...All that is necessary for the triumph of evil
.is for good men to do nothing…
Knesset report on Medical Malpractice
The Global Legal Research Center of the Law Library of the U.S. Congress (The Law Library of Congress) has performed a survey of the accepted arrangements in regards to the bearing of responsibility in cases of medical negligence in Canada, England, Wales, Germany and India (countries with a publicly financed medical system) from which it seems that the claims submitted in regards to medical damage are usually damage claims against the treating party due to neglect or negligence or claims against a medical institution. According to the Law of Torts approach customary in these countries, as well as in Israel, in order for a compensation to be awarded to a patient claiming that he was harmed during a medical procedure he has to prove that the party that treated him bears the responsibility to the damage caused to him.
An alternate model to the Law of Torts is the "no fault" model customary, inter alia, in the Scandinavian countries. While in the approach of the Law of Torts the patient has to prove that the treating party is guilty or bears the responsibility to the damage caused to him, according to the "no fault" approach, the awarding of compensation does not depend on the proof of guilt or negligence of the treating party, but of adequate proof of causal connection between the medical treatment that the patient had undergone and the damage from which he suffers.
IMA has noted to us that already in the 18th Knesset an attempt was made to promote the mechanism of the "no fault" in Israel, which the IMA is of the opinion that it will assist with the distancing of physicians from certain professions and with the use of defensive medicine because of the concern from medical negligence claims. A law proposal of compensation to the damaged at birth 5770 – 2010 of Knesset members Meir Shitrit, Zeev Elkin, Avraham Michaeli, Haim Katz and other Knesset members, has passed in preliminary reading and its essence was: compensating newborns suffering from birth defect even if no medical negligence occurred; limiting the compensation awarded due to damages to children; appointment of a medical committee for compensation to those damaged at birth which will determine the eligibility of the applicant and, inter alia, the level of compensation; the establishment of a trust fund to cover those damaged at birth; the uniqueness of cause – any person who has a cause for claim according to this law will be able to submit a claim only according this law and will not be able to submit a claim under any other law. IMA noted that the legislation process did not advance due to early elections and that IMA is acting these days to promote the law proposal vis a vis the relevant Government Ministries, since, according to them, it is an obvious and essential step in this field.
We shall introduce the principles of the “no –fault" model, customary, inter alia, in Denmark in this chapter. We have chosen to focus on this country since we could find ample on-line information on this subject in Denmark, as well as due to the fact that this country is often depicted in publications on the topic of medical negligence as representing this model.
5.1. The Legal Framework which Regularizes the Compensation Model in Denmark
Until 1992, any patients patient who were interested in submitting a claim for compensation due to damage caused to them within the framework of medical treatment in the health system in Denmark, which is largely publicly financed, had to prove in legal litigation that the damage they have sustained was caused by an error of a health care professional. As it transpires from the professional literature, due to the difficulty associated with proving the occurrence of an error by a health care professional and in order to make it easier on patients that were harmed to receive compensation, it was decided in Denmark on the set up of a public compensation model according which there is no need to prove the occurrence of an error, but in order to receive compensation the existence of a connection between the injury that may have occurred in connection with the medical treatment, examination or due to medication is sufficient. In addition, within this model’s framework, the patient is not required submit his claim to the Court or to be represented by a lawyer.
The stated model had been anchored in the Danish Patient Compensation Act, which came into effect in 1992 and as the legislation was broadened in regards to compensating patients in Denmark over the years, so as of 2004 it relates to almost all the areas of activity of both, the public health and private health systems, including: private and public hospitals, ambulance services, injuries by donors or participants in medical trials according to the established rules, general practitioners and expert physicians, chiropractors, occupational therapists, physiotherapists and Podiatrists (feet physicians), nurses, midwives, clinical dietitians, medical laboratory technicians and other professionals in the medical field. At the present, the stated laws in regards to compensation to patients are collected into the framework of the the Danish Act on the Right to Complain and Receive Compensation within the Health System.
5.1.1 The Danish Patients Association for Compensation (Patientterstatningen )
In order to implement this compensation model Patients Association for Compensation the Danish Patients Association for Compensation – Patienterstatningen was established in 1992 (hereinafter: the Association). According to the Association’s website, it is an independent body, managed by a council of seven members: one of the council members is appointed by the Minister of Health and Prevention and the rest are appointed by the regions authorities. The role of the committee members is to ensure that the work of the Association is performed properly, whereas the daily running of the Association is conducted by the Administrative Department employees, which according to the website of this body their number stands on about 200 people.
The Association is the main body of the patients who were injured during medical treatment compensation system, which purpose is to ensure the awarding of compensation to the injured. This body’s framework, does not include examination of the professional conduct of one certain medical party or another, but with the assessment of the injury itself and the eligibility for compensation due to same. The objectives of the Association, as published in 2008 are, inter alia: professional and efficient management of claims’ compensation; service to the patients and medical personnel; and a promise that injuries recorded in the Association system will be used to prevent future injuries. The vision of the Association, as it appears in the website of this body includes: being the leading expert in Demark for compensation to patients due to injury; to work in cooperation with experts in the medical field; to shorten the length of time of handling applications in the best possible way through improved streamlining of the applications handling process, management and digitations; striving to ensure that both, patients and health care professional will report on the total injuries occurrence for which compensation can be received; to be an active partner in the fields of compensation and injury prevention.
According to the stated in the the Danish Association for Compensation to Patients website it can be learned that the types of injuries for which occurrences during a medical treatment it is possible to submit claims for compensation are: injuries sustained due to medical treatment, medical examination or lack of treatment; injuries caused due to severe adverse effects of medicines approved for marketing in Denmark and given to the patient in a pharmacy, by a physician, a hospital or a dentist or were bought in an authorized store for selling medicines without a prescription. In addition the Danish legislation refers to the rights for compensation for those participating in clinical trials and blood and organ donors and details the terms and conditions to receive them. The Association will compensate the patient if the occurred injury meets one of the following conditions: If an experienced medical expert would have been acting in same situation in a different manner (" The specialist rule"); if the existing complications are very exceptional and severe in relation to the treatment given to the patient due to the disease he is suffering from, and exceed what a person could bear ("the fairness test"); if there was a failure in the medical device; if the injury could have been prevented by using a different method, technique or any other equal treatment.
It should be noted that, within the framework of the Association it is not possible to claim compensations due to mental injury on the background of medicines use. As well as it is not possible to receive compensation due to the suffering and sorrow caused by the loss of a family member due to injury during medical treatment.
In addition, the stated compensation system does not include treatments received by the patients out of Denmark borders without a referral of the attending physician (such as of private initiative); treatments conducted in Greenland; treatments conducted in the Faroe Islands prior to 2012 and in some other cases. We should note, that it is indicated in the Association’s website that in regards to injuries cases which background is not included in the stated legislation, there is a possibility for the injured person to claim compensation according to the general Law of Tort.
As of 1st January 2008 injuries become obsolete (statute-barred) three years after the patient became aware that he has been injured. From an information leaflet of the Association about the possibility to receive compensation due to injury during a medical treatment it transpires that the patient has to submit his claim for compensation within three years from the moment that he discovered about its occurrence and within ten years from the day it occurred. Compensation on injury within the framework of a medical treatment will be awarded only for injuries where the compensation for same is more than 10,000 Danish Krone (approx. NIS 5,300) whereas compensation on injury for medication treatment add to a total of 3,000 Krone (NIS 1,620). The reason for which, according to the researchers, is in order to focus on compensating the more serious injury cases. We should note that the compensation amounts (excluding for the interest accumulated for the compensation amounts) are not subject to taxation, except for compensation due to loss of income.
5.1.2 The Manner Claims are submitted to the Danish Patient Compensation Association
Patients interested in receiving compensation for events happening to them during a medical treatment have to fill a claim form and submit it to the Association either by fax or online by e-mail. We should note, in this context, that the information leaflet of the Association indicates in regards to receiving compensation due to injury sustained during a medical treatment it seems that the medical professionals are obliged to inform the patient about the existence of the Association in case they are of the opinion that the patient was injured in a manner that might make him eligible to receive compensation as well as assist the patient in submitting his claim if it is necessary.
We have no data about the budget of the Association. Nonetheless, as it seems from the information on the Association’s website, the activity of the Association is publicly funded, and therefore those appealing to it are not required to any expenses in connection to the submission of a claim. In addition, any person who receives a treatment either in the private or public health system in Denmark is eligible to receive compensation, and they are not required to represent their claim by lawyer.
With the receipt of the claim from the applicant, the Association is examining it in order to ensure that it holds all the required information and following this sends the claim for the response of the party or place where the injury was sustained (hospital, physician and the like). Following that the stated party has to fill a report about the event and to send to the Association the medical record (journal material). The receipt of the stated material in the Association takes between one or two months and then a copy of the report received by the Association is sent to the claimant and he is given the possibility to submit his comments. With the completion of this process the handling of the case is transferred to the lawyers of the Association who examine if indeed an injury occurred and whether the conditions for compensations to be awarded were filled. The case will be discussed, usually within the framework of "physician meeting" (doctor meeting) where the lawyers and the physicians who are handling the case discuss the claim case details. At times the physician may ask for additional documents for examining the case, such as a physician statement etc. We should note, as can be deduced from the Association’s website, the Danish physicians who discuss claims are banned from handling cases which occurred in the place of their current employment or where they were employed when the occurrences occurred. If it becomes clear that this rule was not adhered to, the case will be reopened and discussed anew.
According to the stated in the Association’s website, the average handling duration of the claims is approx. seven months from the moment the claim has been received until a decision is made on in its regard. In case it was decided that the claimant is eligible for compensation, the calculation of the level of the compensation is performed in accordance with the Danish Law in regards to the responsibility for compensation (The Danish Liability for Damages Act). In general, it is possible to receive compensation in the following cases: expenses for health and other loss; loss of income, pain and suffering; permanent injury; work disability and more.
In cases where injury occurred in the context of a treatment provided by the national health services of Denmark, The compensation are paid by the regions and by the insurance companies in which the private health providers are insured. In cases of injury following use of a medication, the party responsible for the payment of compensations is the Ministry of Health. Compensations due to treatment in private frameworks outside of the national health services are funded through the insurance companies in which the health service providers are insured. Compensations due to injuries caused in the context of a treatment given to prisoners incarcerated in jail houses are funded by the Danish Prison and Probation Service, and compensations due to injuries caused in military clinics are funded by the Danish Ministry of Defense.
In case the claimant is not satisfied with the decision of the Association in his case, he has the option to appeal to the Appeals Compensations Council (the Patient Compensation Appeals Board) which has the power to increase the awarded compensations amount, to reduce it, or even to cancel it altogether. This council is appointed by the Minister of Health. The Chairperson of the Council and his deputies who are appointed by the Ministry of the Interior and the Ministry of Health are judges, and the other members of the council are appointed by various parties among them: the National Council for Health, the Danish Insurance Association, the Danish Bar Association, the Consumers Council and other bodies.
5.1.3 Data on Claims Discussed by the Danish Association for Patients Compensation
The database of the Association is published within the framework of a research on the subject of Existing data sources for clinical epidemiology: The Danish Patient Compensation Association database of a group of researchers in the year 2015 demonstrates that between the years 1996 – 2013 an increase occurred in the scope of claims submitted to the Association from about 2,000 claims in the year 1996 to some 10,000 claims in the year 2013 (the population of Denmark numbers about 5.7 million residents). In regards to the number of claims in which compensation was awarded, it can be learned from the stated article that out of 9,628 claims for compensations submitted to the Association in 2012, 33.1% claims were authorized. The level of compensation awarded due to the authorized claims was at about 144 million U.S. dollars.
It can be learned from the above stated article about the distribution of the authorized claims in that year by the Association according to causes:
Cases which could have been prevented by use of an alternative and equal medical methodology
Donors and participants in medical trials
A rare and severe injury
Treatment at a level lower than an experienced spacialist
Chart no.3: The Distribution of Claims Authorized by the Danish Patient Compensation Association by Causes, 2012
As stated, the database of the Association includes information about the scope of the claims only, and therefore it cannot be deducted from these data on the total number of injury cases of patient occurring in Denmark within the framework of medical treatment.
It is important to note that we do not hold information how is this model actually implemented, and with this mission information for example its position and role within the fabric of the bodies responsible for handling patients claims and drawing conclusions, on the extent that this arrangement eases the claims submission process due to injury during a medical treatment and to what extent it makes the response to the patients population more accessible, as well as the level in which this body succeeds to constitute a suitable response for those applying to it.
 The Law Library of Congress, Global Legal Research Center, Medical Liability: Canada, England and Wales, Germany and India, August 2009, updated on June 6th, 2015
 Baruch Levi, the "No- Fault" approach in the World Countries, 2013. Conveyed to the Knesset Research and Information Center by Chen Shmilo, lawyer, Head Area Public Policy, the Israel Medical Association, 1st February 2017.
 M. Erichsen, The Danish patient Insurance System, Med Law, 2001;20 (3): 355-369
 Law Proposal for Compensation to Injured by Birth-defect-2010 (18/2015/p)
 Chen Shmilo, lawyer, Head Area Public Policy, the Israel Medical Association, letter, 1st February 2017.
 The source of about 85% of the funding is the taxpayers money and the source of about 15% private payments (out of o=pocket) of the patients mainly due
medicine purchase and dental care services.
Existing data source for clinical epidemiology: The Danish Patient Compensation Association database. J. Tilma, M. Norgaard, K.L., Mikkelesen, S.P. Johnsen, U.S National Library of Medicine, National Institutes of Health, 2015: No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012. J.Tilma
 The Patient Compensation Association (Patienterstatningen) What is an injury, accessed on May 24th, 2017; No Fault Compensation for treatment injuries in Danish Public Hospitals 2006-2012 J. Tilma, M. norgaard, K.L. Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, December 2015.
 The Patient Compensation Association (Patienterstatningen). History, accessed on April 9th, 2017.
 The Patient CompensationA ssociation (patienterstatningen), History, accessed on April 9th, 2017. Existing data sources for clinical epidemiology: the Danish Patient Compensation Association database, J/ Tilma, M. Norgaard, K.L., Mikkelesen, s.p. Johnsen, U.S National Library of Medicine, National Institutes of Health, 2015: No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012, j. Tilma, M. Norgaard, K.L., Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, 2016, 28(1), 81-85.
 The Patient Compensation Association (Patienterstatningen), History, accessed on April 9th, 2017
 The Patient Compensation Association ( Patienterstatningen), About the Danish Patient Compensation Association, accessed, April 18th, 2017.
Denmark is divided into five administrative regions which were determined in 2007, and replaced the previous division of districts. The governmental bodies of the regions are the regional councils responsible, inter alia, for the national health services, regional welfare and development services. Statistics Denmark, Statistical Yearbook 2016, June 2016.
 The Patient Compensation Association (Patienterstatningen) , About the Danish Patient Compensation Association , accessed April 18th, 2017.
 The Patient Compensation Association (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9th, 2017
In case the patient has a complaint against a medical body, he has to contact the Patient Safety Authority who decide if the treatment given should be audited. The Patient Compensation Association (Ptienterstatningen), File your Claim, accessed on April 18th, 2017.
 The Patient Compensation Association (Patienterstatningen), Mission and Vision, accessed on April 20t, 2017.
 It is possible that a compensation will be given also due erroneous diagnosis or delay of treatment, however this also in cases in which erroneous diagnosis led to the injury. Patient Injuries, accessed on April 9th, 2017. The Patient Compensation Association (Patienterstatningen)
 We should note that, cases in which compensation will not be given in this regard are: Cases in which the source of the injury is the disease itself; The reason for the injury is that the medicine did not bring the desired result; if the medicine had mental side effects; cases in which life risking disease was treated by a medicine known for its severe side effects
 The Patient Compensation Association (Patienterstatningen) , Patient Injuries, accessed on April 9th, 2017.
 The Patient Compensation Association (Patienterstatningen), Assessment of your Case, accessed on April 9th, 2017; The Patient Compensation Association (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9th, 2017.
 The Patient Compensation Association ( Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9th, 2017.
 The Patient Compensation Association (Patienterstatningen), Areas of Coverage, accessed on April 9th, 2017.
 The Patient Compensation Association (Patienterstatningen), FAQ for Patients, accessed on May 24th, 2017.
 The Patient Compensation Association ( Patienterstatningen) Have you sustained injury following treatment or medication? 2016, retrieved on April 9th, 2017.
 Calculation according to the rate of exchange of the Danish Kroner which stood as at 28th April 2017, on 0.5286 INS. Bank of Israel, Official Rates of Exchange, entrance: 30th April 2017.
 Existing data sources for clinical epidemiology: the Danish Patient Compensation Association database, j. Tilma, M. Norgaard, K.L.,M ikkelesen, S.P. Johnsen, U.S National Library of Medicine, National Institutes of Health, 2015: No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012.
 The Patient Compensation Association ( Patienterstatningen), FAQ for Patients, accessed on May 24th, 2017.
 For the claim form please see attachment no. 1 to this document.
 The Patient Compensation Association (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9th, 2017.
 The Patient Compensation Association (Patienterstatningen) , FAQ for Patients, accessed on May 24th, 2017.
 In case the patient had been treated in few disciplines , the information will be collected from all of them
 The Patient Compensation Association ( Patienterstatningen), Processing of your Case, accessed on April 9th, 2017.
 The Patient Compensation Association ( Patienterstatmimgen), FAQ for Patients, accessed on May 24th, 2017.
 The Patient Compensation Association (Patieterstatningen), Processing of your Case, accessed on April 9th, 2017.
 The Patient Compensation Association ( Patienterstatningen), Have you sustained injury following treatment or medication? 2016, reprieved on April 9th, 2017
 The Patient Compensation Association (Patienterstatningen), Have you sustained injury following treatment or medication? 2016, retrieved on April 9th, 2017.
 The Patient Compensation Association (Patienterstatningen), Danish Act of the Right to Complain and Receive Compensation within the Health Service, accessed on May 24th, 2017.
 Statistical Yearbook 2016, Statistics Demark
 Existing data for clinical epidemiology: the Danish Patient Compensation Association database, J. Tilma, M. Norgaard, K.L., Mikkelesen, S. P. Johnsen, U.S National Library of Medicine, National Institutes of Health, 2015; No-Fault compensation for treatment injuries in Danish Public Hospitals, 2006-2012, J. Tilma, M. Norgaard, K.L., Mikkelesen, S.P. Johnsen, International Journal for Quality in Health Care, 2016, 28(1), 81-85