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Pharmaceutical regulatory law

Regulatory framework and authorities

Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules?

The national applicable legislation for pharmaceuticals includes the Medicines Act (No. 395/1987) and the Medicines Decree (No. 693/1987). The national legislation is also supplemented by the regulations and guidance issued by the Finnish Medicines Agency, Fimea. Pharma Industry Finland (PIF), an organisation of the innovative pharmaceutical industry, has also issued its Code of Ethics, the PIF Code, containing detailed provisions regarding marketing of medicines, which are binding for members of the organisation. Overall, marketing of pharmaceuticals to consumers, if permitted, must also meet the requirements of the Finnish Consumer Protection Act (No. 38/1978) and the Regulation on unfair practices in marketing and customer relations (No. 601/2008). The main bodies responsible for enforcing the legislation are Fimea, the Pharmaceuticals Pricing Board, the National Supervisory Authority for Welfare and Health, and the National Institute for Health and Welfare. These are all subordinated to the Ministry of Social Affairs and Health. In addition, the Supervisory Commission for the Marketing of Medicinal Products enforces the above-mentioned PIF Code.

Pricing

Are drug prices subject to regulatory control?

Drug prices are not subject to regulatory control, but the admission of a drug to the reimbursement system that applies to pharmacy trade requires that the wholesale price of the drug is considered ‘reasonable’. The Pharmaceuticals Pricing Board operating within the Ministry of Social Affairs and Health conducts the assessment on whether the price suggested by a pharmaceutical company can be considered reasonable. In cases where the wholesale price suggested by the marketing authorisation holder is not considered reasonable under the criteria set forth by the Health Insurance Act (No. 1224/2004), the reimbursement application will be rejected, but the price itself is not required to be altered. In hospital trade, drug prices are mostly determined by public procurement process through competitive bidding.

Distribution

Is there specific legislation on the distribution of pharmaceutical products?

The Medicines Act includes detailed provisions regarding the distribution of pharmaceuticals. All distribution activities of pharmaceutical products are subject to a wholesale licence in Finland granted by Fimea. In order to be eligible for a licence, the applicant must, for example, 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. Pharmaceuticals 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 the purposes of veterinary medication. Fimea has also issued the Regulation (No. 5/2013) on good distribution practices. Under the Medicines Act, the operation of a pharmacy business requires a pharmacy licence issued by Fimea. The granting of a licence is subject to, inter alia, a means test based on the population of the area in which the pharmacy is located.

Intersection with competition law

Which aspects of this legislation are most directly relevant to the application of competition law to the pharmaceutical sector?

The mandatory prerequisites for obtaining and maintaining relevant licences under the Medicines Act, as well as compliance with Fimea’s regulations and instructions, set out the framework for distributing and marketing pharmaceutical products in Finland. Further, the national rules on pricing and reimbursement of pharmaceutical products limit possibilities of price adjustments and discounts. For example, under the Medicines Act, the holder of the relevant marketing authorisation is responsible for notifying prices to public price lists, and no individual discounts from distributors to pharmacies are allowed; the price of a pharmaceutical product must be the same for every pharmacy in Finland and in accordance with the notified price.

Competition legislation and regulation

Legislation

Which legislation sets out competition law?

Competition legislation in Finland is, in essence, set out in the Competition Act (No. 948/2011).

The Ministry of Employment and the Economy has further issued regulations concerning the application of the merger control rules included in the Competition Act. The Finnish Competition and Consumer Authority (FCCA) has issued guidelines on topics such as merger control, possibilities to seek immunity or reductions in fines and the prioritisation of the FCCA’s tasks.

The Competition Act is a general law that applies to all sectors of the economy. Only limited exceptions apply, which are within the fields of labour agreements and agriculture.

In addition to the national Competition Act, articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU) apply if a competition restraint may affect trade between member states.

Competition authorities

Which authorities investigate and decide on pharmaceutical mergers and the anticompetitive nature of conduct or agreements in the pharmaceutical sector?

There are no specific authorities or courts dealing with competition law infringements in the pharmaceutical sector.

The FCCA is the competent authority to investigate and decide on all mergers and acquisitions that exceed the turnover thresholds as set out in the Competition Act, regardless of the industry in question. However, the FCCA cannot prohibit a notified merger or acquisition, but has sole jurisdiction to propose the prohibition of such a transaction to the Market Court. Similarly, the FCCA investigates alleged infringements of competition law and can, for example, order the parties to cease and desist from continuing an infringement, but decisions on fines are issued by the Market Court as the first instance.

The Market Court’s decisions are appealable to the Supreme Administrative Court.

Remedies

What remedies can competition authorities impose for anticompetitive conduct or agreements by pharmaceutical companies?

The FCCA may impose various remedies for anticompetitive conduct or agreements. The FCCA has sole jurisdiction to propose fines (an administrative penalty payment) to be imposed by the Market Court on undertakings or associations of undertakings party to an infringement. The amount of the fine shall not exceed 10 per cent of the turnover of the party to the infringement.

The FCCA may also issue a decision ordering the parties to cease and desist an infringement or order a company to deliver its products to another undertaking under the same conditions that it delivers to other companies. The FCCA may also impose commitments by the parties to an alleged infringement as binding and, on that basis, close the case file without further measures.

The FCCA has investigated several suspected infringements in the pharmaceutical sector, but these investigations have ended with the FCCA closing the case without further measures. In cases relating to other industries, the FCCA has proposed fines of up to €70 million to be imposed on an individual company for an infringement relating to the abuse of a dominant position and up to €68 million concerning horizontal cooperation, both of which have been accepted by the Supreme Administrative Court.

Private actions and remedies

Can private parties obtain competition-related remedies if they suffer harm from anticompetitive conduct or agreements by pharmaceutical companies? What form would such remedies typically take and how can they be obtained?

Private parties may submit a complaint to the FCCA in the event they suspect a competition law infringement, and the FCCA may use such a complaint as a basis for launching an investigation into the matter. However, under the Competition Act, the FCCA is entitled to prioritise the cases it investigates, and can close a case without further measures if it is, for instance, unlikely that the conduct in question would have a significant impact on the conditions of sound and effective competition.

Private parties can also claim for damages in the Finnish general civil courts based on a competition law infringement. The Act on Antitrust Damages Actions (No. 1077/2016) includes specific provisions under which damages resulting from an infringement of competition law can be claimed. The Act implements the EU Directive on Antitrust Damages Actions, and it entered into force on 26 December 2016.

To our knowledge, damages have not been claimed by private persons based on an infringement of competition law in the pharmaceutical sector in Finland. However, recently it has become very typical for damages to be claimed by injured parties in cases where the FCCA (and subsequently the courts) have found a company to have been party to an infringement of competition law. The total value of competition law-related damages claims currently pending in the Finnish civil courts is in the range of several hundred million euros.

Sector inquiries

May the antitrust authority conduct sector-wide inquiries? If so, have such inquiries ever been conducted into the pharmaceutical sector and, if so, what was the main outcome?

The FCCA may conduct sector-wide inquiries and publish reports and studies related to the market conditions in specific sectors.

In 2012, the FCCA published a comprehensive study on competition in the Finnish pharmaceutical industry titled ‘From the provision of pharmaceutical products to pharmaceutical markets - Value chain and regulation’. In the study, the FCCA assessed the need to reform the legislation concerning the pharmaceutical industry and the wholesale of medicines. On the basis of this analysis, the FCCA proposed several amendments to the legislation that were aimed at improving the efficiency and productivity of the provision of pharmaceutical products in Finland. However, the proposed amendments were mainly directed at the Finnish pharmacy system and the retail sector of pharmaceutical products. The FCCA recommended, for example, that the means testing in establishing new pharmacies, as well as other restrictions regarding the amount of pharmacies, should be abolished.

NGO involvement

To what extent do non-government groups play a role in the application of competition rules to the pharmaceutical sector?

Non-governmental groups do not play any particular role in the application of competition rules to the pharmaceutical sector, and there are no particular statues in law concerning such interaction between the FCCA and non-governmental groups. The FCCA may consult such non-governmental groups when, for example, analysing market conditions and in the course of sector-wide inquiries, and such groups can, similarly to all other parties, lodge complaints to the FCCA concerning suspected infringements of competition. Non-governmental groups do not have any particular standing in private antitrust litigation.

To the extent a non-governmental group can be considered to be an undertaking or association of undertakings, the conduct of such a group may also infringe competition rules, and the non-governmental group can be targeted by an investigation of the FCCA. The FCCA has investigated practices of trade associations in various fields of industry from time to time.

Review of mergers

Sector-specific considerations

Are the sector-specific features of the pharmaceutical industry taken into account when mergers between two pharmaceutical companies are being reviewed?

In recent years, no pharmaceutical industry mergers or acquisitions have been notified to the FCCA.

Since the introduction of merger control in Finland in 1998, the following cases concerning the pharmaceutical industry have been notified to the FCCA:

  • Kesko Oyj/Oriola Oyj/JV, Decision No. KKV/491/14.00.10/2017, 26 June 2017;
  • Idec Pharmaceuticals Corporation/Biogen Inc, Decision No. 555/81/2003, 4 August 2003;
  • Nycomed Pharma AS/Oy Leiras Finland Ab, Decision No. 1106/81/2002, 23 December 2002;
  • Orion-yhtymä Oyj/Kronans Droghandel Ab, Decision No. 7/81/2002, 22 May 2002;
  • Leiras Oy - Produits Chimiques Auxiliaires de Synthèse SA/Leiras Fine Chemicals Oy, Decision No. 650/81/2001, 1 August 2001; and
  • Nordic Capital III Limited/Nycomed Amersham Norge AS, Decision No. 472/81/99, 24 June 1999.

The merger control decisions adopted by the FCCA in these cases are rather straightforward and do not provide extensive discussion on the FCCA’s analyses in the matters. It is, however, noteworthy that the FCCA has drawn attention to certain sector-specific issues, such as the potential impact of the Finnish pharmaceutical single-channel wholesale distribution system in the competitive assessment of a merger.

Market definition

How are product and geographic markets typically defined in the pharmaceutical sector?

In the cases notified to the FCCA, the product and geographic markets were defined by the notifying party on the basis of the definitions that follow the European Commission’s practice. In Idec Pharmaceuticals Corporation/Biogen Inc, the notifying party referred to the Commission’s decisions where it has applied the anatomical therapeutic chemical (ATC) classification as a basis for product market definition. The ATC classification consists of four different levels, and in this case, the analysis was conducted on the third level, which allows medicines to be grouped according to their therapeutic indications. As regards the geographic dimension of the market, the notifying party submitted that it was national because of the differences in the legislation between the countries at the time of notification (ie, 2003).

In the most recent decision (Kesko Oyj/Oriola Oyj/JV), some of the relevant product markets concerned the pharmaceutical sector, namely the retail sale of medicines, the wholesale of medicines, and the procurement of medicines for the wholesale. The notifying parties submitted that the geographic dimension of the markets was national (or even local, as regards the retail sale of medicines).

Addressing competition concerns

Is it possible to invoke before the authorities the strengthening of the local or regional research and development activities or efficiency-based arguments to address antitrust concerns?

Under the Competition Act, the parties may invoke the ‘efficiency defence’, under which agreements otherwise restrictive of competition are considered to be in accordance with the Finnish Competition Act. For details of the efficiency defence criteria, see question 18.

In the assessment of the efficiency defence criteria, the strengthening of local or regional R&D activities does not play any particular role. The promotion of technical or economic progress is taken into account irrespective of the territory where it is generated (ie, the strengthening of local or regional R&D does not have any particular preference over a similar increase in R&D efforts on a national basis or outside Finland).

Horizontal mergers

Under which circumstances will a horizontal merger of companies currently active in the same product and geographical market be considered problematic?

The FCCA may propose to the Market Court the prohibition of a transaction that may significantly impede effective competition in Finland or a substantial part of it, in particular if the transaction creates or reinforces a dominant position. The FCCA, therefore, assesses notified mergers and acquisitions under a similar framework as the European Commission. In cases where the parties are currently active in the same product and geographical market, the FCCA will investigate whether the transaction may lead to the combined entity (or one or more competitors) having the ability and incentive to raise prices (eg, directly or by foreclosing competitors from the market).

Product overlap

When is an overlap with respect to products that are being developed likely to be problematic? How is potential competition assessed?

A merger of pharmaceutical companies that both have similar products under a late stage of development could potentially lead to competition concerns if the companies could successfully bring the products to market if the transaction does not take place. The FCCA could argue that absent the transaction, the two companies would launch products in competition with each other, whereas the combined entity would not create such competition on the market. For example, in Idec Pharmaceuticals Corporation/Biogen Inc the FCCA drew attention to the fact that the products under development (in phases II and III) by the target would not be competing products to those supplied by the acquirer.

Remedies

Which remedies will typically be required to resolve any issues that have been identified?

The FCCA (and ultimately the courts) may accept, as condition for clearance to a notified merger or acquisition, both structural and behavioural remedies. Generally, divestiture remedies may be more effective in resolving competition concerns. Remedies could also include assigning or licensing acquired patents to third parties.

Patents and licences

Would the acquisition of one or more patents or licences be subject to merger reporting requirements? If so, when would that be the case?

The FCCA has not considered an acquisition comprising solely a patent or a patent licence under merger control rules to date. Nor does the FCCA provide detailed guidance on this issue in its merger control guidelines. However, reference can be made to the European Commission’s consolidated jurisdictional notice, which considers that an acquisition confined solely to patents can be considered a notifiable transaction if the assets transferred constitute a business with a market turnover. The transfer of a patent licence, without additional assets, however, can only fulfil this criterion if the licence is exclusive at least in a certain territory and the transfer of the licence will transfer the turnover-generating activity.

Anticompetitive agreements

Assessment framework

What is the general framework for assessing whether an agreement or practice can be considered anticompetitive?

Under the Competition Act, the general framework in assessing whether an agreement or practice can be considered anticompetitive comprises:

  • a prohibition on agreements by undertakings, decisions by associations of undertakings or concerted practices that have as their object or effect the significant prevention, restriction or distortion of competition (section 5 of the Competition Act). This statute is similar to article 101(1) TFEU except that for the prohibition to apply, the restriction need not affect trade between member states; and
  • an exemption to the prohibition set out above (section 6 of the Competition Act). This ‘efficiency defence’ exemption is similar to that of article 101(3) TFEU. For the exception to apply, the restriction of competition must fulfil the following four cumulative criteria:
  • the restriction contributes to improving the production or distribution of goods or promotes technical or economic progress;
  • it allows consumers a fair share of the resulting benefit;
  • it does not impose restrictions on the parties that are unnecessary to achieve the benefits; and
  • it does not afford the undertakings the possibility of eliminating competition in respect of a substantial part of the products in question.

Technology licensing agreements

To what extent are technology licensing agreements considered anticompetitive?

The Finnish competition legislation does not provide particular guidance concerning the assessment of technology licensing agreements. The guidance provided in the European Commission’s Technology Transfer Block Exemption Regulation (No. 316/2014) and related guidelines provide further insight into the assessment of technology licensing agreements.

Co-promotion and co-marketing agreements

To what extent are co-promotion and co-marketing agreements considered anticompetitive?

Co-promotion and co-marketing agreements have not yet been investigated in detail by the FCCA. However, the same principles (which the European Commission recently followed in the assessment of such agreements) could be expected to be the starting point of the FCCA’s analysis.

Other agreements

What other forms of agreement with a competitor are likely to be an issue? Can these issues be resolved by appropriate confidentiality provisions?

As the prohibition of agreements restrictive of competition in the Competition Act is a general provision and can apply to all kinds of conduct that have as their object or effect the restriction of competition; in particular, competitors should always carefully assess any cooperation agreements that include restrictive terms or could otherwise be seen to have a restrictive purpose or effect.

Depending on the arrangement, confidentiality provisions may be sufficient to mitigate competition concerns (eg, appropriately limiting the amount of information exchanged between two pharmaceutical companies that engage in joint R&D). However, in many kinds of cooperation between competitors, confidentiality agreements alone may not be sufficient to resolve competition concerns.

Issues with vertical agreements

Which aspects of vertical agreements are most likely to raise antitrust concerns?

Similar to the European Commission’s Vertical Block Exemption Regulation (No. 330/2010), the main aspects of vertical agreements that raise concern are provisions relating to the resale pricing of products by a distributor and territorial or customer restrictions imposed on a distributor. However, a distinctive feature of the Finnish pharmaceutical sector is the extensive regulation concerning the pricing of pharmaceutical products. An assessment of, for example, restrictions in resale pricing by a distributor, should take into consideration the complex regulatory framework, which affects the possibilities of pricing products at the various levels of distribution.

As another distinct feature, currently only two major wholesalers exist in Finland, and manufacturers typically distribute their products only through one of them (the ‘single-channel distribution system’). The FCCA has investigated the single-channel distribution system on several occasions and has closed each of its reviews without further measures, most recently in 2012. In a recent merger clearance decision (Kesko Oyj/Oriola Oyj/JV), some of the market players raised concerns relating to the single-channel distribution system and the possible future development of the retail sale of medicines owing to Oriola’s vertical integration. The FCCA did not see the vertical integration as a threat to competition because of the uncertainty surrounding the possible deregulation of the retail sale of medicines.

Patent dispute settlements

To what extent can the settlement of a patent dispute expose the parties concerned to liability for an antitrust violation?

The FCCA has not issued any decisions concerning patent settlement agreements. However, the guidance provided in the European Commission’s technology transfer guidelines and the cases investigated by the European Commission and the General Court’s judgment in Lundbeck (T-472/13) would likely be a starting point in the FCCA’s assessment of the competitive effects of a patent settlement agreement entered into by companies in the pharmaceutical sector.

Joint communications and lobbying

To what extent can joint communications or lobbying actions be anticompetitive?

The FCCA has not issued any decisions concerning joint communications or lobbying actions in the pharmaceutical sector. However, within other sectors in Finland, joint lobbying actions have recently been under public debate. The Market Court took a stand on lobbying actions in December 2017 as a result of the FCCA’s fine proposal that suggested penalty payments for several bus companies, the Finnish Bus and Coach Association and travel-services provider Oy Matkahuolto Ab.

According to the Market Court, lobbying actions, negotiations and discussions relating to ongoing legislative reform were part of normal trade association lobbying actions. However, if the parties were to discuss, agree or decide on anticompetitive measures (eg, collective actions against a market player, the possible effects of the legislative reform on the business, or future market behaviour in the changed circumstances) alongside the lobbying actions, these would be considered as infringements (Market Court, Decision No. MAO:781/17, 14 December 2017, under appeal in the Supreme Administrative Court).

Public communications

To what extent may public communications constitute an infringement?

The FCCA has not issued any decisions concerning public communications in the pharmaceutical sector. In general, public communications of intended future price increases or other future behaviour could constitute an infringement if such communications led to coordination between competing companies. The FCCA has, for example, advised Finnish banks not to indicate their future loan margins of mortgages (which are a significant part of the price of the mortgage for their customers) in press releases, as this could constitute an infringement by means of price signalling.

The Finnish case law on public communications as an infringement relates to trade associations and their price recommendations for their member companies. The Finnish courts have issued two recent decisions where they found that a trade association’s public communications on prices and price increases constituted an infringement (the Finnish Bakery Federation, Leipuriliitto ry, Decision No. MAO:121/16, 29 February 2016, and the Finnish Hairdressers’ Association, Hiusyrittäjät ry, Decision No. 1993/2013, 14 June 2013). In addition, the EU case law on public communications (eg, Commission Decision in case AT.39850 - Container Shipping) would probably be taken into account in any assessment by the FCCA.

Exchange of information

Are anticompetitive exchanges of information more likely to occur in the pharmaceutical sector given the increased transparency imposed by measures such as disclosure of relationships with HCPs, clinical trials, etc?

The fulfilment of transparency requirements set forth in mandatory legislation is not likely to give direct rise to anticompetitive information exchange caught by the Competition Act. Nor should anticompetitive information exchange be considered more likely in the pharmaceutical sector in Finland, as the general guidance provided by the EU Commission regarding information exchange is well known by the Finnish pharmaceutical companies, and they strictly follow applicable competition rules.

Anticompetitive unilateral conduct

Abuse of dominance

In what circumstances is conduct considered to be anticompetitive if carried out by a firm with monopoly or market power?

Under section 7 of the Competition Act, the following conduct in particular, may be considered anticompetitive by a dominant company:

  • directly or indirectly imposing unfair purchase or selling prices or other unfair trading conditions;
  • limiting production, markets or technical development to the prejudice of consumers;
  • applying dissimilar conditions to equivalent transactions with other trading parties, thereby placing them at a competitive disadvantage; and
  • making the conclusion of contracts subject to acceptance by the other parties of supplementary obligations that, by their nature or according to commercial use, have no connection with the subject of such contracts.

This statute is similar to article 102 TFEU. The list of conduct above is not exhaustive, and, in principle, all kinds of conduct with an exclusionary, exploitative or distortionary effect on the market could fall within the prohibition on the abuse of a dominant position.

De minimis thresholds

Is there any de minimis threshold for a conduct to be found abusive?

The Finnish competition legislation does not include any particular de minimis threshold for a conduct to be found abusive within the pharmaceutical sector or within any other industries. However, under the Competition Act, the FCCA is entitled to prioritise the cases it investigates, and can close a case without further measures if it is, for example, unlikely that the conduct in question would have a significant impact on the conditions of sound and effective competition. The EU case law (eg, C-413/14 P, Intel v Commission and previous judgments) would likely be taken into account in assessing the coverage of the abusive conduct.

Establishing dominance

When is a party likely to be considered dominant or jointly dominant?

The Finnish competition legislation does not include any particular thresholds for the assessment of dominance in the pharmaceutical sector. However, in general a market share of 40 per cent in a properly defined relevant market, combined with other factors, may lead to a presumption of dominance, and a market share of 50 per cent may, as such, lead to the presumption of dominance.

To date, the FCCA has not found any company in the pharmaceutical industry to hold a dominant market position.

Can a patent holder be dominant simply on account of the patent that it holds?

It should not be sufficient to find dominance solely on the basis of ownership of an intellectual property right, such as a patent. However, depending on market circumstances, the ownership of a patent may be a relevant factor in establishing dominance.

Patent grant and enforcement

When would life-cycle management strategies expose a patent owner to antitrust liability?

The FCCA has not issued any decisions concerning life-cycle management strategies of pharmaceutical companies. Nonetheless, pharmaceutical companies should be careful in assessing whether life-cycle management strategies include any anticompetitive means to exclude competitors from the market. While pharmaceutical companies may legitimately seek intellectual property protection for their innovations to the fullest extent permitted by law, measures to artificially extend protection beyond the purpose of the intellectual property protection might, in particular circumstances, expose the patent owner to liability for an antitrust violation.

To what extent can an application for the grant or enforcement of a patent expose the patent owner to liability for an antitrust violation?

The FCCA has not issued any decisions where it would have considered that an application for the grant of a patent would have been an antitrust violation or a part of such a violation. However, the Court of Justice of the European Union’s (CJEU) judgment in AstraZeneca v Commission (C-457/10 P) would likely be seen as a relevant precedent in assessing conduct relating to applications for intellectual property protection.

The FCCA has not issued any decision where it would have considered the enforcement of a patent to constitute an antitrust violation or a part of such violation. The FCCA would likely consider the CJEU’s precedent and the European Commission’s practice as relevant, should a case relating to the enforcement of patents come under investigation.

Communications

Can communications or recommendations aimed at the public or HCPs trigger antitrust liability?

The FCCA has not issued any decisions where it considered any communications or recommendations aimed at the public or healthcare professionals to have been an antitrust violation or a part of such a violation. If communications or recommendations aimed at the public or healthcare professionals were to take place during an ongoing tender process or were to include recommendations other than those concerning improved quality and professionalism of the tender processes, it is likely that the FCCA would assess the possible anticompetitive effects of these communications or recommendations carefully. However, contacting public authorities in order to indirectly influence the competitive circumstances related to ongoing legislative reform is considered normal lobbying actions and thus acceptable (eg, Market Court, Decision No. MAO:781/17, 14 December 2017).

Authorised generics

May a patent holder market or license its drug as an authorised generic, or allow a third party to do so, before the expiry of the patent protection on the drug concerned, to gain a head start on the competition?

Authorised generics, as such, have not been seen to raise issues under Finnish competition law. However, pharmaceutical companies must always assess whether their conduct could constitute an abuse of a dominant position or whether an agreement concerning generics could have as its object or effect the restriction of competition.

Restrictions on off-label use

Can actions taken by a patent holder to limit off-label use trigger antitrust liability?

The FCCA has not issued any decisions where it considered actions taken by a patent holder to limit off-label use to have been an antitrust violation. However, the CJEU’s judgment in F Hoffman-La Roche and Others (C-179/16) would likely be seen as a relevant precedent in assessing the possible anticompetitive effects of actions to limit off-label use of medicines.

Pricing

When does pricing conduct raise antitrust risks? Can high prices be abusive?

Pricing conduct raises antitrust risks when the pricing is predatory, discriminatory or excessive, or where unfair price increases without cost justification take place. In practise, all pricing conduct with an exclusionary, exploitative or distortionary effect on the market could constitute an abuse of dominant position. These are assessed in line with the application of article 102 TFEU.

The FCCA has not issued any decisions where it considered high prices within the pharmaceutical sector although high prices in general have been assessed several times in other industries. However, these cases are rather old and the assessment has been somewhat formal. It is likely that the FCCA would concentrate more on economic effects in any future assessments of high prices. In addition, the FCCA would likely take the recent case law on excessive pricing (eg, ongoing Commission investigation on Aspen Pharma’s excessive pricing and the Italian decision on Aspen Pharma’s unfair price increases) into consideration when assessing high prices within the pharmaceutical sector.

Sector-specific issues

To what extent can the specific features of the pharmaceutical sector provide an objective justification for conduct that would otherwise infringe antitrust rules?

The pharmaceutical sector does not enjoy any particular exemption from the application of Finnish competition law. However, the Finnish legislation concerning the pharmaceutical sector should be taken into consideration when assessing whether a particular type of conduct is contrary to competition law. This may be relevant, in particular concerning the distribution of pharmaceutical products in Finland in view of the existing legislation on, for example, pricing and availability.

Has national enforcement activity in relation to life-cycle management and settlement agreements with generics increased following the EU Sector Inquiry?

The FCCA has not published information of any inquiries relating to life-cycle management or settlement agreements since the EU Sector Inquiry.

Update and trends

Current trends and developments

Are there in your jurisdiction any emerging trends or hot topics regarding antitrust regulation and enforcement in the pharmaceutical sector?

At the end of 2017, Fimea submitted a report to the Ministry of Health and Social Affairs concerning the problems that occurred in the wholesale of medicines. Fimea made 10 suggestions on how to improve distribution in future, including a proposal to distribute critical pharmaceutical products through a multi-channel system. Because the wholesale of medicines in Finland is based on a single-channel distribution system, this would be a significant change in Finland. Fimea’s suggestions are now being examined more closely by the Ministry of Health and Social Affairs and as part of other possible developments in the Finnish pharmaceutical sector (including possible deregulation of the retail sale of medicines). First amendments are expected by spring 2019.