532
Ravimiseaduse muutmise seadus (haiglaerand)
Introduced
4 November 2024
Last action
16 April 2025 · Accepted
Status
AVALDATUD_RIIGITEATAJAS
Sponsors
Irja Lutsar, Vabariigi Valitsus
Subjects
Discovery layer
Source updated
16 April 2025
Summary
Eelnõu esitatakse haiglaerandi korras valmistatavate ravimite parema kättesaadavuse tagamiseks. Haiglaerand tähendab erandkorras uudse ravimi, näiteks geeniteraapia, valmistamist ja kasutamist konkreetse patsiendi raviks, kui tavapärane müügiloaga ravim ei ole kättesaadav või puudub sobiv kliiniline uuring. 2022. aastal kehtestati haiglaerandi regulatsioon, mis seab ranged piirangud, kuid praktikas on ilmnenud vajadus nende leevendamiseks. Eelnõuga soovitakse muuta haiglaerandi tingimusi, lubades uudsete ravimite valmistamist laiemale patsientide ringile ning kaotades piirangu valmistajate ja patsientide arvule. Samuti vähendatakse halduskoormust ja lühendatakse loa väljastamise tähtaegu. Siiski jäävad kehtima ravimi kvaliteedi, efektiivsuse ja ohutuse nõuded, ning patsiendi kaitse on endiselt esmatähtis. Haiglaerand soodustab haruldaste haigustega patsientide ravivõimalusi ning toetab innovatsiooni ja kõrgtehnoloogiliste ravimeetodite arendamist. Muudatused ei too kaasa täiendavaid kulusid, kuid mõjutavad Ravimiameti ja Tervisekassa tegevust, sõltuvalt väljastatud lubadest ja võimalikust rahastamisest tervishoiuteenuste loetelus.
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Timeline
4 November 2024
AVALDATUD_RIIGITEATAJAS
Source: SE
16 April 2025
Accepted
Votes
No vote records are attached yet.
Versions
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Documents
26 official files
Lõpptekst
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Lõpptekst
docx · ET · 25 April 2025
Lõpptekst asice
asice · ET · 25 April 2025
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Vabariigi Presidendi otsus
pdf · ET · 25 April 2025
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Vabariigi Presidendi otsus asice
asice · ET · 25 April 2025
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Vastuvõetud seadus asice
asice · ET · 16 April 2025
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Kaaskiri Vabariigi Presidendile
pdf · ET · 16 April 2025
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Vastuvõetud seadus
pdf · ET · 16 April 2025
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Eelnõu
docx · ET · 14 April 2025
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Muudatusettepanekute loetelu
docx · ET · 7 April 2025
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Seletuskiri
docx · ET · 7 April 2025
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Eelnõu
docx · ET · 7 April 2025
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Seletuskirja lisa 2 (märkused ja ettepanekud)
docx · ET · 9 December 2024
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Seletuskirja lisa 1 (rakendusakti kavand)
docx · ET · 9 December 2024
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Eelnõu
docx · ET · 9 December 2024
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EIS teade
txt · ET · 4 November 2024
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pdf · ET · 4 November 2024
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Seletuskirja lisa 2 (märkused ja ettepanekud) docx
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Eelnõu docx
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Kaaskiri
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Algtekstid asice
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Sponsors
- Irja Lutsar · plenary-member
- Vabariigi Valitsus · Vabariigi Valitsus · Initiator
Related records
No cross-record relationships stored yet.
Related across the Repo ecosystem
Direct relationships are identifier-backed. Topic context means shared TopicMembership — not a citation and not causation.
Direct relationships
- Legal framework · Ravimiseaduse muutmise seadus (haiglaerand) · 532 · EE
- Identifier matchPROJECTS_FROM
Same estonia record d0791000-6a5e-453e-a2b2-fe7a41127fc7 projected from PoliticalRepo EE row.
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.riigikogu.ee/tegevus/eelnoud/d0791000-6a5e-453e-a2b2-fe7a41127fc7/
- Open data entity: https://api.riigikogu.ee/api/volumes/d0791000-6a5e-453e-a2b2-fe7a41127fc7
- estonia · d0791000-6a5e-453e-a2b2-fe7a41127fc7 · source updated 16 April 2025