Over the past year, both European and Spanish competition authorities have intensified their scrutiny of business practices within the pharmaceutical sector. Below is a summary of the key decisions issued by the European Commission and the CNMC (Spanish National Markets and Competition Commission), along with the most relevant regulatory developments.
1. Europe: EU Competition Law and the Pharmaceutical Sector
Denigration Practices and Abuse of Dominant Position
The European Commission has addressed several anticompetitive practices, with particular focus on denigration campaigns carried out by undertakings holding a dominant position. Noteworthy cases include:
- Vifor Pharma (Case AT.40577): a campaign targeting Monofer (Pharmacosmos), based on the dissemination of misleading information. Although the infringement was confirmed, the Commission did not impose a fine, having accepted a package of commitments following a confidential settlement.
- Teva Copaxone (Case AT.40588): the Commission imposed a fine of €462.6 million for abuse of the patent system and for conducting a denigration campaign against Synthon GA.
SNBB Cartel
- Case AT.40636: sanctions were imposed on six pharmaceutical undertakings for price-fixing and market-sharing arrangements involving the active ingredient SNBB, which is essential in the manufacture of Buscopan.
Ongoing Investigation: Zoetis
- Case AT.40734: potential abuse of dominance under investigation following the discontinuation of the drug Ranevetmab, acquired through the purchase of Nexvet Biopharma.
Category Management Practices: Belgium
Fines were imposed on Johnson & Johnson Consumer, Boehringer Ingelheim, and Haleon for anticompetitive conduct in the category management of OTC medicines, involving restrictive planogram practices.
Merger Control – Authorised Transactions
In 2024 and Q1 2025, the European Commission cleared seven concentrations in the sector, including:
- Novo Holdings / Novo Nordisk / Catalent
- Carlyle / Vantive
- KKR / Impilo / Immedica
- CD&R / Opella Healthcare SAS
- Roquette / IFF Pharma Solutions
- Carlyle / SK Capital / Bluebird
2. Spain: CNMC Resolutions
Closed Proceedings
- IMQ: no indications of abuse of dominance were found and the case was closed.
- General Council of Dentists: case dismissed due to lack of sufficient evidence concerning restrictions on patients’ choice of dental prosthetics.
Ongoing Sanctioning Proceedings
- CGCOF and several Provincial Pharmaceutical Colleges (Case S/0009/23): under investigation for allegedly recommending the use of specific digital applications to the detriment of competitors.
- Sandoz, Bexal and Bluetab (Case S/0014/23): suspected exchange of sensitive commercial information regarding generic medicine orders.
- Sanitas – Generali (Case S/0008/25): possible coordination of pricing and commercial terms of insurance policies.
- HEFAME: failure to comply with commitments made in a previous merger clearance.
Approved Concentrations
Notable transactions authorised include:
- Haiyingkang / SRAAS
- Rovi / Insud / Innverte / Terafront JV
- Miura / Healthtech HTBA
- Esteve / Takeda
- Eurofins / Synlab
- Bidco / Stamina Topco
One transaction (MCH / CASP / Druni / Arenal) was cleared subject to structural and behavioural commitments. Another (Curium / IRAB) is under Phase II review, as the transaction would result in a combined market share exceeding 60% in a key market.
3. New Pharmaceutical Regulation in Spain
2024–2028 Strategy and Draft Medicines and Medical Devices Bill
In December 2024, the Spanish Government presented its Pharmaceutical Industry Strategy 2024–2028. In April 2025, it published the draft Medicines and Medical Devices Act, which introduces reforms such as:
- A new pricing system: combining selected price models and reference pricing schemes.
- Active ingredient-based prescribing: including new rules for pharmacy-level substitution based on patient preference and price thresholds.
CNMC’s Position
Since its 2022 market study, the CNMC has advocated for a more flexible framework allowing price differentiation to encourage competition. Its recommendations include:
- Allowing alternative medicines to be offered at the point of dispensing.
- Reforming reference pricing to avoid automatic price equalisation.
- Expanding the sets of medicines subject to reference pricing.
Industry Reaction
Five major pharmaceutical associations have raised concerns about the potential impact of the proposed reforms on innovation and international competitiveness. However, the legislative text remains at draft stage and is subject to parliamentary review and potential amendment.
