Medical Devices & Consumer Health Products 2021

Last Updated August 31, 2021

Poland

Law and Practice

Authors



Kieszkowska Rutkowska Kolasiński (KRK) is a highly specialised Polish law firm advising global companies (eg, research-based pharma and medical device companies, manufacturers and distributors of various products and services as well as IT start-ups) in the field of life sciences, new technologies, product liability and safety, personal data protection, and competition and consumer protection law. Its life sciences team supports clients with regulatory advice regarding the healthcare sector, reimbursement, pharmaceuticals (clinical trials, compliance, pharmacovigilance, veterinary drugs), medical devices and the food and cosmetics sectors. KRK also provides legal advice to industry associations (eg, in the legislative process, particularly considering Polish law conformity with the acquis communautaire). KRK’s leadership position in advising on life sciences is confirmed not only by its large group of clients encompassing the world’s largest corporations, but also its highly regarded position in the industry.

Medical Devices

The product safety regulatory regime that applies to medical devices in Poland arises from Regulation (EU) 2017/745 on medical devices (MDR), according to which a device must meet the general safety and performance requirements set out in Annex I. Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will also start to apply next year.

The most important act of national legislation in the healthcare product safety area is the Act on medical devices of 20 May 2010 (implementation of Council Directive 93/42/EEC on Medical Devices (MDD). It sets out the obligations for manufacturers, importers and distributors of medical devices and obliges them to only place medical devices onto the market if they meet the essential requirements and to monitor the safety of medical devices.

A draft of a new medical devices act reflecting the provisions of the MDR is being processed. The draft is publicly available, although the legislative proceedings at parliamentary level have not yet started (as of 13 July 2021). The new law will repeal the Act on medical devices of 20 May 2010.

Pharmaceuticals

The Polish product safety regulatory regime for medicinal products is based on Directive 2001/83/EC (EU Directive 2001/83) and Regulation (EC) 726/2004 (EU Regulation).

These Directives are implemented by the Pharmaceutical Law of 2001, which specifies the pharmacovigilance system and the comprehensive quality, efficacy and safety requirements.

Blood Products

Blood products are also covered by the Pharmaceutical law, according to which a blood product is considered a medicinal product manufactured industrially from blood or its components, in particular albumin, coagulation factors and immunoglobulins.

In addition, the product safety regulatory regime for medical devices might apply in certain specific cases, when a medical device or an active implantable medical device contains a substance which, when used separately, would be a blood product and which may support the operation of a medical device or active implantable medical device.

In the context of the safety of blood products, it is also important to mention the Act on the public blood service of 22 August 1997, which, among other things, regulates the rules regarding donating and collecting blood and its components and ensuring the quality and safety of blood and its components collected to be processed into blood products.

Personal Protective Equipment (PPE)

The basic product safety regulatory regime that applies to PPE arises from Regulation (EU) 2016/425 on personal protective equipment, although, certain specific aspects of it, such as the manufacturer’s obligations or sanctions for placing products onto the market that are non-compliant with the necessary requirements, are covered by the Polish Act on conformity assessment systems and market surveillance of 2016.

Medical Instruments

Medical instruments are considered medical devices, as the definition of a medical device applies to, among others, a tool, instrument or device, intended by the manufacturer for use in humans for the purpose of (i) diagnosing, preventing, monitoring, treating or alleviating the course of a disease; (ii) diagnosing, monitoring, treating, alleviating or compensating for the effects of an injury or handicap; or (iii) testing, replacing or modifying the anatomical structure or a physiological process.

Therefore, there is no separate regime for medical instruments and the product safety regulatory regime for medical devices applies.

Cosmetics

The product safety regulatory regime for cosmetics is based on EU Regulation 1223/2009 on cosmetic products, which lays down the rules for compliance by any cosmetic product made available on the market.

The above EU regulation is complemented by the Polish Act of 4 October 2018 on cosmetic products. This national regulation specifies the authorities that are responsible for cosmetic product safety supervision, and sanctions for breaches of the safety requirements; as well as detailed obligations for entities placing cosmetic products onto the market (eg, those connected with processing data on serious undesirable effects).

Biocides

The product safety regulatory regime for biocides arises from the EU Regulation 528/2012 concerning the making available on the market and use of biocidal products.

Poland also has an Act on biocidal products of 9 October 2015 that regulates certain specific regulatory aspects, which, to large extent, are a repetition of the EU Regulation. The Polish act also covers certain aspects of product safety and specifies some issues, such as sanctions for putting a biocidal product onto the market without valid authorisation.

Food and Nutrition Supplements

The main regulation regarding the food (including food supplements) safety regulatory regime is EU Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

The main country regulation in this area is the Polish Act on food and nutrition safety of 25 August 2006, which implements some detailed obligations from EU Directives and specifies the competent authorities and the applicable sanctions in the case of non-compliance.

Medical Apps and Wearables

Poland has no particular safety regulatory regime regarding medical apps or wearables. The general provisions on medical devices (regarding apps and wearables considered as medical devices) apply.

Telemedicine

Polish law provides that medical activity may be conducted through IT and communication systems. Medical activity is defined as the provision of healthcare services (activities intended to preserve, save, restore or improve health and other medical activities arising from the treatment process), the promotion of health, teaching and research related to the provision of healthcare services and health promotion, or the implementation of new medical technologies and methods of treatment.

Polish law defines “tele-consultations”, which are a primary healthcare service provided remotely using IT systems or communication systems. Primary healthcare is a category of guaranteed (ie, publicly financed) healthcare services provided by a doctor, nurse or midwife, such as basic health advice and diagnostics, consultations by general practitioners, etc.

CBD

As cannabidiol (CBD) can be used in various categories of products; in each case, the product safety regulatory regime that would apply depends on the category of the product.

CBD is used in cosmetics and food in most cases, so the regulatory regimes referred to in 1.2 Healthcare Products apply. However, in terms of food, it is worth mentioning that there is still a great deal of legal uncertainty related to placing CBD onto the Polish market. This is because the Polish authorities base their approach on the position of the EU bodies, considering that all cannabinoids are listed in the official European Commission list as requiring novel food authorisation, whereas no authorisation has been issued for CBD to date.

The issue of borderline products (ie, products that exist on the border of various categories of regulated categories (eg, pharmaceuticals, cosmetics, food supplements and medical devices)) is a challenge both in Poland and the European Union. Every product has to be assessed on a case-by-case basis, especially because different state authorities are responsible for different categories of regulated products.

According to the Polish Pharmaceutical Law, any product that simultaneously meets the criteria of a pharmaceutical and the criteria of another type of product, especially a dietary supplement, cosmetic or medical device, as specified in separate regulations, is considered to be a pharmaceutical. There is a visible tendency in the market of trying to avoid the strict regime of pharmaceutical regulations by marketing products either as cosmetics, food supplements or medical devices.

The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products can issue opinions on borderline products. Such opinions are binding on other authorities competent with respect to non-pharmaceutical products, and can be issued either on its own initiative, or at the request of other state authorities or private applicants (with regard to medical devices).

Under the MDR, in order to ensure consistent qualification decisions in the EU, having consulted the Medical Device Co-ordination Group, the Commission should, on its own initiative or at the duly substantiated request of a member state, be allowed to decide on a case-by-case basis whether or not a specific product, category or group of products falls within the scope of the MDR. When deliberating on the regulatory status of products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food products, the Commission should ensure an appropriate level of consultation of the European Medicines Agency, the European Chemicals Agency and the European Food Safety Authority.

Medical Devices

Manufacturers must ensure that they are designing and manufacturing medical devices in accordance with the MDR, especially its Annex I – General safety and performance requirements.

The manufacture of medical devices does not require any special licence in Poland, but manufacturers of medical devices must register with the EU's EUDAMED database in the actor’s module. EUDAMED has not yet achieved full functionality, so this obligation will start to apply six months after the European Commission declares its full functionality.

Digital healthcare products, which are medical devices, are subject to the same regulations.

Pharmaceuticals

The manufacturing of pharmaceuticals requires a manufacturer’s licence. The Chief Pharmaceutical Inspector issues these. The licence is required for any activity by which a pharmaceutical is created, including the purchase and handling of materials used for production by the manufacturer at the manufacturing site, production, passing to successive stages of manufacturing, packaging or repackaging, as well as storing and distributing own pharmaceuticals and the control measures related to such activities.

Manufacturing must comply with Good Manufacturing Practice (GMP), which is verified by the Chief Pharmaceutical Inspector through inspections.

An applicant for a manufacturer's licence should:

  • file a licence application specifying what types and pharmaceutical forms of drugs will be manufactured, where they will be manufactured and to what extent/within what scope the manufacturing process will take place;
  • attach a Site Master File prepared in accordance with the requirements of GMP and a list of manufactured pharmaceuticals containing their names, doses and pharmaceutical forms;
  • have the appropriate premises and technical and control equipment needed to manufacture, control and store the pharmaceuticals listed in the application;
  • employ a qualified person to be responsible for ensuring that each batch of a medicinal product has been manufactured and inspected in accordance with the law before release onto the market.

A manufacturer's licence is issued for an indefinite period. A decision awarding or refusing to award a licence to manufacture pharmaceuticals must be issued within 90 days of the date on which the application is filed by the applicant. This deadline will be suspended if the application needs to be supplemented. The fee for the application depends on the type of medicinal product (sterile or non-sterile) to be manufactured; it varies between PLN3,300 and PLN5,500 (approximately EUR750 and EUR1,200).

Manufacturing of active pharmaceutical ingredients is subject to entry in the National Register of Manufacturers, Importers and Distributors of Active Pharmaceutical Ingredients.

Personal Protective Equipment (PPE)

Manufacturers must ensure that they design and manufacture PPE in accordance with the requirements set out in Regulation (EU) 2016/425; in particular, PPE must meet the necessary health and safety requirements set out in Annex II.

Cosmetics

The obligations that are applicable to manufacturers primarily depend on whether the particular manufacturer also bears the duties of the responsible person for the particular cosmetic product. It is assumed that a manufacturer based in the EU is also the responsible person for the product, although manufacturers can also designate another entity to be the person responsible for the product. However, if the manufacturer is also the responsible person, it must ensure compliance of the product with all aspects specified in EU Regulation 1223/2009, such as conducting the safety assessment before placing the cosmetic product onto the market or making an appropriate notification in the EU cosmetic product notification portal (CPNP).

The main obligations that are strictly related to the manufacturing process (if the regime of the responsible person is not applicable) are (i) the obligation to ensure the compliance of the manufacturing process with the cosmetic GMP, and (ii) the obligation to register the site in the register of the District Sanitary Inspector, within 30 days of the start of the manufacturing process. It may also be necessary to notify the Director of the Regional Office of Measures of the start of packing products within seven days of the date on which this activity starts.

Food and Nutrition Supplements

Manufacturing of food (including food supplements) is subject to administrative authorisations and registration, including the authorisation of the site by the District Sanitary Inspector (the District Veterinary Officer in the case of food of animal origin and certain foodstuffs of mixed origin) before starting manufacturing activities, as well as registration by the Voivodship Inspectorate of Agricultural and Food Quality Inspection, no later than on the date on which manufacturing activities start. It may also be necessary to notify the Director of the Regional Office of Measures of the start of product packing within seven days of the start of this activity.

The manufacturing process must be in line with all applicable quality requirements, especially those covered by EU Regulation 852/2004 on the hygiene of foodstuffs, including the implementation of the hazard analysis and critical control points (HACCP) approach.

Corporate social responsibility is mostly subject to self-regulation and initiatives rather than legal regulation. For discussion of the environment, see the remarks in 5.1 Policy Development. As for sustainability, it is worth noting the regulation on the prevention of food waste, which applies a number of obligations on the wholesalers and retailers of foodstuffs, including but not limited to, monitoring and reporting food waste, implementing special contracts with NGOs acquiring foodstuffs that would otherwise be wasted, organising educational campaigns and paying special fees for wasted food.

General

All healthcare products are subject to general consumer protection acts such as the Act on Combatting Unfair Competition of 16 April 1993 and the Unfair Commercial Practices Act of 23 August 2012. The Act on Combatting Unfair Competition includes significant provisions on comparative advertising.

Medical Devices

According to the MDR, advertising of devices must not be misleading with regard to the device’s intended purpose, safety and performance, whether this is by:

  • ascribing functions and properties to the device which the device does not have;
  • creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
  • failing to inform the user or the patient of a likely risk related to the use of the device in line with its intended purpose; or
  • suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was conducted.

The Polish Act on Medical Devices does not currently have additional provisions regarding advertising, other than those mentioned in the MDR. However, a draft of a new Act on medical devices is being processed, which will substantially regulate advertising. Legislative work on this is still in progress.

Pharmaceuticals

A medicinal product may be advertised only by or on the instructions of the marketing authorisation holder (MAH). Only information that is consistent with the Summary of Product Characteristics, information on the product and the MAH, as well as the compulsory disclaimers may be provided.

It is permissible to advertise over the counter (OTC) products to the general public. Prescription-only medicinal products may only be advertised to people authorised to write prescriptions or trade medicinal products.

The advertising of a medicinal product cannot:

  • be misleading, must present the medicinal product objectively and should provide information on the rational use of the medicinal product;
  • offer or promise any benefits either directly or indirectly in exchange for purchasing a medicinal product or providing proof that a medicinal product was purchased; or
  • be targeted at children or contain any element targeted at them.

The advertising of a medicinal product to the general public cannot involve:

  • a medicinal product being presented by well-known personalities, scientists, people with medical or pharmaceutical qualifications or people suggested as having such qualifications; or
  • references to recommendations of well-known people, scientists, people with medical or pharmaceutical qualifications or people suggested as having such qualifications.

Biocidal Products

Any advertisement of a biocidal product must be accompanied by the warning “Biocidal product must be used with special precautions. Read the label and leaflet in the package before use.” This text must be distinguished from the rest of the content. The term “biocidal” may be replaced with the exact description of the product group to which the advertisement applies.

Advertising of a biocidal product cannot be misleading with regard to the risk that the product poses to humans, animals and the environment, and must not include the terms “low-risk biocidal product”, “non-toxic”, “harmless” or the like.

Cosmetics

The general rule for product claims arising from EU Regulation 1223/2009 with reference to cosmetics is that they must not be used to imply that these products have characteristics or functions that they do not have. There is no official positive list of approved claims. However, the claims that are being used have to be compliant with the common criteria set out in EU Regulation 655/2013 (as well as supported by appropriate scientific evidence). These common criteria set out more detailed requirements for product claims regarding issues such as legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.

Food and Nutrition Supplements

No information about food (including food supplements) provided to consumers may be misleading; it must be accurate, clear and easy to understand by the consumer. Moreover, food information must not attribute the property of preventing, treating or curing a human disease to any food product, or refer to such properties (with certain exemptions for natural mineral waters and food for special medical purposes, but not food supplements).

Furthermore, health and nutrition claims referring to foodstuffs are subject to the detailed requirements laid down in EU Regulation 1924/2006. Such claims must not:

  • be false, ambiguous or misleading;
  • give rise to doubt about the safety and/or the nutritional adequacy of other foods;
  • encourage or condone excess consumption of a food;
  • state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general; or
  • refer to changes in bodily functions which could give rise to or exploit fear in the consumer, either textually or through pictorial, graphic or symbolic representations.

Furthermore, the use of nutrition and health claims is subject to a number of general conditions (including in relation to the form and quantity of an ingredient in the product, scientific justification, etc) as well as to a number of specific conditions separately for health claims and nutritional claims. The key requirement for health claims is that, as a rule, only health claims authorised by the European Commission may be used (positive list of authorised claims).

Medical Devices

Before placing a medical device onto the market, the manufacturer or authorised representative must ensure that:

  • the product is designed and manufactured in accordance with the MDR, especially its Annex I – General safety and performance requirements;
  • the manufacturer’s Declaration of Conformity (DoC) is in place;
  • EU certification is granted by a Notified Body (if the device class requires a Notified Body’s involvement);
  • the device bears the CE mark;
  • the device bears a Unique Device Identifier (UDI) (subject to a transitional provision); and
  • the applicable registrations are made into the EUDAMED database (subject to a transitional provision).

The manufacturer or authorised representative must implement post-market surveillance, namely a systematic procedure within the quality management system to proactively collect and analyse data on the quality, performance and safety of devices throughout their life cycle to take necessary actions. It also ensures that any residual risks remain at an acceptable level. It is implemented by manufacturers in co-operation with other "economic operators" (importers, distributors and authorised representatives). The post-market surveillance activities must be proportionate to the class of risk and appropriate for the type of device.

To ensure that batch-produced devices continue to comply with the requirements of this Regulation and that experience from the use of the devices they manufacture is taken into account in the production process, all manufacturers should have a quality management system and a post-market surveillance system in place, which should be proportionate to the class of risk and the type of device in question. In addition, in order to minimise risks or prevent incidents related to devices, manufacturers should establish a system of risk management and a system for reporting incidents and field safety corrective actions (FSCAs).

Pharmaceuticals

The Polish regulations implement the EU’s Directives governing the procedures and requirements for obtaining marketing authorisation (MA). As a rule, an MA for a pharmaceutical can be granted either under a centralised procedure or a national procedure.

The centralised procedure enables a pharmaceutical to be marketed in every EU Member State. An MA is issued by the European Commission. The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications.

In the national procedure, an MA is granted on the basis of the Pharmaceutical Law and the secondary regulations to this act. The MA is only valid in Poland. The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products is the competent authority for handling the procedure and granting an MA in Poland.

The Polish Pharmaceutical Law of 2001 sets out the requirements for a comprehensive pharmacovigilance system (based on Directive 2001/83/EC).

Biocidal Products

A biocidal product can be made available on the market and used in Poland if it has (i) authorisation (within the meaning of Article 3(1)(o) of EU Regulation 528/2012), (ii) an authorisation for parallel trade, or (iii) a marketing authorisation (an authorisation to make the product available on the Polish market, in accordance with Article 89(2) of the EU Regulation 528/2012). The status of the active substance in the product determines which of these is required. Biocidal products made available on the Polish market must be entered into the List of Biocidal Products.

Marketing authorisation is issued if the following conditions are met:

  • the biocidal product contains existing active substances under evaluation or under evaluation under Commission Delegated Regulation (EU) No 1062/2014 but which have not been approved for this product type;
  • the biocidal product is effective in combating a harmful organism; and
  • safety rules have been defined for the use of the biocidal product and for handling biocidal product waste and its packaging.

Personal Protective Equipment (PPE)

Manufacturers must ensure that they design and manufacture PPE in accordance with the requirements set in Regulation (EU) 2016/425. In particular, PPE must meet the essential health and safety requirements set out in Annex II. PPE needs to be CE marked before being placed onto the market. PEE manufacturing does not require any special licence in Poland.

According to the Polish Act on conformity assessment systems and market surveillance of 2016, the manufacturers of PPE are obliged to keep and analyse records of (i) complaints about PPE, (ii) non-compliant PPE, and (iii) PPE recalls. In justified cases, manufacturers must examine samples of products made available on the market, considering the risk posed by the product. Additionally, they must inform distributors of the above-mentioned activities. 

Cosmetics

Before being placed onto the market, a detailed safety assessment must be conducted and a safety report needs to be prepared by a qualified safety assessor for every cosmetic product, in line with EU Regulation 1223/2009. The responsible person is also obliged to keep a product information file for a period of ten years from the date on which the last batch of the cosmetic product was placed onto the market. The data in the dossier is to be updated as necessary. The dossier must be prepared in English or Polish. However, some specific parts of the safety report must be prepared in Polish.

Cosmetic products are not subject to licensing, although they need to be notified via the CPNP before being placed on the market.

It is also worth noting the obligation of the responsible person to ensure that the qualitative and quantitative (limited to hazardous substances) composition of the cosmetic product and, in the case of perfumes and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as that existing data on undesirable effects and particularly serious undesirable effects arising from the use of the cosmetic product are made easily accessible to the public through any appropriate means.

Food and Nutrition Supplements

All food products placed onto market must meet all applicable quality requirements. As a rule, placing particular food products onto the market does not require any prior authorisation (without prejudice to the obligations related to the regulatory requirements for activities such as manufacturing, see remarks in 2.1 Design and Manufacture).

However, certain product categories such as fortified foodstuffs, food supplements, food for special medical purposes (FSMP), infant formulae and follow-on formulae containing substances other than those listed in Annex II of Regulation 2016/127 need to be notified to the Polish Chief Sanitary Inspector before being placed onto the market or no later than at the time they are placed onto the market.

It is also worth considering that some ingredients used in food products might need to be additionally pre-authorised (eg, novel food).

Poland as an EU member has a regulatory regime which is compliant with EU Regulations and Directives. Therefore, the legal framework is similar to those of other EU member states.

Specific features of the Polish regulatory regime are measures intended to combat illegal exports of reimbursed healthcare products (whose full or partial cost is covered by the National Health Fund). The Chief Pharmaceutical Inspector publishes a list of products which are subject to export restrictions. However, these restrictions only apply to products that have already been placed onto the market, not those in the manufacturing phase (pre-batch release). Currently, only medicinal products are included on the lists; no medical devices or foodstuffs for particular nutritional uses are listed.

Medical Devices

According to the Polish Act on medical devices, importers and distributors of medical devices who have discovered a medical incident during their activities taking place in Poland are obliged to report it immediately to the manufacturer or the authorised representative, and send a copy of the notification to the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products. The manufacturer investigates the incident that has been reported to it and either notifies the Office of this (if the incident meets the reporting criteria) or informs the Office why it believes there are no grounds for notification.

The manufacturer must ensure that the authorised representative and any other entity authorised by the manufacturer to act on its behalf in cases of medical incidents and in matters relating to the safety of the product will conduct external safety corrective actions FSCAs. The manufacturer takes FSCAs to reduce the risk of death or serious injury associated with the use of a marketed device. Before sending the safety note to recipients or users in Poland, the manufacturer or authorised representative must send it to the President of the Office, attaching the FSCA Report.

Pharmaceuticals

Marketing authorisation holders should be proactively responsible for ongoing pharmacovigilance of the medicinal products they place onto the market.

The marketing authorisation holder that has obtained marketing authorisation is obliged, among other things, to:

  • nominate the people responsible for pharmacovigilance;
  • implement and maintain a system guaranteeing that information on reports of individual cases of adverse reactions sent to this entity will be collected and compiled in one place;
  • keep a register of reports of individual cases of adverse reactions to medicinal products;
  • have a full description of the pharmacovigilance system; and
  • conduct regular audits of the pharmacovigilance system.

Biocidal Products

According to the Polish Act on biocidal products, the marketing authorisation holder is obliged to immediately inform the President of the Office of any data and circumstances that may affect the change of the conditions that were relevant for issuing the marketing authorisation.

Personal Protective Equipment (PPE)

PPE manufacturers are obliged to monitor and keep records of (i) complaints about the PPE, (ii) non-compliant PPE and (iii) PPE recalls. They are obliged to immediately take steps to ensure the compliance of the PPE, its withdrawal from the market or its recall in the event of a justified suspicion that it does not comply with the requirements.

If the product poses a threat, manufacturers are obliged to immediately inform the Office of Competition and Consumer Protection, in particular, providing detailed information on non-compliance with the requirements and the actions taken.

Cosmetics

According to EU Regulation 1223/2009, in the event of serious undesirable effects, the responsible person and distributors shall, without delay, notify the competent authority where the serious undesirable effect took place:

  • all serious undesirable effects which are known to them or which may reasonably be expected to be known to them;
  • the name of the cosmetic product in question, enabling its specific identification; and
  • the corrective measures taken by them, if any.

This information needs to be provided in Poland to the Nofer Institute for Occupational Medicine, which is the entity authorised by the Chief Sanitary Inspector.

See also the other post-marketing obligations for cosmetics referred to in 2.4 Marketing and Sales.

Food and Nutrition Supplements

In accordance with EU Regulation 172/2002, if a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities of this. If the product has reached the consumer, the operator must effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall products from consumers that have already been supplied to them when other measures are insufficient to achieve a high level of health protection.

Food retailers have their own responsibilities adapted to their level of influence on the food product.

Moreover, a food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health.

Operators must inform the competent authorities of the steps taken to prevent risks to the final consumer and must not prevent or discourage anyone from co-operating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food.

The main regulatory authorities for medical devices and consumer healthcare products in Poland are:

  • the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products, which is responsible for pharmaceuticals, medical devices and biocidal products;
  • the State Pharmaceutical Inspectorate headed by the Chief Pharmaceutical Inspector, which is responsible for pharmaceuticals;
  • the Ministry of Health, which decides on the public financing of pharmaceuticals, medical devices, foodstuffs for particular nutritional purposes and telemedicine services;
  • the President of the National Health Fund, which is responsible for the public financing of pharmaceuticals, medical devices, foodstuffs for particular nutritional purposes and telemedicine services;
  • the President of the Agency for Health Technology Assessment and Tariff System, which is the Polish HTA agency and which supports the Ministry of Health in making decisions on financing healthcare services;
  • the Office of Competition and Consumer Protection, which is responsible for personal protective equipment;
  • the State Sanitary Inspectorate headed by the Chief Sanitary Inspector, which is responsible for the safety of cosmetics and food products, including food supplements; and
  • the Trade Inspectorate, which is responsible for the supervision of cosmetics at retail level.

The regulatory authorities for medical devices and consumer healthcare products have the following responsibilities and powers as set out below.

The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (CA)

This body is responsible for issuing decisions regarding medical devices regarding their classification, safety, marketing, use and clinical trials. The Office is also responsible for granting marketing authorisations for medicinal products, parallel import licences and for authorising clinical trials. The CA issues administrative decisions which can be appealed against before administrative courts. The CA may, for instance, reclassify products, suspend or revoke licences or authorisations, order certain actions, impose fines or initiate product recalls. Additionally, the CA issues marketing authorisations for biocidal products and amends or revokes them at the request of the marketing authorisation holder.

The State Pharmaceutical Inspectorate Headed by the Chief Pharmaceutical Inspector (CPI)

Among other things, the Inspectorate supervises quality, manufacturing, imports, distribution, transport and storage of pharmaceuticals. The Inspectorate is also responsible for controlling the labelling and advertising of those products, and inspecting pharmacies and wholesalers. The CPI issues administrative decisions which can be appealed before the administrative courts. For instance, the CPI may suspend or revoke licences or authorisations, order certain actions, impose fines or initiate product recalls.

The Ministry of Health (MOH)

The MOH decides on the public financing of pharmaceuticals, medical devices, foodstuffs for particular nutritional purposes and health services. The MOH issues administrative decisions which can be appealed against before the administrative courts.

The President of the National Health Fund (NHF)

The NHF is primarily responsible for the public financing of health services. The NHF issues administrative decisions which can be appealed before the administrative courts or civil courts (depending on the nature of the decision).

The President of the Agency for Health Technology Assessment and Tariff System (HTA)

HTA opinions are not directly challenged and reviewed by courts.

The President of the Office of Competition and Consumer Protection (OCCP)

The OCCP is responsible, among other things, for monitoring the safety of PPE and its conformity with the requirements introduced by Regulation 2016/425.

The State Sanitary Inspectorate

This body supervises the compliance of cosmetic products and food with the safety requirements. It can order certain actions, impose fines or initiate product recalls or reclassifications. The Inspectorate is also responsible for inspecting the labelling and advertising of such products (in the case of cosmetics, together with the Trade Inspectorate).

General Criminal Healthcare Product Safety Liability

One criminal product safety offence is provided for in the Polish Penal Code, which applies to all products listed in 1. Applicable Product Safety Regulatory Regimes, according to which, the person who intentionally endangers the life or health of many people or property in large proportions by manufacturing or introducing:

  • substances that are harmful to health; or
  • foodstuffs or other products of universal use or pharmaceuticals which do not comply with the applicable quality conditions,

is punishable by imprisonment for between six months and eight years and, if the consequence of such act is the death of a person or serious damage to the health of many people, the perpetrator is punishable with imprisonment for between two and 12 years. The penalties are less severe if the perpetrator acts unintentionally.

Sector-Specific Criminal Liability

Other than this criminal offence, for each category of products listed in 1. Applicable Product Safety Regulatory Regimes, different offences are regulated in separate legal acts regarding individual categories of products. The penalties vary depending on the product’s category.

In some cases, for instance biocidal products and medical devices, there is criminal liability for placing a non-compliant medical device or an unauthorised biocidal product onto the market.

As for PEE, the only sanctions are administrative penalties, for instance, a fine of up to PLN100,000 for placing a non-compliant product onto the market or up to PLN20,000 for placing a product onto the market that was not CE-marked.

As for pharmaceuticals, anyone who breaches the pharmacovigilance obligations, for instance, by not keeping a register of reports of adverse reactions to medicinal products or failing to submit periodic reports on the safety of medicinal products to the competent authorities with the required frequency can be fined between PLN100,000 and PLN500,000.

In terms of food, anyone who produces or places food that is harmful to human health or life onto the market may be punishable with a fine, a restriction of freedom or imprisonment for up to two years.

As for cosmetics, anyone who places a cosmetic product which does not meet the safety assessment requirements referred to in Article 10 of Regulation No 1223/2009 onto the market may be fined up to PLN100,000.

Types of Liability

Product liability is regulated in Poland by the Civil Code. Product liability suits are usually based on:

  • strict product liability, as regulated in the Civil Code that implements the EU Directive 85/374/EEC of 25 July 1985; or
  • fault-based tort liability.

If there is a contractual relationship between the claimant and the defendant, product liability suits are sometimes based on contract law.

The Civil Code applies to all products, regardless of the product category (also to the products listed in 1. Applicable Product Safety Regulatory Regimes). There is one exception in terms of medical apps. Although the definition of a product has been interpreted broadly and covers not only physical products such as medicinal products, cosmetics or medical devices, but also software which is a part of medical apps, standalone software (ie, software which is not incorporated into a physical product) would not be considered as falling under the strict liability regime. In such a case, only the fault-based tort liability regime applies.

Strict product liability does not require proof of fault, so it is preferred by the claimants and referred to more frequently. However, if the claim is time-barred in the strict product liability regime, there are often legal arguments to pursue it on the grounds of the fault-based tort liability regime and, for this reason, claimants often base their suits on both regimes.

With regard to the strict liability regime, the causes of action are (i) damage, (ii) a defect in the product, and (iii) a causal relationship between the damage and the defect and, under tort liability, (i) an unlawful act on the part of the defendant, (ii) the defendant’s fault, (iii) damage, and (iv) a causal relationship between the damage and the defendant’s act. It is assumed that placing a hazardous product onto the market is negligence.

Who Is Liable

A suit under the strict liability regime can be initiated against:

  • the manufacturer;
  • the manufacturer of a 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);
  • the “quasi” manufacturer, meaning any person who presents themselves as a producer by placing their business name, trademark or another distinguishing mark on the product);
  • the importer; and
  • the person who sold the product in their business (eg, the distributor) – but only if none of the persons mentioned above are known to the injured party.

In such a case, liability may be avoided by informing the injured party (within one month of the notification of the damage) of the name and address of any of any of the persons mentioned above or of their supplier(s).

In the tort liability regime, a suit can be filed against anyone who caused the damage and whose fault caused that damage.

As a general rule, Polish courts have jurisdiction if the defendant has their place of residence in, or is a habitual resident of, Poland.

In tort cases, as well as in the cases of the strict product liability regime, Polish courts also have jurisdiction if the harmful event took place in Poland. Pursuant to the well-established CJEU case law, a harmful event takes place in a member state if either the tortious act is performed (eg, the defective product is sold), or the damage take place.

In a breach of contract case, if the claim arises from a contract performed in Poland, Polish courts will have jurisdiction over this claim (eg, if a defective product was delivered to Poland). 

A consumer that has their place of residence in 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 the 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 location of the other party’s registered office or domicile.

As a rule, the winning party can recover the costs of the litigation from the party that loses the case. 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 the advance payment for expert opinions. If the party wins only in part, it may recover only the proportionate part of the costs.

The winning party can be granted the recovery of the costs of legal representation, although this recovery only applies to a partial extent. The statutory recoverable legal costs are calculated according to the regulations on legal fees. These amounts are rather low. They do not usually cover the full amount of actual costs incurred by the winning party.

A natural person who cannot bear the costs of litigation without detriment to their own or their family’s basic needs can be exempted from the obligation to cover the costs related to the court proceedings. Similarly, a legal person that is not in possession of enough funds to bear the costs can be exempted from this burden. Additionally, the party exempted from the obligation to bear the costs of the proceedings may petition the court to be granted the right to a counsel whose fee is paid by the state.

Administrative Courts

A party to administrative proceedings before a regulatory body can file a complaint against final decisions of that regulatory body to the Voivodship Administrative Court. The court will not review the case on its merits but will decide whether the decision was issued in accordance with the law. Both the party and the regulatory body may then challenge the judgment issued by the Voivodship Administrative Court with a cassation complaint to the Supreme Administrative Court. The Supreme Administrative Court will again review whether the Voivodship Administrative Court’s judgment was issued in accordance with the law. Challenging the regulatory body’s decision before the Voivodship Administrative Court is a fairly common procedure in all types of administrative cases, especially as the costs of court proceedings in this situation are much lower than, for instance, in litigation.

Poland has mechanism of a class action, which is described in detail in 4.7 Class Actions, Representative Actions or Co-ordinated Proceedings?

Class Actions

A class action is available under Polish law, although it is not very popular. No landmark judgments regarding medical devices have yet been issued in such proceedings.

Product liability claims may be pursued in this type of action. The class 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 represent them. The representative can be a member of the group or a district consumers’ ombudsman. In the case of personal injury claims, 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). In the case of 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

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

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

Mediation in Administrative Proceedings

A mediation procedure exists in administrative proceedings between the regulatory body and the party to the proceedings. The objective of the mediation is to establish the relevant facts of the case and, within the scope of the regulation, to find the most suitable outcome for the proceedings. This institution, however new, is not yet very popular.

Mediation in Civil Cases

In civil cases the parties in dispute (eg, the claimant and the producer of an allegedly defective product) may decide to take part in mediation proceedings. Mediation is always voluntary and is performed either by a professional mediator or by a mediator chosen by both parties together. Mediation can be initiated at the pre-trial stage, based on an agreement between the parties. If the mediation is successful, the parties may reach a settlement, request that the court approve that settlement and, if applicable, issue an enforceability clause. This would mean that the settlement can be enforced by the public bailiff. Mediation is also possible after court proceedings have already started. The court is obliged to promote methods of amicable dispute resolution, which include mediation and may refer the parties to mediation if a settlement is feasible.

Alternative Dispute Resolution for Consumer Disputes

If the dispute regarding the medical device arises from a contract between the consumer and the trader, the consumer may decide to pursue their claim in a special ADR mechanism introduced in the Directive 2013/11/EU, which was implemented into the Polish legal system in 2016. The proceedings may be held by one of the ADR entities that are registered in Poland (in the case of medical devices – most probably by the Trade Inspectorate). The proceedings can be initiated both by the trader and the consumer and there are usually not many formal requirements; however, each ADR entity can introduce their own procedural regulation. The ADR entity may issue a binding verdict only if both parties have agreed on that ex ante; if not, it can propose a non-binding solution to the dispute. The ADR proceedings are obligatory neither for the consumer, nor for the trader. We note that this method of dispute resolution is still not very common in the Polish practice.

Motion to Summon the Opposing Party to Attempt to Settle

At the pre-trial stage, a party may also petition the court to summon the opposing party to attempt to settle. The objective of this procedure is to settle a dispute amicably. The settlement attempt is handled by the court. The party that files the petition should make a settlement proposal to end the dispute and the other party may decide to agree with it or not. This procedure is popular in Poland, partly because it allows the claimant to interrupt the countdown of the statute of limitations for their claim. However, a new law is currently being processed in the parliament which is intended to curb the practice of using this procedure purely as a tool to prevent a claim from becoming time-barred.

Arbitration

The parties can also agree to resolve their dispute by way of arbitration. The parties may do so both in their agreement before any dispute has arisen (although it is inadmissible to include an arbitration clause in an agreement between an entrepreneur and a consumer) for every potential conflict related to that agreement, as well as afterwards, for a particular dispute. Arbitration proceedings between a producer and an individual claimant in a strict product liability regime are theoretically possible, but non-existent in practice. However, arbitration can be considered as a viable option in different types of B2B disputes (eg, between the producer as a seller and the distributor as a buyer, regarding an alleged defect in medical devices sold). 

The administrative compliance of a product and strict product liability are separated (ie, the fact that the product was registered and is compliant with all the relevant regulations does not prevent its producer cannot be held liable in a strict product liability regime).

However, parties tend to present evidence related to the administrative proceedings (eg, the evidence that the product has or has not passed certain tests; or that the product was or was not registered by the regulatory body) in civil cases and the courts generally accept such evidence. If a decision of the authorities is required for adjudicating on a civil case or if such a decision may have an impact on the court’s judgment, the court can decide to stay the proceedings until such a decision is issued. If issuing such a decision requires a motion from the party, the court may order that party to file that motion at the given time.

Similarly, if criminal proceedings are pending, the civil court may decide to stay the proceedings if the judgment in the criminal trial affects the civil judgment. The civil court would be bound by the criminal court’s judgment, but only if the judgment is a conviction and only in terms of the fact of the crime having been committed.

A bill was recently submitted to the Polish Parliament proposing an obligatory indication what fraction of the packaging of a given product will go to waste. The bill provides for the obligatory placement of information on the correct collection stream. If the bill is passed, it would apply to all products that are sold in packaging. Since the legislative process is pending, it is not currently possible to establish from when it will be applicable.

A draft of a new act on medical devices, reflecting the provisions of the MDR, is being processed. The draft is publicly available, although the legislative proceedings at parliamentary level have not yet started (as of 13 July 2021). The new law will repeal the Act on medical devices of 20 May 2010.

Additionally, legislative work is ongoing on the bill updating the law on preventing and combating infections and infectious diseases in humans, which, among other things, introduces a no-fault compensation fund for damage related to potential adverse reactions to vaccines.

Brexit has had a limited impact on the regulatory regimes applying to medical devices and consumer health products in Poland.

A major obstacle was that UK-notified bodies ceased to operate under EU law, so the certificates they had issued needed to be transferred to notified bodies in other countries. Furthermore, distributors and other economic operators should be aware that, if they source medical devices from UK manufacturers or distributors, they may take on the role of an importer and the responsibilities incumbent upon an importer as per the MDR and Regulation (EU) 2019/1020 on market surveillance and compliance of products.

The distribution schemes for medicinal products that originate in the UK have sometimes had to be altered and additional authorisations for importing have had to be granted to wholesalers operating in the EU. 

Special exemptions were targeted at the medical device and healthcare product market, as well as that of PPE, at the outbreak of the COVID-19 pandemic. The Polish government introduced some extraordinary solutions based on Commission Recommendation (EU) 2020/403. For instance, the Ministry of Health was allowed to buy some COVID-related products that were not CE marked or to buy medical devices that were only authorised in countries outside the EU.

Initially, there was an increase in demand for gloves, tests, disinfectants, masks, etc, which resulted in the placing of many products onto the market which did not comply with EU requirements. According to the report published by the Office of Competition and Consumer Protection issued at the beginning of 2021, 148 notifications were submitted in 2020 regarding almost 3.5 million pieces of hazardous product, where 24 submissions applied to personal protective equipment.

As to liability, a vibrant public debate on the introduction of a no-fault compensation fund for damage related to potential adverse reactions to COVID-19 vaccines started in Poland at the beginning of 2021. If the bill on the fund is not enacted, there is a high probability that there will be an increase in product liability claims related to vaccinations in Poland.

Kieszkowska Rutkowska Kolasiński

25/8 Emilii Plater St
00-688
Warsaw
Poland

+48 22 620 63 25

+48 22 101 73 38

jakub.misiak@krklegal.pl www.krklegal.pl
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Law and Practice

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Kieszkowska Rutkowska Kolasiński (KRK) is a highly specialised Polish law firm advising global companies (eg, research-based pharma and medical device companies, manufacturers and distributors of various products and services as well as IT start-ups) in the field of life sciences, new technologies, product liability and safety, personal data protection, and competition and consumer protection law. Its life sciences team supports clients with regulatory advice regarding the healthcare sector, reimbursement, pharmaceuticals (clinical trials, compliance, pharmacovigilance, veterinary drugs), medical devices and the food and cosmetics sectors. KRK also provides legal advice to industry associations (eg, in the legislative process, particularly considering Polish law conformity with the acquis communautaire). KRK’s leadership position in advising on life sciences is confirmed not only by its large group of clients encompassing the world’s largest corporations, but also its highly regarded position in the industry.

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