Meeting with the Patient Compensation Fund – 14/11 2023
Location: The Association for Adverse Reactions, chairman's private address
1. Detail:
Patient compensation (PE):
Caspar Strand, Communications Manager
Martin Erichsen, Deputy Director
Peter Jakobsen, Chief Consultant
Doctor (Dr.):
Lennart Friis Hansen, an independent physician with an interest in research in the field of vaccine reactions
The Association (FE):
Anette Lindberg Friedrichsen, chairman (rapporteur)
Jeanette Birkelund, treasurer
2. Points discussed:
– Questions from the association to the Patient Compensation Fund
– Challenges for both parties in recognizing vaccination injuries
– Members' contact with the Patient Compensation Fund
– Summary of product characteristics for the vaccines
– The working basis of patient compensation and any shortcomings therein, in relation to vaccination injuries
3. Minutes:
FE: Are there special conditions that apply to Covid vaccines than to other preparations? Is it normal for such a new summary of product characteristics to form the basis for recognition of medicinal damage? When the Covid vaccines were approved, the summary of product characteristics was blank and it was not known what side effects one might risk.
PE: Before the vaccines were approved, they were tested in large-scale clinical trials, where quality, safety and efficacy were tested. The approval of the authorities is an expression that the test results have shown that the benefits of the vaccine outweigh the risks. Products are approved by the EU if they are to be used in Europe. Products are approved by LMST if they are only to be used in DK. The summary of product characteristics used for the Covid vaccines is approved by the EU, which is why the EMA is responsible for this summary of product characteristics. There are no special conditions for the summary of product characteristics for the Covid vaccines.
The Covid vaccines are approved based on the medical trials and these form the basis for the summary of product characteristics. In general, three conditions must be met for compensation to be paid:
– The side effect that you believe you have experienced must, as a rule, be stated in the summary of product characteristics for the preparation, in order to prove medical causation. New side effects are added to the summary of product characteristics as they are approved by the EU. A summary of product characteristics is therefore not a final or complete document, as side effects can be added as they are approved.
– There must be a temporal connection. There must be a connection between the date of vaccination and the appearance of symptoms.
– There must be no previous illness with similar symptoms before vaccination. It is important that injuries are reported within 3 years of the patient becoming aware of the vaccination injury. Otherwise, patients will not be entitled to compensation.
All doctors are obliged to report side effects to the Danish Medicines Agency. This tool is important for identifying side effects that should be added to the summary of product characteristics.
FE: How long after vaccination is it necessary to prove causality? How long after vaccination should one see a doctor to prove that symptoms have started?
PE: It is difficult to put a fixed time frame on this, but it must be within about 4-5 weeks after vaccination. For example, patients with chronic urticaria developed a reaction during this time period after vaccination. A precise time frame cannot be set as this is looked at individually. It must be overwhelmingly likely that the patient has sustained an injury and this requires confirmation by a doctor.
FE: Example, the patient's symptoms started the same day with swollen lymph nodes, high fever and swelling, shortly afterwards heart inflammation, but the damage developed due to the reaction in the body that was not treated. It then spread to the lungs 3 months later where there is now also damage - this due to lack of treatment and triggered by vaccination. This means that the damage spreads and attacks multiple organ systems over time. It is still the vaccine that does it and that is also the doctors' diagnosis. Since many patients with vaccination injuries do not receive the treatment they should have in hospitals, they are sent home without help and this makes the damage develop and get worse. This is because doctors are not aware of what this vaccine can do to the body. This ignorance is the reason why many patients are left without the necessary treatment and help to stop the damage after vaccination. For example, micro blood clots that are not detected and treated.
PE: When the patient sees a doctor and reactions after vaccination are recorded, it is clear when the symptoms occur. If the damage spreads due to lack of treatment, then the consequential damage will also be included in the causal relationship. Provided that the doctors treating the patient agree that it is due to the vaccine.
It is important that all patients who believe they have experienced chronic side effects report it to PE as soon as possible after vaccination. Transient side effects lasting a few weeks are a normal reaction to vaccination, but longer-term and chronic vaccine side effects must be reported.
FE: It is problematic to get side effects after vaccination recognized by doctors and in hospitals. Patients are told that there are no side effects from vaccines. Patients therefore do not receive the necessary treatment or diagnosis. It can therefore be difficult to demonstrate a causal relationship. Often patients are told that this is a psychological belief.
PE: There is a risk that some patients will be rejected based on the summary of product characteristics at the time the decision is made. However, if new knowledge comes along with the reports of side effects, the same patients will be able to resume their compensation claims through the Patient Compensation Fund. PE's system records symptoms and diseases for which rejection has been given. If these are later added to the summary of product characteristics, these patients will be contacted by the Patient Compensation Fund with a view to the possibility of resuming their compensation case. The starting point must be what is stated in the summary of product characteristics at the time of the decision and the assessment of PE's doctors. Individual cases have been registered in Denmark of rare side effects after vaccination. The reports to the Danish Medicines Agency will, if there are many notifications from the different countries, also oblige the EMA to require that it be added to the summary of product characteristics. This was also the reason why VITT was added to the summary of product characteristics for Astra Zeneca. In relation to Pfizer being able to cause blood clots, this has been investigated by EMA doctors who have not found it likely that this vaccine can cause blood clots. This is the reason why blood clots are not stated in the summary of product characteristics for the Pfizer Covid vaccine. Since it is a process that depends on new knowledge in the field and reports, it may be that the summary of product characteristics will be added if a causal relationship is seen. The patient compensation follows the announcements from the Danish Medicines Agency and the EMA. This forms the basis for the decisions made in the compensation cases.
FE: Question to the Patient Compensation Board about examples of refusals given to patients on the grounds that there were general symptoms in the population. In cases where both causality and temporal connection are met, and the diagnosis of vaccine injury has been given by the patients' own doctors. What is the reason for refusal of compensation to these patients? Are the medical consultants employed to assess the injuries perhaps not professionally relevant to assess whether there is vaccine injury?
PE: The medical consultants who are assigned as advisors in compensation cases are selected based on their specialty. For example, cardiologists for heart symptoms, etc. There are, among other things, infectious disease physicians, pulmonary physicians and neurologists assigned. Medical consultants are selected based on the symptoms associated with the individual patient. If there are specialists who have examined the patient and concluded that there is a vaccine injury, then the medical consultant with the same specialty is also informed of this. However, if the doctors disagree, the decisions are based on the assessments of the associated medical consultants. If patients are rejected and wish to appeal the decision to the Appeals Board for Patient Compensation, new lawyers and doctors will decide the case. In the event that new knowledge about vaccine side effects comes to light and the patient has had their appeal rejected as well. The case can then be reopened based on the new knowledge in the area, if it is relevant to the patient's vaccine injury. Ultimately, it is the Danish Medicines Agency and the EMA that decide what new knowledge is applicable in the area. There is a 10-year statute of limitations from the time the vaccine was given. After that, the case cannot be reopened.
FE: Since there is a lack of knowledge about vaccine reactions, it is important that there is a solution for those patients who are in a pinch due to this lack of knowledge. The tests and studies that can reveal whether the vaccine is the cause of their injuries may be far in the future. In cases where the patient's case drags on for a long time and the investigation is still ongoing, does the Patient Compensation Service itself obtain ongoing medical records? Or must the patient himself make it known that the investigation is still ongoing?
PE: Updates the patient's medical record up to the date when the case is decided. You can see if there is new material in the case before making the decision. If it is a report of an injury that is not stated in the product summary, a decision is made more quickly, as the patient's examination is not relevant to the outcome of the case.
FE: Concludes that if the patient's injuries do not meet the requirement that the side effect must be stated in the summary of product characteristics and/or the assessment of the PE's doctors, then they will be rejected and must know this before submitting the application. However, applying for compensation is still important, as the 3-year notification deadline must be met - and as new side effects may appear in the summary of product characteristics. What do you do if patients who, prior to vaccination, have an underlying disease that is at rest or are well medicated, experience significant deterioration after vaccination and can no longer be treated medically for their symptoms because their medication does not work as it otherwise did? In this context, one can have a presumption that the vaccine has caused this deterioration, especially in light of the immune response after vaccination. What do you do with this group of patients, since this group in particular has been told that they should be vaccinated, precisely because of their existing autoimmune disorders?
PE: Have had such cases. Product summary states there may be flare-ups of some symptoms and pain. But a permanent worsening is not stated in the product summary. So it is difficult to get compensation for. The summary of product characteristics plays a major role in the outcome of a compensation case. In order to change the summary of product characteristics, the Danish Medicines Agency must respond to reports and then contact the EMA to change the summary of product characteristics. It is understandable that the association wants to challenge the summary of product characteristics to help patients. It is important for understanding the case processing of compensation cases that the Patient Compensation Agency has no influence on the preparation of the summary of product characteristics, but must simply comply with it.
FE: Who has decided on the three criteria on which decisions must be made?
PE: It follows from the legislation. The Complaints and Compensation Act is the legal basis for the decisions of the Patient Compensation Board. The Act on Complaints and Compensation Access within the Health Service outlines the criteria and conditions on which compensation can be granted. Among other things, probability. It must be proven beyond 50% probability. So it must not be proven beyond all doubt but simply be more likely that it is due to the vaccine than anything else. The Liability Act determines how compensation should be measured for the individual. For example, pain and suffering, permanent damage, loss of ability to work, lost earnings, etc. The legislation forms the basis for the decisions that are made.
FE: The Danish Complaints and Compensation Act says it must be predominantly probable (more than 50% likely that it is due to the vaccine), so how do you deal with patients who have had biopsies performed that show the damage is solely due to vaccination, does that count towards the 50%? Even if the damage in question is not stated in the product summary?
PE: I have not previously come across cases where biopsies are available as documentation of injuries after vaccination. Thanks for the information and thought it was interesting that this could be done. I would very much like to see documentation for these findings as I have not come across such a study before. In cases where patients have documentation of their injuries from tests done abroad, these are welcome to be sent with the applications. Although the Patient Compensation Fund is not a research unit, we would like to look at this documentation that patients have from abroad and studies that are not available in Denmark. It can be difficult to assess what is due to vaccination, as almost the entire population is vaccinated and diseases such as blood clots occur regardless. So even though there may appear to be a temporal connection, it is not certain that it is due to the vaccine. When so many people are vaccinated, some of the citizens who have received the vaccine will immediately subsequently develop a number of different diseases. Therefore, there must be both a temporal connection and a documented medical connection/side effect before compensation can be given.
FE: I think the burden of proof should be reversed. You have to prove through an investigation that it is not the vaccine, because the patient has no chance of proving that it is due to vaccination. Also because some of the few blood tests that can show, for example, an overreaction in the immune response have been removed by the health authorities. This means that the patient has no way of proving that their injuries are due to the vaccination. The association hopes that there are some who are working on doing some more in-depth tests for vaccine-injured patients, precisely because the burden of proof currently lies with the patient and is impossible to resolve. Unfortunately, the picture is that vaccine injuries are persistent. This means that the symptoms that you might attribute to a common disease in the population and therefore serve as a basis for refusal could appear differently over a longer period. These hopefully upcoming tests are important because vaccine late effects (regardless of whether they may resemble common diseases) often have an atypical disease picture, and are difficult to treat since the cause of the injury is still active in the patient. It is just an observation but should be investigated further. Desire for more direct contact with the Patient Compensation Association for members. This could reveal patterns and contribute to problem solving for both parties. Knowledge sharing and dialogue about the problem. Advice for members in relation to their compensation case. Some patients hire lawyers to obtain compensation. The association believes that everyone should have the same rights and the opportunity to obtain compensation regardless of financial leeway or legal assistance. It should not be dependent on legal assistance whether the patient receives compensation.
PE: It is not necessary to hire a lawyer in Denmark. The Patient Compensation Fund collects all the material for the patient and then makes a decision. And it is free to seek compensation. PE has a telephone hotline (Skadelinjen) with a direct number that was set up during Covid. Case managers are on the phone and advise and help patients. The Patient Compensation Fund agrees that there should be an equal opportunity for all citizens to receive compensation, legal assistance or not.
FE: Many senior citizens do not have the opportunity to file a report because everything is done online. Asking if there is also help for this group of patients at the claims line, so that everyone has an equal opportunity to seek compensation.
PE: You can call and get a paper application form sent to you. So not everything is digital. The claims line has been established to help assess whether they have suffered an injury. The case managers cannot and will not decide cases or reject patients over the phone – but must only help patients understand what it means to have suffered a drug injury. Patients who have difficulty applying online can call the Patient Compensation main number and get advice and guidance. In this way, PE has tried to take into account that it is a challenge for some patients to seek compensation. The claims line telephone number is: 33179543 and is open 9.30-15.00. In Denmark, patients are better off than in many other countries, as it is free to apply for compensation and you do not have to file your own compensation claim against the manufacturer. The public compensation system, with more lenient rules of evidence, is better than in other countries. It is easier to get compensation for side effects in Denmark than in other countries in the EU. Denmark and the Nordic countries have a state-regulated compensation system.
Since the meeting was mostly in the nature of a good conversation, those present from the association had many supplementary questions and the impartial doctor had a lot of new information, there was also a good dialogue about the following:
FE/LÆ: The vaccines are manufactured to induce an immune response. When the vaccines were rolled out to the entire population, the only mild and transient side effects were reported. However, the statistical studies on which this is based only cover 99-99.99% of the population. This means that 0.001 – 1 % falls outside the acceptance limits. With so many people vaccinated, there will be different outcomes in the immune system due to vaccination and since the number of vaccinated is very large, the total number of even rare side effects will be countable.
LÆ: The range of variations in immune reactions after vaccination is very large. The immune system is designed to react to everything, including things we do not yet know about and that will happen in the future. Otherwise, humans would be extinct. That is why it is a huge challenge that the range of variations is so large. One should try to find out what has gone wrong for the patients who are affected by serious reactions and illness after vaccination. There may be many solutions to this, and LÆ has tried to tackle a few of them. It will take perhaps 10 years before one finds out exactly what has happened in the immune system of individual patients. It is difficult for doctors to treat patients with vaccine side effects. There is still a lot that is not known about vaccines. For example, it is now known that the vaccine can be detected in the body for a long time after vaccination. A Danish molecular biologist has accidentally found the vaccine in the blood weeks after vaccination. In some people, the body's cells may have difficulty breaking down the vaccine. Some patients have defects or changes in the biological systems that break down the vaccine, which means that the vaccine can be measured in the blood for a long time (more than 6 weeks) after vaccination, which may be the cause of hyperactivation of the system. This means that genetic changes can be decisive for the outcome of vaccination for the individual. So how do you ensure that the patient benefits from the doubt? Since these reactions are rare, it will also take a long time to find tools that can detect the cause. It was not until 2023, 2 years after vaccination, that it was discovered that the vaccine can linger in the body for a long time and cause hyperactivation and overreaction in the patient. They are now looking for which brakes some people may be missing in the immune system. The missing brakes cause the immune system to hyperactivate where it shouldn't. It will take a long time to uncover. Patients can't wait 10 years for doctors and researchers in the laboratories to complete the necessary studies. So how can you identify patients without any doubt who have been injured by vaccination and who have a causal relationship?
If there is no previous illness that resembles symptoms of side effects of vaccination, then it goes against the government and the Danish Health Authority's recognition of ex-cancer diseases as having a large margin of error as it depends on the individual patient. This means that individual medication of cancer patients is necessary as there is no one treatment that works on all of these patients. With reactions after vaccination, it is even more difficult to treat the patients, as there are many more individual reactions in the patient's immune system that can react to vaccination. Just one defect in the immune system can then react in all possible directions and it is therefore unpredictable what damage or disease the individual will suffer both acutely after vaccination and over time. Since these defects are rare, they are also difficult to find and get enough cases to ensure robust correlation. So how does the Patient Compensation handle a symptom that occurs rarely? Many of the patients are categorized as "functional disorders" - i.e. psychologically conditioned, this due to lack of investigation and non-existent studies. But even patients who are depressed do not develop these serious physical injuries (e.g. loss of teeth) due to their mood. However, with the lack of recognition that the summary of product characteristics lags far behind the knowledge already available in the field, the summary of product characteristics is not adequate. All decisions about possible side effects to be added to the summary of product characteristics are made on background of population studies. Population studies cannot be used to assess conditions in individual individuals. In population studies, corners are cut and the individual is not taken into account as it is the majority that determines the outcome of the study. Since it is about statistics.
It was agreed that appendices would be sent with the completed report in the form of studies and documentation for this.
PE: Are not medical experts but will take the information back. The law requires that there must be a preponderance of probability and causality. The Patient Compensation Agency does not review all of this research literature. The summary of product characteristics is used, as it is expected that the EMA and the Danish Medicines Agency have updated this. In relation to the new knowledge about reactions after vaccination, FE and LÆ should contact the Danish Medicines Agency. The Patient Compensation Agency is not a research authority and does not have the ability to recognize new side effects or change the summary of product characteristics. The summary of product characteristics is considered a working tool and the way to change this is by contacting the Danish Medicines Agency.
FE: Since the meeting has provided so much new medical knowledge and references to research and studies that may be important in understanding vaccine reactions, material on this will be sent along with the minutes after the meeting to all meeting participants. The participants from the Patient Compensation Association who attended do not have a medical background but are lawyers and communications managers, respectively. They have therefore not have the professional background to be able to assess or relate to the new research in the area of vaccine reactions. This new knowledge can, for example, be distributed to the medical consultants associated with the Patient Compensation, so that they are updated on this new knowledge in the area.
LÆ: The European Congress of Infectious Diseases had a presentation by a well-known doctor and researcher. This showed how much artificial intelligence can possibly help in understanding problems. (A picture from this presentation with an iceberg is shown, illustrating how little we know today and what should be investigated further). The drawing and the presentation clearly illustrated the structure of the evidence hierarchy and what needs to be included in order to assess the individual patient. The appendix is attached to the minutes.
FE: Since it is politically determined which conditions are set for patients to receive compensation through Patient Compensation. Since politicians have considered vaccination with the Covid vaccines as a civic duty and asked healthy people to get vaccinated. This with vaccine side effects as a consequence for some. Should there therefore also be a special responsibility for politicians when choosing to make such a decision. One should therefore demand that those who have been harmed by vaccination should be compensated. The association will obtain the attachments from LÆ and ensure that they are distributed to all meeting participants. In addition, minutes of the meeting will be made and sent to all meeting participants for approval prior to publication. This is because it will be necessary to talk to politicians about the conditions for vaccine-injured citizens. The working basis of patient compensation does not allow for all patients who have been injured to receive compensation for what has been suffered. With the new research, which may be 10 years into the future, this has major consequences for citizens who have lost their livelihood due to disability and injury after vaccination. They cannot wait 10 years to get the necessary help. A safety net must be established for these citizens.
LÆ: Refers to the American “National Vaccine Injury Compensation Program” established in 1986 as an insurance policy that states that vaccines are different from all other medicines, since vaccines are also taken for the sake of society and not just for the individual. That is precisely why the USA has some different rules for compensation, since the compensation serves both the interests of the individual who has been injured, and the trust in vaccines as a whole. If there is a lack of trust in vaccines, people will no longer take vaccines, either on their own behalf or on behalf of society. In Denmark, there is a lack of recognition of the problem. When If citizens are asked to get vaccinated and take a risk on behalf of others, then there should be responsibility from politicians and authorities and care should be taken for the citizens who are harmed. The evidence on which the decisions in Denmark are based cannot keep up with the latest knowledge and is based on the group and not the individual.
FE: There is a lot of new knowledge and documentation presented during the meeting. FE will present this to politicians who can change the conditions for citizens who suffer from vaccine side effects. This so that patients can get the treatment, recognition and compensation they are entitled to. Attachments for this new knowledge are sent to the Patient Compensation so that it can also be distributed to the medical consultants who advise and assess cases of vaccine injuries. This is so that everyone is updated on what we have talked about during the meeting. The only way to learn more about the injuries is by looking at new knowledge in the area. What currently locks patients is the summary of product characteristics as this is not complete and can never be, as vaccine side effects can be due to immune response, which will be individual for the individual affected. For example, it took over a year before bleeding disorders were recognized as a side effect. But it is still listed as rare. This even though studies show it is frequently occurring among vaccinated women. Even though it is not possible to avoid the summary of product characteristics, we will have to talk about why the incomplete list is a problem. We need to talk about it and make it known that it is a problem. Otherwise, no changes will be made to the terms under which patients can seek compensation. Since there is great distrust among patients towards the Patient Compensation Scheme, as the experience is that everyone gets rejected, it is important that we talk about the basis for decisions. Only by talking about the limitations in the legal framework can we point out what should be changed, for the sake of patients. For patients who became ill the same day they were vaccinated, who lose mobility, ability to work and through examination by specialists have been diagnosed with vaccine injury, it is incomprehensible that these patients are denied compensation. Solely due to the summary of product characteristics and inadequate legislation. No one benefits from this. The individual patient does not know anything about the legal basis of the Patient Compensation or the product summary that cuts them off from compensation. There is a perception that the Patient Compensation itself can decide what to compensate for. Therefore, the minutes and the dialogue are important and politicians must be involved so that patients can get the compensation they are entitled to. If you ask the authorities about what options you have if you are affected by vaccine side effects, it is recommended:
– That you report your side effects to the Danish Medicines Agency
– That you seek compensation from the Patient Compensation Fund
But the reports are not used to establish treatment options, so no help, investigation or treatment is provided to the patients. If the patients had been investigated, they could also prove what they were sick with. So the lack of investigation and treatment stops the entire process of having side effects recognized in the summary of product characteristics. Patients cannot receive compensation because the summary of product characteristics does not allow it. This leaves patients without any form of help or recognition. The burden of proof should be reversed so that it is not the patient who has to prove that the illness and injury are caused by the vaccine. Certainly not without access to a single test that can prove it. It is a shame that Denmark does not choose to be a pioneer in the field of investigation and research into the area of vaccine late effects.
