An insight into regulatory, pricing and reimbursement overview in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

 

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

The President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych oraz Produktów Biobójczych – “URPL”, http://www.urpl.gov.pl/pl) is the Polish authority competent in matters regarding the placing of medicinal products (including biologicals) and medical devices on the market. It is also responsible for matters regarding registration/notification procedures, clinical trials, pharmacovigilance and the safety of medical devices.

The Chief Pharmaceutical Inspector (Główny Inspektor Farmaceutyczny – “GIF”, https://www.gov.pl/web/gif) has jurisdiction over certain issues related to medicinal products for human use and veterinary medicinal products use (e.g. manufacturing, import, distribution, advertising and promotion thereof). GIF has also jurisdiction over certain issues related to veterinary medicinal products.

The Chief Veterinary Officer (Główny Inspektor Weterynarii – “GIW”, https://www.wetgiw.gov.pl/) has jurisdiction over certain issues related to veterinary medicinal products, including the distribution, advertising and promotion thereof.

The Minister of Health (Minister Zdrowia, https://www.gov.pl/web/zdrowie) is generally responsible for public health-related matters and has certain powers in relation to medicinal products and medical devices (e.g., with regard to reimbursement).

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

a) Authorization

Pharmaceutical Law of 6 September 2001 (“Pharmaceutical Law”), as well as a number of supplementary laws thereto, regulate the domestic market authorizations of medicinal products, including biologicals. At the EU level, Directive 2001/83/EC, implemented by the Polish Pharmaceutical Law, and Regulation (EC) 726/2004 set forth the main regulatory framework for the authorization of medicinal products, while Regulation (EU) 2019/6 set main regulatory framework for the veterinary medicinal products.

Act of 7 April 2022 on Medical Devices (“Act on Medical Devices“), as well as a number of supplementary laws thereto, establish the main regulatory framework for the marketing of medical devices in Poland. At the EU level, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices set forth main regulatory framework.

b) Pricing and reimbursement

The pricing of medicinal products and medical devices is not subject to regulation, unless a product is reimbursed (partially or fully) from the state budget. The legal framework for the reimbursement of both medicinal products and medical devices from the state budget is set forth in the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Use, and Medical Devices (“Reimbursement Act”).

A medicinal product is reimbursed on the basis of a decision of the Ministry of Health issued in proceedings initiated by a pharmaceutical company submitting a reimbursement application form. The price of a product is negotiated by the applicant with a special unit of the Ministry of Health. The negotiated price of the product and other terms of reimbursement are set forth in the decision of the Ministry of Health. The price is fixed at a specific amount, with the exception of sales to the hospitals, where a maximum price is fixed. Additionally, risk-sharing schemes may be applied to reimbursed products (e.g., special terms of sale to hospitals), but in contrast to fixed prices, they are not made public.

There are four levels of reimbursement for medicinal products: free-of-charge, lump sum, and co-payment levels of 50% and 30% of the financing limit. A fixed wholesale margin (5%) is applied to reimbursed products and the margin for pharmacies is strictly regulated in the Reimbursement Act.

Medical devices are reimbursed in one of two ways: within the framework for medicinal products as described above (tablets, dressings, gels, etc.) or within the completely different reimbursement model for so-called medical devices provided on prescription (wheelchairs, diapers, CPAP devices, etc.). The Regulation of the Ministry of Health of 29 May 2017 on the list of medical devices provided on prescription sets forth the types of medical devices that are reimbursed in this model, their characteristics, and the limits of their financing from the state budget. Only the type of device and the characteristics are specified, not the manufacturer or trade name. No application or individual decision of any public authority is required to have a product from the list reimbursed. The devices are reimbursed if they satisfy the criteria set forth in the above-mentioned regulation and are prescribed for and bought at a special medical store by a patient who has received confirmation of the prescription from the National Health Fund. Their prices are not fixed, but state financing is limited to a certain amount.

 

3. What are the steps to obtaining authorization to develop, test, and market a product?

A new medicinal product may be placed on the market once it has obtained a marketing authorization from either the URPL or the European Commission. In order to obtain a marketing authorization, the pharmaceutical company in question has to gather quality, safety and efficacy data, which will be included in a dossier of the product. Depending on the character of the medicine (innovative vs generic), the above-mentioned data may be collected in pre-clinical and clinical trials, or a reference may be made to the dossier of another, already registered, medicine. Clinical trials are regulated in the Pharmaceutical Law and the Regulation of Ministry of Health of 2 May 2012 on Good Clinical Practice. Pre-clinical trials are not regulated.

Medical devices do not require any authorization for them to be placed on the market. However, the URPL must be notified in (among others) the following situations:

• at least 14 days before the first device is placed on the market by the manufacturer or its authorized representative residing or established in Poland;
• within 7 days of the date on which the first product is placed on the market in Poland by the distributor or importer residing or established in Poland, which has placed the product on the market in Poland intending it to be used in Poland (not applicable to custom-made devices).

These obligations will be in force up to 1 July 2023. Then they will be replaced by the obligation of distributors to get an entry to a domestic register of distributors of medical devices that will be created under the Act on Medical Devices. Such a register will include certain information about the distributors, but also about the medical devices themselves. On the EU level it will be obligatory to provide information on the devices introduced on the EU market to the EUDAMED database (deadlines regarding coming this obligation into force will vary depending on the class of a medical devices).

Medical devices of all classes must have a CE mark in order to be placed on the market. In order for a medical device to have a CE mark, a conformity assessment procedure must be performed.

 

4. What are the approximate fees for each authorization?

It depends on the type of a medicinal product that is subject to the procedure. Basically, the fees for the market authorization of medicinal products vary between approx. EUR 5.000 – EUR 20.000. These fees may be higher or lower depending on (among other things) the type of registration procedure, number of motions that differ only in strength or form of the product etc.

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

a) Medicinal products

A marketing authorization is valid for five years. When this period ends, the marketing authorization holder (“MAH”) may apply for an extension. If no application is submitted, the marketing authorization expires.

The MAH must submit the application for the extension of the marketing authorization at least nine months before its expiry date (six months for a veterinary medicinal product). If the application is approved, the authorization is extended for an indefinite period. In justified cases, the URPL will issue a decision to extend the validity of the authorization for another five years instead of for an indefinite period.

Additionally, if the medicinal product is not placed on the market within three years of the date of obtaining the authorization, or if it is not marketed for a period of three consecutive years, the authorization expires (so-called “sunset clause”). This may be prevented by submitting a relevant application to the URPL.

 

b) Medical devices

Only notification is required – and it is valid for an indefinite period of time.

 

6. How does the authorization process differ between brandname products and generic products? Are there differences for local manufacturers versus foreign-owned

There are no differences in the authorization process for local versus foreign manufacturers – they must meet the same regulatory requirements. However, only an entity conducting business in a member state of the European Union or a member state of the European Free Trade Association (EFTA) may be granted a marketing authorization.

With regard to the authorization process, Art. 15 of the Pharmaceutical Law provides for certain benefits concerning document filing in the case of generic medicinal products. In contrast to the standard procedure (used in case of a brand-name products), the applicant may reference certain documentation, i.e. the results of non-clinical and clinical trials, without filing it together with the application. This may be done if:

• the marketing authorization holder for the reference medicinal product gave its consent to make such references or

• the reference medicinal product has been authorized in any member state of the EU for at least eight years.

In both situations, the product must be of a generic nature with respect to the reference product in order to benefit from this abridged procedure. A product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, and if the bioequivalence has been demonstrated in bioavailability studies. A generic medicinal product authorized in the way described above may not be placed on the market until ten years (or more, if this period has been extended by the authority) have elapsed from the first authorization of the reference medicinal product.

If biological medicinal products that are similar to a reference biological product, but cannot meet the definition of ‘generic’ set forth above due to differences in raw materials or in production processes in comparison with the reference product (so-called “biosimilar”), the applicant may integrate the data of the reference product referred to in its application by providing the results of appropriate pre-clinical tests or clinical trials.

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

Combinations of drugs (drug + drug and drugs + biologics) are authorized through the standard procedures for medicinal products set out in the answer to Question 3, above. According to the Pharmaceutical Law, the applicant for a fixed-dose combination medicinal product is only required to submit pre-clinical and clinical data relating to the combination, but does not need to provide data concerning each individual active substance.

Medicine-medical device combinations may be considered either as medicinal products or as medical devices. According to the Regulation (EU) 2017/745, in determining whether a product is to be considered a medical device or a medicinal product, the essential way in which the product works is decisive. A product is considered to be a medical device if it contains, as an integral part, a substance which, if used separately, would be a medicinal product and which may act on the human body as an auxiliary to the medical device. If a medical device is supposed to be used to administer the medicinal product, the provisions of the Act on Medical Devices and the Pharmaceutical Law apply to them, respectively. However, when a medical device is placed on the market in such a way that it forms with a medicinal product a single, non-separable product which is intended to be used exclusively in a given combination and which cannot be reused, the provisions of the Pharmaceutical Law apply to it and the relevant essential requirements specified in the Regulation (EU) 2017/745 apply only to the extent to which they relate to the features of a given medical device related to its safety and operation.

 

8. How is compliance with regulations monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

GIF is the authority that monitors compliance with the legal requirements pertaining to medicinal products, including compliance with the standards of Good Distribution Practice (“GDPs”) and  Good Manufacturing Practice (“GMPs”), as well as pharmacovigilance and advertising regulations. Among other things, GIF may carry out inspections at manufacturing sites, pharmaceutical warehouses and pharmacies (in principle the controlling authorities for pharmacies are the voivodeship pharmaceutical inspectors).

The URPL is the authority that monitors compliance with the regulatory regime for medical devices. It supervises the compliance of manufacturers and distributors with safety regulations and monitors whether notification obligations or new registration obligations are met. The URPL also monitors compliance with regulations on clinical trials and GCPs for medicinal products and medical devices.

Both authorities may act ex officio or upon information received from a third party e.g., competitor, patient or other. In case or suspicion of non-compliance with regulations they may initiate administrative proceedings, ask for explanations, hear witnesses etc.

As penalties for non-compliance are partially of a criminal nature, the Polish police cooperates with the competent regulatory authorities in the enforcement of pharmaceutical or medical device regulations.

 

9. What is the potential range of penalties for noncompliance?

The range of potential penalties for regulatory non-compliance is broad and includes both criminal and administrative sanctions. These are regulated in Art. 124 and subsequent articles of the Pharmaceutical Law. GIF may impose administrative financial penalties on those who do not comply with the regulations on the monitoring or distribution of medicines. Criminal sanctions such as fines, restrictions of liberty or imprisonment may be imposed on the person that manufactures and/or places medicinal products on the market without authorization, violates import, distribution and clinical trials regulations, do not comply with regulations on the advertising, etc.

Medicinal products that do not meet the relevant safety and quality requirements may be removed from the market or GIF may suspend their further distribution. Manufacturing facilities that are not compliant with the law may be shut down as a result of an inspection conducted by GIF. Marketing, wholesale and manufacturing authorizations may be withdrawn in the case of non-compliance.

Non-compliance with the regulations on medical devices may result in the imposing of administrative financial penalties. The penalties are regulated in Art. 74 and subsequent articles of the Act on Medical Devices. The URPL may issue an administrative decision prohibiting, suspending or restricting the placing of medical devices on the market, or withdrawing them from the market or from use, or undertaking a field safety corrective action (“FSCA”) or a safety note.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

There is a national public healthcare system administered by the National Health Fund (“NFZ”). Insured persons are entitled to public healthcare services aimed at maintaining health and preventing diseases and injuries, early disease detection, treatment, nursing, and the prevention and limitation of disabilities. These services are provided free of charge. To have access to public healthcare services, it is required to be registered for health insurance purposes and to pay the relevant contributions. Contributions are paid directly by the insured person or by another entity, depending on the situation (e.g. an employer pays contributions for its employees). Most Polish citizens are obligatory or voluntary payers of health insurance contributions.

People who live in Poland but are not covered by obligatory public health insurance may decide to insure themselves voluntarily to have access to the public healthcare system. If they do, they will be obliged to pay monthly contributions (currently approx. PLN 590 – or less for particular categories of people). People not living in Poland do not have access to the public healthcare system – except in the case of an emergency. Every person has a right to the emergency services. European Health Insurance Card (“EHIC”) entitles its holder, to use emergency healthcare during a temporary stay in a member state of the European Union and the European Free Trade Association including Poland, free of charge.

Private healthcare insurance companies also operate on the Polish market.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

Private healthcare providers may cooperate with the NFZ. Cooperation is based on (i) a contract for the provision of healthcare services concluded as a result of a private healthcare provider’s winning a tender organized by the NFZ or (ii) the participation of the private healthcare provider in a so-called hospital chain. Hospital chains have been functioning in Poland since 2017 and hospitals that are a part of a chain receive their funds as a lump sum for a given period (in contrast to the tender system).

Private healthcare providers may also charge the NFZ for emergency services rendered to insured persons without a contract. Emergency services are services required urgently due to a serious threat to the life or health of an insured patient.

 

12. Are prices of drugs and devices regulated and, if so, how?

Prices of drugs and devices are not regulated unless they are reimbursed from the state budget. Please see the answer to question 2, above.

 

13. How are the drugs and devices used by patients paid for? What roles do public and private payers play?

Pharmacies, pharmacy dispensaries and the specialist medical supply shops that have concluded a contract with the NFZ for the realization of prescriptions are reimbursed for the sale of medicines and medical devices dispensed on the basis of a doctor’s prescription (the whole or a part of the price is reimbursed). The rest of the price is paid by the patient, if applicable. Non-reimbursed medicines and devices bought at pharmacies or non-pharmacy outlets are paid for in full by the patients.

Healthcare providers are reimbursed for the medicinal products and medical devices used during treatment covered by the price for services provided on the basis of a contract with the NFZ. Alternatively, the NFZ reimburses the healthcare provider for the medicines used in drug programmes and chemotherapy.

Private healthcare providers that do not act on the basis of a contract with the NFZ are not reimbursed for the services, medicines and devices that they provide, and therefore the price of medicinal products and medical devices is included in the payment for the services.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

The retail sale of OTC medicinal products, except for veterinary medicinal products, can be performed by the following:

1. pharmacies,
2. pharmacy dispensaries,
3. herbal medicine shops,
4. specialist medical supply shops,
5. shops open to the public (general shops with food and cosmetics).

Medicinal products dispensed on the basis of a doctor’s prescription are available only in pharmacies and pharmacy dispensaries. Medicinal products only for hospital use are not dispensed to patients elsewhere. There are no restrictions on the place of sale of medical devices.

Non-reimbursed products are paid for in full by patients in pharmacies, pharmacy dispensaries and non-pharmacy outlets. Pharmacies and pharmacy dispensaries that have concluded a contract with the NFZ for the realization of prescriptions receive from the NFZ the full price or a part of the price of medicines and medical devices dispensed on the basis of a doctor’s prescription, and a part from the patient, if applicable. The same applies to medical devices sold on prescription at specialist medical supply shops.

The reimbursement of hospitals for the drugs and devices that they supply is carried out in two separate ways:

• A wide range of drugs are financed by the payment for the services rendered on the basis of the contract with the NFZ. For example, a healthcare provider treating a person after a stroke is required to provide him/her with all the necessary drugs as part of the price of the procedure billed.
• Certain medicines are financed in such a way that the NFZ reimburses the healthcare provider for them (e.g., drug programmes, chemotherapy). These items can be seen in the expenses for reimbursement in the NFZ’s financial plans.

Private healthcare providers that do not act on the basis of a contract with the NFZ are not reimbursed for the services, medicines and devices that they provide.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Pharmacists provide patients with information and advice on the administration and use of medicinal products and devices that they sell. Pharmacists are obliged to notify the URPL or the entity responsible for placing a medicinal product on the market about any adverse effect of that product.

In a pharmacy that is open to the public, a pharmacist must be appointed to be responsible for operating the pharmacy (”pharmacy manager”). This person can be the manager of only one pharmacy. A pharmacy manager’s duties include:

• organising work in the pharmacy, e.g., handling, dispensing, storing and identifying medicinal products and medical devices, properly preparing magistral medicines and officinal medicines, and providing information about medicines;
• notifying the URPL about any adverse reactions to a medicinal product or a medical device;
• notifying the URPL about finding that a given medicinal product does not comply with the quality requirements set for it, or any suspicion thereof;
• purchasing medicinal products only from licensed pharmaceutical wholesalers and dispensing them in accordance with the law.

A doctor is obliged to practice in accordance with current medical knowledge, methods and means of preventing, diagnosing and treating diseases, in accordance with the principles of professional ethics, and with due diligence. He/she is obliged to provide patients or their legal representative with clear information about their health condition, diagnosis, proposed and possible diagnostic and treatment methods, foreseeable consequences of their use or omission, treatment results and prognosis.

 

Also from this Legal Handbook

All legal aspects surrounding preclinical and clinical trial requirements in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

 

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, there is no requirement to conduct clinical trials locally to receive marketing approval.

 

2. How are clinical trials funded?

Clinical trials may be financed from private or public funds. Commercial clinical trials are usually sponsored by the product manufacturer (pharmaceutical company). The Medical Research Agency, established in 2019, is the public authority competent in financing non-commercial clinical trials, i.e. trials conducted by scientific bodies, universities, etc.

 

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

The protocol of a clinical trial regarding medicinal product is prepared by the study sponsor and submitted to the URPL and to the relevant ethics committee. It has to include numerous elements set forth in § 17 Sec. 1 of the Regulation of the Ministry of Health 2 May 2012 on Good Clinical Practice.

The Pharmaceutical Law follows EU law with regard to any changes made to a clinical trial protocol, i.e. it requires notifying the URPL and the ethics committee only about changes that are of a significant nature and have an impact on the safety of the clinical trial participants. There is no definition of “substantial change”/” change of a significant nature” in Polish law, nor is there a list of such changes. On its website, the URPL refers to the European Commission Guidance (CT-1) in this respect.

 

4. What are the requirements for consent by participants in clinical trials?

Participants in clinical trials of medicinal products must give their informed consent when deciding to take part in the trial. For each trial, specific consent documentation must be prepared and approved by the ethics committee. Informed consent is a written statement of intent, dated and signed, made freely by any person capable of making such statement or, where the person is not capable of making such statement, by his/her legal representative; this statement also contains a note to the effect that it was made after the person had been duly informed of the nature, significance, implications and risks of the clinical trial. If the informed consent cannot be given in writing, consent given orally in the presence of at least two witnesses will be deemed equivalent. A note must be made in the trial documentation if consent is given in this manner. Before obtaining informed consent, the investigator provides the participant of the clinical trial or his/her legal representative, in an understandable manner and without exerting any influence, in oral and written form, with certain information set forth in the Regulation of the Ministry of Health of 2 May 2012 on Good Clinical Practice (information about the aim of the trial, procedures to be used, etc.).

For the clinical trial in regard of medical devices, written informed consent is also required. This consent is given after the investigator or sub-investigator explains to the patient or his/her representative the characteristics of the clinical trial, the risks and inconveniences associated with it, the conditions under which it is to be conducted, and right to withdraw from the clinical trial at any time.

 

5. May participants in clinical trials be compensated?

Healthy patients of legal age that are able to give informed consent may receive financial incentives or other types of benefits (e.g., renumeration) for participating in the clinical trial of a medicinal product. As a rule, this applies to patients of phase I of a clinical trial, as healthy patients usually participate in this phase. All patients may be compensated for any expenses they incur. The ethics committee must be notified about any financial transactions or compensation.

In the field of clinical trials of medical devices, there should be no adverse impact, including financial impact. Incentives and financial gratification should not be used. Compensate for costs incurred and loss of earnings directly related to participation in the clinical trial is acceptable..

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

The Pharmaceutical Law and the Act on Medical Devices require the sponsor and the investigator to provide participants with insurance coverage against any damage caused to them as a result of the experimental activity in a clinical trial. The Regulation of the Ministry of Finance of 30 April 2004 on compulsory civil liability insurance of the investigator and sponsor and the Regulation of the Ministry of Finance of 6 October 2010 on compulsory civil liability insurance of the sponsor and investigator in connection with the conduct of a clinical trial of devices set forth the specific requirements of such insurance, e.g., the date when the insurance obligation arises and the minimum guarantee amount. The Regulation of the Ministry of Finance of 6 October 2010 on compulsory civil liability insurance of the sponsor and investigator in connection with the conduct of a clinical trial of devices was issued under a law that is no longer in effect. The regulation remains in effect until November 2022, hence legislative work in this regard can be expected soon.

 

Also from this Legal Handbook

All about marketing, manufacturing, packaging & labeling, advertising in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

 

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?

a) Medicinal products

Chapter 2 of the Pharmaceutical Law sets forth the rules relating to the marketing of medicinal products (including new drugs, biologics, over-the-counter medications and medicinal products in general). As a rule, medicinal products may be placed on the Polish market only if marketing authorization has been granted by the URPL or European Commission. Marketing authorizations may be granted in one of the following procedures:

• National procedure – national authorization granted by the URPL valid in Poland only;
• Mutual recognition procedure – national authorization granted by the URPL based on the recognition of a marketing authorization already issued by another member state of the European Economic Area (“EEA”);
• Decentralized procedure – national authorization granted in Poland by the URPL and one or more other EU member state in parallel if no authorization had been previously granted in the EU;
• Centralized procedure – marketing authorization granted by the European Commission based on EMA’s recommendation and valid in all EU member states as well as in the EEA. This procedure is mandatory for some medicines (e.g., medicines containing a new active substance to treat HIV, AIDS, cancer or other diseases; medicines derived from biotechnology processes such as genetic engineering) and optional for others.

 In order to receive a marketing authorization, the pharmaceutical company has to gather scientific data, which will be included in a dossier of medicinal product, and submit an application. In the case of generic products there may be made a reference to the dossier of the other, already registered, medicine (please see also answers to questions 3 and 6, on Regulatory, Pricing and Reimbursement Overview).

Traditional herbal medicinal products are subject to a simplified marketing authorization procedure. The homeopathic medicinal products:

1. which are administered orally or externally,
2. whose therapeutic indications are not given on the labelling or package leaflet,
3. which have a sufficient degree of dilution to guarantee the safety of the medicinal product, i.e., they do not contain more than l/10,000th of the mother tincture or more than l/100th of the smallest dose of an active substance contained in a medicinal product issued on prescription
   – are also subject to a simplified marketing authorization procedure.

There are no special rules for the marketing authorization process for biologics and OTC medicines.

 

b) Medical devices

Medical devices do not require any marketing authorization to be placed on the market. However, the notification to the URPL must be made – since 1 July 2023 some changes are planned in this regard (please see answer to question 3, on Regulatory, Pricing and Reimbursement Overview).

 

2. What is the authorization process for the marketing of generic versions of these products?

Generic versions of these products are subject to essentially the same authorization rules, save that certain exemptions may apply regarding the submission of documentation (please see question 6, on Regulatory, Pricing and Reimbursement Overview).

 

3. What are the typical fees for marketing approval?

Please see above (question 4, on Regulatory, Pricing and Reimbursement Overview).

 

4. What is the period of authorization and the renewal process?

Please see above (question 5, on Regulatory, Pricing and Reimbursement Overview).

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

Chapter 21 of the Pharmaceutical Law sets forth post-approval pharmacovigilance requirements. It imposes a number of pharmacovigilance obligations on the marketing authorization holder, including:

• appointing a qualified person responsible for pharmacovigilance who satisfies the requirements set forth in Pharmaceutical Law;
• recording all suspected adverse reactions;
• complying with the notification obligations towards the URPL and / or EMA concerning any suspected serious adverse reaction;
• presenting studies on the benefit-risk balance of the use of the medicinal product;
• notifying the URPL of the need to make immediate changes to the Summary of Product Characteristics
  – and others.

The URPL is the authority competent in regard of the post-approval pharmacovigilance. Its obligations include:

• collecting reports of individual cases of adverse reactions from healthcare professionals, patients and their representatives;
• collecting and analysing documents relating to the safety of medicinal products, in particular studies on the safety of post-authorization studies, periodic safety reports on medicinal products, risk management plans for medicinal products and other studies on the safety of medicinal products;
• issuing safety information for a medicinal product, intended for and addressed directly to medical professionals or the general public – and others.

 

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations are not recognized in Poland. However, under a mutual recognition procedure it is possible to obtain a marketing authorization in Poland on the basis of an authorization granted in another EEA country. There is no similar procedure for recognizing marketing authorizations issued by countries outside the EEA.

 

7. Is parallel import of medicines or devices allowed?

Medicinal products subject to parallel import for which a parallel import authorization has been obtained can also be approved for sale. Parallel import of medicinal product is understood as any activity involving bringing in from member states of the European Union and member states of the European Free Trade Association (EFTA) – parties to the Agreement on the European Economic Area, a medicinal product that meets all the following conditions:

1. the imported medicinal product has the same active substance (active substances), at least: the same features for the 3rd level of the ATC/ATCvet code (Anatomical Therapeutic Chemical Classification Code), the same strength, the same route of administration and the same form as a medicinal product approved for sale in the territory of the Republic of Poland or a similar form that does not give rise to therapeutic differences in relation to the medicinal product approved for sale in the territory of the Republic of Poland,
2. the imported medicinal product and the medicinal product approved for sale in the territory of the Republic of Poland are also either reference medicinal products or equivalents of reference medicinal products in the state from which the product is imported and in the Republic of Poland respectively

Parallel import of medical devices is not regulated under Polish law.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Under the Pharmaceutical Law it is prohibited to advertise medicinal products HCPs by giving  gifts, making offers and promising material benefits, handing in presents and other inducements, prizes, offering trips and  organizing and financing meetings to promote medicinal products during which hospitality exceeds the main purpose of the meeting. Accepting the benefits referred to above is prohibited.

The above-mentioned prohibitions do not apply to gifts that meet the following conditions:

• their value does not exceed PLN 100 (gross value),
• they are related to medical or pharmaceutical practice,
• they bear the mark advertising the specific company or medicinal product.

The Polish Act on Reimbursement prohibits entities that manufacture or sell reimbursed medications, foodstuffs intended for particular nutritional uses or medical devices from providing material or personal benefits to HCPs and patients. It is commonly understood that this prohibition does not apply to the advertising tools allowed by the Polish Pharmaceutical Law (e.g. giving gifts in observance of the standards set forth in the Pharmaceutical Law, giving samples, sponsoring HCPs to attend conferences, etc.).

Pursuant to the Polish Criminal Code, it is not permitted to provide or promise any material or personal benefit to HCPs performing public functions if the benefit is provided or promised in relation to performing their function (i.e., in relation to spending public funds or exercising public powers).

Interactions between pharmaceutical companies and healthcare organizations/professionals are also subject to voluntary self-regulation codes e.g., Code of Good Practices for the Pharmaceutical Industry prepared by INFARMA that is based on the Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA).  With regard to medical devices the most relevant ethical code is the MedTech Code.

As of 1 January 2023, Chapter 12 of the Act on Medical Devices, which deals with advertising, will come into force. It covers e.g., sponsorship of exhibitions, shows, presentations, conferences, conventions and scientific congresses.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

a) Medicinal products

Manufacturing of medicines is regulated in Chapter 3 of the Pharmaceutical Law. The manufacturing of medicinal products requires an authorization from GIF. GIF enters the information on issued authorizations for the manufacture of a medicinal product into the European EudraGMDP database. GIF is also the competent authority for compliance with all applicable requirements and inspects the manufacturing sites.

In order to receive a manufacturing authorization it is required to submit an application and undergo an inspection conducted by GIF. Marketing authorization may be granted if an applicant:

• has appropriate premises as well as equipment necessary for the manufacture or import, inspection and storage of medicinal products;
• employs a Qualified Person that meets the criteria set forth in the law.

The manufacturer of medicinal products is subject to numerous obligations and, among others, is obliged to abide by GMPs.

 

b) Medical devices

The manufacturing of medical devices does not require a formal authorization under Polish law. However, the manufacturer of medical devices, its authorized representative or importer that has its registered seat on the territory of Poland has to register itself (using a unique registration number). When the regulations on the register of distributors come into force – the list will have to indicate certain information about the product. URPL will supervise the process.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?

The Pharmaceutical Law expressly requires the manufacturer to comply with the standards of good manufacturing practice for medicinal products that are set forth in the Polish secondary legislation and mirror EU GMPs. Polish medical device laws do not expressly require compliance with GMPs.

 

11. What is the inspection regime for manufacturing facilities?

a) Medicinal products

GIF is the authority competent in regard of monitoring compliance in manufacturing facilities. GIF can carry out inspections, whether ex officio or at manufacturer’s request, at production sites.

When carrying out an inspection, GIF, within periods not exceeding 3 years, verifies whether the manufacturer of the medicinal product meets the obligations under the Pharmaceutical Law and GMPs. The manufacturer of the medicinal product has to be informed of the date of commencement of the inspection at least 30 days prior to the planned date of the inspection. It is also possible for GIF to conduct ad hoc inspection if there are serious doubts as to the quality and safety of products. Inspection results in preparing a compliance report.

GIF, by way of a decision, may suspend the manufacture or import of a medicinal product completely or until the deficiencies identified in the report are remedied. If the results of the inspection confirm that the manufacturer of a medicinal product meets the GMPs requirements, GIF issues, within 90 days from the date of completion of the inspection, a certificate confirming the compliance of the manufacturing or import conditions of the medicinal product with the GMPs requirements. GIF immediately introduces information on the issuance of the certificate to the European EudraGMDP database.

 

b) Medical devices

According to the Act on Medical devices URPL may conduct inspections at the premises of the manufacturer. Inspectors may in particular:

1. check the production and storage rooms and their equipment;
2. demand that the samples necessary for testing and verification of the product be made available.

Inspection results in preparing a compliance report.

URPL may, in order to protect the life, health or safety of patients, users or other persons or to counteract a threat to health, safety or public order, may, in relation to a product or group of products, issue an administrative decision to subject to specific requirements, prohibit, withhold or limit the introduction of placing on the market, putting into service, putting into service or using these devices, withdrawing them from the market or from use, or undertaking to undertake an FSCA or issue a safety notice.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Inspections at production sites for medicinal products can only be performed by GIF with or without the support of duly appointed third parties. However, inspections may also be carried out upon request from the European Commission, EMA or an EU member state.

The FDA also can carry out inspections in the EU. However, in November 2017, a Mutual Recognition Agreement (MRA) on GMP inspections between the EU and FDA came into effect, with a transitional phase until July 2019 during which the FDA has been conducting capability assessments of the national regulatory authorities in each EU member state on a rolling basis. Polish authority is now recognised as competent by the FDA. It means that FDA should rather avoid duplication of inspecting Polish manufacturers.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Regulation of Ministry of Health of 13 March 2015 on the requirements of Good Distribution Practice and Regulation of Ministry of Health of 3 December 2015 on the requirements of Good Distribution Practice of active substances (“GDPs”) provides for guidelines on the proper storing, packaging and handling of medicinal products and their active substances in wholesale trade. The manufacturer must comply with the requirements set forth therein and is required to perform quality checks and keep proper records of the results therein. There are no GDPs for storage, packaging and handling of devices.

Requirements for storage and handling of medicines and devices in a pharmacy are set forth in the Regulation of the Minister of Health of 18 October 2002 on the basic conditions for running a pharmacy. According to it medicinal products and medical devices must be stored carefully and protected against dust, dirt and damage; stored medicinal products and medical devices must not come into direct contact with the walls and floors of the storage area. Rooms in which medicinal products and medical devices are stored must be clean, dry, adequately ventilated, and medicinal products and medical devices must be protected against sunlight. Pharmacy must keep the proper records regarding the prepared / stored / handled / destroyed products.

 

14. What information must be included in medicine and device labelling?

a) Medicinal products

Requirements for medicines labelling are set forth in the Regulation of the Minister of Health of 20 February 2009 on the requirements for labelling the medicinal product packaging and the content of the leaflet. The outer packaging of the medicinal product, and if the product has no outer packaging, the direct packaging, must include the following information:

1. in this order:

a) the name of the medicinal product and the common name of the active substance, if the product contains only one active substance; if the product contains two or three active substances, the common names of all these substances shall be provided, separated by the “+” sign,
b) the strength of the medicinal product, if the medicinal product contains only one active substance; if the product contains two or three active substances, the strength of the product should be given for each of these substances, separated by the “+” sign,
c) specification of the pharmaceutical form,
d) information whether the product is intended for infants, children or adults, if applicable,
e) specification of the size of the package, indicating the weight, volume or number of dosage units of the medicinal product,

2. content of active substances defined qualitatively and quantitatively per dosage unit, volume or weight, using commonly used names,

3. a list of excipients with recognized action and effect, specified pursuant to art. 65 of Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Journal of Laws EC L 311 of 28 November 2001, p. 67, as amended) d .; Official Journal of the EU, Polish special edition, chapter. 13, vol. 27, p. 69, as amended), and in the case of parenteral, topical and ophthalmic medicinal products – a list of all excipients,

4. the method of use and, if necessary, the route of administration,

5. warning about keeping out of the reach and sight of children,

6. warnings regarding the place and method of storage, if any,

7. other special warnings, if necessary,

8. the category of availability,

9. expiry date (month and year), and for ready-made drugs that require special treatment immediately before their use – also, if necessary due to the properties of the medicinal product, the shelf life after the drug has been brought into a suitable form for use,

10. special precautions that should be observed during the disposal of an unused medicinal product or waste derived from medicinal products, if any,

11. name and address of the responsible entity and, if applicable, name and address of the representative of the responsible entity,

12. marketing authorization number,

13. batch number,

14. instructions for use, if the medicinal product is dispensed without a doctor’s prescription,

15. EAN UCC barcode,

a) in the case of the medicinal product referred to in Art. 54a paragraph. 1 of Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, the security features,

16. in the case of a traditional herbal medicinal product:

a) information that its indication is based solely on long-term use,
b) recommendation that the user should consult a doctor if the symptoms persist while using the product or if there are side effects not listed in the leaflet.

The outer packaging, and if the product does not have an outer packaging the direct packaging, must contain the following information in Braille:

1. name of the medicinal product;

2. the strength of the medicinal product, if the product is available in several strengths;

3. pharmaceutical form, if the product is available in several forms.

Regulation also sets froth mandatory information that should be included on the blisters and other inner packaging of medicinal products as well as on packaging of the homeopathic medicinal products.

 

b) Medical devices

CE mark must be placed on the medical device or on the labelling of the medical device. The CE mark must be affixed in such a way as to be visible, legible and indelible. If this is impossible or unreasonable due to the nature of the product, the CE marking shall be affixed to the packaging.

CE marking shall also be affixed to instructions for use and sales packaging.

There are also many rules regulating certain mandatory disclosures and indications, including the language to be used, which must be affixed to the packaging, depending on the type of the product. General requirements for product labelling are indicated in Annex I to the Regulation (EU) 2017/745.

 

15. What additional information may be included in labelling and packaging?

a) Medicinal products

Symbols or pictograms may be placed on the outer packaging and in the leaflet, in order to make the mandatory information clearer. Additional information may be placed on the medicinal product, consistent with the data contained in the Summary of Product Characteristics, if useful for health promotion purposes and does not contain advertising elements. The symbols or pictograms placed must be approved in the process of authorizing the medicinal product to market.

 

b) Medical devices

No specific regulations in this regard.

 

16. What items may not be included in labelling and packaging?

Packaging of a medicinal product may not include advertising elements and items that ae not approved in the process of authorizing the marketing of the medicinal product. Labelling and packaging of any products may not be misleading.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

a) Medicinal products

Advertising of medicinal products is regulated in the Chapter 4 of the Pharmaceutical Law and the Regulation of the Minister of Health of 21 November 2008 on advertising of medicinal products.

In a nutshell, Pharmaceutical Law provides for a broad definition of “advertising of medicinal products” which includes activities consisting in informing or encouraging the use of a medicinal product, aimed at increasing: the number of prescribed prescriptions, the supply, sale or consumption of medicinal products. Advertising of a medicinal product may be carried out only by or on behalf of the MAH.

The advertising of medicinal products, may consist in particular of:

1. advertising a medicinal product to the public;
2. advertising of a medicinal product addressed to persons authorized to issue prescriptions or persons trading in medicinal products (HCPs);
3. visiting HCPs through sales or medical representatives;
4. providing samples of medicinal products;
5. sponsoring promotional meetings for HCPs;
6. sponsoring conferences, conventions and scientific congresses for HCPs.

The following are not considered advertising of medicinal products:

1. information on the packaging and attached to the packaging of medicinal products in accordance with the marketing authorization;
2. correspondence accompanied by non-promotional information materials necessary to answer questions about a specific medicinal product;
3. non-public informational notices regarding, in particular, packaging changes, warnings about adverse effects, provided that they do not contain content relating to the properties of medicinal products;
4. commercial catalogues or price lists containing only the proper name, commonly used name, dose, form and price of a medicinal product, and in the case of a medicinal product covered by the refund – the official retail price, provided that they do not contain content relating to the properties of medicinal products, including therapeutic indications;
5. information concerning human and animal health or diseases, provided that they do not even indirectly refer to medicinal products.

Advertising of a medicinal product must not:

• be misleading, it should present the medicinal product objectively and inform about its rational use.
• consist in offering or promising any benefits directly or indirectly in return for the purchase of the medicinal product or providing evidence that it has been purchased.
• be directed to children or contain any element that is directed at them.

There are numerous rules on mandatory content of the advertising of medicinal products (traditional and herbal) directed at the general public and at HCPs, which are set forth in the Regulation on advertising medicinal products referred to above.

Advertising of a medicinal product that is a reminder of full advertising, apart from its proper name and commonly used name, may only contain a trademark not containing references to therapeutic indications, pharmaceutical form, dosage, advertising slogans or other advertising content.

It is forbidden to advertise to the public medicinal products:

1. dispensed only on the basis of a prescription;
2. containing narcotic drugs and psychotropic substances;
3. included in the lists of reimbursed drugs, in accordance with separate regulations, and admitted to be dispensed without prescriptions, with the name identical to that on these lists.

Advertising of a medicinal product to the public may not consist of:

1. presenting a medicinal product by people known to the public, scientists, persons with medical or pharmaceutical education, or persons suggesting such education;
2. referring to the recommendations of people known to the public, scientists, people with medical or pharmaceutical education or suggesting such education.

Advertising of a medicinal product to the public may not contain content that:

1. suggest that:

a. it is possible to avoid medical advice or surgery, especially by making a diagnosis or prescribing treatment by correspondence,
b. even a healthy person taking the medicinal product will improve their health,
c. not taking the medicinal product may aggravate the state of health of the person;
d. the medicinal product is a food, cosmetic or other consumer product,
e. the efficacy or safety of the medicinal product is due to its natural origin;

2. ensure that taking the medicinal product guarantees the proper effect, is not accompanied by any side effects or that the effect is better or the same as in the case of another method of treatment or treatment with another medicinal product;

3. may lead to erroneous self-diagnosis by citing detailed descriptions of cases and symptoms of the disease;

a. refer in an inappropriate, disturbing or misleading form to the therapeutic indications;

4. they contain inappropriate, disturbing or misleading definitions of graphically presented lesions, injuries of the human body or effects of a medicinal product on the human body or its parts.

Please see above also answer to question 8, in regard of incentives and self-regulation of advertising.

 

b) Medical devices

Advertising of medical devices can’t be misleading. There are no other specific rules on advertising of medical devices, however general rules on advertising apply. What is more, as of 1 January 2023, advertising of medical devices will be regulated in greater detail in the Act on Medical Devices. Advertising directed to the public will have to be worded in a way that can be understood by a lay person. Ads will not be allowed to use the image of medical professionals, or to encourage children to purchase a product or persuade their parents to buy them advertised products. It has also been specified that advertising of a product can only be carried out by a business entity. Provision has been made for permissible forms of advertising. The regulations also specify the consequences of finding violations of the advertising law.

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

a) Medicinal products

Please see above answer to question 14, on Regulatory, Pricing and Reimbursement Overview). The retail sale of OTC medicinal products can be carried on by the following:

1. pharmacies,
2. pharmacy dispensaries,
3. herbal medicine shops,
4. specialist medical supply shops,
5. shops open to the public (general shops).

Mail-order sales of medicinal products dispensed without medical prescription (OTC) by pharmacies and pharmacy dispensaries are allowed, with the exception of medicinal products dispensing of which is limited by the patient’s age.

 

b) Medical devices

There are no restrictions on channels / ways of sale and delivery of medical devices. They may be sold and delivered also via post. The rules for the distance sale of medical devices are regulated in the Regulation (EU) 2017/745.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?

The same restrictions and requirements apply as are discussed in the answers to the above Questions. Additionally, the requirements for electronic marketing stemming from the general provisions of law apply (applicable to all types of products, not only health-related).

 

20. May medicines and devices be advertised or sold directly to consumers?

a) Medicinal products

Please see answer to question 17, in regard of advertising medicinal products directly to consumers (to the public). As regards sale directly to consumers, there are various categories of availability of medicinal products in Poland – certain medicines are available only for hospital use and others are available to patients, without prescription or only on prescription. Medicinal products released onto the market are classified in one of the following availability categories:

1. dispensed without a doctor’s prescription – OTC;
2. dispensed on a doctor’s prescription – (Polish abbreviation – Rp);
3. dispensed on a doctor’s prescription for restricted use – (Polish abbreviation – Rpz);
4. dispensed on a doctor’s prescription containing narcotic drugs or psychotropic substances specified in separate regulations – (Polish abbreviation – Rpw);
5. only for hospital use – (Polish abbreviation – Lz).

Only the medicinal products indicated in points 1-4 may be sold directly to

 

b) Medical devices

Medical devices may be sold and advertised directly to consumers provided that generally applicable rules on sale and advertising of medical devices are met.

 

21. How is compliance monitored?

Compliance with sales and advertising regulations is monitored, and infringements prosecuted, by GIF in relation to medicinal products and URPL in relation to medical devices. As some penalties are of criminal nature also criminal authorities are competent in case of non-compliance for both types of products.

Due to the fact that many companies are members of industry associations the infringements of the ethical codes are often subject to proceedings initiated by a competitor before private courts of these associations.

 

22. What are the potential penalties for noncompliance?

In case of medicinal products penalties for non-compliance with sales and advertising regulations are of financial character (administrative financial penalty or criminal fine) or personal character (restriction of liberty, imprisonment). Non-compliance may also result in decision of GIF on prohibition to disseminate an advertisement or on withdrawal of the pharmacy license.

Non-compliance with the regulations on medical devices may be punished by administrative financial penalty. If there is a need to protect the life, health or safety of patients, it may also result in decision of URPL on obligation to abide by specific requirements, prohibition, suspension or restriction on placing on the market, putting into service or using these devices, withdrawing them from the market or from use, or undertaking an FSCA or issuance of a safety notice.

 

Also from this Legal Handbook

The legal framework for traditional medicines and OTC products in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

 

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Pharmaceutical Law provides for a simplified procedure for the marketing authorization of herbal medicinal products, provided that they meet criteria for traditional herbal medicinal products:

1. they have indications exclusively appropriate for traditional herbal medicinal products and, by virtue of their composition and purpose, can be used without the supervision of a doctor for medicinal, diagnostic or treatment monitoring purposes and meet the criteria of a medicinal product dispensed without a doctor’s prescription;
2. they are exclusively for administration in accordance with a specified strength and posology;
3. they are intended exclusively for oral, external or inhalation use;
4. they were in traditional use in the period specified by the law (thirty-years period of traditional use, including at least fifteen years within the EU);
5. the data on their traditional use are sufficient; in particular the product proves not to be harmful when used in accordance with the method referred to in point 2 and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.

The simplified nature of this procedure consists in limiting the obligation for such medicines to submit, as part of the registration application, documentation of study results to abstracts and pharmaceutical study reports (physicochemical, biological or microbiological), while excluding the obligation to submit documentation from clinical and non-clinical studies (pharmacological and toxicological).

Under Pharmaceutical Law the homeopathic medicines:

1. which are administered orally or externally,
2. whose therapeutic indications are not given on the labelling or package leaflet,
3. which have a sufficient degree of dilution to guarantee the safety of the medicinal product, i.e. they do not contain more than l/10,000th of the mother tincture or more than l/100th of the smallest dose of an active substance contained in a medicinal product issued on prescription
   – are also subject to a simplified marketing authorization procedure. This procedure limits the scope of data that needs to be submitted in the application.

 

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Generally, advertising for such medicinal products is subject to the same legal provisions (in particular as laid down in the Pharmaceutical Law) like advertising for regular medicinal products (see the answer to question 17, on Marketing, Manufacturing, Packaging and Labeling Advertising). Advertisements for traditional herbal medicines must include the statement: “Traditional herbal medicinal product with specific indications resulting only from long-term use”.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Please see above the answers to questions 2 above, and question 17, on Marketing, Manufacturing, Packaging and Labeling Advertising).

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

OTC medicinal products follow the same procedural paths for authorization generally provided for other medicinal products (see under questions 2 and 3, on Regulatory, Pricing and Reimbursement Overview and questions 1 and 2, on Marketing, Manufacturing, Packaging and Labeling Advertising).

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

OTC medicinal products can be sold by both pharmacies and certain non-pharmacies outlets (please see under question 14, on Regulatory, Pricing and Reimbursement Overview)

 

6. What health, advertising, and marketing claims may be made for OTC products?

Advertising of medicinal products, including OTC, is governed by specific provisions in the Pharmaceutical Law (for further details, please see the answer to question 17, on Marketing, Manufacturing, Packaging and Labeling Advertising).

 

7. Can OTC products be marketed or advertised directly to the public?

OTC products can be marketed and advertised directly to the public provided that the requirements for such activities are met (please see under question 17, on Marketing, Manufacturing, Packaging and Labeling Advertising).

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

There are several categories of availability of medicinal products, but the main distinction is between medicinal products dispensed on doctor’s prescription and non-prescription medicinal products (OTC). Category of availability of each medicinal product is indicated in its marketing authorization. Criteria for classification of medicinal products into a particular availability category are set forth in the Regulation of the Ministry of Health 14 November 2008 on the criteria for classifying a medicinal product into availability categories.

Medicinal products from the one availability category may be converted into another category upon assessment of the URPL. Where an application for a change of the availability category is based on reference to the results of clinical and non-clinical trials previously conducted for another drug by another marketing authorization holder, which obtained a change of the availability category on their basis, the application is suspended until one year from the first decision to change the availability category on the basis of these studies.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Import of traditional medicines and OTCs must comply with the same requirements generally provided for imports of medicinal products.

Import of medicinal products is defined as any activity involving bringing in a ready-to-use medicinal product from outside member states of the European Union and member states of the European Free Trade Association (EFTA) – parties to the Agreement on the European Economic Area, including storage, quality control on batch release and distribution. Importation of medicinal product requires obtaining a proper import authorization accordingly to Art. 40 of the Pharmaceutical Law. As a rule, only authorised medicinal products may be imported.

There are certain exception from the rule that only authorized medicines may be imported, namely:

• It is possible import of a medicine not-authorized in Poland for an individual patient from a foreign country at which this medicine is authorized. In a nutshell, the product is imported by the wholesaler at a hospital’s or doctor’s request, approved by the Health Consultant and the Minister of Health, and delivered to a hospital pharmacy or retail pharmacy;
• The Minister of Health, and as regards veterinary medicinal products, on the request of the Minister of Agriculture, may, in the event of a natural disaster or other danger to human or animal life and health, approve for sale for a specified term medicinal products that are not authorised.
• The Minister of Health, and as regards veterinary medicinal products, on the request of the Minister of Agriculture, may, in the event of a natural disaster or other danger to human or animal life and health, consent to the import, of a medicinal product that at the same time:

• • has the marketing authorization in Poland,
  • is approved for sale in the state from which it is imported,
  • is not available on the territory of the Republic of Poland
    – on condition that a medicinal product having the same active substance(s) and the same strength and form as the imported medicinal product is not available on the territory of the Republic of Poland.

For requirement for parallel import of the medicinal products please see answer to question 7, on Marketing, Manufacturing, Packaging and Labeling Advertising).

Also from this Legal Handbook

The legal framework for product liability in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

 

1. What types of liability are recognized in your jurisdiction?

Under Polish law, the following types of liability are recognized:

• criminal liability;
• administrative liability;
• civil liability for breach of contract or torts.

The injured party may seek compensation for damage before a civil law court. Furthermore, the Polish Civil Code provides for a specific type of tort liability that entitles the injured party to compensation from the manufacturer for damage incurred as a result of a defective product (so-called product liability). Theoretically, compensation may also be sought during criminal proceedings.

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Manufacturers of medicines and devices may be subject to civil liability of a contractual or tortious nature as well as criminal liability, depending on the type of violation.

Generally, product liability under the Polish Civil Code (Art. 4491 and subsequent articles) is the most relevant type of liability for manufacturers. This type of liability applies to:

• a person who produces an unsafe product within the scope of its economic activity,
• the manufacturer of the material, raw material or component part of an unsafe product,
• the importer of an unsafe product into the EU,
• a person that presents itself as the manufacturer of the unsafe product by putting its name, trademark or some other distinguishing feature on it.

The manufacturer is liable under this regime for damage caused by a product which does not ensure the level of safety which one may expect taking into account the ordinary use of the product.

Criminal liability applies to natural persons, not corporate entities. Only in the case of certain offences listed in the Act of 28 October 2002 on the Criminal Liability of Collective Entities for Punishable Offences may the corporate entity be held liable. This list includes the manufacturing of a medicinal product and placing it on the market without the proper authorization.

 

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Liability for defective/unsafe products on civil grounds applies to manufacturers that are legal entities. Civil liability does not extend to corporate executives, representatives or employees. In certain situations, the manufacturer may seek compensation from the natural person (e.g., employee) for the defect that caused the manufacturer’s liability towards a third person.

In contrast, criminal liability caused by defective products, as a rule, only applies to natural persons. Only in certain exceptional situations may a corporate entity be held criminally liable. In such an event, the relevant board member or employee of the manufacturer will be prosecuted, instead of the company itself, for criminal offences caused by the defective/unsafe product.

 

4. How can a liability claim be brought?

A liability claim can be brought by way of a regular lawsuit in civil proceedings before a court. In the case of criminal liability, the criminal law authorities may initiate proceedings ex officio or upon request.

 

5. What defences are available?

The basic defence strategy is to disprove the following:

• the defect in the product and/or
• the alleged damage and/or
• the causal link between the defect and the damage.

When it comes to the product liability of a civil nature, manufacturers can substantiate that they are not responsible by proving the circumstances set forth in Article 4491 and subsequent articles of the Civil Code. These circumstances include the following:

• the manufacturer did not place the product on market;
• the defect in the product did not exist at the time the product was placed on market;
• the state of scientific and technical knowledge at the time the product was placed on the market could not have established that the product was defective;
• in the case of manufacturers of components or raw materials, that the defect was entirely caused by (i) the design of the product in which the components or raw materials were included or (ii) the manufacturer’s instructions.

Also from this Legal Handbook

All legal aspects surrounding patents & trademarks in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

1. What are the basic requirements to obtain patent and trademark protection?

1.1. Patents

An invention (which is patentable) is a new (on a global scale) solution of a technical nature, characterized by a degree of inventiveness (not obvious in prior art), and suitable for industrial application (if, on the basis of the invention a product can be made or a method can be implemented, in any industrial activity, including agriculture).

There are four categories of inventions:

• products,
• devices,
• methods,
• applications.

Biotechnological inventions are a special type of invention. A biotechnological invention is an invention relating to a product consisting of or containing a biological material or a method by which a biological material is produced, processed or used. Biotechnological inventions for which patents may be granted are, in particular, inventions: 1) constituting a biological material that is isolated from its natural environment or made by technical means, even if it has previously been found in nature; 2) constituting an element isolated from the human body or otherwise produced by technical means, including the sequence or a partial gene sequence, even if the structure of that element is identical to that of the natural element; 3) concerning plants or animals, if the technical possibilities of using the invention are not limited to a particular plant variety or breed of animal.

A patent lasts for 20 years from the application date. In the case of patents referring to pharmaceutical products and plant protection products, protection for the product implementing a particular solution might be extended up to 25 years by acquiring a Supplementary Protection Certificate (SPC).

An SPC is granted, among other things, for medicinal products. This is a subjective, erga omnes right, separate from the patent, which can be traded as an element of property and business. An additional protection right is granted based on the patent remaining in force, and the term of protection may not exceed five years (with the exception of paediatric medicinal products, for which protection can be extended for a further six months).

SPCs are subject to the same restrictions as the basic patent, upon the expiry of which supplementary protection arises. Like patent exclusivity, protection under an SPC is territorial.

The subject of the SPC has the same rights as those granted for the patent. The scope of protection resulting from an SPC may be narrower or the same as that resulting from the patent – but not wider. In the event of obtaining an additional protection right based on a basic patent for a product, the scope of exclusivity resulting from the additional protection right extends to the medical applications of the protected substance. The authorized person may use the invention to the extent approved by the regulatory authority in the first marketing authorization for a medicinal product. The additional protective right covers the part of the invention covering the product for which the first marketing authorization was granted.

The SPC loses its force with the main patent. If the main patent loses its validity for a reason not affecting the invention which is the subject of the additional patent, the additional patents to the main patent become patents and remain in force for the period for which the main patent was granted.

 

1.2. Trademarks

A trademark is any sign that is capable of distinguishing the goods (or services) of one enterprise from the goods (or services) of another enterprise. Types of signs include:

• word,
• word-figurative,
• figurative,
• spatial,
• sound.

A trademark right grants the owner the exclusive right to use the trademark in a commercial and professional way in the territory of Poland (or in the EU, based on an EU trademark). A trademark right prohibits any third party from manufacturing, using, offering, marketing or importing and exporting and stocking for these purposes, products marked with an identical, similar or confusingly similar trademark (in the case of renowned trademarks, the level of similarity is lower and does not require that goods marked with such trademarks be identical or very similar).

The right to a registered trademark may last indefinitely if the protection is extended every 10 years.

 

2. What agencies or bodies regulate patents and trademarks?

All proceedings referring to local patents and trademark registrations are handled by the Patent Office of the Republic of Poland (“Polish Patent Office”).

With respect to foreign trademark and patent registrations which can also cover Polish territory, the following authorities are applicable:

• EU trademarks – European Union Intellectual Property Office (EUIPO);
• International trademarks – World Intellectual Property Organization (WIPO);
• European patents – European Patent Office (EPO);
• International patents: Patent Cooperation Treaty (PCT) and The Visegrad Patent Institute (VPI) – filed with the Polish Patent Office.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

3.1. Patents

The Polish Patent Office grants patents for inventions that are patentable. This means inventions that are characterized by a set of features defined in legal provisions, whose existence is necessary for the invention to be patentable.

To assess the patentability of an invention, it is necessary that:

• the invention is presented clearly and comprehensively so that a person skilled in the art can implement it;
• the patent application explains what is to be protected in a clear and concise manner and is fully supported by the description of the invention.

According to Polish law, “patents are granted – regardless of the field of technology – for inventions that are new, have a degree inventiveness, and are suitable for industrial use.”

Patentability testing by the Polish Patent Office requires first to determine whether the subject of the application can be considered as an invention. It should be borne in mind that, above all, an invention is a technical solution. Only after determining the existence of an invention is it possible to check whether the invention meets the statutory conditions required to obtain a patent.

An invention is considered new if it is not part of the state of the art. The state of the art is understood as anything which, prior to the date on which priority is given to obtaining a patent, has been disclosed to the public in the form of a written or oral description, by application, display or otherwise. To assess whether an invention is new, the fact of its being shared (disclosed) is significant – not whether anyone has become acquainted with it.

The disclosure of an invention is deemed to be such a representation of the nature of the invention that one skilled in the art may be able to implement it.

The above criteria regarding the novelty of an invention do not exclude the possibility of granting a patent for an invention concerning a new substance or mixtures forming part of the state of the art for use in a strictly defined manner in methods of treatment or diagnosis, provided that such use is not part of the state of the art.

Legal provisions do not exclude the possibility of granting a patent for an invention if its disclosure occurred not earlier than six months before the date of filing the application and was caused by an obvious abuse in relation to the applicant or its legal predecessor.

An invention is considered to have a degree of inventiveness if the invention is not obvious to a person skilled in the art. The state of the art taken into account when assessing the degree of inventiveness is understood in the same way as when assessing novelty. The difference is that it does not include information contained in the patent applications of inventions or utility models using an earlier priority, not disclosed to the general public, provided that they are announced in the manner specified by law.

An invention is considered to be suitable for industrial use if, as a result of the invention, a product or method can be obtained, in a technical sense, in any industrial activity.

An invention can be considered adaptable if it can be used (implemented) in a reproducible manner with identical effect. Such an invention must contain all technical means possible for its application and must be suitable for use. It must pursue a specific goal of practical importance and satisfy a practical need.

Not all inventions can be granted protection. Patents cannot be granted for:

• inventions, the use of which would be contrary to public policy or decency; using an invention that is prohibited by law is not automatically considered to be contrary to public policy;
• plant varieties or animal breeds and purely biological methods of plant or animal breeding, as well as products obtained by such methods; this does not apply to microbiological or other technical methods or to products obtained by such methods, unless they are plant varieties or animal breeds;
• methods of treating humans and animals by surgical or therapeutic methods and methods of diagnosis used on humans or animals; this does not apply to products, in particular substances or mixtures, used for diagnosis or treatment.

According to Polish law, biotechnological inventions, the use of which would be contrary to public policy or decency or public morals, include: methods of human cloning, ways of modifying the human germline genetic identity, the use of human embryos for industrial or commercial purposes, and ways of modifying the genetic identity of animals that may cause them suffering without bringing any significant medical benefit to humans or animals.

 

3.2. Trademarks

Polish law provides for several circumstances under which trademark protection cannot be granted. The most significant are marks that:

• cannot constitute a trademark;
• are not capable of distinguishing, in trade, the goods for which they have been applied;
• consist exclusively of elements which may serve, in trade, to designate, in particular, the type of goods, their origin, quality, quantity, value, intended use, manufacturing process, composition, function, or usefulness;
• consist exclusively of elements which have entered everyday speech or are customarily used in fair and well-established trade practices;
• consist of only a shape or other property of a product, arising from the very nature of the product, necessary to achieve a technical effect or increase significantly the value of the product;
• have been applied for in bad faith;
• are contrary to public policy or morals;
• incorporate an officially recognised sign adopted for use in trade, in particular a safety, quality, or verification mark, insofar as this could mislead the public as to the nature of such a sign, unless the applicant proves that it is authorised to use such a sign.

It should be noted that all absolute grounds for rejection are assessed ex officio.

 

4. How can patents and trademarks be revoked?

4.1. Patents

Under Polish law, a patent may be revoked -as a whole or in part – if the statutory conditions required to obtain a patent have not been met – in particular with respect to novelty or suitability for industrial use. Invalidation may also occur if an objection is raised against the final decision of the Polish Patent Office on granting the exclusive right. The decision to revoke exclusive rights is issued by the Polish Patent Office in a litigation procedure.

 

4.2. Trademarks

Any legal entity that has a legal interest may apply to the Polish Patent Office for the revocation of a trademark protection right. To achieve the revocation of a protection right, two basic conditions arising from the Polish provisions must be met. First, the applicant must show that it has a legal interest in seeking the revocation of the protection right. Secondly, the applicant must prove that one of the statutory conditions for granting the protection right has not been met.

The grounds for revoking a trademark include:

• Granting the rights to the trademark in violation of the absolute grounds of protection, as described above, and
• Collision with an earlier mark – meaning that the trademark was similar to another trademark to which rights were granted earlier. If the basis for the application for a declaration of invalidity is an earlier right, then the earlier right can only be invoked by its holder.

The application may concern the annulment of the right of protection for a trademark as a whole or in part. Due to the binding limitations of the invalidation application, the Polish Patent Office cannot invalidate an exclusive right to a wider extent that goes beyond the applicant’s request. However, an exclusive right can be invalidated in a narrower scope if the result of the evidence proceedings supports such a decision.

There are also certain restrictions applicable to the invalidation of trademark rights. In particular, an application for a declaration of invalidity may not be submitted in the following circumstances:

1. in the case of collision with an earlier mark or in violation of the applicant’s personal or property rights – if, for a period of five consecutive years of the registered mark being used, the applicant, being aware of its use, did not oppose it;
2. if the trademark was granted a right of protection in breach of the requirement of having a distinctive character – if, by the day of submitting the application, the mark acquired, as a result of its use, a distinctive character in ordinary trading conditions;
3. in the case of a collision with a well-known trademark – if, for a period of five consecutive years of the registered trademark being used, the holder of the well-known trademark, being aware of its use, did not oppose it.

 

5. Are foreign patents and trademarks recognized and, if so, under what circumstances?

5.1. Patents

Patent law is territorial in nature and limited by the geographical borders of the country or region in which protection was granted.

The protection of an invention or a utility model in the territory of Poland can be obtained via national European, or international procedures.

A national procedure is a procedure carried out directly before the patent office of the country in which protection is sought. The applicant submits an application to the patent office of the country in which he/she wants to apply for patent protection for his/her invention. The protection thus obtained is only valid in the territory of that country. If the applicant wants to extend the protection, he/she may, based on the Paris Convention, submit an application in other countries. If the applicant decides to do so, he/she must, within 12 months of the date of the original application, submit an application in each of the additional countries based on the priority resulting from the initial application.

The essence of the regional (European) procedure is to obtain a European patent. This procedure is carried out before the European Patent Office (EPO) in accordance with the principles set out in the Convention of 5 October 1973 on a European Patent (known as the Munich Convention). The decision of the European Patent Office has such effects in the signatory countries designated by the applicant as if national patents were granted there by way of separate proceedings before the competent offices of those countries. When filing a European patent application, the applicant does not designate the specific countries in which the invention should be protected – all states that are parties to the Munich Convention are designated automatically. After obtaining a European patent in the EPO, in order to secure protection in the territory of Poland, the applicant must submit a translation of the European patent into Polish to the Polish Patent Office within three months of the date on which the EPO publishes information on the granting of the European patent. The deadline for submitting a translation cannot be extended.

International patent applications are defined in the PCT procedure. Applications are filed at receiving offices, which are national patent offices or international organizations. This procedure is carried out based on the principles arising from the Patent Cooperation Agreement. The guiding principle of the PCT system is that the applicant, applying for a patent in several countries, submits one application, which is subject to the so-called international procedure prior to its transfer to the national patent offices. . An application for a patent may be filed through the Polish Patent Office. When submitting an international PCT application, the applicant does not designate the countries in which he/she wants his/her invention to be protected. At the time of filing the international application, all states that are parties to the PCTare designated automatically. The PCT procedure consists of two main phases. It begins with an international application – the so-called the international phase, and ends (in the case of a positive result) with the granting of a national or regional patent – the so-called national phase or regional phase.

The Visegrad Patent Institute (VPI) began its operations on 1 July 2016. It is an international organization founded by the four countries of the Visegrad Group – the Czech Republic, Poland, Slovakia and Hungary. The VPI, like the European Patent Office, acts as the International Searching Authority and the International Preliminary Research Body. Tasks related to conducting international searches and international preliminary examinations are performed by the national offices of VPI member states – each office dealing with entities from its own country, thus enabling the procedure to be carried out in the local language. By choosing the VPI, Polish applicants have the option of filing an international application with the Polish Patent Office in Polish; however, the applicant will be required to provide a translation into one of the 10 languages of publication specified in the PCT regulations within 14 months of the priority date.

 

5.2. Trademarks

In Poland there are three regimes of registered trademark rights: national trademarks (registered by the Polish Patent Office); international trademarks (registered by the World Intellectual Property Organization and approved by the Polish Patent Office); and EU trademarks (registered by the EU Intellectual Property Office).

In Poland, a person wishing to seek protection of his/her designation (sign) does not have to register the trademark through any office. This person may benefit from an unregistered trademark right based on unfair competition law on the basis of prior use on the market. The Polish Industrial Property Law Act also confers certain rights on the owners of non-registered but well-known trademarks commonly used in Poland (a high degree of recognition by the relevant public is required).

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

6.1. Patents

Devices and medicines which are patentable, and also those which do not meet the conditions to obtain patent protection, can be protected as a trade secret.

A trade secret is understood as technical, technological and organizational information (know-how) of an enterprise, or other information of economic value, which, as a whole or in the precise configuration and assembly of its components, is not generally known among persons who normally deal with the kind of information in question or is not readily accessible to such persons, and provided that the person entitled to use or dispose of the information (e.g. licensee) has taken, with due care, steps to maintain its confidentiality. Thus, in order to be regarded as a trade secret, the information should be (i) confidential, (ii) not disclosed and (iii) protected.

A trade secret is protected as long as the information is kept confidential and remains of economic value. This often provides a significant advantage to patentable inventions, as patent protection is time-limited.

 

6.2. Trademarks

With respect to trademarks, a trade name or a logotype can be protected against infringement on the basis of unfair competition laws. In parallel with the protection resulting from the registration of the trademark, but also after its expiry or even when it never existed, it is possible for a person to be protected under competition law as long as the following occur: an act of imitation that results in consumers being misled as to the origin of the goods or name or designation of the enterprise, or the use of another person’s reputation in a dishonest manner.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

7.1. Patents

Apart from the general restrictions described above, with regard to the limitation of the monopoly of the patent holder of a biotechnological invention, the provisions stipulate that the patent does not extend to biological material obtained by a single reproduction of biological material marketed by the patent holder or with its consent, if reproduction is an indispensable consequence of the use of the biological material.

The patent for an invention regarding a manufacturing method also includes products obtained directly by this method. The patent for an invention regarding the use of a substance forming part of the state of the art to obtain a product having a new use also includes products specially prepared in accordance with the invention for such use.

A patent for a biological material having the characteristics specified in the claims resulting from the invention includes any biological material obtained from a given biological material by reproduction in an identical or different form and having the same characteristics.

A patent for a method that allows the production of biological material having the characteristics of the invention as defined in the claims also includes biological material obtained directly by this method and any other biological material derived from biological material obtained directly by reproduction in an identical or different form and having the same characteristics. A patent for a product containing or possessing genetic information includes all materials into which the product has been incorporated and in which genetic information has been included that fulfills its function in this material, with the exception of certain materials mentioned by law.

 

7.2. Trademarks

There are no additional rules specific to medicines or devices.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

From the perspective of Polish intellectual property law, there are no such requirements.

 

Also from this Legal Handbook

All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Poland. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

In general, hemp herb other than fibre, containing more than 0.20% of the sum of delta-9-Tetrahydrocannabinol (THC) and Tetrahydrocannabinoleic acid (delta-9-THC-carboxylic acid) is not authorised in Poland. However, certain forms are authorised for specific purposes.

The Act of 29 July 2005 on Counteracting Drug Addiction (“Act on CDA”) addresses, among other things, psychotropic substances. The Regulation of the Minister of Health of 17 August 2018 on the list of psychotropic substances, narcotic drugs and new psychoactive substances (“Regulation”) divides psychotropic substances into groups, according to the risk of developing addiction when used for non-medical purposes and the extent of their medical use.

A group of tetrahydrocannabinols are listed in group I-P, which contains a list of psychotropic substances that have no medical use and high potential for abuse, and which are excluded from the pharmaceutical market and can only be used for scientific research. However, delta-9-THC is enumerated in group II-P, containing a list of psychotropic substances with low medical use and high potential for abuse that can be used for medical, scientific and industrial purposes. Also, some synthetic cannabinoids are to be found in group I-N, which contains a list of narcotics that are substances with high addictive potential that be used for medical, scientific and industrial purposes.

Medicinal Cannabis is regulated separately (see Medicinal Cannabis).

 

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

Cannabinoid Drugs fall under the general jurisdiction of authorities competent for the placing of medicinal products on the market, i.e. the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych oraz Produktów Biobójczych – “URPL”), and – in the area of manufacturing, import, distribution, advertising and promotion of medicinal products, the Chief Pharmaceutical Inspector (“GIF”), as well as the Ministry of Health, which is generally responsible for public health-related matters (see Question 1, on Regulatory, Pricing and Reimbursement Overview).

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

General rules apply to the authorisation, pricing and reimbursement of Cannabinoid Drugs considered medicinal products, together with some specific rules regarding narcotic drugs and psychotropic substances set forth in the Act on CDA.

 

4. Which are the cannabinoid drugs that have received market approval to date?

To date only one finished drug containing cannabinoids has received market approval by way of the mutual recognition procedure (MRP). It contains 27 mg of delta-9-tetrahydrocannabinolum and 25 mg of cannbidiolum per ml. It is used in the treatment of multiple sclerosis, specifically to treat symptoms related to muscular stiffness (spasticity).

 

5. Who can prescribe Cannabinoid Drugs?

Drugs containing cannabinoids can be prescribed by any medical doctor.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

No.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Cannabinoid Drugs containing substances classified as narcotic substances can only be prescribed on an ‘Rpw’ prescription form, i.e. a prescription for medicinal products containing ‘narcotic drugs or psychotropic substances as defined in separate legislation’ (a narcotic drug prescription).

During the COVID-19 pandemic, regulations came into force that authorize the Minister of Health to limit the amount of medicinal products per patient during a certain period of time, in case of a threat of unavailability of a product in the Polish territory. Currently, all restrictions on the dispensing of medicinal products per patient have been repealed.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

Sale is only possible through pharmaceutical wholesalers (who buy medicinal products from manufacturers, MAHs, importers or other pharmaceutical wholesalers) and pharmacies. Organisations wanting to manufacture, process, transform, import or distribute narcotic drugs or psychotropic substances have to obtain a permit from the GIF. In order to obtain a permit, the applicant must have in place specific procedures and a control system covering its activity (in particular to ensure the continuity of activity), it must employ a qualified person responsible for supervision, it must have a system for securing the production and storage rooms of the substances against access by unauthorised persons, it must store the substances in a manner protecting them against theft or access by unauthorised persons, it must keep a record of revenue and expenses related to narcotic drugs or psychotropic substances, and, in the case of manufacturing, processing and transforming narcotic drugs or psychotropic substances, it must keep records of technically justified standards of consumption of precursors substances used in the process and standards of losses allowed at particular stages of production (par. 2 of the Regulation of the Minister of Health of 9 November 2015 on the authorisation of the manufacture, processing, transformation, import, distribution or use for scientific research of narcotic drugs, psychotropic substances or category 1 precursors).

Cannabinoid Drugs are authorised for retail sale in pharmacies.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

There is no specific list of retailers/distributors authorised to sell Medicinal Drugs. The Ministry of Health provides a registry of all pharmacies accessible under https://rejestrymedyczne.ezdrowie.gov.pl/ra/search/public.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Currently, there are no proposals for reform or significant change to the regulation of Cannabinoid Drugs.

 

11. When are they likely to come into force?

Not applicable.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

Medical Cannabis is authorised in Poland.

 

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Medicinal Cannabis falls under the general jurisdiction of authorities competent for the placing of medicinal products on the market, i.e., the URPL, and – in the area manufacturing, import, distribution, advertising and promotion of medicinal products, the GIF, as well as the Ministry of Health, which is generally responsible for public health-related matters. See Question 1, on Regulatory, Pricing and Reimbursement Overview).

 

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

The Act of 7 July 2017 amending the Act on Counteracting Drug Addiction and the Act on the Reimbursement of Medicines, Foodstuffs for Special Nutrition and Medical Devices (the “2017 Act”) introduced Medicinal Cannabis to the Act on CDA by stating that hemp herb other than fibre hemp and extracts, pharmaceutical tinctures and all other extracts of hemp other than fibre and hemp resin other than fibre may constitute pharmaceutical raw material, as defined under Article 2 point 40 of the Pharmaceutical Law, intended for the preparation of compounded medications referred to in Article 3 (4) point 1 of the Pharmaceutical Law, after obtaining a marketing authorisation issued by the URPL. The amending act entered into force on 1 November 2017.

A marketing authorisation for a pharmaceutical raw material intended for the preparation of compounded medications in the form of hemp herb other than fibre hemp and extracts, pharmaceutical tinctures and all other hemp extracts other than fibre and hemp resin other than fibre, issued by the URPL, is valid for five years. The issuance or refusal to issue the authorisation, the amendment of the data on which the authorisation was based or a change in the documentation on which the authorisation was based, the extension of its validity, the refusal to extend its validity, the shortening of its period of validity and its withdrawal is affected by a decision of the URPL.

The rules on the manufacturing, import and distribution and marketing of medicinal products apply to Medicinal Cannabis. See Question 2, on Regulatory, Pricing and Reimbursement Overview).

Under Article 5a of the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Use, and Medical Devices (the “Reimbursement Act”), Medicinal Cannabis, being a compounded medication prepared from pharmaceutical raw materials which obtained a marketing authorisation pursuant to Article 33 of the Act on CDA, is not refundable.

 

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

The general rules for the production and import of medicinal products set out in Chapters 3, 3a and 5 of the Pharmaceutical Law apply to Medicinal Cannabis. The competent authorities are the URPL and the GIF (see Question 13 above).

Cultivation of non-fibre hemp, harvesting of herb and resin of non-fibre hemp for the production of pharmaceutical raw material may be carried out by a research institute after obtaining an authorization from the GIF. The GIF, in issuing such an authorization, must cooperate with the Police, including with regard to opinions on where to grow the hemp, how to secure it, etc. The regulations set out specific conditions and methods for securing and storing the harvest.. The pharmaceutical raw material, e.g., dried hemp, can be imported. The URPL issues the authorisation to market the pharmaceutical raw material. The GIF issues the authorisation to import the pharmaceutical raw material. The pharmaceutical raw material is then used to prepare the compounded medication in pharmacies, on the basis of a medical prescription.

 

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

The commencement of economic activity consisting in the manufacturing or importing of Medicinal Cannabis is subject to authorisation to manufacture or import Medicinal Cannabis (Article 38 of the Pharmaceutical Law). The GIF is the competent authority to issue the authorisation. A copy of such authorisation must be filed as an attachment to and together with the request to grant the marketing authorisation, which is then issued by the URPL.

 

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Medicinal Cannabis, as a pharmaceutical raw material, may be marketed upon the URPL’s authorisation, which is valid for five years (Article 33a of the Act on CDA). It may be extended upon the request of the marketing authorisation holder according to the general rules set out in the Pharmaceutical Law (see Question 5, point A), on Regulatory, Pricing and Reimbursement Overview).

 

18. How can patients obtain Medicinal Cannabis?

Patients can obtain Medicinal Cannabis by receiving a narcotic prescription (an ‘Rpw’ prescription) from a medical doctor, upon which they can purchase Medicinal Cannabis in a pharmacy.

 

19. Who can prescribe Medicinal Cannabis?

In theory, any medical doctor, with the exception of veterinarians, can prescribe Medicinal Cannabis. In practice, not every doctor, due to their specialisation, issues prescriptions falling under the category of prescriptions for medicinal products ‘containing narcotic drugs or psychotropic substances as defined in separate legislation’ (‘Rpw’), i.e., a narcotic drug prescription. In most cases, it will be oncologists, psychiatrists and palliative care specialists who issue such prescriptions.

 

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

There is no specific list of doctors authorized to prescribe Medicinal Cannabis.

 

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

No approvals or notifications are required to prescribe Medicinal Cannabis. However, the prescription for Medicinal Cannabis falls under the category of prescriptions for medicinal products containing ‘narcotic drugs or psychotropic substances as defined in separate legislation’ (‘Rpw’), i.e., a narcotic drug prescription.

Medical treatment with Medicinal Cannabis is not treated as first choice therapy. The doctor decides whether to prescribe Medicinal Cannabis while taking into account the history of the patient’s treatment, and considering the effects of previous treatment methods. Being a pharmaceutical raw material, there is no summary of product characteristics for Medicinal Cannabis, i.e., there is no document regulating what diseases it can be prescribed for.

 

22. Where is Medicinal Cannabis available?

Medicinal Cannabis is available for retail purchase in pharmacies.

 

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

There is no specific list of retailers authorised to sell Medicinal Cannabis. The Ministry of Health provides a registry of all pharmacies accessible under https://rejestrymedyczne.ezdrowie.gov.pl/ra/search/public.

 

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

At this point, there are no proposals for reform or significant change to the regulation of Medicinal Cannabis.

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

Certain Opioid Drugs used for medical purposes are authorised in Poland. Opioids are classified in groups I-N, II-N, III-N and IV-N as defined in the Regulation, i.e. narcotics which are treated as either highly addictive substances (I-N), moderately addictive substances that can be used for medical, scientific and industrial purposes (II-N), mildly addictive and subject to milder control and being non-prescription drugs (III-N, being a sub-group of I-N and II-N), and drugs subject to stricter control which can only be used for research purposes and for animal treatments (IV-N, being a subgroup of I-N).

 

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Opioid Drugs fall under the general jurisdiction of authorities competent for the placing of medicinal products on the market, i.e., the URPL, and – in the area of manufacturing, import, distribution, advertising and promotion of medicinal products, the GIF, as well as the Ministry of Health, which is generally responsible for public health-related matters. See Question 1, on Regulatory, Pricing and Reimbursement Overview).

 

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

Generally, the same rules for the authorisation, pricing, and reimbursement of medicinal products apply to opioids.

However, some stricter rules also apply. In order to manufacture, process, alter, import or distribute narcotic drugs or psychotropic substances, an authorisation from the GIF is required.

 

28. Which are the Opioid drugs that have received market approval to date?

Opioids that have received market approval are, among others, those containing: codeine, dihydrocodine, tramadol, morphine, fentanyl, methadone, tapentadol, oxycodone, oxycodone with naloxone, buprenorphine, pethidine, pentazocine, and diphenoxylate.

 

29. Who can prescribe Opioid Drugs?

Any medical doctor can prescribe Opioid Drugs. In practice, due to their specialisations, not every doctor issues such prescriptions.

 

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

No.

 

31. What approvals or notifications are required to prescribe Opioid Drugs?

No approvals or notifications are required to prescribe Opioid Drugs. However, Opioid Drugs require a special kind of prescription for medicinal products containing ‘narcotic drugs or psychotropic substances as defined in separate legislation’ (“Rpw”), i.e. a narcotic drug prescription. During the COVID-19 pandemic, regulations came into force that authorize the Minister of Health to limit the amount of medicinal products per patient during a certain period of time, in case of a threat of unavailability of a product in the Polish territory. Currently, all restrictions on the dispensing of medicinal products per patient have been repealed.

 

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

Sale is only possible through pharmaceutical wholesalers (who buy medicinal products from manufacturers, MAHs, importers or other pharmaceutical wholesalers) and pharmacies. See Question 8.

 

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no specific list of retailers authorised to sell Opioid Drugs. The Ministry of Health provides a registry of all pharmacies accessible under https://rejestrymedyczne.ezdrowie.gov.pl/ra/search/public.

 

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There are currently no proposals for reform or significant change to the regulation of Opioid Drugs.

 

35. When are they likely to come into force?

Not applicable.

 

Also from this Legal Handbook

All legal aspects surrounding orphan drugs and rare diseases in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

1. What is the definition of Rare Diseases in your country?

There is no legal definition of Rare Diseases in Poland. In accordance with Regulation (EC) no. 141/2000 of European Parliament and of the Council of 16 December 1999 on orphan medicinal products (“Orphan Drug Regulation”) a rare disease is one that affects not more than 5 out of 10,000 persons. Moreover, the appendix to Resolution no. 110 of the Council of Ministers, dated 24 August 2021, on the adoption of the document Plan for Rare Diseases, establishes that such diseases are often genetically determined, have a chronic and often severe course, lead to premature death or cause disability.

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Organ Drug Regulation applies in Poland. Pursuant to the Orphan Drug Regulation, a medicinal product may be designated as an orphan medicinal product if its sponsor can establish:

1. that it is intended for the diagnosis, prevention or treatment of a life-
   threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the Community when the application is made, or
   that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment;
   and
2. that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The Orphan Drug Regulation establishes the Committee for Orphan Medicinal Products (“COMP”) within the European Medicines Agency (“EMA”), which is responsible for examining applications for orphan medicinal product designations.

Once an orphan medicinal product has been designated as such, it requires, like other medicinal products, a marketing authorisation before it is marketed. Marketing authorisation applications for designated orphan medicines must be submitted to the EMA for assessment through the centralised procedure, and the European Commission oversees final authorisation, taking into account the opinion of the Committee for Medicinal Products for Human Use (“CHMP”).

 

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

There are no specific provisions for relaxed clinical trial or scientific evidence requirements with respect to Orphan Drugs.

 

5. Is there an expedited pathway for Orphan Drugs?

In general, the maximum timeframe for the evaluation of marketing authorisations under the centralised procedure is 210 days. In exceptional cases, the CHMP may decide that the product is of major interest for public health and therapeutic innovation, and reduce the timeframe to 150 days, if the applicant provides sufficient justification for an accelerated assessment.

The CHMP may also grant a conditional marketing authorisation valid for one year if it finds that all of the following criteria are met:

• the benefit-risk balance of the medicine is positive;
• it is likely that the applicant will be able to provide comprehensive data post-authorisation;
• the medicine fulfils an unmet medical need;
• the benefit of the medicine’s immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Poland, being a member state of the EU, recognises marketing authorisations granted by the European Commission under the centralised procedure.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?

There is no specific reimbursement procedure for Orphan Drugs. See Question 2 on Regulatory, Pricing and Reimbursement Overview.

In November 2020, the Act of 7 October on the Medical Fund (the “Act on the Medical Fund“) came into force. The Medical Fund set up by this law acts as a complementary element of the public system for financing healthcare. It will be funded from the state budget. One of the relevant sub-funds in terms of orphan drugs is the therapeutic-innovation sub-fund, which would finance emergency access to medicinal technologies and unlimited hospital and specialist services for children.

Under the Act on the Medical Fund, the Agency for Health Technology Assessment and Tariffication (“AOTMiT“) prepares a list of drug technologies of high clinical value and a list of drug technologies of a high innovation level, including therapies for oncology and rare diseases.

Products used within the framework of a drug program or chemotherapy, for which no subsequent reimbursement decisions have been issued, when there are no alternative therapeutic options, may be financed under the existing conditions for those recipients who have started the treatment process until the completion of the therapy, under certain conditions.

Taking advantage of the procedure that allows foreign-language content on the packaging of an Orphan Drug directly limits the possibility of reimbursing the drug.

 

8. How are the prices of Orphan Drugs regulated?

Prices of Orphan Drugs subject to the general regulatory framework for pricing of medicinal products. See Question 2, Regulatory, Pricing and Reimbursement Overview.

 

9. In case of reference price based on a basket of countries, what countries are included?

Not applicable.

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No, there have not been any significant legal/judicial developments in relation to Orphan Drugs.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

Pursuant to the Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02) (OJ C 151, 3.7.2009, pp. 7-10), member states should take national actions in the field of rare diseases. The Ministry of Health announced the National Plan for Rare Diseases in February 2021. It presents a three-year strategy, for the period 2021-2023, defining specific objectives that are to be achieved in that period.

It plans to ensure sustainable implementation of health policies aimed at the needs of patients with rare diseases, introducing systemic solutions to the health and social problems of those patients.

In February 2021, the Medical Research Agency, a governmental body, announced the launch of its PLN 100 million grant dedicated to research and development activities focused on rare diseases. The aim of this programme is to increase access to diagnostics and drug therapies in rare diseases.

Three additional expert bodies were established in May 2022 to provide support in implementing the plan.

Also from this Legal Handbook

All legal aspects surrounding localization in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

No, there are no rules or regulations requiring or encouraging localisation in Poland. However, certain activities are subject to authorisation by Polish authorities.

For example, placing medicinal products on the Polish market is subject to an authorisation by the President of the Office for the Registration of Medicinal Products or the European Medicines Agency. Some entities must have to have their seat in an EU/EEA member state, e.g. the representative of a sponsor of a clinical trial.

 

 

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

There have not been any recent significant changes involving localisation rules.

 

3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the process of obtaining a marketing authorisation is not impacted by localisation policies. However, as mentioned in the answer to Question 114, placing a medicinal product on the Polish market is subject to authorisation by local authorities.

 

4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the pricing process for pharmaceutical products is not impacted by localisation policies.

 

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, the reimbursement of pharmaceutical products is not impacted by localisation policies.

 

6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

No, access to public tenders of pharmaceutical products is not impacted by localisation policies. The contracting entity cannot require the tenderer to be a company registered in Poland, hence, any company may submit offers for public tenders.

 

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?

In general, import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products are not impacted by localisation policies. However, as mentioned in the answer to Question 1, importation is subject to authorisation by local authorities.

In terms of taxation, PIT and CIT payers can benefit from an R&D tax credit allowing them to deduct up to 100% of the amount of so-called qualified expenses.

 

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

No, there are currently no other incentives or advantages offered by localisation rules.

 

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

No, there are currently no discussions about the possibility of implementing localisation policies in Poland. However, one of the strategic goals defined in the Medicines Policy 2018 – 2022 is strengthening and developing the potential of the pharmaceutical sector located in Poland. It is emphasised that national medicines policies should put in place mechanisms encouraging investments in the pharmaceutical sector in Poland. Nonetheless, there are no specific plans to regulate this by way of localisation requirements or advantages.

Also from this Legal Handbook

1. Are biosimilar medicines considered the same as generic medicines in your country?

Under the Pharmaceutical Law, a product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, and if the bioequivalence has been demonstrated in bioavailability studies. There is no legal definition of biosimilar medicine in Poland.

In terms of the abridged authorisation procedure regulated in Art. 15 of the Pharmaceutical Law, if biological medicinal products that are similar to a reference biological product (so-called “biosimilar”), but cannot meet the definition of ‘generic’ set forth above due to differences in raw materials or in production processes in comparison with the reference product, the applicant may integrate the data of the reference product referred to in its application by providing the results of appropriate pre-clinical tests or clinical trials. This is not required for generics in the abridged authorisation procedure.

 

 

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

Yes, biologic medicines and biosimilar medicines are regarded as innovations (inventions) in the field of biotechnology, and therefore, patentable, provided that the patentability requirements are met. The main criteria of patentability include novelty, inventiveness and industrial application.

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

No, there is no specific regulatory framework for the marketing authorisation of biosimilar medicinal products in Poland. General rules apply (see Question 22, Marketing, Manufacturing, Packaging and Labeling Advertising) if one of the national procedures are to be applied.

Under Regulation (EC) No. 726 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (“Regulation No 726”), generally, biosimilars are eligible for the centralised procedure and for some of them this is the mandatory authorisation procedure.

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

Generally, under Art. 15 of the Pharmaceutical Law, biosimilar drugs may potentially use the abridged authorisation procedure, which does not require presenting all clinical and pre-clinical data (which is required in the case of the original Biologics drug). However, if a biosimilar drug does not meet the definition of ‘generic’ due to differences in raw materials or in production processes in comparison with the reference product, the applicant may integrate the data of the reference product referred to in its application by providing the results of appropriate pre-clinical tests or clinical trials. Please see the answers to Question 6, Regulatory, Pricing and Reimbursement Overview, and Question 1 on Marketing, Manufacturing, Packaging and Labeling Advertising.

 

5. What are the requirements for the choice of the reference comparator product?

The reference comparator product is relevant in the case of the abridged authorisation procedure, when for a generic product instead of filing all pre-clinical and clinical data, only references to the data of the reference product is made. It is possible if:

• the marketing authorization holder for the reference medicinal product gave its consent to make such references
  or
• the reference medicinal product has been authorised in any member state of the EU for at least eight years.

The product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, and if the bioequivalence has been demonstrated in bioavailability studies. If the biosimilar product is not of a generic nature, then references to the pre-clinical and clinical data of the reference product cannot be made without filing documentation in the relevant scope.

When it comes to placing product on the market in the case of a biosimilar, it will be possible after the expiration of the market exclusivity period, which may be 10 or 11 years.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

The reference medicinal product must be authorised in the EU/EEA.

However, in the EMA’s procedural advice for users of the centralised procedure for similar biological medicinal product applications (EMA/940451/2011), the EMA states that it may be possible for an applicant to compare the biosimilar product in certain clinical studies and in in vivo non-clinical studies with a non-EEA authorised comparator, i.e. a non-EEA authorised version of the reference product, which will then need to be authorised by a regulatory authority with similar scientific and regulatory standards as the EMA.

 

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

Polish legislation does not contain specific provisions on the pricing of biosimilar medicines or the original Biological drug. In general, the pricing of medicinal products is not subject to regulation; unless the product is reimbursed from the state budget.

Article 13 of the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Use, and Medical Devices (the “Reimbursement Act”) distinguishes the way of establishing the official selling price depending on the existence of at least the ‘substitute in the given therapeutic indication’ – although the substitute’s legal definition indicates generics, in practice this term also applies to biosimilars. The basic rule is that the official selling price of medicinal products that have a substitute must not be (a) higher than 75% of the official selling price of the only substitute reimbursed in a given indication, or, (b) higher than the official selling price of the substitute determining the basis of the financial limit for the limit group, or the cheapest substitute, provided that the basis for the financial limit in a given limit group is a medicinal product with another active substance, in the case of a consecutive substitute reimbursed in a given indication.

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

Polish legislation does not contain specific provisions on the reimbursement of biosimilar nor biologicals. See Question 2, Regulatory, Pricing and Reimbursement Overview.

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

A medicinal product with no substitute is reimbursed on the basis of a decision of the Minister of Health, who sets its original selling price. However, if a substitute for such a product is reimbursed, the official selling price of the originator reference product is limited.

The official selling price of the originator reference product must be (1) not higher than 75% of the official selling price of the substitute reimbursed in a given indication, if there is only one substitute, or, (2) not higher than the official selling price of a substitute determining the limit basis or the cheapest substitute if the limit basis in a given limit group is determined by a medication with another active substance, in the case of another substitute reimbursed in the given indication. What is more, the validity period of the reimbursement decision cannot be longer than the market exclusivity period, i.e. the expiry of the exclusivity period is followed by the lowering of the price in a new decision.

This mechanism aims to lower the prices of originator reference products in a situation of biosimilar (or generic) competition.

In addition, the wholesale price of the first substitute reimbursed in a given limit group, i.e. a group of medicinal products covered by a common financing limit, dictates the limit basis in that limit group, which is then used to calculate the financing limit. This in turn can lead to a further price reduction of the originator reference product.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

No specific rules apply to the prescription of non-reimbursed biosimilars.

 

11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?

In general, physicians can switch the medicinal product used in the therapy, not excluding biosimilars.

Additionally, as for reimbursed medicinal products, pharmacists are obliged to inform customers wanting to purchase a reimbursed medicinal product of the possibility of purchasing a medicinal product other than the one prescribed, which has the same international non-proprietary name (INN), dosage, and pharmaceutical form, does not cause therapeutic differences, has the same therapeutic indication, and whose retail price does not exceed the public financing limit and the retail price of the medicinal product prescribed. The pharmacy is obliged to ensure the availability of such medicinal products. In practice, these criteria may not be applicable to biosimilars due to their nature.

 

12. What are the post – authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

General post-authorisation requirements apply to biosimilar medicines and biologicals (see Question 5, Marketing, Manufacturing, Packaging and Labeling Advertising).

 

13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?

In general, substitutes (generics and biosimilars) for a reference product may be authorised for any indication for which the reference product was authorised, provided its protection period has expired. However, if – for example – one or more of these indications are still protected by patents for a second medical use, the marketer of the substitute may not include such indications, i.e. the novel patented indication, in its SmPC.

Article 11 of the Directive 2001/83/EC describing what information the SmPC should contain introduces a mechanism called “skinny labelling” for generic medicinal products (applicable to biosimilars). Under this mechanism, those parts of the SmPC of the reference medicinal product referring to indications or dosage forms which were still covered by patent protection at the time the generic was marketed need not be included. This aims to facilitate the marketing of substitute medicinal products before all the patents protecting the reference medicinal product have expired.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

In 2018, the Patients’ Ombudsman decided that switching a biological drug to a biosimilar drug by a hospital due to financial reasons is not acceptable and violates patients’ rights. In its view, the decision on administrating a particular drug should not be made automatically, but adjusted to an individual patient. This decision was upheld by the Administrative Court in Warsaw and the Supreme Administrative Court.

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars?  If yes, when are they likely to come into force?

There are no specific proposals for reform with regard to biosimilars. However, the Ministry of Health has been emphasising the promotion of biosimilars as substitutes and the wider reimbursement of biosimilars, significantly reducing the costs of therapy.

Also from this Legal Handbook

All legal aspects surrounding the regulatory reforms in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.

1. Are there proposals for reform or significant change to the healthcare system?

Act  on Medical Devices

In May 2022, a new Act on medical devices went into effect. Nevertheless, it has not entered into force in its entirety. Regulations on medical device advertising will take effect on 1 January 2023, while regulations on the list of distributors and information systems maintained in this regard will take effect on 1 July 2023.

Proposed legislation on clinical trials

Legislative work is underway on a new bill on clinical trials, which will regulate, among other things, issues concerning the system of ethical evaluation of clinical trials of medicinal products, the civil liability of the investigator and the sponsor, and, above all, will ensure that Poland complies with the European legal order. The most important solutions to be introduced in the proposed legislation concern safeguarding the interests of the patient, for example through the establishment of a Guarantee Fund, which will make it easier to receive compensation. In addition, not only doctors, but also nurses or midwives with a university degree will be able to be the principal investigators of clinical trials.

Proposed legislation on veterinary medicinal products

At the beginning of 2022, Regulation 2019/6, which deals with veterinary medicinal products, came into force. It is not yet known whether the changes resulting from the EU regulation will be implemented at the domestic level in the Pharmaceutical Law, or whether a separate act will be created to cover only veterinary medicinal products. This also applies to new veterinary good distribution practice.

 

2. When are they likely to come into force?

Probably within the next one or two years, but this has not been decided yet.