The Swiss product safety legal framework consists of regulations that fall into two broad categories: sector-specific and horizontal framing regulations.
Sector-Specific Federal Regulations
These regulations apply to specific product categories and include, for instance, the following.
Horizontal Framing Regulations
These are subsidiary, applicable and cross-sectoral to all products, and include the following.
The enforcement of product safety regulation in Switzerland is generally sector-specific. This means that the enforcement authorities that are competent in a specific product sector are likewise competent to enforce the specific product safety regulations for that sector. Depending on the sectoral law, the responsibility for enforcement lies with either the cantons or the federal government. The main regulators are the following.
Generally, for consumer products (ie, products that are intended for consumers or likely to be used by consumers under reasonably foreseeable conditions), the Swiss Product Safety Act obliges the producer or any other distributor to take adequate measures (ie, corrective actions) in the course of its business to prevent potential dangers arising from those products.
A corrective action is deemed “adequate” if the disadvantages that arise for the producer or other distributor are not considered completely disproportionate in comparison with the advantages resulting for the affected consumers. Potential measures include the issuing of warnings, a sales stop, the withdrawal from the market or the recall of the product. The law does not provide for any fixed formal requirements. Therefore, any corrective action may be chosen if it ultimately serves to avert the danger emanating from the product. In practice, the competent enforcement bodies regularly require a producer/importer to issue a warning throughout the supply chain as well as towards consumers (provided that the product has already reached the consumer). Depending on the actual safety risk, the enforcement body may also require that the warning is made public – eg, on the producer’s website and/or on the website of the Swiss Federal Consumer Affairs Bureau (regarding the role of the Bureau, please refer to 1.2 Regulatory Authorities for Product Safety).
Switzerland follows a risk-based approach regarding the obligation to notify the regulatory authorities. Generally, the duty to notify the authorities in respect of a product safety issue is triggered – for consumer products – if a producer or any other person placing a product on the market knows or ought to know that the product in question presents a risk to the safety or health of users or third parties (Article 8, paragraph 5, Swiss Product Safety Act). The respective provision in the Product Safety Act corresponds to the producer’s or other distributor’s obligation to notify the authority according to Article 5, paragraph 3 of the EU General Product Safety Directive (2001/95/EC). Regulation (EU) 2023/988 on General Product Safety, which replaces the EU General Product Safety Directive by 13 December 2024, will use, however, the new wording “considers or has reason to believe” (Article 9 paragraph 8, Article 11 paragraph 8 and Article 12 paragraph 4).The notification obligation of the Product Safety Act applies where the specific sectoral law does not provide for any separate notification obligation.
The notification must be made immediately. According to an FAQ guide published by the State Secretariat for Economic Affairs (SECO), “immediately” means no later than one to two days, depending on the associated safety risk. Swiss legal scholars advocate a longer period of a maximum of ten days pursuant to the European Commission’s Guidelines for the Notification of Dangerous Consumer Products to the Competent Authorities of the Member States by Producers and Distributors in accordance with Article 5, paragraph 3 of Directive 2001/95/EC.
The Swiss Product Safety Act defines the minimum content of the notification. There are no legal requirements as to the form of the notification. However, some regulatory bodies provide for voluntary notification templates on their websites but emphasise that the completion of the form should not delay the notification.
Generally, whoever fails to timely notify the authorities of a dangerous or potentially dangerous consumer product according to Article 8, paragraph 5 of the Swiss Product Safety Act or whoever violates the duty to collaborate with the enforcement authorities (Article 11 Swiss Product Safety Act) is liable for a fine of up to CHF40,000 (in the case of wilfulness) or CHF20,000 (in the case of negligence). Further, any person who intentionally places a product on the market that does not meet the requirements of Article 3 paragraphs 1 and 2 of the Swiss Product Safety Act (general safety requirements) and thereby endangers the safety or health of users or third parties shall be liable to a custodial sentence not exceeding one year or to a monetary penalty (if the offender acts on a commercial basis, a custodial sentence up to three years or a monetary penalty). Further sanctions are possible if the person acted by negligence or in the case of false certifications, the unauthorised issuing of declarations of conformity or the use of labelling or warning and safety instructions that do not correspond to the specific hazard potential of a product. Sectoral law, however, sometimes provides for different criminal liability. In any case, the law sets forth that the person within the producer’s organisation who is responsible for the offence should be punished. The principal is only punished if they wilfully or negligently, in breach of a legal obligation, failed to prevent the offence.
There are no publicly available examples of companies being prosecuted or fined for breaching these obligations. However, that does not mean that no such cases exist. Under Swiss criminal prosecution law, the courts may generally only publish a judgment if the publication is in the public’s interest or in the interest of the injured party.
Depending on the respondent of the action (eg, a producer, distributor or retailer), an injured party would likely base its claim for damages on the following grounds.
Against the Producer
The Federal Product Liability Act provides for the non-contractual strict liability (ie, not depending on fault) of a producer for damages if a defective product leads to the death or injury of a person or the damaging or destruction of property. “Producer” means the person who has manufactured the end product, a basic material or a partial product; any person who claims to be the producer by affixing its name, trade mark or other distinctive sign to the product (“quasi-producer”) as well as any person importing the product for distribution purposes to Switzerland. The liability is only triggered if the product is deemed defective – ie, if it does not offer the safety that one may expect considering all circumstances (such as the get-up or overall appearance of the product, the expected use or the time of market placement). The Federal Product Liability Act, however, provides for several defences (please refer to 2.12 Defences to Product Liability Claims for further details).
In addition, the injured party could base a damages claim on contract (if the producer is the seller and the injured party is the buyer) or general tort law. The latter, however, would require proof of fault. Given this obstacle, a claimant would generally invoke the respective tort claim only on a subsidiary basis.
Against the Seller
The Swiss Code of Obligations provides for the strict contractual liability of a seller for the direct damage suffered by a buyer due to a defective object purchased from that seller. “Direct damage” would also include any personal damage or damage to property which was directly caused (ie, without any additional causal link) by the product’s defect. If the seller were also the producer of the defective product, the injured buyer could alternatively base its claim for damages on the Federal Product Liability Act as discussed above.
In Switzerland, the standing to bring claims for product liability is – such as with any other claim – a matter of substantive law – ie, it depends on the legal basis of a claim. A party has standing to sue if it (at least allegedly) has a substantive claim under a certain law or legal relationship.
In the context of product liability, claims are usually based on either the Federal Product Liability Act, a contract or tort law (as discussed in 2.1 Product Liability Causes of Action and Sources of Law).
Under the Federal Product Liability Act, any person injured by a defective product or any person suffering property damage due to a defective product may bring a claim against the responsible producer.
For contractual claims, a party to a contract usually has standing to sue if it suffers damage following a violation of the contract by the other party (in the context of product liability – eg, in case of the delivery of a defective product).
Under general tort law, any person who has suffered damage following a civil wrong committed by another person – whether or not the injured party is linked to that person by a legal relationship, such as a contract (eg, as often in product liability cases: the consumer and the producer of a product) – has standing to sue.
Which of these legal bases is the most favourable for an injured party to bring claims related to a product depends largely on the underlying facts of the case. Whenever there is a contractual relationship, an injured party will most probably bring claims under that contract given that, under Swiss law, there is a presumption of fault – ie, the burden of proof is on the breaching party causing damage, and in sales contracts there is even a strict liability without requirement of fault for direct damage. If there is no such contract – which is usually the case between an injured party and a producer – the injured party would generally try to sue a producer primarily under the Federal Product Liability Act because of its strict liability, whereas under tort law the producer can only be held liable in case of fault.
The applicable time limit depends on the legal basis that the respective claim is based on. For claims based on the Federal Product Liability Act, the statute of limitations is three years, starting from the date on which the injured person became or should have become aware of the damage, the defect of the product and the identity of the producer (Article 9 of the Federal Product Liability Act).
For claims based on contract law (in the context of product liability, most likely a sales contract), the statute of limitations is two years, starting from the day the defective product was delivered (Article 210, Swiss Code of Obligations).
For claims based on tort law, the Swiss Code of Obligations provides for two different statutes of limitations: a relative and an absolute one (Article 60, Swiss Code of Obligations). The relative limitation period is three years, starting from the date on which the injured person became aware of the damage and the person liable for it. The absolute limitation period is ten years for damaged goods and 20 years for personal injuries, starting from the date on which the damaging event occurred or ended. This longer limitation period, under tort law with regard to personal damage, has the effect that a producer may be held liable by an injured party under tort law, even if the limitation period for claims under the Federal Product Liability Act has already lapsed. This absolute limitation period generally runs regardless of whether the injured person has any knowledge of the damage and even if the damage has not yet occurred. However, the European Court of Human Rights has recently ruled that Swiss courts need to reconsider the limitation period, taking into account the lengthy latency period of asbestos-related diseases and the realistic opportunity for victims to recognise the damage. It remains to be seen whether Switzerland will appeal against this decision and how the Swiss courts will implement this ruling.
The Swiss Civil Procedure Code defines the locally competent court for a dispute in domestic matters, whereas the Swiss Federal Act on Private International Law or the Lugano Convention (applicable in civil and commercial matters involving parties from EU or European Free Trade Association (EFTA) states) deals with the question of territorial jurisdiction of a Swiss court in international, cross-border disputes.
Rules regarding the place of jurisdiction are quite comparable both in domestic and in international cases. As a general rule, proceedings can be initiated in the competent court at the domicile or seat of the respondent (eg, at the seat of the liable producer). Depending on the area of private law concerned, a claimant may also initiate proceedings at another forum – eg, in product liability cases, a consumer would be entitled to bring a claim at its own domicile.
With regard to subject-matter jurisdiction, it can be said that, generally speaking, all cantonal courts in Switzerland have jurisdiction in all areas of the law and apply both cantonal and federal law. There are no specific/specialised courts for product liability claims, which can therefore be brought before any locally competent court.
However, the Swiss Civil Procedure Code grants the cantons the option to establish specialised commercial courts, in which the panel of judges is mixed – ie, composed of regular judges and experts (so-called expert judges) in the economic sector relevant for the case. Four cantons – Zurich, Berne, Aargau and St Gallen – have established such a court, which is part of the cantonal supreme court and serves as a court of first instance for commercial matters. Such a commercial court has subject-matter jurisdiction if:
Where only the defendant is registered in the commercial register, a claimant can choose to initiate proceedings before either the commercial court or the locally competent ordinary court. If a producer has its registered seat in a canton with a commercial court, an injured party can thus choose to bring its product liability claim before either the commercial court or the ordinary court. Due to a revision of the Swiss Civil Procedure Code, coming into force on 1 January 2025, it will no longer be necessary that the decision can be appealed to the Swiss Federal Supreme Court; however, the amount of dispute must still be at least CHF30,000.
If a claiming party has the possibility to choose where to bring its claims, which court is the most favourable depends on the underlying facts and on the party’s perspective. Commercial courts have the advantage that experts from the relevant sectors are part of the judges’ panel, whereas judges of ordinary courts generally do not have expert knowledge in the specific product sector, but their decisions might be more consumer-friendly. Another difference to take into consideration is that there is only one legal remedy against decisions rendered by a commercial court, whereas decisions of the ordinary courts can be appealed against twice (see 2.11 Appeal Mechanisms for Product Liability Claims).
Swiss procedural law provides for mandatory reconciliation proceedings. Before initiating the main proceedings, the claimant must submit a reconciliation request to the Conciliation Authority (the so-called justice of the peace), following which the Authority will schedule a conciliation hearing. If no agreement can be reached, the Conciliation Authority will issue an authorisation to proceed (ie, to file a claim before a court), which is valid for three months. If a claim is filed before a court without a valid authorisation to proceed, the court will not decide on the merits but dismiss the case for procedural reasons.
Despite the mandatory nature of the reconciliation proceeding, the Civil Procedure Code provides for a few exceptions which might be of relevance in product liability cases. A claimant may unilaterally waive conciliation if the respondent’s registered domicile is outside Switzerland. The parties may mutually agree to waive reconciliation if the amount in dispute is at least CHF100,000. In addition, and irrespective of the amount in dispute, the parties may agree to replace the reconciliation procedure with mediation pursuant to Article 213 of the Swiss Civil Procedure Code.
In addition, and as set out in 2.4 Jurisdictional Requirements for Product Liability Claims, certain cantons have established commercial courts. If a producer has its registered seat in one of these cantons, an injured party may choose to bring its product liability claim either before the commercial court or the ordinary court, as long as the criteria as set out in 2.4 Jurisdictional Requirements for Product Liability Claims are met. If a claimant decides to bring a claim before a commercial court, no reconciliation proceedings take place and the claim must be filed directly with the commercial court.
There are no specific rules, under Swiss product liability law or Swiss procedural law, obliging a producer or other distributor to preserve any evidence in product liability cases.
There are, as in many other jurisdictions, general evidentiary risks in not preserving evidence. In a product liability case, the claimant is generally required to prove that the defendant’s product is defective, and that the product defect is the cause of their injury or damage to property. Under Swiss product liability law, the defendant (producer or other distributor) has several defences (please refer to 2.12 Defences to Product Liability Claims for further discussion of these). In this light, a producer or other distributor is well advised to preserve documentation (eg, random samples, technical documentation, consumer feedback, etc) and product samples for every batch so that such evidence can be readily produced if necessary. Furthermore, under some sectoral laws, producers may be required to preserve the conformity declaration or technical documentation.
There are no specific rules on the taking of evidence in product liability cases, and the Swiss Civil Procedure Code does not provide for any pretrial or discovery mechanisms. Pursuant to the general rules on the taking of evidence in civil procedure, each party must indicate the evidence it wants to rely on in its briefs. To the extent that such evidence is already in its possession, the party must file the evidence together with its briefs. For product liability cases, in particular this holds true for:
Court-Ordered Evidence
To the extent that it is the responsibility of the court to order the taking of evidence, parties must submit respective requests together with precise descriptions of the evidence. In particular, this holds true for:
If a party wants to rely on evidence in the possession of the opposing party or a third party (eg, a defective product, purchase receipt or medical reports), it has to precisely identify the evidence and request that the court order that the evidence be provided.
Preventative taking of evidence
If a potential claimant (ie, an injured person) has reason to believe that evidence is at risk, it may request the preventative taking of evidence by the court. This request can be filed at any time during the proceedings and even prior to the commencement of the proceedings.
The preventative taking of evidence is considered an interim measure. The request is usually granted if:
In any case, the requesting party has to credibly demonstrate (but not prove) the grounds on which it bases its request. In case of imminent harm, the request can be granted ex parte.
The court may seek an opinion from one or more experts at the request of a party or ex officio. However, the court will do so only if it considers an expert opinion necessary to prove relevant facts that are disputed by the parties. If such an opinion is sought, it is the court that appoints as well as instructs the experts and submits the relevant questions to them. Prior to this, the parties are given the opportunity to submit additional questions or to have the questions modified. The court can order that the experts submit their opinion in writing or present it orally. It may also summon the experts to the hearing to present and explain their written opinion. In that case, the parties will be given the opportunity to ask for explanations or to put additional questions to the expert. However, cross-examination of the expert is not permitted.
Furthermore, the court may put questions to a witness with expert knowledge in order to assess the merits of the case. The expert witness must have special expertise in the subject so that the court can examine the expert witness not only with regard to the merits, but also on its assessment thereof. However, an expert witness cannot replace an expert opinion. In contrast to an expert, the expert witness is not subject to an appointment procedure. Finally, an expert witness is liable to prosecution only for giving false testimony and not for giving a false expert opinion.
Parties are free to individually commission an expert opinion and to submit it in the proceedings. As opposed to an expert opinion that was produced by a court-appointed expert, the party expert opinion is not considered to be evidence but will only qualify as a party allegation.
As a general rule under Swiss civil law, it is incumbent upon the party who wants to rely on a certain fact to establish and prove this fact. For product liability cases, this means that it is generally the injured person who bears the burden of proof for all facts underlying its claim.
This holds true for all claims (and the respective requirements) based on tort law and on the Federal Product Liability Act. For claims based on a contract there is one deviation from this rule: the burden of proof for fault is reversed. This means that, if all other requirements are met, it is assumed that the defendant was at fault and it will be upon the defendant (ie, the producer) to prove that this was not the case. From a procedural perspective, it may thus be favourable for an injured person to bring a claim based on contract rather than based on tort law. For claims based on a sales contract, provided that a direct nexus between the damage and the defect of the product can be established, fault is not a requirement at all. The same holds true for claims based on the Federal Product Liability Act.
The Federal Product Liability Act provides, however, for several exceptions to this strict liability (see 2.1 Product Liability Causes of Action and Sources of Law). In accordance with the general rule as set out above, it is the producer who bears the burden of proof for any fact it wants to rely on in order to exonerate itself from liability.
As to the relevant standard of proof: the general threshold is full proof, meaning that the court has to be convinced beyond any reasonable doubt. Where this is not possible (eg, because the defective product has been destroyed or disposed of or the amount of damage suffered cannot reasonably be quantified), the courts may apply a less strict standard.
There are no specific or specialised courts for product liability cases in Switzerland. Therefore, such cases generally must be brought before ordinary courts (ie, the competent local court) or – in certain cantons and if the statutory prerequisites are fulfilled (see 2.4 Jurisdictional Requirements for Product Liability Claims) – before the competent commercial court.
Depending on the value in dispute, the proceeding is held in a simplified proceeding (for claims below CHF30,000) or in an ordinary proceeding (for claims above CHF30,000 or claims without monetary value).
In Switzerland, cases are decided by judges and the exact composition of a bench depends on local, cantonal law. In simplified proceedings, the court is, however, often composed of a single judge (Einzelrichter), whereas there are usually three or more judges (Kollegialgericht) on the panel in ordinary proceedings.
There is usually no minimum threshold with regard to the damages that can be claimed. If claims are brought under the Swiss Product Liability Act, however, the claimant must bear a deductible of CHF900 in case of a claimed damage to property.
With regard to the damages that can be awarded to a claimant, there is no maximum in absolute numbers. However, a claimant can only be compensated for the damages it actually suffered. In other words, Swiss courts do not award so-called punitive damages that exceed the amount of the actual loss. Swiss law does not allow a damaged party to take monetary advantage (enrichment) from the event of damage. Accordingly, the claimant must prove each individual damaged position (exact amount) and the causal link between the damaging event (in product liability cases: the defective product) and the respective position.
There are no specific rules governing the appeal mechanisms in product liability cases. The general procedural rules provide essentially for two appeal opportunities which are relevant for product liability cases: a first one to the high court of the respective canton and a second one to the Swiss Federal Supreme Court.
Appeal to the High Court of the Respective Canton
Final and interim decisions and decisions on interim measures of a court of first instance can be appealed if the amount in dispute is at least CHF10,000. The time limit for the filing of an appeal is 30 days in the case of an ordinary proceeding and ten days in that of a summary proceeding. The appellant may submit that the first-instance court has (i) applied the law incorrectly, and/or (ii) established the facts incorrectly. The conduct of the proceeding is, to a large extent, at the discretion of the appeal instance – ie, the court of second instance will decide whether to conduct a second round of written submissions or to hold an oral hearing. The appeal instance may conclude the proceedings either by confirming the challenged decision, by rendering a new decision or by remitting the case to the court of first instance.
Appeal to the Swiss Federal Supreme Court
The decision of the court of second instance may be appealed to the Swiss Federal Supreme Court if the amount in dispute is at least CHF30,000 or if a question of fundamental interest is to be decided. The time limit for filing the appeal is 30 days. The appellant may essentially claim that the previous instance has (i) violated federal law, and/or (ii) established the facts manifestly wrongly or in violation of the federal law, provided that such deficiency was relevant for the outcome of the case. The procedure will be conducted in writing and will usually be limited to two written submissions. As in the previous instance, the Swiss Federal Supreme Court may confirm the challenged decision, render a new decision or remit the case to the previous instance.
Exception: Decisions of the Commercial Courts
There is only one legal remedy against a decision rendered by a commercial court, which is the appeal to the Swiss Federal Supreme Court. The procedure will be the same as described above.
The Federal Product Liability Act provides for the strict liability of a producer. The producer is, however, not liable under the Federal Product Liability Act if it can prove that:
Furthermore, the producer of a raw material or part product is not liable under the Act if it can prove that the product defect is due to the construction of the product or the instructions of the producer of the end product.
A producer’s failure to meet the regulatory requirements is considered a breach of the product user’s justified safety expectations and can be decisive for the determination of the defectiveness of the product. Swiss courts, however, have repeatedly found that adherence to regulatory requirements is the minimum standard only when determining the justified safety expectations. The producer must assess, in each individual case, whether its product meets the user’s safety expectations and may not rely on adherence to regulatory requirements or the conformity assessments of regulatory bodies.
In Switzerland, the claiming party has to pay an advance on the court costs to initiate court proceedings. The payment of the advance is a procedural requirement for the action, meaning that if no payment is made the case will be declared inadmissible. This has been quite a threshold for claiming parties in general and in particular in product liability cases involving consumers, given that the amounts to be advanced are calculated based on the amount in dispute and are generally relatively high.
However, the claiming party may get reimbursement of the advance if it wins the case as, in Switzerland, the “loser pays” principle applies. Accordingly, the costs follow the event, which means that the losing party must bear the court costs and, on top of that, must compensate the successful party for its legal costs. Court costs are determined and allocated by the court ex officio, while party costs are awarded upon request.
Currently, the court does not directly reimburse an advance payment of court costs made by a successful party, but only grants this party a compensation claim against the unsuccessful party, so that the successful party bears the risk that the costs cannot be collected.
The compensation for legal costs is determined in accordance with a tariff that is primarily based on the amount in dispute. The tariffs vary between cantons, but in the majority of cases the compensation granted does not cover the real legal costs incurred by a party; depending on the amount at stake, the amount payable as compensation for legal fees can be higher or lower than the actual costs incurred.
If no party succeeds entirely, the costs are allocated in accordance with the outcome of the case and unnecessary costs are charged to the party that caused them, independently of whether it was the losing party.
The Swiss Civil Procedure Code is currently undergoing a revision which will affect the costs in civil proceedings. In particular, under the revised law, the advanced payments will be cut in half (as a general rule but with certain exceptions such as summary proceedings), which will lower the threshold to initiate proceedings. Furthermore, the law provides that the successful party will be directly reimbursed by the court for the advance it paid and will no longer have to reach out to the losing party to be reimbursed. The revised Civil Procedure Code will enter into force on 1 January 2025.
Third-Party Funding
Third-party funding is permitted and exists, although it is not very common in Switzerland. In principle, there are no restrictions to it, as long as the funded party is still in control of the claim. If the funded party is represented by legal counsel, it is important to avoid any set-up that might impair the counsel’s ability to act independently and to pursue only their client’s interests. Otherwise, such a set-up might interfere with the counsel’s obligations pursuant to the rules of professional conduct.
Contingency Fee Agreements
“No win, no fee” and contingency fee agreements are not permitted under Swiss law since they are considered to stand in contradiction to the counsel’s obligations to act independently. According to the Swiss Federal Supreme Court, the attorney’s rules of professional conduct require a base salary, which does not only cover the attorney’s costs but must also guarantee a certain profit. Only if this precondition is met, may the parties agree on an additional success fee element in the sense of a top-up fee.
Legal Aid
Legal aid is available (mostly) for private individuals under the preconditions that (i) the requesting party does not have the funds to finance the proceedings itself, and (ii) the case is not devoid of any chance of success. The request must be placed with the same court that is also deciding on the merits. The court will decide on the request in a formal, preliminary proceeding, during which the requesting party must fully disclose its financials and state its position on the merits. If legal aid is granted, the applicant is relieved from the obligation to pay any court costs (including any advance on costs) and the state will cover any reasonable lawyer’s fees. Legal aid does, however, not relieve the applicant from the obligation to pay party compensation to the opposing party in the case of defeat.
Legal Protection Insurance
Since the threshold for receiving legal aid is high and the costs for initiating proceedings are considerable, legal protection insurance is becoming more and more common amongst consumers. Even standard insurance packages include a legal protection policy. While the conditions of such policies vary significantly and most insurance policies tend to avoid litigation and to settle potential disputes, it is, however, difficult to quantify the impact of legal protection insurance on product liability claims.
There are no real collective redress procedures in Switzerland. However, it is possible to jointly bring several claims (eg, by a number of claimants filing their claims together when there are similar facts and legal grounds) in one proceeding or by way of an assignment of the individual claims to a claimant party. However, since this is usually cumbersome, it is rare.
When the general revision of the Swiss Civil Procedure Code was initiated in 2018, it was envisaged that it would introduce certain collective redress mechanisms. However, the proposed amendments triggered so many debates that the Federal Council decided to split them off and to deal with them in a separate revision project in order not to jeopardise the revision as such.
There are not many published decisions concerning product liability in Switzerland because most cases are settled. The following cases are noteworthy.
In its decision of 5 January 2015 (4A_365/2014; 4A_371/2014), the Federal Supreme Court held that in the case of prescription drugs, the justified safety expectations of the product need to be assessed with regard to the safety expectations of the patient, but also with regard to the knowledge of the prescribing physician. In the specific case (it concerned the contraceptive pill “Yasmin”), it was deemed sufficient that the warning of a possible increased risk of a thromboembolic event, compared to contraceptive pills of previous generation, was only included in the expert information, not in the patient information.
In its decision of 31 May 2019 (2C_60/2018), the Federal Supreme Court specified that missing expert information from a preparation label, which therefore does not warn of a preparation-specific risk, is not to be considered a product defect in every case.
Furthermore, the Swiss Federal Supreme Court clarified that the provisions of food law also apply to intermediaries. In the case at hand, the package leaflet was qualified as inadmissible, even though it was only directed at the sales staff of drugstores and pharmacies (Decision 2C_733/2020 of 15 March 2021).
In its decision of 9 September 2013 (2C_13/2013), the Federal Supreme Court held that the malfunction of a product is considered a product defect if the product’s value is specifically based on its serviceability (ie, a fire extinguisher).
On 18 March 2011 (137 III 226), the Federal Supreme Court decided that a producer was not liable for any defects that were not detectable at the time of the market placement according to the then current state of science and technology (so-called development risks).
In its decision of 19 June 2010 (4A_255/2010), the Federal Supreme Court had to rule on a product liability claim relating to a defective window. The court held that the producer was not liable because the window was manipulated after it had been placed on the market, which was beyond the reasonable expectation of the producer.
On 4 October 2010, the Federal Supreme Court found that the compensation of an injured party is to be reduced if that party has failed to carefully study the product manual before using the product (4A_319/2010).
On 26 November 2021, the Higher Court of the Canton of Berne found in its decision (ZK 20 399) that the court of first instance had unjustifiably rejected a claim for product liability brought against Johnson & Johnson by a patient who had suffered from several complaints after the implant of a hip prosthesis. The prosthesis was finally removed. The Higher Court held that it was reasonable to conclude that a prosthesis which had caused a toxic reaction in half of the cases:
did not meet the user’s justified safety expectations and was, therefore, faulty in the sense of Article 4 of the Federal Product Liability Act.
Medical Devices
Switzerland and the EU have gradually tightened the requirements for medical devices in recent years in order to improve the quality and safety of these products. In parallel, the chapter on medical devices in the MRA (Agreement between the Swiss Confederation and the European Community on mutual recognition in relation to conformity assessment) should have been completely updated. This agreement is intended to avoid barriers to trade between Switzerland and the EU and to ensure joint market surveillance by the enforcement authorities of Switzerland and the EU. The necessary update of the chapter in the MRA on medical devices has not yet been possible. After the Federal Council unilaterally decided in May 2021 not to sign the institutional framework agreement with the EU, the EU linked the updating of the agreement in the area of medical devices to institutional issues for political reasons. As long as there is no progress on the latter, no update will take place. As a result, medical device providers established in Switzerland can no longer benefit from the facilitation of the Swiss-EU MRA as of May 2021. At that time, an update of the MRA was necessary to take into account the application of the EU Medical Device Regulation (MDR) and the corresponding legislation in Switzerland. The European Commission also reiterated in 2022 that an update of the MRA can only be envisaged in the context of a resolution of the institutional issues. The same problem also applies to in vitro diagnostics since 26 May 2022, for which the EU has classified Switzerland as a third-party country, meaning that previously existing trade facilitations under the MRA are suspended.
Despite the institutional deadlock, Switzerland has embarked on a major legislative project in recent years to comprehensively revise Swiss legislation on medical devices and in-vitro diagnostics and bring it into line with the EU regulations on medical devices (MDR and In Vitro Diagnostic Medical Device Regulation (IVDR)). The latest changes in this field adopted the requirements on product groups without an intended medical purpose of the Implementing Regulations (EU) 2022/2346 and (EU) 2022/2347. Devices without an intended medical purpose are mainly cosmetic in nature but have a risk profile similar to that of medical devices. Therefore, devices without an intended medical purpose must be treated as medical devices subject to the Swiss Medical Devices Ordinance, in accordance with the transitional periods applicable in the EU.
Biocidal Products and Fertilisers
As of 1 January 2024, amendments to the Ordinance on Biocidal Products came into effect that aim to improve data interpretation in order to identify potential health and environmental risks caused by the use of biocidal products. The amendment introduces a new annual reporting requirement for biocidal products placed on the market. This reporting obligation applies to the person who first places a biocidal product on the market in Switzerland within the supply chain. Such notification must include information on the responsible party as well as information on the biocidal products placed on the market (eg, the quantity of biocidal products distributed, the active ingredients in the biocidal products and their concentrations). Notifications must be made electronically. The first report, covering the data of 2024, is due by 31 May 2025. Additionally, indicators based on water measurements have been established to assess and reduce the risks posed by biocidal products. Repeated significant instances of exceeding the limits set in the Waters Protection Ordinance may lead to the modification or revocation of biocidal product authorisations.
Furthermore, following the entry into force of the new EU Regulation 2019/1009 with provisions for the making available on the market of EU fertiliser products, the Fertilisers Ordinance was completely revised in order to avoid technical barriers to trade, with effect from 1 January 2024. The content of the EU regulation was adopted as far as possible or adapted to the Swiss context. In particular, the approval system, the names of the fertilisers and the structure of the Ordinance have been harmonised with the EU Regulation.
Drop-Shippers are Considered Distributors
In a recent ruling, the Federal Administrative Court (A-4413/2021 of 20 September 2023) specified the definition of “placing on the market” according to the Ordinance on Low-Voltage Electrical Products (LVEO). The court ruled that an operator offering products for sale on its website while acting as a drop-shipper (ie, selling products to customers without delivering or storing the products itself but instead having them delivered to customers by a wholesaler or supplier) is considered to be a distributor placing a product on the market in accordance with the LVEO. By selling the product, the definition of making the product available on the market is fulfilled, whereby it is irrelevant whether the operator owned and stored the product itself. Drop-shippers are therefore obliged to comply with the regulations of the LVEO on market access and post-market surveillance of low-voltage electrical products. This ruling is presumably transferable to other sector-specific ordinances that use the term “placing on the market”.
There are several areas of focus concerning future policy development in respect of product liability or product safety. The following developments are noteworthy.
Partial Revision of the Swiss Product Safety Act
With the enactment of the Regulation (EU) 2023/988 on General Product Safety in December 2024, a partial revision of the Swiss Product Safety Act will be expected pursuant to the State Secretariat for Economic Affairs, the responsible Swiss authority. The Regulation provides for a new EU framework for general product safety in the context of digitalisation and e-commerce. It can be assumed that the partial revision of the Swiss Product Safety Act not only serves to update the law to these developments but also to maintain existing harmonisation with EU law.
Swiss Product Liability Act – Mandate for Revision is Still Missing
The European Commission issued a proposal for a Directive of the European Parliament and the Council on liability for defective products (COM/2022/495) to adapt the current system on product liability to developments linked to transition towards a circular and digital economy and artificial intelligence (AI). Since the Swiss Product Liability Act has been in line with the current Directive 85/374/EEC, an adaption of Swiss law to such new developments seems conceivable. However, the competent Swiss authority has not yet received a mandate to initiate any revision of the Swiss Product Liability Act (as of publication of this chapter of the guide in June 2024).
Partial Revision of the Swiss Therapeutic Products Act
In the context of new technologies and legal development in the EU, Switzerland is currently revising the Swiss Therapeutic Products Act, inter alia, in relation to drug safety for patients and drug safety in paediatrics, namely by creating a legal basis for a mandatory electronic medication plan or with an obligation to use electronic systems to calculate drug dosage of medicines for children respectively. In light of Regulation (EC) No 2007/1394, new regulations in relation to advanced therapy medicinal products (ATMPs) shall also be implemented in order to grant access to new products and create a comparable level of safety to that in the EU. In relation to veterinary medicinal products, the partial revision aims to ensure equivalence of the Swiss law with EU law and to guarantee market access to novel and innovative therapies.
Tobacco Regulation
Parliament passed a new Federal Act on Tobacco Products and Electronic Cigarettes (the “Tobacco Products Act”) on 1 October 2021. In addition to tobacco products, it also regulates electronic cigarettes and herbal smoking products, especially low-THC hemp cigarettes with CBD. With regard to the protection of minors, advertising for tobacco products and electronic cigarettes that is directed at minors or that may reach minors is prohibited. As a result, the Tobacco Products Act prohibits the advertising of tobacco products and electronic cigarettes on posters, in cinemas, on sports fields, in and on public buildings, and in and on public transport. It also prohibits the sponsorship of events for minors or events of an international character. Currently, the implementing ordinance to the Tobacco Products Act is being drafted (publication of this chapter of the guide, June 2024). Both the Federal Act and its implementing ordinance are expected to enter into force in autumn 2024.
Plant Protection Ordinance
A comprehensive revision of the Plant Protection Ordinance is planned, aiming to align the ordinance with EU legislation (Regulation (EC) 1107/2009). Under the proposed draft, active ingredients approved in the EU will be considered approved in Switzerland, though exceptions may apply. The draft also simplifies the authorisation of plant protection products already approved in EU member states and includes provisions for environmental organisations’ involvement in the approval process. Additionally, a new digital system for submitting and processing authorisation applications and recording sales volumes of plant protection products will be introduced. Authorisation fees will significantly increase to cover the related costs. The legislative process for these amendments is currently in progress (June 2024).
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annemarie.lagger@walderwyss.com www.walderwyss.com/enNew Legal Frameworks on Product Safety, Product Liability and Green Advertising
In the context of digitalisation, new technologies and environmental governance aspects, legislators have enacted or are about to enact new laws. In the EU, a new regulation on general product safety, a proposal for a directive on liability for defective products and a directive against misleading environmental advertising have been issued. While Switzerland is not a member of the EU, it has adapted (and may continue to do so) its legislation to new legal developments in the EU. The following will discuss the developments in the EU from a Swiss law perspective and its implications for Switzerland. In the context of green advertising claims, an overview of the current legal situation in Switzerland will be provided.
GPSR and its implications for Switzerland
On 13 December 2024, the Regulation (EU) 2023/988 on General Product Safety (the “Regulation on General Product Safety” or GPSR) will enter into force. It replaces the general product safety directive from 2001 and provides for a new EU framework for general product safety in the context of digitalisation and e-commerce. The State Secretariat for Economic Affairs, ie, the responsible Swiss authority, is currently analysing the GPSR and will partially revise the Swiss Product Safety Act (PSA) and the Swiss Product Safety Ordinance (PSO) accordingly. However, no public documents or information regarding this partial revision are available as of the time of publication of this guide (June 2024). Since the PSA transposed the former Directive 2001/95/EC on general product safety into Swiss law in order to reduce technical barriers to trade by harmonising legislation with the rules of the EU, it can be assumed that the partial revision of the PSA is also designed to maintain existing harmonisation to facilitate trade and secure continued access to the European market. Even though the PSA has not been revised yet, Swiss companies doing business in the EU or in Switzerland should get prepared since the GPSR will be relevant for them, either directly because of their EU business or indirectly due to the anticipated change of Swiss law.
Scope of application of the GPSR
The GPSR applies to products that are placed or made available on the (EU) market unless there are specific EU provisions with the same objective regulating the safety of the products concerned. “Product” means any item which is intended for consumers or is likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them. This also includes products sold online or through other means of distance sales if the offer is targeted at consumers in the EU. An offer for sale shall be considered to be targeted at consumers in the EU if the relevant economic operator directs, by any means, its activities to one or more member states (Article 2 and 4 GPSR). Whether an offer is targeted at consumers in the EU is to be determined on a case-by-case basis, taking into account factors such as the geographical areas to which dispatch is possible, the languages available, the use of currency of the member state or a domain name registered in one of the member states. Thus, companies located in Switzerland selling products in the EU will fall under the scope of the GPSR.
In terms of personal scope of application, the GPSR applies to economic operators. “Economic operators” means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products or making them available on the market in accordance with the GPSR. As specific obligations for providers of online marketplaces are listed in the GPSR, they also fall under its scope of application. The GPSR provides for various obligations for economic operators, such as the obligations to set up internal processes for product safety. New information obligations apply for distance sales, such as the clear and visible indication of the manufacturer details, information allowing the identification of products and any warnings or safety information in a language easily understood by consumers of the relevant member state in which the product is made available on the market. Therefore, Swiss providers of online marketplaces targeting consumers in the EU should be aware of such new obligations.
Responsible person for products placed on the EU market
A product covered by the GPSR may only be placed on the EU market if an EU-based economic operator fulfils the obligations set out in Article 4(3) of Regulation (EU) 2019/1020 (such as verification obligations in relation to the declaration of conformity or performance and technical documentation). Thus, Swiss companies with no economic operator located in the EU should designate in due time a responsible person to secure market access for their products in the EU.
Providers of online marketplaces
The GPSR provides for a set of obligations for providers of online marketplaces. “Provider of an online marketplace” means a provider of an intermediary service using an online interface, ie, any software, including a website, part of a website or an application, including mobile applications, which allows consumers to conclude distance contracts with traders for the sale of products. Providers of online marketplaces have to fulfil various obligations, such as the following:
Thus, providers of online marketplaces located in Switzerland with an international scope should carefully review and implement their new obligations under the GPSR, particularly considering that providers of online marketplaces are also subject to penalties in case of infringement of their obligations under the GPSR (Article 44 GPSR).
Product safety recalls and recall notice
In the case of a product safety recall or a safety warning, economic operators and providers of online marketplaces shall ensure that all identifiable consumers affected are notified directly and without undue delay. If they have product registration systems or customer loyalty programmes in place, they shall offer the possibility to their customers to provide separate contact details only for safety-related purposes. If not all affected consumers can be contacted by such means, they have to be informed through other appropriate channels, including newsletters and retail outlets, mass media and other communication channels. Regarding the recall notice, the GPSR defines the required information to be included (Article 36 GPSR).
While some rules provide for new requirements (eg, possibility of customers to provide contact details or the extension of the obligation to providers of online marketplaces), the basic tone of these GPSR obligations has been general practice under Swiss law. However, the GPSR provides for explicit information to be included in a recall notice to consumers and prohibits the use of terms and expressions such as “voluntary”, “precautionary”, “discretionary”, “in rare situations” or “in specific situations” that could decrease consumers’ perception of risk. In contrast, the PSA currently provides for a list of mandatory information only in the notice to the surveillance authority, not in a recall notice to consumers. Thus, even though it is not explicitly prohibited to use expressions such as “voluntarily” in any recall notice under Swiss law as of now, wording chosen in any recall notice that could conceal a product safety risk will not be accepted.
Remedies in the event of a product safety recall
Pursuant to the GPSR, economic operators responsible for a product safety recall shall offer consumers effective, cost-free and timely remedies. Remedies shall not entail significant inconvenience for consumers such as bearing the costs of returning the product (eg, shipping costs). Without prejudice to any other remedies that the economic operator responsible for the recall may offer the consumer, the economic operator shall offer the consumer the choice between at least two of the following remedies:
These new remedy obligations under the GPSR are more far-reaching than existing Swiss law. Generally, Swiss product safety law on its own does not provide for any consumer remedies in case of a recall or other corrective action, with the exception of some sector-specific provisions that provide for more far-reaching after-market obligations. Generally, the Swiss Code of Obligations (CO) contains several material warranty claims that buyers can assert towards sellers (eg, the manufacturers) in case of a recall (eg, rescission of the contract, repair of the product or reduction of the sales price).
Safety Gate Rapid Alert System and Safety Business Gateway
The former “Rapid Exchange of Information System” (RAPEX) will be changed to “Safety Gate”, which comprises three elements:
Switzerland is currently not a member of the RAPEX reporting system. However, under the GPSR, the European Commission can co-operate with authorities of third countries in order to improve the overall level of safety of products made available on the market, including through the exchange of information. Full participation of third countries in the Safety Gate Rapid Alert System requires full alignment with EU law, participation in the European Standardisation System and a respective agreement with the EU. While Switzerland may adapt its legislation to the EU, it remains to been seen whether full harmonisation with EU legislation is achieved and whether participation in the Safety Gate Rapid Alert System will be considered. Until then, companies doing business in the EU and Switzerland should be aware that product compliance must be assessed for each of their products for both markets. Corrective measures (including recalls if necessary) must be separately co-ordinated with the respective surveillance authorities in the EU and Switzerland.
Proposal for a Directive of the European Parliament and of the Council on liability for defective products
On 28 September 2022, the European Commission issued a proposal for a Directive of the European Parliament and the Council on liability for defective products (COM/2022/495; adopted by the European Parliament in its first reading on 12 March 2024, the “Proposal”) to adapt the current system on product liability under which producers compensate consumers for damage caused by defective products to developments linked to transition towards a circular and digital economy and artificial intelligence (AI).
The Proposal provides for the following.
Since the Swiss Product Liability Act has been in line with the current Directive 86/374/EEC, an adaption of Swiss law to such new developments seems conceivable, in particular as the problems in relation to new technologies and the respective liability questions are the same in Switzerland. However, the competent Swiss authority has not yet received a mandate to implement any changes of the EU revision into Swiss law. In the context of civil law, there is no “harmonisation” automatism so that a revision may only be initiated by a political decision. At the time of publication of this guide (June 2024), such a decision has not yet been made. However, companies are well advised to monitor any developments in this area.
Green advertising
On 26 March 2024, the EU’s “Anti-Greenwashing Directive” entered into force (Directive (EU) 2024/825 as regards empowering consumers for the green transition through better protection against unfair practices and through better information). With this Directive, the EU aims to better protect consumers from misleading advertising regarding the sustainability and eco-friendliness of products (so-called green claims). In specific terms, all green claims and environmental labels must in future be correctly, fully and transparently documented, comparable and verifiable. Companies can be held liable for false or misleading green claims.
It remains to be seen whether Switzerland will adopt the EU’s Anti-Greenwashing Directive as a model for similar Swiss provisions. While not explicitly addressing green claims, current Swiss laws already have measures to prevent and penalise companies spreading false or deceptive information regarding product sustainability, as illustrated by the following examples.
Contractual claims
Liability towards customers for false or misleading green claims could arise from a contractual claim. For the enforcement of contractual claims, it is relevant whether the misleading statement has become a contractual component. This may occur, in most cases, either because the statement has become a warranty of the product’s quality, or because the lack of the advertised characteristic is considered a material defect of the product.
Nevertheless, depending on the specific form of the incorrect product information and the other circumstances of the situation, customers may have a contractual claim against sellers due to the incorrect statements. Potential claims include rescission of the purchase contract, reduction of the purchase price, or substitute performance (Article 205 CO).
If customers seek compensation (Article 97 CO), they must, in addition to a breach of contract, demonstrate the resultant damage. In the context of misleading claims, a claim for damages would be justified if customers can demonstrate that the misinformation led to an actual economic loss. Claims for disappointed expectations, lost opportunities for use, and wasted expenditure are not recognised as compensable damages. This requirement makes it challenging for customers to successfully claim damages based on false advertising information. Furthermore, for a claim for damages to be enforced, the opposing party must be at fault. While, for contractual claims, the seller is presumed to be at fault for the breach of contract, exculpation is possible in the case of sellers that carry out their business activities independently of the misleading claim or are neither intentionally nor negligently responsible for the misleading claim or its falsity (eg, distributors selling products unaware of other distributors’ misleading advertising).
Tort law
Customers in their role as injured parties may also claim compensation under tort law as specified in Article 41 CO, provided they can demonstrate actual damages incurred – with the same challenges as set out above for contractual claims. Additionally, injured parties would have to prove that the potentially liable person’s conduct was unlawful. In the case of purely financial losses, this would require a breach of a “protective provision”, ie, the violation of a provision that is intended to protect buyers from this financial loss. According to Swiss legal authors, Article 152 of the Swiss Criminal Code (CC) constitutes such a protective norm. Article 152 CC prohibits false or incomplete statements of considerable importance by founders, authorised representatives and other persons of similar position in public announcements, communications, reports, etc that could cause another person to dispose of their own assets in such a way that they suffer financial loss. However, it remains to be seen whether Article 152 CC will be recognised by the courts as a protective provision allowing a claim for damages under tort law based on misleading green claims.
Unfair competition
Alternatively, it would also be conceivable to base a claim on a violation of the Unfair Competition Act (UCA), prohibiting any false or misleading green claims or even for seeking damages (Articles 10 et seq UCA and Article 41 CO). Article 3(1)(b) UCA defines incorrect or misleading information about (inter alia) a company’s goods, works or services as an unfair act, encompassing false or misleading statements by companies concerning the sustainability of their products.
In November 2023, the privately organised Swiss Commission for Fair Trading (FTC) issued guidelines on commercial communication with environmental references/arguments. These guidelines require, for example, that environmental representations adhere to the principles of clarity and truthfulness and that all green claims must be based on widely acknowledged scientific facts and be objectively verifiable, which must be substantiated within the commercial communication itself. For instance, claims of CO₂ net neutrality should specify whether the CO₂ offsetting pertains to emission reductions or the removal of greenhouse gases, with phrases like “CO₂-neutral due to compensation through CO₂ storage”. Additional information on the explanation of such claims should be accessible via web link or QR code. Further, advertising must not use self-evident statements that are standard or even mandatory in the industry. In this regard, it is worth noting that international claims used in Switzerland must also hold true in Switzerland and reflect local conditions, considering factors like recycling or manufacturing capabilities for claims on recyclability and local manufacturing.
Although the FTC cannot issue binding judgments but only recommendations, its guidelines provide important points of reference for courts and other authorities when deciding on unfair competitive practices. In the event of violations of the UCA, a court can prohibit the infringing act, order the elimination of an existing violation and declare the unlawfulness of the violation (Article 9(1) UCA). Furthermore, competitors and customers can file an action for damages and satisfaction in accordance with the CO (Article 9(3), Article 10(1) UCA). In addition, criminal sanctions of up to three years’ imprisonment or a monetary penalty can be imposed (Article 23(1) UCA).
Sector-specific regulations
In addition to such general provisions, sector-specific regulations may prohibit misleading information for certain products, which would also cover any false or misleading environmental claims. For example, the Ordinance on Foodstuffs and Utility Articles requires that product information be truthful and not mislead consumers regarding certain aspects such as composition, nature, production method, and origin of ingredients (Section 12(1)). Similar provisions can be found in many other product-specific areas: eg, in the legislative framework on medicinal products (Articles 31 et seq and 51 Therapeutic Products Act and the corresponding ordinances).
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