Draft law amending the Medicinal Products Act (501 SE) – First Reading

Session: 15th Riigikogu, 4th sitting, plenary session

Date: 2024-10-24 01:26

Total Speeches: 45

Membership: 15

Agenda Duration: 54m

AI Summaries: 45/45 Speeches (100.0%)

Analysis: Structured Analysis

Politicians Speaking Time

Politicians

Analysis

Summary

The Riigikogu discussed the draft law amending the Medicines Act 501 during its first reading as today's penultimate agenda item. The draft law aims to grant hospital pharmacies the right to purchase and import medicines and their active ingredients in order to improve patient access to medicines and respond to supply difficulties and urgent situations. The right to import does not create wholesale or retail rights for hospital pharmacies, but may allow for the limited distribution of medicines in crisis situations and situations where the supply chain cannot deliver the medicine quickly enough. It was also emphasized that the goal is to strengthen crisis preparedness and add competition to the wholesale market, but nationalization or extensive imports by hospitals are not planned. The second part of the discussion focused on potential risks and dimensions: the impact on prices, equal competition conditions, data requirements, and further steps before the law is adopted, including notifications to the European Commission. The influence of eight listeners with varying viewpoints highlighted the need for a thorough analysis, and the discussion concluded with a decision to move to the end of the first reading and set deadlines for submitting further amendments.

Decisions Made 2
Collective Decision

Draft 501 first reading completed according to the leading committee's proposal.

Collective Decision

The deadline for submitting amendments is set for November 6th at 5:15 PM.

Most Active Speaker
Riina Solman
Riina Solman

Fraktsiooni mittekuuluvad Riigikogu liikmed

The most active speaker was Riina Solman (Deputy Speaker of the Riigikogu). Her participation demonstrated a strong leadership position in the discussion, and she posed and corrected questions, as well as guided the course of the negotiations. Political position: from a right-wing party (the position denotes "right").

Aseesimees Toomas Kivimägi
01:26:08
AI Summary

Toomas Kivimägi announced that today’s penultimate agenda item, number seven, is the government-initiated draft law to amend the Medicines Act, first reading, and he invited the honorable Minister of Health Riina Sikkut to the floor of the Riigikogu to present the report.

Terviseminister Riina Sikkut
01:26:31
AI Summary

The amendment bill to the Medicines Act gives hospital pharmacies the right to import medicines and active pharmaceutical ingredients, expands their supplier base to include wholesalers registered in Estonia and EU-approved wholesalers, in order to improve patients’ access to medicines, accelerate deliveries, and strengthen crisis preparedness, without hospital pharmacies becoming wholesalers or retailers or causing the state any additional costs or revenues, and it is voluntary and does not affect the hospital pharmacies’ overall business activities.

Aseesimees Toomas Kivimägi
01:30:36
AI Summary

The deputy chair thanks the audience and invites Riina Solman to take the floor to answer questions.

Riina Solman
Riina Solman
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
01:30:38
AI Summary

Riina Solman claimed that although the plan may initially seem reasonable and aimed at boosting competition, it would create an unequal situation between Estonian and foreign wholesalers, because domestic companies are subject to Estonia's restrictions on markups and price-fixing, while foreign wholesalers operate without restrictions, and the administrative and state fees associated with publicly funded hospitals further widen the gap between entrepreneurs.

Terviseminister Riina Sikkut
01:31:25
AI Summary

Riina Sikkut confirmed that by restricting the markup on medicines, equal treatment is ensured and no excessive profit is earned, and although foreign wholesalers are not subject to the same restrictions, they must not have an unequal advantage; if a medicine is in stock in Estonia, local delivery to hospitals is cheaper than importing, but in cases where the medicine is unavailable in Estonia or does not have a marketing authorization, hospital pharmacies' right to import can ensure the necessary treatment for patients.

Aseesimees Toomas Kivimägi
01:33:13
AI Summary

The vice-chairman Toomas Kivimägi asks Irja Lutsar to speak.

Irja Lutsar
Irja Lutsar
Profiling Eesti 200 fraktsioon
01:33:14
AI Summary

Irja Lutsar pointed out that medicines for rare diseases are delivered to only a few individual patients, and most treatment for chronic diseases takes place in outpatient care. She asked how a patient moving from hospital care to outpatient care would receive the medicine, since hospital pharmacies are not allowed to sell to the public, and who would be responsible for its delivery.

Terviseminister Riina Sikkut
01:34:07
AI Summary

Riina Sikkut said that the arrangement of medications administered in hospital will not change, and if the patient moves home under the supervision of a family doctor, there may be another drug to keep a chronic condition under control — this situation remains the same and the addition of import rights does not change anything.

Aseesimees Toomas Kivimägi
01:35:28
AI Summary

Riina Solman is invited to perform during the speech.

Riina Solman
Riina Solman
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
01:35:30
AI Summary

Riina Solman drew attention to the fact that hospitals use state money for the wholesale of medicines, and asked whether this is hidden state aid that cannot be accepted in the EU internal market.

Terviseminister Riina Sikkut
01:35:50
AI Summary

I stressed that hospital pharmacies' import rights are designed to ensure the best possible health for patients and to provide the hospital with an initial supply of the necessary medicines, not for anything commercial, and they do not have rights to mark up prices or to wholesale, and they do not resell medicines.

Aseesimees Toomas Kivimägi
01:36:58
AI Summary

Urve Tiidus is invited to speak.

Urve Tiidus
Urve Tiidus
Profiling Eesti Reformierakonna fraktsioon
01:37:00
AI Summary

They ask whether the real motive behind this amendment to the law is the practical needs of daily life.

Terviseminister Riina Sikkut
01:37:09
AI Summary

Riina Sikkut said that due to supply difficulties there is a need for greater flexibility of hospital pharmacies to quickly find a suitable medicine for patients with rare diseases and for children, because bespoke solutions made in the name of a single patient do not fit a broad assortment, and the proposal received support from hospital pharmacies.

Hele Everaus
01:38:48
AI Summary

Hele Everaus noted that motivation is not the reason, brought Finland as an example, where hospital pharmacies have had this option and it is used about 30 times a year, and asked how much additional work for hospital pharmacies will be required in Estonia after the law is adopted, because the Ministry of Social Affairs wants to know this in advance.

Aseesimees Toomas Kivimägi
01:38:48
AI Summary

The vice-chairman Toomas Kivimägi asks Hele Everaus to come and deliver a speech.

Terviseminister Riina Sikkut
01:39:31
AI Summary

Riina Sikkut said that, based on Finnish experience, the import right is used about 30 times a year for different medicines, and due to problems of hospital pharmacies and the procurement of active ingredients, granting the import right would be suitable for faster access to medicines.

Aseesimees Toomas Kivimägi
01:40:30
AI Summary

The vice-chairman Toomas Kivimägi asked Helmen Kütt to speak.

Helmen Kütt
Helmen Kütt
Profiling Sotsiaaldemokraatliku Erakonna fraktsioon
01:40:31
AI Summary

Helmen Kütt emphasizes that the draft bill is a choice and an option, not an obligation, and it gives hospital pharmacies across Estonia the opportunity to order from wholesalers in Estonia or from EU-authorized suppliers, and to conduct procurements.

Terviseminister Riina Sikkut
01:41:00
AI Summary

Riina Sikkut emphasizes that the new regulation gives hospital pharmacies flexibility to ensure the treatment the patient needs, does not bring significant risks or costs, and opens up competition and strengthens cooperation with wholesalers, reducing the need to apply for exceptional import rights.

Aseesimees Toomas Kivimägi
01:41:58
AI Summary

Toomas Kivimägi always thanks the thorough and honorable minister, states that there are no further questions, and informs us that what was discussed in the steering committee and the decisions made there will be presented to us by our colleague Irja Lutsar.

Irja Lutsar
Irja Lutsar
Profiling Eesti 200 fraktsioon
01:42:20
AI Summary

Irja Lutsar describes in the Social Committee the discussion held about a draft bill intended to speed up and make medicines more affordable, addressing the possibility of a broad import right, supply difficulties, and the impact of competition, and making a consensus decision to put the bill on the plenary's agenda and to conclude the first reading.

Aseesimees Toomas Kivimägi
01:51:20
AI Summary

Toomas Kivimägi thanked the presenter for the presentation, informed that there were no questions, opened the negotiations, and invited Eero Merilind on behalf of the Reform Party faction.

Eero Merilind
Eero Merilind
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
01:51:34
AI Summary

The amendment to the law will increase the availability of medicines through hospital pharmacies, make inventory planning more efficient, increase competition and enable direct delivery, which will lead to cost savings and better quality of care for patients.

Aseesimees Toomas Kivimägi
01:53:48
AI Summary

The deputy chairman Toomas Kivimägi thanks very much and, on behalf of the Isamaa faction, turns to his colleague Riina Solman.

Riina Solman
Riina Solman
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
01:53:55
AI Summary

Riina Solman warns that a hastily pushed-through draft bill nationalizes up to one-third of the drug market, disrupts the current system and puts the private sector and foreign wholesalers in an unequal competitive situation, which requires thorough analysis and dialogue.

Aseesimees Toomas Kivimägi
01:54:00
AI Summary

The vice-chairman Toomas Kivimägi asked for three more minutes.

Riina Solman
Riina Solman
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
01:58:36
AI Summary

Riina Solman warns that the government's rushed and at times covert interference in the drug market could reduce the availability of medicines and present a dangerous precedent as a socialist move that restricts economic freedoms, recalling past lessons and emphasizing that Estonia must defend freedoms.

Aseesimees Arvo Aller
02:00:13
AI Summary

The vice-chairman Arvo Aller submitted a request on behalf of the Eesti 200 faction to invite Irja Lutsar.

Irja Lutsar
Irja Lutsar
Profiling Eesti 200 fraktsioon
02:00:15
AI Summary

The proposal to give hospital pharmacies the right to purchase medicines and their components directly for hospital care could improve the availability of medicines for patients with rare diseases and increase competition, through which prices may fall, but the actual impact will only become clear when the law comes into force and will depend on hospitals' procurement activity and the availability of medicines outside hospitals as well.

Aseesimees Arvo Aller
02:05:03
AI Summary

Deputy Chairman Arvo Aller asked for two more minutes.

Irja Lutsar
Irja Lutsar
Profiling Eesti 200 fraktsioon
02:05:05
AI Summary

Irja Lutsar emphasized that in extraordinary situations the best possible care must be provided and the routine procurement of medicines should remain the same, but the law's impact on the drug market and the size of the problem is unknown, and one should not expect significant cost savings or price reductions, but life-saving medicines will become available to patients more quickly and this may improve treatment outcomes.

Aseesimees Arvo Aller
02:05:57
AI Summary

Next, Tanel Kiik was registered; he likely has authorization and is presumably representing the Social Democratic Party faction.

Tanel Kiik
Tanel Kiik
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
02:06:10
AI Summary

Tanel Kiik asks for three minutes of extra time just in case.

Aseesimees Arvo Aller
02:06:16
AI Summary

Vice-chairman Arvo Aller announced that three more minutes are needed.

Tanel Kiik
Tanel Kiik
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
02:06:17
AI Summary

Tanel Kiik explains that granting rights to hospital pharmacies has been discussed for years and has stalled due to Isamaa's opposition, although it serves the health interests of the people and stimulates competition.

Aseesimees Arvo Aller
02:12:14
AI Summary

Deputy Speaker Arvo Aller announced that the factions no longer have any requests to speak, and it was decided to give Riina Solman a reply speech when the minister finishes speaking.

Riina Solman
Riina Solman
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
02:12:33
AI Summary

Riina Solman criticizes Tanel Kiik's speech as demagogy, emphasizes better access to medicines for rare diseases, and warns that the draft bill will lead to an increase in government intervention and nationalization, and reiterates that such steps will lead back to old mistakes.

Aseesimees Arvo Aller
02:14:34
AI Summary

The deputy chair Arvo Aller said that he could not answer Tanel Kiik's rebuttal and promised to submit one procedural question to the Minister of Health in advance.

Tanel Kiik
Tanel Kiik
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
02:14:43
AI Summary

Tanel Kiik clarifies that he referred to factually verifiable circumstances when Isamaa blocked discussion of a similar proposal during his tenure as health minister.

Aseesimees Arvo Aller
02:15:32
AI Summary

Arvo Aller noted that although he did not see a procedural error, everything has been said and the preceding speech from the podium has been recorded in the stenogram, and it can be reviewed precisely later; Riina Solman asked the chair of the meeting a question.

Riina Solman
Riina Solman
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmed
02:15:48
AI Summary

Riina Solman criticizes demagogy and states that Tanel Kiik uses a procedural question to accuse his opponent, while emphasizing that every MP has the right to stand up for their beliefs and for the private sector, without receiving inappropriate judgments.

Aseesimees Arvo Aller
02:16:16
AI Summary

Vice-chair Arvo Aller said that the entire speech is recorded in the stenogram and can be checked later, and delivered the closing remarks during the negotiations to Health Minister Riina Sikkut.

Terviseminister Riina Sikkut
02:16:38
AI Summary

Riina Sikkut explained that a broader right to import for hospital pharmacies is not nationalisation and comes with obligations, but it would enable patients to quickly access the medicines they need during crises and supply disruptions, which is a pressing need in light of the coalition agreement and post-COVID-19 crisis preparedness and heightened supply shortages.

Aseesimees Arvo Aller
02:21:07
AI Summary

Arvo Aller ended negotiations and announced that the first reading of Draft Bill 501 has been completed, the deadline for submitting amendments is November 6 of this year at 17:15, and the seventh item on today's agenda has been completed.