Medicinal product regulation and product liability in Poland: overview

A Q&A guide to medicinal product regulation and product liability law in Poland.

The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Poland: overview.

To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

The pharmaceutical sector in Poland is regulated in compliance with European law and the following:

  • Pharmaceutical Law of 6 September 2001: main regulations for the pharmaceutical sector.

  • Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices of 12 May 2011. This lays down the rules for the reimbursement of medicines, foods and medical devices in Poland.

  • Act on Medical Devices of 20 May 2010: applies to the whole area of medical devices.

  • Act on Publicly Funded Healthcare Benefits of 24 August 2004.

  • Act on Medical Activity of 15 April 2011.

These acts are supplemented by several national regulations laying down more precise requirements and technical rules for the pharmaceutical sector. These include:

  • Good distribution practice (GDP), good manufacturing practice (GMP) and good clinical practice (GCP).

  • Rules for mail order of medicinal products.

  • Medicinal product advertising requirements.

Guidelines and statements of EU authorities are also useful and highly respected documents, and are commonly used in practice.

Regulatory authorities

Pharmaceutical regulations in Poland are supervised and enforced by the:

  • President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL President).

  • State Pharmaceutical Inspectorate.

  • The Ministry of Health.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

The national authorities have exclusive power to regulate the manufacture, advertising and sale of biological products. The Main Pharmaceutical Inspector (GIF) is responsible for supervising these areas.

Rules for registration of biological medicines vary depending on the nature of the product. According to Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, medicinal products developed by means of one of the following biotechnological processes are subject to a mandatory central marketing approval procedure:

  • Recombinant DNA technology.

  • Controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes, including transformed mammalian cells and hybridoma and monoclonal antibody methods.

Marketing authorisations are issued by the European Commission after the application has been examined by the European Medicines Agency (EMA).

Other types of biologicals are not subject to a mandatory central procedure for marketing authorisation via the EMA and the Commission.

Although the manufacture and advertising of biological products are governed by the same regulations as for chemical/conventional molecule medicinal products, to date there is no clear practice for advertising or switching between biosimilars and reference medicinal products.

Combination products, that is, products (medicines or devices) consisting of two or more regulated components, are regulated in the Act on Medical Devices of 20 May 2010. However, if a medicinal product is an integral part of a medical device, it is subject to the Pharmaceutical Law, while the Act on Medical Devices applies insofar as they relate to the safety and performance characteristics of the medical device.

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

Medical devices and diagnostics

Medical devices and diagnostics are regulated in the Act on Medical Devices of 20 May 2010. It defines them as an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings.

Medical devices must satisfy various requirements set out in the Act on Medical Devices, including basic requirements regarding design, manufacturing, packaging and labelling. A medical device must be marked appropriately with the CE mark. Exceptions in this respect are:

  • Custom-made devices.

  • Products for clinical trials.

  • Products for performance evaluation.

  • Products made by the user of a medical device.

  • Procedure packs marked with the CE mark and sterilised systems or procedure packs or other CE-marked sterilised medical devices.

The URPL President must be notified in advance of any medical device released into the market, and periodic reports must be sent to him regarding any changes in the data, cessation of marketing, and so on.

There are two draft European regulations on medical devices (in vitro and other) currently being examined by the European Parliament, which will in future replace national regulations.

Health IT issues and mobile medical applications

Regulations on IT issues and mobile medical applications are at a very basic level in Poland. The first provisions regulating telemedicine were introduced at the end of 2015, through amendments to the Act on Doctor and Dentist Professions of 5 December 1996. These amendments allow doctors to provide medical advice through ICT systems.

The telemedicine market is still developing, as is legislation in this respect.

Some innovative medical applications which can be used to provide healthcare services have to be registered as special medical devices.

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

Stakeholders in the healthcare system can be divided into the following categories:

  • Beneficiaries (patients).

  • Health insurance institution acting as payer (National Health Fund).

  • Providers, that is:

    • healthcare entities that can operate as entrepreneurs, independent public healthcare centres (SPZOZ), budgetary units, research institutes, foundations and associations and churches;

    • pharmacies; and

    • other providers.

  • Control and supervision, that is:

    • State Sanitary Inspectorate;

    • State Pharmaceutical Inspectorate;

    • Patient Ombudsman;

    • provincial governors, provincial public health centres and consultants in various medical specialties;

    • the Minister of Health, who sets out the country's healthcare policy and has inspection powers; and

    • national health consultants in various medical specialties.

The healthcare system in Poland is financed from the following sources:

  • The main source of financing is health insurance within the National Health Fund. Employees pay mandatory social security contributions of 9% of their personal income to the social security institution.

  • State budget.

  • Some highly specialised services are financed directly from the Ministry of Health budget, not by the National Health Fund.

  • Local authorities.

 
5. How are the prices of medicinal products regulated?

The public authorities do not control the prices and margins of pharmaceuticals unless they are classified as reimbursable.

This means that only products that are formally classified as reimbursable by way of a positive reimbursement decision are subject to restrictions on selling prices and margins. A reimbursement decision can be issued for two, three or five years, depending on the specification of the medicinal product. There are no restrictions on the prices of non-reimbursed products.

Prices and margins are controlled at three levels:

  • Reimbursement decisions set the official selling price of the pharmaceutical and this is the mandatory fixed price for the manufacturer.

  • Official wholesale margins are fixed at 5% of the official selling price.

  • Official retail margins are set on the wholesale price of the pharmaceutical, and depend on the wholesale price level.

In effect, a reimbursed pharmaceutical has to be marketed in accordance with fixed prices and margins concluded in a reimbursed decision. As a rule such product cannot be marketed under a higher, or even lower price, without a prior change of the reimbursement decision.

As an exception, to provide financed healthcare services, a service provider must acquire medicines and foodstuffs for particular nutritional uses and medical devices at a price no higher than the official selling price, plus a margin no higher than the official wholesale margin, and in the case of acquisition from an entity other than a wholesaler within the meaning of the Pharmaceutical Law of 6 September 2001, at a price no higher than the official selling price.

The reimbursed pharmaceutical can be covered by a specific risk sharing agreement concluded during the process of issuing the reimbursement decision.

Prices are controlled by the Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices of 12 May 2011 (Reimbursement Act).

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

The costs of pharmaceuticals are reimbursed from public funds within the limits laid down by the Reimbursement Act and in reimbursement decisions, and in a notice list of reimbursed products published by the Minister of Health.

To obtain the best health effects for the public funds available, the Minister of Health will issue an administrative decision on reimbursement, official selling price and co-payment terms, with regard to:

  • The stance taken by the Ministry of Health Economic Commission.

  • Recommendations of the President of the Agency for Health Technology Assessment.

  • The significance of the clinical condition to which the reimbursement application relates.

  • Clinical and practical efficacy.

  • Safety.

  • The benefits to risk ratio.

  • A comparison between the benefits to cost ratio of the previously reimbursed pharmaceutical and that covered by the application.

  • Price competitiveness.

  • The impact on the costs of an entity obliged to finance healthcare services from public funds and on service recipients.

  • The existence of alternative medical technology and its clinical efficacy and safety.

  • Health priorities laid down by the Minister of Health.

  • The threshold cost of gaining an additional year of life adjusted by quality, set at three times the gross domestic product per capita referred to in Article 6(1) of the Act on the Method of Calculating the Value of Annual Gross Domestic Product of 26 October 2000 (and if this cost cannot be established, the cost of gaining an additional year of life).

  • Other medical procedures which may be applied for a given clinical condition, and which may be replaced with the medicine, foodstuff for particular nutritional uses or medical device covered by the application.

Under the Reimbursement Act, medicinal products for which a reimbursement decision was issued are dispensed to a service recipient as follows (up to the financing limit and against payment of the difference between the retail price and the financing limit):

  • Free of charge.

  • At a fixed payment level.

  • At a payment level of 30% or 50% of their financing limit.

The reimbursement decision also gives the specific medical indications for which the medicinal product is to be reimbursed. This means that public reimbursement for medicinal products will cover only particular uses of the product. The majority of products are reimbursed for all indications listed in the marketing authorisation. However, the reimbursement decision can be limited to selected indications, or be expanded to include indications not stated in the marketing authorisation (off-label reimbursement).

Compensation

Pharmacies keep records of reimbursed medicines sold on prescription in electronic form, and send data compiled by e-mail to their local National Health Fund voivodship branch.

The branch examines the data and asks the pharmacy to supplement it, if necessary. Pharmacies then send to the competent National Health Fund voivodship branch in writing the reconciled collective specification, constituting the basis for reimbursement.

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

The requirements for conducting clinical trials of medicinal products are laid down in the Pharmaceutical Law of 6 September 2001 (Pharmaceutical Law) and in a number of implementing regulations.

According to the Pharmaceutical Law, clinical trials are controlled by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL President). To facilitate the URPL President's work, in 2011 the Medicinal Products Inspection Department was set up. Inspections can be carried out in a domestic procedure and on the request of the European Medicines Agency. They can cover the trial centres, the sponsor's head office, organisations conducting clinical trials to order and other recognised sites. The procedure for and scope of clinical trial inspections are laid down in the Minister of Health Regulation on Clinical Trial Inspections of 26 April 2012.

For this purpose, the URPL President keeps a Central Clinical Trial Register, which contains details of all new, registered clinical trials, that is:

  • Title of the clinical trial.

  • Number of the clinical trial protocol.

  • Number of the clinical trial in the European database of clinical trials (EudraCT).

  • Names and addresses of the trial centres in which the clinical trial is conducted.

  • Description of the clinical trial phases.

  • Name of the investigational medicinal product.

  • Name of the active substance.

  • Number of clinical trial subjects.

  • Features of the group of clinical trial subjects.

  • Sponsor's name and address or business name and registered office address.

  • Name, title and educational qualifications of the investigator.

  • Name, title and science degree of the clinical trial co-ordinator, if a co-ordinator participates in the trial.

  • Clinical trial notification date.

  • Clinical trial end date.

  • Information on decisions regarding the clinical trial.

  • Number of the clinical trial in the Central Clinical Trial Register.

Polish regulations on clinical trials are to be replaced in the near future by Regulation (EU) on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. It has not yet been decided what form some of the implementing provisions will take (for example, how the sponsor will co-operate with bioethics committees). For example, whether the Polish legislator will introduce a separate Clinical Trials Act regulating these issues, or whether the relevant provisions of the Pharmaceutical Law will be significantly amended.

Authorisations

Clinical trials can only be conducted based on an authorisation issued by the URPL President (as an administrative decision) and also on a positive bioethics committee opinion. The URPL President then registers the clinical trial in the Central Clinical Trial Register. Under the Pharmaceutical Law, clinical trials of investigational medicinal products are conducted in accordance with Good Clinical Practice, which lays down the method for designing, conducting, monitoring, documenting and reporting the results of clinical trials conducted on humans. All trials have to be registered in the Central Clinical Trial Register.

Consent

Patients participate in clinical trials voluntarily. Before taking part in a trial, patients have to give their informed consent, at which time they will be given all the details of the trial. It is essential for patients to be given sufficient time to learn about the trial and to take a decision.

Information provided to patients must be assessed by independent bioethics committees in terms of, among other things, whether it is comprehensible to the average patient.

Once a patient has agreed to take part in a trial, he will receive a copy of information about the trial and an informed consent form, to be signed by both the patient and the doctor.

Trial pre-conditions

The Minister of Health Regulation on Good Clinical Practice of 2 May 2012 (GCP Regulation) lays down the obligations of the investigator and the sponsor in the clinical trial. The GCP Regulation also lays down the rules for drawing up the trial protocol, insurance requirements, the investigator's brochure and the clinical trial agreement.

Both the trial sponsor and the doctor conducting the trial must be insured against civil liability for the trial. The requirements, the scope of the insurance and the minimum guaranteed sum of civil liability insurance for the investigator and the sponsor are laid down in the Minister of Finance Regulation on mandatory civil liability insurance for investigators and sponsors of 30 April 2004. The minimum guaranteed sum of the civil liability insurance depends on the number of clinical trial subjects, up to EUR5 million if there are more than 100 subjects.

If, due to the administration of an investigational medicinal product, a patient has to bear additional costs of healthcare services, he is entitled to have these costs reimbursed based on documentation (bills, invoices) which should be given to the doctor conducting the trial. The costs of treating possible adverse reactions are covered by the trial sponsor.

In 2015, amendments were made to provisions to facilitate the conduct of non-commercial clinical trials. One of the key amendments excluded the requirement for a non-commercial sponsor to finance potential health services for a trial subject, if that subject receives publicly financed healthcare. The aim of these changes is to increase the number of non-commercial clinical trials conducted in Poland. This is particularly important as the costs of conducting trials in Polish is still low compared to other EU states and Poland has a large population of potential trial subjects.

Procedural requirements

A trial protocol has to be kept. This is the main document in a clinical trial. The protocol describes the objectives, design, methodology, statistical considerations and organisation of the clinical trial, and is the research agenda based on which all clinical trials are conducted in Poland. The aim of the protocol is to protect trial subjects and also to answer questions asked in the trial. The protocol stipulates which persons can be trial subjects, gives the trial time schedule and specifies the medical procedures, medicines, dosages and length of the trial.

During a clinical trial, subjects are regularly examined by the investigational team to monitor their health and confirm the safety and efficacy of the treatment. According to the Pharmaceutical Law, clinical trials of an investigational medicinal product are conducted in compliance with good clinical practice, which lays down the method for designing, conducting, monitoring, documenting and reporting the results of clinical trials conducted on humans.

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

Manufacturing licences are granted by an administrative decision issued by the Main Pharmaceutical Inspector. The application form is attached to the Minister of Health regulation of 10 March 2015 on the form for applications for licences to manufacture or import medicinal products. The following documents must be attached to the application:

  • Documentation regarding the main place of business.

  • Notification of the qualified person.

  • Copy of a certificate showing that a National Official Business Register (REGON) identification number has been issued.

  • Statement on entry in the Central Registration and Information on Businesses, if required.

  • Excerpt from the Polish Court Register or a printout from the Central Information of the Polish Court Register as at the date the application is filed, if required.

  • Proof of payment of the fee for the licence to manufacture or import medicinal products.

The licence application must:

  • Include the applicant's business name and tax identification number.

  • Specify the medicinal product's type and name, pharmaceutical form, manufacturing site, scope of manufacture and place of inspection.

  • Provide data on quality assurance and data showing that good manufacturing practice requirements are met.

Conditions

The applicant must:

  • Have the appropriate premises and technical and control equipment needed to manufacture, control and store the medicinal products listed in the application.

  • Employ a qualified person to be responsible for ensuring, prior to market release, that each batch of the medicinal product has been manufactured and controlled, in accordance with the law and the requirements in the specifications and documents based on which the product was approved for sale.

Restrictions on foreign applicants

There are no special restrictions or barriers for foreign entities. They have to meet the same criteria as domestic businesses.

Key stages and timing

To obtain a medicinal product manufacturing licence, an application must be filed with the Main Pharmaceutical Inspector for a medicinal product manufacturing licence, in accordance with the Minister of Health regulation on the form for applications for licences to manufacture or import medicinal products.

A hard copy of the documentation should be submitted to or sent to the Main Pharmaceutical Inspector.

The documentation will be examined in both formal and substantive terms.

If any deficiencies are found (if documents are missing), the applicant will be required to remedy (or provide) them, indicating the legal grounds for this. If the company does not remedy formal deficiencies within seven days, the application will not be examined, in accordance with the Code of Administrative Procedure.

Fee

The fees are listed in the Minister of Health Regulation of 9 July 2015 on the amount and manner of collecting fees for applications for licences to manufacture or import medicinal products or for variations in a licence to manufacture or import medicinal products.

For filing an application for a licence to manufacture or import medicinal products, the following fees apply (irrespective of the number of medicinal products):

  • PLN3,300 for manufacture of non-sterile medicinal products.

  • PLN4,300 for manufacture of sterile medicinal products.

  • PLN5,500 for manufacture of non-sterile and sterile medicinal products.

  • PLN2,300 for import of medicinal products.

  • PLN5,600 for import of medicinal products and manufacture of non-sterile medicinal products.

  • PLN6,600 for import of medicinal products and manufacture of sterile medicinal products.

  • PLN7,800 for import of medicinal products and manufacture of non-sterile and sterile medicinal products.

Period of authorisation and renewals

According to the Pharmaceutical Law, the Main Pharmaceutical Inspector will issue a licence or refuse to issue a licence within 90 days of the date the application is filed. This term ceases running if the applicant is asked to supplement documentation or if the proceedings are suspended.

The Main Pharmaceutical Inspector issues administrative decisions:

  • Granting a licence to manufacture or import medicinal products.

  • Varying a licence to manufacture or import medicinal products.

  • On expiry of a licence to manufacture or import medicinal products.

Monitoring compliance and imposing penalties

The quality of medicinal products is monitored at voivodship level by 16 Voivodship Pharmaceutical Inspectors, and at national level by the Main Pharmaceutical Inspector officers.

Monitoring covers preventative measures regarding the quality of medicinal products, such as:

  • Inspecting medicinal product transport, handling and storage conditions.

  • Inspecting pharmacies and other units carrying on the retail sale and wholesale of medicinal products.

  • Inspecting that medicinal products are labelled and advertised correctly.

Medicine quality is directly controlled by:

  • Inspecting the quality of magistral and officinal medicines made up in pharmacies.

  • The Pharmaceutical Inspectorate sending medicinal products marketed for the first time under Polish law for quality tests, in specialist institutions and research laboratories.

  • Sending medicinal products for tests under the National Surveillance Plan, in accordance with an approved schedule and scope of control. Medicine samples for testing are taken from various units in all voivodships.

If, during inspections and tests, there is good cause to suspect that a medicinal product does not meet requirements, State Pharmaceutical Inspectorate authorities will issue the relevant decisions:

  • Voivodship pharmaceutical inspector: decisions to suspend trade in particular batches of a medicinal product in its voivodship.

  • Main Pharmaceutical Inspector: decisions to suspend trade in particular batches of a medicinal product nationwide.

After these decisions, trade in (sale of) indicated batches of a medicinal product is suspended in all wholesale dealers and pharmacies until laboratory test results confirming or excluding a quality defect are obtained.

If the test results confirm that a medicinal product does not meet quality requirements, the Main Pharmaceutical Inspector will take a decision to withdraw the medicinal product from the market (or to ban it, if it has not yet been released onto the market).

Decisions can:

  • Temporarily prohibit the sale of a specific product.

  • Suspend trade in this product.

  • Withdraw the product from the market.

These decisions are issued on the request of the URPL President.

If medicinal products give rise to a risk to public health, the Main Pharmaceutical Inspector will, on the request of the Minister of Health or the URPL President, issue a decision temporarily banning the product from being released onto the market, suspending trade in the product or withdrawing it from the market.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?

Application

Marketing authorisation applications in national procedures are submitted to the URPL President. A detailed description of the application is given in the Pharmaceutical Law.

Authorisation conditions

To obtain a marketing authorisation, the applicant must file the appropriate application form, with all the elements and documents required under the Pharmaceutical Law, including:

  • Details of the packaging.

  • Accompanying leaflet.

  • The results of adequate clinical and non-clinical trials.

Under the Pharmaceutical Law, the URPL can carry out a pre-registration inspection of the place of manufacture if a medicinal product is manufactured abroad. Such an inspection can be commissioned if the URPL President doubts whether the conditions of manufacturing in the facility are in line with the copy of the manufacturing authorisation attached to the application for marketing authorisation of the medicinal product.

Medicinal products can also be authorised by the EMA or the European Commission through the centralised procedure, under Regulation (EC) No 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMA Regulation).

Products that do not require a marketing authorisation include:

  • Medicinal products intended for clinical trials.

  • Medicinal products used by manufacturers.

  • Pharmaceutical raw materials.

Key stages and timing

There are three main types of marketing authorisation proceedings that differ in terms of rules and time limits:

  • Full national procedure: must be concluded within 210 days of the application filing date.

  • Mutual recognition procedure: based on the medicinal product having already been registered in other countries, and cannot take more than 90 days.

  • Decentralised procedure: parallel registration of the medicinal product in a number of EU countries, and takes no more than 210 days.

Fee

The fees are listed in an annex to the Minister of Health Regulation of 16 June 2015 on data on sales of medicinal products to be provided by pharmaceutical wholesale dealers.

If the marketing authorisation holder files more than one application for a marketing authorisation for a medicinal product at the same time, the fees are as follows:

  • Form of the medicinal product: fee for filing another application is 70% of the fee for the first application.

  • Strength of the medicinal product: fee for filing another application is 30% of the fee for the first application.

  • Form and strength of the medicinal product: fee for filing another application is 100% of the fee for the first application.

Period of authorisation and renewals

Marketing authorisations are issued for five years (trial period). The authorisation term can, on the request of the marketing authorisation holder, be extended or shortened. If the marketing authorisation holder submits a request at least six months before the expiry date, the next authorisation can be issued for a non-fixed term.

Monitoring compliance and imposing penalties

In the event of non-compliance, the URPL President will issue one of the following decisions to:

  • Vary the marketing authorisation.

  • Suspend the marketing authorisation.

  • Revoke the marketing authorisation.

  • Refuse to extend the marketing authorisation term.

The most severe decision is for a marketing authorisation to be revoked. The URPL President will revoke an authorisation if:

  • An unexpected serious adverse reaction to the medicinal product occurs that endangers human life or health.

  • The medicinal product does not have the declared therapeutic efficacy, or the risk of using the product is found to be disproportionate to its therapeutic effect.

  • The medicinal product is found to be distributed in breach of the authorisation or the Pharmaceutical Law.

  • The recommended withdrawal period is too short to ensure that food products obtained from treated animals do not contain residues that could pose a danger to consumers' health.

  • The URPL President is not notified of new information, covered by the documentation referred to in Article 10 of the Pharmaceutical Law, that could lead to use of the medicinal product being restricted.

If an authorisation is revoked, the URPL President will remove the medicinal product from the register. The URPL President must notify the European Council or the European Commission if an authorisation has been revoked.

The URPL President must also inform the Main Pharmaceutical Inspector that an authorisation has been revoked. In case of veterinary medicinal products, the URPL President also informs the Chief Veterinary Officer.

 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

A marketing authorisation holder must:

  • Appoint a qualified person for pharmacovigilance (QPPV).

  • Implement and regularly audit a pharmacovigilance system.

  • Keep a record of adverse reactions.

  • Have a full description of the pharmacovigilance system implemented by the marketing authorisation holder on receipt of the marketing authorisation for a given medicinal product.

  • Within seven days of a request, send the URPL President a full description of the pharmacovigilance system.

  • Provide the URPL President by a set date with documents showing the risk-benefit ratio of the medicinal product.

  • Provide scientific data showing the risk-benefit ratio for the medicinal product.

  • Send the URPL President without delay:

    • any data that could have a material impact on or change the scope of the marketing authorisation documentation;

    • information on any restrictions imposed by another country in which the product is being marketed; and

    • any new information that could affect the risk-benefit ratio.

  • Set up special pharmacovigilance and monitoring systems for medicinal products by notifying the name and batch number of these products to the URPL President, which:

    • are to be administered to pregnant women;

    • may cause adverse reactions; and

    • are biological medicinal products;

  • Notify the URPL President the first time a medicinal product is released onto the market.

  • Notify the URPL President if a medicinal product ceases to be distributed, either temporarily or permanently, no less than two months before the medicinal product ceases to be distributed, and if distribution of the product is ceased due to exceptional circumstances, without delay after these circumstances arise.

  • On the request of the URPL President, provide data on the volume of sales of the medicinal product.

  • In respect of medicinal product manufacture and control measures, take account of scientific and technical progress in accordance with generally accepted scientific methods.

  • Supply medicinal products only:

    • to authorised wholesalers;

    • to healthcare providers and hospital pharmacies;

    • to research and development units, scientific establishments of the Polish Academy of Science and main organisational units of public higher education establishments for scientific testing purposes;

    • within export activity carried on by the marketing authorisation holder itself, or by an entity contracted by the marketing authorisation holder.

  • Immediately notify the URPL President, all other competent authorities and the EMA about measures taken by the marketing authorisation holder to:

    • periodically or permanently suspend the sale of a medicinal product; and

    • withdraw from the marketing authorisation, together with the reasons for doing so,

  • Send pharmacovigilance data to the EMA.

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

An applicant can use an abridged procedure for marketing authorisation in certain circumstances. In particular, the applicant does not have to provide the results of non-clinical or clinical trials if it can show that its medicinal product is the equivalent of a reference medicinal product already marketed in Poland or in another EU or EFTA member state (except Switzerland) (generic product) and either:

  • It obtains consent from the MAH of the reference product to the results of clinical and non-clinical trials being used in the application.

  • At least eight years have passed from the day the first authorisation to market the reference product was issued in an EU or EFTA member state (except Switzerland) to the day the marketing application for the generic is filed in Poland (data exclusivity period).

Regardless of marketing authorisation, the generic cannot be placed on the market until ten years have elapsed from the day the initial authorisation for the reference product is issued in an EU or EFTA member state, except Switzerland (marketing exclusivity period). This ten-year period can be extended for 12 months if authorisation is obtained for a new indication(s) for the reference medicinal product which, in the Registration Office's opinion, have significant clinical benefits.

The results of non-clinical or clinical trials can be replaced or supplemented by scientific publications if the applicant can show that the active substance(s) in the medicinal product have been both:

  • Widely used for medical purposes in an EU or EFTA member state (except Switzerland) for at least ten years from the first systematic and documented use of the substance in a medicinal product.

  • Deemed effective and of an acceptable safety level.

In an application containing new therapeutic indications based on relevant non-clinical or clinical trials of substances widely used for medical purposes, one year's data exclusivity is granted from the day of the decision.

In addition, the applicant does not have to provide detailed documentation (for example, a description of the product manufacturing process and control methods) if it obtains the consent of a marketing authorisation holder to use the documentation for a medicinal product already marketed in Poland, which is of both the same:

  • Quality and quantity concerning active substances.

  • Pharmaceutical form.

The following can also benefit from an abridged registration procedure, subject to certain conditions:

  • Traditional herbal medicinal products.

  • Homeopathic medicinal products.

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

Foreign marketing authorisations are recognised in Poland by the following procedures:

  • Centralised procedure. This enables a product to be marketed in all EU member states at once. The European Commission issues a marketing authorisation once the application has been examined by the EMA (based in London). The centralised procedure is compulsory for medicinal products for human use that are:

    • used to treat HIV/AIDS-related cancer, diabetes, neurodegenerative disorders, autoimmune diseases and other immune dysfunctions and viral diseases;

    • produced by biotechnological processes;

    • used in advanced therapy (for example, gene therapy); and

    • orphan medicines used to treat rare diseases.

  • Decentralised procedure. This applies where a medicinal product is marketed in the EU and the applicant applies for registration in another member state. The URPL President will issue a marketing authorisation within 30 days of examining an assessment report prepared by the relevant body in the reference state.

  • Mutual recognition procedure. In this procedure, a previously unregistered product is registered in a member state specified as the reference state and subsequently registered in secondary member states where the applicant wants the product to be marketed. This procedure is used as an alternative to the centralised procedure, and enables a product to be registered in selected member states at the same time. The URPL President will issue a marketing authorisation within 30 days of examining an assessment report prepared by the relevant body in the reference state.

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

Parallel import of medicines into Poland is possible under the Pharmaceutical Law.

According to Article 2(7b) of the Pharmaceutical Law, parallel import is any activity within the meaning of Article 72(4) involving bringing in from member states of the EU and 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:

  • The same active substance(s), strength, route of administration and form as a medicinal product approved for sale in Poland (or a similar form that does not give rise to therapeutic differences in relation to the medicinal product approved for sale in Poland).

  • The imported medicinal product and the medicinal product approved for sale in Poland are in the state from which the product is imported and in Poland respectively at the same time, either as reference medicinal products or equivalents of reference medicinal products.

Under the Pharmaceutical Law, the URPL President issues parallel import licences for five years. A licence can be renewed for a subsequent five years on the request of the parallel importer, filed at least six months before the end of the current licence term.

To start up activity, a parallel importer must obtain a parallel import licence for each product. The authority with power to issue parallel import licences is the URPL President (also the authority with power to vary and revoke a licence). The application for a parallel import licence must contain:

  • The main data contained in the authorisation issued by the member state of the EU or EFTA (party to the Agreement on the European Economic Area) from which the medicinal product is imported.

  • Details of the parallel importer.

  • A mock-up of the package labelling and package leaflet.

  • A copy of the manufacturing licence issued by the authorised body of a member state of the EU or EFTA, a party to the agreement on the European Economic Area, including as regards packaging.

  • Proof of payment of the application filing fee.

The licence must be issued within 45 days of a correct application being filed.

An importer does not have to market a medicine in Poland just because it has obtained a licence. If it wishes to do so, it has to inform:

  • The Main Pharmaceutical Inspector.

  • URPL President.

  • The marketing authorisation holder with the marketing authorisation for Poland.

The parallel importer must provide this information at least 30 days before the date on which the medicinal product is planned to be released onto the market. If the medicine is registered in a central procedure, the licence for parallel distribution from a member state in which it was released onto the market to the target country is issued by the EMA.

If a change is made to the design of the label or package leaflet of a medicinal product, the trade mark holder must be informed. Although this requirement is not explicitly laid down in national provisions, it derives from case law of the Court of Justice of the European Union (ECJ). Regardless of whether there are statutory requirements, these requirements under ECJ case law should be borne in mind.

 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

It is prohibited to aim the following at persons authorised to write prescriptions and persons that distribute medicinal products:

  • Advertising involving gifts.

  • Offers or promises of material benefits.

  • Presents or other inducements.

  • Prizes.

  • Trips or the organisation and financing of meetings to promote medicinal products, during which the hospitality exceeds the main purpose of the meeting.

Accepting such benefits is also prohibited. However, these prohibitions do not apply to giving or accepting items bearing a mark advertising a given firm or medicinal product and valued at under PLN100, and that are relevant to the practice of medicine or pharmacy.

Free samples can be provided to professionals up to a maximum of five per year.

Pharmaceutical companies affiliated within the Employers' Union of Innovative Pharmaceutical Companies (INFARMA) have limited this number in INFARMA regulations to four free samples per year, and only for five years after the date the first marketing authorisation is issued for a product.

INFARMA also has regulations on gifts to doctors. According to the INFARMA Code, it is permitted to give items that are directly related to medical practice (informative or educational) of under PLN100.

Advertising that involves free product samples being given cannot involve medicinal products containing psychotropic or narcotic substances.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

To market a medicinal product, a person must apply for a marketing authorisation from the URPL President (see Question 9).

Under the Pharmaceutical Law, the retail sale of medicinal products must be carried out in:

  • Pharmacies open to the public.

  • Pharmacy dispensaries, which can be run by an individual, a legal entity and an unincorporated commercial company.

A pharmacy manager must be a pharmacist with one year's practical experience, or a pharmacy technician with three years' practical experience in pharmacies open to the public. A licence is required to operate a pharmacy dispensary.

The retail sale of over the counter (OTC) medicinal products, except for veterinary medicinal products, can be carried on by:

  • Herbal medicine shops.

  • Specialist medical supply shops.

  • Shops open to the public.

The direct mailing of drugs is permitted in Poland. Pharmacies open to the public and pharmacy dispensaries are allowed to sell non-prescription medicinal products by mail order. Specific requirements for the direct mailing of drugs (that is, the methods by which medicinal products are supplied to recipients, the requirements to be met by premises of pharmacies open to the public and pharmacy dispensaries) are laid down in the Ministry of Health Regulation of 26 March 2015 on the direct mailing of medicines.

Information about retail pharmacies and dispensaries that directly mail drugs can be found in the National Register of Licences to Run Pharmacies Open to the Public and the Register of Consents to Run Hospital and Institutional Pharmacies.

Any website on which medicinal products are offered for sale by mail order must display the logo referred to in paragraph 85c(3) of Directive 2001/83/EC on the Community code relating to medicinal products for human use. Medicines can also be mailed outside Poland.

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

The advertising of medicinal products is regulated in two acts of law:

  • Pharmaceutical Law of 6 September 2001.

  • Minister of Health Regulation of 21 November 2008 on medicinal product advertising.

Some pharmaceuticals companies that are members of business organisations have additional requirements for advertising that are often more restrictive than provisions of law. For example, member companies of INFARMA have an internal Code of Good Practices for the Pharmaceutical Industry and a Transparency Code which governs disclosures regarding co-operation between healthcare professionals and healthcare organisations.

Regulations on fair market practice which are mandatory for all companies are laid down in the following legislation:

  • Unfair Competition Act of 16 April 1993.

  • Competition and Consumer Protection Act of 16 February 2007.

Restrictions

There is a prohibition on advertising to the general public medicinal products that:

  • Are only available on medical prescription.

  • Contain psychotropic or narcotic substances.

  • Are listed as reimbursed medicines in accordance with other regulations and can be dispensed over the counter and have names identical to those on these lists.

The prohibition also applies to the advertising of any medicinal product whose name is identical to that of a medicinal product dispensed only on prescription. However, it does not apply to preventive vaccinations specified in a communication from the Chief Sanitary Inspector.

The advertising of medicinal products is prohibited if (chapter 4, Pharmaceutical Act):

  • The products have not been approved for sale in Poland.

  • The products have been approved for sale but a direct import licence has not been obtained.

  • The advertising contains information that is not compatible with the summary of product characteristics.

Medicinal product advertising cannot be misleading, must show the product in an objective light and provide information on its sensible use.

In general, the advertising of a medicinal product cannot be directed at children or contain any element directed at them. The advertising of a medicinal product which refers to a full advertisement, apart from its invented name and international non-proprietary name, can only contain a trade mark that contains no references to therapeutic indications, pharmaceutical form, dose, advertising slogan or other advertising content.

There are other restrictions on the advertising of a medicinal product to the general public, for example it cannot involve:

  • A medicinal product being presented by well-known persons, scientists, persons with medical or pharmaceutical education or purporting to have such education.

  • References to recommendations of well-known persons, scientists, persons with medical or pharmaceutical education or purporting to have such education.

The advertising of a medicinal product to the general public cannot contain any content which suggests that:

  • A medical consultation or surgical operation is unnecessary, particularly by offering a diagnosis or by suggesting treatment by mail.

  • Even a healthy person's health can be enhanced by taking the medicinal product.

  • A person's health could be affected by not taking the medicine. This does not apply to vaccinations campaigns run by the Main Sanitary Inspectorate.

  • The medicinal product is a foodstuff, cosmetic or other consumer product.

  • The safety and efficacy of the medicinal product is due to it being natural.

  • The effects of taking the medicinal product are guaranteed, are unaccompanied by adverse reactions or are better than or equivalent to those of another treatment method or treatment with a medicinal product.

  • Could, by citing detailed descriptions of cases and symptoms of illness, lead to erroneous self-diagnosis.

  • Refers to therapeutic indications in inappropriate, alarming or misleading terms.

  • Contains inappropriate, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or the action of a medicinal product on the human body or parts of it.

The advertising of a medicinal product to the general public cannot promise directly or indirectly any material or immaterial benefits.

The Pharmaceutical Act specifies several types of medicinal products that cannot be advertised to consumers, that is, those:

  • That are available on medical prescription only.

  • That contain narcotic or psychotropic substances.

  • That have been placed on the lists of reimbursed medicines in accordance with separate regulations and can be dispensed over the counter with a name identical to those on these lists.

  • Whose name is identical to that of a medicinal product available on medicinal prescription only.

Only medicines not listed in these restrictions can be advertised to the general public.

Internet advertising

Only over-the-counter medicinal products can be marketed. Marketing is in practice limited to advertising through the press, radio, television, the internet and other written material, all of which is regulated in the same way.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

The Personal Data Protection Act regulates personal data processing, and is aimed at standardising personal data processing and data flows and ensuring that these processes are carried on correctly and in compliance with the law.

According to the Personal Data Protection Act, personal data means any information relating to an identified or identifiable natural person. Personal data enables a person to be identified directly or indirectly without excessive costs, time or actions having to be incurred/taken.

There are different levels of personal data protection under the Personal Data Protection Act. It ensures a higher level of protection for the personal data indicated in Article 27, that is, sensitive data. Section 1 of Article 27 contains a general prohibition on processing sensitive data, except for the cases listed in section 2.

Sensitive personal data includes data on the state of a person's health. The nature of this data is broad and unspecified, which means that generally all information about the state of a person's health (for example, that he wears spectacles) must be treated as sensitive data. This stance is also taken by a data protection working group set up under Article 29 of Directive 95/46/EC on the protection of personal data.

Data on the state of a person's health covers not only information about a patient's illnesses and diagnostic and therapeutic procedures but also personal data with a clear and strong link with the state of the person's health, such as data on medicines, alcohol or drugs and genetic data. In fact, all data in medical documentation and in electronic healthcare documentation must be treated as sensitive data subject to special protection.

 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.

Legislation and regulatory authority

Package labelling and package leaflets are controlled by the Main Pharmaceutical Inspector and the URPL President, under:

  • Minister of Health Regulation of 20 February 2009 on requirements for medicinal product packaging, labelling and package leaflets.

  • Minister of Health Regulation of 5 November 2013 amending the regulation on requirements for medicinal product packaging, labelling and package leaflets.

Product information on medicinal products (summary of product characteristics, package leaflet, graphic design of packaging and leaflets) to be administered to humans is assessed in a national or European procedure (decentralised (DCP) and mutual recognition (MRP)). Substantive assessments are made by the URPL President.

Information requirements

The package leaflet contains information for patients about the medicinal product. It is approved during the medicine registration process and is enclosed in each package. The package leaflet contains key information that a patient should read before using the medicine for the first time.

Information that must be given on the package leaflet includes:

  • The name of the medicine and the international non-proprietary name of the active substance (if the medicine contains only one active substance).

  • Therapeutic indications.

  • Information needed when starting to take the medicine (counterindications, appropriate precautions when using the medicine, and interaction, for example with alcohol).

  • Warnings for certain user groups (particularly children, pregnant or breastfeeding women, and elderly patients).

  • Description of adverse reactions that could arise during proper administration of the medicinal product.

  • Warning that the medicinal product must not be used after the sell-by date.

  • Description of special storage requirements, if any.

Medicinal product packaging comprises direct packaging, which is in direct contact with the medicinal product (for example, sachets, ampoules, blister packs, and bottles) and outer packaging (optional) comprising direct packaging and a package leaflet.

Information that must be on outer packaging includes:

  • The name of the medicine and the international non-proprietary name of the active substance (if the medicine contains only one active substance).

  • Strength (content of active substance per dosage unit, for example in one tablet, per unit of volume or weight).

  • Pharmaceutical form (for example, coated tablet, capsule, and suspension).

  • Method of use and (optionally) route of administration.

  • Special storage conditions, for example inaccessible to children.

  • Details of marketing authorisation holder (the manufacturer).

  • Sell-by date.

Braille for the blind is also used on outer packaging. It gives the name of the medicinal product, its strength and pharmaceutical form.

Information that must be on direct packaging includes:

  • The name of the medicine and the international non-proprietary name of the active substance (if the medicine contains only one active substance).

  • The name of the marketing authorisation holder.

  • Sell-by date.

  • Batch number.

Direct packaging must also bear printed symbols or pictograms, so that the information is more accessible and comprehensible to patients, but it cannot be used to advertise the product.

Other conditions

Package labelling and package leaflets must be in Polish. Information can also be in any of the official languages of the member states of the EU or European Free Trade Association (EFTA) (party to the Agreement on the European Economic Area), provided that it accords with the Polish version.

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

Main Pharmaceutical Inspector

Its main tasks under the Pharmaceutical Law are to:

  • Supervise compliance with the Pharmaceutical Law as regard advertising. It can, therefore, by way of a decision, order that:

    • advertising a medicinal product contrary to applicable provisions be ceased;

    • the decision be published in the places where the advertising was shown, together with a correction of the advertising.

  • Issues decisions to:

    • suspend or withdraw a medicinal product from the market or from use in healthcare centres, if it is suspected or found that the product or device has not been approved for sale in Poland;

    • suspend or withdraw a medicinal product from the market or from use in healthcare centres, if it is suspected or found that the product or device does not meet applicable quality requirements;

    • suspend or withdraw from pharmacies open to the public and pharmaceutical wholesale dealers goods, the trade in which is illegal;

    • suspend from trade in pharmaceutical wholesale dealers, pharmacies, pharmacy dispensaries or non-pharmacy outlets referred to in Article 71(1)(1) to (4), and from use in healthcare centres, medical devices if it is suspected that a product or device does not meet the applicable quality requirements;

  • Grant, vary, withdraw or refuse to grant a medicinal product manufacturing licence or a wholesale dealer's licence for medicinal products and medical devices, and ensure that inspections of manufacture and wholesale distribution are carried out according to uniform standards.

Office for Registration of Medicinal products, Medical Devices and Biocidal Products

The URPL President's tasks include:

  • Conducting proceedings and taking measures regarding medicinal products, particularly:

    • issuing, by way of a decision, marketing authorisations for medicinal products;

    • supervising and monitoring the safety of medicinal products and veterinary medicinal products;

  • Conducting proceedings and taking measures regarding safety, trade and use of medical devices, particularly:

    • issuing decisions regarding medical devices;

    • monitoring incidents with medical devices and activities regarding the safety of medical devices;

    • issuing, by way of a decision, licences to conduct clinical trials of medical devices and to changes in a clinical trial;

    • supervising medical devices manufactured or released onto the market and used in Poland;

    • resolving disputes over classification rules and setting classification of medical devices and of medical device accessories, and qualification of medical devices for in vitro diagnostics;

    • issuing certificates of free sale; and

    • co-operating and exchanging information with international organisations, including information on safety.

  • Co-operating with the competent EU institutions, the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines and Healthcare (EDQM), competent authorities of member states of the EU and EFTA.

Competition and Consumer Protection Office (UOKiK)

The UOKiK President brings administrative proceedings on receiving information from the Trade Inspectorate, which is the authority that controls whether products meet safety requirements. Measures are also taken on information from other sources, for example from consumers or the supervision authorities of other EU member states.

If the UOKiK President finds that a product poses a danger to the life and health of users it can, by a decision, impose on the manufacturer or distributor specific obligations, including banning the product from the market or ordering:

  • The product to be labelled with warnings about the dangers it poses.

  • Warnings for consumers, for example by a notice published in the press.

  • Dangers to be eliminated.

  • The product to be withdrawn from the market.

  • The product to be withdrawn from consumers.

A product being withdrawn from consumers means that the company has to buy it back from users for the price at which it was sold, regardless of the degree of destruction. A consumer that has proof of purchase can claim against the distributor from which it purchased the product, and if it does not have proof directly against the manufacturer.

Products that the UOKiK President deems do not meet safety requirements are entered in the dangerous products register. An entrepreneur that releases such products onto the market can face a fine of up to PLN100,000.

The UOKiK President can also, on his own initiative, inform the public about products that pose a danger to consumers.

 
20. Are there any mandatory requirements relating to medicinal product safety?

In Poland pharmacovigilance is carried out by the URPL President, who can inspect marketing authorisation holders in this respect, demand to be provided with pharmacovigilance documentation and request clarifications.

The list of inspection powers of the URPL President as regards pharmacovigilance is not exhaustive. A detailed description of the scope of inspections and the course of them is in the Minister of Health regulation of 6 August 2007 on the manner of conducting pharmacovigilance of medicinal products.

Marketing authorisations are revoked by way of a decision. If marketing authorisation holders do not meet the pharmacovigilance requirements listed below, their marketing authorisations can be revoked:

  • Taking into account the risk management system for a medicinal product the requirements imposed in Article 23b-23d of the Pharmaceutical Law.

  • Pharmacovigilance in respect of situations indicated in Article 36g(1)(12) of the Pharmaceutical Law (for example, concerning medicines being administered to pregnant women).

  • Giving, by the deadline set by the URPL President, the estimated number of patients covered by the medicine.

  • Failure to meet other obligations imposed under Article 23b-23d of the Pharmaceutical Law.

The URPL President has a certain discretion in applying these sanctions. If a breach does not lead to direct danger to public health, it can issue a decision suspending the marketing authorisation for the medicine (Article 33(1a) , Pharmaceutical Law). Suspension of a marketing authorisation means that the medicine cannot be released onto the market. Suspension is for a fixed term. If the aim of the suspension is not attained during the suspension term, the marketing authorisation can be revoked.

The URPL President can, by way of an administrative decision, impose fines for breaches of pharmacovigilance requirements other than those mentioned above, for example for failing to:

  • Keep a register of adverse reactions.

  • Send Periodic Safety Update Reports (PSUR) when required.

  • Send Individual Case Safety Reports (ICSR).

Failing to meet pharmacovigilance requirements can also lead to a medicinal product being deemed a dangerous product, as defined in the Civil Code.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Substantive test

Liability for damage caused by a dangerous product is based on risk. The following must be shown:

  • Damage to property or persons.

  • That the damage was caused by a traded dangerous product.

There is no specific legal regime regarding liability for pharmaceuticals, but there is a regime regarding liability for damage caused by a dangerous product (including a dangerous medicinal product), which is considered tortious (ex delicto) liability. A causal link between the damage and the use of the product must be shown.

The general rule in Article 449 of the Civil Code is that anyone who, within the scope of his business activity, manufactures (manufacturer) a hazardous product is liable for any damage caused to anyone by the product.

The following entities bear the same liability as the manufacturer:

  • The manufacturer of materials, raw materials or a constituent part of a product, unless the sole cause of the damage was the defective construction of the product or the manufacturer's instructions.

  • Anyone who, by placing its name, trade mark or other distinguishing mark on the product, purports to be the manufacturer.

  • The importer of a dangerous product, that is, an entity that imports a product from abroad into the country as part of its business activity.

The burden of proof lies with the injured party, though the injured party does not have to show that the product had dangerous properties.

Liability

The manufacturer of a dangerous product is liable for any damage caused by the product.

 
22. Who is potentially liable for defective medicinal products?

The manufacturer of a defective product is liable for any damage caused by the product (Article 449(1), Civil Code).

The following entities have the same liability as the manufacturer:

  • The manufacturer of the material, raw material or product ingredient, unless the sole cause of the damage was due to either:

    • defective product construction;

    • the producer's instructions.

  • The nominal producer, that is, the entity that passes itself off as the producer by placing its name, trade mark or other distinguishing mark on the product.

  • The importer of a dangerous product, that is, an entity that imports a product from abroad into the country as part of its business activity.

Doctors' liability can be fault-based under Article 415 of the Civil Code, under which anyone who by fault on his own part causes damage to another person must remedy it. If a doctor treats a patient in a private clinic, he has contractual liability under Article 471 of the Civil Code, according to which a debtor must remedy any damage arising from non-performance or improper performance of an obligation, unless the non-performance or improper performance is due to circumstances for which the debtor is not liable, and non-contractual liability under Article 415 of the Civil Code.

For example, a doctor has liability for incorrectly prescribing medicines, and this applies to both administering the wrong medicine and giving the wrong dosage. As the person supervising the treatment process, the doctor is also liable for any failure to inform patients of the side effects of a medicine, even if the medicine has a package leaflet.

Both public and private healthcare centres can have not only liability (that is, substitute) for culpable damage caused by doctors and medical personnel working there (under Article 430 and Article 474 of the Civil Code), but also for a fault (organisational) on their own part. This involves improper organisation and incorrect functioning of a healthcare centre.

Entities providing health services must be covered by civil liability insurance.

 
23. What defences are available to product liability claims? Is it possible to limit liability for defective medicinal products?

The manufacturer or other entities liable for damage caused by a dangerous product can be released from liability for a dangerous product if:

  • It can show that it did not introduce the product to trade.

  • The product was introduced to trade outside the scope of the manufacturer's business activity.

  • The dangerous properties arose in the product after it was introduced to trade, unless they arose from causes previously characteristic of the product.

  • The product's dangerous properties arose after the product was introduced to trade, taking into account the scientific and technical knowledge at the time the product was introduced to trade.

  • The product's dangerous properties are the result of the producer applying applicable legal provisions.

One possible strategy to defend against product liability is for adverse reactions to a pharmaceutical product to be registered, and for this information to be included in the summary of the product characteristics. In the event of adverse reactions, liability can be avoided by adverse reactions being properly described and registered.

However, liability cannot be fully excluded. The risk can be managed by showing that adverse reactions to a medicinal product were registered earlier. In the event of a dispute, liability can be avoided if no causal link can be shown between the medicinal product and the adverse reaction.

 
24. How can a product liability claim be brought?

Limitation periods

The limitation period for product liability claims for pharmaceuticals is three years from the date the claimant learns of the damage and also of the person(s) obliged to remedy it. However, all liability claims involving pharmaceuticals become time-barred ten years after the batch release date.

The limitation period starts running when the claimant learns of the damage and of the potentially liable party. Knowledge of only one of these factors is insufficient to start the limitation period running.

In the event of a dispute, the court will examine evidence concerning the running of the limitation period when examining limitation claim arguments.

Class actions

The Act on Pursuing Claims in Group Proceedings came into force on 19 July 2010. This introduced a simplified procedure for claims to be brought jointly by a large group of at least ten claimants. To the best of the authors' knowledge, only 170 class actions have been brought in the five years since the Act came into effect, with only a few of them involving pharmaceuticals.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

In Polish Law, there are two main types of damage: property damage and personal damage.

In product liability, both property and personal damage may occur. However, according to Article 449(2) of the Civil Code, a manufacturer is liable for damage to property only if the thing destroyed or damaged is considered a thing which is usually intended for personal use, and the aggrieved party primarily used it for this purpose.

Possible claims in product liability cases are numerous and can be grouped as follows:

  • Property damage:

    • claim covering actual loss; and

    • claim covering lost profits.

  • Personal damage:

    • application for an injunction to prevent the defendant taking any further steps that could damage the claimant;

    • application for a relevant statement to be made in a specified form and of a specified content, usually in the media;

    • claim for recompense for damage caused during medical treatment;

    • claim for compensation, in the form of the difference between the claimant's profits before the accident caused by the product and the claimant's profits after the accident caused by the product; and

    • claim for recompense for damage suffered by the claimant (pain, stress, and so on).

In the Civil Code, there are no punitive damages.

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

There have been no proposals recently regarding amendments to the legal regime for liability for pharmaceuticals.

 

Patent protection and data and marketing exclusivity

 

Online resources

Internet system of legal acts (ISAP)

W http://isap.sejm.gov.pl

Description. This website is maintained by the lower chamber of the Polish parliament (Sejm). It contains bibliographic and legal texts published in official publications, including the Journal of Laws and the Polish Monitor issued by the Prime Minister. Legal texts are available in Polish only.

Main Pharmaceutical Inspector (MPI)

W www.gif.gov.pl/pl/decyzje-i-komunikaty/decyzje/decyzje

Descrption. The official website of the MPI provides access to decisions of the MPI (available in Polish only). The English version of the website does not provide access to decisions (www.gif.gov.pl/en).

Office for the Registration of Medicinal Products, Medical Devices and Biocides (Registration Office)

W http://en.urpl.gov.pl/general-information

Description. The official website of the Registration Office provides access to acts, rules and guidelines regarding the procedures for registration of medicinal products.

Office for Competition and Consumers' Protection

W https://uokik.gov.pl/home.php

Description. The official website of the Office for Competition and Consumers' Protection provides access to the main European and Polish legal competition regulations (in English).

Main Sanitary Inspectorate (MSI)

W http://gis.gov.pl/?go=news

Description. The official website of the MSI provides access to the acts, rules and guidelines regarding the marketing of food products.



Contributor profiles

Marcin Matczak, Partner, Head of Life Sciences Practice

Domanski Zakrzewski Palinka

T +48 22 557 86 28
F +48 22 557 76 01
E marcin.matczak@dzp.pl
W www.dzp.pl

Professional qualifications. Poland, Legal adviser

Areas of practice. Pharmaceutical and biotechnology law; competition law; administrative law; advertising law; food law; medical law; constitutional law.

Non-professional qualifications. Professor, Warsaw University

Languages. Polish, English, German.

Professional associations/memberships. Member of the District Chamber of Legal Advisers in Warsaw.

Publications. Author of over 40 academic publications, including two monographs:

  • Lobbying in the EU. Representation of business interests after accession, Warsaw, 2003.
  • Legal framework for the functioning of baskets of guaranteed benefits and private healthcare insurance) [in:] Healthcare insurance and benefit baskets. Przegląd rozwiązań, W.P. Kalbarczyk, K. Łanda, M. Władysiuk (ed.), Kraków/Warsaw, 2011.
  • Matczak M., Czarnuch M., Kaczyński T., Poland – Law & Practice, Chambers & Partners, 2015.
  • Matczak M., Kaczyński T., Kumala K., Distribution and marketing of drugs in Poland: Overview (Thomson Reuters – Practical Law Global Guides, 2015).
  • Matczak M., Kaczyński T., Kumala K., Commercialisation of healthcare in Poland: Overview (Thomson Reuters – Practical Law Global Guides, 2015).

Tomasz Kaczyński, Partner, Life Sciences Practice

Domanski Zakrzewski Palinka

T +48 22 557 86 53
F +48 22 557 76 01
E tomasz.kaczynski@dzp.pl
W www.dzp.pl

Professional qualifications. Poland, Legal adviser

Areas of practice. Pharmaceutical and biotechnology law, competition law, administrative law, advertising law, food law.

Languages. Polish, English.

Professional associations/memberships. Member of the District Chamber of Legal Advisers in Warsaw. Expert Council Member in the Polish Council for Supplements and Nutritional Foods (KRSiO).

Publications.

  • Matczak M., Czarnuch M., Kaczyński T., Poland – Law & Practice (Chambers & Partners, 2015).
  • Matczak M., Kaczyński T., Kumala K., Distribution and marketing of drugs in Poland: Overview (Thomson Reuters – Practical Law Global Guides, 2015)
  • Matczak M., Kaczyński T., Kumala K., Commercialisation of healthcare in Poland: Overview (Thomson Reuters – Practical Law Global Guides, 2015).

Krzysztof Kumala, Associate, Life Sciences Practice

Domanski Zakrzewski Palinka

T +48 22 557 86 40
F +48 22 557 76 01
E krzysztof.kumala@dzp.pl
W www.dzp.pl

Areas of practice. Pharmaceutical and biotechnology law; medical devices; administrative law; food law; cosmetics.

Languages. Polish, English.

Publications

  • Matczak M., Kaczyński T., Kumala K., Distribution and marketing of drugs in Poland: Overview (Thomson Reuters – Practical Law Global Guides, 2015).
  • Matczak M., Kaczyński T., Kumala K., Commercialisation of healthcare in Poland: Overview (Thomson Reuters – Practical Law Global Guides, 2015).
  • Kumala K., Stankiewicz R. (ed.), Jablonski M., Pieklak M., Madry M, Niedzinski T., Piecha J., Institutions of the pharmaceutical sector (Wolters Kluwer, 2016).

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