EU Critical Medicines Act Proposal: Swiss and US Manufacturing in Public Tenders

A US manufacturer that sells to the federal government knows what a domestic-content rule for medicines looks like, and knows how Washington set out to reconcile it with trade law. Executive Order 13944 of 6 August 2020 directed federal agencies, within existing legal limits and specified exceptions, to limit competition for essential medicines, medical countermeasures and critical inputs to products made in the United States. It also sought their exclusion from US procurement commitments under trade agreements. The United States later withdrew the related WTO Government Procurement Agreement modification notifications on 16 April 2021.1Executive Order 13944 of 6 August 2020, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States, 85 Fed. Reg. 49,929 (14 August 2020), § 2(a), (d) and (f) Executive Order 13944; WTO Secretariat, Trade Policy Review: Report by the Secretariat: United States, WT/TPR/S/434 (9 November 2022), para. 3.295 and note 436 (the related GPA modification notifications were withdrawn on 16 April 2021). The EU's proposed rule for critical medicines takes a different approach. Art. 18(2) ST-11059/26 (Critical Medicines Act, CMA), in the final compromise text that the Permanent Representatives Committee endorsed on 30 June 2026, obliges public buyers to favor medicines and active substances manufactured in the Union wherever a critical medicine has been found to depend on one or a few third countries. It then says, in one sentence, that the preference is to be applied in compliance with the Union's international commitments.2Final compromise text for a Regulation of the European Parliament and of the Council establishing a framework to strengthen the security of supply and the availability of critical medicinal products, as well as the availability and accessibility of medicinal products of common interest, and amending Regulation (EU) 2024/795 (Critical Medicines Act, CMA), annexed to Council document ST-11059/26 (30 June 2026), recitals 16, 24b and 26–26d; Art. 1–3, 18, 19, 22 and 31 ST-11059/26. A negotiating compromise, not yet adopted law; the five-year minimum concerns the procurement requirements. The operative text does not say which commitments, toward which suppliers, in which tenders. For a sponsor whose active substance or finished product is made in Switzerland or in the United States, that sentence makes treaty coverage part of the answer. The result depends on the buyer, supplier, goods and tender; plant location alone cannot settle it.

1. What the Critical Medicines Act Would Require Public Buyers to Favor

The Critical Medicines Act was not yet law on the date of this article. The Commission proposed it on 11 March 2025, the Parliament and the Council reached a provisional agreement on 12 May 2026, the Permanent Representatives Committee endorsed the final compromise text on 30 June 2026, and the Parliament's Committee on Public Health approved the agreed text on 14 July 2026. Formal adoption and publication were still pending on 24 September 2026.3European Commission, Commission welcomes political agreement on Critical Medicines Act, press release IP/26/1017 (12 May 2026); European Parliament, Legislative Observatory, procedure 2025/0102(COD), committee approval of the agreed text on 14 July 2026. Formal adoption remained pending at the article date. Art. 31 ST-11059/26 would bring the Regulation into force on the twentieth day after its publication, but makes it apply from the first publication in the Official Journal of the Union list of critical medicinal products established under Art. 137 ST-7105/26 (Pharma Package Regulation text), which was itself awaiting final adoption on the date of this article, and applies the requirements of Art. 18(1) and (2) ST-11059/26 only to procurement procedures launched after that date.4Text for the Council position at first reading on a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulations (EC) No 1394/2007 and (EU) No 536/2014 and repealing Regulations (EC) No 141/2000, (EC) No 726/2004 and (EC) No 1901/2006 (Pharma Package Regulation), Council document ST-7105/26 (17 September 2026), Art. 136, 137(1)–(3) and 138(2), pp. 309–315: MSSG evaluation and proposal, followed by Commission implementing acts. Pending text at the article date. For these requirements, the procurement procedure's launch date controls. An award made after the list appears does not by itself bring an earlier-launched procedure within Art. 18(1) and (2) ST-11059/26; a framework resulting from a later-launched procedure may govern supply for years.

The rule works in two tiers. The first reaches every public procurement procedure for a critical medicinal product that falls within the scope of Directive 2014/24/EU. Under Art. 18(1) ST-11059/26 the contracting authority must apply resilience requirements that support the diversification of supply sources of active substances and, where applicable, of medicinal products, including within the Union, and that reward reliable and compliant suppliers, implemented through at least one of four routes: selection criteria, technical specifications, a best price-quality award or contract performance clauses.2 Nothing in that tier requires a plant to be in the Union. Recital 24b of the CMA compromise text says as much: any dependence on only one supplier, irrespective of whether established in the Union or outside the Union, threatens the security of supply. A Swiss second source for an active substance otherwise made in one Asian country could support that diversification. Whether and how a particular tender credits it depends on the resilience requirements chosen.

The second tier is the one this article is about, and its trigger sits outside the procurement file. Art. 18(2) ST-11059/26 applies where a vulnerability evaluation has identified a vulnerability in the supply chains of a critical medicine pointing to the high level of dependency on a single or a limited number of third countries. Under Art. 138(2) ST-7105/26 (Pharma Package Regulation text), the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) would perform the vulnerability evaluation using the methodology developed under Art. 136 ST-7105/26 (Pharma Package Regulation text). Under Art. 137(3) ST-7105/26 (Pharma Package Regulation text), the Commission would take the MSSG's proposal into account when adopting and updating the Union list by implementing acts, specifying among the vulnerable products those, including their active substances, vulnerable because of high dependency on one or a limited number of third countries.4 The sponsor does not apply for the designation and cannot decline it. It learns that its product has entered the second tier when an implementing act says so, and Art. 18(2a) ST-11059/26 then keeps the preference running for as long as the product stays on the list with that designation, and for a minimum of five years from the entry into force of the last implementing act that designated it.

Once the trigger is met, the contracting authorities shall favour manufacturing of such medicinal products in the Union and must use at least one of two mechanisms. The first is a technical specification that, in a multi-winner procurement, reserves at least one lot representing at least 50 percent of the total volume of all lots for suppliers offering the critical medicinal product and its active substance manufactured in the Union. The second is a best price-quality award that favors suppliers of critical medicinal products and their active substances manufactured in the Union by applying a scoring that proportionately rewards the share of manufacturing in the Union and a weighting that effectively achieves that objective, with the option of additional points for a manufacturer that offers 50 percent or more of the product and its active substance manufactured in the Union.2 Art. 18(5) ST-11059/26 permits an exceptional departure from paragraphs 1, 2, 2a and 3 where market circumstances or considerations related to the financing of health services duly justify it, and one of four conditions is met: only a specific operator can supply, no reasonable alternative or substitute exists, and the absence of competition is not caused by artificially narrowing the procurement parameters; no suitable tenders or suitable requests to participate were submitted in a similar procedure launched by the same contracting authority in the two years before the planned new procedure begins; compliance would oblige the authority to acquire the medicine at disproportionate cost; or the procedure is a negotiated procedure without prior publication under Art. 32(2)(c) of Directive 2014/24/EU. Art. 18(5a) ST-11059/26 requires that justification to be documented in writing and, where relevant, open to verification and redress.

The text hardened on its way from proposal to compromise. The Commission's proposal of March 2025 asked contracting authorities to apply, where justified, requirements that favor suppliers manufacturing a significant proportion of the critical medicinal products in the Union.5European Commission, Proposal for a Regulation laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (Critical Medicines Act proposal), COM(2025) 102 final (11 March 2025), Art. 18(1) and (2) COM(2025) 102 final: the original second-tier requirement used “where justified” and “a significant proportion”. The compromise drops the qualifier, prescribes the two mechanisms, fixes the 50 percent thresholds, adds the active substance to the finished product and adds a five-year floor. Each change narrows the room a buyer had to credit a plant outside the Union. The qualification concerning the Union's international commitments came through the negotiation essentially unchanged.

The proposed manufacturing preference concerns where a medicine is made. Treaty coverage also depends on the goods, the supplier and the procurement; neither question can replace the other.

For a US reader the design is recognizable and still unfamiliar. Executive Order 13944 sought an exclusion from procurement commitments, but the related GPA modification notifications were withdrawn.1 The Critical Medicines Act keeps the trade agreement and subordinates the preference to it without saying how. Art. 18(6) ST-11059/26 requires the Commission to issue guidelines within twelve months of entry into force to support the Member States and the contracting authorities in applying the Article, and Art. 19 ST-11059/26 requires each Member State to establish, within the same period, a national program that promotes the consistent use of the procurement requirements. Whether the line between Union and non-Union manufacturing is drawn in the guidelines, in twenty-seven programs or tender by tender is the first of the open questions, and the answer may differ between a hospital in one Member State and a regional purchasing body in another.

2. What “Manufactured in the Union” Leaves Out

The compromise text defines the term only for the purposes of the second tier: manufacturing in the Union shall include manufacturing steps that are carried out within the Union other than import, repackaging, packaging other than immediate packaging, labelling, quality testing and, where applicable, certification.2 The list of exclusions reads like the last mile of a typical transatlantic supply chain. Under Art. 40(2) and (3) of Directive 2001/83/EC a manufacturing authorization is required for total and partial manufacture, for the processes of dividing up, packaging or presentation, and for imports from third countries. Under Art. 51 of the Directive a qualified person in the Union certifies each batch, and a batch coming from a third country must first have been tested in a Member State unless arrangements with the exporting country allow the controls to be carried out there.6Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [2001] OJ L 311/67, consolidated text of 1 January 2025, Art. 23b, 40(2)–(3) and 51(1)–(3) of Directive 2001/83/EC: manufacturing/import authorization, batch controls and certification, and risk-dependent variation procedures are separate from the CMA manufacturing preference. A company can therefore hold a Union manufacturing authorization, employ a Union qualified person, run a Union secondary-packaging line and still, for Art. 18(2) ST-11059/26, have manufactured nothing in the Union.

What remains inside the definition is everything before the last mile: synthesis of the active substance, formulation, filling and immediate packaging. The test is about sites, not ownership. A supplier under Art. 3, point (17), ST-11059/26 is the manufacturer or marketing authorization holder of the finished dosage form or the manufacturer of key inputs or active substances, so the group's nationality does not determine whether its manufacturing steps meet the Union-location condition. A Swiss or US group can carry out qualifying manufacturing in the Union; a European group's Swiss active-substance plant does not become Union manufacturing through ownership. Bidder eligibility and treaty coverage remain separate questions. The two mechanisms then ask about two things at once. The reserved lot is open to suppliers offering the critical medicinal product and its active substance manufactured in the Union. The scoring rewards the share of manufacturing in the Union of the products and their active substances. Assume, for purposes of illustration, a US sponsor whose active substance is made in the United States and formulated and filled by a contract manufacturer in Ireland. It does not meet the Union-manufacturing condition for the reserved lot, because its active substance is manufactured outside the Union. Under the scoring mechanism it may earn something, because one of two manufacturing stages sits in the Union, but the text does not say how a share is computed, whether by stage, by cost or by value, or whether an active substance made outside the Union caps the score. Reverse the facts, with a Swiss active substance formulated by a Swiss affiliate and released for the Union market through an importer in the Netherlands, and those facts supply no Union-manufacturing credit under either mechanism. The separate effect of treaty coverage is considered below.

Recital 26b of the CMA compromise text adds a gloss that the operative text does not repeat. When assessing whether medicinal products and active substances have been manufactured in the Union, contracting authorities should be able to rely on claims and evidence provided by the tenderers and should take into account manufacturing steps that add the most value. That recital helps interpret the operative manufacturing rule; it does not replace the exclusions with a separate mathematical value test. Fill-finish may contribute differently to the value of different medicines. The text supplies no fixed formula converting that contribution into a share of Union manufacturing, so the methodology and evidence required by the tender documents matter. The operative text then places the evidentiary burden on the tenderer: evidence supporting the claim that manufacturing takes place in the Union is to be provided, where required, by the tenderers and supported by documents facilitating the independent verification by the contracting authority. Whether a buyer will accept a site master file, a manufacturing authorization, a certificate of good manufacturing practice or the manufacturing section of the marketing authorization dossier as that evidence is not settled by the text, which leaves it at most to the Commission's guidelines under Art. 18(6) ST-11059/26, and each of those documents was designed to demonstrate compliance with quality rules, not to apportion manufacturing steps between jurisdictions.

The definition also departs from the origin rules that the rest of Union law applies. Art. 60(2) of Regulation (EU) No 952/2013 (Union Customs Code) attributes a product made in more than one country to the country where it underwent its last, substantial, economically-justified processing or working in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture.7Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code [2013] OJ L 269/1, consolidated text of 12 December 2022, Art. 59–60 of Regulation (EU) No 952/2013. The multi-country rule in Art. 60(2) of Regulation (EU) No 952/2013 concerns non-preferential origin, distinct from the CMA manufacturing-step test. That test looks for one country. The Critical Medicines Act counts steps and splits them between the product and its active substance. The two tests can give different answers for the same pack, and the difference matters, because the trade commitments distinguish goods' origin from the status of the supplier, while the proposed Public Procurement Act expressly refers goods' origin to the Union Customs Code. None of those questions is answered solely by the CMA's list of manufacturing steps.

3. How GPA Coverage Differs for Swiss and US Supply

Recital 26d of ST-11059/26 names the commitment that Art. 18(2) ST-11059/26 must respect: the resilience requirements are to be applied subject to the Union’s international commitments including the Government Procurement Agreement in WTO and other relevant international agreements to which the Union is bound. The Union, Switzerland and the United States are all parties to the revised GPA, which entered into force on 6 April 2014 and, for Switzerland, on 1 January 2021.8Agreement on Government Procurement (Marrakesh, 15 April 1994), as amended by the Protocol Amending the Agreement on Government Procurement (adopted 30 March 2012) [2014] OJ L 68/2 (GPA), Art. III:2(b), Art. IV and Art. X:4 GPA; European Union, Appendix I to the GPA, Annexes 1, 2, 4 and 7, especially Annex 2 Note 1(a). Revised GPA in force for Switzerland from 1 January 2021. Council Decision 2014/115/EU of 2 December 2013 on the conclusion of the Protocol Amending the Agreement on Government Procurement [2014] OJ L 68/1, Art. 3 of Decision 2014/115/EU. For covered procurement, Art. IV:1 GPA protects goods and services of another party and suppliers of another party offering goods or services of any party, requiring treatment no less favorable than for domestic goods, services and suppliers or those of another party. Art. IV:2 GPA also protects locally established suppliers against discrimination based on foreign ownership or affiliation, or on their offering goods or services of another party. Art. IV:5 GPA prohibits procurement-specific rules of origin that differ from those applied in the normal course of trade. Art. X:4 GPA forbids technical specifications that require or refer to a specific origin unless there is no other sufficiently precise way of describing the requirement, and then only with the words or equivalent. Those provisions give a covered bidder grounds to challenge an origin-based reserved lot or a scoring scale that disadvantages covered goods made elsewhere. They do not themselves settle how the proposed preference and the GPA's exceptions would interact. Art. 25 of Directive 2014/24/EU carries the obligation into Union procurement law, requiring contracting authorities, in so far as the Union's annexes and general notes to the GPA cover a procurement, to accord the supplies and economic operators of the other signatories treatment no less favorable than those of the Union.9Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC [2014] OJ L 94/65, Art. 4(b)–(c) and Art. 25 of Directive 2014/24/EU; Commission Delegated Regulation (EU) 2025/2152 of 22 October 2025 amending Directive 2014/24/EU of the European Parliament and of the Council in respect of the thresholds for public supply, service and works contracts, and design contests for the years 2026–2027 [2025] OJ L 2025/2152, Art. 1(1)(b)–(c) and Art. 2 of Regulation 2025/2152.

Coverage is where Switzerland and the United States part company. In the Union's Appendix I schedule to the GPA, Annex 4 covers all goods procured by the covered entities unless otherwise specified, subject also to the General Notes in Annex 7 of the Union's GPA schedule. Even the restricted list for defense and security procurement includes pharmaceutical products. Annex 1 of the Union's GPA schedule covers, for the goods and suppliers of Switzerland, procurement by all central government contracting authorities of the Member States. Annex 2 of the Union's GPA schedule covers all regional and local contracting authorities and all contracting authorities that are bodies governed by public law, and nothing in its notes excludes Switzerland. The supply thresholds are SDR 130,000 for central and SDR 200,000 for sub-central entities.8 For ordinary public supply contracts, the corresponding thresholds in Art. 4(b) and (c) of Directive 2014/24/EU for 2026 and 2027 are EUR 140,000 and EUR 216,000, estimated net of VAT.9 Art. 18 ST-11059/26 applies only to procedures within the scope of Directive 2014/24/EU, including its applicable threshold and exclusions. For ordinary supply contracts, the threshold is met where the estimated value equals or exceeds the relevant amount. A public hospital or regional health authority may be a regional or local contracting authority or a body governed by public law within Annex 2 of the Union's GPA schedule; the particular buyer must qualify. The effect is that a large part of the procurement in which Art. 18(2) ST-11059/26 can operate is procurement the GPA covers for goods of Swiss origin.

The bilateral agreement of 21 June 1999 between the Community and Switzerland on certain aspects of government procurement supplements the GPA in defined areas. Its first chapter adjusts the two parties' GPA schedules: the Community removed Switzerland from a general note so that Swiss suppliers could challenge awards by the entities listed in paragraph 2 of the Community's Annex 2 to the GPA, and Switzerland extended its coverage to districts and municipalities. Its second chapter covers specified telecommunications and railway operators, energy entities other than electricity, and private utilities. Art. 6 of the agreement links its non-discrimination obligations to those covered entities and the thresholds in Art. 3(4) of the agreement.10Agreement between the European Community and the Swiss Confederation on certain aspects of government procurement (Luxembourg, 21 June 1999, in force 1 June 2002) [2002] OJ L 114/430 (EC–Swiss Procurement Agreement; SR 0.172.052.68), Art. 1–2, Art. 3(1)–(4) and Art. 6 of the EC–Swiss Procurement Agreement. It does not create a separate hospital-procurement guarantee. The substantive coverage of an ordinary hospital supply tender therefore turns on the GPA schedule, including the review access the bilateral agreement helped secure.

The US position requires a separate analysis of the supplier and the goods. At central-government level, access for US goods and suppliers depends on the listed entities and schedule conditions. Note 1(a) to Annex 2 of the Union's GPA schedule excludes procurement by the regional, local and public-law entities it covers in regard of suppliers, services and service providers from the United States until the Union accepts that the United States provides satisfactory reciprocal access.8 In Kolin, the Court of Justice considered a Turkish operator in a procurement governed by Directive 2014/25/EU. Because no agreement guaranteed equal and reciprocal access for that operator, it could not claim the directive's right to no less favorable treatment. A contracting entity could nevertheless admit the operator and state arrangements reflecting its objectively different legal position; the Court did not require automatic exclusion.11Case C-652/22 Kolin Inşaat Turizm Sanayi ve Ticaret AŞ v Državna komisija za kontrolu postupaka javne nabave, judgment of 22 October 2024, ECLI:EU:C:2024:910, paras 41–46 and 63–66 (operator access under Directive 2014/25/EU). A US supplier offering US-origin medicines to a buyer within the reservation in Annex 2 of the Union's GPA schedule cannot claim the access the reservation withholds. An EU-established supplier offering the same goods raises a different question: the reservation expressly names suppliers, services and service providers, not goods, while Art. IV:2 GPA protects locally established suppliers in covered procurement. The goods' origin and the supplier's position must therefore be assessed separately. Extending Kolin to this partial-coverage situation is an argument, not the judgment's holding.

Coverage does not settle the Swiss case either. The Council decision concluding the 2012 Protocol provides that the Protocol confers no rights or obligations that can be directly invoked in Union or Member State courts, so a Swiss supplier's route runs through Art. 25 of Directive 2014/24/EU and the national review bodies, with any dispute under the treaty itself left to the governments.8 Art. III:2(b) GPA, moreover, preserves measures necessary to protect human, animal or plant life or health, provided they are not applied as a means of arbitrary or unjustifiable discrimination between parties where the same conditions prevail or as a disguised restriction on international trade. A Union that justifies a preference for Union manufacturing by pointing to dependency on one or a few third countries will be asked why a plant in Switzerland, which is not the source of the dependency, is treated like a plant in the country that is. The Act does not decide whether the preference, applied to a covered procurement, must read Union as Union or covered party, whether the health exception carries it as written, or whether a buyer faced with a covered Swiss product should fall back on the exceptions in Art. 18(5) ST-11059/26. The compromise leaves that reconciliation open; treaty coverage does not automatically convert Swiss manufacturing into Union manufacturing.

One Member State has already written a rule of this kind, and it shows how awkward the reconciliation becomes in practice. Under § 130a Abs. 8a SGB V, the German statutory health insurance code, the sickness funds that tender rebate agreements for off-patent antibiotics must tender at least half of the lots for companies that use active substances produced in the Union or in the European Economic Area. For that reserved group of lots, the same provision treats active substances produced in a GPA party or another country covered by an agreement binding the Union as equivalent only where the particular contract falls within the agreement and at least half of the active substance needed to perform the rebate agreement is produced in the Union or the European Economic Area.12Sozialgesetzbuch (SGB) Fünftes Buch (V) – Gesetzliche Krankenversicherung vom 20. Dezember 1988 (BGBl. I S. 2477, 2482) (SGB V), § 130a Abs. 8a SGB V, sentences 3–7 (reserved lots, conditional agreement-country equivalence and the remaining lots). Swiss active substance can therefore contribute to a reserved lot under that formula, but cannot alone satisfy it. The other lots remain a separate route: the funds must provide for contracts with more than one pharmaceutical company, and the same quantity must be tendered for both groups of lots. Whether the Critical Medicines Act displaces that formula, adopts it, or leaves it standing beside the national program Germany must establish under Art. 19 ST-11059/26 is an open question for a market in which a comparable rule already runs.

4. The Public Procurement Act Proposal and the Swiss Response

Two developments in September 2026 frame the question from opposite sides. On 9 September the Commission proposed a Public Procurement Act that would replace Directives 2014/23/EU, 2014/24/EU and 2014/25/EU with a single regulation.13European Commission, Proposal for a Regulation on public contracts and concessions, repealing Directives 2014/23/EU, 2014/24/EU and 2014/25/EU, and amending Regulations (EC) No 1370/2007, (EU) 2023/1542, (EU) 2024/1157, (EU) 2024/1252, (EU) 2024/1735, (EU) 2024/1781, (EU) 2024/2847, (EU) 2024/3110 and (EU) 2025/40, and Directives 2008/98/EC, (EU) 2019/882, (EU) 2022/2381, (EU) 2023/1791 and (EU) 2024/1760 (Public Procurement Act proposal), COM(2026) 590 final (9 September 2026), recitals 32–35 and Art. 70, 73, 74 and 77 COM(2026) 590 final (Public Procurement Act proposal). Covered operators and covered goods are distinct; sectoral preference rules take priority where they regulate otherwise. A proposal, not adopted law. Its chapter on European preference treats goods as covered where they originate, under the Union Customs Code, in a third country that is party to the GPA and the procurement falls within the Union's commitments under that agreement, taking into account the applicable Annexes. Art. 73 COM(2026) 590 final (Public Procurement Act proposal) would let public buyers require that goods originate in the Union or be covered goods, and Art. 77 COM(2026) 590 final (Public Procurement Act proposal) would apply those rules to sectoral preferences unless the sectoral act regulates otherwise. On that design, a Swiss-origin product in a covered procurement would stand where a Union product stands. Recital 35 of the proposal then sets critical medicines apart. It states that Art. 18(2) ST-11059/26 (Critical Medicines Act compromise) establishes mandatory rules for favouring the suppliers of critical medicinal products and their active substances manufactured in the Union, which exhaustively regulates the application of European preference with regard to the critical medicinal products falling within its scope, and adds that where sectoral legislation does not provide the modalities for applying such requirements, public buyers should rely on the horizontal rules.

The unresolved point is how the sector-specific manufacturing preference and any horizontal gap-filling rules would operate together. Recital 35 of the Public Procurement Act proposal points toward the CMA supplying the preference's substantive design, while Art. 77 COM(2026) 590 final (Public Procurement Act proposal) preserves horizontal rules where the sectoral legislation does not regulate otherwise. Neither establishes that covered Swiss goods lose the protection of the applicable international commitments. Under the existing framework, Art. 25 of Directive 2014/24/EU also remains relevant. The practical question is how a buyer would reconcile that protection with a manufacturing-based reserved lot or score, rather than whether one recital can remove it. The proposal also carries Kolin forward: recital 33 of the proposal states that the rights and principles derived from Union procurement law do not extend to economic operators, goods, services or works originating in third countries not covered by international commitments, including components of the products procured. The proposal was at the start of the legislative procedure on the date of this article, and none of it is law, but it records how the Commission reads Art. 18(2) ST-11059/26.

Switzerland meets the question as an outsider to the Union's instruments. The Federal Council's dispatch of 20 March 2026 records that Switzerland has been a member since March 2025 of the Critical Medicines Alliance, a dialogue forum of national authorities, the Commission and industry launched in 2024, and that as a non-member of the EU it has only einen sehr eingeschränkten Zugang, very limited access, to the EU's initiatives on the security of supply of medicines.14Swiss Federal Council, Botschaft zur Volksinitiative «Ja zur medizinischen Versorgungssicherheit» und zum direkten Gegenentwurf (Bundesbeschluss über die Versorgung mit wichtigen medizinischen Gütern), 20 March 2026, BBl 2026 894, §§ 2.2.2, 2.2.4, 2.3.3, 6.4 and 6.6.1–6.6.2 (Alliance membership, existing supply powers and the proposed powers’ limits); Bundesverfassung der Schweizerischen Eidgenossenschaft vom 18. April 1999 (BV; SR 101), version of 3 March 2024, Art. 94 and Art. 102 BV. The instruments Switzerland has used so far are of another kind: mandatory stockholding of essential medicines under the LVG, a reporting office for supply disruptions, and the national-supply competence under Art. 102(1) BV: securing vital goods and services against threats of power politics or war and serious shortages that the economy cannot overcome by itself, including precautionary measures.

The dispatch proposes to widen that competence. The direct counter-proposal to the popular initiative Ja zur medizinischen Versorgungssicherheit would insert Art. 117c BV, under which the Confederation monitors the supply of important medical goods and, where necessary, issues rules to secure it. The law may in particular provide that the Confederation promotes that supply through economic incentives and solche Güter beschafft, herstellt oder herstellen lässt: procures such goods, manufactures them or has them manufactured.15Bundesbeschluss über die Versorgung mit wichtigen medizinischen Gütern (direkter Gegenentwurf zur Volksinitiative «Ja zur medizinischen Versorgungssicherheit») (Entwurf), BBl 2026 896, section I (proposed Art. 117c BV) and section II (vote of the people and cantons); Art. 140(1)(a) and Art. 142(2) BV (n 14). On 23 September 2026 the National Council recommended rejection of the initiative and adopted the counter-proposal by 110 votes to 78 with three abstentions, after a minority motion to strike the power to manufacture had failed by 88 votes to 101.16Swiss Parliament, Curia Vista 26.036, «Ja zur medizinischen Versorgungssicherheit». Volksinitiative und direkter Gegenentwurf (Bundesbeschluss über die Versorgung mit wichtigen medizinischen Gütern), National Council proceedings of 23 September 2026, votes 38783 and 38784 (manufacturing-power amendment rejected 101–88–2; counter-proposal adopted 110–78–3). Council of States consideration remained pending as of 24 September 2026. The Council of States had not debated the proposal by the date of this article. If Parliament adopts the constitutional counter-proposal, it must also be approved by the people and the cantons.

In parallel, the Federal Council opened a consultation on 19 June 2026 on an amendment to the HMG that includes measures against supply shortages, with responses due by 16 October 2026.17Swiss Federal Chancellery, Vernehmlassungsverfahren: Eidgenössisches Departement des Innern, Änderung des Heilmittelgesetzes 3b, 24 June 2026, BBl 2026 1709 (opened 19 June 2026; deadline 16 October 2026; includes supply-shortage measures). According to the dispatch, future measures must respect Switzerland's relevant international trade commitments. It also treats state manufacturing as exceptional and subsidiary, and says the proposed constitutional article does not authorize departures from economic freedom.14 That is the mirror image of the question the Critical Medicines Act leaves open. Procurement of medical goods by the Confederation would, to the extent the Swiss schedule to the GPA covers it, be procurement by a GPA party in which goods of Union origin are entitled to the treatment Art. IV GPA requires, and any Swiss preference would be read against the same provision a Swiss supplier reads against Art. 18(2) ST-11059/26.

5. Procurement Exposure for Sponsors With Swiss or US Production

The first questions concern the product rather than the plant. Whether a given medicine enters the second tier depends on the Union list, on a vulnerability evaluation and on a Commission implementing act, none of which the sponsor controls, and the designation that triggers the preference is about dependency on one or a few third countries, which may or may not describe the sponsor's own supply chain. A sponsor whose active substance comes from its own Swiss plant may find its product designated because the rest of the market depends on a single Asian source, and may then find that its diversified supply earns no Union-manufacturing credit under the second tier's literal location test while a competitor that moved its fill-finish into the Union earns points. Whether the first tier's resilience requirements, which credit diversification wherever it sits, will outweigh the second tier's weighting in a given award, is something each set of tender documents decides for itself.

The next questions concern the buyer. The same product may be offered to a central purchasing body listed in Annex 1 of the Union's GPA schedule, to a regional authority or a public hospital under Annex 2 of the same schedule, or to a buyer below the thresholds where Art. 18 ST-11059/26 does not apply at all. The coverage of Swiss and US goods and suppliers must be assessed for the particular procurement. For a qualifying joint request by five or more Member States under Art. 22(1) and (2) ST-11059/26, Art. 22(5a) ST-11059/26 requires, where relevant, resilience requirements equivalent to those of Art. 18 ST-11059/26, specified under the Financial Regulation and in the participating states' mandate to the Commission, and the Commission is itself an entity on the Union's schedule to the GPA; whether equivalence imports the Union-manufacturing preference into those procedures, and on what terms toward US suppliers, the text does not say. Whether a buyer that meets a covered Swiss product will score it as Union manufacturing, rely on the health exception, or invoke one of the Art. 18(5) ST-11059/26 exceptions and document it under Art. 18(5a) ST-11059/26 is a decision taken inside each procurement, subject to the applicable national review procedures.

The evidentiary and contractual questions follow. The records a manufacturer holds were built to demonstrate quality, not to apportion manufacturing between jurisdictions. Whether they show, in a form a contracting authority can verify independently, where each manufacturing step of the product and of its active substance takes place, and whether the sites registered in the marketing authorization match what a tender claims, are questions of fact that each bid will test. Any proposed site change must be checked against the marketing authorization and the applicable variation procedure. Art. 23b of Directive 2001/83/EC distinguishes procedures according to their risk and impact; the five-year floor in Art. 18(2a) ST-11059/26 is not a deadline for relocating production. A supply agreement with a European distributor or marketing authorization holder that bids in these tenders may say nothing about which plant supplies which tender, who bears the loss of points when the plant changes, or whether the distributor may represent a product as manufactured in the Union at all.

Manufacturing-location decisions must also account for the procurement rules applicable to the company's US contracts. Executive Order 13944 illustrates the historical pressure toward domestic production; it does not establish that the withdrawn GPA exclusions apply to a particular tender. For a Swiss site serving both markets, the proposed Swiss powers could create opportunities if the constitutional counter-proposal is adopted and implemented in legislation. The proposed Union preference could instead disadvantage its production, subject to treaty coverage and the tender's terms. Neither proposal guarantees that outcome, and the two legislative processes follow different timetables.

The calendar compounds each of these questions. On 24 September 2026, the CMA still awaited formal adoption; its list-dependent application and implementing measures remained ahead. The Public Procurement Act was a proposal, and Switzerland's constitutional counter-proposal had passed only the National Council. Those different legislative stages leave manufacturers facing several decisions on different timetables. The exposure depends on each manufacturing stage, the origin of the goods, the bidder's status, the buyer and the procurement coverage. A supply agreement that treats an authorized product as eligible for every public tender can leave those distinctions, and the resulting commercial risk, unaddressed.