Lareb director Kant — batches were checked, no cover-up

District Court of the Northern Netherlands, Leeuwarden location

Hearing of 21 February 2024

Case number / docket number C/17/190788 / HA ZA 2023-172

STATEMENT OF DEFENCE

In the matter of:

1. Agnes Catharina van der Voort-Kant, electing domicile in Amsterdam, lawyer: Mr A.H. Ekker

and

2. The State of the Netherlands, having its seat in The Hague

3. Everhardus Ite Hofstra

4. Jaap Tamino van Dissel

5. Maria Petronella Gerarda Koopmans

6. Mark Rutte

7. Sigrid Agnes Maria Kaag

8. Hugo Mattheüs de Jonge

9. Ernst Johan Kuipers

10. Diederik Antonius Maria Paulus Johannes Gommers

11. Wopke Bastiaan Hoekstra

12. Cornelia van Nieuwenhuizen

13. Feike Sijbesma

all electing domicile in The Hague, lawyers: Mr R.W. Veldhuis and Mr M.E.A. Möhring

and

14. Albert Bourla, lawyer: Mr D. Roessingh

15. Giselle Jacqueline Marie-Thérèse Van Cann

16. Paul Edwin Jansen, lawyer: Mr L. Broers

17. William Henry Bill Gates III, lawyer: Mr W.H. Heemskerk

Defendants

versus

1. [claimant 1]

2. [claimant 2]

3. [claimant 3]

4. [claimant 4]

5. [claimant 5]

6. [claimant 6]

7. [claimant 7]

Claimants, lawyers: Mr P.W.J. Stassen and Mr A.G.W. van Kessel

The Defendant respectfully submits as follows:

1. INTRODUCTION

1. The Claimants contend that the Defendants intentionally and unlawfully misled them and thereby called on them to be vaccinated against Covid-19, while the Defendants knew that the vaccines offered in the Netherlands were not safe and not effective. Kant is specifically accused of having concealed information about side effects of the vaccine and of having lied about the existence of data on side effects for specific batches of the vaccine. The Claimants claim – in short – a declaratory judgment that the Defendants (as a group and each individually) thereby acted unlawfully towards the Claimants. In addition, the Claimants claim that the Defendants be ordered to pay damages, to be assessed in separate damages-assessment proceedings.

2. The Claimants' position is incorrect and finds no support in the facts. The contentions and claims of the Claimants are based on the Claimants' theory that the Defendants are taking part in a worldwide conspiracy aimed at carrying out a ‘Great Reset’. Kant disputes that this is the case and endorses the observations that the State and a number of other Defendants have already made on this in their statement of defence (Statement of defence on behalf of the State of the Netherlands et al., paras. 1.4 to 1.12).

3. Serious allegations are made against Kant in these proceedings. As regards the accusation that Kant intentionally misled the Claimants and thereby induced them to take a Covid-19 vaccination, Kant observes that this contention is in no way substantiated. The Claimants have submitted no information showing 1) that they had themselves vaccinated, 2) which vaccine would then be involved, 3) at what moment or moments the vaccination took place, and 4) which acts of Kant were decisive in this. In the absence of any explanation on this point, Kant disputes that there is any causal relationship between what Kant is accused of and the Claimants' decision to have themselves vaccinated.

4. Below, Kant will first give a general explanation of the work of Lareb and then respond to the Claimants' contentions. She will explain that the Claimants' factual contentions are (largely) incorrect, that Kant did not lie about batch-related problems in the administration of vaccines, and that there was no ‘cover-up’ either. There was therefore no intentional and unlawful misleading of the Claimants to induce them to take a Covid-19 vaccine while Kant knew or ought to have known that this vaccine was not safe and effective. Kant submits at the outset that the Claimants have substantiated their contentions not at all or hardly at all and have thus not discharged their burden of assertion. For this reason alone, all the Claimants' claims must be dismissed.

2. THE WORK OF LAREB

5. The Lareb Pharmacovigilance Centre (Bijwerkingencentrum Lareb) is the reporting and knowledge centre for side effects of medicines and

vaccines.[fn 1] Lareb's role differs from that of the State, the EMA and other defendant parties in these proceedings: Lareb is specifically charged with recording side effects of medicines, vaccines and health products. This only comes into play after the use of a medicine, vaccine or health product has been authorised. It is therefore not Lareb's task or responsibility to form a judgment on the admission of medicines to the Dutch market.

6. Lareb gathers new knowledge about medicines by analysing reports of suspected side effects and conducting questionnaire studies. After all, in addition to its intended effect, any medicine or vaccine can cause side effects. Despite extensive studies prior to the registration of the medicine, some side effects only come to light when, after it has come onto the market, many different people use the medicine or vaccine.

7. Where there is reason to do so, Lareb carries out an analysis in response to and on the basis of the reports received. This takes into account, among other things:

- How many reports have been received (including in other countries).

- How long it took for the complaints to arise.

- Whether there is a logical explanation (mechanism of action) for the complaints.

- How often the complaints normally occur.

- Whether other causes may also have played a role.

- What can be found about the possible side effect in scientific studies.

8. When analyses lead to new knowledge about side effects, Lareb disseminates that knowledge. Lareb also informs the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen, CBG) of newly discovered knowledge about side effects by means of signals. In the case of vaccines, Lareb also informs the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM). Both bodies can then take measures, for example by amending the package leaflet (CBG), by tightening who may use the medicine (CBG) or may receive the vaccine (CBG, RIVM), or by withdrawing a product from the market (CBG).

9. The side effects reported to Lareb are shared, together with the age and sex of the person concerned, with the Medicines Evaluation Board (CBG) and the European Medicines Agency (EMA). The marketing authorisation holders of the product concerned have access to the reports in the EMA's database (Eudragvigilance).

10. Lareb also conducts research into side effects by means of questionnaire studies. Through online questionnaires, specific groups of people are asked about their experience with medicines or vaccines. In this way Lareb obtains, among other things, further information on how often side effects occur, how much discomfort side effects cause and how long they last.

11. Lareb is funded by the CBG and the Ministry of Health, Welfare and Sport (VWS) and additionally receives funding from subsidising bodies for specific projects. In carrying out analyses and interpreting results, however, Lareb acts autonomously and independently.

Lareb and the monitoring of the coronavirus vaccines

Preparations

12. When the coronavirus pandemic began, Lareb started preparing in good time for its task of properly monitoring the safety of the new coronavirus vaccines. A specific reporting form and a questionnaire study were developed, and organisational measures were taken so that the reports and questionnaires to be received could be processed and analysed in good time, and so that monitoring could be scaled up in good time in order to cope with it properly.

[fn 1] Lareb is the acronym for Landelijke registratie evaluatie bijwerkingen (National Registration and Evaluation of Side Effects).

13. Arrangements were also made with the RIVM to request vaccine data, including batch numbers, from the Covid Information and Monitoring System (CIMS) at the RIVM, if a reporter gave consent for this. This information was added to the record of the report. CIMS is the national register of who has received which vaccine(s), set up by the RIVM.[fn 2]

Implementation

The number of reports turned out to be higher than initially estimated, probably because of the extensive media attention for side effects and for the importance of reporting. At the beginning, about 1 in 100 vaccinated persons reported suspected side effects. As the table below shows, the number of reports at vaccination moments 2 and 3 was relatively somewhat lower. This is a known effect with new medicines/vaccines.

Table 1. Number of reports received 2021

Vaccination moment | Number of vaccinations given | Number of reports received | Reporting rate (%)

1 | 12,403,566 | 114,929 | 0.93%

2 | 10,825,369 | 61,218 | 0.57%

3 | 4,314,695 | 8,268 | 0.19%

Total | 27,543,630 | 184,411 | 0.67%

14. Up to October 2023, Lareb received a total of 235.386 reports of suspected side effects of coronavirus vaccines.

Table 2. Number of reports received and number of vaccines administered up to May 2023

[Table 2 is not contained in the extracted text (image in the original).]

15. Overviews of reports received were shared weekly, and every other week there were meetings with the CBG and RIVM. Where there was/is reason to do so, analyses of reports received were and are carried out.[fn 3]

[fn 2] See https://www.rijksoverheid.nl/onderwerpen/coronavirus-vaccinatie/aanpak-coronavaccinatie/registratie-van-persoonsgegevens-over-coronavaccinatie.

[fn 3] This article describes how safety monitoring for COVID-19 vaccines was carried out: https://link.springer.com/article/10.1007/s40264-022-01253-5.

16. Through a questionnaire study, more than 27.000 vaccinated persons were followed for six months in order to map the side effects experienced after coronavirus vaccination.

Results

17. In the period up to and including May 2023, Lareb published new knowledge about side effects of the coronavirus vaccines a total of 60 times and shared it on its website (see Knowledge about side effects shared on the Lareb website up to September 2023, Exhibit 1). Up to and including May 2023, the EMA added 49 new side effects to the package leaflets – mainly as a result of reports of side effects in the EU (see Overview of added side effects, Exhibit 2). Reported deaths after vaccination were continuously monitored and analysed by Lareb. Various reports have been published on this.[fn 4]

18. Lareb periodically posted updates on its website on the numbers of suspected side effects received (how many of which side effect with which vaccine). In addition, a great deal of information about side effects of vaccines can be found on Lareb's website. Lareb also has a knowledge base on (alleged) side effects of vaccines in which information can be looked up.[fn 5]

Batch analyses

19. In order to detect possible batch-related problems, Lareb carried out batch analyses. In these analyses, the spectrum of reported side effects per batch number is compared with the spectrum in the other batches. If something stands out for a specific batch, these reports are examined more closely. During the COVID-19 pandemic, Lareb carried out these analyses once every 2 weeks. No batch-related problems were identified, however.

3. RESPONSE TO THE CLAIMANTS' CONTENTIONS

20. In support of their claims, the Claimants have put forward a large number of factual contentions. Kant responds to these contentions below.

Statutory task of the RIVM

21. The Claimants contend that the RIVM, in addition to supporting and informing the CBG, could take ‘measures’, such as amending package leaflets, tightening who may use the medicine, or withdrawing a product from the market (Summons, para. 229). This is incorrect. The measures mentioned can be taken by the CBG.

Covid Information and Monitoring System (CIMS)

22. The Claimants contend that the RIVM awarded Lareb the contract to develop the ‘Covid Information and Monitoring System (CIMS)’ (Summons, para. 230). This is incorrect. CIMS falls under the responsibility of the RIVM. Moreover, side effects per batch number are not recorded in this system.

Supplementing data on side effects in CIMS

23. The Claimants contend that, by means of a data processing agreement, Lareb was enabled to request from CIMS the vaccine product and the batch number on the basis of the patient's citizen service number (BSN). In this way, according to the Claimants, Lareb supplemented the data on the side effects of the COVID-19 injections in the RIVM's CIMS system (Summons, para. 231). The latter is incorrect. Lareb does not supplement CIMS with data on side effects; it is the other way round. For reported suspected side effects, Lareb requests vaccine data, including batch numbers, from CIMS at the RIVM if the reporter has given consent for this. This information is added to the record of the report.

[fn 4] See for example here: https://www.lareb.nl/news/overzicht-meldingen-overlijdens-na-coronavaccinatie.

[fn 5] See: https://www.lareb.nl/vaccin-kennis.

No contract for services

24. The Claimants contend that an agreement was concluded between Minister De Jonge and Lareb under which Lareb was instructed to record the side effects of the Covid-19 vaccines on the basis of the BSN number and batch number (Summons, para. 232). This is incorrect, as is apparent from the explanation above concerning the data processing agreement relating to CIMS (see para. 23).

Recording of batch numbers

25. The Claimants contend that there can be no effective identification of defects in quality, safety and effectiveness without recording by batch number (Summons, para. 234). This is correct insofar as batch-related problems are concerned. Batch numbers are necessary in order to identify problems related to a specific batch. However, as the defendant has explained above (paras. 12 to 19), other kinds of defects in quality, safety and effectiveness that are not batch-related can also be monitored without batch numbers.

No overview of recorded side effects per batch number

26. According to the Claimants, there is no doubt that the RIVM and Lareb are able to provide an overview per batch number of the recorded side effects of the Covid-19 injections (Summons, para. 235). According to the Claimants, Lareb's statement that it cannot make available data on side effects on the basis of batch numbers cannot be reconciled with Lareb's task in pharmacovigilance (Summons, para. 237, last sentence).

27. It is true that Lareb would in fact be able to produce overviews of recorded side effects per batch number. To date, however, Lareb has not done so, because this is not meaningful for safety monitoring. Such overviews are not a suitable means of detecting any batch-related problems. To detect possible batch-related problems, Lareb does carry out so-called ‘batch analyses’. During the COVID-19 pandemic this was done once every 2 weeks. Using an automated analysis tool, the spectrum of reported side effects per batch number is compared with the spectrum of the other batches. If certain side effects come up more often for a specific batch, these reports are examined more closely. The foregoing, however, does not result in a list, but in a signal. This signal indicates that a certain side effect occurs more often with a certain batch.

Woo decision of Kuipers

28. The Claimants point to a Woo request (request under the Open Government Act) asking for the publication of summary lists of all batch numbers of the Pfizer, Moderna, AstraZeneca, Janssen and Novavax vaccines. This Woo request also asked for the publication of a summary register of the number of side effects and deaths linked to the batch numbers of the aforementioned vaccines. By decision dated 29 March 2023, Minister Kuipers of VWS indicated that this decision [sic], among other things with regard to Lareb, could not be granted. According to the Claimants, no documents requested by the applicant had been found at Lareb (Summons, para. 236 and Exhibit 79 on behalf of the Claimants).

29. The Claimants' account is incomplete. Kant points to the decision on the objection concerning the said Woo request (Decision on objection Woo request, Exhibit 3, p. 4). In it, the Minister of VWS upheld the applicant's objection and after all provided one document that had been found at the RIVM. In addition, the minister once again contacted the bodies concerned, including Lareb.

30. With regard to Lareb, the minister considered as follows:

Lareb has indicated that it does not have the requested documents, because such documents do not fit the way in which Lareb works. Lareb works with a fortnightly batch analysis. This batch analysis is part of the regular

safety monitoring of vaccines. The batch analysis does not produce a list, as requested by you, but only gives a signal if something occurs more often with a certain batch. The article "Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience', which can be consulted online, describes how safety monitoring specifically for COVID-19 vaccines was carried out. Furthermore, the results of the batch analyses are shared on Lareb's website if an analysis yields results worth mentioning.

31. In addition, the minister explained that Lareb is not obliged to produce data that has not already been recorded in existing documents:

It follows from the above responses of Lareb and the CBG-meb that they do not have the documents requested by you. It is relevant here that it follows from the settled case law of the Administrative Jurisdiction Division of the Council of State (hereinafter: the Division) that the Woo contains no obligation to produce data that has not been recorded in existing documents, regardless of the degree of effort. The fact that Lareb, for example, does carry out batch analyses and that certain signals may result from them does not mean that it should create and provide the summary register of batch numbers linked to side effects and deaths requested by you. Such a summary register does not exist and, in view of the settled case law of the Division, need not be produced either. […]

[Underlining by counsel]

32. It follows from the foregoing that Lareb did not have the requested documents, nor was it obliged to draw up such documents after all for the purposes of a Woo request. The Claimants' contention that this cannot be reconciled with Lareb's task in pharmacovigilance is therefore incomprehensible and incorrect.

Lareb did not state that no data could be provided on the basis of batch numbers

33. The Claimants argue that Lareb, and therefore Kant, stated that no data could be provided on the basis of batch numbers (Summons, para. 238). This is incorrect. Lareb, through Kant, merely indicated that these overviews have not been produced because this is not meaningful for safety monitoring (see above, para. 26 et seq.).

No batch-related problems identified

34. According to the Claimants, Kant is lying about the data on batch numbers, and this lie conceals enormous differences in harmful short-term effects between the various Covid-19 injection batches (Summons, paras. 238 and 239). This is incorrect. As explained above, batch analyses were carried out for the purposes of safety monitoring. No batch-related problems were identified in them. Kant therefore did not lie.

35. In this connection Kant observes that all matters identified by Lareb can be found on Lareb's website.[fn 6]

No ‘cover-up’

36. The Claimants contend that Lareb kept a record of the side effects of all Covid-19 injections and in doing so always recorded the relevant batch number (Summons, para. 241). In this connection Kant observes that the recording of reports of suspected side effects is done by Lareb, and the national registration of who has received which vaccine(s) in CIMS, set up by the RIVM. Lareb requested the reporter's vaccine data, including batch numbers, from CIMS at the RIVM – if the reporter of the suspected side effect(s) gave consent for this in the reporting form in answer to a question asked about it. If this information could be provided from CIMS, it was added to the record of the report at Lareb.

[fn 6] See: https://www.lareb.nl/vaccin-kennis.

Registration in Vaers

37. The Claimants contend that until 19 November 2022 Lareb recorded the side effects and deaths reported to it not only for the RIVM but also for the international data system named ‘Vaers’ (Summons, para. 242).

38. This is incorrect. Lareb itself did not record any side effects and/or deaths in VAERS. The side effects reported to Lareb are shared without personal data (with the exception of the age and sex of the person concerned) with the Medicines Evaluation Board (CBG) and with the European Medicines Agency (EMA). The marketing authorisation holders of the product concerned then have access to the reports in the EMA's database, called EudragVigilance. The purpose of this is to be able to monitor medicine safety both nationally and internationally. Pharmaceutical companies are obliged to share information about reports of side effects with medicines authorities worldwide. Under American law, for example, manufacturers are obliged to submit certain reports to the FDA, so that reports made to Lareb may end up in the FDA's VAERS database.

39. It is true that data at Dutch level – including batch numbers – were publicly findable in VAERS via EU country codes. Previously these data could be viewed per country. In order to minimise the risk of tracing back to individual persons, the FDA has changed this.

Batch EM0477

40. The Claimants contend that Covid-19 Pfizer batch EM0477 led to many and serious reports of side effects and deaths (Summons, para. 245). Shortly after its use in February and March 2021, more than thirty deaths were allegedly reported. According to the Claimants, the harmfulness of this batch cannot have escaped Lareb, and therefore Kant.

41. According to the Claimants, that Pfizer batch EM0477 was particularly deadly could easily be established by comparison with other Pfizer batches. This would appear from a comparative overview of batches administered in the Netherlands. International data on Covid-19 Pfizer batch EM0477 would also show enormous differences as regards the number of reported deaths and injured (Summons, paras. 246 and 247 and Exhibits 81 and 82 on behalf of the Claimants).

42. Kant disputes the Claimants' reasoning. No conclusions can be drawn from the number of reports concerning a specific batch number. For instance, the expected number of side effects and reporting behaviour depend, among other things, on who received vaccines with those batch numbers, at what point in the vaccination campaign they received the vaccines and, of course, on how many people received vaccines with that batch number (see also below, para. 47 under d) and e)).

43. Finally, Kant points out that Lareb continuously monitored and analysed reported deaths and side effects and also reported on them regularly (see Exhibit 4, ‘Overview of reports of deaths after coronavirus vaccination’).

Study by Professor Hansen

44. According to the Claimants, a study by Professor Peter Riis Hansen shows that there are very large differences in lethality and side effects between Pfizer Covid-19 injection batches (Summons, para. 248). According to the Claimants, this study shows that approximately 4% of all batches are responsible for more than 70% of all reported side effects, 27% of all serious side effects and 47% of all reported deaths after vaccination.

45. Kant disputes this contention of the Claimants. In its batch analyses Lareb found no signals of batch-related problems. In Hansen's article, the number of reports is related

to batch numbers, with more reports for certain batch numbers. However, no conclusions about safety can be drawn from the number of reports for a specific batch number, for the following reasons:

a) The article is not about the safety of the batches, as the title suggests, but about reporting behaviour per batch. A report in many cases concerns a suspicion of a side effect, where it is not certain whether it is actually related to the administration of a medicine.

b) More was reported at the beginning of the vaccination campaign than later in the campaign. No account was taken of any media attention for certain side effects in a specific time window.

c) Large quantities of vaccines are made from one batch, which are then distributed, sometimes across different countries. A batch is used for only a limited time because it naturally runs out. The time windows within which these batches are used differ. This too was not taken into account in this article.

d) No account was taken of who received the vaccines per batch number. Both the expected number of side effects and reporting behaviour differ between different groups. In the vaccination campaign, for example, vaccination largely proceeded from older to younger.

e) The nature of the reports was not examined substantively. In Lareb's analysis, the content and nature of the reports are examined and the necessary clinical analysis is made.

46. Finally, Kant points out that various critical responses have appeared following Hansen's article. One of them observes the following:

“The evidence presented in the study is not sufficient to indicate that there is a safety signal and that it is batch-dependent as the authors conclude given the lack of information and the targeting of each batch. Therefore, this study should not be used to guide any decision regarding the use of the vaccines.”[fn 7]

Article in the Algemeen Dagblad

47. In support of their position that there was a ‘cover-up construction’, the Claimants refer to an article in the AD of 20 November 2021. In it, Kant made the following statement: “We can say that the fear of the vaccine was unfounded” (Summons, para. 249).

48. It is important first of all that this statement must be read in the broader context of the entire article. The statement mentioned was an answer to the question: “Do the coronavirus vaccines show many strange side effects because they were developed in such a short time? Many people had that fear.”

49. The fear that there would be many strange side effects proved unfounded. As Kant explains in the interview, new serious side effects were indeed discovered, but these are rare:

“That as yet unknown side effects would be discovered was to be expected. They are used in a much larger and more diverse group of people than in the studies during development. But that is always the case. The combination of thrombosis with a shortage of blood platelets (thrombosis with thrombocytopenia syndrome, or TTS, ed.) was a big surprise, that is perfectly clear. As was the number of allergic reactions to the vaccine, that was simply higher than expected. That in a small percentage of, at any rate, young men, inflammation of the heart muscle (myocarditis, ed.) and of the pericardium (pericarditis, ed.) can be a consequence of the Pfizer or Moderna vaccine is also clear. But fortunately the side effects are rare.”

[fn 7] See Del Saz BS. Batch. Dependent safety of the BNT162b2 mRNA COVID-19 vaccine. Eur J Clin Invest. 2023;00:e14050. doi:10.1111/eci.14050 and Scot et Al. Methodological and statistical considerations: Batch-dependent adverse effects of COVID-19 vaccines. Eur J Clin Invest. 2023. DOI: 10.1111/eci.14073.

50. In view of the foregoing, Kant's statement was correct, and there was therefore no lie or deception. Nor can this statement therefore be called unlawful.

Kant is not paid by the pharmaceutical industry

51. The Claimants contend that Kant allowed herself to be paid by the pharmaceutical industry and the Ministry of VWS and that over a period of ten years she corrupted Lareb, so that the Covid-19 project and the ‘Great Reset’ could be launched by means of the Covid-19 injection campaign (Summons, para. 250).

52. It is incorrect that Kant was paid by the pharmaceutical industry. Lareb is funded by the CBG and VWS and additionally receives funding from subsidising bodies for specific projects. Kant is paid by Lareb as its director.

Participation in the Disinformation Think Tank

53. According to the Claimants, Kant, as a participant in the Disinformation Think Tank (Denktank Desinformatie), promoted the provision of disinformation and was personally involved in courses for general practitioners in which she kept these general practitioners ignorant of what Lareb actually recorded for the various batches (Summons, para. 251). The Claimants have not further substantiated this position.

54. This contention of the Claimants is incorrect. Kant did indeed take part in a number of meetings of the think tank. The input of Lareb and of Kant, however, was directed precisely at the importance of independent, clear and correct information about known as well as alleged side effects.

55. The foregoing is apparent from the explanation of the working method of the Disinformation Think Tank in various letters from the Minister of VWS to the House of Representatives. In his letter of 13 April 2021, the minister says the following:

The Senate has requested information on the efforts of the State Secretary for VWS with regard to tackling disinformation about vaccination. In November 2018 the State Secretary for VWS introduced an approach to tackle the declining vaccination rate. This approach and the associated measures and progress are described in various letters. These letters also contain an explanation of the disinformation think tank. In summary, the think tank operates under the flag of the vaccination alliance, and in the think tank a group of participants works to refute disinformation in the field of vaccination or to flank it with the correct information. The think tank includes, among others, representatives of RIVM, CBG, Lareb, IGJ, Facebook and Google. VWS facilitates the think tank, and the participants work to make reliable information available and to provide rebuttals of factual inaccuracies, each from its own role, responsibilities and channels. Furthermore, members of the think tank are active in refuting incorrect information on social media, television, and in newspapers and professional journals. The efforts through the think tank operate within the framework of the approach to disinformation of the Minister of the Interior. In response to the coronavirus pandemic, disinformation about COVID vaccination is now also a focus area of the think tank's efforts.[fn 8]

Courses for general practitioners

56. The Claimants find it objectionable that Kant was personally involved in giving Covid-19 courses for general practitioners. Kant allegedly kept general practitioners ignorant of what Lareb actually recorded for the various batches (Summons, para. 251).

57. This contention is incorrect and is in no way substantiated by the Claimants. Kant disputes this contention and refers in this connection to the answer of Minister Kuipers of VWS to parliamentary questions from

[fn 8] Letter from the Minister of Health, Welfare and Sport to the Speaker of the House of Representatives of the States General, The Hague, 13 April 2021, House of Representatives, parliamentary year 2020-2021, 25 295, no. 1105, p. 83. See also Parliamentary Paper 32 793, no. 338, Parliamentary Paper 32 793, no. 393, Parliamentary Paper 32 793, no. 473, Parliamentary Paper 32 793, no. 485 and Parliamentary Paper 32 793, no. 539.

the member of parliament Van Haga (Groep Van Haga) on the involvement of Lareb in the coronavirus vaccination campaign. In the letter mentioned, the minister answers the following question:

Question 16

How do you reflect on the refresher training for general practitioners offered by Lareb in September 2022, in which active efforts were made to increase and cultivate willingness to be vaccinated? Why did Lareb propagate such an objective, while its core task is to look objectively and neutrally at potential side effects of vaccines, instead of promoting/encouraging them? Why was Lareb engaged in informing/teaching general practitioners about disinformation by/from patients and dealing with critical patients? What kind of information was classified as «disinformation» in this case? Can you explain in what way this is a competence/expertise of Lareb?

58. The minister answers this question as follows:

Answer 16

The presentation referred to in the question is public and freely accessible via MedischeScholing.nl and concerns training for doctors. The programme of this training for doctors consisted of three parts: 1) side effects of COVID-19 vaccination, 2) communication with clients and 3) the new vaccination round. Lareb was involved only in the first part, in which common reports of side effects were explained, to ensure that doctors were aware of what they could expect during the announced autumn round. The main message was therefore that doctors must be alert to side effects, that they must report suspected side effects, and that they can refer patients to Lareb's website for more information about side effects. The other parts of the programme were provided by a general practitioner and by an employee of the RIVM.

No ‘cover-up’

59. According to the Claimants, Kant intentionally and falsely reassured them by covering up the signal that some Covid-19 batches were much more deadly and/or much more harmful than others. Had Kant shared information about the large differences in reports with the Dutch population, the Claimants would not have had a Covid-19 injection and would not have suffered damage, according to the Claimants (Summons, para. 252).

60. This contention is not substantiated by the Claimants and is incorrect. Kant has already explained above that there was no ‘cover-up’ (para. 36 et seq.).

4. NO UNLAWFUL CONDUCT

61. In the summons, the Claimants take positions that are at odds with the scientific consensus that the Covid-19 vaccines administered in the Netherlands are safe and effective. They further argue that Kant and the other Defendants knew that the vaccines were not safe and not effective. The Claimants, however, do not substantiate these contentions. In this connection Kant endorses the observations of the State and a number of other Defendants concerning the way in which the Claimants have based their contentions on incorrect information or on contentions that are not legally conclusive (Statement of defence on behalf of the State of the Netherlands et al., paras. 6.1.2. to 6.6.4).

62. It is also relevant that the Claimants have not substantiated the (personal injury) damage and non-material damage they allegedly suffered, nor have they explained how this damage would be the result of administered Covid 19 vaccines. In this connection too, Kant refers to the observations of the State and a number of other Defendants (Statement of defence on behalf of the State of the Netherlands et al., paras. 7.1 to 7.8).

5. CONCLUSION

63. In view of the foregoing, there was no intentional and/or unlawful misleading by Kant with the aim of inducing the Claimants to have a Covid-19 vaccine administered. For these

reasons the declaratory judgment claimed by the Claimants cannot be granted. The Claimants have in no way demonstrated that Kant acted unlawfully. For that reason there can also be no question of group liability.

6. DUTY TO OFFER EVIDENCE AND OFFER OF PROOF

64. In support of the grounds she has put forward, the defendant submits the following evidence:

Exhibit 1: Overview of signals and news website Lareb on AEFI after COVID-19 vaccination until 4th September 2023.

Exhibit 2: Overview of package leaflet amendments for COVID-19 vaccines.

Exhibit 3: Decision on the objection by the Minister of Health, Welfare and Sport against the decision of 29 March 2023 concerning the request under the Open Government Act (Wet open overheid) for the publication of summary lists of all batch numbers of the Pfizer, Moderna, Astrazeneca, Janssen and Novavax vaccines.

Exhibit 4: Overview of reports of deaths after coronavirus vaccination.

65. The defendant offers – without thereby assuming any burden of proof that does not rest on her by law – to prove the facts stated in this statement of defence by all legal means, including by means of expert statements and the hearing of witnesses.

66. The above-mentioned exhibits are attached to this statement of defence.

7. CONCLUSION

On these grounds the defendant moves that the District Court, insofar as legally possible with immediate enforceability (uitvoerbaar bij voorraad):

a) dismiss the Claimants' claims; and

b) order the Claimants jointly and severally to pay the costs of the proceedings, as well as the customary subsequent costs (both without and with service), plus statutory interest as referred to in Article 6:119 DCC from fourteen days after the date of the judgment;

c) order the Claimants jointly and severally to pay the subsequent costs, assessed in accordance with the liquidation tariff at € 173 or, in the event of service, € 271;

d) declare that these orders as to costs are enforceable immediately (uitvoerbaar bij voorraad).

Lawyer

This case is handled by Mr Dr A.H. Ekker

Ekker Advocatuur

Panamalaan 6G

1019 AZ Amsterdam

T: +31 (0)6 43 77 53 35

anton@ekker.legal