Mergers: Commission approves the merger of Mylan and Pfizer's Upjohn division, subject to conditions
The European Commission has approved, under the EU Merger Regulation, the proposed merger between the global pharmaceutical company Mylan and Upjohn, a business division of Pfizer, which operates Pfizer's off-patent branded and generic established medicines. The decision is conditional on the divestment of Mylan's business for certain generic medicines.
The transaction will lead to the combination of Mylan, one of the top five generic suppliers in the EEA with the originator Upjohn, whose products have lost exclusivity following patent expiries.
Executive Vice-President Margrethe Vestager, responsible for competition policy, said: "Ensuring that patients and hospitals have access to medicines at fair and competitive prices, as well as ensuring security of supply, is always a key priority which resonates even more strongly in the current challenging context. Our decision ensures that the merger between Mylan and Upjohn does not harm competition, thus preserving competitive access to certain genericised medicines for national health services and European citizens".
The Commission's investigation
The Commission's investigation focused on the market for genericised medicines, which are sold to pharmacies and hospitals. Mylan and Upjohn overlap in various therapeutic areas such as cardiovascular, genito-urinary, musculoskeletal, nervous system, and sensory organ treatments.
The Commission found that for the genericised medicines involved in this case, competition between suppliers typically takes place (i) at the national level, given the differing national regulatory/reimbursement schemes and competitive dynamics between pharmaceutical suppliers, (ii) between medicines using the same chemical molecule as an active pharmaceutical ingredient for a specific therapeutic indication. Generally, the molecules covered by the investigation are not interchangeable with other molecules for patients or health practitioners and should therefore be assessed separately.
The Commission's investigation found that no competition concerns arise for the majority of the products supplied by both Mylan and Upjohn. However, in some countries and for some molecules, the Commission found the transaction would raise competition concerns because of the strong position of the two companies and the limited number of significant competitors on the market. In particular, concerns were found for 36 molecule-country pairs as indicated in the table below:
Molecules
Countries
Alprazolam
Greece, Iceland, Ireland, Italy, Portugal
Atorvastatin
Norway
Doxazosin
Czechia, France
Eletriptan
Denmark, Finland, France, Norway, Sweden
Eplerenone
Belgium, Hungary
Gabapentin
Ireland
Latanoprost
Belgium, Luxembourg
Latanoprost/timolol
Belgium, France, Italy, Luxembourg, Netherlands, Portugal
Pregabalin
Belgium, Czechia, Luxembourg, Norway
Sildenafil (for pulmonary arterial hypertension)
Estonia, France, Latvia, Lithuania, Romania, United Kingdom
Venlafaxine
Belgium
Ziprasidone
Czechia
The Commission also investigated the vertical relationships between Mylan and Upjohn With respect to (i) active pharmaceutical ingredients and (ii) out-licensing which are both upstream to the supply of genericised medicines. The Commission concluded that no competition concerns arise in this regard.
The commitments
To address these concerns, Mylan and Upjohn offered to divest to one or more suitable purchasers, Mylan's business in the relevant markets, including the applicable marketing authorisations, contracts and brands, as well as transitory manufacturing and supply arrangements. These include certain generic medicines across 20 countries throughout the EEA and the UK.
The proposed commitments remove the entire overlaps between Mylan and Upjohn in the markets raising serious doubts and fully address all of the Commission's competition concerns.
The Commission therefore concluded that the proposed transaction, as modified by the commitments, would no longer raise competition concerns in the EEA. The decision is conditional upon full compliance with the commitments.
Companies and products
Mylan, based in the Netherlands, is a vertically-integrated global pharmaceutical company that develops, licenses, manufactures, markets and distributes generic, branded generic and specialty pharmaceuticals.
Upjohn, based in China, is a business division of the global pharmaceutical company Pfizer, which operates Pfizer's off-patent branded and generic established medicines business, including products sold under the brands Viagra, Xanax and Lipitor.
Merger control rules and procedures
The transaction was notified to the Commission on 28 February 2020.
The Commission has the duty to assess mergers and acquisitions involving companies with a turnover above certain thresholds (see Article 1 of the EU Merger Regulation) and to prevent concentrations that would significantly impede effective competition in the EEA or any substantial part of it.
The vast majority of notified mergers do not pose competition problems and are cleared after a routine review. From the moment a transaction is notified, the Commission generally has a total of 25 working days to decide whether to grant approval or to start an in-depth investigation. This deadline is extended to 35 working days in cases where remedies are submitted by the parties, such as in this case.
More information will be available on the Commission's competition website, in the Commission's public case register under the case number M.9517.