Competition law enforcement in the pharmaceuticals sector in Poland

There is no specific competition law regulatory framework that applies exclusively to the pharmaceutical sector. General competition rules apply.

The authority responsible for enforcing competition rules, including in the pharmaceutical sector, is the Office of Competition and Consumer Protection (the “OCCP”).

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In anti-trust cases, the OCCP can conduct explanatory proceedings and anti-monopoly proceedings.

Exploratory proceedings are initiated when the OCCP suspects that in a case, competition rules may have been infringed. These proceedings are often initiated on the basis of notices filed by private parties alleging anti-competitive practices (e.g. competitors or dissatisfied consumers) or ex officio (e.g. due to an informal market inquiry conducted by OCCP). During explanatory proceedings, the OCCP may call on undertakings to submit documents and information as well as decide to conduct inspections or searches of undertakings’ premises and belongings.

Explanatory proceedings may be concluded without charges being brought for an infringement of competition rules or with the initiation of anti-monopoly proceedings for practices infringing competition, which involves charges being brought against particular entities. This phase ends with a formal decision on whether or not the alleged conduct violates competition law. The decision is subject to appeal by the parties to the Court of Competition and Consumer Protection.

The maximum fine that the OCCP can impose on an undertaking for an anti-competitive practice is 10% of the turnover achieved by the undertaking in the financial year preceding the year in which the decision stating the infringement of competition was issued.

In addition, the OCCP may impose a fine on individual person(s) in a managerial position in the undertaking of up to PLN 2 million (EUR 433,000).

Aside from enforcement actions by the OCCP, actions can also be brought in private enforcement claims by a party that suffers damages due to a breach of competition law. The amount of damages claimed must be indicated in the claim. In determining the amount, it is necessary to consider the counterfactual scenario, i.e. how the situation on the market would have looked in the absence of the infringement. Generally, the damage will be the amount equal to the excess of the price paid by the claimant due to the anti-competitive practices (in scope that was not passed on by the claimant on its own clients).

Recently, there have been no published market research reports regarding the pharmaceutical sector. However, in the past, the OCCP has been involved in cases concerning the protection of consumers and relating to dietary supplements advertised in a way that might suggest a pharmaceutical effect or otherwise mislead consumers. The OCCP initiated numerous proceedings, organised meetings with the industry participants and co-authored consumer guidelines on supplements, However, no official report has been published in this regard.

In the past, the OCCP published two papers relating to competition issues in the pharmaceutical sector: (i) anti-competitive practices in the pharmaceutical sector in the context of EU law (2012); and (ii) delaying the market entry of generic medicinal products in the context of patent and competition law (2015).

The 2012 publication notes that a particular focus from the point of view of an infringement of EU competition rules must be attributed to the role of research and development in the pharmaceuticals market, patent protection mechanisms and competition between originators and generic producers. According to this analysis, the fact that originator pharmaceutical manufacturers seek to limit the entry of generics into the common market and want to have full control over which distribution channels their own innovative medicines are sold through makes it the most common objective of practices which distort competition in the EU to limit or eliminate parallel imports of medicinal products, whether through price fixing, refusal to supply or limiting purchases. On the other hand, as the publication indicates, entities in the pharmaceutical sector—although acting for their own benefit—indirectly influence the level of health of patients in Member States, and for this reason the Commission and the EU courts must consider the important role played by these companies in the process of raising standards of the protection of health and the lives of EU citizens. 

The 2015 publication discusses issues related to infringements of competition law rules in the pharmaceutical sector, such as: pay-for-delay agreements between potential competitors, the problem of creating “patent thickets”, seeking legal protection for low-inventive solutions as well as the possibility of violating competition law through the strategic use of procedures provided by law.

There are no official statistics regarding the rate of enforcement of competition laws in the pharmaceutical sector. However, based on our experience, it appears that the rate of enforcement of competition laws in the pharmaceutical sector is low compared to other industries.

There is a lack of official statistics on this matter. The OCCP’s most recent activities in the pharmaceutical market relate to merger proceedings, infringements of consumers’ collective interests and anti-competitive agreements relating to price fixing and resale price maintenance.

In 2019, the OCCP instigated anti-monopoly proceedings in the dietary supplements market. The alleged anti-competitive practice may have started in 2010. According to the OCCP, the manufacturers might have set and monitored the price levels of supplements and intervened if supplements were being sold at lower prices than agreed. These monitoring activities included calling for a change in prices, threating to withdraw the possibility to order the supplements on preferential terms, and in some cases threating to terminate the cooperation agreements. The case is still ongoing.