Legislation: reimbursement of medicines

Updated 09 January 2012

The Danish Health Act: reimbursment of medicines

Please find below a translation of Title X of the Danish Health Act.

Title X regulates the reimbursement of medicinal products and the personal electronic medicine profiles. The Act is available in its full length in the box to the right (in Danish).

Only the Danish version has legal validity.


Title X

Reimbursement of medicinal products

Part 42

Reimbursement right

143.–(1) The Regional Council reimburses medicinal products which have been granted reimbursement by the Danish Medicines Agency according to the provisions laid down in Title X.

(2) Reimbursement of medicinal products is granted to persons entitled to such grant under this Act.

General reimbursement

144.–(1) Reimbursement is granted for prescription-only medicinal products which have been approved for general reimbursement by the Danish Medicines Agency.
(2) Reimbursement of prescription-only medicinal products of subsection (1) may be conditional upon the medicinal product being prescribed for the treatment of specific diseases or patient groups (general conditional reimbursement).
(3) Reimbursement of over-the-counter medicinal products is subject to the medicinal product being prescribed for the treatment of specific diseases or patient groups determined by the Danish Medicines Agency (general conditional reimbursement) or to persons receiving pension benefits under the Danish Social Pension Act or the Danish Highest, Intermediate, Increased Ordinary and Ordinary Early Retirement, etc. Act.
(4) The provision of subsection (1) does not cover general reimbursement for vaccines intended for disease prevention in healthy persons.

Single reimbursement

145.–(1) In special circumstances, the Danish Medicines Agency may grant reimbursement for the purchase of a medicinal product prescribed on prescription to a specific patient (single reimbursement) notwithstanding that the medicinal product has not been granted general reimbursement under section 144.
(2) The provision of subsection (1) does not cover single reimbursement for vaccines intended for disease prevention in healthy persons.

The size of reimbursement

146.–(1) The size of reimbursement depends on the total expenses stated at reimbursement prices, cf. section 150, for medicinal products reimbursable under sections 144, 145 and 158A which the person has purchased over a period of one year calculated from the first day of purchase. A new period begins the first time the patient purchases medicinal products reimbursable under sections 144, 145 or 158A after the close of the preceding period.
(2) If the total expenses incurred in a one-year period do not exceed DKK 800, reimbursement is not granted to persons over the age 18. If the total expenses incurred in a one-year period exceed DKK 800, reimbursement is granted to persons over the age of 18 according to the rates below:
(i) 50 percent of the share exceeding DKK 800, but not exceeding DKK 1,300,
(ii) 75 percent of the share exceeding DKK 1,300 but not exceeding DKK 2,800, and
(iii) 85 percent of the share exceeding DKK 2,800.
(3) If the total expenses incurred in a one-year period do not exceed DKK 1,300, the size of reimbursement granted to persons under the age of 18 is 60 percent. If the total expenses incurred in a one-year period exceed DKK 1,300, reimbursement is granted to persons under the age of 18 according to the rates below:
(i) 75 percent of the share exceeding DKK 1,300 but not exceeding DKK 2,800, and
(ii) 85 percent of the share exceeding DKK 2,800.
(4) If a person turns 18 after the commencement of a one-year period, reimbursement is calculated according to subsection (3) until the close of that period.

146A. Repealed.

Reimbursement for the chronically ill and terminally ill

147. The Danish Medicines Agency may decide that for persons with an extensive, permanent and professionally documented need for medicinal products, the purchase of medicinal products reimbursable under sections 144, 145 and 158A be reimbursed at the rate of 100 percent calculated on the share of the patient's total co-payment stated at reimbursement prices which exceeds DKK 3,270 per year (reimbursement for the chronically ill).
(2) Repealed.

148. The Danish Medicines Agency grants reimbursement of 100 percent for medicinal products prescribed by a physician to terminally ill persons when a physician's prognosis is a short life expectancy and hospital treatment with a view to curing the patient is futile. Reimbursement is granted at the medicinal product's consumer price published by the Danish Medicines Agency in pursuance of section 81 of the Danish Medicines Act regardless of whether this price may exceed the reimbursement price under section 150 (reimbursement for the terminally ill).

Adjustment of reimbursement

149.– (1) In the event that a patient has been granted reimbursement in excess of the entitlement according to the rules set out in 146(2) and (3) and sections 147 and 148, an adjustment shall be made in connection with the patient's first coming purchase of medicinal products reimbursable under sections 144, 145 and 158A. However, in exceptional circumstances, this adjustment may be postponed to the subsequent purchase of reimbursable medicinal products. In the event that a patient has been granted reimbursement which is lower than the entitlement according to the rules set out in 146(2) and (3) and sections 147 and 148, an adjustment shall be made in connection with the patient's first coming purchase of reimbursable medicinal products.
(2) In the event of the death of the patient, the Regional Council's claim for adjustment is extinguished, while any claims against the Regional Council shall be raised within one year from the death of the patient. Information about the purchase of medicinal products, including information about outstanding amounts, etc., is deleted from the Central Reimbursement Register of the Danish Medicines Agency, cf. section 156, one year after the death of the patient.

Adjustment of reimbursement thresholds

149A.– (1) The amounts referred to in section 146(2) and (3), and section 147 are adjusted every year on 1 January by the rate adjustment percentage, cf. the Act on a Rate Adjustment Percentage.
(2) The reimbursement thresholds are rounded down to the nearest amount in DKK divisible by five.

Calculation of reimbursement

150.–(1) Reimbursement is calculated using the reimbursement price. The reimbursement price is the medicinal product's consumer price published by the Danish Medicines Agency in pursuance of section 81 of the Danish Medicines Act, cf. however, subsection (3).
(2) The Danish Medicines Agency may group medicinal products that are used to treat the same indication and which have a comparable effect of treatment into reimbursement groups with a view to setting the same reimbursement price for the medicinal products in question.
(3) The reimbursement price for medicinal products included in a reimbursement group, cf. subsection (2), is equal to the lowest consumer price of that reimbursement group. The Danish Medicines Agency may lay down rules that a reimbursement price shall apply until the close of a price period even though a cheaper medicinal product may become available on the market within that price period.
(4) In cases where only a part of a package with medicinal products is dispensed to patients (dose dispensing), a reimbursement price is calculated per medicinal product unit (unit reimbursement price) on the basis of the reimbursement price determined in pursuance of subsection (1). The Danish Medicines Agency may lay down detailed rules for the reimbursement of medicinal products dispensed in doses, including the calculation of unit reimbursement price.

Increased reimbursement

151. In exceptional cases, the Danish Medicines Agency may decide that the size of reimbursement for a medicinal product prescribed to a certain person shall be calculated using the consumer price published by the Danish Medicines Agency in pursuance of section 81 of the Danish Medicines Act even though this price may exceed the reimbursement price of section 150 (increased reimbursement). The Danish Medicines Agency shall make its decision within 14 days from receipt of an application for increased reimbursement from the treating physician. In special circumstances, the Danish Medicines Agency may extend the time limit to 60 days for the purpose of presenting the case to the Reimbursement Committee, cf. section 155, before making its decision.

Administration and reassessment

152.–(1) The Danish Medicines Agency's decision on general reimbursement under section 144 (1) for a prescription-only medicinal product is made upon application from the company placing the medicinal product on the Danish market, cf. however, subsection (2). In considering an application for general reimbursement, the Danish Medicines Agency may decide that reimbursement is conditional upon the medicinal product being prescribed for the treatment of specific diseases or patient groups. The company cannot apply for general conditional reimbursement.
(2) There is no requirement to submit an application for general reimbursement for medicinal products generic to medicinal products for which the Danish Medicines Agency has already granted reimbursement.
(3) A decision on general conditional reimbursement by the Danish Medicines Agency for over-the-counter medicinal products under section 144 (3) is made without application from the company placing the medicinal product on the Danish market.
(4) In addition, the Danish Medicines Agency may in special circumstances grant reimbursement for a medicinal product without application from the company placing the medicinal product on the Danish market.

153.–(1) The Danish Medicines Agency's decision on reimbursement pursuant to sections 144, 147, 148 and 151 is made upon application from the treating physician. A decision on reimbursement pursuant to section 145 may furthermore be made upon application from a treating dentist.
(2) The physician or dentist having submitted the application is a party in the application cases listed in subsection (1).
(3) The patient is not a party in the application cases listed in subsection (1).
(4) Notwithstanding subsection (3), the patient has right of access to cases involving his own applications for reimbursement according to the principles of Part 4 of the Danish Public Administration Act.
(5) The decisions by the Danish Medicines Agency under sections 145, 147, 148 and 151 cannot be brought before another administrative authority.

154.– (1) The Minister for the Interior and Health specifies rules for the granting of reimbursement and for the withdrawal of reimbursement granted, including rules governing what information shall be included in an application for reimbursement of a medicinal product covered by the provisions of Title X.
(2) The Minister for the Interior and Health may decide that detailed rules are to be laid down for the reassessment of reimbursement granted under section 144.
(3) The Danish Medicines Agency publishes its decisions on general reimbursement, including general conditional reimbursement, at the website of the Danish Medicines Agency.

Reimbursement Committee

155.– (1) The Minister for the Interior and Health sets up a Reimbursement Committee which advises the Danish Medicines Agency in cases involving reimbursement of medicinal products.
(2) The Reimbursement Committee shall consist of maximum seven members of whom one shall be appointed by the Minister for the Interior and Health upon nomination by the negotiation committee mentioned in section 227. The other members, of whom two shall be general practitioners, shall be appointed by the Minister for the Interior and Health upon nomination by the Danish Medicines Agency. Members are appointed for terms of four years. The Minister appoints a chairman from among the members of the committee.
(3) The Minister for the Interior and Health may lay down rules of procedure for the Reimbursement Committee. The members of the Reimbursement Committee may not have a financial interest in any company that manufactures, imports or markets medicinal products.

The Danish Medicines Agency's Central Reimbursement Register (CTR)

156.–(1) The Danish Medicines Agency keeps an electronic register of the information necessary to calculate reimbursement according to sections 143-151 and 158A (the Central Reimbursement Register of the Danish Medicines Agency).
(2) The register may, apart from the information mentioned in subsection (1), contain information necessary to administrate a special agency or pharmacy-operated payment system for medicinal product purchases and information used by the pharmacies to administrate reimbursement of medicinal products under the Danish social legislation.
(3) The Minister for the Interior and Health specifies the rules applicable to the operation of the register, e.g. governing
(i) what information may be registered in the register,
(ii) the reporting of information about reimbursement of medicinal products pursuant to the Danish social legislation,
(iii) the municipalities' obligation to report information to the register electronically,
(iv) the obligation to delete registered information,
(v) pharmacists', physicians' and other persons' access to information in the register,
(vi) pharmacists' obligation to connect to the register and use the information in the register for the calculation of reimbursement, and
(vii) pharmacists' obligation to report information to the register electronically.

The Danish Medicines Agency's electronic recording of citizens' medical information

157.–(1) The Danish Medicines Agency is responsible for running an electronic register of the individual citizen's medical information, including prescriptions, purchases, dispensing, consumption, dose adjustments, discontinuation and the instructions on how to use the medicinal products given by healthcare professionals as well as information related to the individual citizen's medical information.
(2) A physician who is currently treating a patient may access the information available on the patient in the register when this is necessary for the treatment. General practitioners can also use the register to find own patients who are being treated inappropriately with medicinal products. Specialist practitioners can also use the register to find patients for whom he or she has prescribed one or more medicinal products and who are being treated inappropriately with medicinal products.
(3) A dentist, midwife, nurse, health visitor, social and healthcare worker or nursing home assistant who is currently treating a patient may access registered patient information when this is necessary for the treatment.
(4) A hospital pharmacist or pharmaconomist who upon appointment by the hospital management for reasons of patient and medicine safety reviews the patient's medicines or carries out medicines reconciliation, may access registered patient information when this is necessary for him/her to treat the patient.
(5) The Minister for the Interior and Health may lay down rules permitting other persons, who as part of their professional activities dispense medicinal products to a patient or handle medical information, access to the information registered about the patient when this is necessary for them to treat the patient.
(6) Pharmacists and pharmacy staff may access information registered on a medicine user provided that he or she has given his or her oral or written consent. Pharmacists and pharmacy staff may access information registered about prescribed medicine when such access is necessary to process the prescription.
(7) The Minister for the Interior and Health may lay down rules stipulating that the Danish National Board of Health may access registered patient information when this is necessary for the supervision of physicians' and dentists' prescription of specific medicinal products, including habit-forming medicinal products and antipsychotics.
(8) The Danish Medicines Agency may access information in the register when this is required to operate the system or follows from the Danish Medicines Agency's obligation as data controller, and when this is necessary for the Agency's review of adverse reaction reports. Furthermore, the Danish Medicines Agency has access to retrieving statistical information about medicine consumption from the registered information, to the extent that such information is not available in the Danish Medicines Agency's Register of Medicinal Product Statistics.
(9) The persons who, as provided by subsections (2)-(4) and (6) and rules laid down pursuant to subsection (5) have access electronic medical information, may only use the information to enhance the quality, safety and efficacy of the medicine users' medicine use, unless a medicine user has given his oral or written consent to use the information for other purposes.
(10) The Minister for the Interior and Health lays down detailed rules for the operation of the register, including specific rules governing
(i) what information may be registered in the register,
(ii) the obligation to delete and change registered information,
(iii) the registered person's direct electronic access to the electronic medical information registered about himself in the register, and the systematic registration (logging) of all use of the information registered,
(iv) access to making electronic queries and entries in the electronic registration of medical information for physicians, dentists, midwifes, nurses, health visitors, social and healthcare workers, nursing home assistants, hospital pharmacists and pharmaconomists who pursuant to subsection (4) have access to the registered information, proprietary pharmacists, pharmacy staff, the National Board of Health and other persons who pursuant to rules laid down in subsection (5) have access to the registered information.
(v) the Danish Medicines Agency's access to making electronic queries and entries in the register and disseminating information from the register to pharmacy systems, the electronic health records of the municipalities, electronic patient records at hospitals and medical practices, other filing systems containing patient records and the Danish Vaccination Register, and
(vi) the access and obligation of the persons mentioned in subsections (2)-(6) to report information to the register electronically, update information originating from the register and to correct incorrect information, including technical requirements and requirements to the format of such reports, updates and corrections.