Part 1
Not relevant for the Patient Insurance Association
Part 2
Not relevant for the Patient Insurance Association
Part 3
Patient Insurance
Coverage
§ 19. Compensation shall be paid pursuant to the provisions of this Part to patients or the bereaved families of patients who suffer injury in Denmark in connection with examination, treatment or the like carried out
1) at a hospital or on its behalf;
2) by healthcare professionals or other staff in the course of pre-hospital care under the provisions of the Danish Health Care Act;
3) by authorised health care staff employed by the regional dental care service, by an odontological regional or knowledge centre function or in connection with the supply of municipal health care services pursuant to Parts 36-41 or on their behalf;
4) at university schools of dentistry;
5) by privately practicing, authorised health care professionals;
6) by doctors who, without being in private practice, carry out vaccinations pursuant to section 158 of the Health Care Act;
7) by doctors who, without being in private practice, act as emergency service doctors; or
8) by the National Board of Health in cases pursuant to Part 21 of the Danish Health Care Act, rules issued pursuant to that Act or rules issued pursuant to section 5(d) of the Hospitals Act as upheld in section 277(12) of the Health Care Act.
(2) Individuals taking part in biomedical trials that do not form part of the diagnosis or treatment of their illness shall have the same status as patients.The same shall apply to donors from whom tissue or other biological material is taken.
(3) This Part shall also apply to patients who receive free treatment or a subsidy for treatment at hospitals, clinics etc. abroad under the Health Care Act.
(4) The Minister of the Interior and Health shall lay down rules on which areas are covered by subsections (1) – (3).
(5) The Minister of the Interior and Health may wholly or partly assign the processing of claims under this Part to a private institution.If so, the Minister of the Interior and Health shall enter into the necessary agreements in this respect.
(6) If the Minister of the Interior and Health assigns the processing of claims under this Part to a private institution, the Public Administration Act shall apply to the institution’s activities.
(7) If the Minister of the Interior and Health assigns his powers pursuant to subsection (5) to a private institution, he may lay down rules on the rights of appeal.
Injuries entitling patients to compensation
§ 20. Compensation shall be paid if, on a preponderance of the evidence, the injury was caused in one of the following ways:
1) If it may be assumed that an experienced specialist in the field in question would in the given circumstances have acted differently during examination, treatment or the like, thereby avoiding the injury;
2) if the injury is due to the malfunction or failure of technical apparatus, instruments or other equipment used for or in connection with examination, treatment or the like;
3) if, on the basis of a subsequent evaluation, the injury might have been avoided using another available treatment technique or treatment method that would have been just as effective in treating the patient’s illness from a medical point of view; or
4) if injury occurs as the result of examination, including diagnostic procedures, or treatment in the form of infections or other complications that are more extensive than the patient should reasonably have to endure.Account must be taken in this respect of the severity of the injury, the patient’s illness and general state of health, the unusualness of the injury and the general possibility of taking the risk of its occurrence into consideration.
(2) The Minister of the Interior and Health may lay down rules on which injuries shall be covered by the Act under subsection (1).The Minister may also lay down rules specifying that certain injuries according to subsection (1)(3) shall be exempted from this Part.
§ 21. Compensation for injury resulting from the patient’s illness not being diagnosed correctly shall only be paid in the instances specified in section 20 (1) (1) and (2).
(2) In the event of an accident not covered by section 20(1)( 2) compensation shall only be paid if the injured person is being treated etc. at a hospital and the accident occurred on its premises and in such circumstances that the hospital may be assumed to have incurred liability in damages for it under the general law of damages.
(3) Compensation pursuant to this Part shall not be paid for injuries resulting from the properties of the drugs used for examination, treatment or the like.
§ 22. Compensation shall be paid to trial subjects and donors covered by section 19(2), for any injury that may be caused by the trial or the removal of tissue etc. unless the injury, on a preponderance of evidence, had another cause.
(2) The rule contained in subsection (1) shall not apply to injuries covered by section 21(3).
(3) Compensation shall be paid to blood donors covered by section 19(2) for injuries suffered in accidents in connection with transport to an agreed or ordered collection at a blood bank or mobile blood bank unless the donor contributed to the injury wilfully or through gross negligence.However, compensation shall not be paid under subparagraph (1) if the blood donor is entitled to compensation for the injury under other legislation.
§ 23. It shall be incumbent on every authorised healthcare professional who, in the course of his work, becomes aware of injuries that may be assumed to entitle the patient to compensation under this Part to inform the injured person thereof and to help to the necessary extent with notification of the Patient Insurance Association or the private institutions to which the processing of claims under this Part has been assigned pursuant to section 19(5).
Assessment of compensation etc.
§ 24. Compensation shall be fixed in accordance with the provisions of the Danish Liability for Damages Act.
(2) Compensation etc. pursuant to subsection (1) shall be paid if it exceeds DKK 10,000.The Minister of the Interior and Health may lay down rules to the effect that compensation for loss of earnings and pain and suffering shall only be paid if the injury resulted in incapacity for work or illness above and beyond a fixed period, which shall not exceed three months.
(3) Subsection (2) and rules laid down pursuant to subsection (2) shall not apply to injuries covered by section 22(1) or (3), cf. section 19(2).
(4) Compensation shall not be paid to cover recourse claims.
§ 25. Compensation for the patient or his bereaved family can be reduced or, depending on the circumstances, invalidated if the patent contributed to the injury wilfully or through gross negligence.
§ 26. In so far as the patient or his bereaved family have received or are entitled to receive compensation in accordance with section 24, a claim for compensation may not be made against anyone who may have incurred liability for the injury.
§ 27. If the person who may have incurred liability to pay compensation to the patient or his bereaved family under the general rules on compensation is covered by section 19, compensation paid under section 24 shall only form the basis for recourse claims if the injury was caused wilfully or through gross negligence.
§ 28. In so far as liability to pay compensation exists pursuant to the provisions of the Product Liability Act, the provisions of sections 26 and 27 shall not apply.
The structure of the compensation scheme
Liability to pay compensation
§ 29. Pursuant to this Part, the following shall be liable to pay compensation:
1) Administrators of public hospitals and pre-hospital care under the Health Care Act;
2) The patient’s region of residence or, if the patient is not resident in Denmark, his region of residence with regard to injuries in connection with treatment for which a hospital etc. abroad is liable under section 19(3);
3) Administrators of regional dental care, odontological regional and knowledge centre functions and municipal health care services pursuant to Parts 36—41 of the Health Care Act;
4) Administrators of the university schools of dentistry;
5) The region where a privately practicing, authorised healthcare professional has his practice or where a private hospital or clinic etc. is located or where a doctor acts as an emergency service doctor, without being in private practice, or where a doctor, without being in private practice, carries out vaccinations pursuant to section 158 of the Health Care Act, cf., however, subsection (2);
6) The Government as regards injuries comprised by section 19(1)(8).
(2) In so far as the processing of claims under this Part is assigned to a private institution in accordance with section 19(5), the Minister of the Interior and Health may stipulate that the liability to pay compensation under this Part shall be incumbent on the institution in question or the particular privately practicing, authorised healthcare professional whom the institution represents.
(3) If a regional council etc. has repeatedly paid compensation for injuries caused by privately practicing. authorised healthcare professionals, private hospitals etc. in accordance with subsection (1)(5), the regional council shall be obliged to report this to the National Board of Health with a view to an assessment of whether there is a basis for implementing supervisory measures pursuant to the Health Care Act and the Central Administration of the Health Service Act.The National Board of Health may lay down rules on when a report shall be submitted to the Board.
Legal obligation to insure
§ 30. Claims for compensation under this Part shall be covered by an insurance policy with an insurance company, cf., however, section 31(1).
(2) Insurance companies underwriting insurance policies covered by this Part shall notify the Patient Insurance Association thereof.
(3) The Minister of the Interior and Health shall determine the annual cover amounts with regard to the insurance policies specified in subsection (1).
(4) The cover amounts fixed pursuant to subsection (3) shall be adjusted in accordance with the provisions of section 15 of the Liability for Damages Act.
(5) The Minister of the Interior and Health shall lay down provisions for the implementation of the legal obligation to insure, including minimum terms and conditions for the underwriting by insurance companies of insurance policies covered by this Part.This shall include regulations to the effect that
1) insurance companies underwriting insurance policies covered by this Part shall pay compensation jointly in case of violation of subsection (1);
2) insurance companies underwriting insurance policies covered by this Part shall pay compensation jointly in cases where the liability of the individual administrator to pay compensation exceeds the insurance policy’s cover amount set pursuant to subsection (3);
3) insurance companies underwriting insurance policies covered by this Part and self-insuring authorities shall pay compensation under section 24 jointly in cases where it is not possible to single out with reasonable certainty the party liable to pay compensation in accordance with section 29.
(6) The Minister of the Interior and Health shall lay down regulations on the fixing of limits for joint liability to pay compensation in accordance with subsection (5)(1)–(3).
(7) Distraint may be levied for premiums for the policies and premiums may be collected by means of withholding of pay etc. pursuant to the rules on the collection of personal taxes of the Withholding Tax Act.
§ 31. The Government, Regional and district/city councils shall be exempt from the legal obligation to insure pursuant to section 30.
(2) The Minister of the Interior and Health may accept that regional and district/city councils may agree to take over the legal obligation to ensure pursuant to section 30(1) from private administrators, cf. section 29.They may only take over from private administrators who practice within the region’s or municipality’s area.
(3) Regional and district/city councils may demand that the private administrators covered by the schemes pay the costs of the insurance schemes specified in subsection (2).
(4) The Minister of the Interior and Health shall determine the annual cover amounts for the insurance policies specified in subsection (2).
(5) Cover amounts fixed pursuant to subsection (4) shall be adjusted according to the provisions of section 15 of the Liability for Damages Act.
(6) Section 30(5)(1) and (2) and section 6 shall not apply if a regional or district/city council has taken over the legal obligation to insure pursuant to subsection (2).
(7) Distraint may be levied for the costs specified in (3).
The Patient Insurance Association
§ 32. Insurance companies underwriting insurance policies covered by this Part and self-insuring regional and district/city councils shall jointly set up a Patient Insurance Association and elect a committee for the Association.The Minister of the Interior and Health may lay down rules to the effect that the Government may be a member of the committee.
(2) The Minister of the Interior and Health shall lay down rules on the governing and activities of the Association.The cost of running the Association and any other costs imposed on the Association pursuant to this Part shall be met by the insurance companies and the self-insuring authorities according to the distribution of costs specified in the rules.
(3) The Patient Insurance Association shall submit an annual report on its work to the Minister of the Interior and Health.
Procedure
§ 33. The Patient Insurance Association shall receive, elucidate and decide all compensation claims under the provisions of this Part.The Association may, in accordance with detailed provisions in the rules, authorise the individual insurance companies and self-insuring authorities to elucidate and decide specified types of claim themselves.
(2) The Patient Insurance Association may arrange for the district court to question witnesses in the jurisdiction where they live.
(3) The decisions of the Patient Insurance Association shall be communicated to the relevant insurance company, the Government or the self-insuring regional council or district/city councils who shall then pay out the specified benefits.
Patients’ Complaints Board of Appeal
§ 34. The Minister for the Interior and Health shall appoint a Patients’ Complaints Board of Appeal consisting of a chairman and a number of deputy chairmen and officially appointed members as determined by the Minister of the Interior and Health.
(2) The chairman and deputy chairmen, who shall be appointed by the Minister of the Interior and Health, shall be judges.The remaining members shall be appointed by the National Board of Health, the regional councils in concert, the National Association of Local Authorities in Denmark, the Board of the Danish Law and Bar Society, the Danish Council of Organisations of Disabled People and the Danish Consumer Council.
(3) The National Board of Health shall, where this is considered necessary for the processing of claims, appoint a number of specialist members for specialist areas, all of whom shall have professional qualifications, cf. subsection (4).
(4) When deciding individual claims, the board shall consist of:
1) the chairman or a deputy chairman;
2) two specialist members appointed by the National Board of Health pursuant to subsection (3) depending on the specialist nature of the claim;
3) one member appointed by the regional councils in concert;
4) one member appointed by the National Association of Local Authorities;
5) one member appointed by the Board of the Danish Law and Bar Society;
6) one member appointed by the Danish Consumer Council; and
7) one member appointed by the Danish Council of Organisations of Disabled People.
(5) The chairman or the deputy chairman in question shall decide the specialist area or areas within which expert members shall participate in the decision of individual cases pursuant to subsection (4).
(6) The Board shall form a quorum if, when deciding a case, it consists of a chairman or deputy chairman and at least four members, including at least one member pursuant to subsection (4)(2) or (5), one member pursuant to subsection (4)(3) or (4) and one member pursuant to subsection (4)(6) or (7).
(7) The Minister of the Interior and Health may authorise the Board’s chairman or a deputy chairman to decide claims that are considered to be beyond doubt.
(8) The Board’s chairman or the deputy chairman in question may decide that particular specialists or others may take part in the Board’s consideration of claims without the right to vote.
(9) Members of the Board shall be appointed for a term of four years.If an appointment is made during a four-year period, it shall only be valid until the end of that period.
(10) Following negotiations with the Board, the Minister of the Interior and Health shall decide its the rules of procedure.
(11) The operating costs of the Board shall be met by the insurance companies and self-insuring authorities according to the distribution of costs decided by the Minister of the Interior and Health according to section 32(2)(2).
§ 35. Decisions made in accordance with section 33 may be brought before the Patients’ Complaints Board of Appeal, which shall make the final administrative decision.The Patients’ Complaints Board of Appeal may grant an appeal a stay of execution.
(2) Appeals to the Patients’ Complaints Board of Appeal shall be submitted within three months of the complainant receiving notification of the decision.
(3) The Patients’ Complaints Board of Appeal may disregard failure to comply with the deadline for appeals in case of special grounds for doing so.
§ 36. Decisions by the Patients’ Complaints Board of Appeal may be brought before a court, which may uphold, annul or change a decision.
(2) The case must be brought within six months of the decision being communicated.
§ 37. The Patient Insurance Association may require district/city councils, regional councils and other relevant parties, including hospitals, institutions, attending physicians etc. and the injured person to disclose any information, including hospital records, casebook entries etc. that the Association considers to be of relevance to the consideration of claims pursuant to this Part.
(2) The Patient Insurance Association shall provide the Patients’ Complaints Board of Appeal and the Ministry of the Interior and Health with the information necessary for these authorities to perform their duties pursuant to this Part.
Part 4
Damages for Pharmaceutical Injuries
Scope
§ 38. Damages are paid pursuant to the rules of the present Part to patients who sustain physical injury as a result of properties in pharmaceuticals which are used in connection with examination, treatment or the like (pharmaceutical injury). The same shall apply to the dependants of such persons.
(2) Patients are persons who take part in clinical tests of pharmaceuticals (biomedical trials) which do not form part of the diagnostics or treatment of the person’s disease or disorder. The same applies to donors from whom tissue and other biological material are taken. Damages shall also be paid for mental injury to trial persons and donors covered by this provision.
(3) Pharmaceutical injury shall cover an injury caused by a pharmaceutical to a person who is nursing or treating the person for whom the pharmaceutical has been prescribed. Damages are only paid to the extent to which the injury is not covered by the Danish Act on Insurance against Consequences of Occupational Injuries.
(4) The Minister of the Interior and Health may lay down further rules on the injuries which are covered by the present Part in accordance with subsections 1-3.
§ 39. Damages are only paid if the pharmaceutical has been dispensed commercially in Denmark for consumption or clinical tests of pharmaceuticals (biomedical trials). The pharmaceutical must have been dispensed through a pharmacy, hospital, physician, dentist or a sales outlet authorised to sell non-pharmacy over-the-counter drugs in pursuance of the Danish Medicinal Products Act.
§ 40. Under the present Part, a pharmaceutical is an article which is intended for human administration in order to prevent, identify, alleviate, treat or cure a disease or disorder, disease symptoms and pain or to affect body functions.
(2) The pharmaceutical must have been approved for marketing in Denmark in accordance with existing rules. However, this shall not apply to pharmaceuticals which are used in clinical tests (biomedical trials), cf. § 38, section 2.
(3) Magistrally produced pharmaceuticals and pharmaceuticals which are imported for use for individual persons in accordance with prior permission from the Danish Pharmaceutical Agency are covered by the present Part.
(4) Naturophatic pharmaceuticals, homeopathic pharmaceuticals, vitamin and mineral preparations are not covered by the present Part. However, this shall not apply if these products are used in clinical tests (biomedical trials) in order to obtain a marketing licence as a pharmaceutical, cf. subsection 2, first sentence.
(5) The Minister of the Interior and Health may lay down further rules on the pharmaceuticals, etc. which are covered by the present Part in accordance with subsections 1-4.
§ 41. Damages are only paid for a pharmaceutical injury caused by a prescription pharmaceutical if the pharmaceutical has been prescribed for the injured person.
§ 42. A pharmaceutical injury shall not include any disease or disorder or other injury which
1) is due to the pharmaceutical not having had the intended effect on the patient in question or
2) is due to errors or negligence in connection with prescription or dispensing of the pharmaceutical to the patient.
§ 43. Damages are only paid for a pharmaceutical injury which has occurred as a result of adverse drug reactions if the nature or extent of the adverse drug reactions exceeds that which the injured person should reasonably accept. The provision comprises both known and unknown adverse drugs reactions as well as concretely foreseeable and unforeseeable adverse drug reactions.
(2) In connection with decisions made in pursuance of subsection 1, the following must be taken into special consideration:
1) the nature and degree of severity of the disease or disorder at which the treatment was aimed,
2) the injured person’s state of health,
3) the extent of the injury and
4) the general possibilities of taking the risk of the occurrence of the injury into consideration.
(3) The Minister of the Interior and Health may lay down further rules on the pharmaceutical injuries which are covered by the present Part in accordance with §§ 41-43.
§ 44. Damages are only paid if there is a preponderance of evidence that the injury has been caused by the use of pharmaceuticals.
§ 45. It shall be incumbent on every authorised healthcare professional who, in the course of his work, becomes aware of injuries that may be assumed to entitle the patient to compensation under the present Part to inform the injured person thereof and to help to the necessary extent with notification of the Patient Insurance Association.
Meting out Damages, etc.
§ 46. Damages and compensation will be fixed in accordance with the rules in the Danish Act on Liability for Damages, cf., however, the rules in the present Part.
(2) Damages, etc. are only paid if the amount fixed in pursuance of subsection 1 exceeds DKK 3,000.
(3) The Minister of the Interior and Health may lay down rules that compensation for loss of earnings and compensation for pain and suffering are only paid if the injury has resulted in incapacity for work or illness in excess of a fixed period, which may be maximum three months.
(4) Subsections 2 and 3 shall not apply to pharmaceutical injuries covered by § 38, sektion (2).
§ 47. Damages are not paid to cover any derived claims of recourse, cf. § 17 of the Danish Act on Liability for Damages.
§ 48. The damages for the patient or the patient’s dependants may be reduced or lapse completely, depending on the circumstances, if the patient has contributed to the injury intentionally or by gross negligence.
§ 49. A serial injury is pharmaceutical injuries sustained by several persons and caused by the same property in the same substance in one or more pharmaceuticals and
1) which are the result of adverse drug reactions which, at the time at which the pharmaceutical was dispensed, were not stated in the summary of the properties of the pharmaceutical approved by the Danish Pharmaceutical Agency or registered in the Catalogue of Pharmaceuticals and which cause an injury of such a nature that this should not have been foreseen by an expert in connection with the dispensing of the pharmaceutical or
2) which are due to a defect in the pharmaceutical as a result of instruction errors, defects in manufacture or distribution errors.
(2) A serial injury is allocated to the year in which the first claim for damages is made against the Minister of Health or the Patient Insurance Association, cf. § 55, irrespective of when the subsequent notices of claim are filed.
§ 50. The amount of damages for injuries in pursuance of the present Act shall be limited to DKK 150 million per calendar year.
(2) The amount of damages for each individual serial injury, cf. § 49, shall, however, be limited to DKK 100 million.
(3) The amount of damages for pharmaceutical injuries in connection with clinical tests of pharmaceuticals (biomedical trials) shall be limited to DKK 25 million per trial.
(4) The damages cannot exceed DKK 5 million per injured person.
§ 51. If the amounts stated in § 50 are insufficient to cover all the claims brought by the injured persons, a pro rata reduction of the individual claims will be made, however, only in amounts of damages which have not already been paid out. If, after the occurrence of an injury, it turns out that such a reduction may be necessary, it may be provided that, for the time being, damages are only to be paid for part of the recognised claims.
§ 52. To the extent to which the patient has or the patient’s dependants have become entitled to or is or are entitled to damages in pursuance of the present Act, a claim for damages cannot be brought against any party who may have incurred liability for damages for the injury.
(2) The rules in subsection 1 shall not apply in those cases in which there is liability for damages in accordance with the rules laid down in the Danish Product Liability Act.
§ 53. To the extent to which the State pays damages in pursuance of the present Act, the Minister of the Interior and Health
shall be subrogated to the patient’s claim against pharmaceutical producers and middlemen in pursuance of the Danish Product Liability Act.
(2) The State may pay expenses for a lawyer, legal proceedings, etc. for recovery of damages from pharmaceutical producers and middlemen in pursuance of the Danish Product Liability Act, cf. Subsection 1. Amounts of damages recovered in connection with this shall accrue to the State.
Financing of the Scheme for Damages
§ 54. Expenses for damages and other expenses for the scheme for damages will be paid by the State.
(2) The Minister of the Interor and Health will calculate and disburse damages. The Minister of the Interior and Health may authorise other parties, including private persons, to calculate and disburse damages, etc. in pursuance of the present provision.
Case Handling
§ 55. The Minister of the Interior and Health handles and makes decisions in cases pursuant to the present Part.
(2) The Minister of the Interior and Health may authorise the Patient Insurance Association, cf. Part 3, to handle and make decisions in cases in pursuance of Subsection 1. The expenses incurred by the Patient Insurance Association in this connection will be paid by the State, cf. § 54, section 1.
(3) In cases in which the Minister of the Interior and Health has authorised other parties than public authorities to handle tasks under the present Part, the Danish Public Administration Act shall apply correspondingly.
The Pharmaceutical Injury Complaints Board
§ 56. The Minister of the Interior and Health will set up a Pharmaceutical Injury Complaints Board consisting of
1) a Chairman appointed by the Minister of the Interior and Health – the Chairman must be a judge,
2) 2 members appointed by the Minister of the Interior and Health,
3) 1 member appointed by the National Board of Health,
4) 1 member appointed by the Danish Pharmaceutical Agency,
5) 2 members appointed by the regional councils in concert,
6) 1 member appointed by the Federation of Organisations for the Disabled – De Samvirkende Invalideorganisationer,
7) 1 member appointed by the Danish Consumer Council.
(2) The Minister of the Interior and Health may authorise the Chairman of the Board to make a decision in cases that are not found to involve matters of uncertainty.
(3) The members of the Pharmaceutical Injury Complaints Board are appointed for a term of four years. If the appointment is made during a term, it shall only apply until the expiry of the term.
(4) The Minister of the Interior and Health will lay down the Rules of Procedure for the Pharmaceutical Injury Complaints Board following negotiations with the Complaints Board. In these Rules of Procedure, the Minister may lay down rules on fees for the Chairman and members of the Complaints Board.
(5) Expenses for running the Pharmaceutical Injury Complaints Board will be paid by the State, cf. § 54, section 1.
§ 57. The decisions which are made pursuant to § 55, section 1 may be brought before the Pharmaceutical Injury Complaints Board, which makes the final administrative decision. The Pharmaceutical Injury Complaints Board may grant a stay of execution pending the outcome of a complaint.
(2) A complaint to the Pharmaceutical Injury Complaints Board must be submitted within three months of the complainant having been informed of the decision.
(3) The Pharmaceutical Injury Complaints Board may make an exemption from a failure to meet the above deadline if there are special grounds for this.
(4) The decision of the Pharmaceutical Injury Complaints Board may be brought before a court. Any such decision must be brought before the High Court within six months of notice of the decision having been received.
§ 58. The Minister of the Interior and Health or the party authorised by the Minister to handle tasks pursuant to the present Part may demand that municipal authorities, regional councils and other relevant bodies and persons, including hospitals, pharmacies, institutions, physicians in charge, et al. as well as the injured person and the relevant pharmaceutical company disclose all information, including hospital records and case notes, etc., which is found to be of importance to the handling of cases in accordance with this Part.
(2) The Minister of the Interior and Health or the party authorised by the Minister to handle tasks pursuant to the present Part shall provide the Pharmaceutical Injury Complaints Board with the information which is necessary for the Complaints Board to handle its tasks in accordance with this Part.
Part 5
Provisions on Limitation of Actions
§ 59. Claims for damages pursuant to Part 3 must be filed with the The Patient Insurance Association not later than three years after the person who is entitled to recover damages has acquired or should have acquired knowledge of the injury.
(2) Claims for damages shall, however, become barred by limitation not later than ten years after the day on which the injury was caused.
§ 60. Claims for damages pursuant to Part 4 must be filed with the Minister of the Interior and Health or the party authorised by the Minister to handle tasks pursuant to the present Act not later than three years after the person who is entitled to recover damages has acquired or should have acquired knowledge of the injury.
(2) Claims for damages pursuant to the present part shall, however, become barred by limitation not later than ten years after the day on which the pharmaceutical was dispensed to the injured person.