INSIGHT // 62 Strategic Risk

Switzerland Adopts the SIEC Test: The Revised Kartellgesetz and Its New Merger-Control Reach for US MedTech and Pharma Deals

Abstract: On 19 December 2025 the Swiss Federal Assembly adopted a partial revision of the Kartellgesetz that replaces the qualified-dominance test in merger control with a significant-impediment standard modeled on the EU Merger Regulation. For US MedTech and pharma acquirers with Swiss revenues, the change converts Swiss merger review from a near-formality into a substantive assessment: concentrations WEKO could previously reach only at the edge of monopoly become contestable, remedies become the currency of clearance, and an efficiencies defense that assigns the burden of proof to the notifying parties enters Swiss statutory law. The notification thresholds do not move. Entry into force is expected in 2027, and a transitional rule keyed to the filing date makes deal timing itself a legal variable.
Plain Language Summary

This article examines Switzerland's competition statute, the Kartellgesetz (KG), and the amendment the Swiss parliament approved on 19 December 2025. The KG plays the role that the Clayton Act and the merger-review rules play in the United States. Under the version still in force, the Swiss competition authority (the Wettbewerbskommission, WEKO) may block a merger only in an extreme case: the deal must be able to wipe out effective competition. The approved amendment lowers that bar. It lets WEKO intervene against any merger that significantly impedes effective competition. The wording is the standard the European Commission applies, and it was chosen to track it. The Swiss version is not identical. Efficiency gains enter the prohibition test as a separate element that the merging companies must prove. No Swiss authority has yet applied the new standard to a case. The article explains why this matters for US medical-technology and pharmaceutical companies that buy or sell businesses with Swiss sales. It also explains how the Swiss change interacts with EU and US merger filings, and why the timing of a transaction affects which rules apply. It does not provide advice on any specific transaction.

Table of Contents
  1. From Qualified Dominance to SIEC: What Changed
  2. WEKO Merger Review: Thresholds, Timing, and the New Test
  3. Where a Swiss Filing Stacks on EUMR, FSR, and US HSR
  4. Exposure for US MedTech and Pharma Transactions
  5. Strategic Considerations

A US deal team stress-testing a MedTech or pharma acquisition thinks in two substantive standards: Section 7 of the Clayton Act, which asks whether the effect of the acquisition may be substantially to lessen competition,115 U.S.C. § 18 (Section 7 of the Clayton Act); 15 U.S.C. § 18a (HSR Act premerger notification, thirty-day waiting period). and the EU Merger Regulation, which asks whether the concentration would significantly impede effective competition.2Council Regulation (EC) No 139/2004 (EC Merger Regulation) [2004] OJ L24/1, Art. 2(3): the SIEC standard. Switzerland has asked a narrower question. Under the Kartellgesetz (KG) as it stands, the Wettbewerbskommission (WEKO) can intervene against a concentration only where it creates or strengthens a dominant position capable of eliminating effective competition.3Bundesgesetz über Kartelle und andere Wettbewerbsbeschränkungen (Kartellgesetz, KG) vom 6. Oktober 1995 (SR 251): Art. 9 (notification), Art. 10(2) (substantive test), Art. 32–34, Art. 51(1)–(2). On 19 December 2025 the Federal Assembly voted to retire that test.4Änderung des KG vom 19. Dezember 2025, BBl 2026 18: SIEC standard in Art. 10, Art. 9(1bis) exemption, transitional rule. What replaces it reads like the EU standard. Treating it as the EU standard, arrived at by other means, would be the first analytical mistake.

1. From Qualified Dominance to SIEC: What Changed

The height of the bar Switzerland is abandoning is easy to understate. Art. 10(2) KG in its pre-revision form permits WEKO to prohibit a concentration, or clear it subject to conditions and obligations, only where the transaction creates or strengthens a dominant position by which effective competition can be eliminated, in the statutory words eine marktbeherrschende Stellung, durch die wirksamer Wettbewerb beseitigt werden kann, and only where the concentration does not improve competitive conditions in another market to an extent that outweighs that harm. Dominance alone was never enough; the statute demanded the prospect that competition could be eliminated outright. The practice that grew on this text looks the way the text predicts. WEKO sees a few dozen notifications a year, clears nearly all of them within the preliminary month, and its outright prohibitions are rare enough to name individually: Berner Zeitung/20 Minuten in 2004 (annulled on appeal), France Télécom/Sunrise in 2010 and Ticketcorner/Starticket in 2017,5Botschaft vom 24. Mai 2023 zur Teilrevision des Kartellgesetzes, BBl 2023 1463: the pre-revision intervention threshold, described statistically rather than by case; the three prohibitions cited by decision. and Post/Quickmail in January 2024, where the incumbent postal operator sought to absorb a nationwide private rival in letter, parcel and press delivery, a combination WEKO found would eliminate effective competition in the market for national addressed bulk business letters above fifty grams.6WEKO, Medienmitteilung vom 19. Januar 2024: prohibition of the Post/Quickmail concentration. Each sits at the edge of monopoly. That is where the test lived.

A test that bit only at the edge of monopoly becomes a test for any transaction that significantly impedes effective competition, applied by an authority that has never applied it, under implementing ordinances that were still in consultation as of publication.

The revised Art. 10(2) KG changes both limbs. WEKO may prohibit a concentration, or clear it with conditions and obligations, where the examination shows that the transaction significantly impedes effective competition, den wirksamen Wettbewerb signifikant behindert, in particular by creating or strengthening a dominant position, and where the notifying undertakings fail to establish verifiable efficiency gains for customers that arise specifically from the concentration and offset the disadvantages of that impediment.4Änderung (n 4), revised Art. 10(2) KG: significant-impediment standard plus the efficiencies limb, with the burden on the notifying undertakings. Dominance moves from necessary condition to illustrative example. The elimination-of-competition ceiling disappears, which brings mergers in concentrated but not monopolized markets, the non-collusive oligopoly cases familiar from Brussels, within reach for the first time. And the efficiencies limb arrives as operative statutory text with its burden assigned: the gains must be substantiated by the notifying undertakings, must be verifiable, must be merger-specific, and must accrue to customers. The wording deliberately tracks Art. 2(3) of the EU Merger Regulation, and alignment was the declared purpose; the Botschaft diagnosed a Swiss intervention threshold that had drifted out of step with international practice. The familiar words nonetheless carry Swiss-specific texture. The EU regulation treats efficiencies as part of the overall appraisal; the revised KG writes them into the prohibition standard as a distinct limb with an express allocation of proof. Nothing in the amending act itself imports the European Commission’s decisional practice on closeness of competition, elimination of an important competitive force, or innovation effects. The Botschaft, however, equates the Swiss signifikant with the EU German erheblich, the divergent word chosen only to keep the merger test clear of the Erheblichkeit of Art. 5(1) KG, and directs that European practice be taken into account in assessing a significant impediment.5Botschaft (n 5): ‘signifikant’ is to be equated with the EU German ‘erheblich’, and the European practice is to be taken into account (mitberücksichtigt) when assessing a significant impediment. Taking European practice into account is not the same as following it, and what the direction leaves open is how far WEKO, and on appeal the Bundesverwaltungsgericht, will adopt the Commission’s reasoning on those theories. A US company’s EU precedent file supplies the vocabulary and, on the Botschaft’s own instruction, some of the reasoning; it does not supply the outcomes.

2. WEKO Merger Review: Thresholds, Timing, and the New Test

What the revision does not change is who must file. The duty to notify continues to attach where the undertakings concerned together generated worldwide turnover of at least CHF 2 billion, or turnover in Switzerland of at least CHF 500 million, and at least two of them each generated turnover in Switzerland of CHF 100 million or more.3KG (n 3), Art. 9(1) (turnover thresholds) and Art. 9(4) (notification duty following a final finding of dominance, for the affected market and any upstream, downstream or neighboring market). Two US-headquartered groups with no Swiss production and no Swiss deal nexus in the US sense can meet those numbers on sales alone, which is why foreign-to-foreign transactions have long been notified in Bern. There is no transaction-value threshold of the kind US counsel know from the HSR size-of-transaction test, and the revision declined to add one. A separate trap survives untouched: where a final decision has established that an undertaking dominates a Swiss market, every concentration involving that undertaking that concerns the same market, or an adjacent, upstream or downstream market, must be notified regardless of turnover. Art. 9(4) KG has no HSR analogue, and it is the provision serial acquirers overlook.

The procedural architecture keeps its shape and gains slack. The preliminary examination remains one month and the in-depth examination four, the latter running longer only where the parties themselves cause delay; the revision permits WEKO to extend the first by up to one month and the second by up to two, in each case only for good cause and only with the consent of the notifying undertakings, an outer envelope of eight months where the authority’s grounds and the parties’ agreement line up.4Änderung (n 4), Art. 32(3) and Art. 33(4) KG: extensions of the one-month and four-month periods, available only for good cause and with the notifying undertakings’ consent. The stakes of impatience are unchanged in substance, though the revision writes the standstill during the in-depth examination expressly into the statute for the first time: implementation before clearance is prohibited absent provisional authorization, the civil-law effectiveness of a notifiable concentration remains suspended while clearance is outstanding, and closing in breach carries administrative sanctions of up to CHF 1 million. None of this is exotic to a US reader. What changes is the probability that a Swiss filing ends up in the four-month phase at all, and that the remedies conversation inside that phase, not the notification itself, becomes the transaction’s critical path.

Timing is where the revision becomes a present-tense problem for transactions signing in 2026. The amending act leaves commencement to the Federal Council; the referendum deadline of 17 April 2026 passed without a referendum, the consultation on the total revision of three of the four implementing ordinances, among them the VKU governing merger notifications, opened on 27 May 2026 and runs to 17 September 2026,7Bundesrat, Medienmitteilung vom 27. Mai 2026: consultation on the total revision of the VKU, SVKG and GebV-KG, until 17 September 2026. and entry into force is not expected before 2027, a date that had not been fixed as of publication. The transitional rule is keyed neither to signing nor to closing: concentrations are assessed under the law in force when the notification is filed.4Änderung (n 4), Art. 62(1) KG: assessment under the law in force at the time the notification is filed. A transaction signed while the qualified-dominance test still governs, and notified after commencement, is a SIEC case.

3. Where a Swiss Filing Stacks on EUMR, FSR, and US HSR

For an acquisition with a European footprint, the Swiss filing has never been absorbed by Brussels. The one-stop shop of the EUMR displaces the merger-control laws of the Member States, not of third countries; a concentration with a Community dimension, cleared in Brussels on the SIEC standard since 2004, still went to Bern for a separate examination whenever the Swiss thresholds were met.2EC Merger Regulation (n 2), Art. 21(3): Member States may not apply national competition law to concentrations with a Community dimension, the Regulation’s own term. Switzerland is outside that discipline. The revision builds the first bridge. Under the new Art. 9(1bis) KG, no Swiss notification is required where two conditions hold: every product market affected by the transaction must be delineated geographically so as to comprise Switzerland and at least the European Economic Area, and the European Commission must be reviewing the transaction. The parties then owe WEKO a complete copy of the EU filing within ten days.4Änderung (n 4), Art. 9(1bis) and (1ter) KG: exemption conditions and the ten-day copy obligation.

The exemption’s condition is the analytical problem. Whether every affected market is at least Switzerland-plus-EEA wide is a market-definition judgment, and market definition is precisely what a contested merger review exists to fight about. Pharmaceutical distribution, hospital procurement and MedTech sales channels have repeatedly been treated as national markets in European practice; a single Swiss-national market anywhere in the transaction defeats the carve-out, and parties who invoke it wrongly have implemented a notifiable concentration without clearance, with the consequences Art. 51 KG attaches. The bridge also opens only at commencement. Until then the parallel filing persists; after it, reliance on the exemption is a self-assessment whose risk the deal documents have to carry. Who signs off on the market-definition call, on what evidence, and who bears the cost if WEKO disagrees are allocation questions, not filing mechanics.

The Swiss clock is not the only European clock running beside the EUMR. Since October 2023 the FSR has added a further mandatory notification for concentrations where the acquired undertaking, one of the merging undertakings or the joint venture is established in the Union with at least EUR 500 million in Union turnover, and the parties received more than EUR 50 million in aggregate third-country financial contributions in the three years before the agreement, the public bid announcement or the acquisition of a controlling interest, with twenty-five working days of preliminary review and ninety more from the opening of an in-depth investigation,8Regulation (EU) 2022/2560 (FSR) [2022] OJ L330/1: Art. 20(3) thresholds; Art. 24–26 standstill, review periods and fines. a regime whose appetite for US tax credits and federal funding is examined in the analysis of the Foreign Subsidies Regulation for US biotech M&A. The HSR Act runs its thirty-day waiting period and Second Request practice at home. Four clocks, four substantive standards, one signing. Which authority’s remedy theory gets priced first, and whether a divestiture shaped for one regulator satisfies the other three, are coordination questions that surface after signing, when the leverage to answer them has already been spent.

Four merger-review clocks that can run on one signing, and the standard each applies A diagram with four horizontal tracks showing the review timetables that can apply in parallel to a US MedTech or pharma acquisition with Swiss revenues. The Swiss track under the Kartellgesetz shows a one-month preliminary examination and a four-month in-depth examination, each extendable under the revised KG, for good cause and with the consent of the notifying undertakings, by one and two months respectively, with a note that the substantive standard changes from qualified dominance to significant impediment when the revision enters into force, a date the Federal Council had not fixed as of publication. The EU Merger Regulation track shows twenty-five working days of Phase I and ninety working days of Phase II under the SIEC standard applied since 2004. The Foreign Subsidies Regulation track shows twenty-five working days of preliminary review and ninety plus fifteen working days in depth, testing distortion by foreign subsidies. The US HSR track shows a thirty-day waiting period followed by Second Request practice without a fixed outer limit, under the Clayton Act standard of substantial lessening of competition. A legend notes that the bars are schematic and that the revised Art. 9(1bis) KG can lift the Swiss filing only where every affected market is at least Switzerland-plus-EEA wide and the European Commission reviews the transaction. FOUR CLOCKS ON ONE SIGNING parallel merger-review tracks for a US acquirer with Swiss revenues, and the standard each applies SWITZERLAND · KG · WEKO standard: qualified dominance; SIEC on commencement (expected 2027) 1 month +1 consent 4 months in-depth +2 consent EU · EUMR · EUROPEAN COMMISSION standard: SIEC, Art. 2(3) EUMR, applied since 2004 25 working days 90 working days, extendable EU · FSR · EUROPEAN COMMISSION standard: distortion by foreign subsidies, plus balancing 25 working days 90 working days in depth +15 US · HSR ACT · FTC / DOJ standard: substantial lessening of competition, Clayton Act § 7 30 days Second Request, no fixed outer limit Bars are schematic review windows, not a shared calendar. Dashed segments are extension windows; the two Swiss ones require good cause and party consent. Art. 9(1bis) revised KG lifts the Swiss filing only where every affected market is at least CH-plus-EEA wide and the European Commission reviews.
Fig. 1. Merger-review clocks potentially applicable in parallel to a US MedTech or pharma acquisition with Swiss revenues, with the substantive standard each track applies. The Swiss track changes its standard, and gains the two dashed extension windows, but not its thresholds, when the revised KG enters into force; that date remained open as of publication.

4. Exposure for US MedTech and Pharma Transactions

The sector exposure is structural rather than incidental. Life-sciences transactions concentrate exactly the features the new test reaches. Swiss positions in pharmaceuticals and medical devices are frequently held through national distribution arrangements, hospital purchasing runs through Swiss-specific channels, and the combined Swiss revenues of two US groups with Basel-area operations can meet the Art. 9(1) KG thresholds without either party thinking of the transaction as Swiss. Under the qualified-dominance test, an overlap that stopped short of threatened monopoly was, in practical terms, invisible to Bern. Under a significant-impediment standard, the theories familiar from EU life-sciences practice, closeness of competition between the merging parties, elimination of an important competitive force, harm to innovation through overlapping development pipelines, become arguable in Switzerland for the first time. Whether WEKO adopts them, with what evidentiary appetite and what taste for behavioral rather than structural remedies, is unwritten.

Remedies change value accordingly. A regime whose prohibitions were rare enough to name individually produced a thin Swiss record on divestiture design and on the sequencing of remedy discussions against a four-month deadline that can be extended only by consent, which is to say at a price. Clearance subject to conditions and obligations has always been available under Art. 10(2) KG and WEKO has used it, but that practice was built under a test that reached only the edge of monopoly, and it says little about what a significant impediment short of dominance will cost to remedy. The first generation of SIEC-era remedies will be negotiated against an authority with no settled template, while the same overlap is being remedied in Brussels and Washington under standards that do not match the Swiss statute’s efficiencies limb. The efficiencies defense itself has a proof architecture no one has tested. Gains that are verifiable, merger-specific and passed on to customers must be established by the notifying parties; what WEKO will accept as verification, at which procedural moment, and on which documents are questions the ordinances in consultation may or may not answer. For the US side of the house, the exposure feeds back into familiar places: a Swiss in-depth examination that outlasts the EUMR and HSR clocks becomes the long pole in the longstop; a prohibition risk that was previously negligible moves into the conditions-precedent architecture, the reverse-termination-fee discussion and the disclosure calculus of a listed acquirer; and an incumbent with a prior Swiss dominance finding inherits Art. 9(4) KG filings on adjacent-market acquisitions its US playbook would treat as immaterial. None of this makes Switzerland the hardest jurisdiction on the map. It makes Switzerland a jurisdiction that must be mapped, which for nearly three decades it effectively was not.

5. Strategic Considerations

The strategic questions compound where substance meets calendar. Because the applicable test follows the filing date, a transaction signing in the second half of 2026 with closing expected in 2027 may be assessed under either standard, and the parties’ incentives can point in opposite directions: a deal whose markets are plausibly EEA-wide gains the Art. 9(1bis) carve-out only under the new law, while a deal with Swiss-national overlaps may prefer the old test to the new standard that the carve-out arrives with. Both incentives converge on a commencement date the Federal Council had not fixed as of publication. Whether a notification can responsibly be sequenced around an unannounced date, what happens to that sequencing if the date moves, and who bears the cost if it moves the wrong way are questions a signing protocol has to answer in advance, on facts the parties cannot fully know.

The evidentiary questions are no easier. If the efficiencies limb is to carry weight, the record that substantiates it, synergy quantifications, integration plans, pass-through analysis, is assembled long before a notification is drafted, in board papers and financing documents produced under US disclosure incentives that never anticipated a Swiss proof burden. Which of those documents help, which hurt, and how one data room reads under four merger regimes simultaneously is a question of preparation rather than filing technique. The ordinances in consultation until 17 September 2026 will determine what the first SIEC-era notifications must contain,7Bundesrat, Medienmitteilung vom 27. Mai 2026 (n 7): the VKU is being totally revised alongside the SVKG and GebV-KG. so the shape of the filing itself was, as of publication, a moving target. And beneath all of it sits the question with no Swiss answer yet: what counts as a significant impediment to effective competition in a market the size of Switzerland, where concentration arrives faster and the decisional record starts empty.

None of these questions has a general answer. A transaction’s Swiss exposure under the revised KG is a function of its market geography, its calendar, its remedy tolerance and its evidentiary posture, and each of those is specific to the deal. The analysis here maps where the complexity sits; resolving it requires the facts.

REFERENCES

01
15 U.S.C. § 18 (Section 7 of the Clayton Act): an acquisition is prohibited where, in any line of commerce or in any activity affecting commerce in any section of the country, its effect “may be substantially to lessen competition, or to tend to create a monopoly.” The premerger notification regime is the Hart-Scott-Rodino Antitrust Improvements Act of 1976, 15 U.S.C. § 18a, with an initial thirty-day waiting period and the Second Request mechanism.
02
Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (the EC Merger Regulation) [2004] OJ L24/1, Art. 2(3): a concentration “which would significantly impede effective competition, in the common market or in a substantial part of it, in particular as a result of the creation or strengthening of a dominant position” is declared incompatible. Art. 21(3) bars the Member States, not third countries, from applying national competition law to concentrations with a Community dimension, the Regulation’s own term; Switzerland sits outside that discipline.
03
Bundesgesetz über Kartelle und andere Wettbewerbsbeschränkungen (Kartellgesetz, KG) vom 6. Oktober 1995 (SR 251), Art. 10(2) (pre-revision substantive test: creation or strengthening of a dominant position by which effective competition can be eliminated, absent an outweighing improvement of competitive conditions in another market), Art. 9(1) (turnover thresholds), Art. 9(4) (notification duty, irrespective of thresholds, following a final finding of dominance, for concentrations concerning the affected market or an adjacent, upstream or downstream market), Art. 32–33 (one-month preliminary and four-month in-depth examination, with implementation prohibited absent provisional authorization), Art. 34 (suspended civil-law effectiveness), Art. 51(1) (administrative sanctions of up to CHF 1 million for implementing without notification, disregarding the provisional prohibition on implementation, breaching an obligation attached to a clearance, implementing a prohibited concentration, or failing to carry out a measure to restore effective competition), Art. 51(2) (up to 10 per cent of the aggregate Swiss turnover of the undertakings concerned for repeated breach of an obligation attached to a clearance).
04
Änderung des KG vom 19. Dezember 2025, BBl 2026 18: revised Art. 10(1)–(2) (examination where a concentration significantly impedes effective competition, in particular by creating or strengthening a dominant position; prohibition or conditional clearance absent verifiable, merger-specific efficiency gains for customers substantiated by the notifying undertakings), new Art. 9(1bis)–(1ter) (no notification where every affected product market is geographically at least Switzerland plus the European Economic Area and the European Commission assesses the transaction; complete copy of the EU notification to WEKO within ten days), Art. 32(3) and Art. 33(4) (extension of the examination periods by up to one and two months, on the cumulative conditions of good cause, aus wichtigen Gründen, and the consent of the notifying undertakings), Art. 33(2) (express prohibition on implementing the concentration during the examination, with provisional implementation authorized only exceptionally and only on the request of the notifying undertakings), Art. 34(1) (civil-law effectiveness suspended unless the periods under Art. 32(1) and (3) have expired or provisional implementation has been authorized), Art. 62(1) (transitional rule: concentrations are assessed under the law in force at the time the notification is filed). Ziff. II leaves entry into force to the Federal Council; the referendum deadline of 17 April 2026 passed without a referendum, and no commencement date had been fixed as of publication.
05
Botschaft vom 24. Mai 2023 zur Teilrevision des Kartellgesetzes, BBl 2023 1463: the qualified-dominance threshold is described as out of step with international merger-control practice, permitting intervention only in narrow circumstances; the Botschaft treats the prohibition practice statistically and names no case. The prohibitions themselves are WEKO, Berner Zeitung AG/20 Minuten (Schweiz) AG (Verfügung vom 19. Januar 2004, RPW 2004/2), annulled on appeal, the Bundesgericht confirming in 2007 that creation of a dominant position does not suffice absent the possibility of eliminating effective competition; WEKO, France Télécom SA/Sunrise Communications AG (Verfügung vom 19. April 2010, RPW 2010/3); and WEKO, ‘WEKO untersagt Zusammenschluss von Ticketcorner mit Starticket’ (Medienmitteilung, 23. Mai 2017).
06
WEKO, ‘WEKO verbietet Übernahme von Quickmail durch Post’ (Medienmitteilung, 19. Januar 2024): prohibition of the concentration on the ground that it would have eliminated effective competition in at least one market.
07
Der Bundesrat, ‘Kartellgesetz: Bundesrat eröffnet Vernehmlassung zur Revision der Verordnungen’ (Medienmitteilung, 27. Mai 2026): total revision of three of the four implementing ordinances to the KG, among them the Verordnung über die Kontrolle von Unternehmenszusammenschlüssen (VKU) vom 17. Juni 1996 (SR 251.4); consultation until 17 September 2026.
08
Regulation (EU) 2022/2560 of the European Parliament and of the Council of 14 December 2022 on foreign subsidies distorting the internal market [2022] OJ L330/1 (FSR), Art. 20(3) (notification thresholds: an acquired undertaking, one of the merging undertakings or the joint venture established in the Union with aggregate Union turnover of at least EUR 500 million, and combined aggregate third-country financial contributions of more than EUR 50 million in the three preceding years), Art. 24–26 (standstill, review periods of twenty-five working days and, from the opening of an in-depth investigation, ninety working days extendable by fifteen, and fines); the concentration notification obligations have applied since 12 October 2023.

Merger clearance under a test Switzerland has never applied before turns on market definition, filing timing and remedy design, and each of the three is transaction-specific.

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