Regulatory, Pricing and Reimbursement Overview
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 75.
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 (e.g. manufacturing, import, distribution, advertising and promotion thereof).
The Chief Veterinary Inspector (Główny Inspektor Weterynarii – “GIW”, https://www.wetgiw.gov.pl/) has jurisdiction over certain issues related to medicinal veterinary products, including the distribution 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?
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.
Act of 20 May 2010 on Medical Devices (“Act on Medical Devices”), as well as a number of supplementary laws thereto, establish the main regulatory framework for the authorization of medical devices in Poland and implement Directive 93/42/ EEC, Directive 90/385/EEC and Directive 98/79/EC. This EU legislative framework for medical devices will soon be replaced by the new Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, which is going to be mirrored in the new Polish Act on Medical Devices (bill is already in the legislative process).
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).
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 manufacturers?
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
- 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 Act on Medical Devices, 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 Act on Medical Devices 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.
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 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, distribution and advertising 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, 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 criminal sanctions such as fines, restrictions of liberty and imprisonment. The penalties are regulated in Art. 92 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 450 – 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:
- pharmacy dispensaries,
- herbal medicine shops,
- specialist medical supply shops,
- 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;
- notyfing the URPL about any adverse reactions to a medicinal product or a medical device;
- notyfing 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.