Draft law amending the Medicinal Products Act (hospital pharmacy) – first reading
Session: 15th Riigikogu, 4th session, plenary sitting
Date: 2024-12-18 17:14
Participating Politicians:
Total Speeches: 31
Membership: 15
Agenda Duration: 30m
AI Summaries: 31/31 Speeches (100.0%)
Analysis: Structured Analysis
Politicians Speaking Time
Politicians
Analysis
Summary
The budget and health legislation debate focuses on the first reading of bill 532 amending the Medicines Act, which concerns the creation and use of medicines handled within the hospital exemption. The bill aims to ease restrictions from 2022 and allow wider access to innovative treatment options when a similar medicine with a marketing authorization is not sufficiently available in Estonia. The permitted duration of use within the hospital exemption is also being increased and procedure deadlines reduced to accelerate accessibility for patients. Medicines prepared within the hospital exemption are exceptional and intended for specific patients, not for sale or export, and quality, efficacy, and safety requirements remain paramount.
The second part of the debate focuses on risk mitigation, oversight, and financing: how to ensure safety and quality, when hospital pharmacies’ capacity and production conditions must meet stringent standards; how to address the specific challenges of cell therapy (CAR-T) and gene therapy; and how the bill addresses the situation where similar innovative medicines may be available on the market, potentially reducing the need for the hospital exemption. The discussion also includes funding and reimbursement, along with critical examples from around the world that emphasize careful risk assessment and the importance of clinical trials.
Decisions Made 1
The leading committee decided to conclude the first reading of the bill and set the deadline for submitting amendments as January 7, 2025, at 5:15 PM.
Most Active Speaker
The most active speaker was Irja Lutsar, a member of the social affairs committee; her position is member of the social affairs committee (political position: other).
Aseesimees Toomas Kivimägi
AI Summary
As the seventh item on the agenda, the Government-initiated draft law to amend the Health Care Act (hospital exemption), No. 532, will be discussed in its first reading, and Health Minister Riina Sikkut will speak from the Riigikogu's podium.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut introduces the draft amendment to the hospital exemption, by which the restrictions on the number of patients and on a single manufacturer are removed, the processing of the authorization is accelerated to 90 days, the validity period is extended to five years, and a broader and faster access to innovative medicines for specific patients is created when a similar marketing-authorised medicine is not available in Estonia, though the hospital exemption remains an exception and safety requirements remain, and a marketing-authorised medicine is preferred when it is available.
Aseesimees Toomas Kivimägi
AI Summary
The vice-chairman Toomas Kivimägi thanks the audience, notes that there are a few questions, and asks Irja Lutsar.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar thanks Riina for the presentation and checks whether she understood correctly that with the new drug entering the market the hospital exemption will be abolished, adding that it is based on the old Medicines Act § 167, subsection 2, point 4, which, according to amendments, has now been declared invalid, and her reading may be incomplete.
Terviseminister Riina Sikkut
AI Summary
Hospital exemption will not disappear overnight, but in the long run it will not be possible to provide treatment if there is a similar novel drug with a marketing authorization available on the market.
Aseesimees Toomas Kivimägi
AI Summary
At the beginning of the speech, Urve Tiidus is invited onto the stage.
Urve Tiidus
Profiling Eesti Reformierakonna fraktsioonAI Summary
Urve Tiidus noted that before medicines go to market, they undergo multiple clinical tests, and she briefly asked how the risks are mitigated in the case of this hospital's exemption.
Terviseminister Riina Sikkut
AI Summary
Safety, quality, and efficacy of medicines manufactured under hospital exemption are at the same level as medicines with a marketing authorization, and implementing a hospital exemption requires the approval of the State Agency of Medicines; however, the restrictions on the number of patients and the validity of the hospital exemption are relaxed, while the quality requirements do not change.
Aseesimees Toomas Kivimägi
AI Summary
Vice-chairman Toomas Kivimägi asks that Irja Lutsar present the second question.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar asks Riina why the two-year law that has been in force has been used only twice, and whether its restrictiveness is the reason there could have been more potential users, and whether there are data from hospitals or elsewhere.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut said that the use of hospital rounds has occurred twice, and in addition to the 10-patient limit there are inclusion requirements for enrollment in a clinical study in Estonia, which may require changing the law if a situation arises regarding the 11th patient's qualification.
Aseesimees Toomas Kivimägi
AI Summary
The vice-chairman Toomas Kivimägi invited Hele Everaus onto the stage and asked her to perform.
Hele Everaus
AI Summary
They are asking whether medicines that are not available in Estonia would also be extended to foreign patients, and whether they could in the future receive in our centers the same treatment under an exemption that cannot be bought elsewhere.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut said that in Estonia treatment is mainly available to insured patients; without insurance the treatment is paid for by the patient, hospital exemption applies to Estonian patients at the discretion of a specialist, and before the law is adopted it must be clearly decided how we will treat those who pay themselves or are foreign patients, and medicines will not be exported as a service, but are intended for Estonian patients in exceptional circumstances.
Aseesimees Toomas Kivimägi
AI Summary
The vice-chairman Toomas Kivimägi invited Karmen Joller to speak.
Karmen Joller
AI Summary
Karmen Joller asks whether a drug brought to market under hospital exemption is automatically on the Estonian Health Insurance Fund's list of subsidized medicines.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut said that the manufacture of medicines in exceptional circumstances is allowed for specific patients, but this does not mean automatic reimbursement, and for reimbursement by the Health Insurance Fund one must follow the same procedures and criteria; for rare diseases, the draft does not provide exemptions.
Aseesimees Toomas Kivimägi
AI Summary
They ask Margit Sutrop to come onto the stage.
Margit Sutrop
Profiling Eesti Reformierakonna fraktsioonAI Summary
Margit Sutrop asks to what extent Estonia's pharmaceutical procurement practice has adopted models from other countries, whether there has been an exchange of experiences with Latvia's and Lithuania's experiences, and what we base it on.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut confirmed that the hospital exemption regulation adopted in 2022 follows a pan-European trend, where the treating specialist is responsible for the quality of the treatment the patient needs and for on-site production, and even medicines prepared in exceptional circumstances may not be exported before a medicine with a similar marketing authorization reaches the market.
Aseesimees Toomas Kivimägi
AI Summary
Toomas Kivimägi thanks and states that there are no more questions, and Irja Lutsar, a member of the Social Committee, outlines the steering committee's focus areas and the decisions that have been made.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar described the draft under discussion in the Social Committee's December 9 debate, which addressed the adequacy of safety and efficacy data for medicines under hospital exemption that are not registered, the quality monitoring of hospital pharmacies, the safety of CAR-T therapy and its cost impact on patients' access, and as a result it was decided to place the draft on the full Assembly's agenda, to conclude the first reading, and to designate by consensus a representative of the lead committee.
Aseesimees Toomas Kivimägi
AI Summary
Toomas Kivimägi thanks the participants, says that there are no questions, and opens negotiations.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
They want to participate in negotiations, but they don't have time to press the button.
Aseesimees Toomas Kivimägi
AI Summary
Toomas Kivimägi announces that he will open negotiations on behalf of the Eesti 200 faction and asks Irja Lutsar to speak soon.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
They apologize and note that they don't know how to behave in a situation where things are coming one after another.
Aseesimees Toomas Kivimägi
AI Summary
Everything is fine, there is no problem.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
The presentation emphasizes that the expansion of use of medicines approved in accordance with the hospital formulary without clinical trials endangers patient safety and may lead to medicines entering the market without sufficient evidence, while the bill seeks to broaden the criteria and allow extension of exemptions—taking BioBlock as an example—and underscores the need for rigorous trials and quality assurance.
Aseesimees Toomas Kivimägi
AI Summary
The vice-chairman, Toomas Kivimägi, asks for three more minutes.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
The presentation emphasizes that the use of hospital rounds may jeopardize the quality of medicines and patient safety, highlights the large gap between the high price of CAR-T medicines and production costs, and stresses that before any legislative change is made, practical bottlenecks must be thoroughly clarified and that consideration must be given to funding, availability, and the use of unregistered medicines.
Aseesimees Toomas Kivimägi
AI Summary
Thank you! I am concluding the negotiations and I inform you that the first reading of Bill 532 has been completed in accordance with the lead committee's proposal, and the deadline for submitting amendments is January 7, 2025 at 17:15.