Agenda Profile: Irja Lutsar
First Reading of the Draft Act on Amendments to the Medicines Act (Bill 162 SE)
2024-01-23
15th Riigikogu, 3rd sitting, plenary session
Political Position
The political position is strongly policy-driven and focuses on protecting the standards of pharmaceutical regulation. The speaker supports the Social Affairs Committee’s proposal to reject the draft Act amending the Medicinal Products Act (162 SE) at its first reading, based on European Union directives and data provided by the State Agency of Medicines. It is stressed that banning vaccines in Estonia would require very robust data regarding their danger, which is currently unavailable.
7 Speeches Analyzed
Topic Expertise
The speaker demonstrates profound expertise in infectious diseases, vaccines, and clinical trials. Technical terminology is employed, and reference is made to specific procedures, such as the requirements for carcinogenicity and genotoxicity studies, the execution of blinded trials (involving 40,000 participants), and the role of the ethics committee and informed consent. Furthermore, knowledge is presented regarding drug marketing authorizations (temporary vs. permanent) and the registration of adverse events with the State Agency of Medicines.
7 Speeches Analyzed
Rhetorical Style
The style of the speech is formal, factual, and corrective, focusing on facts and procedures. The speaker employs logical appeals, refuting the arguments made by previous speakers (such as those of Kalle Grünthal) and stressing that vaccines helped us emerge from the pandemic, preventing deaths and severe outcomes. The tone is authoritative, relying on scientific consensus and regulatory sources (the EMA website).
7 Speeches Analyzed
Activity Patterns
The speaker's professional activity is centered on legislative work within the Social Affairs Committee, where they participated in the bill's discussion on September 29, 2023, and were appointed as the representative for the lead committee. The presentation to the Riigikogu plenary session took place in January, despite initially being scheduled for October. The speaker delivers reports based on committee hearings and the involvement of experts (the Ministry of Social Affairs, the State Agency of Medicines).
7 Speeches Analyzed
Opposition Stance
The speaker takes a stand against the claims made by previous speakers, particularly Kalle Grünthal and Mr. Poolamets, who questioned the safety of vaccines and the ethics of pharmaceutical companies. The critique is primarily fact-based and procedural, refuting misconceptions regarding European regulations and the transparency of clinical trials. The speaker is delivering a rebuttal to correct the impression that pharmaceutical companies are solely engaged in criminal activity.
7 Speeches Analyzed
Collaboration Style
The speaker demonstrates a willingness to cooperate, both internally within the committee and with experts, citing the participation of members of the Social Affairs Committee and specialists from the Ministry of Social Affairs and the State Agency of Medicines during the session. Procedural decisions (adopting the agenda, appointing a representative) were made by all participants within the committee. Although the proposal to reject the draft bill was not unanimous (7 in favor, 1 against), the committee's work was structured and inclusive.
7 Speeches Analyzed
Regional Focus
The focus is on achieving a balance between the national level (specifically, the Estonian Agency of Medicines and Estonian research) and the international/European Union level. It is stressed that Estonia's decisions concerning the banning of medicines impact other member states, and that regulation is conducted centrally via the European Medicines Agency.
7 Speeches Analyzed
Economic Views
No data available
7 Speeches Analyzed
Social Issues
The speaker focuses on public health issues, defending the role of vaccination in preventing severe illness and death during the pandemic. The topic of vaccine adverse events is acknowledged, but it is emphasized that these are rare and are registered by the State Agency of Medicines. Furthermore, the rise in cancer cases is explained as being linked to age, not vaccines.
7 Speeches Analyzed
Legislative Focus
The legislative priority is the processing of the Draft Act on Amendments to the Medicinal Products Act (162 SE). The speaker is acting as the representative of the leading committee and is strongly opposed to the adoption of the bill, advocating for its rejection during the first reading.
7 Speeches Analyzed