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Competition Policy

Overview (Pharmaceuticals & Health Services)

Reports and Studies

Report on Competition enforcement in the pharmaceutical sector (2018-2022)

The Commission’s main enforcement actions in antitrust and mergers in the pharmaceutical sector are described in its updated Report on competition enforcement in the pharmaceutical sector 2018-2022 (available in all EU languages). The Report was drawn up in close co-operation with the national competition authorities of the EU Member States. It explains how antitrust decisions adopted by national competition authorities and the Commission (finding an infringement or accepting binding commitments in antitrust investigations) during that period, as well as Commission merger decisions, contributed to affordable and innovative medicines for EU patients.

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You can also download the Report on competition enforcement in the pharmaceutical sector 2009-2017 (available in DE/EN/FR and all other EU languages). 

See also:

Study on the impact of mergers and acquisitions on innovation in the pharmaceutical sector (21.12.2017)


Cooperation with national competition authorities

The Commission cooperates closely with national competition authorities (NCAs) through the European Competition Network (ECN). This cooperation includes regular discussions between colleagues working on pharmaceuticals, medical devices and health services.


Cooperation with the ECN during the Coronavirus Pandemic

Joint statement by the European Competition Network (ECN) on the application of competition law during the Coronavirus crisis

…it is of utmost importance to ensure that products considered essential to protect the health of consumers in the current situation (e.g. face masks and sanitising gel) remain available at competitive prices. The ECN will therefore not hesitate to take action against companies taking advantage of the current situation by cartelising or abusing their dominant


The life cycle of pharmaceutical products

The focus of competition law scrutiny, whether in merger control or in antitrust investigations, will vary depending on the stage of a product’s life cycle.

The life cycle of any new medicine begins with a new chemical compound, which is usually discovered through basic research conducted by so-called “originator manufacturers” or independent research facilities (universities, specialised laboratories) that are often supported by public funding. Once the basic research is completed, the pharmaceutical product containing the chemical compound is tested to verify if it would be safe and effective.

Once studies have shown that a new medicine is safe and effective, the originator company applies for a marketing authorisation to the competent regulatory agency. This could be either the European Medicines Agency (EMA) or a national authority.

The development cycles for innovative drugs are usually risky and lengthy, and entail high development costs. Recent estimates suggest that the costs of bringing a medicine from the lab to the market are between EUR 0.5 billion and EUR 2.2 billion (converted from USD) - see the Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe, May 2018 by Copenhagen Economics. Moreover, only a small minority of candidate molecules survive the development stage and finally make it to the market.

Pharmaceutical (originator) companies may enjoy an exclusivity on the market through patent protection for their products in order to recoup such research and development costs. Once the awarded patent has expired, producers of copy (so-called “generic”) products can enter the market. Such "generic entry” has typically the effect of bolstering competition and of driving prices for competing pharmaceuticals down.

Certain practices of pharmaceutical companies to protect their exclusivity may, under certain circumstances, lead to violations of EU competition law. These include, for example, patent clusters, patent thickets and patent settlements, which aim at prolonging market-exclusivity, and other anti-competitive strategies that result in higher prices. These types of behaviour entail not only the risk of price increases, but can also take away the incentive to innovate. See Sector Inquiry.

In the AstraZeneca case, the Commission investigated AstraZeneca's suspected abuse of the patent system and the system for authorisation of medicines, with the aim of delaying competition to a blockbuster drug from generic and parallel imported pharmaceuticals. The abuse of Astra Zeneca consisted in providing misleading information to a number of EEA patent offices in order to obtain supplementary protection certificates (SPCs) and misusing rules and procedures applied by national medicines agencies by selectively deregistering its market authorisations. AstraZeneca was fined EUR 60 million in 2005.