Act on General Product Safety

In Poland, the main product safety legislation is the Act on General Product Safety, implementing Directive 2001/95/EC on general product safety. It sets a general standard of safety that applies to products intended for consumer use, for which no product-specific requirements have been introduced in other acts. The Act on General Product Safety sets out the obligations of persons trading on the Polish market, and is the basis for product safety inspections and product safety surveillance.

Acts Implementing the New Approach Directives

Many aspects of product safety are also covered by two acts implementing the New Approach Directives:

• the Act on the conformity assessment system of 2002; and
• the Act on conformity assessment systems and market surveillance of 2016.

These acts do not apply to all products, but only to certain categories of products that are subject to EU essential requirements, such as personal protective equipment, toys, electrical equipment, machines, electronic equipment, etc.

Product-Specific Regulations

There are also various product-specific laws and regulations that implement EU directives – eg, the pharmaceutical law, the Act on safety of food and nutrition, the Act on medical devices and the Act on cosmetics.

Office for Competition and Consumer Protection

The main regulator responsible for product safety monitoring in Poland is the President of the Office for Competition and Consumer Protection (OCCP). The OCCP is responsible, among other things, for monitoring compliance with general product safety requirements and conformity with the essential requirements introduced in the New Approach Directives. It initiates administrative proceedings on the basis of information obtained from the Trade Inspectorates, consumers or regulators of other EU Member States. Product inspections are conducted by the Trade Inspectorates, which inform the OCCP about the likelihood of the lack of safety of the inspected product. If the proceedings show that a product poses a threat to consumers, the President of the OCCP may impose specific obligations on that product's manufacturer or distributor. Fines may also be imposed for not following product safety requirements or not conforming with the essential requirements.

Sector-Specific Regulators

Some product groups have sector-specific regulators – eg, pharmaceuticals, medical devices and food products. Medicinal products and medical devices are within the jurisdiction of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products, whose product safety and market surveillance activities include:

• granting, suspending and withdrawing marketing authorisations for medicinal products;
• collecting information on adverse reactions of medicinal products;
• monitoring the safety of medicinal products;
• supervising medical incidents; and
• implementing measures regarding the safety of medical devices.

Additionally, the Chief Pharmaceutical Inspector is competent in terms of the quality of medicinal products (which relates to their safety) and can issue decisions suspending the distribution thereof or recalling them from the market.

The main regulator for food products and cosmetics is the Chief Sanitary Inspector, who is responsible, inter alia, for monitoring the safety of food products and cosmetics. Food product inspections are conducted by the Agricultural Inspection Agency (IJHARS), which, inter alia, informs the national Rapid Alert System for Food and Feed (RASFF) contact points about decisions issued when food and agri-products are not safe.

In terms of general product safety, the subject of corrective action is covered by the Act on General Product Safety, which obliges manufacturers to take appropriate steps to minimise the potential risks posed by the product – in particular, to take steps to withdraw the product, warn consumers or recall the product from the market whenever necessary. Distributors are required not to place on the market products that they know or, given the information in their possession and their professional experience, should have known are not safe.

Corrective action can be demanded by the President of the OCCP as a result of proceedings or a safety notification. The authority may order the following corrective actions, as provided for in the Act on General Product Safety:

• the introduction of a warning on the product label informing consumers about the risk that the product poses;
• making the placement of the product onto the market conditional on complying with the general product safety requirements;
• warning consumers about the risk – the authority may indicate the form of such a warning and its timing; and
• ordering the elimination of the risks, or the withdrawal, recall and destruction of the product.

Whether ordered by the President of the OCCP or undertaken as a result of the manufacturer’s or distributor’s own decision, the corrective actions should be proportionate to the risk that the product poses.

In addition, for more regulated products such as medicinal products, medical devices or food products, the product-specific legislation provides for specific obligations regarding corrective action. Different authorities are involved for such products, as follows:

• the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products for medicinal products and medical devices;
• the Chief Pharmaceutical Inspector for medicinal products (as regards suspension of distribution and recalls); and
• the relevant state district sanitary inspector for food product safety issues.

According to the Act on General Product Safety, the trigger for notification is learning that a product placed onto the market is unsafe. The notification obligation applies to manufacturers and distributors. The system is risk-based. The manufacturer and distributor are obliged to notify the President of the OCCP that the product is not safe without undue delay – ie, within ten days according to the OCCP’s guidelines on the timing of the notification, or three days if the threat is serious.

Polish law provides that the notification can be made via a form. The form is not mandatory, although the notifying party is required to provide all the information required in the form to the President of the OCCP. After the notification, the OCCP posts an online notice providing information about the affected product and the corrective measures taken by the manufacturer.

If the manufacturer or distributor is represented by a third party (eg, a legal counsel), a power of attorney should be attached to the notice, along with documents proving the authorisation of the persons granting the power of attorney to represent the company.

The procedures for products that are subject to stricter surveillance, such as medicinal products, medical devices and food products, can vary and are laid down in specific regulations.

According to the Act on General Product Safety, the penalties for breaching the product safety obligations are administrative fines of up to PLN100,000 (approximately EUR22,000).

In addition, the President of the OCCP can impose a fine of up to PLN100,000 for putting a product that does not comply with the essential requirements onto the market. This only applies to certain types of products (eg, personal protective equipment or toys).

There are examples of companies being fined for placing unsafe or non-compliant products onto the market. However, the fines imposed by the President of the OCCP for a breach of the general product safety requirements have not exceeded PLN60,000 (EUR13,400) over the past year.

If the President of the OCCP issues a final decision that a product is unsafe or non-compliant, said product is entered into the register of unsafe or non-compliant products.

In some categories of products (eg, machines and aerosol products), the manufacturer or distributor may be subject to criminal liability. In such a case, a criminal court can sentence an individual who has been found guilty to a fine, the amount of which is specified by the court in every case. Theoretically, the maximum amount of the fine could be PLN1.08 million (approximately EUR254,118), although it is very unlikely that the court would impose such a high fine for a breach of the provisions in question.

A person liable for placing medical devices that are non-compliant onto the market, or food products that are unsafe, can also be subject to criminal liability.

Product liability is regulated in Poland in the Civil Code. There are two basic regimes of product liability: strict product liability and fault-based tort liability. Strict product liability in the Civil Code implements EU Directive 85/374/EEC of 25 July 1985. Product liability claims can also arise under contract law but only if there is a contractual relationship between the claimant and the defendant.

Causes of Action

In the case of strict product liability, the causes of action are:

• damage;
• a defect in the product; and
• a causal link between the defect and the damage.

Strict product liability applies to death, personal injury and damage to property normally intended for private use.

Under tort liability, causes of action are:

• an unlawful act of the defendant;
• the defendant’s fault;
• damage; and
• a causal link between the defendant’s act and the damage.

It is assumed that putting a dangerous product on the market constitutes negligence (ie, the producer of such a product is deemed to be at fault).

Under contract law, the causes of actions are:

• a breach of contract;
• damage; and
• a causal link between the breach of contract and the damage.

The risk-based liability regime does not require proof of fault, which is more convenient for claimants.

Defendants

Under the strict liability regime, an action can be initiated against:

• the manufacturer;
• the manufacturer of material, raw material or a part of a product (unless the exclusive cause of the damage was the defective design or instructions given by the manufacturer of the product in which those materials or parts were used);
• the “quasi” manufacturer, which means any person who presents themselves as a producer by placing their business name, trade mark or another distinguishing mark on the product;
• the importer; and
• the person who sold the product in the course of their business (eg, the distributor) but only if none of the persons mentioned above is known to the injured party – such a person can avoid liability by informing the injured party (within one month of the notification of the damage) of the name and address of any of those persons or of their supplier.

In the tort liability regime, an action can be initiated against anyone who caused the damage through their fault.

An action can be initiated against the other party to the contract under contract law.

According to the Polish Civil Code, a person who has suffered damage caused by a defective product can file a claim for product liability. A claim for damages (compensation for financial damage) can be inherited, but a claim for compensation for pain and suffering can only be inherited if the person who suffered the damage filed the action before they died.

If the injured person dies as a result of the damages suffered, their relatives have a separate claim against the person responsible for the defective product. This claim covers medical and funeral costs. Under certain circumstances, the relatives of the deceased party can also claim their own damages (if the death of the victim caused a deterioration in their standard of living), the payment of a monthly annuity, and compensation for their suffering.

Additionally, relatives of the party who suffered death or serious bodily injury caused by a defective product can also claim compensation for their own pain and suffering if, as a result of the damage, they are unable to make or sustain the family relationship with the injured person.

The Polish Civil Code foresees several limitation periods for product liability claims. First of all, in the strict product liability regime, the limitation period is three years from the day on which the injured party learned or, acting with due diligence, could have learned about the damage and the person who is obliged to remedy it; however, the claims become time-barred ten years after the date when the product was placed onto the market in any case. Please note that Polish law differs from Directive 85/374/EEC, which provides that product liability claims shall be extinguished upon the expiry of that ten-year period.

There is also a limitation period for claims in the fault-based tort regime, which is three years from the day on which the injured party learned about the damage and the identity of the liable person. The general rule is that a claim in tort becomes time-barred ten years after the event that caused the damage.

However, if the damage is personal injury, the limitation period is three years from the day on which the injured party learned about the damage and the identity of the liable person, and it is not limited by any additional period. Therefore, claimants whose claims are time-barred in the strict liability regime sometimes decide to pursue a claim in the tort liability regime.

In addition, if the damage is the result of a crime, the statute of limitations with respect to the claim for damages is 20 years from the date when the crime was committed.

Please note that, on 9 July 2018, a new provision entered into force which provides that all limitation periods that are longer than two years end on the last day of the calendar year, which means they are practically prolonged until 31 December of the given year. There are ongoing discussions over whether this applies to the limitation periods relating to tort and product liability claims. Given the latest judgment of the Polish Supreme Court, the limitation period that started running before 9 July 2018 and did not end prior to that date continues to run until the end of the calendar year (ie, is prolonged in practice).

In general, under the Polish Civil Procedure Code, courts have jurisdiction if the defendant has their place of residence in Poland, or is a habitual resident of Poland.

Additionally, in tort cases, Polish courts are competent if the harmful event occurred in Poland. Pursuant to well-established CJEU jurisprudence, the harmful event occurs in a Member State if either the tortious act is performed (eg, the defective product is sold) or the damage occurs (eg, the party suffers injury) there. The same rules apply to claims in the strict product liability regime.

Similarly, if the claim arose from a contract that was performed in Poland, Polish courts will have jurisdiction over this claim (eg, if a defective product was delivered to Poland).

A consumer who has their place of residence in Poland, or is a habitual resident of Poland, can file a statement of claim in Poland if their claim arose from a contract, and the consumer’s efforts to execute this contract were applied in Poland. A consumer can also file a statement of claim if the other party has its enterprise or branch in Poland and the contract with the consumer involves the operations of that enterprise or branch. Additionally, if EU Regulation 1215/2012 applies, the consumer can always file a statement of claim in Poland if they are domiciled in Poland, regardless of the other party’s registered office or domicile.

There are no mandatory pre-action procedures.

However, in the statement of claim, the plaintiff has to disclose whether the parties undertook mediation or any other method of alternative dispute resolution and, if not, the reason for such an omission.

There is a financial risk for the claimant if they do not contact the defendant before filing the statement of claim (eg, by sending a letter of claim). They will have to pay all the defendant’s costs related to court proceedings if that defendant gave no reason to bring a lawsuit and acknowledged the claim at the first opportunity in the court proceedings.

There is no requirement to preserve documentation or other evidence for the purpose of product liability claims.

The obligation to keep certain documents or batch samples may arise from product-specific administrative laws (eg, pharmaceutical law), but this is not strictly related to the product liability regime. The failure to satisfy the administrative obligation does not have a direct impact on civil liability, but it can impact the court’s evaluation of the defendant’s due diligence.

Additionally, the court can secure evidence before civil proceedings are initiated. This means that the court can order the production of certain documents or the preservation of other evidence if there is a risk that it will be impossible or very difficult to obtain such documents or evidence in the future. This procedure is used, for example, to preserve explanted medical devices, which formally constitute medical waste and should be disposed of appropriately by the relevant healthcare centre.

There is no general disclosure requirement under Polish law. Each party presents evidence, including documents, to support their position. However, the court may request any person, including a party to the proceedings, to produce a particular document that is in their possession, unless such document contains confidential information. A party may not refuse to produce a document if the loss that the party could suffer as a result would only be the loss of the case.

If a party to the proceedings refuses to produce a document pursuant to the court’s request, the court shall assess the justification of the refusal and take the refusal into consideration when determining the relevant facts of the case. If an individual that is not a party to the proceedings refuses to produce the requested document without valid justification, they can be punished with a fine of up to PLN3,000 (approximately EUR675).

Expert evidence is required under Polish law whenever there is a need for expertise in any scientific or technical area. It can be provided by an individual expert, a team of experts with various areas of expertise, or an academic institute (eg, a university faculty).

A court expert can only be appointed by the court. The parties are allowed to suggest a particular expert to be appointed as a court expert and to propose a list of questions for the expert, but the court is not bound by those suggestions. Private expert opinions may be submitted by the parties, although they have purely persuasive value for the court expert and the court cannot rely on them when issuing its judgment.

Expert opinions are generally prepared in writing; after submitting their opinion, the expert may be examined by the court and the parties at a hearing.

Generally, the party that claims a certain fact to be true must prove it, which means that the claimant has the burden of proof with regard to all the facts required for the cause of the action. The defendant must prove all the facts that are required for their defence (for the facts that need to be proved in product liability cases, see 2.1 Product Liability Causes of Action and Sources of Law; for potential defences, see 2.12 Defences to Product Liability Claims).

This burden of proof may be shifted from time to time by the court. The court is allowed to accept prima facie evidence or to consider certain facts as having been proved if they are a logical consequence of a fact already established.

Product liability cases are brought in civil courts. They can be filed in a district or regional court, depending on the value of the claim: if the value of the claim is more than PLN75,000 (approximately EUR17,000), the claim should be brought in the regional court. The cases are decided by a professional judge (no jury) in the first instance and – with certain exceptions – by three professional judges in the second instance.

Polish law does not foresee any upper threshold for the award of damages; the damages depend on the actual losses of the winning claimant. The compensation for pain and suffering depends on multiple factors, with the court’s assessment of the type and magnitude of the winning claimant’s suffering being paramount.

It is worth noting that Polish courts do not award compensation at levels that are as high as those awarded in Western Europe or the USA, although there has been a significant increase in the sums adjudicated in recent years.

There are no special proceedings for product liability cases: they are heard in general civil proceedings, regardless of whether the basis of the claim is strict product liability, tort or contract.

The party that loses the case before the court of first instance is allowed to file an appeal. The losing party petitions the court to be served with the judgment, with the reasons. After the judgment with the reasons is served, the party has two weeks to file an appeal.

The party may challenge the factual findings of the court of first instance, as well as a breach of substantive law or the rules of procedure.

The court of second instance may confirm, revoke and remand, or revise the judgment of the court of first instance.

The party may file a cassation complaint with the Supreme Court against the judgment of the court of second instance. However, this is limited, as the party can only challenge issues of substantive law or procedural rules if the breach thereof has had a significant impact on the outcome of the case. The Supreme Court only hears a cassation complaint if particular criteria are met (eg, the value of the claim is not less than PLN50,000).

Even if the judgment of the second instance becomes final, the party may file a motion to reinstate the proceedings if certain significant rules of procedure were breached during the court proceedings.

If a cassation complaint is not allowed in the case, the party may seek to declare a final judgment inconsistent with the law. However, such a declaration does not revise the final judgment but allows the claimant to claim compensation from the State if damage was caused to said claimant by the defective judgment.

According to the Polish Civil Code, the following defences are available under the strict liability regime:

• the manufacturer has not placed the product onto the market;
• the product was not placed onto the market in the course of the manufacturer’s business;
• the defect in the product arose after it had been placed onto the market (however, to use this defence the defect in the product must not arise from a cause that is inherent in the product);
• the defect in the product was unforeseeable considering the state of scientific and technical knowledge at the time the product was placed onto the market (the so-called development risks defence); and
• the defect in the product arose from compliance with the provisions of the law.

In addition, if the manufacturer only provided a component of the product, they have a defence if the damage was caused solely by the defective design or by instructions given by the producer.

Under tort liability, the defendant can defend themselves by proving that there was no fault on their part.

In both regimes, the defendant may prove that there was no causal relationship between the defect and the damage if the damage was caused entirely through the fault of the claimant or a third party. The defendant could also argue that the injured person or third party contributed to the damage, which would have an influence on the level of damages awarded to the claimant.

In terms of the strict liability regime, the fact that the product is compliant with the regulatory requirements alone cannot exempt the defendant from liability. If the examination of the product reveals that it has a defect, it is irrelevant whether the product adhered to the regulatory requirements. Such a defence is only available when the defects in the products are due to compliance with the provisions of the law.

However, in the case of the tort liability regime, adherence to the regulatory requirements could be useful for arguing that the manufacturer was not negligent and that they had the right to believe that the product was safe.

In Poland, the rules regarding the payment of litigation costs allow the winning party to recover the costs of the litigation. As a rule, the court orders the losing party to cover all the necessary costs of the successful party. The successful party can recover court fees; for instance, if the claimant wins, they can recover the court fee paid when filing the claim. The successful party can also recover the costs of an advance payment for expert opinions.

The winning party can be granted recovery of the costs related to legal representation, although the recovery only applies to some extent. The statutory recoverable legal costs are calculated according to the regulation on legal fees. These amounts are rather low, and do not usually cover the full amount of actual costs.

Third-party litigation funding is legal under Polish law but is almost non-existent in practice.

No win, no fee arrangements are permissible by law in Poland but are prohibited under the code of ethics of attorney-at-law practice. A contingency fee understood as a win fee can be arranged but only as an additional payment. The attorney must be paid their basic fee regardless of the outcome of the proceedings.

There is also a system of public funding, which is available for parties that cannot afford the cost of the proceedings due to their financial standing. Such parties can be exempt from court fees in full or in part, and can be granted a legal counsel within the framework of legal aid.

A group action is available under Polish law, but is not very popular. Product liability claims may be pursued in this type of action. The group action is always heard by the regional court as the court of first instance.

The Polish system uses the opt-in model. At least ten people are required to select a representative to act on their behalf. The representative can be a member of the group or a district consumers’ ombudsman.

Regarding claims relating to personal injuries, the group may only seek to establish the defendant’s liability in general (and then individual members will follow this up with individual claims of a given amount in separate proceedings). For other types of claims, it is possible to seek compensation in the form of monetary claims in equal amounts in groups of at least two people. New claimants can join the group once the action is filed, until the court closes the initial stage of the proceedings.

The defendant may demand that the claimants pay a security deposit for its legal fees if the claim fails.

Co-ordinated proceedings are also admissible under Polish law, in the form of the formal joinder of parties. The conditions are as follows:

• the claims have to be of one type;
• the claims have to arise from the same type of legal and factual basis; and
• the court’s jurisdiction has to be justified for such claims or liabilities, both for each of them and for all of them jointly.

Supreme Court Judgment of 6 July 2021 (III CZP 34/20)

The claimant was injured when he tried to open a water bottle, which exploded in his hands.

The claimant filed an action against the insurer of the bottle’s manufacturer in the product liability regime. The insurer raised a defence that the claimant failed to indicate and prove the exact unsafe feature (a defect) that the bottle had, and which caused the explosion. The court of first instance dismissed the claim but the court of second instance decided to ask the Supreme Court for clarification on whether the claimant can seek compensation for his pain and suffering (instead of only damages), and on the burden of proof in product liability cases.

The Supreme Court decided that the claimant is entitled to seek compensation for his pain and suffering since the product liability regime is a modification of the wider general tort regime, which provides the injured party with such remedy. This notion had commonly been accepted by earlier jurisprudence and legal scholars. On the second question, the Supreme Court ruled that, although the claimant bears the burden of proof that the product was unsafe, they do not have to prove any particular characteristic of the product that made it unsafe. If the circumstances of the incident show that the product generally does not provide the safety a person is entitled to expect and that there were no external factors that caused the incident, the claimant does not have to determine or prove the actual defect of a product.

Supreme Court Judgment of 29 May 2019 (III CSK 209/17)

The claimant was injured by automatic doors in a supermarket. The doors had a defect because they could not detect a person standing between them if the person did not move.

The claimant filed an action against the partners of the partnership who installed the door and were responsible for its maintenance. The partners’ defence was that they did not manufacture the defective doors and were therefore not liable. The courts of first and second instance dismissed the claim.

The Supreme Court revoked and remanded the case to the regional court. The Supreme Court held that, according to the Polish Civil Code, when determining whether the injured party knew that the person who sold the defective product was not its manufacturer, the court has to take the average consumer’s knowledge into consideration. If the injured party files a claim against the person who sold the defective product, even if the injured party does not specify that it is seeking liability in a strict liability regime, the seller has to inform the injured party about the producer or importer if it wants to be exempted from liability.

Judgment of the Appellate Court in Białystok of 29 April 2016 (I ACa 20/16)

The plaintiff was the lessee of a sawmill with a sharpener, and the defendant was the lessor of that sawmill. Under the lease contract, the defendant was the owner of the facility, but the plaintiff was responsible for buying the necessary equipment to operate the sawmill, including saws. The sawmill was not operating properly, because of either a defect or the plaintiff’s incorrect choice of saws. The plaintiff claimed that the sawmill should be considered a hazardous product because it was not operating property and did not have a CE certificate, and therefore the defendant should be liable under the strict liability regime.

The court of the first instance dismissed the claim and the appellate court upheld this judgment. Specifically, the appellate court rejected the plaintiff’s argument that the lack of CE certificate automatically meant that the product was hazardous. The court held that the conclusion that a product does not meet the required safety standards solely because it lacks a CE certificate is premature, especially if said product has never undergone an examination. On the other hand, the court mentioned that the situation may have been different if the product had been examined for a CE certificate and failed.

Supreme Court Judgment of 2 October 2015 (II CSK 816/14)

The claimant was injured by a phone charger that scalded her skin during use.

The claimant filed an action against two entrepreneurs, from whom she claimed to have bought the charger. Later, the company that allegedly imported the phone charger to the EU joined the proceedings as co-defendant. The courts of first and second instance dismissed the claim, because the plaintiff failed to prove that she bought the phone charger from the sued entrepreneurs and that the sued company imported the phone charger to the EU.

The Supreme Court revoked and remanded the case against the company that imported the phone charger. The Supreme Court held that, although the claimant has to prove that a particular entity imported the product to the EU, the burden of proof then switches to the defendant, who has to prove that it did not place the product onto the market. The Supreme Court also pointed out that the court might accept the prima facie evidence that the particular entity placed the product onto the market.

There has been an increase in recent years in the presence of companies that assist people to pursue compensation claims, primarily against insurers. These companies usually do not employ qualified lawyers and often rely on a heavy load in claims without an in-depth analysis of each case.

There is no particular trend in product safety with regard to specific products, although it is notable that the Trade Inspectorate and the OCCP have recently focused on toys and vehicles, with those being the product categories most frequently reported via the Rapid Exchange of Information System (RAPEX) in 2021. Toys constituted 64% of the total number of reported products, while motor vehicles accounted for 14%. The most frequently reported risks were related to harmful chemical substances (37%) and trauma (28%).

In 2021, the OCCP submitted 158 notifications concerning more than 1.9 million pieces of dangerous products to the Safety Gate/RAPEX system.

Most notifications concerned toys (101), vehicles (22) and electrical appliances and lighting equipment (17).

There is a quite stable trend in the most common types of products with regard to which the OCCP publishes alerts based on manufacturers’ and distributors’ notifications – these are mainly cars and motorcycles.

There are no recent trends regarding software in the product liability context. In general, "dangerous product" has been interpreted broadly and covers not only physical products such as toys or electronic devices, but also the software that is part of such products (although standalone software – ie, software that is not incorporated in a physical product – would not be considered to fall under the defective product liability regime).

No amendments are currently being proposed to the legislation, and no new legislation is planned exclusively for product liability and product safety in Poland. Polish legislation reflects the law and guidelines that are applicable in the EU, so any amendments to EU legislation would be respectively introduced in Poland.

As regards product law, a draft law on products’ labelling was published on 5 September 2021, which proposes two main amendments:

• the person placing products in packaging on the market will be obliged to put marking on the packaging indicating separate collection of waste (resulting from these packaging) according to the fraction of waste; and
• these markings must be designed in a way that meets the needs of visually impaired and blind people. At this point, the draft does not clarify how they should be designed.

A failure to meet this obligation may result in an administrative fine ranging from PLN10,000 to PLN500,000 (approximately EUR2,160 to EUR108,000) (Article 57 point 1 of the Draft).

In addition, on 8 October 2021, the Ministry of Digital Affairs published a new draft law that addresses the certification of ICT products and services. The aim of the act is to reflect EU Regulation 2019/881 (the EU Cybersecurity Act) as fully as possible.

The draft law addresses high-risk suppliers and the introduction of new instruments related to the response to a critical incident (warning and protective order).

The draft also sets out a national cybersecurity certification system aimed at supporting the manufacturing of high-quality ICT products, ICT services and ICT processes. It sets down mandatory requirements for ICT products and includes respective manufacturers’ obligations. The draft also introduces the notion of "provider", which is defined as "manufacturer, authorised representative, importer or distributor" within the meaning of EU Regulation 765/2008.

Under the draft, ICT products, services or processes may be subject to voluntary conformity assessment, in particular through certification by the conformity assessment body. The draft also entitles the Polish Council of Ministers to set a national cybersecurity certification programme to develop certification procedures for ICT products, services or processes in line with the current scientific and technical knowledge and increasing the cybersecurity of businesses.

In addition, the recent "Policies for the development of artificial intelligence in Poland from 2020" seem particularly intriguing in terms of product compliance or liability therefor, among other things. The policies (published at monitorpolski.gov.pl) set the actions that are yet to be implemented in Poland, and the goals that Poland should achieve in the short term (by 2023), medium term (by 2027) and long term (after 2027), to help Polish society, economy and science develop in the field of AI. It also includes an overview of possible changes and new regulations in the field of, inter alia, liability related to the use or creation of AI (the proposals include the liability of AI producers based on the principle of diligence, as opposed to the risk-based liability of AI operators, as well as differentiating the liability of end users from the liability of AI operators).

The President of the OCCP has announced that a new draft regulation on representative action (implementing the 2020/1828 Directive) is to be published in 2022, but no such draft has yet been announced to the public.

COVID-19 and the Product Liability and Product Safety Regime

Legislation passed to combat COVID-19 in Poland has not brought any relevant changes to the substantive rules of the product liability regime.

During the state of epidemic or the state of epidemic threat (the latter is applicable in Poland at the time of writing – June 2022), and for one year thereafter, public hearings in civil court proceedings are to be conducted online unless a standard hearing with traditional attendance of the parties is necessary and does not pose an excessive threat to the health of the participants. No technical requirements have been set but the courts have seemed to cope with this challenge thus far. If the party is unable to participate in an online hearing due to the lack of necessary equipment, it may petition the court to allow online participation in the court’s building.

The COVID-19 legislation extended the possibility of hearing cases in camera. During the epidemic or the state of epidemic threat, and for one year thereafter, a case may be considered in camera if conducting an online hearing is impossible and a standard hearing with traditional attendance is impossible or unnecessary.

If the proceedings on taking evidence in the case have been conducted in full, the court may close the trial and issue a decision at a session held in camera, after having previously collected the positions of the parties or participants in writing.

Special Exemptions/Policies

From the product safety point of view, the most important area targeted for special exemptions in connection with the COVID-19 pandemic was the market for medical devices and personal protective equipment. In connection with Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat, the Polish government introduced a temporary solution that allowed the Ministry of Health to buy personal protective equipment without a CE mark, before the conformity assessment of such products was completed. Upon introducing these exemptions, the Ministry of Health became entitled to buy medical devices and personal protective equipment that were authorised in different countries outside the EU.

Projected Impact of COVID-19

Increased interest in selling pandemic-related products has sometimes resulted in products that do not meet essential EU requirements being placed onto the market. This phenomenon may result in product liability claims in the future. As such products were often bought from entities outside the EU, the most exposed persons are importers, who cannot free themselves from civil liability.

This phenomenon may also result in an increased number of safety notifications and increased activity by the President of the OCCP.