Swiss Anti-Kickback Rules for Medical Devices: What the Integrity Ordinance Extension Would Change for US MedTech

A US medical device company's interactions program often starts with the Anti-Kickback Statute. It prohibits knowing and willful remuneration to induce referrals or purchasing, leasing or ordering where a federal health care program may pay for the item or service. A violation carries up to $100,000 in fines, ten years' imprisonment, or both.142 U.S.C. § 1320a-7b(b)(1)–(2) (knowing and willful remuneration for the specified referrals or business involving federally payable items or services; up to $100,000 or ten years' imprisonment, or both), § 1320a-7b(b)(3)(A) (discount exception conditioned on proper disclosure and reflection in costs claimed or charges made) and § 1320a-7b(h) (actual knowledge of the statute or specific intent to violate it not required). Detailed safe harbors protect qualifying equipment leases, service agreements, discounts and warranties.242 C.F.R. § 1001.952(c)(1)–(6) (equipment rental: signed written lease specifying all equipment; exact intervals and rent for periodic use; at least one year; aggregate rent fixed in advance at arm's-length fair market value, without regard to the volume or value of federally payable referrals or business; equipment limited to reasonable commercial need), § 1001.952(d)(1)(i)–(vi) (personal services: signed written agreement specifying all services for at least one year; compensation methodology fixed in advance at arm's-length fair market value, without regard to the volume or value of federally payable referrals or business; no counseling or promotion of unlawful activity; services limited to reasonable commercial need), § 1001.952(g) (conditional warranty protection) and § 1001.952(h)(5)(ii) (free or reduced-price different goods excluded from the discount definition unless the same federal program reimburses both under the same methodology and the reduction is fully disclosed and accurately reflected as appropriate). All applicable safe-harbor conditions must be met; failure to qualify does not alone establish an offense. A sale to a Swiss hospital may lack that US program nexus, but the proposed Swiss integrity regime would not depend on who pays. Its product and recipient tests could reach the same commercial arrangements for different reasons.

1. Enacted in 2019, Not Yet in Force: Where the Swiss Device Integrity Rule Stands

Under Art. 55(1) HMG, persons who prescribe, dispense or use prescription-only medicines, or purchase them for those purposes, and their employing organizations may not solicit, be promised or accept an undue advantage for themselves or a third party. Offering, promising or granting one is likewise prohibited.3Bundesgesetz über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG) vom 15. Dezember 2000 (SR 812.21), Art. 55(1)–(3) (prescription-medicine integrity prohibition, employing organizations and the four qualified exceptions), Art. 56(1) and (3) (rebate and refund records on both sides, disclosure on request and power to exempt low-risk products), Art. 58(4)–(5) (cooperation and cantonal reporting), Art. 82(1) (BAG enforcement), Art. 86(1)(h) and (4) (intentional integrity breach: up to three years' imprisonment or monetary penalty; negligence: monetary penalty, with a fine possible in minor cases), Art. 87(1)(h) and (3) (intentional transparency breach: up to CHF 50,000; negligence: up to CHF 20,000) and Art. 90(1) (federal administrative-criminal prosecution by Swissmedic and BAG within their responsibilities). Version in force on 25 August 2026. Art. 55(2) HMG recognizes four qualified exceptions: modest benefits relevant to medical or pharmaceutical practice; research and training support; equivalent counter-performances; and purchase rebates or refunds that do not influence the choice of treatment. The details sit in the VITH, in force with the statutory rule since 1 January 2020.4Verordnung über die Integrität und Transparenz im Heilmittelbereich (VITH) vom 10. April 2019 (SR 812.214.31), Art. 2 (professionals and employing organizations), Art. 3 (practice-relevant modest benefits, up to CHF 300 per professional annually), Art. 4 (qualified research, teaching and infrastructure support), Art. 6(1)–(4) (written event support; one-third continuing-education or one-fifth further-training contribution to the defined costs; waiver for equivalent work during the event or a half-day event without local overnight stay, excluding a subsequent meal; no contribution refund, indirect attendance costs, non-subordinate ancillary programs or companion costs), Art. 7(1)–(4) (written, proportionate compensation; writing exception for meals up to CHF 100 during a professional discussion; no compensation for own-benefit, legally required or otherwise paid services; specified logistics, research, consulting and non-promotional work), Art. 8 (standard-price rebate definition and no over-delivery), Art. 10 (rebates to prescribing, dispensing, applying or purchasing end recipients; BAG disclosure; category E and classic class I exemptions) and Art. 11 (contact, ordinance-agreement retention for ten years after last use, and permissible-benefit recipient register). The class I reference in Art. 10(2) VITH is to Annex IX of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [1993] OJ L169/1. See also Bundesamt für Gesundheit, Erläuterungen zur Verordnung über Integrität und Transparenz im Heilmittelbereich (VITH) und zur Änderung der Verordnung über die Krankenversicherung (KVV) (April 2019), pp. 15–18 and 20–21 (training, compensation, final trading stage, differentiated Art. 11 duties and tariff accounting). The related analysis of pharmaceutical promotion considers those restrictions for a medicine launch.

On 22 March 2019 Parliament amended Art. 55(1) HMG to include medical devices and Art. 55(3) HMG to permit device-category exemptions. The referendum period expired unused on 11 July 2019. The Federal Council's order of 1 July 2020 commenced most of the amending act on 26 May 2021 but reserved these two sentences for a later date.5Bundesgesetz über Arzneimittel und Medizinprodukte, Änderung vom 22. März 2019 (AS 2020 2961; BBl 2019 2589), Art. 55(1) HMG, first sentence, and Art. 55(3) HMG, second sentence; Federal Council order of 1 July 2020 appended to the act (referendum period expired unused on 11 July 2019; general commencement on 26 May 2021, Art. 46(3) HMG on 1 August 2020, and the two Art. 55 HMG sentences reserved for later commencement). Consequently, Art. 55 HMG still covered prescription-only medicines, not medical devices, on 25 August 2026.3 Enactment in 2019 did not make the device prohibition operative.

The Federal Council opened consultation on the accompanying VITH revision on 6 May 2026, with a deadline of 25 August 2026.6Schweizerischer Bundesrat, Verordnung über die Integrität und Transparenz im Heilmittelbereich (VITH), Änderung vom … (consultation draft, 6 May 2026), Art. 1(2) (integrity exemptions for class I, class A and intended lay-use devices acquirable without prior professional advice), Art. 1(3) (transparency exemptions for category E medicines, class I and class A, not a general lay-use exemption), Art. 2(a)(2) (device professionals and purchase/use decision-makers), Art. 3(3)(b)–(c) (competition conditions), Art. 4 (research/teaching infrastructure and no product-linked grant conditions), Art. 7(4)(a), (c) and (cbis) (acquisition-related work, published prescription-medicine experience reports and device user evaluations without advertising purpose), Art. 9a (appropriate annual sample/demonstration quantities, no resale, and reusable samples returned within a reasonable period capped at 60 days from receipt without acquisition of ownership as a sample), repeal of Art. 10(2) VITH, and Part II (blank commencement date, no transition clause). Eidgenössisches Departement des Innern, cover letter to cantonal governments, 6 May 2026, confirms consultation from 6 May to 25 August 2026. The explanatory report envisages joint commencement of the amended statute and ordinance. It cites an impact assessment completed in July 2025 estimating roughly 580 affected companies. Enforcement would rest with the BAG, the federal health office already responsible for integrity and transparency under Art. 82(1) HMG.7Bundesamt für Gesundheit, Änderung der Verordnung über die Integrität und Transparenz im Heilmittelbereich (VITH) (Erweiterung der Integrität auf Medizinprodukte): Erläuternder Bericht zur Eröffnung des Vernehmlassungsverfahrens (6 May 2026), §1 (joint intended commencement), §3.2–3.4 (co-development, compensation, evaluations and use decisions), §3.5 (device pricing, associated services and reconstruction of benchmarks), §3.6–3.7 (samples, demonstrations, class and lay-use exemptions, including the public-dispensing limits for communicable-disease tests), §4, explanations of Art. 4, Art. 7 and Art. 9a VITH (infrastructure clarification; written evaluations with manufacturer ownership and return; reasonable quantities and sample return, with genuine purchase contemplated instead), §5.1 (BAG enforcement) and §5.3.1–5.3.2 (the July 2025 impact assessment's estimate of roughly 580 companies and expanded professional categories). The draft leaves commencement blank and contains no transition clause. Those omissions matter to existing contracts, but neither establishes the eventual commencement or transitional arrangements.

Existing Rules for Device Rebates and Hospital Staff

Device transactions are already subject to several separate Swiss rules. Art. 56 HMG requires covered rebates and refunds to appear in both parties' receipts, invoices and business books and to be disclosed to the authorities on request.3 Art. 10(1) VITH identifies the recipients as persons or organizations that prescribe, dispense or use therapeutic products, or buy them for those purposes. BAG's April 2019 explanation calls this a restriction to the final trading stage. The ordinance's device exemption on 25 August 2026 covered "classic" class I devices under the old Medical Device Directive; it did not exclude all devices.4 An intentional transparency breach carries a fine of up to CHF 50,000, and a negligent breach up to CHF 20,000.3 The 2026 report confirms that the VITH rebate definition already applies to devices through the transparency regime.7

Within compulsory health insurance, Art. 56(3)(b) KVG requires the care provider to pass direct or indirect supplier advantages to the debtor of the remuneration. An insurer-provider agreement may allow partial retention, but most of the advantage must be passed on and the retained portion must demonstrably improve treatment quality. Under Art. 76a KVV, an advantage normally appears on the provider's invoice; separate disclosure is unnecessary where lower costs have already entered the relevant tariffs or prices.8Bundesgesetz über die Krankenversicherung (KVG) vom 18. März 1994 (SR 832.10), Art. 56(3)(b), (3bis) and (4) (within compulsory health insurance, supplier advantages passed to the debtor of the remuneration; agreed partial retention only with majority pass-on and proven treatment-quality use; recovery of unpassed advantages), Art. 59(1) and (3)(e) (sanctions including a CHF 20,000 maximum fine and repeat-offense exclusion); Verordnung über die Krankenversicherung (KVV) vom 27. Juni 1995 (SR 832.102), Art. 76a(1)–(2) (invoice disclosure and pass-on; no separate invoice disclosure where the advantage already enters tariffs or prices through lower costs) and Art. 76b (conditions of partial-retention agreements). The tariff exception does not waive the underlying pass-on duty. That exception changes the accounting, not the underlying pass-on duty. Failure to pass on advantages is a ground for Art. 59 KVG sanctions, including a fine of up to CHF 20,000 and, for repeated breaches, exclusion from compulsory-insurance billing. The manufacturer's rebate structure therefore affects a legal duty addressed to its customer.

Bribery offenses can also apply. A physician at a cantonal public-law hospital can be an official under the StGB; private persons performing public tasks can also have that status. Art. 322quinquies StGB punishes offering, promising or granting an undue advantage in view of the conduct of office with up to three years' imprisonment or a monetary penalty. Art. 322ter StGB raises the maximum to five years where the advantage concerns a breach of duty or discretionary act. In the private sector, Art. 322octies StGB addresses undue advantages to an employee, agent or other auxiliary of a third party in connection with business activity for such an act. Where these specified active offenses occur in business activity within an enterprise's purpose, Art. 102(2) StGB permits corporate liability independently of individual liability if necessary and reasonable organizational precautions were omitted. The corporate fine can reach CHF 5 million.9Schweizerisches Strafgesetzbuch (StGB) vom 21. Dezember 1937 (SR 311.0), Art. 102(1)–(2) (enterprise business/purpose nexus; up to CHF 5 million; independent corporate liability for listed active bribery offenses where necessary and reasonable organizational precautions were omitted), Art. 110(3) (officials), Art. 322ter (undue advantage for an official's breach of duty or discretionary act: up to five years or monetary penalty), Art. 322quinquies (undue advantage in view of conduct of office: up to three years or monetary penalty), Art. 322octies–322novies (private-sector active/passive bribery in the stated business relationship: up to three years or monetary penalty) and Art. 322decies (employment-law/contractually approved and minor socially customary advantages; private persons performing public tasks equated with officials).

Potential federal-program payment is a condition of the US Anti-Kickback Statute. The Swiss device integrity extension would instead turn on the product, recipient and advantage, irrespective of the payer.

Once applicable, Art. 55 HMG would reach some advantages that the bribery provisions leave outside their prohibitions. For private-sector bribery, the connection with a breach of duty or discretionary act matters, and Art. 322decies(1)(a) StGB recognizes employer approval by contract.9 Employer consent does not itself satisfy any of the four exceptions in Art. 55(2) HMG. Nor does private payment put a covered device outside that provision. Intentional violation carries up to three years' imprisonment or a monetary penalty; Art. 86(4) HMG also punishes negligence, with a fine possible in minor cases.3 The US statute dispenses with actual knowledge of the statute or specific intent to violate it, but still requires knowing and willful conduct.1 A US approval process and a Swiss integrity assessment therefore address different legal predicates.

2. Which Devices and Persons the Draft Would Cover

Draft Art. 1(2) VITH would exempt class I devices, class A in vitro diagnostics and devices intended for lay use that consumers or patients can acquire without prior professional advice from the integrity rule.6 According to the report, the class I exemption includes sterile, measuring and reusable instruments. The lay-use exemption can cover higher-class products, including contact lenses and pregnancy tests. For self-tests, Art. 61(2) IvDV requires the dispensing point to ensure professional advice is available; it does not require every buyer to take it. The report distinguishes communicable-disease tests insofar as they cannot be dispensed to the public.7 Art. 61(3) IvDV allows Swissmedic exceptions to that public-dispensing prohibition in the interests of public health.10Verordnung über In-vitro-Diagnostika (IvDV) vom 4. Mai 2022 (SR 812.219), Art. 12(2)(a) and Art. 15(6) (exclusive demonstration/exhibition products: no conformity marking and visible identification), Art. 14 (Annex VIII IVDR classification) and Art. 61(1)–(3) (intended purpose and manufacturer information; self-test dispensing requires the ability to provide professional advice and satisfy operating conditions, with genetic-testing law reserved; public dispensing of communicable-disease tests prohibited subject to Swissmedic exceptions in the interests of public health). The exemption depends on the product's intended use and acquisition conditions, so professional application of an otherwise qualifying lay-use product would not alone remove it.7

Classification would acquire an additional legal consequence. Art. 15 MepV and Art. 14 IvDV refer to Annex VIII of the MDR and the IVDR.11Medizinprodukteverordnung (MepV) vom 1. Juli 2020 (SR 812.213), Art. 13(2)(b) and Art. 16(6) (exclusive demonstration/exhibition products: no conformity marking and express visible identification), Art. 15 (Annex VIII MDR classification, also taking account of the implementing acts in Annex 5a MepV) and Art. 68 (dispensing according to intended purpose and manufacturer information).12Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices [2017] OJ L117/1 (MDR), Annex VIII, section 3.5 (the strictest applicable rule or sub-rule determines classification), section 5.2, Rule 6 (transient surgically invasive devices generally IIa; reusable surgical instruments normally I), section 5.4, Rule 8 (implants generally IIb; total/partial joint replacements III except ancillary components such as screws, wedges, plates and instruments) and section 6.3, Rule 11 (diagnostic/therapeutic decision-support software IIa, III for possible death or irreversible deterioration and IIb for possible serious deterioration or surgical intervention; separate monitoring rules; other software I). Relevant text unchanged in the 19 July 2026 consolidation.13Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices [2017] OJ L117/176 (IVDR), Annex VIII, section 2.5, Rule 5 (class A: general-laboratory products, noncritical accessories, buffer/washing solutions, general culture media and histological stains intended by the manufacturer for specific IVD examinations; instruments specifically intended for IVD procedures; specimen receptacles) and section 2.6, Rule 6 (class B for devices not covered by the preceding classification rules). Relevant text unchanged in the 10 January 2025 consolidation. The manufacturer must apply those rules to the device's intended purpose and risk; it cannot freely choose whether the integrity prohibition applies. The same intended-purpose and labeling decisions inform dispensing under Art. 68 MepV and Art. 61(1) IvDV. A classification made for conformity assessment thus also determines the proposed integrity boundary.

The draft's transparency exemption is narrower in a different respect. Art. 1(3) of the draft VITH would replace the old Directive-based class I reference with class I under Art. 15 MepV and add class A diagnostics; it would not extend the lay-use exemption to every higher-class consumer device.6 A product formerly class I but classified higher under the MDR could therefore lose the exemption suggested by the old wording. Decision-support software illustrates the issue: Rule 11 of Annex VIII MDR generally assigns software informing diagnostic or therapeutic decisions to class IIa, with higher classes for specified consequences. Whether a particular product enjoyed the old exemption still depends on its classification and the interpretation of the existing reference.12

The class boundary can divide a commercial bundle. Rule 6 of Annex VIII MDR generally places reusable surgical instruments within class I; Rule 8 of Annex VIII MDR generally places implants in class IIb and total or partial joint replacements in class III, excepting ancillary components such as screws, plates and instruments from that latter rule.12 Rule 5 of Annex VIII IVDR places instruments specifically intended for IVD procedures in class A. Reagents not covered by the preceding classification rules fall within residual class B under Rule 6.13 An exempt loaner instrument set or analyzer may support purchases of covered implants or reagents. The draft and report do not specifically resolve how that combination affects the characterization of a free placement.

The proposed recipient definition is broader than a list of medical professions. It includes people who prescribe, dispense or apply devices, buy them for those purposes, or participate in purchase or use decisions.6 The report names procurement staff, midwives and nursing professionals. Its reference to decisions on Gebrauch, use, also addresses rented, leased and hire-purchased equipment, rather than only application to patients.7 Organizations employing professionals are themselves covered addressees.4

The US Sunshine Act instead organizes reporting around defined covered recipients, including physicians, teaching hospitals and specified non-physician practitioners, excluding professionals employed by the reporting manufacturer. Applicable manufacturers report qualifying transfers for publication in a searchable database.1442 U.S.C. § 1320a-7h(a)(1)(A), (c)(1)(C), (e)(2), (e)(6) and (e)(10)(B) (applicable manufacturers, reporting and public database, recipient categories and payment exclusions); 42 U.S.C. § 1395x(bb)(2); 42 C.F.R. § 403.902 and § 403.904(h). Covered recipients include teaching hospitals, physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants and certified nurse-midwives. Professionals employed by the reporting manufacturer are excluded; the regulatory physician definition excludes residents. Only reportable transfers are included. See Centers for Medicare & Medicaid Services, Open Payments: Report to Congress, Fiscal Year 2025 (March 2026), p. 1 n. 2. A Swiss purchasing manager or biomedical engineer participating in a device-use decision could fall within the draft without belonging to one of those professional categories. VITH records also serve a different purpose: Art. 11 VITH requires covered manufacturers and distributors to designate a BAG contact, retain agreements within the ordinance for ten years after their last use, and register recipients of permissible advantages. It does not establish a Sunshine-style public database. BAG's 2019 explanation distinguishes the contact duty from the particular agreements and benefits subject to the other duties.4

3. Placed Analyzers, Loaner Sets and Consignment Stock: When a Commercial Term Becomes an Advantage

The rebate exception in Art. 55(2)(d) HMG requires that purchase rebates or refunds have no influence on treatment choice. Art. 8(1) VITH measures a rebate against the product's standard price; for medicines on the list of reimbursed specialties, a price below the ex-factory price is a particular example.34 Devices often lack a binding published standard price. The report distinguishes MiGeL reimbursement ceilings from sale prices and recognizes the role of associated training, maintenance and advice. It says BAG may obtain list prices under Art. 58(4) HMG or, where none exists, derive an average from invoices and contracts or require the company to calculate one.7 The benchmark can thus emerge from the company's own dealings. Art. 8(2) VITH also prohibits quantities exceeding those ordered and invoiced, a restriction the extension would bring to covered device arrangements.4

An analyzer supplied without charge against reagent purchases exposes the comparison. The US discount safe harbor generally excludes a free or reduced-price product used to induce purchase of another, subject to its same-program, same-reimbursement-methodology and disclosure qualification. Equipment-rental protection has separate conditions, including a signed lease of at least a year, rent fixed in advance, fair market value, restrictions on referral-sensitive pricing and reasonable commercial need.2 The Swiss proposal contains no equivalent safe-harbor structure. A free analyzer might be characterized as part of a reagent rebate, an independently supplied benefit or another contractual exchange. Those characterizations affect both the applicable product exemption and the distinct transparency and compulsory-insurance pass-on duties.8 A class A analyzer does not by itself settle the treatment of the covered reagents whose purchase it supports.

Consignment stock reverses the direction of a familiar payment. Draft Art. 7(4)(a) VITH would allow proportionate compensation for device-related logistics, storage costs or storage risk undertaken by the recipient. The change from Einkauf, purchase, to Bezug, acquisition, accommodates arrangements without an outright purchase.67 In consignment, however, the manufacturer may retain title, finance the stock and bear obsolescence risk at the hospital, which pays only for implanted units. Whether that allocation is an ordinary supply term, a rebate or another advantage is not specifically resolved by the proposal. Loaner sets collected after a procedure add the further distinction between exempt instruments and covered implants.

Those questions already matter where the transparency or compulsory-insurance pass-on rules apply. The first concerns covered rebates at the final trading stage; the second concerns advantages received by the care provider, with the tariff-accounting qualification in Art. 76a(2) KVV.48 US law also conditions its statutory discount exception on proper disclosure and reflection in claimed costs or charges.1 But Swiss transparency is an independent duty with its own sanctions, not simply a condition of protection against an anti-kickback charge.

4. Consultants, Evaluation Units, Samples and Training Under the Draft

Co-Developers, Consultants and User Evaluations

The report recognizes clinicians and hospitals as co-developers, consultants, shareholders and licensors, and regards those relationships as valuable to innovation. It nevertheless directs compensation back to Art. 7 VITH.7 For consulting and comparable work, Art. 7(1) VITH requires a written agreement defining the work and compensation, with a reasonable relationship between them. Compensation is excluded for services performed for the recipient's own benefit, to meet a legal obligation or already paid for elsewhere.4 The report accepts that proportionate fees, equity participation or revenue participation may be possible, while leaving the variety of arrangements to enforcement practice.7

The US personal-services safe harbor takes a different route: among its cumulative conditions are a signed agreement for at least a year, specification of all services, a compensation methodology fixed in advance, fair market value and limits on remuneration linked to federal-program referrals or business.2 Swiss statutory proportionality does not reproduce that formula. It also does not displace a restriction already present in the Swiss Medtech Code. For companies bound through membership or contract, chapter 7 of the Swiss Medtech Code requires, subject to national law, exclusion from the royalty calculation of units purchased, prescribed, used or ordered by the inventor-professional and/or members of that professional's practice or healthcare institution.15Swiss Medtech, Swiss Medtech Kodex zum ethischen Geschäftsverhalten (Swiss Medtech Code; adopted 25 May 2023; implementation by 1 January 2024), preliminary remarks and scope (membership obligations and applicable national law), ch 2 §2 (conditional support for third-party procedure training), ch 7, pp. 25–26 (royalties: subject to national rules, exclude units purchased, prescribed, used or ordered by the professional and/or members of the professional's practice or healthcare institution) and ch 9 §3 (reasonable sample quantities; company ownership of reusable samples and agreed prompt return after familiarization, without a fixed day count). German edition controls. A royalty base containing the inventor's own hospital purchases therefore already raises a Code issue. Whether a different royalty structure satisfies the future statutory proportionality test remains a separate question; the Code restriction is not itself the criminal prohibition in Art. 55 HMG.

Draft Art. 7(4)(cbis) VITH expressly addresses user evaluations without an advertising purpose; practice-experience reports would be confined to prescription medicines and retain their scientific-publication requirement.6 The report expects a prior written agreement covering the evaluation, provision of products, compensation and its basis, and an appropriate period before reusable products return. Unused single-use products return at the end. The manufacturer retains ownership; the report treats non-return of a reusable evaluation unit as an impermissible advantage.7 This is distinct from the sample regime and its 60-day maximum. A capital system evaluated by the department considering its purchase still raises the question whether the arrangement serves evaluation or advertising.

Samples and Demonstration Devices

Draft Art. 9a VITH limits samples and exclusive demonstration units to an appropriate annual number per professional or organization and prohibits resale. For reusable samples, recipients may not acquire ownership as a free benefit and must return them within a reasonable period, at the latest 60 days after receipt.6 The report separately contemplates genuine acquisition instead of return; it does not permit an indefinite free placement. Samples are marketable products. Exclusive demonstration devices are different: MepV and IvDV rules require visible identification and exclude conformity marking for those units.71110 The report leaves appropriate quantities to enforcement practice rather than supplying a numerical allowance.

Art. 10 AWV allows medicine samples only in small numbers and on the professional's initiative and written request.16Verordnung über die Arzneimittelwerbung (Arzneimittel-Werbeverordnung, AWV) vom 17. Oktober 2001 (SR 812.212.5), Art. 10(1) and (1bis) (small numbers of medicine samples per medicine, year and professional, at the professional's initiative and written request; other labeling, information and record conditions also apply). The device proposal contains no equivalent request condition. The Swiss Medtech Code requires a reasonable sample quantity, continued company ownership of reusable samples and agreed prompt return after familiarization, but sets no fixed day count.15 The report expressly draws on that model while adding a 60-day ceiling.7 An imaging component supplied for familiarization and the same component placed under a structured evaluation contract would therefore engage different provisions. The label used by the commercial team cannot alone determine which one applies.

Training, Events and Infrastructure

The draft does not amend Art. 6 VITH. Its extension to covered devices would therefore bring the existing written-agreement and participant-or-employer contribution rules to further and continuing training: at least one fifth of the defined costs for further training and one third for continuing education. A contribution may be waived for an equivalent counter-performance during the event, or where no local overnight stay is required and the event lasts at most half a working day, excluding a meal after the professional part. Refunds of the contribution, lost-work or income costs, non-subordinate ancillary programs and companion costs are prohibited.4 The Code's permission to support third-party procedure training is expressly subject to applicable law.15 Such funding would become subject to Art. 6 VITH, not automatically satisfy it. Training supplied as part of purchased equipment presents a different characterization question, since the report also treats training as a possible component of the device price.7

For grants, the draft clarifies Art. 4 VITH by specifying infrastructure serving research or teaching. The report explains that the existing statutory basis does not authorize an unrelated third category of infrastructure support; it gives a practice waiting room and pharmacy shelves as examples outside that exception.67 The draft also extends the prohibition on product-linked grant conditions to devices. Device competitions would no longer share the prescription-medicine restriction to the professional-advertising audience, but participation could not be tied to acquisition and the modest-value, practice-relevance conditions would remain.6 These are limited adjustments within the statutory exceptions, not a general authorization of promotional support.

5. Existing Contracts for US Device Companies

An arrangement signed in 2026 may continue after the device integrity rule begins. The consultation draft offers no adjustment period, although the final commencement and transitional terms remain undecided. A reagent commitment priced around a free analyzer, a consignment arrangement or a development royalty could therefore encounter different rules during its term. The parties' allocation of price, return and amendment risks matters before that date is known.6

Some duties precede the extension. BAG's April 2019 explanation supports an existing contact duty for manufacturers and distributors of covered therapeutic products; it does not support a blanket device-company exemption until the integrity rule starts. The separate Art. 11 VITH retention and register duties depend on the agreements and permissible advantages within the ordinance.4 For a US parent paying a Swiss surgeon under a global advisory or licensing arrangement, the relevant group entity, territorial connection and legal characterization require their own assessment. The absence of a Swiss signature does not itself answer who granted the advantage, but neither do the VITH definitions alone settle cross-border criminal attribution.39

The regulatory classification of the analyzer or implant, the commercial explanation for its placement and the hospital's accounting may point in different directions. A covered rebate belongs in the transparency records; an advantage within compulsory insurance must be passed on or retained under the statutory conditions, with separate invoicing unnecessary where it is already reflected in the tariff or price.48 Consistent records do not make an unlawful arrangement lawful, but inconsistent descriptions can obscure which transaction the parties actually agreed.

US law may remain relevant independently of the Anti-Kickback Statute. Whether a cantonal hospital's physician is a foreign official under the Foreign Corrupt Practices Act depends in part on whether the hospital is a governmental instrumentality and on the person's position. For issuers, the books-and-records provision requires transactions and asset dispositions to be accurately and fairly reflected in reasonable detail.1715 U.S.C. § 78dd-1(f)(1)(A) (foreign-official definition includes officers/employees of a foreign government, department, agency or instrumentality and persons acting in an official capacity); 15 U.S.C. § 78m(b)(2)(A) (covered issuers' books, records and accounts must in reasonable detail accurately and fairly reflect transactions and asset dispositions). Different ledger descriptions alone do not establish breach of that standard. Recording an analyzer as a marketing expense in one ledger and a price concession in another is not automatically a violation: the question is whether the records fairly reflect the underlying arrangement. Swiss and US legal characterizations need not coincide.

For a US device portfolio, the pending extension adds a new prohibition to duties that already reach selected transactions. Its effect depends on product classification, contractual substance, the recipient's role and the applicable insurance and corporate arrangements. The unresolved commencement date leaves those distinctions important both to existing contracts and to benefits promised for future performance.