Life Sciences 2024 Comparisons

Polish legislation regarding pharmaceuticals and medical devices is heavily influenced by EU legislation.

The manufacturing, registration, distribution, marketing and advertising of pharmaceuticals are regulated by the Pharmaceutical Law Act of 6 September 2001 and its executive regulations. Since 2022, clinical trials of pharmaceuticals have been regulated by the Clinical Trials of Medicinal Products for Human Use Act of 9 March 2023, which adjusted Polish law to Regulation 536/2014. The Medical Devices Act of 7 April 2022 and its executive regulations deal with the regulation of medical devices, including safety and quality. Polish legislation has been adjusted to comply with the following EU Regulations relating to medical devices:

• the Medical Device Regulation (MDR); and
• the In Vitro Diagnostic Device Regulation (IVDR).

The Act on Reimbursement of Medicines, Food Products Intended for Particular Nutritional Uses and Medical Devices of 12 May 2011 regulates reimbursement from public funds. A major amendment of this statute entered into force in November 2023.

The key regulatory authority for medicinal products is the Pharmaceutical Inspection, which is led by the Chief Pharmaceutical Inspector and supervises the quality, manufacture, import, distribution, transport and storage of pharmaceuticals, among other matters. The Inspection is also responsible for overseeing the advertising of those products, and for controlling the operations of pharmacies and wholesalers.

The Pharmaceutical Inspection is also comprised of regional pharmaceutical inspectors, but these are formally subordinate to voivodes (regional governors in charge of governmental administration) rather than to the Chief Pharmaceutical Inspector. The Pharmaceutical Law was due to be amended in 2023 so that regional inspectors would report to the Chief Pharmaceutical Inspector instead, but this amendment has not yet been made.

The Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) is the regulatory body responsible for the registration and approval of pharmaceuticals and medical devices. It is also responsible for issuing decisions regarding medical devices in relation to their classification, safety, advertising, marketing and use. For a brief period of time, the Minister of Health and the Chief Sanitary Inspector supervised the advertising of business or professional activity in which a medical device is used to provide a service, but this competence has been moved to the URPL and henceforth the latter has sole charge over the enforcement of medical devices advertising regulation.

The Ministry of Health decides on the reimbursement of pharmaceuticals and medical devices.

The procedure for challenging administrative decisions is generally similar for all regulated products, since all of the proceedings are at least partially regulated by the Administrative Procedure Code of 14 June 1960. As a rule, there is always a legal remedy.

Decisions made by local branches of the authorities can be challenged by appealing to the main authority (eg, a decision of the Regional Pharmaceutical Inspector can be appealed to the Chief Pharmaceutical Inspector), and the final decision is subject to judicial review by the Administrative Courts. In general, the administrative appeal is free of charge and not subject to any specific formal requirements other than the explicit disagreement of the party. The judicial review is subject to a fee, which differs depending on the type of decision that is being questioned.

It is not possible to appeal against decisions made by the central authorities, such as the Chief Pharmaceutical Inspector. The party may file a motion for the decision to be reconsidered, or proceed directly to a judicial review by the Administrative Courts.

In principle, the regulations of the legislation mentioned in 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices apply to all categories of medicines.

Medical devices and in vitro diagnostic medical devices are regulated separately at the level of EU law, but in national law they are regulated by a single statute.

Clinical trials of pharmaceuticals and medical devices are subject to similar regulations, in accordance with the relevant European regulations. Clinical trials of pharmaceuticals are regulated by the Clinical Trials of Medicinal Products for Human Use Act of 9 March 2023, while clinical investigations/performance studies relating to medical devices and in vitro diagnostic medical devices are regulated by the Medical Devices Act (Articles 31 to 47). The Act of 9 March 2023 adjusted the local legal landscape to Regulation No 536/2014.

The provisions of the Clinical Trials of Medicinal Products for Human Use Act clarify the rules of procedure for issuing a clinical trial authorisation set forth in Regulation 536/2014.

A clinical trial can be started after a decision from the President of the URPL to issue a clinical trial permit (subject to the possibility of “so-called” implied consent in cases specified by Regulation No 536/2014) has been obtained and a bioethical committee has issued a positive opinion on the study. The application for permission is submitted through the Clinical Trials Information System. As a rule, it is possible to submit documentation in English or Polish (with the exception of certain elements which the law provides must be in Polish).

The rules for the payment of the application fee are determined in Article 58 of the Act. The amount of the fee depends on the phase of the clinical trial. In the case of a commercial phase I-III clinical trial, the fee is PLN30,000 (circa EUR7,000) when Poland acts as rapporteur and PLN 5,000 (circa EUR5,800) when Poland does not act as rapporteur.

Clinical trials for medical devices are required for higher-risk devices. The provisions of the Medical Devices Act detail the rules set by the MDR for applying for a clinical trial permit and the rules set by the IVDR for applying for a performance study permit.

In Polish law, there is no legal requirement for a compulsory, publicly available database of ongoing clinical trials and their results. The Employers’ Association of Innovative Pharmaceutical Companies (INFARMA – member of EFPIA) represents pharmaceutical companies engaged in research and development activities in Poland, and has voluntarily established a publicly available database of ongoing clinical trials conducted by its members (ie, pharmaceutical manufacturers).

There is no specific restriction against using online tools to support clinical trials. The processing of personal data connected with clinical trials is subject to the general provisions of the Personal Data Protection Act. Sponsors and clinical investigators have to ensure that any online tools used to recruit or monitor study participants comply with the Personal Data Protection Act and other relevant data protection regulations.

Data obtained from the conduct of a non-commercial clinical trial may not be used for marketing purposes nor for the purpose of obtaining a marketing authorisation for a medicinal product or making changes to the granted authorisation, except for changes to the marketing authorisation for a medicinal product with respect to the safety of the medicinal product's use.

The use of clinical trial data may be either primary or secondary. All processing operations related to a specific clinical trial protocol throughout the period covered by the protocol – from the start of the trial to the deletion of the data after the end of the archiving period – are to be understood as primary uses of clinical trial data.

Secondary use occurs if the sponsor processes the clinical trial participant's data outside the clinical trial protocol, for scientific purposes.

The provisions of the Clinical Trials of Medicinal Products for Human Use Act do not specify additional technical obligations for the maintenance of databases obtained in the course of a clinical trial. The provisions of Regulation No 536/2014 and the GDPR apply. In practice, entities conducting clinical trials in Poland usually maintain at least three databases:

• a database of clinical trial participants;
• a database of research team members; and
• a database of persons reporting adverse events.

It is the responsibility of these entities to implement technical and organisational measures to protect the processed information and personal data from unauthorised or unlawful access, disclosure, dissemination, alteration, destruction or accidental loss, especially in the case of processing involving transmission over a network.

The provisions of the Pharmaceutical Law Act shall apply to a product that simultaneously meets the criteria of a medicinal product and the criteria of another type of product, in particular a dietary supplement, a cosmetic product or a medical device, as defined by separate regulations.

Product qualification is carried out by the manufacturer, in accordance with the statutory definitions of a medical device and pharmaceutical. Competent authorities have the opportunity to react if there is a misclassification. However, the competences of authorities in this respect are not clearly defined or demarcated, which sometimes leads to delays in decisions.

Marketing authorisations for biologic medicines are granted in accordance with Regulation 726/2004; therefore, they are not granted by the President of the URPL.

The marketing authorisation is issued for five years and may be renewed indefinitely, at the request of the marketing authorisation holder. An application for an extension should be made at least nine months before the expiry date of the authorisation.

The President of the URPL is obliged to revoke a marketing authorisation if any of the circumstances described in Article 33 of the Pharmaceutical Law occur, including:

• an unexpected serious adverse reaction;
• the pharmaceutical does not have the declared therapeutic efficacy; or
• the risk of using it is found to be disproportionate to its therapeutic effect.

The President of the URPL can suspend a marketing authorisation when the circumstances described above do not pose a direct threat to public health.

The marketing authorisation expires if the marketing authorisation holder does not actually place the medicinal product on the market within three years of receiving the authorisation.

The national procedure for obtaining marketing authorisation is as follows.

• The applicant should submit an application for a marketing authorisation for the medicinal product to the President of the URPL.
• The President of the URPL formally verifies the application and attached documentation.
• If formal deficiencies are found, the President of the URPL calls for the application to be supplemented within at least seven days, under pain of leaving the application unprocessed.
• If there are substantive comments on the submitted documentation, the President of the URPL calls on the applicant to submit supplements and clarifications.
• Proceedings for the issuance of a marketing authorisation for a medicinal product should be completed within no more than 210 days of the application being submitted.
• If it is necessary to supplement the documents or to submit explanations, the President of the URPL shall issue a decision to suspend the deadline.

The costs for obtaining a marketing authorisation depend on the nature of the medicinal product, and can be up to PLN84,000 (circa EUR19,500).

The procedure for a variation of a market authorisation is governed by Commission Regulation No 1234/2008 of 24 November 2008 and the Pharmaceutical Law Act (Article 31). The change procedure depends on the type of change. Changes are made by the President of the URPL at the request of the marketing authorisation holder.

If there is a change of marketing authorisation holder, the President of the Office shall issue a new authorisation on the basis of the application of the person assuming the rights and obligations of the existing marketing authorisation holder. The decision issued in favour of the new marketing authorisation holder shall come into force no later than six months after it is issued. The new permit shall be issued no later than 30 days after the application is made.

The requirements that have to be satisfied before medical devices can be placed on the market are contained primarily in the MDR and the IVDR.

The following products are approved for sale without a marketing authorisation:

• magistral formulas;
• official formulas;
• radiopharmaceutical products prepared at the time of use in authorised medical entities, from authorised generators, kits, radionuclides and precursors, in accordance with the manufacturer's instructions, and radionuclides in the form of sealed radiation sources;
• blood and plasma in full composition or blood cells of human or animal origin, excluding plasma processed by an industrial process;
• pharmaceutical raw materials not intended for the preparation of prescription and pharmacy pharmaceuticals;
• immunological veterinary medicinal products made from pathogens or antigens derived from animals on a farm and intended for the treatment of animals on that farm; and
• advanced therapy medicinal products (hospital exceptions).

There are no Polish regulations relating directly to compassionate use programmes. Any medicinal products imported from abroad are allowed to be marketed without the need for authorisation if their use is necessary to save the life or health of a patient, provided that the medicinal product is authorised in the country from which it is imported and has a current marketing authorisation.

In accordance with Article 59(1) of the MDR, the competent authority (ie, the President of the URPL in Poland) may, upon receiving a duly justified request, allow the placing on the market or putting into service in the territory of the member state concerned of a specific device for which the relevant procedures referred to in the relevant provisions of the MDR have not been carried out, but the use of which is in the interest of public health or the safety or health of patients.

The following obligations may be imposed in the marketing authorisation:

• to take measures, within the framework of the risk management system for the use of the medicinal product, to ensure the safe use of the medicinal product;
• to conduct post-authorisation safety studies;
• to record or report adverse reactions;
• to use an appropriate system for the supervision of the safe use of medicinal products;
• to conduct post-authorisation efficacy studies where doubts have arisen regarding certain aspects of this medicinal product's efficacy that can only be clarified after it is placed on the market; and
• to provide information on the safety and efficacy of the medicinal product in question resulting from scientific and technical progress and the expansion of knowledge about that medicinal product.

With regard to medical devices, each manufacturer analyses all the complaints about the device, as well as cases of errors in use and misuse. The analysis depends on risk management, ergonomics, design validation, and corrective and preventative actions. The manufacturer shall make the results of the analysis available at the request of the President of the URPL and the notified body involved in the conformity assessment of the device. The manufacturer assesses the risks associated with the devices affected by the medical incident and, based on the assessment of the risk analysis, decides whether corrective actions are necessary and to what extent. The manufacturer shall describe the corrective action in the Field Safety Corrective Action Report. The corrective action must be communicated to customers via a Field Safety Notice.

The manufacturer initiates an investigation into the reported medical incident and decides whether said incident meets the criteria for reporting to the President of the URPL.

Third parties have access only to information on medicinal product authorisation published by the URPL (ie, the authorisation itself, the Summary of Product Characteristics, the Patient Information Leaflet and a summary of the Risk Management Plan). Other documents are available on request but only to entities that can substantiate their legal interest (eg, violation of rights), and subject to the protection of proprietary information. There are no specific regulations allowing disclosure of the process of applying for the marketing authorisation.

In the case of medical devices, it is possible to obtain public information on information contained in safety notes and certificates of conformity, and on the issuance, amendment, supplementation, suspension and withdrawal of certificates of conformity.

The Pharmaceutical Law imposes an obligation on manufacturers, importers and wholesalers to notify the Chief Pharmaceutical Inspector, the President of the URPL and the relevant marketing authorisation holder of any suspected falsification of a medicinal product. If a medicinal product is suspected or found to be counterfeit, pharmaceutical inspection authorities are authorised to withhold it from the market, prohibit its introduction or withdraw it. In addition, the Pharmaceutical Law states that a fine, restriction of liberty or imprisonment of up to five years can be imposed for the manufacturing, supplying or making available of a falsified medicinal product.

The Medical Devices Law states that fines can be imposed for the distribution of medical devices in violation of regulations.

In addition, the National Organisation for Drug Verification (KOWAL) was established in July 2017 to create a drug verification system and to co-operate with the European Medicines Verification Organisation. The Integrated System for Monitoring the Circulation of Medicinal Products (ZSMOPL) operates in Poland independent of EU regulations.

The Customs Service is responsible for preventing the import or release of counterfeit products. It is entitled to inspect and review imported goods, and may suspend the release of the goods or detain them for a period of three working days if it has sufficient grounds to suspect that goods are counterfeit products.

In order to counter the threat of counterfeit medicinal products, the Minister of Health has established a Team for Counterfeiting and Illegal Trade in Medicinal Products and Other Counterfeit Products Meeting the Criteria for a Medicinal Product. This team includes the Chief of the Customs Service.

Undertaking the business of manufacturing pharmaceuticals requires a manufacturer's licence, issued by the Chief Pharmaceutical Inspector. The manufacturing of a medicinal product is any activity leading to the creation of a medicinal product, including the purchase and receipt at the manufacturing site by the manufacturer of materials used for production and their release for subsequent manufacturing stages, including packaging or repackaging and storage and distribution of manufactured medicinal products covered by the application for a manufacturing authorisation, as well as control activities related to these activities.

An applicant for a manufacturer’s licence should submit an application containing, among other things, the type and pharmaceutical form of the medicinal product, the place of manufacture of the medicinal product, and a determination of the scope of manufacture of the medicinal product.

The model application is specified in the Regulation of the Minister of Health of 29 April 2019 on the model application for a change in the authorisation to manufacture or import medicinal products.

The permit is issued for an indefinite period of time.

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

The manufacture of medical devices does not require a special licence. The President of the URPL controls medical device manufacturers.

Undertaking the business of operating a pharmaceutical wholesaler requires a licence from the Chief Pharmaceutical Inspector. Wholesale is any activity involving the acquisition, possession, supply or export of pharmaceuticals or veterinary drugs by holders of a marketing authorisation.

An applicant for a licence should submit an application that includes:

• a definition of the scope of the wholesale business;
• the date on which the intended activity is to be undertaken;
• the name of the person responsible for the operation of the wholesale business; and
• the number of the professional licence for those who are pharmacists, or the PESEL number in the case of other individuals (PESEL is the Polish acronym for “Universal Electronic System for Registration of the Population”).

The following items should be submitted with the application:

• relevant declarations, including a declaration from the responsible person that they undertake this function as of the date the wholesale business started;
• an opinion of the competent district pharmacy chamber regarding the responsible person, if they are a member of the pharmacy chamber;
• a description of the procedures for effective withholding or withdrawal of the medicinal product or veterinary medicinal product from the market and from distributors;
• a document confirming the legal title to the premises intended for the business;
• a technical description including illustrations concerning the premises intended for the business, prepared by an authorised person; and
• an opinion on the suitability of the premises.

The model of the application is specified in the Regulation of the Minister of Health dated 29 April 2019 on the model of the application for a licence to operate a pharmaceutical wholesaler.

A wholesaler engaged in the wholesale distribution of medicines must:

• have adequate facilities to carry out this activity;
• employ a qualified person;
• have a description of the procedure for the effective cessation of distribution or withdrawal of a drug from the market; and
• comply with the more specific obligations set forth in the Pharmaceutical Law.

A wholesale licence is issued for an indefinite period of time, unless the applicant has applied for a fixed-term licence. The fee for granting a licence to operate a pharmaceutical wholesaler is PLN6,756 (approximately EUR1,440).

The distribution of medical devices does not require any special licence. The President of the URPL controls distributors of medical devices and, as of 2023, keeps a record of distributors of devices with headquarters in Poland.

The Pharmaceutical Law Act divides pharmaceuticals into the following categories:

• available without prescription (OTC);
• available on prescription only (Rp);
• available on prescription only, for restricted use (Rpz);
• available on prescription only, containing narcotic drugs or psychotropic substances specified in separate regulations (Rpw); and
• for hospital use only (Lz).

In accordance with the Pharmaceutical Law, the import of medicinal products takes place only if such products are brought in from a territory outside the European Economic Area (EEA). If a medicinal product is delivered to Poland from another country within the EEA, such delivery is deemed to be wholesale of medicinal products, rather than being qualified as an import. Export and parallel import are also classified as instances of wholesale.

Similarly, the Medical Devices Act defines an importer by reference to the MDR and the IVDR, under which the importer is an entity that places a medical device from a third country on the EU market.

Articles 38 to 51a of the Pharmaceutical Law govern the import of medicinal products. The import of medical devices is regulated primarily in the MDR and the IVDR, although important provisions might be found in the Medical Devices Act as well. The main obligations for an importer are contained in Articles 13 and 16 of these two Regulations.

The Chief Pharmaceutical Inspector is a central organ of the Polish administration, which issues licences for the import of medicinal products. Importers of medical devices have to register with the President of the URPL.

Any person, natural or legal, can act as an importer of record of pharmaceuticals. However, an importer of pharmaceuticals cannot apply for a licence to run a pharmacy.

Any person, natural or legal, whose place of residence or headquarters, respectively, is in the EU can act as an importer of record of medical devices.

The importation of medicines requires a licence from the Chief Pharmaceutical Inspector. Obtaining such a licence is compulsory even if the pharmaceuticals are only intended to be imported for the purpose of further exporting them outside the EEA. It is likewise compulsory for the import of investigational medicinal products, for example.

An application for a licence should specify which medicinal products are going to be imported. An importer can only import medicines that are covered by a licence. The Pharmaceutical Law also allows imports on the basis of an agreement with another importer.

Information on importers is publicly available in the Register of Manufacturers and Importers of Medicinal Products provided by the Chief Pharmaceutical Inspector.

Licensed importers of a medicinal product are not exempt from civil or criminal liability in relation to the use of the medicinal product.

The import of medical devices will require registration with the European Database on Medical Devices (EUDAMED) prior to a device being placed on the market. After filing with the register, the importer should apply to the President of the URPL for a single registration number. The obligation to register will not apply to custom-made devices.

Parallel import is allowed (it is an instance of wholesale trade) as required by EU law, especially the standards related to the single market. However, this requires obtaining a licence for a particular medicinal product from the President of the URPL. The licence is valid for five years, although it is possible to extend it for a further five years.

In order for the parallel import of the medicinal product to be allowed, the medicines in question have to have:

• the same active substances;
• at least the same indications up to level 3 of the Anatomical Therapeutic Chemical (ATC) code;
• the same strength;
• the same route of administration; and
• the same form or a similar form that does not result in therapeutic differences.

The medicinal product subject to parallel import has to be properly repackaged in order to satisfy all the demands of the Pharmaceutical Law. Generally, if such repackaging is necessary, it is a legal requirement and the trade mark holder cannot object to it.

Poland is a member state of the EU and thereby is part of the European single market comprised of all EU member states and three countries of the European Free Trade Association (EFTA) that chose to be part of the EEA: Iceland, Liechtenstein and Norway. Poland is also a member of the EU Customs Union. The EU itself is a party to an array of free trade agreements with third countries, which thus have an impact on Poland.

Poland is also a member of the World Trade Organization (WTO) and the Organisation for Economic Co-operation and Development (OECD).

Following the aggression of the Russian Federation against Ukraine in 2022, sanctions have been imposed on the import and export of certain goods to and from Russia and Belarus. Poland applies EU sanctions and has also adopted a national law that allows the application of further sanctions on Polish entities and their related companies that deal with Russian/Belarussian entities that support the aggression. The trading of pharmaceuticals and medical devices has not been expressly excluded from these national regulations.

Generally, only the prices for publicly reimbursed medicinal products or medical devices are regulated. Key pieces of legislation in this respect are the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices and the Act of 27 August 2004 on the Financing of Health Services by the State Fund. In accordance with the former, the following products may be publicly reimbursed:

• medicinal products, medical devices and foodstuffs intended for particular nutritional uses that have to prescribed;
• medicinal products and foodstuffs intended for particular nutritional uses available within a drug programme;
• medicinal products available within chemotherapy; and
• medicinal products, medical devices and foodstuffs intended for particular nutritional uses available for use within the provision of publicly funded services other than those listed above.

Until recently, OTC medicines could not be publicly reimbursed, so their prices could not be regulated. However, the recent amendment of the Reimbursement Act opens the possibility to reimburse OTC drugs from public funds, although no such cases have yet arisen.

If a product is reimbursed, its price is fixed unless it is procured by an entity providing publicly funded health services, in which case the net disposal price serves as the maximum price at which the product may be bought by said entity. Net disposal prices are uniform nationwide and so are the margins: the wholesale margin is 6% (not more than PLN150), while the retail margin depends upon the gross price of the medicinal product, medical device or foodstuffs intended for particular nutritional uses that is the limit basis for the given limit group.

For a product to be publicly reimbursed, the marketing authorisation holder has to apply for inclusion in the public reimbursement system.

The recent amendment of the Reimbursement Act envisages special incentives for products manufactured in Poland. Available preferences include expedited processing of the application, exemption from price negotiations with the Economic Commission or prolonged term of reimbursement. Net selling prices are set by the Minister of Health. The negotiations with the Economic Commission, which is an institution within the Ministry, are a key element here. The resulting prices are put on the reimbursement list, which is published on a three-monthly basis.

Medicinal products, medical devices or foodstuffs intended for particular nutritional uses are assigned to reimbursement limit groups (internal reference pricing). Medicines with the same international name or with a different international name but similar therapeutic effects and similar mechanisms of action should be classified in a single group. Medical devices or foodstuffs intended for particular nutritional uses are classified in a single group if they have the same or similar reimbursement indications or uses and similar efficacy.

The net disposal price of the first equivalent on the list may not be higher than 75% of the net selling price of the presentation with the lowest cost per defined daily dose (DDD), calculated according to the net selling price of the only counterpart reimbursed in a given indication. In the case of subsequent counterparts, the net disposal price may not be higher than the price of the counterpart determining the basis of the financing limit or the cheapest counterpart if the basis for the limit in the limit group is a drug that is not equivalent to the subject of the application.

After the market exclusivity expires, the new net disposal price cannot be higher than 75% of the product’s price during the market exclusivity period.

The prices in other countries are legally relevant for the Minister of Health when pricing medicinal products and foodstuffs intended for particular nutritional uses that are not classified as any of the following categories of reimbursement availability:

• available in pharmacies on prescription;
• available within a drug programme; or
• available within chemotherapy.

Therefore, this broad category of reimbursement availability encompasses medicines, medical devices and foodstuffs intended for particular nutritional uses used within the provision of publicly funded services, including services provided in hospitals, in outpatient clinics and as part of dental treatment or therapeutic rehabilitation.

The criteria that are to be taken into account by the Minister of Health when setting the net disposal price of such products include the minimum net selling price of those products within the publicly funded system of reimbursement of particular member states of the EU or EFTA. If a given product is not publicly funded in some of these countries, then the market prices are taken into account.

Moreover, in the course of the negotiations, the Economic Commission is obliged to take into account the minimum and maximum net selling price of the product that is the subject of negotiations within the publicly funded system of reimbursement of particular member states of the EU or EFTA. If a given product is not publicly funded in some of these countries, then the market prices are taken into account. The Economic Commission can also consider rebates, discounts or price agreements in these countries.

Usually, it is expected that the price will be among the lowest in the EEA member states. An applicant must provide the prices of a product, together with information on the reimbursement status of the product (level of reimbursement, conditions, restrictions, existence of risk-sharing schemes, for which indications it is reimbursed) in all EEA member states.

Polish public health funding includes reimbursement of medicinal products, medical devices and foodstuffs intended for particular nutritional uses that are provided to patients in publicly funded establishments and purchased by them in pharmacies and pharmacy outlets.

The levels of reimbursement are as follows:

• 100% reimbursement (free of charge) – products with proven efficacy in the treatment of malignant cancer, psychotic disorders, mental disability and development disorders, or contagious diseases posing a special epidemic risk for the population, or products administered in drug programmes;
• lump sum (PLN3.20):
1. products that must be administered for more than 30 days and whose monthly administration cost for the service recipient would, in the case of a payment level of 30% of the financing limit, exceed 5% of the minimum wage; and
2. products that must be administered for no more than 30 days and whose cost for the service recipient would, in the case of a payment level of 50% of the financing limit, exceed 30% of the minimum wage for work;

• partial reimbursement – 50% of the financing limit, for products that must be administered for not more than 30 days; and
• partial reimbursement – 70% of the financing limit, for other products.

The abovementioned patient payment amounts are reduced by 10% if the medicine is made in Poland or if an active substance made in Poland was used in its manufacture. If both of these conditions are met, the payment is reduced by 15%.

Medical devices are publicly funded in several ways.

• Prescribed medical devices available in pharmacies are covered by the Minister of Health’s reimbursement decisions and published in its reimbursement list. This category consists of devices that do not require personalisation for every patient – eg, diagnostic strips for blood glucose monitoring and special types of dressings. The pricing of this device group is regulated as for pharmaceuticals.
• Medical devices supplied on the instructions of an authorised healthcare professional are included in the Minister of Health’s regulation, which indicates, for example, the device’s public fund financing limit, the patient’s own share in the limit and the criteria on which devices are granted. There are no negotiation procedures; conditions apply to every device and are set formally. This group consists of devices that require personalisation (eg, infusion sets for a personal insulin pump, lenses, prostheses, adult diapers and wheelchairs).
• Medical devices provided in an inpatient setting are financed from the public fund as part of the medical procedure and are supplied to patients free of charge. These devices are procured by hospitals and clinics in public procurements.

During the reimbursement procedure, a health technology assessment (HTA) is provided for originators with no reimbursement equivalents. The reimbursement decision has to be made on the basis of scientific evidence. The applicant marketing authorisation holder has to prove the product’s cost-effectiveness compared to the alternative therapeutic substance that is already reimbursed from public funds. The Agency for Health Technology Assessment and its advisory body, the Transparency Council, play a crucial role in the assessment process.

The Minister of Health issues an individual administrative decision on the reimbursement of a product, taking into account other medical procedures that may be applied for a given clinical condition and that may be replaced with the medicine, foodstuffs for particular nutritional uses, or medical device covered by the application. The following are also taken into account:

• the stance of the Economic Commission;
• the recommendations of the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT);
• the significance of the clinical condition to which the reimbursement application relates;
• clinical and practical efficacy;
• safety;
• the relationship between health benefits and administration risk;
• the cost to health effects ratio of the previously reimbursed products compared to that covered by the application;
• price competitiveness;
• the impact on the expenses of the entity obliged to finance healthcare services from public funds and on service recipients;
• the existence of an alternative medical technology and its clinical efficacy and safety;
• the map of health needs developed by the Minister to identify priority health needs and challenges for the organisation of the healthcare system and to ensure sustainable and co-ordinated spending of public funds;
• the threshold cost of gaining an additional quality-adjusted life year; and
• commitment to continuity of supply.

While dispensing reimbursed medicinal products, medical devices or foodstuffs intended for particular nutritional uses, pharmacy staff (pharmacists and pharmacy technicians) should inform a patient about the availability of an affordable and publicly reimbursed equivalent whose retail price does not exceed the price of the prescribed product and the financing limit. In the case of medicines, the equivalent has to share its international name, dosage and indication with the prescribed product, and must have a pharmaceutical form that cannot give rise to therapeutic differences. The pharmacy is obliged to display this information on its premises.

Pharmacy staff are also obliged to issue an equivalent to patients who make such requests. This obligation also extends to equivalents with the same or even higher price and to equivalents that are not publicly reimbursed. In the latter case, the cost is fully payable by the patient.

These rules also apply to pharmacy outlets.

Apps can be classified as medical devices. There are no regulations specific to apps in Poland: EU regulations apply. The criteria for qualifying an app as a medical device are that it fulfils the definition of a medical device from the MDR/IVDR and that it has a medical purpose. An app can be independent or can be connected with another medical device.

To consider an app as a medical device, it is crucial that the manufacturer indicates its specific medical purpose. All implementing rules in Annex VIII of Regulation (EU) 2017/745 or Annex VIII of Regulation (EU) 2017/746 shall be considered.

The Polish Ministry of Health announced the start of the certification process for medical apps in the first quarter of 2023.

According to the Medical Activity Act of 15 April 2011, health services may be provided via telemedicine systems. Telemedicine advice constitutes a health service that is equal to medical advice given in a traditional manner. When providing telemedicine services, it is important to remember the basic duties of a doctor: to act in accordance with the indications of current medical knowledge, available methods and means of prevention in the diagnosis and treatment of diseases, in accordance with the principles of professional ethics and with due diligence.

In addition, the Regulation of the Minister of Health of 12 August 2020 on the organisational standard of teleportation in primary healthcare sets out the doctor's information duties and the rules for providing online consultations.

In 2021, the public payer (National Health Fund) announced that it would be entitled to cancel contracts for primary care if a clinic switches to operating mainly as telemedicine.

There are restrictions on prescriptions for medicines containing certain categories of narcotic drugs, psychotropic substances or precursors. Such prescriptions are issued after verification through the system or after ascertaining through an interview with the patient that the amount and type of pharmaceuticals prescribed to the patient in prescriptions issued and filled are not sufficient for the proper conduct of pharmacotherapy.

A prescription for the above preparations necessary for the continuation of treatment, if it is justified by the patient's health condition reflected in the medical records, may be issued without examining the patient if no more than three months have passed since the last examination of the patient.

The above does not apply to primary care doctors.

Regulations on advertising to the public are applicable. In addition to the general rules for the advertising of medicines and medical devices, further restrictions are imposed on advertising directed to the public – eg, it may not include images of medical professionals or celebrities, it may not contain forbidden suggestive content, and it may not contain anything that encourages children to purchase medical devices.

The advertising of prescription-only medicines that contain narcotics and psychotropic substances and are included in the lists of reimbursable pharmaceuticals is not allowed.

Access to online platforms for healthcare professionals must be effectively protected from general public access.

Online promotion is hindered by a strict ban on pharmacy advertising. The European Commission filed a complaint against the ban with the CJEU in 2023.

Electronic prescriptions are allowed in Poland. Paper prescriptions are issued exceptionally, in strictly defined cases. The rules for issuing e-prescriptions derive from the Pharmaceutical Law and the Regulation of the Minister of Health of 23 December 2020 on prescriptions.

Online sales of medical devices and non-prescription medicines are allowed, except for medicines for which dispensing is limited by the age of the patient. The terms and conditions for online sales of medicines are set forth in the Regulation of the Minister of Health of 26 March 2015 on the mail-order sale of medicinal products.

The rules for maintaining electronic medical records are contained in the Health Care Information System Act of 28 April 2011. The Regulation of the Minister of Health of 6 April 2020 on the types, scope and models of medical records and the manner of their processing is also in force, and introduced the principle of keeping medical records in electronic form.

Health-related data is considered sensitive and is protected in accordance with the GDPR and the Data Protection Act of 10 May 2018. The use of cloud platforms is permitted, and there are no specific obligations for cloud platforms. The operation system should comply with the provisions of the GDPR and provide the required level of security.

Patents and other key types of intellectual property (excluding copyright), such as trade marks, utility models and industrial designs, are regulated by the Industrial Property Law of 30 June 2000. In accordance with Article 24 of this statute, an invention must be new, have an inventive step and be suitable for industrial application in order to be patentable.

Generally, provisions regarding patents apply to pharmaceuticals and medical devices on a general basis. However, although only new inventions are generally patentable, there is an exception in Article 25.4 of the Industrial Property Law for inventions relating to substances or mixtures that are used for diagnosis and treatment. Even if such substances or mixtures are not new, applying said mixtures or substances for diagnosis or treatment purposes might be patentable if this application itself is new. Likewise, if their particular diagnostic or therapeutic application is not new, another diagnostic or therapeutic application might be new and thereby patentable.

Although products used in diagnostics or treatment (in particular, substances or mixtures) can be patented, the treatment of humans and animals by surgical or therapeutic methods and methods of diagnostics applied on humans or animals cannot.

Most disputes regarding patents revolve around the expiry of the patent for the original medicinal product and the placement of a generic product on the market by the generic manufacturer.

New dosage regimes and new patient populations can justify additional patent protection under the new medical use rule established in Article 25.4 of the Industrial Property Law. Pursuant to this provision, a patent might be granted for a new (or specific) use of a substance or mixture in the methods of treatment or diagnosis if such use does not constitute the current state of the art.

Any actions regarding the use of the product for the patented use, such as manufacturing, placement on the market or offering of the product, would be considered an infringement of second and subsequent medical uses.

As a rule, patents are granted for a period of 20 years. The patent term cannot generally be extended, except for pharmaceuticals, where the term can be extended by up to another five years by obtaining a supplementary protection certificate (SPC). An application for an SPC must be made within six months of the marketing authorisation being issued.

The decision to grant the SPC will be declared to have expired by the Polish Patent Office if the basic patent has expired before the end of the term for which it was granted, or if, during the term of the basic patent, the market authorisation for the product has been withdrawn or the right-holder has surrendered their supplementary protection right.

The SPC can be revoked on the following grounds:

• if it has been granted in contravention of the conditions required to obtain it; or
• if the basic patent was invalidated insofar as it was the basis for the existence of a supplementary protection right.

If the basic patent is invalidated in its entirety, the granted SPC becomes null and void by virtue of law.

A patent confers the exclusive right to exploit the invention, for profit or for professional purposes, throughout the territory of the Republic of Poland. Exploiting a patent holder’s invention without the holder’s consent for profit or for professional purposes in the following ways is considered an infringement of the patent:

• making, using, offering or putting on the market a product that is the subject matter of the invention, or importing the product for such purposes; or
• employing a process that is the subject matter of the invention, as well as using, offering, putting on the market or importing for such purposes the product directly obtained by that process.

However, the Bolar exemption is expressly set out in Article 69.1.4 of the Industrial Property Law. By virtue of this provision, one does not infringe a patent if one uses the invention by making, applying, storing, depositing, offering, placing on the market, exporting or importing in order to conduct acts which, under the law, are required for obtaining registration or authorisation, also by a third party, as a condition for allowing the marketing of certain products, including medicines, in the territory of the EEA or of another country.

The threat of infringement is actionable under Polish law. According to Article 285 of the Industrial Property Law, the holder of a patent, an SPC, a right of protection or a right in registration, or another entitled person, may demand the ceasing of infringing activities. According to the case law and doctrinal writings, the threat of infringement should be real and actual (plausible), and not merely hypothetical. The plausibility of the threat can be indicated by the nature of the actions taken (for instance, preparatory steps to produce products that violate exclusive rights).

The following actions are not considered as patent infringements:

• using an invention for national purposes, to a necessary extent, without the exclusive right, where it is indispensable to prevent or eliminate a state of emergency relating to the vital interests of the State, particularly security or public order;
• the employing of an invention for search and experimental purposes, for the evaluation thereof, analysis or teaching;
• the use of the invention by making, applying, storing, depositing, offering, placing on the market, exporting or importing in order to conduct acts which, under the law, are required for obtaining registration or authorisation, also by a third party, as a condition for allowing the marketing of certain products, including medicines, in the territory of the EEA or of another country (the Bolar exemption); and
• the extemporaneous preparation of a medicine in a pharmacy on a physician’s prescription (the Galenic exemption).

According to Article 82 of the Industrial Property Act, a compulsory licence may be granted under the following circumstances:

• if it is necessary to prevent or eliminate a state of national emergency, particularly in the fields of defence, public order, the protection of human life and health, and the protection of the natural environment;
• if it has been established that the patent has been abused; or
• if it has been established that the patent holder enjoying the right of priority of an earlier application (the earlier patent) refuses to conclude a licence contract and thereby prevents the meeting of home market demands through the exploitation of the patented invention (the dependent patent), whose exploitation would encroach upon the earlier patent; in such case, the holder of the earlier patent may demand to receive an authorisation for the exploitation of the invention that is the subject matter of the dependent patent (a cross-licence).

A compulsory licence may be granted if the applying party is able to prove that it has previously made efforts to obtain a licence, in good faith. This requirement may be waived in the case of a compulsory licence granted for the purpose of preventing or eliminating a state of national emergency.

Any person holding a patent or rights stemming from a patent (such as a licence holder) can bring proceedings for patent infringement after the patent has been granted. The remedies include:

• cessation of the infringement;
• the handing over of unlawfully obtained profits; and
• compensation for damages (under general provisions of the Civil Code, including lost profits, or the equivalent of the licence fee or other relevant remuneration for the use of the invention).

Furthermore, the judgment can be made public (in a manner specified by the court) and the infringer can be ordered to publish a statement in the press. Upon a court order, any unlawfully manufactured or marketed products and materials used to produce them can be disposed of (destroyed or withdrawn from the market).

At the infringer’s request, if the infringer was not culpable and the order to cease the infringement would be disproportionately harsh for the infringer, the court may order the payment of an appropriate sum of money (but only if it is also in the interest of the entitled person).

The invalidity of the patent can be used as an indirect defence that would require a motion to be filed at the Patent Office. Such a motion is possible and will be successful if a person with a legitimate interest is able to prove that the requirements for the granting of the patent were not met.

The procedural rules for granting interim injunctions in IP cases were altered in 2023. Until recently, injunctions were granted in ex parte proceedings, but the court is now obliged to hear the opposite party before deciding whether to grant an injunction against it. A deadline has also been introduced for seeking interim injunctions against infringements of IP rights, which is only possible within six months from the date the IP right holder became aware of the infringement.

There are no specific requirements in the area of patent law for generic market entry, but also no specific procedures available to “clear the way” for generic entry. It is theoretically possible to file a declaratory action but, in practice, it would last too long to be effective. A generic entrant can perform all the necessary actions in order to obtain market authorisation while the patent is still binding. However, even if the marketing authorisation is granted, the product cannot be marketed until the patent has expired.

There is no patent linkage in Poland, and patent protection is not considered possible grounds for the refusal of a marketing authorisation under the Polish Pharmaceutical Law. The market authorisation holder (not the registration authority) is responsible for any patent infringement stemming from manufacturing or marketing the product.

However, even though the Pharmaceutical Law perceives patents as being irrelevant to the procedure of marketing authorisations, it does include data and market exclusivity rules, established in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001. After the market authorisation has been granted, the beneficiary can withhold access to the results of clinical and non-clinical studies from other entities (including generic entrants) for a period of eight years from the date the first (initial) marketing authorisation was granted in an EU or EFTA member state (data exclusivity). In addition, the generic of the referenced pharmaceutical product cannot be released onto the market until ten years have passed since the date of the initial marketing authorisation in an EU or EFTA member state (market exclusivity).

Depending on the type and scope of the counterfeit infringement, the infringer can be held responsible on the following grounds:

• general civil responsibility for torts regulated in the Civil Code;
• violation of the Industrial Property Law (trade marks, designs);
• violation of the Act on Copyright and Related Rights;
• violation of the Unfair Competition Act; or
• violation of Regulation 608/2013 of 12 June 2013 concerning customs enforcement of IP rights.

The procedure and possible remedies differ significantly in each of these regimes.

General rules regarding trade marks also apply to pharmaceuticals and medical devices. Any sign capable of being represented graphically can be a trade mark, as long as it possesses the attribute of distinctiveness (ie, it is capable of distinguishing the goods of one business from those of other businesses). A trade mark will not be granted for signs that:

• were filed in bad faith;
• are contrary to public order or good customs;
• consist of customary elements that are present in current business practices; or
• may mislead consumers, especially with respect to the safety or quality of the product.

The Pharmaceutical Law contains special rules regarding the name of medicinal products, which might be an invented name that is not liable to cause confusion with the common name, or a common or scientific name that bears the trade mark or the name of the marketing authorisation holder.

The URPL issues guidelines for naming pharmaceuticals used by human beings. The latest one, including the issue of umbrella branding, was published on 24 September 2019. Despite being a soft law regulation, the guidelines have a significant impact on the practice of the Pharmaceutical Inspection.

The trade dress or design of pharmaceuticals and medical devices or their packaging can be protected as industrial designs or trade marks under the Industrial Property Law. Remedies are also available under general civil law rules and unfair competition regulations, and include cessation of the infringement, surrender of the unlawfully obtained profits and redress of the damage. In certain cases (violation of industrial property and fair competition), the judgment can be made public and the infringer can be obliged to publish a statement in the media.

Polish law follows the data and market exclusivity rules established in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. After the market authorisation has been granted, the beneficiary can withhold access to the results of clinical and non-clinical studies for a period of eight years from the date the first (initial) marketing authorisation was granted in an EU or EFTA member state (data exclusivity).

With regard to market exclusivity, irrespective of whether a marketing authorisation has been issued, the equivalent of a reference pharmaceutical product cannot be released onto the market by the marketing authorisation holder until ten years have passed since the date the initial marketing authorisation for the reference pharmaceutical was issued in an EU or EFTA member state.

If a decision is issued to add a new indication or indications that are held to bring significant clinical benefits, the ten-year period of market exclusivity can be extended by a maximum of 12 months during the first eight years after the marketing authorisation was issued for the reference pharmaceutical.

Rules on pharmaceutical prescriptions have been made more flexible. Pharmacists can now issue prescriptions even if there is no life-threatening emergency; a mere threat to health suffices.

Measures adopted in order to adjust ongoing clinical trials to the COVID-19 pandemic primarily consisted of soft law rules.

The European Commission issued Guidance on the management of clinical trials during the COVID-19 pandemic, prepared in co-operation with the Good Clinical Practice Inspectors Working Group, the Clinical Trials Facilitation and Co-ordination Group (a working group of the Heads of Medicines Agency), the Clinical Trials Expert Group and, especially, the European Medicines Agency. The document includes measures to be taken in relation to ongoing trials as well as initiating new ones.

In general, it urges sponsors of ongoing trials to make changes in clinical trials based on risk assessment and to consider adopting an array of measures in their risk assessment adequacy. Sponsors should seek the approval of investigators. The well-being and best interests of the trial participants take priority in these considerations. Changes should be balanced and proportionate, and the compliance with the trial protocol should be secured to a relevant degree. Such measures include:

• the postponement of trials;
• the extension of a trial's duration;
• the postponement, limiting or even cancelling of physical visits;
• the cancelling or slowing of the recruitment of new participants;
• moving participants to other safer sites; and
• the closing of sites.

Initiating new trials is to be critically assessed.

Five versions of this document were issued, with the version dated 10 February 2022 being the latest.

The obvious key emergency approvals during the COVID-19 pandemic were for COVID-19 vaccines. Despite the extraordinary situation, the procedure used for that purpose was the standard procedure for conditional marketing authorisation provided for in Regulation (EC) No 726/2004, Article 14-A of which includes requirements that have to be satisfied if conditional marketing authorisation is to be issued. Further relevant rules are provided for in Commission Regulation (EC) No 507/2006.

Such conditional marketing authorisation can be granted for a medicine in order to meet unmet medical needs of patients if this medicine is intended for the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases. In standard situations, it may be granted prior to the submission of comprehensive clinical data, provided that the benefit of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data is still required. However, in emergency situations even comprehensive pre-clinical or pharmaceutical data is not required.

Article 14-A specifies some further conditions and imposes certain obligations on marketing authorisation holders.

Conditional marketing authorisation is valid for one year and is renewable.

The possibility of extraordinary flexibility in regulatory requirements for medicinal products introduced during the COVID-19 pandemic has been withdrawn. During the pandemic, on-site good manufacturing practice (GMP) and good distribution practice (GDP) inspections were postponed or conducted remotely, but these have now resumed. The GMP/GDP Inspectors Working Group has determined that the validity of GMP and GDP certificates will be extended until 2024 or until the conclusion of the next on-site inspection, whichever comes first, unless otherwise specified in the document's clarifying remarks.

No new specific legislation has been adopted in this respect. However, Poland has numerous measures aimed at counteracting the illegal export of medicines and monitoring such trade.

The digitalisation of healthcare in Poland began before the COVID-19 pandemic started. One of the most significant developments was the introduction of the electronic prescription as a default form of prescription, which took place not long before the implementation of the first lockdown measures in Poland. The process of digitalisation then continued, to a significant extent in response to challenges posed by COVID-19.

The development of telemedicine is one of the examples, as it became much more dynamic after the beginning of the pandemic, as regulations were adopted to facilitate that development (although telemedicine in principle was provided for beforehand).

The key legislative development happened at the very beginning of the pandemic, when the Minister of Health chose to use its right to issue subordinate legislation determining organisational standards of healthcare in selected fields of medicine and issued such standards for primary care. The Minister’s ordinance regulated various technical issues.

Under standard Polish patent regulations, the Patent Office may grant a compulsory licence. The Industrial Property Law of 30 June 2000 allows the granting of such licence if it is necessary to prevent or remove a threat to the security of the State, particularly in the fields of defence, public order, the protection of human life and health, and the protection of the environment.

However, the Polish authorities have made no publicly available declarations about a plan to use this clause or to introduce new regulations of compulsory licences tailored specifically to COVID-19-related treatments.

Legislation aimed at counteracting COVID-19 introduced liability exemptions for persons providing healthcare services.

The regulation exempts criminal liability for a few unintentional offences: manslaughter, bodily harm and exposing a person to imminent danger of loss of life or grievous bodily harm. It provides that a healthcare professional who engages in conduct that would otherwise be classified as a criminal offence during the period of the declaration of an epidemic emergency or epidemic, while providing healthcare services in the prevention, diagnosis or treatment of COVID-19 and acting under special circumstances, does not commit a crime. The liability exemption does not apply if the effect caused by the perpetrator was the result of a grave failure to take due care, as required under the given circumstances.

However, the period of the declaration of an epidemic emergency ended on 30 June 2023, so the exemptions no longer apply.

The Act of 2 March 2020 on specific solutions related to the prevention, counteraction and eradication of COVID-19, other communicable diseases and emergencies caused by them introduced several legal measures enabling certain authorities to issue orders to other public bodies, as well as private entities (entrepreneurs).

These provisions are very generally worded and thus give authorities broad leeway as to the contents of orders that can be issued. Amongst other things, they can be used to convert manufacturing sites in a way deemed necessary by the authorities due to COVID-19.

The orders can be issued during a period when an epidemic emergency or an epidemic has been declared, and for up to three months after such emergency has ended. This period has already expired.

Some COVID-19-related changes to the system of public procurement were enacted in order to make it more flexible – eg, new provisions excluded the application of the provisions regulating public procurement if procured goods or services are needed for counteracting COVID-19 and there is a high likelihood of rapid and uncontrolled spread of the disease, or if the protection of public health so requires.