Agenda Profile: Irja Lutsar
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)
2024-09-11
Fifteenth Riigikogu, fourth session, plenary session
Political Position
The political position is strongly supportive of the draft bill amending the Medical Devices Act, which grants competence to the State Agency of Medicines. This support is politically justified by the necessity of bringing the regulation into alignment with the complexity and medicine-centric nature of the devices (e.g., algorithms, insulin pumps). Furthermore, support is given to granting the Health Board access to data for the rapid intervention in infectious disease outbreaks. The political framework is clearly grounded in policy and expertise.
2 Speeches Analyzed
Topic Expertise
The speaker demonstrates expertise in the field of medical device and pharmaceutical regulation, highlighting technical examples (X-ray machines, algorithms, dosage calculators). Emphasis is placed on the crucial role of expertise—specifically the medical and physician education background—of the employees of the Medicines Agency when making complex decisions. This expertise is utilized to justify differences in institutional competence.
2 Speeches Analyzed
Rhetorical Style
The rhetorical style is formal and explanatory, focusing on logical arguments and institutional expertise. The address begins with an apology for a procedural error, but the substantive portion is direct and supportive. Emotional appeals are not used; the emphasis is placed on rational justification.
2 Speeches Analyzed
Activity Patterns
The pattern of activity is limited to a single appearance in the Riigikogu, where a procedural error was initially made (pressing the wrong button), immediately followed by a substantive address in support of the bill. This indicates active participation in the legislative process.
2 Speeches Analyzed
Opposition Stance
The speaker clearly opposes the earlier proposal to merge the Health Board and the Agency of Medicines, labeling it a bad idea because of the distinct expertise held by the two agencies. This opposition is politically justified and focuses on the functional differentiation of the institutions. The stance is directed either at the previous questioner or at earlier discussions.
2 Speeches Analyzed
Collaboration Style
The style of cooperation is supportive, expressing strong favor for the minister’s positions regarding both the transfer of authority and granting the Health Board access to data. This signals a readiness to support government-initiated bills and to collaborate.
2 Speeches Analyzed
Regional Focus
Insufficient data.
2 Speeches Analyzed
Economic Views
Insufficient data
2 Speeches Analyzed
Social Issues
In the social sphere, emphasis is placed on the aspect of public health and safety, supporting the provision of data access to the Health Board to ensure rapid intervention during infectious disease outbreaks. This demonstrates a clear priority on guaranteeing national health security.
2 Speeches Analyzed
Legislative Focus
The legislative focus is on supporting the draft amendment to the Medical Devices Act (Bill 448 SE), actively advocating for the transfer of competence to the State Agency of Medicines. Furthermore, the need to regulate new complex medical devices and algorithms related to drug dosing is emphasized.
2 Speeches Analyzed