Finland's strong life sciences sector has a solid industrial ecosystem that produces globally relevant health care innovations. The country's robust start-up scene, national health and social care registries, and biobank network are well known for their unique features and high quality. In recent years, the global pharmaceutical industry and private equity funds have increased their interest in Finland's medical sector, particularly in digital health care. Health technology is one of the fastest growing high-tech export sectors in Finland.

The M&A market in the life sciences sector has been quite active recently, with about 70 deals made over the last two years. One of the most notable transactions has been the sale of Forendo Pharma Ltd, a Finnish clinical-stage drug development company focused on novel treatments in women's health, to Organon & Co for a sum of up to EUR830 million at the end of 2021.

One of Finland's key advantages is access to good quality clinical data. The reform of the Biobank Act (688/2012) is expected to improve opportunities for researchers to use biobank samples in their research. Preparation for a total reform of the Act has ceased, but amendments to the Act are expected in the future. The latest amendment ensuring compliance with the General Data Protection Regulation ((EU) 2016/679) (GDPR) will enter into force 1 January 2024. This Act has a strong connection to:

Internationally, Finland is considered a good country for research, with high standard research expertise and patients in favour of research. Co-operation between international pharmaceutical companies and Finnish researchers has contributed to increasing clinicians' research expertise.

In 2017, Finland launched a personalised medicine project called FinnGen that aims to obtain the genomic data of 500,000 citizens, almost 10% of its total population. One of the largest of its kind globally, the project is funded by the government and 11 major pharmaceutical companies.

Finland has been overhauling the structure of its social welfare and health care services, to improve the availability and quality of basic public service throughout Finland. Responsibility for organising these services was transferred from municipalities to well-being services counties on 1 January 2023 and changes have been made in over 100 national acts.

Funding for life sciences research comes mostly from private companies, the government, and European Commission funding programmes. Other relevant sources of funding include private funds and foundations. The Academy of Finland is the most important funding agency for life sciences research. Sitra, the Finnish Innovation Fund, is another important source of funding for science and technology.

Public authorities must guarantee adequate social, medical, and health services for everyone, and promote the health of the population (Constitution of Finland (731/1999)).

The Ministry of Social Affairs and Health is responsible for the planning, guidance, and implementation of social and health care policies. As a government body, it:

It is assisted by agencies and institutions, including:

On 1 January 2023, responsibility for organising health care, social welfare, and rescue services was transferred from municipalities to 21 new well-being services counties. In addition, the City of Helsinki is responsible for organising health, social, and rescue services within its own area. The joint county authority for the Hospital District of Helsinki and Uusimaa is responsible for organising demanding specialised healthcare separately laid down by law.

The well-being services counties are self-governing and funded by the central government. They do not currently have the right to levy taxes. Their health care duties include:

Most hospitals are owned by the well-being services counties. Each well-being services county has either a university or central hospital and may have other hospitals. Each well-being services county belongs to one of the five collaborative areas. Each area has one university hospital providing highly specialised health care. The provision of certain treatments and operations is centralised at national level in the university hospitals. Further provisions on the organisation and centralisation of highly specialised health care are laid down by decree.

The New Act on Supervision of Social Welfare and Health Care (741/2023) will enter into force on 1 January 2024. The Act includes regulations on supervision of social welfare and health care organisers:

Operating conditions and registration of both public and private service providers are harmonised in the Act. All service providers are required to have a self-monitoring plan.

Most employers also provide their employees with private health care. The Health Insurance Act (1224/2004) entitles Finnish residents to health insurance compensation for the costs of medical care, reduced by the patient's share (see Question 4). However, the insurance does not cover all costs.

After a medicinal product obtains marketing authorisation under the national procedure or one of the EU procedures (see Country Q&A, Life Sciences Regulation in Finland: Overview, Question 4), the next step is, if desired, to apply for the product's reimbursement and wholesale price to the Pharmaceuticals Pricing Board (PPB) (see Question 4). Fimea publishes a list of interchangeable medicinal products four times a year (Fimea: Substitutable medicinal products). Based on this list, the PPB confirms reference price groups, reference prices, and products included in reference price groups.

Introducing a medicinal product onto the market requires notification to Fimea.

Until recently, the wholesale price of a medicine was the same in all pharmacies and subsidiary pharmacies, as granting discounts was not allowed. Amendments to the Medicines Act (395/1987) and the Medicinal Tariff Decree (713/2013) entered into force on 1 April 2022 (see Question 18).

Legislative amendments to improve cost efficiency of pharmaceutical services entered into force on 1 January 2023. The amendments included, among other things:

The Medicinal Tariff Decree determines the retail price of a medicine based on its national wholesale price. Retail prices are calculated according to the formulas in the decree. The sales margin of a pharmacy decreases when the wholesale price of a medicine increases. The final price consists of the reported wholesale price, the pharmacy's margin, and value added tax (VAT).

The PPB operates under the Ministry of Social Affairs and Health. The PPB decides on the reimbursement status and wholesale prices of medicinal products, clinical nutritional preparations, and basic ointments reimbursable under the Health Insurance Act. The PPB also monitors the effects of reimbursement and wholesale price decisions on reimbursement costs. If the PPB has not confirmed the reimbursement of a medicine, the patient pays for the medicine.

The pricing of hospital medicines is subject to a competitive bidding process, normally organised every two years. Patients do not pay separately for medicines administered in hospital care. Every patient has an expense ceiling after which the days of treatment are fully paid by the state.

The Health Insurance Act provides that the insured has the right to be reimbursed for the costs of a medicinal product prescribed by a doctor to treat a disease. The product must be a prescription medicinal product for internal or external use to cure or alleviate a disease or its symptoms. In addition, the PPB must have confirmed the reimbursement and a reasonable wholesale price for the product.

The reference price system applies to reimbursable medicinal products that are included in the sphere of generic substitution, that is, products that are biologically equivalent and whose active substance and concentration are the same. It is a condition for the forming of a reference price group that a group of mutually interchangeable medicinal products contains at least two reimbursable medicinal products available on the market and at least one of them is a generic, parallel-imported, or parallel-distributed product. Products are divided into groups and a reference price is determined for each group. The reference price is the highest price based on which reimbursement for a medicinal product in the same group can be calculated. Reference price groups are based on Fimea's interchangeable drug list and pharmaceutical companies' price notifications. The PPB determines reference price groups, products included in the groups, and reference prices for each quarter of a year.

Reference price groups consisting of both biological medicines and biosimilars that are interchangeable with them will be introduced as from 1 January 2025.

Reimbursements for prescription medicines are available after meeting an initial deductible of EUR50 per calendar year (this does not apply to persons under 18 years of age). Health insurance reimburses 40%, 65%, or 100% of the costs of medicinal products prescribed by a doctor to treat a disease. The rate of reimbursement depends on the reimbursement category of the medicinal product.

An annual maximum fixed sum of EUR592.16 (in 2023) is payable by a patient for medicines in the reimbursement system. If the medicine expenses paid by the patient exceed the annual maximum in a calendar year, a EUR2.50 co-payment by the patient applies to each purchase. Otherwise, the expenses are reimbursed.

To cover the costs of medicinal products that are not reimbursed, a patient can purchase insurance from the private market.

See above, Price Regulation. There is no specific compensation for pharmacists for their dispensing services. A pharmacy business requires a pharmacy licence issued by Fimea and medicines can only be sold by pharmacies. The number of pharmacies is limited. The amount of medicinal products, equipment and supplies to administer medicinal products, and dressings kept by a pharmacy must correspond to the average of its usual customers' needs for a two-week period. Fimea monitors pharmacy activities and legal compliance.

Persons entitled to prescribe medicines are:

All medicines can only be sold and distributed to the general public from pharmacies, subsidiary pharmacies, pharmacy service points, and regulated online pharmacy services. The same restriction applies to marketing medicines on the internet, by email, and by mail order.

Prescription medicinal products can only be supplied from online pharmacy services subject to an electronic prescription (Act on Electronic Prescriptions (61/2007)). Licensed pharmacists and the licensed pharmacies of the University of Helsinki and the University of Eastern Finland can provide pharmacy services through an online pharmacy service. Operating an online pharmacy service requires advance notification to Fimea. Fimea must also be notified of the commencement and termination of operations and essential amendments to the service. Provisions of the Consumer Protection Act (38/1978) on distance selling also apply to online pharmacy services.

The EU common logo rules for online pharmacies to combat falsified medicines apply in Finland.

Wholesale distribution is regulated in the Medicines Act and Fimea Administrative Regulation 1/2019: Good distribution practice of medicinal products. Distributing medicinal products requires a medicinal product wholesale dealer's licence issued by Fimea. Licence applications are made with an application form available on Fimea's website (Fimea: Forms (in Finnish)). A licence is required for all activity with the purpose of:

The licence covers the operations specified in the licence conditions. Conditions for a medicinal product wholesale dealer's licence include:

There are only a few wholesalers in Finland that specialise in medicine distribution with operations covering the whole country. Finnish wholesale distribution of medicines is based on the one-channel principle, whereby a pharmacy or hospital can only buy a pharmaceutical company's products from one wholesaler. In practice, other wholesalers and manufacturers enter into contracts with the wholesalers in Finland that specialise in medicine distribution and that deliver products to pharmacies and hospitals.

Fimea supervises the distribution of medicines. Fimea monitors wholesale dealers' compliance with their licence terms and applicable law through licensing procedures and regular inspections. Fimea inspectors must be allowed access to all facilities. During the inspection, all documents necessary to carry out the inspection and requested by the inspector must be presented. In addition, the inspector must be provided free of charge with:

The inspector can also take photographs during the inspection.

Fimea can give orders to correct any defects found. Immediate action must be taken following any orders given in an inspection (Medicines Act).

On request, medicinal product wholesalers must provide Fimea with information and documents on the import, manufacture, inspection, distribution, sale, or other release for consumption of medicinal products as are necessary for Fimea to carry out its duties (subject to confidentiality provisions).

Fimea can revoke for a fixed period or in full a licence granted to a medicinal product wholesaler if:

The party concerned can bring a claim to revise a decision and an appeal under the Administrative Procedure Act (434/2003).

The Medicines Act and the Criminal Code (39/1889) also impose criminal sanctions for some breaches of the legislation.

The following persons can import medicinal products:

To import a medicinal product from outside the EEA, the importer must have a medicinal product manufacturer's licence.

All importers must keep a register of medicinal product imports indicating the products imported and their quantity, country of origin, supplier, and date of import. Importers of medicinal products must ensure that medicinal products imported from countries outside the EEA have been manufactured by legal manufacturers of medicinal products in compliance with at least EU GMP.

Fimea grants authorisations for parallel imported medicines based on an application, which must meet the following conditions:

(Section 21 d, Medicines Act.)

Fimea Administrative Regulation on Parallel Import of Medicinal Products 4/2014 sets out the conditions for an application for marketing authorisation for a parallel imported medicine. Licence applications are made with an application form available on Fimea's website (Fimea: Application for parallel import of a medicinal product). When processing applications for parallel import marketing authorisations, Fimea ensures that the products are sufficiently similar to be regarded as the same medicinal product.

The future holder of the marketing authorisation must, at the time of the application, hold an authorisation for wholesale distribution in Finland.

A proprietor of a patent or trade mark cannot prohibit the use of an intellectual property right (IPR) for goods put on the market in the EEA under that patent or trade mark by the proprietor or with their consent. However, the proprietor can enforce their IPRs and stop parallel imports from outside the EEA based on a patent or trade mark.

Advertising of medicinal products is regulated by the Medicines Act and Medicines Decree. When medicinal products are advertised to consumers, the marketing regulation provisions of the Consumer Protection Act (38/1978) also apply. The Unfair Business Practices Act (1061/1978) also includes general requirements for advertising.

Fimea monitors the advertising of medicinal products.

Regulations are complemented by voluntary self-regulation of the pharmaceutical industry, based on the Pharma Industry Finland (PIF) Code of Ethics (PIF Code). Member companies are committed to the PIF Code and adhere to it. The voluntary control of marketing by the pharmaceutical industry is an open system. Anyone can lodge a complaint with PIF if a PIF member company's operations violate the PIF Code. The PIF Code includes rules on, for example:

The independent Supervisory Commission for the Marketing of Medicinal Products and its Inspection Boards guide and monitor the application of and compliance with the PIF Code.

Marketing of medicinal products includes all publicity, marketing, and promotional activities intended to promote the prescription, supply, purchase, or use of medicinal products. This includes:

(Section 25, Medicines Decree.)

It is prohibited to market a medicinal product without a valid marketing authorisation or registration (see Country Q&A, Life Sciences Regulation in Finland: Overview, Question 3 and Question 4.)

Advertising/marketing includes:

Advertising prescription medicines to the general public is prohibited (see Question 17). Advertising of medicinal products must encourage people to use the products appropriately (Medicines Act). It must not be improper or induce people to use the products unnecessarily.

The nature, motive, method, and contents of the communications are decisive for whether a message is considered advertising.

Impartial medicine information that is not considered advertising can include, for example:

Marketing containing the product's name and statements promoting sales is considered marketing even if it is called a press release. Advertising also includes, for example, medical sales representation, radio or TV commercials, market research, and online advertising.

Informing the general public about vaccination campaigns approved by the authorities is not considered marketing.

Legislation does not contain specific requirements for internal advertising processes. However, it is advisable to establish appropriate procedures. In connection with marketing surveillance, Fimea can request a copy of the company's internal operating instructions for approval of marketing materials.

A marketing authorisation holder must ensure in advance that advertising agencies used by the company, and its own personnel, master the special characteristics and regulations for marketing medicinal products. They must ensure that operating instructions consider all legislative requirements in internal processes. For example, a press release can be marketing. Therefore, internal marketing supervisors should also check bulletins and releases about medicinal products to ensure they comply with regulations.

Fimea does not approve medicinal product advertising in advance. Non-promotional materials do not have to be submitted to Fimea for advance approval, with certain exceptions, including:

If the marketing authorisation holder is a member of the PIF, there is a compulsory preliminary inspection of TV and radio advertisements for over-the-counter (OTC) products. Advertising prescription medicines to the general public is prohibited. Inspections are conducted by the PIF Inspection Board. In the preliminary inspection of TV and radio spots, the Inspection Board may approve the planned spot without changes, approve the spot with changes, or fail the planned spot. If necessary, the Inspection Board can hear the applicant before making the decision.

Fimea can request marketing authorisation holders to provide:

Comparisons that are not relevant to medical treatment should not be used. For example, using superlatives or emphasising superiority in marketing is prohibited in accordance with Fimea's established interpretation.

If comparisons or statements about a medicinal product's characteristics are made while marketing a prescription medicine, the origin of the data should be indicated individually, accurately, and unambiguously, so that the listener or reader can familiarise themselves with the information and its source. Reliable trial data should not be combined in an ambiguous manner with other data.

It is prohibited to market a medicinal product that does not have a valid marketing authorisation or registration in Finland. Advance marketing of a product is prohibited. Medicinal products can be promoted after the marketing authorisation has been granted but before the product has been introduced to the market.

Regulation of pharmaceutical advertising focuses on the content of various actions, not on the platform. The content and use of an application or similar platform are decisive in setting rules on a case-by-case basis. In the digital environment, interactivity, transfer of data, and distribution methods often differ from conventional communications and must be considered.

Email marketing requires consent in advance from the recipient if the recipient is a natural person (for example, a physician). Direct email marketing to legal persons is allowed without prior consent. As marketing of prescription medicines to the general public is prohibited, digital marketing of prescription medicines must be password protected so that only health care professionals can access it.

When a pharmaceutical company operates in the digital environment, they are responsible for the compliance of each digital activity. For example, social media provides the opportunity for interaction, distribution of information, networking, and "likes". These are often used by third parties but the pharmaceutical company remains responsible for the actions and functions.

There are specific regulations in the PIF Code on websites containing health awareness information and linking. For instance, the links must always lead to the company's homepage, not to the product pages.

Foreign websites can be used in marketing if they meet the criteria in Finnish regulations.

Fimea monitors the advertising of all medicinal products. PIF members commit to comply with the PIF Code and its own rules on non-compliance, procedures, and sanctions. In both systems, it is common for competitors and third parties to submit complaints.

Fimea can intervene in the illegal advertising of medicinal products based on a defect or fault in that advertising. The process can be initiated by a complaint submitted by a company or a private individual. Fimea sends a clarification request in writing to the company that is the subject of the complaint which can then submit a rejoinder, based on which Fimea will decide on any further action. If further action is required, the company is informed of the action in writing and can also submit a rejoinder. To conclude the process, Fimea sends a guiding summary letter to the company.

Fimea can prohibit advertising. Parties must be heard before making a decision. Rectification of advertising can be required. A prohibition can be backed up with a conditional fine, and if necessary, a new conditional fine. The party concerned can bring a claim to revise the decision and an appeal under the Administrative Procedure Act (434/2003). Intentional breach of marketing regulations can also lead to criminal proceedings and sanctions.

Anyone can lodge a complaint with the PIF Inspection Board against actions by companies committed to the PIF Code that fall within the Code. The parties can appeal to the Supervisory Commission against PIF Inspection Board decisions. The PIF can impose :

In addition, the Supervisory Commission can impose a contractual penalty.

Marketing prescription medicinal products or products containing narcotic drugs or psychotropic substances to the general public is prohibited. Prescription-only medicines can only be marketed to persons entitled to prescribe or supply medicinal products. Marketing a medicinal product without a valid marketing authorisation or registration in Finland is prohibited (sections 91 and 91 a, Medicines Act).

Advertising of OTC medicines to the general public must include at least:

(Section 91 a, Medicines Act.)

Advertising to the general public must not:

(Section 25 b, Medicines Decree.)

Distribution of free medicinal product samples to the general public for sales promotion purposes is prohibited.

Granting discounts in pharmacies was not allowed in Finland until amendments to the Medicines Act and the Medicinal Tariff Decree entered into force on 1 April 2022. The new regulation allows differences in pricing for OTC medicines. Pharmacies can now determine the retail price of OTC medicines within certain limits:

A pharmacy's pricing cannot be different in its other service points or online pharmacy services.

Loyalty discounts are allowed. A pharmacy can grant a discount on self-medication to all customers or only to its regular customers. Sale of two or more medicinal product packages or medicinal product packages and a free trade product at a reduced combined price is prohibited. In addition, an offer and sale of a medicinal product or packaging at a reduced price cannot be combined with the purchase of another medicinal product, packaging, or other commodity. A medicinal product cannot be sold at a reduced price because its expiration date is near.

Marketing authorisation holders and other parties engaging in the marketing of medicinal products must keep publicly available an up-to-date list of all direct and indirect financial and comparable support they have given to associations in the fields of medicine and health care and to patient organisations (section 91 c, Medicines Act).

The PIF Code includes detailed provisions on co-operation between the pharmaceutical industry and patient organisations. Marketing prescription-only medicines to the general public is prohibited and this includes co-operation with patient organisations. Financial support provided to or any other significant sponsorship of patient organisations, direct or indirect, must be detailed in a written agreement. In addition, the PIF Code includes provisions on:

According to the PIF Code, health care organisations include:

Marketing prescription-only medicines is only permitted to persons entitled to prescribe or supply medicinal products who are:

(Section 91 b, Medicines Act.)

Persons entitled to supply medicinal products are pharmacists: certified Masters of Pharmacy or certified Bachelors of Pharmacy.

Such marketing can only take place in sales promotional events arranged for persons entitled to prescribe or supply medicinal products, in publications intended for them, and in electronic communication media in protected form to prevent it from reaching third parties.

Marketing material directed at persons entitled to prescribe and supply medicinal products must always include:

(Section 25 e, Medicines Decree.)

All information given in bulletins used in marketing must comply with the approved summary of product characteristics and be accurate, up-to-date, verifiable, and sufficiently complete for the reader to form an opinion of the therapeutic value of the medicinal product. Quotations and tables from medical publications and scientific research or other illustrative material must be reproduced faithfully and their source accurately indicated.

Section 92 of the Medicines Act provides:

The bribery provisions of the Criminal Code (39/1889) also apply.

Fimea monitors the marketing of pharmaceuticals. Fimea has established quality criteria for sales promotional events on the communication of appropriate information about medicines to promote their correct and safe use. Fimea also monitors the extent to which the criteria are followed at these events.

Regulations are complemented by voluntary self-regulation of the pharmaceutical industry, based on the PIF Code. The PIF Code has a detailed set of norms on pharmaceutical marketing and information targeted at both consumers and health care professionals.

The PIF Code includes detailed provisions on sponsorship, events organised or sponsored by the pharmaceutical industry, and hospitality in the events. For example, a company can engage in sponsorship only through its business name or logo, and sponsorship must not encourage its viewers to purchase the sponsor's or a third party's products.

Healthcare professionals can be used as experts or advisors, either as a group or on an individual basis. The PIF Code lists detailed criteria that must be met in the arrangements involving experts. For example, in their expert agreements with healthcare professionals, the pharmaceutical companies must include a clause whereby the expert is obliged to always state that they are or have been in a contractual relationship with the company when publicly writing or speaking about the issue focused on by the agreement or otherwise related to the company.

Donations, grants, and benefits in kind offered to institutions, organisations, or associations are permitted but subject to the PIF Code provisions. The pharmaceutical company must not expect to be the only party financing the healthcare organisation or any of that organisation's projects.

See also Question 22.

Marketing authorisation holders and other parties that market medicinal products must keep publicly available an up-to-date list of all direct and indirect financial and comparable support they have given to associations in the fields of medicine and health care and to patient organisations (section 91 c, Medicines Act). Information is usually available on the relevant company's website.

PIF member companies must publish fees and economic benefits they pay to health care professionals and organisations (PIF Code). Health care professionals in this respect includes nurses. The obligation applies to both public and private health care providers.

The consequences of non-compliance are the same as those for non-compliance with the rules on advertising (see Question 16).

The basic requirements for patentability of an invention are that it must be:

In addition, the invention must:

The main national legislation on patents is the Patents Act (550/1967) and the Patents Decree (669/1980). The Patents Act was amended by Act 23/2016, including provisions on the Unitary Patent and the Unified Patent Court.

The types of patents available in Finland include product patents and process patents.

The types of inventions that can be claimed in a patent include:

The scope of protection is determined by the patent claims, taking into consideration the description and drawings. However, the doctrine of equivalents has been widely discussed in legal literature, and case law has confirmed that the scope of protection may extend beyond a literal interpretation of the claims when an element can be replaced by an equal element without changing the invention.

The exclusions from patentability correspond to the European Patent Convention 1973 (EPC). Finland has also implemented the Biotechnology Directive (98/44/EC).

Generally, the following (among others) cannot be patented:

Finland has implemented the Biotechnology Directive. Biological material can be patentable if it is the subject of an invention and both:

(Section 1, subsection 6, Patents Act.)

There are discussions on the patentability of biotechnological inventions in relation to, among other things, potential restrictions on the availability of medicines and nutritious substances. It may be difficult to distinguish between patentable biotechnological inventions and those excluded from patentability.

National patent applications are filed with the Finnish Patent and Registration Office (PRH). Its website provides guidance on the application requirements and procedure. Applications for European patents can be filed with the PRH or directly with the European Patent Office (EPO).

A Patent Co-operation Treaty 1970 (PCT) application can be filed through the PRH or the EPO, or directly with the World Intellectual Property Organization (WIPO). The PRH checks that applications filed with it meet the formal requirements and forwards them to the international searching authority.

The applicant must provide:

The application procedure can be roughly divided into three phases:

Details of patent application fees are on the PRH website.

The PRH has a target time of eight months for the first office action for examination of the novelty and inventiveness of the invention. In this office action, the applicant receives an evaluation on the patentability of the invention. Before the final decision, there may be several office actions and each time the applicant has from two to four months to reply.

The PRH aims to complete the whole application process in less than three years.

Any litigation proceedings on the right to an invention may prevent regulatory review of a patent application. Processing of the patent application may be suspended until the dispute is resolved.

Fast-track processing of patent applications is available on separate request. In this process, the first office action on examination of novelty and inventiveness is issued within three months from the filing date and the second office action within two months from the applicant's reply. The fast-track system is free of charge, but one of the following requirements must be met:

After filing a first patent application in a country party to the EPC or the Paris Convention for the Protection of Industrial Property 1883 (Paris Convention), the applicant can file a corresponding application within 12 months (the priority period) in Finland and claim priority from the first application. Priority means that the later application, when assessing novelty and inventive step, is regarded as filed at the same time as the first application. The later application can be:

A patent is granted when it is announced in the Patent Gazette. There is then a nine-month opposition period, during which anyone can lodge an opposition against the patent to revoke it. An opposition must specify the grounds on which it is made. An opposition must be filed with the PRH in Finnish or in Swedish, even if the patent is in English. When the opposition period has expired, a patent can still be revoked by the Finnish Market Court (see Question 27, Defences to a Patent Infringement Action).

An opposition can be filed on the following grounds:

(Section 25, Patents Act.)

Patent approval is conditioned on technology transfer, that is, a prerequisite for the grant of a patent is that the invention or technology is transferred by the inventor to society, which can use the invention in accordance with the patent application as a solution to the (technical) problem.

A patent lasts 20 years from the filing date, subject to payment of annual renewal fees.

The validity of pharmaceutical patents can, under certain conditions, be extended by up to five years through a supplementary protection certificate (SPC). The extension period is equal to the period between the application date for a basic patent and the first authorisation date to place the product in the market in the community, reduced by a period of five years. Patents relating to medicines for paediatric use can be extended by a further six months.

The renewal fee must also be paid annually for the extended period.

A patent is an exclusive right that enables its owner to prohibit others from using their invention commercially. Commercial use means, for example, manufacturing, selling, using, or importing a product. However, a patent does not automatically give the owner the right to use the invention commercially, as the owner may need permits from other authorities or authorisation from other patent owners. The owner can sell their patent or license a person to commercially use the patented invention.

A patent gives the owner the exclusive right to exploit the invention commercially. Generally, the following acts without the owner's consent are a direct infringement:

Indirect infringement is committed when an instrument that is suitable and intended for the use of the invention is offered or supplied to any person not entitled to exploit the invention. The provisions on indirect infringement have rarely been subject to litigation in Finland.

Invalidity claim. A main defence to a patent infringement action is to bring an invalidity claim against the patent owner. A patent will be declared invalid by the court if one of the following applies:

(Section 52, Patents Act.)

Research exemption. An exemption for research or experimental use, including research required to obtain marketing authorisation (Bolar-style exemption) applies in Finland. The Patents Act implements the Code for Human Medicines Second Amendment Directive (2004/27/EC). Therefore, the exclusive right of a patent does not apply to examinations, experiments, or measures arising from practical demands needed for an application to obtain a marketing authorisation for a medicine, and which relate to the invention concerning that medicinal product (section 3, Patents Act).

The examinations, experiments, and measures cannot extend to other actions anticipating or promoting the entry into the market of the new product after the patent lapses, for example, manufacturing medicines for storage. In addition to generic medicines, the exception in the Patents Act covers examinations needed to obtain a marketing authorisation for an original medicine.

IP exhaustion. An IP exhaustion doctrine applies in Finland. The exclusive right of a patent owner does not apply to the use of a patented product that has been put on the market in the EEA by the patent owner or with their consent (section 3, Patents Act).

Other exemptions. Other exemptions for patent infringement include:

Finland is a party to the following international treaties.

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The PCT.

The European Patent Convention and a member of the European Patent Organisation.

The WIPO Madrid Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989.

The Paris Convention.

A trade mark is a sign that distinguishes goods and services of one undertaking from those of another undertaking. The basic requirements to obtain trade mark protection are that:

A trade mark can be, for example, a word or a set of words, a figurative element, a slogan, or a combination of any of these, a sound, or a three-dimensional mark covering the shape of a product or its packaging. A trade mark can also include moving images, a product's packaging, or a colour. A trade mark can also be, for instance, a multimedia mark or a position mark.

The main legislation on trade marks includes the Trade Marks Act (544/2019) and Government Decree on Trade Marks (799/2019). The Trade Marks Act implemented the Trade Marks Directive ((EU) 2015/2436).

A trade mark gives the owner the right to prevent others from using the same mark or a mark that causes a risk of confusion in relation to identical or similar goods or services. EU trade marks are valid in all member states.

A medicinal brand can be registered subject to the same conditions as any other mark. The absolute and relative grounds for refusing trade mark registration are set out in sections 12 and 13 of the Trade Marks Act. The absolute grounds mainly relate to marks that are contrary to law, order or morality, or marks that mislead the public. The relative grounds relate to infringement of earlier third-party rights.

A medicinal product trade name is an essential part of an application for marketing authorisation and registration with Fimea and must comply with certain rules. The requirements for medicinal product trade names are set out in Fimea Administrative Regulation 4/2019 on Applying for and Maintaining a Marketing Authorisation for a Medicinal Product.

National trade mark applications are filed with the PRH. Its website provides guidance on the application procedure.

In Finland, trade mark protection can also be acquired without registration by becoming established through use. A mark is considered established if it is generally known in Finland in its target group as a symbol specific to its owner's goods or services. Section 5 of the Trade Marks Act provides protection for widely known trade marks in Finland. The PRH maintains a separate list of marks with reputation in Finland.

Applications are filed online but the PRH may accept a paper application in special circumstances. Applications can be submitted in English (in addition to Finnish and Swedish). However, even if the application is written in English, applicants must choose Finnish or Swedish as their processing language.

Details of trade mark application fees are on the PRH website.

The average processing time for national trade mark applications at the PRH is under one month. The application procedure can be divided into three phases:

The PRH does not provide a search report.

The grant of a trade mark is published in the Trade Mark Gazette information service, and the PRH sends a registration certificate to the applicant. Within two months from the date of publication, anyone can lodge an opposition against a trade mark. An opposition must include grounds for the opposition and specify which goods and services are concerned. Oppositions must be filed in Finnish or Swedish.

After filing an application for an EU trade mark or in a country party to the Paris Convention or TRIPS, the applicant can file a corresponding application within six months in Finland and claim priority from the first application. The Finnish application will be deemed made on the date of the first application, to determine priority over other trade mark applications or the use of other trade symbols.

The Competition Act (948/2011) forms the basis of Finnish competition legislation. The Competition Act prohibits:

The Competition Act also regulates merger control.

Finnish competition legislation and policy are largely based on EU competition rules and policy. There are also government decrees on merger control and non-regulatory documents (mainly guidelines) issued by the Finnish Competition and Consumer Authority (FCCA).

The FCCA is primarily responsible for enforcing and applying Finnish competition legislation. The FCCA is responsible for protecting sound and effective economic competition by intervening, where necessary, in restrictive practices violating competition legislation. The FCCA must also apply EU competition rules in Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU) if a restraint on competition may affect trade between EU member states.

The FCCA investigates competition issues on its own initiative and based on complaints. The FCCA acts mainly as an investigative authority. Where the FCCA identifies conduct that infringes competition law, it can:

In contrast with the European Commission, the FCCA cannot impose fines on its own. Where the FCCA finds an infringement of competition law, it can propose a fine to the Market Court, a specialist court in competition and IP matters, after which the Market Court can impose a fine. Market Court decisions can be appealed to the Supreme Administrative Court. In addition, in most cases, the FCCA can also impose conditional fines to enforce an order, prohibition, or obligation issued based on the Competition Act.

The FCCA also investigates mergers that exceed statutory turnover thresholds and must be notified to the FCCA. In these cases, the concentration can only be implemented after the FCCA has given its approval. After reviewing a concentration notification, the FCCA can submit a proposal to the Market Court to prohibit a concentration, order a concentration to be dissolved, or attach conditions to its implementation.

In addition, the FCCA investigates public sector business activities when they apply operating models or structures that prevent or distort competition on a market. The FCCA also takes proactive advocacy measures through initiatives, opinions, stakeholder co-operation, and participation in competition-related working groups.

The Competition Act empowers the FCCA to carry out inspections at a company's business premises, storage and land areas, or vehicles, where violations of competition rules are suspected. The Regional State Administrative Agencies (RSAA) can assist in the inspections. Inspections can be performed at other locations, provided that the Market Court has granted permission to do so. The European Commission can also order the FCCA to conduct inspections.

Private enforcement of competition rules through damages actions in national civil courts (district courts) is increasingly common in addition to public enforcement.

Competition law investigations into pharmaceutical companies have not been very common. There have been only two publicly reported investigations or national case law on pharmaceutical companies since 2012:

Both were closed without further action. This may be because pharmaceutical companies in Finland usually have a strong compliance culture and competition issues are regularly self-assessed.

In June 2017, the FCCA cleared a merger between Kesko Oyj and Oriola. Kesko is a large player on the grocery retail market, while Oriola focuses on pharmaceutical distribution. It acts mainly as a wholesaler to hospitals and pharmacies and has minor activities on the retail market. Some market players raised concerns about the single-channel distribution system and possible future development of market power at the retail sale of medicines' level, following Oriola's vertical integration and potential relaxation of pharmaceutical regulation. At that time the FCCA considered it unlikely that regulation of the pharmaceutical market would be liberalised in the near future. However, preparations for liberalisation of the pharmacy regime have been initiated in the 2020s.

In October 2020, the FCCA cleared a merger between Orifarm Generics Holding A/S and Takeda Pharmaceuticals International AG without further action. Orifarm operates in the European market for pharmaceuticals and Takeda is the largest pharmaceutical company in Japan and a leader in the global pharmaceutical industry.

Potential competition issues with the entry of generic pharmaceuticals on the Finnish market are consistent with related issues at EU level. The FCCA has investigated a few cases on the entry of generic pharmaceuticals but the investigations have been closed without further action.

The exclusive right of a patent does not apply to examinations, experiments, or measures arising from practical demands needed for an application to obtain a marketing authorisation for a medicine, and which relate to the invention concerning that medicinal product (section 3, Patents Act) (see Question 27, Defences to a Patent Infringement Action).

Certain patent settlements in the pharmaceutical sector may be problematic from a competition law perspective. Settlements that can delay generic market entry in exchange for benefits (pay-for-delay deals) may be prohibited under Article 101 of the TFEU.

The FCCA has investigated a few cases on abuse of dominance in the pharmaceutical sector, including:

The FCCA has investigated some cases on parallel imports (see Question 8, Parallel Imports) but they were all closed without further action or did not lead to an infringement fine proposal to the Market Court.

The Supreme Court of Finland has issued a ruling (KKO 2011:7) in which co-branding of pharmaceuticals by a parallel importer was prohibited, on the grounds that the repackaged product created an erroneous impression among consumers.

There are also a few decisions on trade marks and parallel imports by the Helsinki District Court and Helsinki Court of Appeal. For example, the Helsinki Court of Appeal ruled on a trade mark dispute concerning the parallel import and repackaging of another company's pharmaceutical products (Dnro S 15/3093). A company imported repackaged products without sufficiently indicating in the packaging that another company owned the relevant trade mark. In this case, the court ruled that the requirements to use the trade mark were met and the packaging did not infringe the applicants' trade mark rights.

The Patents Act includes provisions on compulsory licensing. If there is considerable public interest, a person wishing to commercially exploit an invention for which another person holds a patent can obtain a compulsory licence to do so (section 47, Patents Act). A compulsory licence can only be granted to a person who both:

Compulsory licences are granted by a court, which decides the extent to which the invention can be exploited, the remuneration to be paid, and any other licence conditions.

A compulsory licence does not prevent the patent owner from exploiting the invention or granting licences under the patent. In addition, Regulation (EC) 816/2006 on the compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems applies.

Licensing, research and development (R&D) agreements, and distribution systems that restrict competition or are considered abusive are prohibited by national competition and EU rules. In addition, sharing sensitive information, for example about future market behaviour between competitors, is usually deemed unlawful. Companies with a limited market share may be able to benefit from:

There are no restrictions on licensing or transferring patents to foreign parties. It is quite common to license and transfer patents to foreign parties.

There are no restrictions on transfers for inventions funded or partially funded by public investment. Centres for Economic Development, Transport, and the Environment (ELY Centres) can grant funds to support SMEs in commercialising their inventions and building new successful businesses. The beneficiary must ensure that it owns the IPRs in its invention in accordance with law or under a separate agreement. If the beneficiary uses IPRs owned by a third party (including employees and owners), it must ensure that it has sufficient rights to use these rights in R&D and business activities in accordance with the project plan.

A patent or trade mark licence and payment of royalties under it to a foreign licensor need not be approved or accepted by a government or regulatory body. A licence is enforceable between the parties. To create certain legal effects and benefits in relation to third parties and the licensee, a patent or trade mark licence can be registered in the patent or trade mark registers.

Fimea is the key regulator of medicinal product safety and ensures that measures related to product defects are adequate and appropriate. The Medicines Act empowers Fimea to prohibit the distribution, sale, and other dispensing of a defective or allegedly defective medicine.

In relation to medicinal product liability, Fimea has the same general powers to monitor compliance and impose penalties as it has relating to manufacturing and marketing authorisations (see Country Q&A, Life Sciences Regulation in Finland: Overview, Question 3, Monitoring Compliance and Imposing Penalties).

Fimea can disclose sensitive or confidential information if a general announcement about a medicine's safety is made and it is necessary for public health.

A product is defective if it is not as safe as reasonably expected (section 3, Product Liability Act (694/1990)). When evaluating the safety of the product, the following criteria are taken into account:

To receive compensation, the injured party must show:

The Product Liability Act applies to compensation for injury or damage caused by a product to a person or property that is meant and primarily used for private purposes. This includes damage caused by medicines.

Injuries caused by the distribution of prescription medicines from a pharmacy are covered by mandatory insurance under the Patient Insurance Act (948/2019), provided that the medicine has been distributed in a manner contrary to the prescription or to regulations on the distribution of medicines. The Patient Insurance Act only covers other distribution of medicines if the professional who issues the medicine makes an error that deviates from the general professional standard expected from them.

The Patient Insurance Act does not cover injuries if a medicine was prescribed or distributed appropriately but an adverse effect or injury still occurred. Instead, the voluntary Pharmaceutical Injuries Insurance (PII) scheme applies. The scheme is not based on legislation but is agreed by the Finnish Co-operative for the Indemnification of Medicine-Related Injuries, formed by manufacturers and distributors of pharmaceuticals and some insurance companies.

The Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities, formed by the Finnish Co-operative for the Indemnification of Medicine-Related Injuries, is responsible for insurance and compensation claims for pharmaceutical injuries that cannot be indemnified from another source. Indemnification can be sought from the PII if the manufacturer, importer, marketer, or research company of the medicinal product is a member of the co-operative.

The most recent case of injuries caused by defective medicinal products is the Pandemrix case, concerning GlaxoSmithKline's swine flu vaccine. The vaccine was used in Finland in the winter of 2009 to 2010 to prevent the swine flu epidemic. After the epidemic, it was observed that narcolepsy among children and young people had increased. The vaccinations were suspended in August 2010. In July 2011, the EMA stated that there was a connection between the Pandemrix vaccine and the increased narcolepsy in children and young people. PII funds were not sufficient to compensate all the discovered narcolepsy cases, so the government enacted a separate law to guarantee funding for the rest of the compensation (about EUR60 million).

Disputes are heard by the district courts and settlements are possible. District court decisions are public. There is no obligation to publish settlements.

Any of the following individuals or legal entities can be liable for a defective medicinal product:

(Section 5, Product Liability Act.)

If the product does not contain information about its producer or manufacturer, any party responsible for putting the medicinal product on the market can be liable, unless it informs the claimant within a reasonable time of receiving a claim of either:

The PII covers pharmaceuticals if the product manufacturer, importer, distributer, or marketer is a member of the Finnish Co-operative for the Indemnification of Medicine-Related Injuries (see Question 36). In practice, pharmaceutical injury insurance claims are more beneficial to claimants than product liability claims.

A party is not liable for damages under the Product Liability Act if they prove that either:

Other commonly used defences in tort may also apply, for example, the injured party had misused the medicine or otherwise acted with gross negligence and therefore contributed to the injury.

It is possible to agree on the distribution of risks in the supply chain (for example, on recovery claims between the manufacturer and the distributor). However, liability to the injured party cannot be limited for defective medicinal products.

An action for damages under the Product Liability Act must be brought within three years from the date on which the claimant became aware or should have become aware of the damage, the defect in the product, and the identity of the liable party. However, the claim must be filed within ten years from the date on which the defective product was put on the market.

If the claim is made under the PII, it must be filed within a year of the date on which the person claiming compensation became aware of the validity of insurance, the injury caused by the pharmaceutical or blood product involved, and the injuring event. However, the claim for compensation must be submitted no later than ten years from the occurrence of the injuring event.

Under the Act on Class Actions (444/2007), the Consumer Ombudsman has exclusive standing to bring a class action and exercise a party's right for a case to be heard in court. Although product liability claims fall under the scope of the Act, no class actions have been filed.

Compensation for personal injury can be sought for the following:

(Tort Liability Act (214/1974).)

Punitive damages are not permitted.

The scope of compensation under the PII is limited to certain types of damage. Liability for each injured person is also limited to EUR4 million, including the value of annuities capitalised at the date they are fixed, in accordance with sound insurance principles. The limit for all injuries reported during the same year is EUR30 million.

If the amount of compensation is not sufficient to satisfy those entitled to compensation, all compensation paid will be reduced in an equal proportion.