The Polish pharmaceutical market is regulated by the following legislation, supplemented by several statutes, regulations and guidelines:
The scope of regulatory and supervision competencies regarding pharmaceuticals and medical devices is divided between the Minister of Health (the “MoH”), the President of the Office for Registration of Medicinal Products, Medical Devices and Biocides (the “President of the Office”), and the State Pharmaceutical Inspection led by the Chief Pharmaceutical Inspector (the “CPI”).
The MoH is responsible for issuing consents for early access schemes/named patient import of drugs, and for decisions on pricing and reimbursement.
The President of the Office is the competent in:
The CPI is competent with regards to the following:
The procedure for challenging decisions of the regulatory bodies for pharmaceuticals and medical devices (as well as other regulated products, such as foodstuffs) is regulated by the Code of Administrative Procedure (“KPA”).
Pursuant to the KPA, administrative decisions can be challenged by:
As a rule, having received a decision in the first instance, the party has the right to appeal against it, either to a higher-rank authority or to the same institution (application to reconsider). There are no particular requirements for an appeal in the first instance, but the decision issued in the second instance is subject to administrative judicial review. Judicial review requires a fee, depending on the type of decision in question.
As for distinguishing borderline products, definitions indicate the characteristic features of each product category, as well as its function.
Pursuant to the PL, if a product fits the definition of both a pharmaceutical and another type of product, the classification as a medicinal product shall prevail. Additionally, the President of the Office can issue a binding opinion on borderline products.
There is no regulation regarding functional foods or nutraceuticals – such categories are not recognised in Polish law. However, there are other specific categories of foodstuffs under the Act on Food and Nutrition Safety (“AoFaNS”). Manufacturers or distributors of foodstuffs should bear in mind that any health or nutrition claims must be compliant with EU Regulation 1924/2006.
Poland is bound by the following classification of food products imposed by EU Regulation No 609/2013:
The PL provides for the following categories of pharmaceuticals:
Pursuant to the AoMD, there are three main categories of medical devices:
The key legal acts governing the conduct of clinical trials of pharmaceuticals and medical devices are the PL and the AoMD. In 2019, a new Act on Clinical Trials is going to come in force adjusting Polish provisions to EU Regulation No 536/2014.
The provisions of the PL and the AoMD state that a clinical trial cannot be conducted before the bioethics committee issues a positive opinion on the sponsor’s application. Moreover, the President of the Office must issue an authorisation to start the trial.
In the case of medicinal products, a clinical trial may also be commenced if the President of the Office has not requested any additional information within the period of time specified in the PL.
The sponsor of a clinical trial submits an application to the President of the Office. The PL and AoMD specify which information has to be included in the documentation. The dossier of a clinical trial may be submitted in English, with the exception of information intended for patients and the informed consent form, which have to be in Polish.
Once the clinical trial of a medical device has been initiated, the sponsor can make modifications. However, if changes are significant and may affect the safety of study participants or the way a clinical trial is conducted, the President of the Office must issue permission for such changes.
An authorisation or its refusal shall be granted by the President of the Office within 60 days of submission of the complete dossier. In the case of medicinal products, the time limit may be extended by a maximum of 90 days.
There is no publicly available database containing information about current clinical trials and their results. However, the Employers' Union of Innovative Pharmaceutical Companies (INFARMA) runs a website with information about ongoing clinical trials conducted by the companies associated in the Union.
There are no restrictions on using online tools to support clinical trials. For example, online tools may be used during the recruitment procedure or in order to monitor the clinical trial. The General Data Protection Regulation (the “GDPR”) provides for general rules with regards to the processing of personal data in connection with clinical trials.
According to the GDPR, the resulting data from clinical trials should be considered as sensitive as it may contain genetic or biometric data, or data concerning health or a natural person's sex life.
The resulting data from clinical trials can legally be transferred to a third party or an affiliate if relevant consent is obtained from the study participant. In accordance with the information obligation under the GDPR, the controller should provide the data subject with information about the recipients or categories of recipients of their data.
The creation of a database containing sensitive data of the patients is subject to the general requirements of the GDPR, including that there must be written consent from the participants.
The PL applies to products that simultaneously meet the criteria for a pharmaceutical and another type of product (eg, a food supplement or a medical device). For more information on borderline products, please refer to 1.4 Borderlines Between Pharmaceuticals and Other Life Sciences Products.
A marketing authorisation (“MA”) for a medicinal product is granted either locally by the President of the Office (a national procedure or so-called decentralised and mutual recognition procedure), or by the European Commission. An MA issued by the European Commission is effective in all EU Member States.
No MA is required for medical devices. As a general rule, however, in order to introduce a medical device to the market, it is mandatory that such a medical device is marked with a “CE” mark, and has a valid certificate of conformity issued after the performance of a conformity assessment procedure and a declaration of conformity. Regardless of the above, the manufacturer and authorised representative have a reporting obligation towards the President of the Office.
An MA for a pharmaceutical is valid for five years. The validity period of an MA may be extended (for an indefinite period) or shortened by the President of the Office, upon the petition of the marketing authorisation-holder (MAH).
As regards medical devices, if the characteristics of a given medical device change, affecting the safety of such a device, or if legal requirements for a given medical device change, the dossier regarding such a medical device has to be updated.
In certain situations, an MA for a pharmaceutical expires by operation of law or is revoked by the President of the Office.
MA expires by operation of law if the MAH does not introduce the medicinal product into the market within three years of receiving the MA, or if a medicinal product has not been distributed for three consecutive years.
The President of the Office may suspend an MA if there are circumstances obliging the President of the Office to revoke an MA but such occurrence does not directly threaten public health. The MA is suspended for a definite period; suspension is lifted when reasons for suspension cease to exist. The suspension of an MA results in the MAH’s inability to introduce the product into the market.
Variations to the data encompassed by an MA and variations to the dossier based on which an MA was issued are made by the President of the Office, upon the request of the MAH.
In order to receive an MA in a national procedure (or MRP /DCP), a petition has to be submitted to the President of the Office. Attachments to the petition may be drawn up in English, apart from the Summary of Product Characteristics and the specimen of packaging. As a general rule, the President of the Office is obliged to issue or refuse to issue the MA within 210 days of the petition being filed.
Poland follows EU law in respect of the obligation to conduct clinical trials in the paediatric population or to obtain a waiver from this requirement, as provided for by Regulation (EC) no 1901/2006.
As a general rule, the procedure for variation of an MA is initiated upon the request of the MAH, who determines the scope of variation. The variation is of either the data encompassed by the MA and/or the dossier based on which the MA was issued.
The procedure of submitting variations is determined in Commission Regulation (EC) No 1234/2008.
In the event of a change of the MAH, the President of the Office issues a new MA based on the petition of an entity stepping into the rights and obligations of the previous MAH. The MA issued to the new MAH becomes effective no later than six months following its issuance.
Medicinal products are approved for sale without an MA if their use is required to save the life or health of a patient, on the condition that a given medicinal product is approved for sale in the country from which it is imported and has a valid MA in such country. This is a so-called import for a particular use.
Furthermore, in emergency situations due to natural disasters or other dangers to human or animal life and health, the Minister of Health may, for a specified term, approve medicinal products that do not possess an MA.
To date, there is still no legal provision directly implementing a notion of compassionate use of medicinal products in Poland. However, in practice, compassionate use programmes are sometimes approved, on the basis of existing legal provisions (eg, the one allowing for approving medicinal products without a marketing authorisation in case of danger to human life).
Pharmacovigilance is defined here as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term side effects of medicines. Technovigilance is defined here as the science relating to the detection, assessment, understanding and prevention of adverse incidents, particularly long-term and short-term side effects of medical devices.
A number of ongoing obligations are imposed on an MAH, also covering pharmacovigilance. Those obligations include but are not limited to the following:
Regarding MAs for medicinal products other than generics, MAHs are generally obliged to prepare and submit a Periodic Safety Update Report (PSUR). The President of the Office has a right to impose on an MAH the obligation to conduct a post-authorisation safety study (PASS) and a Post-authorisation Efficacy Study (PAES).
An importer/distributor of medical devices is obliged to ensure that devices are safe to use and properly labelled, and have the appropriate manual. Also, an importer/distributor with its seat in Poland is obliged to co-operate with the President of the Office and manufacturer, among others, in cases of medical incidents and in matters of safety, in particular by reporting any dangers caused by devices.
Manufacturer is legally responsible for a medical device and should store a list of all healthcare providers and distributors, to whom it has delivered medical devices for the period of use of a medical device; the list should be made available during inspections. In addition, a manufacturer is obliged to store documentation regarding conformity assessment.
A manufacturer is notified on medical incidents that occurred during the use of a medical device and is obliged to commence an investigation procedure regarding each notified medical incident and analyse whether the incident should be reported to the President of the Office and, if so, prepare a report regarding such incident. A manufacturer also analyses all notified complaints regarding the medical device and usage errors and, in certain events, provides the President of the Office with a report on usage errors. A manufacturer describes and undertakes a Field Safety Corrective Action in order to reduce risk of death and/or serious health deterioration related to the use of a medicinal product. A manufacturer prepares a safety notice informing receivers or users about the Field Safety Corrective Action.
According to the PL, the register and documents submitted in authorisation proceedings are available to persons who have a legal interest, subject to regulations on the protection of confidential information and industrial property.
In the case of medical devices, the following information is available:
Decisions regarding the granting, withdrawing and suspending of a medicinal product from the market are publicly available online.
Commercially confidential information is protected under the Act on Combating Unfair Competition. Commercially confidential information is any technical, technological, organisational or other information of economic value concerning an enterprise and not disclosed to the public, with regard to which an entrepreneur has taken appropriate measures to preserve their confidentiality. Information relating to individuals is governed by the GDPR.
In Poland, the acts of producing falsified medicinal products, falsifying a medicinal product or active substance, or making them available for financial gain or for free are criminal offences, punishable by imprisonment.
Poland has implemented Directive 2011/62/EU to prevent the introduction of falsified medicinal products into the legal distribution chain. From 9 February 2019, entrepreneurs in Poland are obliged to place unique identifiers and safety features on the packaging of medicinal products, in line with the Directive and Delegated Regulation 161/16.
Border measures are available to track counterfeited pharmaceuticals and medical devices. The National Revenue Administration (“NRA”), which is a mix of tax administration, fiscal control and customs service, is responsible for preventing the import or release of counterfeit products. The NRA has the right to keep the imported goods and inspect them.
The prices of medicinal products that are reimbursed from public funds (within the legal frames of the AoR) are officially set. Each individual administrative decision on the reimbursement of a drug establishes an official price on the product. Wholesale and retail sale (ie, pharmacy) margins on reimbursed medicinal products are directly regulated by the AoR, so each reimbursed drug (of those available in pharmacies) has the same price to patients in all pharmacies in Poland.
Some medical devices are reimbursed following the same rules and procedure as medicinal products; prices of those devices are then subject to the same principles and restrictions.
Suppliers of reimbursed medicinal products (and of medical devices that are reimbursed on the same basis/in the same procedure as medicinal products) need to strictly obey the rules concerning the official prices. In the case of reimbursed products that are available in pharmacies, official prices and official margins (wholesale and retail ones) are fixed and cannot be altered by any means. On the other hand, official prices and margins are considered maximum ones when they are applied in the distribution of reimbursed products to hospitals.
In addition, the Reimbursement Law prohibits certain trade practices with respect to reimbursed medicinal products or medical devices. Manufacturers or wholesalers of those products are forbidden to:
Manufacturers and wholesalers of reimbursed medicinal products and medical devices, as well as pharmacy owners, pharmacy managers, and pharmacists dispensing reimbursed medicinal products and medical devices, are prohibited to offer any financial or personal benefits (including, for example, rebates, package sales, loyalty programmes, donations, awards, etc) to physicians and patients.
The reimbursement procedure involves obligatory price negotiations. After formal verification of the application and (where applicable) assessment of the application by the local HTA agency (Agency for Medical Technologies Assessment and Tarification – the “AfMTAaT”), the MAH who filed an application for reimbursement (or its representative) is invited to price negotiations. Negotiations are run by a team composed of five members of the Economic Commission (the “EC”), which is the advisory body responsible for recommending to the MoH whether or not to accept a price proposal from the applicant.
Price negotiations take place after the HTA assessment performed by the AfMTAaT, so the effects of that assessment can be taken into account by the EC during the negotiations. However, the most important factor during the price negotiations is the price of a product.
Prices on a medicinal product applied in other Member States of the EU may have an impact on the price negotiations, because those prices (maximum and minimum prices obtained in all Member States of the EU/EFTA within the year prior to submission) need to be revealed in the application and are frequently discussed during the price negotiation. There is no strict mechanism of price referral, however, in Polish law, so the MoH is not bound by any strict rule on whether the Polish price may or may not be higher than prices in some or all States of the EU.
There are different grounds and different paths for reimbursing the costs of medicinal products and medical devices from public funds. The cost of medicinal products and medical devices can be co-financed from public funds on the basis of a reimbursement decision issued on the grounds of the AoR. Reimbursement proceedings are initiated further to the application filed by the MAH (or its representative). Medicinal products and medical devices that obtained a positive decision are then listed on reimbursement lists (published once every two months).
Further to the AOR, medicinal products and medical devices can be subject to reimbursement in pharmacies, in which case a patient pays only part of the product’s price and the rest is borne by the National Health Fund (the “NHF”).
In addition, medicinal products can also be reimbursed within the so-called drug programmes – ie, programmes of treatment of particularly serious diseases, which describe in detail the conditions of entering patients into programmes, of their exclusion from the programme, and of treatment. The AoR also provides for the reimbursement of medicinal products used in chemotherapy.
In the case of medicinal products and medical devices on reimbursement lists, the part of the product’s price that is paid for from public funds is dependent on the co-payment level set under the AoR (whether a patient bears 50% or 30% of the product’s price, or just a fixed payment of PLN3.20, or 100% of the price is reimbursed) and on the reimbursement limit. Medicinal products (and, when applicable, medical devices) are reimbursed in limit groups (composed of similar products having the same composition, or a different composition but the same reimbursement indications). The AoR sets the exact rules on establishing a limit base – ie, on choosing a product that determines the group’s reimbursement limit.
Most medical devices that are reimbursed from public funds are not placed on reimbursement lists and do not undergo the standard reimbursement proceedings. Their cost is reimbursed from public funds (not less than 50% of the reimbursement limit’s price) on the basis of an individual order issued for the benefit of a particular patient.
Apart from the AoR, the cost of medicinal products and medical devices can also be covered from public funds if those products are used in the course of medical procedures financed on the basis of the Act on healthcare services financed from the public funds (the act dated 27 August 2004). In such cases, the NHF simply covers the cost of the entire procedure, in line with the detailed rules on the valuation of healthcare services set by the NHF.
Each application for reimbursement of a medicinal product or medical device contains some health technology assessment reports. An application for a product that does not have its equivalent reimbursed in a particular indication must include the following:
Those reports are sent to the AfMTAaT, which prepares a verification analysis on the basis of the HTA reports of the applicant; the Transparency Board (affiliated with the AfMTAaT) then prepares its position on the application. Finally, the President of the AfMTAaT issues a recommendation on the product.
An application for reimbursement of a medicinal product or medical device that has at least one equivalent reimbursed should only include a budget impact analysis.
The recommendation from the President of the AfMTAaT is taken into account by the EC during the price negotiations. The recommendation is also one of the criteria that the MoH takes into account when establishing a product’s official price and when deciding on reimbursement.
Physicians in Poland are free to prescribe any medicinal products that are subject to reimbursement, regardless of their official prices. A physician is also allowed to make a note on a medical prescription, further to which a product prescribed cannot be replaced by any equivalent in a pharmacy.
A pharmacist is obliged to inform a patient about the possibility of purchasing a product other than the one prescribed (an equivalent which is also reimbursed from the public funds), the price of which is lower (and does not exceed the reimbursement limit). What is more, a pharmacy should have that product in stock. A pharmacist is also obliged to give the patient a reimbursed equivalent of the product prescribed, if that equivalent is cheaper, unless the prescription includes a note from a physician prohibiting the change of the product. The provisions of the AoR also allow for the switch from the prescribed product to a more expensive reimbursed equivalent, or to an equivalent that is not reimbursed from public funds.
The advertising of pharmaceuticals is governed by the PL and the Regulation of the MoH on advertising of medicinal products, while the advertising of medical devices is governed by the AoMD. Additionally, there are requirements concerning comparative advertisements and fair market practices arising from the Act on Unfair Commercial Practices (the “AoUCP”) and the Act on Combating Unfair Competition (the "AoCUC").
Legal provisions distinguish between the advertising of pharmaceuticals to the general public, and to healthcare professionals.
The general rule on advertising pharmaceuticals is that it must be compliant with the Summary of the Product’s Characteristics, cannot be misleading or aimed at children, and should present the product objectively and inform about its rational use.
Advertising principles may differ depending on the recipient (general public or HCPs) – for example:
Advertising of medical devices cannot mislead, guarantee successful treatment or indicate features other than those declared; it must also inform about the expected risk connected with its use.
It is not required by law either to obtain authorisation or file a notification in order to advertise or promote pharmaceuticals or medical devices.
The advertising of pharmaceuticals in Poland is self-regulated by industry organisations. The most notable organisations for pharmaceuticals are INFARMA, PASMI, the “Farmacja Polska” Chamber of Commerce and PZPPF, while the crucial industry organisations for medical devices manufacturers and distributors are POLMED and IPDDL.
In the case of a breach of promotional rules for pharmaceuticals, the CPI can issue an administrative decision ordering:
Such proceedings are relatively fast and usually take up to a few months, unless the party appeals against the decision to the administrative court. Such proceedings may last even a few years.
Misleading advertising of medical devices may result in a criminal fine, restriction of liberty or imprisonment.
Advertising and promotion regulations can be enforced by competitors or third parties, as well as by the competent authorities. The advertising of pharmaceuticals is supervised by the CPI, while the President of the Office oversees the advertising of medical devices. The Competition and Consumer Protection Office can control both.
The self-regulatory/disciplinary court proceedings are separate to state administrative court proceedings. The most common sanctions for breaching ethical and disciplinary codes are ordering discontinuation of the challenged activity, compulsory publishing of clarified information, and suspension or expulsion from the organisation. Such proceedings are usually very fast.
Generally, no gifts or monetary benefits in cash or in kind may be given, offered or promised to HCPs. The exceptions are gifts of negligible value bearing the company's advertising mark. Under the INFARMA Code of Good Practices for the Pharmaceutical Industry (the “CoGP”), informational or educational materials or objects may be provided to HCPs if their value does not exceed the gross amount of PLN100. The gifts must be directly related to the medical or pharmaceutical practice, and beneficial to the care of patients. They cannot reduce the routine costs of running a practice, nor incentivise to recommend, prescribe or administer a medicinal product.
Offering benefits and sponsorship to HCPs and HCOs is restricted by the CoGP, according to which it is prohibited to offer a fee as compensation only for the time devoted by the HCPs to participation in, inter alia, a conference or a promotional event. Donations to HCOs are only allowed under specific requirements (eg, if they are explicitly intended to support healthcare or research and properly documented). Donations to an individual HCP are prohibited.
Common violations of rules on advertising medicinal products to HCPs regard offering gifts, delivering samples and compliance with the Summary of Product’s Characteristics.
Common violations of advertising medicinal products to the general public are connected with misleading by suggesting a successful treatment. There are also many advertisements that are not compliant with the Summary of the Product’s Characteristics and presenting products non-objectively.
Rules of advertising medical devices are commonly breached by attributing non-existent features or functions to a medical device.
The AoCUC and AoUCP outline provisions on misleading or illegal advertising; such advertising may be considered as infringing collective consumer interests by the Competition and Consumer Protection Office.
In Poland there are no particular rules regarding medical applications: general provisions concerning patient consent, data protection and data transfer, etc, apply.
Medical apps can potentially be regarded as medical devices. If an application is intended to support – eg, diagnosis, treatment or alleviation of a disease – it may be considered a medical device. Such application may be developed in order to control other medical tools, to generate information about the patient’s health automatically or to support the doctor’s decisions. If the application does not operate independently but is a part of another medical device, it cannot be considered a medical device.
Pursuant to Polish law, a physician can also provide healthcare services via information and communications technology (ICT) or connection systems – eg, through a mobile device.
A physician providing medical attention online must comply with regulatory criteria regarding, inter alia, the provision of services by electronic means, effective patient verification or data protection.
The promotion and advertising of pharmaceuticals and medical devices online is subject to the general requirements further explained in 5 Promotion and Advertising.
E-prescriptions were introduced in Poland in 2018. By the end of 2019, HCPs will be required to send prescriptions directly to pharmacy systems. Without examining a patient, a doctor may only issue an e-prescription that is necessary for the continuation of treatment.
According to Polish law, pharmacies may sell OTC pharmaceuticals online, with the exception of medicinal products that are age-restricted. It should be noted that an amendment to the PL is proceeding, providing that pharmacies may sell online medicinal products that have been prescribed to a person with a disability certificate.
The online sale of medical devices is also possible under the AoMD and is supervised by the President of the Office.
The Act on Information System in Healthcare imposes an obligation on healthcare services-providers to record patients' medical documentation as Electronic Health Records (EHR), which consist of:
The obligation to record patients' medical documentation in an electronic form entered into force on 1 January 2019, but many providers of healthcare service have still not complied with this duty.
In order to undertake the manufacturing of medicinal products, it is necessary to obtain a manufacturing authorisation (“MA”). For the purpose of obtaining an MA, an entrepreneur must submit an application to the CPI.
The application for an MA should be accompanied by, inter alia, the Site Master File developed in accordance with the Good Manufacturing Practice, notification of a Qualified Person, and proof of payment of the fee for submitting an application for an MA. An applicant is also obliged to prove that it has at its disposal suitable premises, technical equipment and control facilities necessary for the manufacture, control and storage of the medicinal products referred to in the application.
An authorisation is issued in the form of an administrative decision and is granted for an indefinite period of time. The CPI shall grant an authorisation or a refusal decision within 90 days of the date of the proper submission of the application. The aforementioned time limit shall be suspended if the authority sends the entrepreneur a request for supplementation, or if the proceedings are suspended
The manufacturing of medical devices in Poland is regulated by the AoMD and does not require the obtaining of any additional authorisations or licences.
The wholesale distribution of medicinal products refers to activity that consists of procuring, holding, supplying or exporting medicinal products owned by the entity performing these activities or another entitled entity. Commencement of activity in the scope of the wholesale distribution of medicinal products requires an authorisation issued by the CPI. Granting and the refusal to grant an authorisation, and its modification or withdrawal, shall be effected by way of an administrative decision within 90 days of the date of the proper submission of the application.
An application for authorisation to operate a pharmaceutical wholesale store shall contain, inter alia, information on the place of business, the scope of wholesale activities – including the types of medicinal products to be distributed in the event of a restriction of the product range – and the date of commencement of the intended activity. An entrepreneur is obliged to attach to the application a description of the procedures enabling the effective suspension or withdrawal of a medicinal product from the market and from other distributors, a document confirming the legal title to the premises, a technical description, together with a drawing part concerning the business premises, drawn up by the authorised person, and other documents.
The authorisation to operate a pharmaceutical wholesale store is granted for an indefinite period of time, unless the applicant has applied for a fixed-term authorisation. In relation to the wholesale distribution of medical devices, an entrepreneur who has been properly authorised in accordance with the above-mentioned requirements shall also be entitled to distribute medical devices. However, only the wholesale distribution of medical devices does not require the obtaining of a separate authorisation. The regulatory body supervising distributors (including pharmaceutical wholesale stores) of medical devices is the President of the Office.
For the classification of pharmaceuticals, please see 1.7 Different Categories.
The import and export of pharmaceuticals is regulated by the PL, while the import and export of medical devices is regulated by the AoMD.
The CPI is the authority that is competent to issue, refuse to issue, withdraw and vary an import licence for medicinal products. Importers and distributors of medical devices are required to co-operate with the President of the Office. No import licences are required in relation to medical devices.
An entity authorised by the CPI may act as an importer of medicinal products. An entity that imports medical devices does not need a special permit, but there is an obligation to notify the President of the Office.
The importer of medicinal products is required to obtain a licence from the CPI.
As a general rule, only medicinal products authorised for trade in Poland can be imported legally. By way of exception, it is possible to import a non-authorised medicinal product if it is necessary for saving the life or health of a patient. Moreover, in the event of a natural disaster or other danger to the life and health of the people, the MoH can issue an authorisation for the import of medicinal products that are not authorised in Poland, subject to conditions specified in the PL.
The import of medical devices does not require authorisation. However, it should be notified to the President of the Office.
As a general rule, Polish law provides for the possibility of parallel import. Parallel import is allowed if an imported medicinal product has the same active substance, the same indications up to the third level of ATC classification, the same strength, the same administration route and the same form as a pharmaceutical product that is authorised in Poland. The information leaflet attached to the product has to be consistent with the parallel import licence.
As a general rule, the exportation of intangibles is not controlled in Poland. The exception is the export of dual-use items.
The export of dual-use goods is regulated in Poland, and requires the authorisation of the minister competent for economic issues. This issue is regulated under the Act on foreign trade in goods, technologies and services of strategic importance to the security of the State and to maintaining international peace and security, which introduces the solutions contained in Council Regulation (EC) No 428/2009.
Poland is a member of the European Union, the World Trade Organization (WTO), and the Organisation for Economic Co-operation and Development.
Poland is part of the European Economic Area (EEA) and the European Union Customs Union (EUCU), which are parts of the European single market. The European Union has free-trade agreements with several countries.
As an EU Member State, Poland adheres to sanctions (embargoes) applied under the provisions of the EU. The list of sanctions is contained in the List of European Union Restrictive Measures (sanctions) in force. At present, sanctions in the field of medicinal products and medical devices are not applied.
Patents in Poland are regulated by the Act of 30 June 2000 Industrial Property Law (the “IPL”) and the Regulation of the President of the Council of Ministers of 17 September 2001 on the filing and processing of patent and utility model applications.
The most commonly encountered issues revolve around generic products and the application of research exemption (the so-called Bolar provision).
Pharmaceutical inventions have to meet general patent requirements in order to obtain protection. However, unlike other inventions, pharmaceutical products can enjoy a more liberal approach to the novelty requirement as it is possible to patent second and subsequent medical uses of a particular substance.
Pharmaceutical products may also have their protection extended by up to five years by obtaining a Supplementary Protection Certificate (the “SPC”).
According to the IPL, second and subsequent medical uses are patentable after they meet general requirements of novelty, involvement of an inventive step and being susceptible to industrial application. Those principles apply equally to new dosage and new or selected patient populations.
Infringement of second and subsequent-use patents takes place when the producer of a generic product based on the expired “first-use” patent registers or advertises his or her product for a second and subsequent use as well.
Since Poland’s accession to the UE, pharmaceuticals enjoy additional protection through obtaining an SPC. In order to obtain the SPC, the active substance of a medicinal product must be protected by the basic patent, which must be valid and remain in force at the time of applying for the SPC. The SPC may be granted for a maximum of five years after the patent has expired.
Another mechanism is the registration of second and subsequent medical uses of already known substances.
All solutions except for the SPC have to meet standard requirements of a patent, but third parties may challenge such patents in an invalidation procedure. A patent may be invalidated in whole or in part on the request of a person who has a legal interest therein if that person demonstrates that the conditions to obtain a patent are not met, if the invention was not depicted sufficiently clearly and completely for it to be carried out by a person skilled in the art, or if the patent was granted for an invention that is not covered by the scope of the application or the original application.
Under the IPL, the patent-holder may prohibit a third party that does not have its consent from using an invention for profit or for professional purposes involving making, using, offering, putting on the market or importing for these purposes the product that is the subject-matter of the invention, or from using the process that is the subject-matter of the invention, and also using, offering, putting on the market or importing for these purposes products obtained directly by such a process. The holder of a patent may also demand the cessation of any activity that threatens to infringe his or her right.
Applying for a generic marketing authorisation does not infringe a patent, as it is acceptable under the Bolar provision.
According to the IPL, both the Bolar provision and compulsory licences are implemented.
In particular, using an invention to the extent required to perform activities that are necessary to obtain registration or a permit, particularly for medicinal products, does not constitute patent infringement (ie, the Bolar provision).
The Patent Office may grant compulsory licences to a third party's patented invention if:
A compulsory licence is a non-exclusive licence and is subject to a fee.
Proceedings against patent infringement may be brought by the patent holder or any person entitled to do so under the law – eg, the exclusive licensee.
In particular, they may demand that the patent infringer ceases the infringement, hands over any unlawfully obtained benefits and, if the infringement is culpable, also repairs damage in accordance with general civil law principles or by paying a sum of money of an amount corresponding to the licence fee or other relevant remuneration.
The lawsuit should be filed with the regional civil court after obtaining the patent, within three years of the date when the patent-holder learned about the infringement and the patent infringer, and no later than during a period of five years.
Invalidity is an available defence method and may be invoked before the Polish Patent Office. A person having a lawful interest in bringing such action should demonstrate that the invention does not meet the statutory requirements to obtain a patent.
Pursuant to the Polish patent law, there are no obligatory actions a potential generic entrant has to undertake in advance of attempted market entry. However, while applying for a market access permit, he or she may file a statement of claims that the product in question is not protected by a patent or SPC.
In Poland, there are a number of regulations concerning the fight against counterfeit products. General regulations apply to all types of products, including pharmaceuticals and medical devices. Individual regulations focus on other aspects of counterfeiting.
The provisions of the IPL penalise the marking of goods with counterfeit trade marks for the purpose of their subsequent placing on the market. The act also provides for the right to pursue the claims in civil proceedings in connection with misleading by labelling goods with a similar or identical trade mark.
Misleading product labelling is also an act of unfair competition, as is copying the external form of the product. This is both a crime and a civil tort, according to the AoCUC.
In addition, manufacturing and activities related to the supply, provision and storage of counterfeit medicinal products and active substances is penalised under the PL.
Under the general rules of Polish law, a trade mark should be capable of distinguishing the goods or services of one company from those of another company. A trade mark should also be capable of being represented on the register in a manner that enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor. New regulations entered into force in 2019, which abolish the requirement of graphic representativeness of trade marks.
According to the amendment which entered into force in 2019, the proprietor of a trade mark will not have the right to prevent a third party from bringing goods into an EU Member State where the trade mark is registered without being released for free circulation there, based upon similarities between the INN for the active ingredient in the medicines and the trade mark. The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products has released guidelines concerning the nomenclature of medicinal products.
Under Polish law, the trade dress and design of medicinal products, medical devices and their packaging may be protected as trade marks or industrial designs. In such case, a person whose right has been infringed may find protection under the Industrial Property Law Act. It is also possible to assert rights on the basis of the provisions of the Act on Combating Unfair Competition, in which case the infringement will mainly consist in misleading labelling of products.
The PL is consistent with the principles of data exclusivity and market exclusivity set out in Directive 2001/83/EC.
Documentation containing the results of non-clinical and clinical studies of the reference medicinal product will not be required for the registration of an equivalent of a reference product, if a period of at least eight years has elapsed from the date of issue of the first marketing authorisation for the reference medicinal product (whether in Poland, another EU Member State or an EEA country) until the date of submission of the application for a marketing authorisation of the equivalent.
Regardless of the marketing authorisation granted, a generic product cannot be placed on the market before the lapse of ten years from the date of the first marketing authorisation for the reference medicinal product in a Member State of the European Union or an EEA Member State.
If, within eight years of the date of granting the marketing authorisation for the reference medicinal product, a decision is issued to add a new indication or indications which, in the opinion of the President of the Office carried out prior to the issuance of that decision, represent significant clinical benefits, the period of ten years shall be extended by a period not exceeding 12 months.
Polish law does not provide for data exclusivity or market exclusivity for medical devices.
As a rule, imports of goods bearing a trade mark which have previously been put on the market in the EEA by or with the consent of the trade mark proprietor are lawful (within the frames of parallel import). However, the proprietor may oppose the further distribution of goods if there are legitimate grounds for doing so. One of the main problems in the case of parallel imports of medicinal products in terms of industrial property rights is the question of repackaging, which in turn may be interpreted as a change or deterioration in the condition of goods.
There are no competition regulations dedicated specifically to the pharmaceutical market. In general, the Office for Competition and Consumer Protection (“OCCP”) may investigate and assess activities such as:
As far as is known, there is no case law concerning pay-for-delay agreements in Poland.
As far as is known, there is no recent case law in Poland regarding life cycle strategies.
Proceedings before the OCCP can be initiated ex officio, in cases regarding abuse of dominant position and cartels. However, most commonly the OCCP initiates investigations on the basis of notifications sent by third parties (usually competitors). The procedure before the OCCP is separated into phases. First, the OCCP assesses whether there is sufficient data to initiate informal preliminary proceedings.
On the basis of this, the OCCP decides whether or not to initiate anti-monopoly proceedings. This phase is concluded by a formal decision indicating whether a company was in breach of competition law. The decision can be appealed to the Court of Competition and Consumer Protection within one month from the date of the service of the decision.
In order to accelerate the proceedings, the OCCP may approach the party of the proceedings and propose a settlement scheme.
The OCCP can fine not only the undertaking itself but also the person managing said enterprise (should they intentionally allow the company to be in breach of competition law).
The proceedings concerning infringement of competition law cannot be commenced if at least five years has elapsed from the end of the year in which such practice ceased.
There are no proceedings specifically concerning the pharmaceutical market. Over the last couple of years the OCCP conducted proceedings with regards to such issues as:
As regards share deals, it is important to satisfy the legal requirements for sales of shares of particular types of companies, as provided for by the Polish Commercial Companies Code.
As a rule, the sale of shares of a company allows that company to continue its business activities without affecting the status of permits and licences held by the company, as a change of ownership of shares does not generally impact said authorisations.
Asset deals tend to be more complicated as they generally require enumerating in the asset sale agreement all parts of an organised business enterprise that are a subject of the transaction.
There are no specific provisions in Polish law regarding joint ventures.
In licence agreements it is important to list specifically fields of exploitation. Sub-licensing is possible only if the right to sub-license was provided for in the licence agreement.
Commercial agreements should be compliant with the Polish and EU laws regarding unfair competition and pharmaceuticals, particularly those regarding the reimbursement and marketing of pharmaceuticals.
In Poland, earn-out clauses and contingent value rights are used to bridge the valuation gap between the buyer and the seller.
Common purchase-price adjustments are based on net working capital or net debt at the date of transaction. The mechanisms based on the achievements of the acquired company are also encountered. However, the locked-box approach is increasingly adopted, whereby a fixed price is established, usually based on a financial statement.
There are a few commonly used deal-protection agreements. At the negotiation stage, the parties may include a letter of intent, a preliminary contract or a non-disclosure agreement. A contractual penalty may be used in order to secure performance of the contract, while an escrow agreement, bank guarantee or promissory note can serve to secure the payment.
Pursuant to Polish antitrust law, certain transactions may be subject to approval by the OCCP, including the following:
These types of transactions are subject to mandatory notification to the OCCP, provided that the parties have realised an aggregate global annual turnover exceeding EUR1 billion, or an aggregate annual turnover in Poland exceeding EUR50 million.
The regulation on merger review provides for exceptions to the mandatory notification.
Share deal transactions are subject to tax on civil law transactions. The tax rate of 1% is calculated on basis of the market value of shares sold.
As a general rule, asset deal transactions are subject to VAT, whereby the net price is increased by 23%. If the seller is not an entrepreneur, asset deals are subject to tax on civil law transactions, with tax rates of 2% if a deal involves real estate and 1% if a deal does not involve real estate. The tax rate is calculated on the basis of the market value of the assets sold.
The income gained from the transaction is subject to relevant personal or corporate income tax.
The effects of declaring bankruptcy with regard to the liabilities of the bankrupt are comprehensively regulated by the Polish Act – Bankruptcy and Rehabilitation Law.
Provisions contained in contracts for the automatic termination of such contracts or giving the parties the possibility of such termination in the event of bankruptcy of one of the parties shall be null and void. Both "automatic" termination provisions and provisions giving the parties the right to terminate the contract will be invalid.
Much more controversial is the question of the possibility for the receiver (syndic) to withdraw from the licence agreement in the event of bankruptcy. According to this provision, if the obligations under the mutual agreement have not been performed in whole or in part on the day of bankruptcy, the receiver may perform the obligation of the bankrupt and require the other party to perform the mutual performance or withdraw from the agreement. As a rule, the receiver has the right to choose – he or she can either perform the agreement or withdraw from it.
The investigational authorities in Poland focus mainly on the following aspects of pharmaceutical business:
An investigation, let alone criminal proceedings, can have a detrimental impact on a pharmaceutical company, so it is essential to establish a transparent compliance system. Such a system consists of detailed standard operating procedures (SOPs) presenting ways of conduct in different aspects of business. A company should also provide employees with periodical training to make sure that internal procedures and policy are known and abided by.
As far as is known, there has been no recent landmark criminal case regarding the pharmaceutical market in Poland.
There are no formal differences between investigations in the pharmaceutical or medical device sector and investigations in other industries. These are jointly regulated by the Criminal Procedure Code.
There is no specific legal regime regarding the liability for pharmaceuticals and medical devices under Polish law – it is based on the general liability for damage caused by a hazardous product.
The hazardous product liability is based on risk, which signifies that it is not necessary to prove fault. There are the following prerequisites for product liability:
As a general rule, the manufacturer is liable for damage caused by a hazardous product. Additionally, the following types of entities bear equal liability as the manufacturer:
The burden of proof lies with the injured party, although the claimant does not have to demonstrate that the product has had hazardous properties.
To rebut potential liability, the manufacturer can prove that:
The manufacturer shall not be held liable for damage caused by a hazardous product in the following circumstances:
Additionally, to avoid their own liability, a professional distributor shall provide the injured party with a name and the address of the manufacturer (alternatively, the entity presenting itself to be a producer or the importer). The distributor shall also be released from liability by indicating the distributor from whom they purchased the product in question.
Another possible defence strategy is properly informing the users of the product by putting clear and relevant information in the leaflet.
The regulatory compliance defence has not been adopted in Poland. Compliance with regulatory requirements does not exclude product liability.
Market-share liability has not been introduced in Poland. Should the claimant have insufficient evidence to indicate the exact product that cause the damage, the claim should be dismissed on the grounds of lack of causal link.
The general statute of limitation in hazardous product liability cases equals three years. However, in every case the claim shall be barred by limitation after the lapse of ten years from the day when the product was marketed.
The course of the general limitation period commences on the day when the sufferer first knew or, with due diligence, was able to have known of the damage and the person liable to repair it.
The lapse of the limitation period should be raised by the claimant’s statement as it is not considered by courts ex officio.
Pursuant to Polish law, a person can file a petition to the authorities in order to obtain so-called public information. The authorities shall generally be obliged to disclose such information, unless it is restricted by confidentiality principles. With regard to manufacturers, there is no specific claim for information. Such data could potentially be a part of trade secrets.
There are two main types of damages that can be claimed in Polish legal system. The first applies to direct damages for the injury, while the latter applies to indirect damages related to the loss of future profits.
Depending on the type of injury (material or non-material), the plaintiff may claim compensation for actual, material losses or compensation for non-material injuries (ie, pain, fear or discomfort). Punitive damages are not recognised under Polish law.
Pursuant to Polish law, there are no legal measures to claim compensation if the damage has not yet materialised.
There is no maximum limit of damages available for one claimant and/or available from one manufacturer.
As far as is known, no decisions regarding liability for medicinal products have been issued in the last year.
In Polish civil proceedings, trials are conducted by a judge, not by jury.
As a general rule, during Polish civil proceedings, all documents or materials that substantiate the parties' assertions must be submitted to the Court, as well as to the opposing party.
Furthermore, anyone is obliged, upon the court’s order, to disclose documents proving facts that are relevant to ongoing proceedings, unless said materials contain classified information.
As far as is known, there are no recent material discussions regarding potential changes in the legal regime for liability for pharmaceuticals.
In Poland, privacy and personal data protection are regulated by the GDPR and the Personal Data Protection Act.
The competent authority with regard to privacy and data protection in Poland is the President of the Personal Data Protection Office (“President of the PDPO”).
According to the GDPR, "health data" refers to data about the physical or mental health of a natural person. This constitutes a broad definition, as it also includes information on the use of healthcare services. Health data is included in a specific category of so-called sensitive data.
As a general rule, health data cannot be processed. Exceptions to the rule include the following:
The President of the PDPO may impose financial penalties for a breach of the GDPR. The maximum penalty can reach up to EUR20 million or 4% of the annual turnover for the previous financial year. The infringer is also subject to criminal sanctions.
Even though Poland has not adopted regulations concerning cloud platforms, it is possible to process patients' data in the cloud. However, the Act on Patients' Rights requires that a healthcare provider using outsourcing services (including cloud computing) has the right to control the compliance of personal data processing.