The regulatory regime
The legislation of medicines and medical devices in Finland is harmonised with EU legislation. The national applicable legislation for medicines includes the Medicines Act (395/1987) and the Medicines Decree (693/1987). Additionally, the national codification is supplemented by the regulations and guidance issued by Fimea. Pharma Industry Finland (PIF), an organisation of the innovative pharmaceutical industry, has also issued a Code of Ethics (PIF Code) containing very detailed provisions regarding marketing of medicines, which are binding for members of PIF. The PIF Code is based on medicine, competition and consumer legislation and on the marketing guidelines of the equivalent European and international federations, the European Federation of Pharmaceutical Industries and Associations, and the International Federation of Pharmaceutical Manufacturers and Associations.
The Finnish Medical Devices Act (629/2010) and orders issued by Valvira govern medical devices and the marketing of such devices. Regulations EU/2017/745 and EU/2017/746 govern or will govern the medical devices sector after the transitional periods. This chapter reflects the applicable legislation as at the beginning of 2018. Sailab – MedTech Finland, a registered association of health technology suppliers, has issued its own code of ethics, which is based on the MedTech Europe Code of Business and governs, inter alia, the marketing of medical devices. This code entered into force on 1 January 2018, but it contains a transitional period which will end on 1 January 2019.
Generally, the marketing of medicines and medical devices to consumers is also regulated by the Finnish Consumer Protection Act (38/1978) and Regulation on Unfair Practices in Marketing and Customer Relations (601/2008).i Classification
According to the Medicines Act, a medicinal product means a product or substance intended for internal or external use to cure, alleviate or prevent a disease or its symptoms in human beings or animals. Medicinal products are also considered to include substances or combinations of substances, used internally or externally, that can be used to restore, correct or modify the vital functions of human beings or animals through pharmacological, immunological or metabolic influence, or to determine the state of health or the reason for a disease. In ambiguous cases, the provisions of the Medicines Act are primarily applied if no special grounds for other interpretations exist. Such borderline cases have concerned mainly dietary supplements, cosmetic products and medical devices. The definition of medicinal products is rather broad in Finland and may include products that would not be considered medicinal products in some other EU Member States.
The Medical Device Act defines a medical device as any instrument, apparatus, appliance, software, material or other article intended by the manufacturer to be used for human beings for the purpose of, inter alia, diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap. Medical device also means any product intended for the purpose of investigation, replacement or modification of the anatomy or of a physiological process or control of conception. The Medical Device Act states that when assessing the distinction between the Medicines Act and Medical Device Act, the primary action of the product in question must be considered. The final assessment is concluded by Fimea, which adheres to a large extent to the European Commission's guidance. Finally, the distinction between a medical device and a cosmetic product is defined by the intended purpose of the product itself.ii Non-clinical studies
The Medical Research Act (488/1999) and the Medicines Act together regulate pre-clinical safety tests of medicines, which are subject to an approval granted by Fimea. Fimea's approval may include restrictions or supplementary conditions for laboratories. The tests are also supervised by Fimea.
The Act on the Protection of Animals Used for Scientific or Educational Purposes (497/2013) is applied to the use and breeding of animals for scientific or educational purposes and for the supply of their organs or tissues for scientific or educational purposes. The purpose of the Act is to ensure that animals are kept and used for the above-mentioned purposes only for necessary and important reasons. Additionally, the Animal Welfare Act (247/1996) must be complied with. The Gene Technology Act (377/1995) may also be applicable if gene technology is used. Good laboratory practice must be complied with in all non-clinical studies intended to be submitted to a national registration authority for the purpose of registering or licensing substances such as chemicals, medicinal products or cosmetic products.
Non-clinical studies are not compulsory before placing a medical device on the market.iii Clinical trials
The definition of a clinical trial includes intervention research conducted in human beings to investigate the effects of a medicinal product on human beings and the absorption, distribution, biotransformation or excretion of the product in the human body. Clinical trials are regulated by the Medical Research Act, implementing Directive 2000/20/EC, and by the Medicines Act; further regulations or guidelines may be issued by Fimea, Valvira and the National Committee on Medical Research Ethics. Fimea has issued a regulation regarding clinical trials.
All clinical trials must be planned, conducted and reported on, observing the principles of good clinical research practice set forth in Directive 2005/28/EC. Fimea must be notified of every interventional clinical drug trial on medicinal products regardless of whether the product has an MA prior to proceeding. A notification is not required, however, if the trial is non-interventional. In uncertain cases, Fimea decides whether a notification is required.
A party commissioning a clinical trial of a medicinal product (the sponsor) is obliged to have an insurance policy or other appropriate guarantee to cover the liability of the commissioning party and the researcher. However, the sponsor is not required to have an established place of residence in Finland. Commencement of the research is subject to a favourable opinion of the ethics committee and a licence granted by Fimea, if required. There are no particular insurance requirements for a sponsor of research of medical devices under Finnish local legislation.iv Named-patient and compassionate use procedures
For special reasons relating to treatment or public health, Fimea may grant a temporary authorisation (special authorisation) for releasing a medicinal product, according to Section 21(f) of the Medicines Act, implementing the Medicines Directive's Article 5(1).
Special authorisation must be granted if no other means are available to treat an individual patient or animal or group of animals, or if an available treatment would not yield the desired result. Additionally, special authorisation may be granted when a medicinal product with marketing authorisation is not available to treat a group of patients or the population or to prevent an illness, and there are particularly weighty reasons for granting the authorisation. Special authorisation is subject to any statement issued by the European Medicines Agency's Committee for Medicinal Products for Human Use.
When special authorisation is granted, the supplier is obliged to ensure that the user of the product receives sufficient instructions on the correct and safe use of the product, and storage and other instructions.
The Medical Devices Act does not include any equivalent provisions regarding named-patient and compassionate use procedures.v Pre-market clearance
A medicinal product may be sold to the public or otherwise released for consumption only after it has been granted an MA, either nationally by Fimea or by the European Medicines Agency. An MA is valid for five years from being granted and it may be renewed. After the MA is granted, the MA holder must file a notification with Fimea upon the launch of the product. The MA holder also has an obligation to ensure that medicinal products that have been granted an MA are constantly available to medicinal product wholesalers and pharmacies to meet the needs of patients and other users.
Any medical device placed on the Finnish market must comply with the essential requirements of law; these requirements can also be defined more precisely by Valvira. Overall, the device must be fit for its intended purpose, achieve the intended functionality and performance when used for its intended purpose, and must not endanger the health or safety of the patient, user or other person. The device must also bear the CE marking that indicates conformity with the set requirements.
If a medical device has the potential to cause severe risk to health, the manufacturer or an authorised agent with a registered office in Finland must file a notification with Valvira before the device is placed on the Finnish market or at most within one week after the sale of the device has begun. Valvira must also be informed of all adverse incidents relating to medical devices as soon as possible. Valvira has issued several regulations regarding medical devices concerning, for example, conformity assessment and the CE marking.vi Regulatory incentives
Finland grants supplementary protection certificates under Council Regulation 1768/92/EEC and the Patent Act (550/1967, as amended) for the first patent covering a new medicinal substance. The relation between patents and the MA process is clear in Finland, since patents do not have relevance in the MA application process. The Bolar exemption of Directive 2004/27/EC has been implemented in the Finnish Patent Act to cover research activities required for the MA application. Patent exclusivity does not, therefore, cover research activities required for applying for an MA. Finland also grants the data exclusivity protection for medicinal products, and recognises the paediatric investigation plan exemption for paediatric products of Regulations 1901/2006/EC and 1902/2006/EC. If a medicinal product has been accepted for children, the data exclusivity is extended for six months as a main rule. Finland has no specific national legislation concerning orphan medicine products, but Regulation 141/2000/EC is applied, as is the data exclusivity extension of two years under Regulation 1901/2006/EC for orphan medicine products.vii Post-approval controls
Finnish national legislation has been updated to conform to the Pharmacovigilance Directive 2010/84/EC, and Fimea has issued instructions and guidelines for the national implementation of the Directive. The MA holder is obliged to monitor the safety of medicinal products and to take appropriate measures if changes are identified in the benefit-risk analysis commenced by the MA holder. The MA holder is also obliged to keep a record of possible adverse effects and side effects. According to the Medicines Act, the MA holder must report all serious adverse reactions originating in Finland to Fimea. Fimea's task is to supervise all product defect procedures and to ensure that measures taken by the operators are appropriate.viii Manufacturing controls
The industrial manufacturing of medicinal products requires a licence granted by Fimea, which may have conditions attached. Medicinal products may only be manufactured industrially by medicinal product manufacturers that have acceptable production facilities and equipment for production. A medicinal product manufacturer may have a medicinal product manufactured or controlled in part or entirely by another medicinal product manufacturer if it is required for technical, economic or production-related reasons, provided that the contract manufacturer has a industrial manufacturing licence granted by Fimea. Fimea may issue regulations concerning the procedures to be observed. Detailed requirements for an application are stated in the Medicines Decree.
A manufacturer must also comply with the EU Good Manufacturing Practice Guidelines. Only those active substances that have been manufactured in accordance with these guidelines may be used in the manufacture of medicinal products. Medicinal product manufacturers must also have an accountable director, who is primarily responsible for ensuring that manufactured products meet the requirements set for them in the Medicines Act. Additionally, at least one person involved in the manufacturing has to meet the qualification requirements set forth in Directives 2001/82/CE, 2001/20/EC and 2001/82/EC.
Unlike the manufacturing of medicinal products, the manufacturing of medical devices is not regulated in such a detailed manner, and thus, no licence or approval for manufacturing is required. Manufactured medical products must, however, meet the essential requirements set forth in the Medical Devices Act, namely, the manufactured product must be safe and suitable for its intended purpose.ix Advertising and promotion
The marketing of medicinal products is regulated under the Medicines Act and Medicines Decree and the concept of marketing is interpreted expansively. Generally, advertising of medicinal products must encourage people to use the products appropriately and it must not induce people to use products unnecessarily. The marketing information provided has to be accurate; it may not include any obsolete information or omit any essential details. Fimea is the supervising authority for marketing and advertising.
Additionally, general consumer protection legislation is applied when medicinal products are marketed directly to the general public. However, the marketing of prescription-only medicines must be targeted only at persons entitled to prescribe or dispense the medicine. Voluntary control of pharmaceutical marketing and self-regulation has traditionally been one of the key forms of activity in Finland. Pharmaceutical marketing is, therefore, also covered under the PIF Code and it is controlled by the Supervisory Commission for the Marketing of Medicinal Products, which operates under the PIF. The PIF Code is binding only on members of the PIF, but it may provide evidence of established practices and acceptable conduct.
The marketing rules for medical devices are largely the same as general Finnish marketing legislation, orders and principles, such as the Finnish Consumer Protection Act and the Regulation on unfair practices in marketing and customer relations. The marketing of medical devices is therefore generally allowed, but all marketing activities must be objective and give a truthful and reliable description of the product. The Act on Medical Devices contains a specific provision on marketing. Marketing of medical devices may not be inappropriate and it may not give an exaggerated or erroneous impression of the device, its effect or use. The marketing of medical devices includes all possible direct or indirect actions that have the purpose of promoting the product and influencing the product's sales. Marketing of medical devices is supervised by Valvira and the Consumer Ombudsman.
Sailab – MedTech Finland ry accepted a new Code of Ethics on 14 December 2017, which entered into force on 1 January 2018. The Code is based on the based on the MedTech Europe Code of Business Practice. This Code will be binding on members of Sailab – MedTech Finland ry from 1 January 2019, and sanctions will be applicable to members not complying with the Code.x Distributors and wholesalers
The wholesale of medicinal products, meaning all activities aimed at receiving and forwarding orders for medicinal products, to acquire and keep medicinal products in order to distribute them and to export medicinal products, is subject to a licence. The licence is granted by Fimea, which may incorporate certain conditions concerning the operations in a licence. In order to be eligible for a licence, the applicant must be situated in Finland and have proper facilities and equipment for the storage of medicinal products and for ensuring the operations and the personnel required for the operations.
The applicant must also have an accountable director, who is responsible for ensuring that the medicinal products sold by the wholesaler meet the requirements set for them in the Medicines Act or in provisions issued pursuant to it. The accountable director is also responsible for ensuring that the wholesaler complies with regulations and guidelines issued on the storage, handling and labelling of medicinal products. The accountable director must have a master of pharmacy degree and he or she cannot act simultaneously as an accountable director in any other licensed medicinal product wholesale company.
Medicinal products may be sold or otherwise supplied by the wholesaler to a medicinal product manufacturer, another medicinal product wholesaler, a pharmacy, subsidiary pharmacy, the Military Pharmacy, a hospital pharmacy or dispensary, or to a veterinary surgeon for purposes of veterinary medication. In addition, medicinal products that have not had sales restricted by law or other provisions may be sold or otherwise supplied to retailers of these products. Good medicinal product distribution practice based on the EU provisions must be complied with in all medicinal product wholesaling. Fimea has also issued a regulation regarding good distribution practices.
The Medical Device Act does not regulate how the distribution of medical devices takes place. Therefore, medical devices can be distributed by different operators, such as pharmacies or other distributors, and the distribution or wholesale of such products is not subject to any licence.xi Classification of products
In connection with granting an MA for a medicinal product, Fimea decides whether the medicinal product may be sold or otherwise released for consumption only on the basis of a prescription. Fimea may also alter its decision on the basis of new information received about the medicinal product that affects its supply classification.
The classification affects the marketing of medicinal products, since products subject to medical prescription can be marketed solely to individuals authorised to prescribe or dispense medicines. The Medicines Decree defines detailed requirements for such marketing, and the marketing activities may only take place at medical sales representations organised exclusively for such an audience, in expert field publications or via electronic media targeted and directed solely at such an audience.
Medical devices are classified according to Directives 93/42/EEC and 98/79/EC. The Directives determine the procedures to be used in verifying that products comply with all applicable requirements.xii Imports and exports
The import and export of medicines is permitted only under a valid MA. Additionally, if medicinal products are imported to Finland from outside the EEA, a licence for the industrial manufacture of medicines is required (see Section II.viii on manufacturing controls). A national wholesale licence is mandatory for import and export from inside the EEA.
In general, provisions applicable to the distribution and wholesale of medical devices also apply to the import and export of such products (i.e., imported and exported products must meet the essential requirements and bear the CE mark and then they may be freely imported within the EEA area). The marketing of medical devices in Finland and placing them on the local market is not subject to any sales permit or licence, unlike for medicines, but the manufacturer is responsible for the product's compliance with all essential requirements. No permit procedures are applied, and the manufacturer indicates compliance with all necessary requirements by a mandatory CE mark.xiii Controlled substances
In general, the production, manufacture, import to the territory of Finland, export from the territory of Finland, transportation, transit through the territory of Finland, distribution, trade, handling, possession and use of drugs is prohibited under the general prohibition of the Narcotics Act (373/2008).
Substances regarded as drugs are listed in Finnish Decree 543/2008, as amended, and medicinal products mainly affecting the central nervous system or containing narcotics or psychotropic substances are listed in the Medicines Agency's Decision 3176/4.6.4/2009. Fimea grants authorisations for the manufacture, import into Finland, export from Finland and handling of these substances. The operator will need a handling authorisation for a drug, which may be granted for a certain limited time. According to the Narcotics Act, the operator is also obligated to notify Fimea every year of drugs, substances, amounts, preliminary estimate of demand, etc.xiv Enforcement
Intentional or negligent violation of provisions of the Medicines Act is punishable by a fine for a medicinal product offence, namely:
- manufacturing, importing, storing, carrying for sale or supplying medicinal products;
- neglecting to make a notification, provide information or keep records concerning medicinal products; or
- failing to comply with a prohibition issued by Fimea.
A medicinal product offence may also be punished under the Finnish Criminal Code, in which case the penalty is either a fine or a maximum of one year's imprisonment.
Fimea has the right to prohibit the import, manufacture, distribution, sale or other release for consumption of a medicinal product if conditions for granting the MA or for registration no longer exist, or if the requirements and obligations concerning manufacture or import of the medicinal product are no longer met. Fimea may also revoke, in part or in full, a licence granted for practising the manufacture or wholesaling of medicinal products, if any of the requirements for granting the licence are no longer met or if an obligation essential to safety or quality has not been met.