Draft law amending the Medical Devices Act and, in consequence, amending other laws (granting competence to the Medicines Agency) (Bill 448 SE) – second reading
Session: 15th Riigikogu, 4th sitting, plenary session
Date: 2024-10-24 01:15
Participating Politicians:
Total Speeches: 6
Membership: 15
Agenda Duration: 3m
AI Summaries: 6/6 Speeches (100.0%)
Analysis: Structured Analysis
Politicians Speaking Time
Politicians
Analysis
Summary
The second reading of the draft law amending the Medical Devices Act and other related laws (delegating authority to the Medicines Agency) – draft 448, initiated by the Republic's Government – was considered among four agenda items. The purpose of the draft is to clarify the regulation of medical devices and to divide authorities between the Medicines Agency and the Health Authority. Guests from Tehnopol, the Ministry of Social Affairs, the Health Authority, the Estonian Association of Pharmacy Owners, and the Laboratory Medicine Association were included in the proceedings. The opinions presented reflected different viewpoints: Tehnopol supported the draft and suggested aligning the regulation of advertising and gifts with the Medicines Act; the Ministry of Social Affairs considered the proposal sensible, but did not wish to expand the scope of the draft at this stage; the Association of Pharmacy Owners highlighted the administrative burden on pharmacies and the desire to make changes to simplify the process; the Health Authority reported on the development of a new database aimed at reducing the burden and requested feedback. The leadership committee submitted a technical proposal to include the Medicines Agency in the wording and to combine the relevant provisions, which was unanimously adopted. The following procedural actions were decided: to place the draft on the agenda of the full assembly on October 13th; to complete the second reading; to authorize the committee chairman to sign the procedural documents for the second reading; to place the draft on the agenda of the full assembly when the second reading is completed; to hold the final vote on November 2nd, and to authorize the committee chairman to sign the procedural documents for the third reading. All decisions were made unanimously.
Decisions Made 6
It was decided to put the draft on the plenary session agenda for October 23rd.
It was decided to finish the second reading.
To empower the committee chair to sign the procedural documents for the second reading.
When the second reading is concluded, place the draft on the full assembly’s agenda.
Conduct the final vote on November 6th.
Authorize the commission chair to sign the procedural documents for the third reading.
Most Active Speaker
The most active speaker was pid -YQdcxPPIcs, who represents the social committee and presented and developed primarily an overview of the discussion and procedural decisions regarding the draft. As a position, he can be categorized as 'other,' neither left-wing nor right-wing.
Aseesimees Toomas Kivimägi
AI Summary
We can move on to the fourth item on the agenda, where the Government-initiated draft law amending the Medical Devices Act and related laws (transferring powers to the Medicines Agency) will be discussed in its second reading; the presentation will be given by Eero Merilinn, a member of the Social Committee.
Eero Merilind
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
The Riigikogu's Social Committee gave an overview of the bill on the regulation of medical devices, listened to guests and various positions, and, by consensus, arrived at a plan for the procedural steps: the bill will be placed on the plenary's agenda on October 23, the second reading will be completed, the committee chair will sign the procedural documents for both the second and the third readings, and the final vote will take place on November 6.
Aseesimees Toomas Kivimägi
AI Summary
The deputy chair thanked Riina Solman and invited her to present a question.
Riina Solman
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Riina Solman pointed out that the draft bill seems technical and creates confusion, because cotton swabs and Leukoplast plasters could fall under medical devices, and why the items are not called by their proper names.
Eero Merilind
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
We discussed this in the committee.
Aseesimees Toomas Kivimägi
AI Summary
Toomas Kivimägi announced that one amendment proposal (No. 1) has been submitted from the Social Committee; the lead committee wishes to take it fully into account. We have reviewed all amendment proposals, and a decision has been made to conclude the second reading of Bill 448.