Second reading of the bill amending the Medicines Act (hospital pharmacy) (532 SE)
Session: 15th Estonian Parliament, 5th session, plenary session
Date: 2025-04-09 22:00
Participating Politicians:
Total Speeches: 9
Membership: 15
Agenda Duration: 12m
AI Summaries: 9/9 Speeches (100.0%)
Analysis: Structured Analysis
Politicians Speaking Time
Politicians
Analysis
Summary
Following is the consideration of agenda item six: the second reading of the draft law amending the Medicines Act (hospital exemption). This draft concerns the use of hospital exemptions – the use of medicines, as an exceptional remedy, in hospitals or in other exceptional circumstances, in addition to medicines that are normally sold under a sales license, for the treatment of a specific patient. The aim is to increase access to and flexibility in medicines, while maintaining safety and oversight. The draft provides for improvements to restrictions and control mechanisms to ensure that the hospital exemption does not become a widespread substitute for market remedies and to preserve patient rights and the quality of healthcare management.
Decisions Made 2
Two amendments to the social affairs committee were approved; they were unanimously endorsed and will be considered in the second reading of the bill.
The second reading is concluded; the draft will be added to the plenary session's agenda, and the final vote is scheduled for April 16th.
Most Active Speaker
The most active speaker was Riina Sikkut (pid ceP4u0B31_k), who represents a right-wing political viewpoint. She acted as a controller of technical and substantive aspects in the discussions and emphasized patient safety and the smooth implementation of procedures.
Esimees Lauri Hussar
AI Summary
Today’s agenda item is the second reading of the government-initiated draft law amending the Medicines Act, draft No. 532, and the rapporteur is requested to be Irja Lutsar, a member of the Social Committee.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar explained the proposed amendment to the law, which would give hospitals and doctors the right to use an effective, unregistered drug to treat patients, and would additionally require the ethics committee's assessment, informed consent, and involvement of experts before the authorization is issued.
Esimees Lauri Hussar
AI Summary
The chair thanks the presenter, notes that there are no questions, opens negotiations, and asks Riina Sikkut to take the floor.
Riina Sikkut
Profiling Sotsiaaldemokraatliku Erakonna fraktsioonAI Summary
Riina Sikkut explains that the preparation of a novel drug under a hospital exemption improves patients' access and safety when a similar drug with marketing authorization is not sufficiently available in Estonia or the patient does not participate in a clinical trial, and the change reduces administrative burden and shortens the deadline for issuing the authorization from 120 days to 90 days.
Esimees Lauri Hussar
AI Summary
The chair, Lauri Hussar, asks whether extra time is desired.
Riina Sikkut
Profiling Sotsiaaldemokraatliku Erakonna fraktsioonAI Summary
Riina Sikkut asks to have three minutes of extra time.
Esimees Lauri Hussar
AI Summary
Chairman Lauri Hussar asked for three more minutes.
Riina Sikkut
Profiling Sotsiaaldemokraatliku Erakonna fraktsioonAI Summary
Riina Sikkut said that hospital exemption is, by name, an exception and is rarely used, but it offers solutions for Estonian patients and is a development opportunity for hospitals, universities and companies, promoting the development of innovative high-tech treatment methods in Estonia and the possibility to provide patients with the best treatment in their home country, while laying the groundwork for the advancement of science and cooperation.
Esimees Lauri Hussar
AI Summary
The chair declared the negotiations closed and announced that, with respect to Bill 532, two amendments proposed by the Social Committee have been reviewed, and the closure of the second reading has been adopted.