Agenda Profile: Irja Lutsar
Second reading of the bill amending the Medicines Act (hospital pharmacy) (532 SE)
2025-04-09
15th Estonian Parliament, 5th session, plenary session
Political Position
The speaker strongly supports the amendments to the Medicinal Products Act that expand the possibilities for utilizing the hospital exemption, removing previous restrictions and thereby making medicines more accessible. This stance is policy-based, emphasizing changes beneficial to patients and ensuring safety through the requirement for an ethics committee review. The objective of these amendments is to improve treatment options for the sick using effective, yet unregistered, medicines.
1 Speeches Analyzed
Topic Expertise
The speaker demonstrates a profound understanding of pharmaceutical legislation and the concept of the hospital exemption, detailing technical amendments (such as the removal of the ten-patient restriction). This expertise is grounded in institutional processes, citing the involvement of the State Agency of Medicines and the Ministry of Social Affairs, as well as detailed deliberations within the Social Affairs Committee.
1 Speeches Analyzed
Rhetorical Style
The rhetorical style is formal, informative, and procedural, focusing on presenting the results and consensus achieved by the social committee. The tone is neutral and objective, emphasizing logical arguments and the transparency of the legislative process while avoiding emotional appeals.
1 Speeches Analyzed
Activity Patterns
The speaker is actively involved in legislative committee work, serving as the rapporteur and detailing four discussions held by the Social Affairs Committee with the State Agency of Medicines and the Ministry of Social Affairs. They provide an overview of the specific meeting dates and propose a future schedule for the draft legislation (with the final vote set for April 16).
1 Speeches Analyzed
Opposition Stance
The opposition is neither criticized nor identified; the speaker stresses that no amendments were submitted during the consultation process, and organizations agreed with the changes to the law. This indicates broad support for the bill outside the parliamentary chamber.
1 Speeches Analyzed
Collaboration Style
The style of cooperation is consensual and inclusive. The speaker emphasizes the complete consensus among the members of the Social Affairs Committee regarding the ethics committee's requirement, and notes the successful collaboration achieved with the Ministry of Social Affairs and the State Agency of Medicines. He/She stresses that all participating members were in full, consensual agreement with the proposed amendments.
1 Speeches Analyzed
Regional Focus
The focus is entirely on the national level, covering amendments to the Medicinal Products Act and defining the jurisdiction of state authorities (the Agency of Medicines and the Health Board) in regulating the use of medicines within Estonian hospitals.
1 Speeches Analyzed
Economic Views
The economic perspective addresses the sufficiency of liability insurance, concluding that the current mandatory liability insurance is adequate both to ensure compensation for patients and to protect the rights of physicians. New financial obligations are not emphasized; instead, reliance is placed on the existing regulatory framework.
1 Speeches Analyzed
Social Issues
The main social focus is ensuring patients' rights and safety when utilizing novel medicines. The speaker strongly supports implementing the requirement for ethics committee review and informed consent to protect patients' welfare and rights.
1 Speeches Analyzed
Legislative Focus
The legislative priority is the completion of the second reading of the Draft Act on Amendments to the Medicinal Products Act (hospital exemption) (Bill 532 SE). The speaker is a supporter and the rapporteur of the bill, emphasizing two main amendments made in the Social Affairs Committee: the assessment by the ethics committee and the right of the Agency of Medicines to involve external experts.
1 Speeches Analyzed