First Reading of the Draft Act on Amendments to the Medicines Act (Bill 162 SE)
Session: 15th Riigikogu, 3rd sitting, plenary session
Date: 2024-01-23 13:52
Participating Politicians:
Total Speeches: 47
Membership: 15
Agenda Duration: 1h 3m
AI Summaries: 47/47 Speeches (100.0%)
Analysis: Structured Analysis
Politicians Speaking Time
Politicians
Analysis
Summary
Today’s agenda item concerned the first reading of Bill 162, initiated by Riigikogu member Kalle Grünthal, which proposed amendments to the Medicines Act. The purpose of the bill was to prohibit the sale and use in Estonia of COVID-19 vaccines for which genotoxicity or carcinogenicity studies had not been conducted. Grünthal justified his proposal by arguing that the COVID-19 crisis had demonstrated the dangers of experimental medicines, and decisions affecting public health must not be based merely on assumptions, but must rely on thorough scientific research. Irja Lutsar, representing the Social Affairs Committee, presented the committee's position, according to which the bill should be rejected during the first reading. The committee found that, according to the European Union directive, carcinogenicity and genotoxicity studies are not required for vaccines, and there is no strong evidence regarding the danger of these vaccines. During the debate, a sharp discussion ensued regarding vaccine safety, the quality of clinical trials, and the trustworthiness of pharmaceutical companies.
Decisions Made 1
The Riigikogu adopted the leading committee's proposal to reject Bill 162 at the first reading. The voting result was 53 in favor, 7 against, and there were no abstentions. With this decision, the bill was dropped from the proceedings, and the consideration of the second item on the agenda was concluded.
Most Active Speaker
The most active speaker was Kalle Grünthal, the initiator of the bill, who delivered a comprehensive presentation on the risks associated with COVID-19 vaccines and answered numerous questions. He represented a conservative viewpoint, sharply criticizing the current vaccination policy and demanding stricter safety studies. Grünthal highlighted several claims regarding the harmfulness of the vaccines and accused pharmaceutical companies and government agencies of jeopardizing public health.
Aseesimees Toomas Kivimägi
AI Summary
The Riigikogu now moves on to the second item on the agenda, which is the first reading of Kalle Grünthal’s bill concerning amendments to the Medicinal Products Act. Mr. Grünthal is then asked to serve as the rapporteur.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Kalle Grünthal asserted in a speech that the safety and efficacy of COVID-19 vaccines have not been sufficiently studied because the data is classified, and evidence regarding genotoxicity and long-term effects has emerged. He called for the restoration of critical thinking, taking responsibility, and expanding cooperation in the name of public health.
Aseesimees Jüri Ratas
AI Summary
Deputy Chairman Jüri Ratas expresses his thanks, invites questions, and calls upon Varro Vooglaid.
Varro Vooglaid
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Varro Vooglaid emphasizes that serious risks have not been sufficiently addressed in public debate, and that officials and politicians should be carefully monitoring them. He then asks what the reasons might be for failing to investigate the carcinogenic effect, and why his main proposal should not be supported.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Grünthal states that the draft legislation is based on the greed of large corporations, the profit of vaccine manufacturers, and funding from Bill Gates, and questions whether mass vaccination is actually concealing deeper, unknown goals.
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas asked Anti Poolamets to take the floor.
Anti Poolamets
Profiling Eesti Konservatiivse Rahvaerakonna fraktsioonAI Summary
Anti Poolamets is raising concerns about proposed changes to the European Union’s pharmaceutical regulation, which would allow the use of scientifically unproven drugs during emergencies. He warns of the potential side effects and fatalities, questioning where this path is leading us and whether it will result in more external control and less control for us.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Grünthal asserts that this regulation contradicts laws, human rights, and the Convention on Biomedicine. He recalls previous instances of illegal human research and violations of consent and additional protocols, criticizes the restrictions imposed in the name of vaccination as criminal activity, and stresses that we must not permit the intentions of the European Union Commission, which constitute one of the draft bill's goals.
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas asked Aivar Kokk to take the floor.
Aivar Kokk
Profiling Isamaa fraktsioonAI Summary
Aivar Kokk emphasized that vaccination must remain voluntary, and no one should be prohibited from vaccinating themselves or their grandchild, because otherwise diseases could arise in kindergartens and schools.
Kalle Grünthal
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Grünthal explains that his proposal does not concern the vaccination of children; in his view, children are not a COVID risk group, and if the draft bill proceeds to the second reading, the matter must be thoroughly discussed with specialists.
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas calls upon Aivar Kokk.
Aivar Kokk
Profiling Isamaa fraktsioonAI Summary
Aivar Kokk asks why he and his family are being denied vaccination, and notes that the proposal stipulates the banning of vaccine sales.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Kalle Grünthal refuses the COVID vaccine.
Aivar Kokk
Profiling Isamaa fraktsioonAI Summary
There is talk about COVID and the idea that vaccination should be voluntary, and that everyone – including one's spouse and 85-year-old mother – has the right to get vaccinated. However, Estonia should not prohibit what is possible in other EU countries, as this could lead to the emergence of cross-border vaccine trade, similar to buying fuel from Latvia.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Kalle Grünthal claims that connections have been drawn between vaccines and death and diseases, citing examples of harm to well-known individuals, and calls for banning or strictly limiting the use of vaccines until thorough studies are completed, in order to protect public health.
Aseesimees Jüri Ratas
AI Summary
This address is merely a request to invite Evelin Poolamets onto the stage.
Evelin Poolamets
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Evelin Poolamets asks how we should regard the advertising of COVID-19 vaccines in the media alongside other products, and whether it is ethical, or if information about vaccines should instead be conveyed to people via their family doctor.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Grünthal claimed that Kanal 2's COVID vaccine advertisements presented the vaccine without the required proper drug information, and due to Pfizer's sponsorship, the content constituted drug advertising, which violates the Estonian Medicines Act.
Aseesimees Jüri Ratas
AI Summary
The Chair thanked the audience, announced that there were no questions, and invited Irja Lutsar, a member of the Social Affairs Committee, to the Riigikogu rostrum to deliver her report.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
In short, the Social Affairs Committee discussed the draft bill on September 29, 2023, together with experts from the Agency of Medicines and the Ministry of Social Affairs. The committee stressed that under European Union directives and central regulation concerning vaccines, data from carcinogenic and genotoxic studies are not required, and that a prohibition imposed by one member state could compel other countries to act, although such data is currently unavailable in Estonia. They further recalled that the vaccines used in Estonia had marketing authorization and that clinical trials were conducted based on ethical consent. The Social Affairs Committee decided that the draft bill would be presented to the full assembly by October 11 (though circumstances have forced a postponement until January), to appoint Irja Lutsar as the representative of the lead committee, and to reject the draft bill at the first reading (7 votes in favor of rejection, 1 against, with no abstentions).
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas thanked the presenter and called upon Kalle Grünthal to ask a question.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Grünthal clarified that the draft bill had also existed in the previous Riigikogu, but it was not rejected; rather, the proceedings lapsed due to the termination of the Riigikogu’s work. He further stressed that regarding the issue concerning the placebo group, it is extremely unethical that the benefit-risk analysis of the vaccines was only possible if the placebo group was maintained, yet the control group was eliminated during the study. Now, all control groups have disappeared, and this is unacceptable.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar said that the discontinuation of the placebo group and the offering of the vaccine to the people who had been in the placebo group took place at the participants' request, and that such a practice is not exceptional because vaccines are usually voluntary.
Urve Tiidus
Profiling Eesti Reformierakonna fraktsioonAI Summary
Urve Tiidus asks, reflecting in hindsight, whether vaccines could undergo clinical testing in the future for potential cancer risk or genetic damage, even though she, as a non-medical person, realizes that this would be extremely difficult and almost impossible.
Aseesimees Jüri Ratas
AI Summary
Jüri Ratas invites Urve Tiidus to speak.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar stated that decisions regarding each drug are made individually based on its ingredients. If a component is deemed to have no potential for carcinogenic or genotoxic risk, the absence of risk is presumed, and further studies are not conducted. Instead, these tests are performed on animals, and if any suspicion arises, the studies are certainly carried out. Furthermore, cancer is closely linked to age, and unfortunately, malignant tumors are more prevalent in people aged 60 and over.
Aseesimees Jüri Ratas
AI Summary
Vice-Speaker Jüri Ratas calls upon Eero Merilind to speak.
Eero Merilind
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A question for Irja Lutsar: she is asked to confirm that vaccines are vital for public health and provide protection against diseases.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar confirms that COVID-19 vaccines have genuinely reduced the risk of death and severe illness. She is skeptical, yet she has found no studies demonstrating harm, and the vaccines continue to protect against severe illness and death, having helped us emerge from this pandemic.
Aseesimees Jüri Ratas
AI Summary
Vice-Speaker Jüri Ratas invites Kalle Grünthal to take the floor.
Kalle Grünthal
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Kalle Grünthal criticizes the violation of clinical trial principles and the elimination of control groups, raises concerns about the reliability of COVID studies, and questions why Pfizer classified the data for 75 years and how long this protein persists in the human body.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
He confirms that he is not currently a Pfizer employee, even though he worked there 20 years ago, and there were no vaccines at that time. He adds that he does not know what studies or what technology is classified.
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas thanked the rapporteur, stated that there were no further questions, opened the debate, and invited Anti Poolamets, the representative of the EKRE faction, to the podium.
Anti Poolamets
Profiling Eesti Konservatiivse Rahvaerakonna fraktsioonAI Summary
Anti Poolamets voiced profound concern that amendments to the European pharmaceutical regulation might permit the release of untested medicines onto the market during an emergency. He further noted that during the pandemic, false claims regarding vaccines were disseminated, citing the interests of pharmaceutical companies and substantial fines (like those levied against Pfizer) as evidence of a lack of reliability.
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas requests three minutes.
Anti Poolamets
Profiling Eesti Konservatiivse Rahvaerakonna fraktsioonAI Summary
Anti Poolamets criticizes pharmaceutical companies and vaccine side effects, highlighting mandatory vaccination and illegal experiments, and calls for extreme vigilance in protecting people’s health.
Aseesimees Jüri Ratas
AI Summary
Ratas explained that the Rules of Procedure and Internal Rules Act does not permit approaching the Riigikogu podium without authorization, and even the initiator is not allowed to speak at that moment, but he invited Kalle Grünthal to the microphone on the spot.
Kalle Grünthal
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Kalle Grünthal thanks, noting that the topic is important and seems unfair, and asks what should be said about it.
Aseesimees Jüri Ratas
AI Summary
He/She emphasizes that he/she is not being given the floor, and consequently, nobody can say anything—that is the problem.
Kalle Grünthal
Profiling Fraktsiooni mittekuuluvad Riigikogu liikmedAI Summary
Speech is simply the expression of affirmation.
Aseesimees Jüri Ratas
AI Summary
Jüri Ratas invited Irja Lutsar, the representative of the Eesti 200 parliamentary group, to the Riigikogu rostrum for her address.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
He apologizes and explains that his name has been mentioned here repeatedly.
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas said that everything was clear and that this was a response speech.
Irja Lutsar
Profiling Eesti 200 fraktsioonAI Summary
Irja Lutsar emphasized that in Estonia, the Agency of Medicines registers and analyzes the side effects of medications. She noted that adverse reactions to COVID vaccines are rare compared to the benefits gained, and if anyone experiences a side effect, they can easily register it with the Agency of Medicines.
Aseesimees Jüri Ratas
AI Summary
Deputy Speaker Jüri Ratas announced that the discussions had concluded and that the leading committee's proposal was to reject Bill 162 at the first reading, and he subsequently put the proposal to a vote.
Aseesimees Jüri Ratas
AI Summary
Draft Bill 162 was rejected during its first reading, with 53 votes in favor, 7 against, and no abstentions. It is consequently dropped from the proceedings. Consideration of the second agenda item is concluded.