First Reading of the Draft Act (Bill 448 SE) on the Amendment of the Medical Devices Act and the Consequential Amendment of Other Acts (Granting Authority to the State Agency of Medicines)
Session: Fifteenth Riigikogu, fourth session, plenary session
Date: 2024-09-11 20:09
Participating Politicians:
Total Speeches: 15
Membership: 15
Agenda Duration: 13m
AI Summaries: 15/15 Speeches (100.0%)
Analysis: Structured Analysis
Politicians Speaking Time
Politicians
Analysis
Summary
Regarding the fifth item on the agenda, Draft Act 448 concerning the amendment of the Medical Devices Act and related amendments to other acts (granting competence to the Agency of Medicines) is being discussed. The main objective of the draft act is to centralize the competence and supervision related to medical devices into a single institution, ensuring that the Agency of Medicines and the control of medical devices are handled by a unified expert system. One of the main positions leading to the approval by the Social Affairs Committee and the government involves three packages of changes: (1) organizing sectoral responsibility, (2) correcting the situation caused by an error made in 2021 (concerning the definition of a product under a medical device), and (3) reducing bureaucracy. Furthermore, the Agency of Medicines will be granted access to the data within the health information system, and officials will be transferred while maintaining the substance of the service. The draft act is planned to enter into force on January 1st of next year. The discussion also covers the budget, personnel needs, and potential cost impacts. Minister Riina Sikkut explains that the reallocation is technical and no significant additional costs have been planned; the real impact will primarily stem from the reduction of administrative burden and the smoothness of supervision. Members of both the opposition and the coalition participate in the debate; Irja Lutsar, representative of Eesti 200, emphasizes the need to maintain specialized competence regarding medical devices within the Agency of Medicines and praises the idea of improving access data, but points out that CE marking and medical device regulation are necessary functions to be carried out by the Agency of Medicines. Finally, the results of the discussion indicate that the first reading may conclude, and preparations for further steps will continue.
Decisions Made 1
Decisions to be taken: to propose placing the draft legislation on the plenary session agenda on September 11; to appoint Eero Merilind as the representative of the lead committee; to conclude the first reading of the draft legislation and set the deadline for submitting amendments for September 25 at 17:15. These decisions reflect the recommendation of the lead committee and establish the framework for further proceedings.
Most Active Speaker
The most active speaker was Irja Lutsar (a member of the Eesti 200 faction). Representing the opposition, she emphasized the need to maintain specialized competencies for regulating medical devices and stressed the importance of data access during crisis situations. Her stated political position was categorized as "other"—meaning neither left nor right—but she nonetheless articulated a strong legal and regulatory factional standpoint, helping to clarify the consensus regarding the necessity of specialized expertise and data access.
Aseesimees Arvo Aller
AI Summary
The Parliament moves on to the fifth item on the agenda, which involves discussing the government-initiated draft legislation No. 448 concerning amendments to the Medical Device Act and related legislation. Minister of Health Riina Sikkut is invited to give the initiating report on behalf of the proposer.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut introduced a draft bill consisting of three parts: transferring responsibility for the field of medical devices to the State Agency of Medicines, abolishing the obligation to submit documents to reduce bureaucracy, and correcting a 2021 error by restoring the right to determine which product qualifies as a medical device and granting the Health Board direct access to data in the health information system, with all provisions entering into force on January 1st next year.
Aseesimees Arvo Aller
AI Summary
The speaker invited questions and asked Lauri Laats to take the floor.
Lauri Laats
Profiling Eesti Keskerakonna fraktsioonAI Summary
Lauri Laats said that while streamlining the system is reasonable, the issues are financial savings, the clear division of tasks between the two agencies, and when such a unified understanding emerged.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut stated that critical medicines and medical devices have been consolidated at the European level, and in Estonia, their reorganization is planned starting from January 1, 2025. This reorganization involves no additional costs and aims to reduce the administrative burden and establish clarity in the definition of medical devices.
Aseesimees Arvo Aller
AI Summary
The text refers to Lauri Laats and the second question.
Lauri Laats
Profiling Eesti Keskerakonna fraktsioonAI Summary
In a small country, Lauri Laats suggests considering the merging of offices and the reorganization of the structure to achieve cost savings.
Terviseminister Riina Sikkut
AI Summary
Riina Sikkut stated on a personal level that past mergers, such as the consolidation of KredEx and EAS, have not demonstrated significant cost savings or major substantive changes. Therefore, she believes it is incorrect to assume that the same level of savings would be achievable in the healthcare sector. Furthermore, she is convinced that small teams and organizations with clear tasks and objectives yield better results in the public sector than large, multi-tiered management systems.
Aseesimees Arvo Aller
AI Summary
Vice-Chairman Arvo Aller concludes the round of questions for the Minister and yields the floor to Eero Merilind, a member of the Social Affairs Committee.
Eero Merilind
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
The Riigikogu Social Affairs Committee discussed on June 10 the transfer of responsibility for medical devices from the Health Board to the State Agency of Medicines, in order to ensure competence regarding medicines and medical devices within a single institution, and to improve national oversight and access to health information system data. They also discussed, among other things, the budget and staffing needs, as well as the regulation of the medical device market and CE marking. Decisions were made by consensus: to include the draft legislation on the plenary session agenda on September 11, to appoint Eero Merilind as the lead member, and to conclude the first reading.
Aseesimees Arvo Aller
AI Summary
The Vice-Chair notes that you also have a question and asks colleague Irja Lutsar to take the floor.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
He apologized to Eero, explaining that he had wanted to speak, but pushed the wrong button instead.
Aseesimees Arvo Aller
AI Summary
He announced that the questioning period had concluded, opened the debate, and gave the floor to the representatives of the factions, starting with the address by Irja Lutsar on behalf of the Eesti 200 faction.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar stated that she supported the proposal put forth by Eesti 200, but emphasized that the regulation of medical devices has been left in the hands of the Health Board for far too long. Furthermore, she noted that access to data must be granted, and the merging of the Agency of Medicines and the Health Board is not seen as a good idea, as they possess distinct professional expertise.
Aseesimees Arvo Aller
AI Summary
Deputy Speaker Arvo Aller announced that the debate was closed and the first reading of Bill 448 had been concluded. The deadline for submitting amendments is 17:15 on September 25, and the fifth item on the agenda has been completed.