Agenda Profile: Eero Merilind

Draft law amending the Medical Devices Act and, in consequence, amending other laws (granting competence to the Medicines Agency) (Bill 448 SE) – second reading

2024-10-24

15th Riigikogu, 4th sitting, plenary session

Political Position
The political position focuses on streamlining the regulation of medical devices and granting authority to the State Agency of Medicines. The draft bill is supported with moderate strength, emphasizing the necessity of reducing the administrative burden on pharmacies and harmonizing advertising rules with the Medicines Act. The position is clearly policy-driven, focusing on regulatory clarity and efficiency.

2 Speeches Analyzed
Topic Expertise
The speaker demonstrates expertise in the field of medical device regulation and administrative procedures. Specific terminology is employed, such as "administrative burden" and "data register," and references are made to specific legal sections and relevant authorities (the State Agency of Medicines and the Health Board). This expertise is grounded in extensive consultation with the Ministry of Social Affairs, the Health Board, and various professional associations.

2 Speeches Analyzed
Rhetorical Style
The rhetorical style is formal, neutral, and procedural, serving the purpose of presenting an overview of the Social Committee's work. The discourse is logical and fact-based, relying directly on the opinions of consulted parties and procedural decisions adopted by consensus. Emotional or persuasive appeals are entirely absent.

2 Speeches Analyzed
Activity Patterns
The pattern of activity is related to legislative committee work, providing a detailed overview of the Social Affairs Committee session held on October 15th. The speaker handles the signing of procedural documents and the determination of the voting schedule, acting within the scope of the committee chairman's authority.

2 Speeches Analyzed
Opposition Stance
No data available.

2 Speeches Analyzed
Collaboration Style
The working style is highly consensus-driven and open to compromise, as all procedural decisions were reached by consensus. The Commission broadly engaged various stakeholders, such as Tehnopol, the Union of Pharmacists, and the Health Board, and fully considered the technical amendment.

2 Speeches Analyzed
Regional Focus
The regional focus is strictly national, centering on Estonian legislation and the operations of state authorities (the Agency of Medicines, the Health Board) and professional associations (the Estonian Association of Pharmacist-Run Pharmacies).

2 Speeches Analyzed
Economic Views
Economic views are focused on regulatory efficiency, emphasizing the need to reduce the administrative burden on pharmacies regarding the handling of medical devices. Support is also given to streamlining regulations that concern business interests, such as harmonizing the advertising rules for medical devices.

2 Speeches Analyzed
Social Issues
Social issues revolve around public health and the regulation of medical devices, focusing on granting the necessary competence to the State Agency of Medicines. Emphasis has been placed on simplifying administrative processes that would support the work of pharmacies within the healthcare system.

2 Speeches Analyzed
Legislative Focus
The legislative focus is on the draft amendment to the Medical Devices Act (Bill 448 SE), the purpose of which is to grant competence to the State Agency of Medicines. The speaker is the leading proponent of the bill and the official responsible for the proceedings, proposing to conclude the second reading and schedule the final vote for November 6th.

2 Speeches Analyzed