, Lif, and the Association for Generic Medicines and Biosimilars, FGL, have warned in their referral statements that a possible sanction fee of 100 million entails a risk that medicines will disappear from the Swedish market.
In light of the concerns that have been raised, we Social Democrats believe that the government should task an appropriate authority with monitoring the effects of the new legislation and continuously reviewing the need for adjustments.
At their core, the proposals are good and will certainly increase the ability to provide medicines, but they will not solve the problem of backordered medicines. It is a serious societal problem that I believe the government must do significantly more to solve.
Madam Speaker! The Government argues that the work to strengthen the healthcare system's preparedness for supply must be conducted with a long-term perspective and carried out in several stages. Even though long-term perspective is of importance, we want to emphasize that this work must be done as soon as possible.
The investigation on the healthcare's preparedness has submitted a number of proposals that need to be taken further. This applies in particular to the proposals regarding the obligation of municipalities and regions to maintain stocks, which the Swedish Civil Contingencies Agency has presented in its referral response. A basic stockholding in regions and municipalities is needed to reduce the healthcare's vulnerability when it comes to medical products.
We consider it important that the government takes this further and presents sharp proposals.
I support all reservations, but for the sake of time, I move for approval of only reservation number 1.
Source: The Swedish Parliament. The speeches come from the open data of the Riksdag, translated into English by AI, which may contain errors.