Pricing and reimbursement
The Finnish reimbursement system is a national system that forms a part of the Finnish national health insurance system. The insurance scheme covers all permanent residents of Finland. The reimbursements are made directly to the patient when the medicinal product is sold by the Social Insurance Institution of Finland. There are three types of reimbursement: basic, lower special reimbursement and higher special reimbursement. The special reimbursement categories are set according to the severity of the treated condition and the necessity of the drug treatment, and they are specified by a government regulation. Some medicinal products may also have a restricted eligibility for reimbursement.
According to the Health Insurance Act (1224/2004, as amended), the costs of a medicinal product may be reimbursed only if the valid MA holder has applied for reimbursement and a reasonable wholesale price has been set. The Pharmaceutical Pricing Board, which operates under the Ministry of Social Affairs and Health, confirms the reimbursement status and the reasonable wholesale price. The medicinal product's therapeutic value is taken into consideration in the decision on basic reimbursement status and the assessment is made by overall consideration. If reimbursement status is not sought and no reasonable wholesale price has been confirmed, the pricing may be implemented without any restrictions. Non-prescription medicines can also be reimbursed, provided that the doctor has prescribed the medicine to the patient and the board has confirmed a reasonable wholesale price and the reimbursement for the medicine. The reimbursement status can also be granted on a conditional basis if the pharmaceutical company and the board so agree. The relevant conditions may include an agreement on further evidence provided by the company or on financial credits payable to the Social Insurance Institution of Finland (KELA).
Under the reference price system that applies in Finland, medicinal products are divided into reference groups by substance. Reference prices are determined based on MA holders' price notifications, and prices are updated four times a year. This determined reference price is the highest possible price based on which the reimbursement can be calculated. The price notification is the prerequisite for reimbursement of the products in this system. A generic substitution policy is applicable, whereby if a patient prefers the more expensive medicine prescribed by a doctor, the excess costs are paid by the patient. The patient must also be informed about the lowest-priced prescription medicine at the time when the medicine is collected by him or her from the pharmacy.
As the pricing of medical devices is not regulated in Finland, the pricing is basically free, taking into account, however, general competition law pricing principles. Generally speaking, medical devices are not reimbursed in Finland, except in some very limited cases; for example, when a person has a disability or illness that restricts him or her from undertaking work or study-related tasks. In these limited cases, the costs incurred by the purchase of such assistive devices may be reimbursed.