Contributed By Czyżewscy Kancelaria Adwokacka
The Polish pharmaceutical market and the market of medical devices are regulated by several acts, as well as by implementing regulations issued on their basis. The most important acts that should be mentioned are as follows.
The Pharmaceutical Law – the Act dated 6 September 2001 (the PL), which regulates in particular:
The Act of 20 May 2010 on medical devices (the AoMD), which regulates in particular:
The Act of 12 May 2011 on reimbursement of drugs, food elements of a particular nutritional purpose and medical devices (the AoR), which regulates in particular rules on reimbursement of those products from public funds, including conditions and procedures for making administrative decisions on product reimbursement.
There are three main regulatory bodies that apply and enforce pharmaceutical and medical product laws in Poland:
The Minister of Health (the MoH), served and supported by the Ministry of Health. As part of this service, the Minister performs tasks in the field of:
The Ministry of Health is an office of the central government administration, and the Minister of Health himself or herself initiates, develops and implements the government's policy in the field of health protection, including supervising offices that are subordinate to him or her, eg, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocides and the Chief Pharmaceutical Inspector.
The President of the Office for Registration of Medicinal Products, Medical Devices and Biocides (the President of the Office), is competent for matters concerning:
The President of the Office is the central government administration body and is supervised by the Minister of Health.
State Pharmaceutical Inspection is led by the Chief Pharmaceutical Inspector (the CPI), who is competent with regard to the following:
The CPI is the central government administration body and is supervised by the Minister of Health.
The procedure for challenging decisions of the regulatory bodies for pharmaceuticals and medical devices is regulated by the Code of Administrative Procedure - the Act dated 14 June 1960 (CAP).
Pursuant to the CAP, administrative decisions can be challenged by the addressee of a decision, or by a public prosecutor or, in some particular cases, by a social organisation.
An administrative decision issued by a body of first instance may be appealed against either to a higher-ranking authority or to the same institution (application to reconsider). The decision issued in the second instance is subject to administrative judicial review. In such a situation, entitled persons may file a complaint against the administrative decision to the court. This complaint requires a fee, depending on the type of decision in question.
The above procedure applies to administrative decisions issued by all government administration bodies, not only in the field of the pharmaceutical or medical devices sector.
The PL provides different categories of drugs, depending on the category, for example, the regulations on advertising a drug or its availability differ (understood both as a place where you can get it, ie, a store, pharmacy, hospital, and the requirement to have a prescription for certain drugs). The PL distinguishes the following categories of drugs:
Pursuant to the AoMD, there are three main categories of medical devices (however, AoMD regulation does not differentiate their legal situation as much as in the case of PL):
The key legal acts governing the conduct of clinical trials of pharmaceuticals and medical devices are the PL and the AoMD. It is predicted that in 2021 a new Act on Clinical Trials of Medicinal Products is going to come into force, adjusting Polish provisions to EU Regulation No 536/2014, as well as a new Act on Medical Devices which will adapt Polish law to EU Regulation No 2017/745 and EU Regulation No 2017/746.
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.
A clinical trial may also be commenced if the President of the Office does not issue a decision authorising the conduct of the clinical trial within the time limit provided in PL, or accordingly for medical devices in the AoMD, and if the President of the Office has not requested any additional information within the period of time specified in the PL or the AoMD. However, the President's lack of response cannot be interpreted as authorisation to conduct a clinical trial if the scope of the proposed clinical trial includes medicinal products for gene or cell therapy, or if the investigational medicinal products contain genetically modified organisms.
The sponsor of a clinical trial submits an application to the President of the Office. The PL and the AoMD specify which information has to be included in the documentation. The dossier of a clinical trial for medicinal products 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 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, a positive opinion of the bioethics committee and approval of the President of the Office on such changes are required.
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, there are publicly available databases operated by private entities, eg, 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 (GDPR) provides for general rules with regard 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 the 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 the requirement that any such data in a database requires written consent from the participants.
Pursuant to the PL, a medicinal product is a substance or combination of substances presented as having properties for treating or preventing disease in humans or animals or administered for the purpose of making a medical diagnosis or restoring, correcting or modifying physiological functions of an organism by pharmacological, immunological or metabolic action.
However, pursuant to the AoMD, a medical device is a tool, instrument, device, software, material or other article, used separately or together with another, also with software designed by its maker to use specifically for diagnostic and/or therapeutic purposes and necessary to its proper use, designed by its maker to use in humans for the purpose of:
As for borderline products, the PL also applies to products that simultaneously meet the criteria for a pharmaceutical and another type of product (eg, a food supplement or a medical device). 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.
Marketing authorisations for biologic medicinal products are granted solely in the centralised marketing authorisation procedure co-ordinated by the European Medicines Agency. There are no additional obligations or requirements for such products at a national level in Poland.
An MA – a marketing authorisation – 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 that 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.
The 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 an occurrence does not directly threaten public health. The MA is suspended for a definite period; suspension is lifted when the 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 mutually recognised product (MRP) or decentralised procedure (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 that 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 the case of danger to human life).
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 the manufacturer, among others, in cases of medical incidents and in matters of safety, in particular by reporting any dangers caused by devices.
The 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.
The manufacturer is notified on medical incidents that have 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 that incident. The 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. The 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. The 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 cause, 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. Such information is understood as 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 free of charge 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. Since 9 February 2019, entrepreneurs in Poland have been 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.
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 Chief Pharmaceutical Inspectorate (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, and a technical description, together with a diagram of the business premises, drawn up by an 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.
The PL provides for the following categories of pharmaceuticals:
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 Anatomical Therapeutic Chemical (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.
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.
The prices of medicinal products that are reimbursed from public funds (within the legal framework of the Act dated 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Purposes and Medical Devices (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 obey the rules concerning the official prices strictly. 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. However, 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 from offering any financial or personal benefits (including, for example, rebates, package sales, loyalty programmes, donations, awards, etc) to physicians and patients.
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 whether 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 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 Agency for Medical Technology Assessment and Tarification (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.
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 an 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, 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 their general requirements.
The general rule on the advertising of 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 healthcare professionals (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 risks connected with its use.
E-prescriptions were introduced in Poland in 2018 as a pilot scheme. Since the beginning of 2020, traditional prescriptions have been practically withdrawn and HCPs are only allowed to issue them under specific circumstances (eg, in the case that a physician has no internet access or a prescription is issued for a foreigner without a national identification (PESEL) number).
According to Polish law, pharmacies may sell over-the-counter (OTC) pharmaceuticals online, with the exception of medicinal products that are age-restricted. 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 providers of healthcare services to record patients' medical documentation as Electronic Health Records (EHR), which in particular consist of:
Health-related data is considered to be a special category of personal data under the GDPR and so it is subject to stricter regulations – please see in particular Article 9 of the GDPR.
As to cloud platforms, there are no specific restrictions – general requirements of the GDPR apply. Therefore, before using a cloud platform, a controller should, in particular, conduct a data protection impact assessment (Article 35 of the GDPR).
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 their product for a second and subsequent use as well.
Since Poland’s accession to the EU, pharmaceuticals enjoy additional protection through obtaining a Statistical Process Control (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 their right.
Applying for a generic marketing authorisation does not infringe a patent, as it is acceptable under the Bolar provision.
According to the Industrial Property Law (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 cease the infringement, hand over any unlawfully obtained benefits and, if the infringement is culpable, also repair 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 who has a lawful interest in bringing such an 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, they may file a statement of claims that the product in question is not protected by a patent or a supplementary protection certificate (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 Act of 16 April 1993 on Combating Unfair Competition (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 March 2019, which abolished the requirement of graphic representativeness of trade marks.
According to the amendment which entered into force in March 2019, the proprietor of a trade mark does 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 international non-proprietary name (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 a 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.
When a biological medicinal product similar to a reference medicinal product does not meet requirements for a reference medicinal product equivalent, the marketing authorisation-holder is obliged to submit results of clinical or non-clinical studies for the requirements that have not been met.
On the basis of the guidelines (Q&A one regulatory expectations for medicinal products for human use during the COVID-19 pandemic)) of the European Commission, Heads of Medicines Agencies and the European Medicines Agency of 10 April 2020, an exceptional change-management process (ECMP) is made available to MAHs of crucial medicines for treatment of COVID-19 patients. The ECMP is only available for the changes in the manufacturing and/or control sites that are necessary to prevent/mitigate shortages of supplies in the EU and changes in suppliers of starting materials, reagents, intermediates or active substances where that is necessary to prevent/mitigate shortages of supplies in the EU.
In terms of Good Manufacturing Practice for key medicinal products for the treatment of patients with the COVID-19 coronavirus, the following activities were permitted:
Within the scope of Good Distribution Practice for medicinal products, the activities listed below, resulting from the pandemic status of the COVID-19 coronavirus, relating to the following aspects, are permitted:
According to the Statement of the President of the Office for Medicinal Products, Medical Devices and Biocidal Products of 19 March 2020 regarding clinical trials conducted during the pandemic, investigators, sponsors and other persons/entities involved in conducting clinical trials are advised to introduce amendments arising from the need to adapt to the epidemiological situation and to consider them as urgent safety measures (in accordance with Article 37y of the Pharmaceutical Law.)
Article 37y of the Pharmaceutical Law allows abstention from conducting a clinical trial in accordance with the applicable protocol if any event which is likely to affect the safety of the clinical trial participants occurs. The Pharmaceutical Law provision previously referred to applies only to initiated and pending trials. The sponsor shall immediately inform the President of the Office and the bioethics committee which has issued an opinion on the clinical trial about the above circumstances and the safety measures taken.
Based on the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic issued by the European Commission, sponsors should consider in their risk assessment whether the following measures could be the most appropriate during COVID-19. Measures should generally be agreed with investigators and could be: conversion of physical visits into phone or video visits, postponement or complete cancellation of visits to ensure that only strictly necessary visits are performed at sites, a temporary halt of the trial at some or all trial sites, interruption or slowing down of recruitment of new trial participants, extension of the duration of the trial, postponement of trials or of activation of sites that have not yet been initiated, etc.
New pharmaceuticals, including COVID-19 vaccines, may be authorised under a conditional marketing authorisation procedure by a decision of the European Commission, following a recommendation by the European Medicines Agency (EMA). An assessment of the quality, safety and efficacy of the pharmaceutical is carried out here exactly as is done for the approval of vaccines or medicines outside of a pandemic. Conditionality refers to the aspect of additional reporting obligations resulting from the clinical trials still in progress.
COVID-19 vaccines are conditionally authorised on the basis of all the required laboratory studies, non-clinical studies on an animal model, phase I and phase II clinical trials and periodic evaluation of ongoing clinical trials of the most advanced phase III trials. Authorisation is granted when the benefits of the vaccine being immediately available to patients outweigh the risks associated with the fact that not all data from the ongoing phase III trials are yet available. Despite the marketing authorisation decision, phase III clinical trials on the safety and efficacy of COVID-19 vaccines are still ongoing, according to the approved plan.
According to the guidelines (Q&A one regulatory expectations for medicinal products for human use during the COVID-19 pandemic)) of the European Commission, Heads of Medicines Agencies and the European Medicines Agency of 10 April 2020, Good Manufacturing Practices (GMP) certificates and authorisations to manufacture and import medicinal products issued for a limited period shall be automatically extended until the end of 2021 - without any additional action by the authorised persons. For manufacturing sites located outside the EEA, the automatic extension of the validity of certificates and authorisations does not apply if their issuing authority or another supervisory authority takes any action affecting their validity. Also, Good Distribution Practices (GDP) certificates and medicinal products wholesale authorisations issued for a limited period are subject to automatic renewal until the end of 2021 - without the need for any additional action by those authorised.
According to Pharmaceutical law, the Minister of Health, based on information provided by the Chief Pharmaceutical Inspector, compiled in the Integrated System for Monitoring the Trade in Medicinal Products or other information on the availability of medicinal products, foodstuffs intended for particular nutritional uses or medical devices, having regard to trade dynamics, publishes at least once every two months, by way of a notice, a list of the medicinal products, foodstuffs intended for particular nutritional uses and medical devices the availability of which is at risk in the territory of the Republic of Poland. The export of listed products is not excluded a priori, but a specific export procedure applies (the Chief Pharmaceutical Inspector's approval is required).
Since the beginning of the COVID-19 pandemic, the Minister of Health has been issuing a series of lists covering an increasingly wide range of products whose availability is threatened. The purpose of the aforementioned publications is to ensure access to medicinal products and medical devices to patients in Poland.
COVID-19 has accelerated the implementation of certain telemedicine solutions in the Polish health system. Paragraph 7 of the COVID-19 Act describes in detail the rules for the provision of healthcare services by the use of phone advice (using the Central TC Advice System provided by the central system CSIOZ). The use of electronic medical check-ups, due to the risk of coronavirus infection, is recommended by the Ministry of Health, the National Health Fund and the Patient Ombudsman, among others. It is possible to issue prescriptions, referrals, sick leaves and orders for the supply of medical devices in electronic form.
The COVID-19 vaccination process and its monitoring is based on IT systems, ie, the P1 central system covering e-referral for vaccination, vaccination e-Cards and e-registration integrated with work schedules of vaccination centres. The system handles the distribution of vaccines (vaccination chain from the manufacturer to vaccination centres).
The Polish government has not announced any intention to issue compulsory licences for COVID-19-related treatments or vaccines so far.
On the basis of the COVID-19 Act during a declared state of epidemic emergency or a state of epidemic, healthcare professionals who, in the course of providing health services relating to the diagnosis or treatment of COVID-19 and acting in special circumstances, committed a medical malpractice, shall not be held criminally liable, unless the effect caused was due to gross negligence under the circumstances.
However, the exclusion of liability applies only to cases of providing healthcare services as part of the diagnosis or treatment of COVID-19. This regulation excludes from the "protected" group all other diagnostic and therapeutic activities that are not related to the infection of the patient with SARS-CoV-2.
The provisions of the Building Law, the Act on Planning and Spatial Development and the Act on the Protection and Care of Monuments do not apply to the design, construction, reconstruction, renovation, maintenance and demolition of buildings, including the change of use, in connection with COVID-19.
For the purposes of facilities related to the prevention of COVID-19, neither a decision on conditions of development and land use (even if there is no local zoning plan for the property), nor a building permit, nor an occupancy permit need be obtained.
This solution is intended to accelerate the construction process, which in practice takes several months which cannot be afforded in the current situation.
Although there are no specific changes to the system of public procurement of medicines and medical devices due to COVID-19, the COVID-19 Act stipulates that the provisions of the Public Procurement Law shall not apply to procurements of goods or services which are necessary to prevent COVID-19 if there is a high probability of the rapid and uncontrolled spread of the disease or if the protection of public health so requires. As a result, in this situation, the public procurement process becomes less formalised.