2023-04-132022/23:SoU11 · p.4SoUHealth & social services
Follow-up of the effects of the legislative proposal
Follow-up on the effects of sanction fees for drug-shortage reporting
What's at stake: The question concerns how the risks of a new sanction fee for pharmaceutical companies that fail to notify the Medical Products Agency of a supply stoppage should be managed - specifically, whether companies might respond by withdrawing medicines from the Swedish market instead. It affects patients who depend on medicines being available, as well as how pharmaceutical companies act.
Case texts and AI reasoning are AI-translated from the Swedish originals; the Swedish text is authoritative.
What the vote decides
Whether parliament should formally direct an authority to monitor the effects of the new sanction fee for failing to report drug-supply disruptions, or whether it is enough for the government itself, as announced, to follow developments.
Yes Yes — the committee proposal
The committee shares the concern about the effects of the legislative proposal but welcomes that the government has announced in the bill that it intends to follow developments after the sanction fee is introduced, both regarding compliance with the notification duty and any other consequences; the committee stresses the importance of such follow-up but considers that parliament need not take its own initiative.
No No — the reservations
Reservation 3 (S, C, MP)
The reserving parties support introducing a sanction fee but warn that a fee of up to 100 million kronor risks leading pharmaceutical companies to withdraw products from the Swedish market; they want the government to task an appropriate authority with following up the effects of the new legislation and continuously reviewing the need for regulatory adjustments.
Summarised from the committee report. Party labels in the summary come from the report, not from the vote.
What do the votes mean here?
Yes The committee proposal: rejecting the motions (keeping things as they are).
No Backing the counter-proposal: reservation 3 by S, C, MP.
Abstain The party marks a position of its own that is not one of the two final alternatives.
What each plan points to — and how the party voted
For each party: the vote its own election manifesto and party programme point to in this case, next to how the party actually voted. A plan can only point to Yes or No; a party can also abstain.
| Plan | Vote | Confidence | Evidence | ||
|---|---|---|---|---|---|
| V | No | Yes 20/0/0/4 | departs from the plan | confidence: low | not addressed |
| S | No | No 0/93/0/14 | follows the plan | confidence: low | not addressed |
| MP | No | No 0/12/0/6 | follows the plan | confidence: low | not addressed |
| C | No | No 0/21/0/3 | follows the plan | confidence: low | not addressed |
| L | No | Yes 13/0/0/3 | departs from the plan | confidence: low | not addressed |
| KD | No | Yes 14/0/0/5 | departs from the plan | confidence: medium | not addressed |
| M | No | Yes 59/0/0/9 | departs from the plan | confidence: low | derived |
| SD | No | Yes 64/0/0/9 | departs from the plan | confidence: low | not addressed |
Committee proposal
The Riksdag rejects the motions 2022/23:2327 by Anders W Jonsson et al. (C) and 2022/23:2329 by Fredrik Lundh Sammeli et al. (S) demand 3.
Original (Swedish)
Riksdagen avslår motionerna 2022/23:2327 av Anders W Jonsson m.fl. (C) och 2022/23:2329 av Fredrik Lundh Sammeli m.fl. (S) yrkande 3.
Riksdag decision: The Riksdag approved the government's legislative proposal to clarify requirements for healthcare providers conducting healthcare activities. It concerns that they must provide healthcare products needed to provide good care. Healthcare products include medicines, medical devices, personal protective equipment, food for special medical purposes and raw materials for manufacturing. The proposals also mean that outpatient pharmacies have an obligation to stock medicines and wholesale distributors have a delivery obligation to hospital pharmacies. A penalty charge is introduced for companies that do not inform the Medical Products Agency if the sale of a medicine ceases temporarily or permanently. Information about any shortage in the supply of medicines or medical devices is proposed to be able to be protected by confidentiality when the information is transferred from the Medical Products Agency to regions or municipalities in connection with investigation. The legislative changes shall enter into force on 1 July 2023. The Riksdag also approved the government's proposal that the state-owned company Apotek Produktion & Laboratorier AB receives an expanded public mandate. This means that the company must maintain its operations even during peacetime crises, heightened preparedness and ultimately war. For example, it could be ensuring the supply of active substances, excipients and packaging materials for products needed for care that cannot wait.
Counter-proposals
- The counter-proposal wants the health care law to be supplemented to protect healthcare personnel's health and safety regarding personal protective equipment. (S, C, MP) — Reservation 3
Plan vs actual vote
Every party, in chamber order: what its own plan pointed to, how it voted, and the reasoning behind both. Highlighted rows are where the two differ — but a vote that follows the plan is a result too, so the reasoning is there for every party.
The plan does not address penalty fees for pharmaceutical companies, but it attaches great importance to medicine availability being poor in large parts of the country and that market solutions have worsened supply.
Plan documents: 2022 manifesto
Reasoning and quotes
The plan does not address penalty fees for pharmaceutical companies, but it attaches great importance to medicine availability being poor in large parts of the country and that market solutions have worsened supply. That a government agency gets to monitor legislation's effects and the risk that products are withdrawn protects precisely that availability. The conclusion is based on derivation from the plan's requirement that healthcare is provided according to need.
Original (Swedish)
Planen tar inte upp sanktionsavgifter för läkemedelsföretag, men den fäster stor vikt vid att tillgången till läkemedel är dålig i stora delar av landet och att marknadslösningar försämrat försörjningen. Att en myndighet får följa lagstiftningens effekter och risken att produkter dras tillbaka värnar just den tillgången. Slutsatsen bygger på härledning från planens krav att vården ges efter behov.
- secured medicine supplydecisive»I stora delar av Sverige är det svårt att få tag på medicin, fast i storstädernas rikare områden finns det flera olika apotek i varje gathörn.« (2022 manifesto ↗)“In large parts of Sweden it is difficult to get medicine, while in wealthy areas of major cities there are several different pharmacies on every street corner.”
- market worsens supply»Privatiseringar har lett till dyrare elpris, att apoteken flyttar från landsbygd till städer och från fattiga till rika områden« (2022 manifesto ↗)“Privatizations have led to higher electricity prices, pharmacies moving from rural areas to cities and from poor to rich areas”
- healthcare according to need»Vård måste ges efter människors behov och inte efter kapaciteten i felaktigt konstruerade system.« (2022 manifesto ↗)“Healthcare must be provided according to people's needs and not according to capacity in incorrectly constructed systems.”
The plan takes no explicit position on what the committee actually decided — often because the committee's reason was procedural. The stance is derived and fully cited, but it does not show the party broke a commitment.
The plan wants to step up oversight of healthcare to guarantee quality and build stockpiles so that medicines and healthcare materials are available when needed.
Plan documents: 2022 manifesto · party programme
Reasoning and quotes
The plan wants to step up oversight of healthcare to guarantee quality and build stockpiles so that medicines and healthcare materials are available when needed. Formal monitoring of whether the penalty fee leads to medicines being withdrawn from the market serves both these commitments. The penalty fee as such is not addressed in the documents.
Original (Swedish)
Planen vill växla upp tillsynen av sjukvården för att garantera kvaliteten och bygga beredskapslager så att läkemedel och sjukvårdsmateriel finns när de behövs. En formell uppföljning av om sanktionsavgiften får läkemedel att dras tillbaka från marknaden tjänar båda dessa åtaganden. Sanktionsavgiften som sådan behandlas inte i dokumenten.
- stepped-up healthcare oversightdecisive»Tillsynen av sjukvården ska växlas upp för att garantera kvaliteten.« (2022 manifesto ↗)“Healthcare oversight shall be stepped up to guarantee quality.”
- stockpiles for healthcare»Rusta upp det civila försvaret. Arbetet att förstärka det civila försvaret och krisberedskapen måste fortsätta, bland annat genom ökade resurser för att rusta och bygga beredskapslager för sjukvården« (2022 manifesto ↗)“Strengthen civil defence. Work to strengthen civil defence and crisis preparedness must continue, among other things through increased resources to equip and build stockpiles for healthcare”
- healthcare as a public matter»Skola, vård och omsorg har en central roll för fördelningen av möjligheter i livet.« (party programme ↗)“School, healthcare and care have a central role in distributing life opportunities.”
The plan does not address penalty fees against pharmaceutical companies.
Plan documents: party programme
Reasoning and quotes
The plan does not address penalty fees against pharmaceutical companies. The closest principle is that no patient shall be harmed and that healthcare shall be accessible and of good quality, with quality constantly monitored. That an agency is able to monitor the effects of legislation and the need for adjustments protects access to pharmaceuticals and is therefore weakly supported by the plan.
Original (Swedish)
Planen behandlar inte sanktionsavgifter mot läkemedelsföretag. Närmast liggande princip är att ingen patient ska komma till skada och att vården ska vara tillgänglig och av god kvalitet, med kvalitet som ständigt följs upp. Att en myndighet får följa lagstiftningens effekter och behovet av justeringar skyddar tillgången till läkemedel och stöds därför svagt av planen.
- no patient shall be harmeddecisive»En av grundprinciperna i vården är att ingen patient ska komma till skada.« (party programme ↗)“One of the basic principles of healthcare is that no patient shall be harmed.”
- accessible healthcare of good quality»Vården ska hålla god kvalitet, vara tillgänglig, fördelas efter behov och vara solidariskt finansierad.« (party programme ↗)“Healthcare shall be of good quality, be accessible, be distributed according to need and be solidarically financed.”
- continuous monitoring»Kvaliteten ska ständigt följas upp med olika slags verktyg.« (party programme ↗)“Quality shall be constantly monitored with different kinds of tools.”
The plan says nothing about penalty fees or drug supply.
Plan documents: party programme · 2022 manifesto
Reasoning and quotes
The plan says nothing about penalty fees or drug supply. The closest commitments are that the economy shall have given and predictable rules and that the regulatory thicket shall be cleared for businesses of all sizes, which speaks to the effects of a new and noticeable fee being followed up and adjusted if needed. The stance is therefore derived from general principles.
Original (Swedish)
Planen säger inget om sanktionsavgifter eller läkemedelsförsörjning. Närmast liggande åtaganden är att ekonomin ska ha givna och förutsägbara spelregler och att regelträsket ska rensas för företag av alla storlekar, vilket talar för att effekterna av en ny och kännbar avgift följs upp och justeras vid behov. Ställningstagandet är därför härlett ur allmänna principer.
- predictable rulesdecisive»Ekonomin ska ha givna och förutsägbara spelregler,« (party programme ↗)“The economy shall have given and predictable rules,”
- reasonable regulatory burden for businesses»Rensa upp i regelträsket för entreprenörer, stora som små. Vi vill införa en ny och förenklad företagsform för mikroföretag, så att fler ska våga testa att driva företag.« (2022 manifesto ↗)“Clean up the regulatory jungle for entrepreneurs, large and small. We want to introduce a new and simplified business form for micro-enterprises, so more people dare to try running a business.”
The plan does not address sanction fees for pharmaceutical companies, but requires rules that make it easy to do right and that unnecessary obstacles for businesses are removed.
Plan documents: party programme
Reasoning and quotes
The plan does not address sanction fees for pharmaceutical companies, but requires rules that make it easy to do right and that unnecessary obstacles for businesses are removed. If a high fee leads to products being withdrawn, patients' right to good care is also harmed. A formal mandate to monitor the effects of legislation and adjust as needed thus aligns with the plan's direction.
Original (Swedish)
Planen behandlar inte sanktionsavgifter för läkemedelsföretag, men kräver spelregler som gör det lätt att göra rätt och att onödiga hinder för företag undanröjs. Om en hög avgift leder till att produkter dras tillbaka drabbas dessutom patienternas rätt till god vård. Ett formellt uppdrag att följa lagstiftningens effekter och justera vid behov ligger därför i planens riktning.
- predictable rulesdecisive»Vi vill ha spelregler som gör det lätt att göra rätt« (party programme ↗)“We want rules that make it easy to do right”
- remove obstacles for businesses»Politikens uppgift måste vara att snabbt undanröja hinder för att underlätta för företag« (party programme ↗)“Politics' task must be to quickly remove obstacles to facilitate for businesses”
- right to good care»Var och en har rätt till god vård och omsorg oavsett bakgrund, kön, ålder, ekonomi« (party programme ↗)“Everyone has the right to good care regardless of background, gender, age, economics”
The plan takes no explicit position on what the committee actually decided — often because the committee's reason was procedural. The stance is derived and fully cited, but it does not show the party broke a commitment.
The plan makes evaluation, cost monitoring and quality control a central political task and requires that the state's rules for companies are long-term.
Plan documents: party programme
Reasoning and quotes
The plan makes evaluation, cost monitoring and quality control a central political task and requires that the state's rules for companies are long-term. Medicines are an essential part of treatment and shall be covered by a solidaristically financed system, which presupposes that products are not withdrawn from the market. Formally tasking an authority with monitoring the effects of the legislation is thus in line with the plan.
Original (Swedish)
Planen gör utvärdering, kostnadsuppföljning och kvalitetskontroll till en central politisk uppgift och kräver att statens regler för företagen är långsiktiga. Läkemedel är en väsentlig del av behandlingen och ska omfattas av ett solidariskt finansierat system, vilket förutsätter att produkter inte dras tillbaka från marknaden. Att formellt ge en myndighet i uppdrag att följa lagstiftningens effekter ligger därmed i linje med planen.
- evaluation as a political taskdecisive»Utvärdering, kostnadsuppföljning och kvalitetskontroll är därför viktiga politiska« (party programme ↗)“Evaluation, cost monitoring and quality control are therefore important political”
- access to medicines»efter särskilt godkännande omfattas av ett solidariskt« (party programme ↗)“after special approval are covered by a solidaristically”
- long-term rules for companies»företagen är långsiktiga.« (party programme ↗)“companies are long-term.”
- patient safety»säker för patienterna« (party programme ↗)“safe for patients”
The plan takes no explicit position on what the committee actually decided — often because the committee's reason was procedural. The stance is derived and fully cited, but it does not show the party broke a commitment.
The plan does not address the sanctions fee, but the programme holds fast to constant readiness to evaluate, reconsider and improve carried-out reforms, and that reforms should rest on tried experience.
Plan documents: party programme · 2022 manifesto
Reasoning and quotes
The plan does not address the sanctions fee, but the programme holds fast to constant readiness to evaluate, reconsider and improve carried-out reforms, and that reforms should rest on tried experience. Formally assigning an agency to follow legislation's effects and continuously review adjustment needs aligns with that. The plan also values medicine supply, which is risked if products are withdrawn.
Original (Swedish)
Planen behandlar inte sanktionsavgiften, men programmet håller fast vid ständig beredskap att utvärdera, ompröva och förbättra genomförda reformer, och att reformer ska vila på beprövad erfarenhet. Att formellt ge en myndighet i uppdrag att följa lagstiftningens effekter och löpande se över justeringsbehovet ligger i linje med det. Planen värnar dessutom läkemedelsförsörjningen, som riskeras om produkter dras tillbaka.
- reforms shall be evaluateddecisive»beredskap för att utvärdera, ompröva, förändra och förbättra« (party programme ↗)“readiness to evaluate, reconsider, change and improve”
- secured medicine supply»Utöver bättre livmedelsberedskap behöver Sverige bygga upp bättre beredskapslager av till exempel läkemedel och sjukvårdsmateriel.« (2022 manifesto ↗)“Beyond better food preparedness, Sweden needs to build up better emergency stocks of for example medicines and medical supplies.”
flags: citat_blockerat
The plan takes no explicit position on what the committee actually decided — often because the committee's reason was procedural. The stance is derived and fully cited, but it does not show the party broke a commitment.
The plan requires that self-sufficiency in medical material increases and that every public expenditure is followed up with clear results, and that new rules shall be cost-effective.
Plan documents: 2022 manifesto
Reasoning and quotes
The plan requires that self-sufficiency in medical material increases and that every public expenditure is followed up with clear results, and that new rules shall be cost-effective. The counter-proposal's requirement that an authority formally follows the effects of the sanction fee, given the risk that medicines are withdrawn from the market, responds to these commitments. The plan does not address the matter directly, so the confidence is low.
Original (Swedish)
Planen kräver att självförsörjningen av medicinskt material ökar och att varje offentlig satsning följs upp med tydliga resultat, samt att nya regler ska vara kostnadseffektiva. Motförslagets krav på att en myndighet formellt följer effekterna av sanktionsavgiften, med tanke på risken att läkemedel dras tillbaka från marknaden, svarar mot dessa åtaganden. Planen behandlar inte frågan direkt, varför säkerheten är låg.
- secured pharmaceutical supplydecisive»Sveriges självförsörjning av energi, livsmedel och medicinskt material behöver öka och snabbt kunna skalas upp vid långvariga störningar.« (2022 manifesto ↗)“Sweden's self-sufficiency in energy, food and medical material needs to increase and quickly be able to scale up in case of prolonged disruptions.”
- follow-up of reforms»Begära tydliga resultat för varje offentlig satsning« (2022 manifesto ↗)“Require clear results for every public expenditure”
- cost-effective rules»Nya regler ska vara kostnadseffektiva och befintliga regler behöver ses över.« (2022 manifesto ↗)“New rules shall be cost-effective and existing rules need to be reviewed.”
- proportional regulatory burden»För att få fler och växande företag är det viktigt att ta bort onödiga regler där kostnaderna för företagen inte motsvarar nyttan för samhället.« (2022 manifesto ↗)“To get more and growing businesses it is important to remove unnecessary rules where the costs to businesses do not match the benefit to society.”
The plan takes no explicit position on what the committee actually decided — often because the committee's reason was procedural. The stance is derived and fully cited, but it does not show the party broke a commitment.
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Sources and documents
- The committee report on riksdagen.se (2022/23:SoU11)
- Committee report full text (HA01SoU11)
- Per-MP voting data (API)
- Case status (API)
Documents under consideration
- Motion 2022/23:2325 — med anledning av prop. 2022/23:45 Vissa frågor om hälso- och sjukvårdens försörjningsberedskap av Karin Rågsjö m.fl. (V)
- Motion 2022/23:2327 — med anledning av prop. 2022/23:45 Vissa frågor om hälso- och sjukvårdens försörjningsberedskap av Anders W Jonsson m.fl. (C)
- Motion 2022/23:2329 — med anledning av prop. 2022/23:45 Vissa frågor om hälso- och sjukvårdens försörjningsberedskap av Fredrik Lundh Sammeli m.fl. (S)
- Motion 2022/23:2331 — med anledning av prop. 2022/23:45 Vissa frågor om hälso- och sjukvårdens försörjningsberedskap av Ulrika Westerlund (MP)
- Proposition 2022/23:45 — Vissa frågor om hälso- och sjukvårdens försörjningsberedskap
Source: The Swedish Parliament