Concepts related to quarterly notifications submitted by pharmaceutical companies
A product containing a certain active substance or combination of substances which is the first to enter the market. Generic products containing the same active substance or combination of substances cannot enter the market until the patent for the original reference medicine has expired.
A central agency under the Ministry of Social Affairs and Health acting as the Finnish licensing and supervisory authority for the pharmaceutical industry (e.g. sales licenses). Fimea updates a list of substitutable medicinal products (fimea.fi).
Authority functioning in connection with the Ministry of Social Affairs and Health which confirms reimbursability and maximum wholesale prices for medicinal products. It also defines the reference prices of the medicinal products included in the reference price system 4 times a year (hila.fi).
Medicinal product for which a quarterly notification must be submitted to Kela. The price notification procedure applies to medicinal products included in generic substitution and in the reference price system as well as products undergoing a so-called transition period. See the lists published by Hila to find out which products are subject to the price notification procedure (hila.fi) (in Finnish).
Price range of EUR 0.50 determined by Kela where the pharmacies must substitute products that exceed the price range. The price range is calculated on the basis of the price of the cheapest product in the group of substitutable packages. If the cheapest price is e.g. EUR 2.00, the price band is EUR 2.00–2.50. Price bands are defined 4 times a year based on the prices notified by pharmaceutical companies to Kela. See also Upper limit of the price band and Reference price.
Price limit determined by Kela at which the pharmacy must substitute products whose price exceeds the limit for cheaper substitutable products. The upper limit is calculated by adding EUR 0.50 to the price of the cheapest product within the group of substitutable packages. If the cheapest price is e.g. EUR 2.00, the upper limit of the price band is EUR 2.50. See also Reference price.
An online search portal containing up-to-date information about the prices of medicines, about their reimbursement status, and about substitutable products. The service is based on data from the Pharmaceutical Database. Go to the Medicinal Products Database.
A Kanta service that contains up-to-date data on medicinal products available on the market in Finland. Medicines are prescribed and dispensed on the basis of the product information in the Pharmaceutical Database. Pharmaca Health Intelligence Oy provides technical maintenance for the Pharmaceutical Database.
Substitution of a medicine for a less expensive one at the pharmacy. The aim of generic substitution is to increase the use of less expensive medicines and reduce the medicine expenses for the customers and for society at large. The system for generic substitution was introduced in Finland in 2003.
Medicinal product for which there are equivalent substitutable products. See also substitutable products.
A portal maintained by Kela which pharmaceutical companies can use to submit quarterly notifications. Log in to the service with Suomi.fi e-identification. The service can only be used by pharmaceutical companies that have a Finnish business ID (Y-tunnus). The service is only available in Finnish and Swedish.
Price notification for products subject to the price notification procedure in generic substitution and the reference price system. The price notifications are submitted to Kela, and Kela forwards them to the Pharmaceuticals Pricing Board (HILA). On the basis of the prices notified, Kela determines the price bands and HILA determines the reference prices.
An original reference medicine which a parallel distribution company repackages and imports to Finland. Before the product is put on sale, the company must submit a parallel distribution notification for the product with the European Medicines Agency.
An original reference medicine that a parallel import company buys from another EU or EEA country, repackages and imports to Finland. Before the product is put on sale, the company must apply for a sales license with Fimea.
A medicinal product that has entered the market after the patent of the original reference medicine expired. The product contains the same amount of the same active substance as the original reference medicine, but may differ e.g. as regards the excipients in the product.
See Generally available.
Information reported by the pharmaceutical company in the quarterly notification. If the company states Yes, the reimbursability of the product will end starting from the beginning of the quarter. This information can only be reported for products included in the reference price system.
A product that has previously been included in the reference price system. Products undergoing a transition period are subject to the price notification procedure, which means that a quarterly notification for the product must be submitted to Kela. Read more about the termination of a reference price group and the transition period (hila.fi).
A group of substitutable medicinal products as defined by Fimea. Medicines that are included in the same group contain the same amount of the same active substance. All packages of different sizes are included in the same group. See Fimea’s list of substitutable medicinal products to check the substitution group of individual medicinal products (fimea.fi).
10-digit code identifying the group of substitutable packages. The medicines included in the same group contain the same amount of the same active substance and their package size is the same, e.g. 20 tablets. The same code is used both in generic substitution and in the reference price system.
Price band determined by Kela if none of the products in the group of substitutable packages is available throughout the quarter. In that way it is possible to make sure that the pharmacy can substitute the medicines during the time they are available.
Medicinal products that contain the same amount of the same active substance and that are biologically equivalent. Fimea updates a list of substitutable medicinal products (fimea.fi).
Another organisation authorised by a pharmaceutical company to submit quarterly notifications to Kela on its behalf.
Highest price determined for a medicine for which the customer can receive reimbursement. The Pharmaceuticals Pricing Board (Hila) defines the reference prices 4 times a year based on the prices notified by pharmaceutical companies (hila.fi). The reference price is calculated on the basis of the cheapest price for the reimbursable substitutable packages by adding EUR 0.50 to this price. If the cheapest price is e.g. EUR 2.00, the reference price is EUR 2.50. See also Upper limit of the price band and Reference price group.
System established with the aim of curtailing the growth in medicine reimbursement expenditure and promoting the use of less expensive substitutable products. The reference price system concerns reimbursable medicines to which generic substitution applies. The reference price system was introduced in Finland in 2009. Read more about the reference price system (hila.fi).
A group of substitutable medicines which includes at least two reimbursable products, at least one of which is a generic, parallel import, parallel distribution or biosimilar product. The Pharmaceuticals Pricing Board (Hila) confirms the reference price groups 4 times a year (hila.fi).
Information reported by the pharmaceutical company in the quarterly notification in addition to the wholesale price. If the company states Yes, the product must be available at the wholesalers at the time of notification and throughout the following quarter. When determining the price bands and the reference prices, only the products that are generally available are taken into account.