Life sciences in Poland: overview

A Q&A guide to life sciences 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, patents, trade marks, and product liability.

To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.

This Q&A is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Marcin Matczak and Aleksandra Auleytner, Domanski Zakrzewski Palinka Sp. k. Law Firm
Contents

Regulatory overview

1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?

Legislation

The Pharmaceutical Law of 6 September 2001 is the main law regulating the medicinal products' market. It is largely based on EU law.

Some of the most important issues that it regulates are the:

  • Principles and methods of marketing medicinal products (particularly concerning quality, efficacy and application safety requirements).

  • Requirements for conducting clinical trials of medicinal products.

  • Medicinal products':

    • manufacturing requirements;

    • advertising requirements;

    • marketing requirements.

  • Requirements for pharmacies, pharmaceutical wholesalers and non-pharmacy sale outlets.

  • Responsibilities and powers of the Pharmaceutical Inspectorate (see box, The regulatory authorities).

There are numerous implementing provisions to the Pharmaceutical Law, which provide additional regulations on the:

  • Advertising, manufacture and distribution of medicinal products.

  • Required forms for applications and authorisations.

Medical devices are mainly regulated in the Medical Devices Law of 20 May 2010. There is no specific law regarding biologicals, which are regulated within other acts, especially the Pharmaceutical Law.

Regulatory authorities

The key institutions regulating the medicinal product market include the:

  • Ministry of Health, which issues decisions on reimbursement of medicinal products (see Question 4).

  • Office for the Registration of Medicinal Products, Medical Devices and Biocides (Registration Office), which issues decisions on marketing authorisations (see Question 8).

  • National Health Fund (NHF), which funds the national healthcare system (see Question 2).

  • Main Pharmaceutical Inspectorate (MPI), which, for example, supervises medicinal product manufacturing and marketing requirements (see Questions 5 and 8).

See box, The regulatory authorities

Biotechnology and combination products

For biotechnology and combination products, Regulation EC/1394/2007 on advanced therapy medicinal products applies directly.

 

Pricing and state funding

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

The healthcare system is based on an insurance model (with certain exceptions relating to the uniformed forces, the judiciary, and so on). The main financing source is healthcare insurance entered into by Polish citizens with the Social Security Institution (SSI). Individuals contribute 9% of their personal income to the SSI, which the SSI then transfers to the payment institution, the National Health Fund (NHF). The NHF then transfers these funds to voivodship branches (Polish territorial branches).

Healthcare is provided to patients by both public and private healthcare institutions.

Both types of institution are regulated by the Act on Healthcare Services.

The NHF finances healthcare services, and covers the costs of reimbursable medicines, through agreements with the healthcare institution. The NHF enters into agreements with healthcare institutions that offer the most favourable terms. These institutions are selected through a tender process.

The Ministry of Health directly finances certain types of treatment (for example, vaccinations and highly specialised treatments), bypassing the NHF system.

 
3. How are the prices of medicinal products regulated?

In 2011 major changes in the pricing and reimbursement system were introduced. In many cases interpretative doubts about the changes are likely. The regulations set out below (and in Question 4) came into force on 1 January 2012.

Official prices are set for medicinal products reimbursed from public funds (see Question 4) which means both:

  • Prescribed medicinal products accessible in pharmacies.

  • Medicinal products which are part of other guaranteed healthcare services acquired by entities (including hospitals) that provide healthcare services under contracts executed with the NHF.

Hospitals include, among others:

  • Hospices.

  • Sanatoriums.

  • Any other centre that provides 24-hour care.

Official prices are set out in decisions issued by the Ministry of Health individually for each medicinal product.

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

See Question 3.

The reimbursement system covers all medicinal products for which a reimbursement decision has been issued by the Ministry of Health. The amount reimbursed depends on the payment category assigned in the Ministry of Health decision.

Applications for a medicine to receive a reimbursement decision should be filed with the Ministry of Health by:

  • Marketing authorisation holders (MAHs).

  • MAH representatives.

  • Parallel importers.

Official prices are set for medicines reimbursed from public funds at factory, wholesale and retail level. The prices set are fixed prices. The prices set for medicinal products which are part of guaranteed healthcare services and which are acquired by entities that provide healthcare services under contracts executed with the NHF are maximum prices.

Reimbursement is paid to pharmacies based on specifications of reimbursable medicine sales. It is not paid to the manufacturer or the pharmaceutical wholesaler.

 

Manufacturing

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

Application

Applications must be made to the MPI for a manufacturing licence. The MPI has the power to issue, refuse to issue, change and revoke licences. There are specific regulations on obtaining a licence for manufacturing advanced therapy medicinal products.

Conditions

The applicant must:

  • File a licence application.

  • Supply details of quality assurance, including fulfilment of Good Pharmaceutical Practice requirements.

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

  • Hire a qualified person.

Restrictions on foreign applicants

The MPI issues an opinion on whether the manufacturing conditions comply with requirements of Good Manufacturing Practice for a medicinal product manufactured abroad. This opinion is based on either:

  • An inspection conducted by the MPI manufacturing inspectors.

  • A report on an inspection carried out within the past three years by the competent authority of a:

    • member state of the EU or the European Free Trade Agreement (EFTA) (except Switzerland);

    • state which has an understanding on mutual recognition of inspections with an EU or EFTA member state (except Switzerland).

The MPI issues the opinion once it either:

  • Confirms that all the requirements have been met to manufacture a medicinal product corresponding to the declared quality.

  • Receives a manufacturing licence issued by the competent authority in the state where the product is presented.

Key stages and timing

Timings depend on the nature of the application:

  • Application to grant a new licence to manufacture medicinal products: the decision must be made within 90 days of the application date.

  • Application to change a manufacturing licence: the decision must be made within 30 days of the application date. The process can be extended by 60 days, where the circumstances justify this.

These periods are suspended if the application must be supplemented (for example, with additional evidence).

Fee

The fee for a licence to manufacture medicinal products depends on the nature of the production process:

  • Non-sterile production:

    • up to ten medicinal products: PLN3,300;

    • over ten: PLN4,300.

  • Sterile production:

    • up to ten medicinal products: PLN4,300;

    • over ten: PLN5,300.

  • Both sterile and non-sterile production:

    • up to ten medicinal products: PLN5,500;

    • over ten: PLN5,800.

(As at 1 November 2011, US$1 was about PLN3.1.)

For a change in the data specified in one point (for example, a change in the name of the manufacturer), the fee is PLN200, while the total fee for changing the licence cannot be more than PLN800.

Period of authorisation and renewals

A manufacturing licence is issued for an indefinite term once the MPI confirms that the applicant meets all the requirements.

 
6. What powers does the regulator have in relation to manufacturing authorisations?

Monitoring compliance

To monitor that the manufacturer's activities comply with the provisions of law and the licence, the MPI manufacturing inspector can carry out the following inspections:

  • Regular inspections of the manufacturers. The MPI carries these out at the manufacturer's premises at least once every three years.

  • Provisional inspections of the manufacturers. These are carried out if the MPI has cause to suspect the manufacturer of irregularities posing a danger to quality, application safety or the efficacy of the medicinal products it manufactures.

  • Provisional inspections of manufacturers of active substances or MAHs. These are carried out:

    • if the MPI has cause to suspect irregularities posing a danger to the quality or safety of the active substance;

    • on the request of the competent authority of:

      • an EU or EFTA (except Switzerland) member state;

      • the European Medicines Agency (EMEA);

      • the European Commission.

Imposing penalties

As the result of an inspection:

  • The MPI can order the manufacturer to remove any irregularities confirmed in the report by a set deadline.

  • The MPI can order the manufacture of a medicinal product to be halted.

The MPI can revoke the licence if the manufacturer has ceased to meet the requirements specified under the licence and the legal provisions. Depending on the type of obligation breached, withdrawal of the manufacturing licence can be mandatory or left to the MPI's discretion.

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

Clinical trials are regulated by a number of legal provisions, including the:

  • Pharmaceutical Law (see Question 1, Legislation).

  • Act of 5 December 1996 on the Professions of Doctor and Dentist, and the Minister of Health and Social Security Regulation of 11 May 1999 issued under that act, on detailed rules on setting up and financing bioethics committees and committee operations.

  • Various Minister of Health regulations.

  • The Criminal Code.

The key institutions regulating clinical trials include:

  • The Ministry of Health.

  • The Registration Office.

  • Bioethics committees.

Authorisations

To start a clinical trial, the following two authorisations are required:

  • A positive opinion on the trial from a bioethics committee.

  • A licence from the Registration Office.

Applications for the positive opinion and licence are made by a sponsor to the bioethics committee and to the Registration Office respectively. The applications must include the necessary documentation (for example, the clinical trial protocol and a patient consent form).

Consent

A person can only participate in a clinical trial if that person gives consent voluntarily and consciously. This consent must either:

  • Be in writing, dated and signed by the person or his statutory representative.

  • When it cannot be in writing, given orally in the presence of at least two witnesses, and a note made to this effect.

Consent must also include a statement to the effect that consent was given after receipt of the appropriate information on the fundamental nature, significance, effect and risks of the clinical trial.

Trial pre-conditions

The sponsor and the investigator must execute an agreement for mandatory civil liability insurance at the latest on the date the application is filed for authorisation to start a clinical trial with the Registration Office (see above, Authorisations).

Procedural requirements

A sponsor (for example, a pharmaceutical company) initiates a clinical trial and is responsible for conducting the trial in accordance with the law and Good Clinical Practices.

A sponsor must cover the cost of medicinal products connected directly with the trial, and cover any healthcare services required:

  • To remove the effects of health complications arising from usage of the medicinal product under trial.

  • Due to use of the medicine.

  • For the patient to qualify for the clinical trial.

Under the Pharmaceutical Law sponsors and investigators must meet a range of notification requirements concerning, for example:

  • Serious adverse reactions to a tested medicine.

  • The end of a clinical trial.

 

Marketing

Authorisation and abridged procedure

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

Application

To market a medicinal product, the MAH must apply for authorisation from the Registration Office.

The Registration Office can also, on its own initiative, issue authorisation to market a medicinal product if:

  • This is justified to protect public health.

  • The product is marketed in another EU or EFTA member state (except Switzerland) in accordance with the requirements of Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive).

Authorisation conditions

To obtain authorisation, the MAH must file the appropriate application, containing all the required elements, for example:

  • The name of the medicinal product.

  • The name and address of the MAH.

  • Detailed qualitative and quantitative data on active substances and other substances.

The application must also include all the documents required under the Pharmaceutical Law, including:

  • Description of the manufacturing methods.

  • Description of the control methods used in the manufacturing process.

  • Information about any special requirements regarding the storage of the medicinal product, its administration to patients and the disposal of expired products.

  • Results of tests and clinical trials.

  • Description of the adverse reactions monitoring system.

  • Details of the packaging and accompanying leaflet (see Question 16).

Other conditions

A medicinal product has to be marketed within three years of authorisation being obtained, otherwise the authorisation expires. First time marketing of the medicinal product has to be notified to the Registration Office President.

There are a number of obligations after market entry including:

  • Informing the Registration Office President of a temporary or permanent halt in marketing on specified dates.

  • Providing, on the demand of the Registration Office President, data on medicinal product sales.

  • Supplying medicinal products only to entitled entities in Poland or by export.

  • Providing (together with wholesale entrepreneurs) a proper and uninterrupted supply, meeting the demand of both entitled entities and wholesale entrepreneurs.

See below, Post-marketing commitments and pharmacovigilance obligations.

Key stages and timing

The licensing procedure comprises the following stages:

  • The MAH applies for marketing authorisation (see above, Application).

  • The application is examined and the Registration Office draws up an assessment report containing a scientific opinion on the medicinal product.

  • The Registration Office issues a decision based on the Registration Office report and other documentation and analyses.

The procedure to obtain a marketing authorisation should take a maximum of 210 days.

Fee

The fee for a medicinal product marketing authorisation is set as a percentage of the base amount of PLN1,500 (from 1 January 2012).

For example, the fee for filing an application for a marketing authorisation for:

  • A reference medicinal product is 5,000% of the base amount.

  • A medicinal product whose active substance is widely used for medical purposes is 4,000% of the base amount.

Period of authorisation and renewals

A marketing authorisation is issued for five years. The MAH can apply for the validity period to be extended indefinitely. The MAH must file this application, together with the necessary documentation, at least six months before the end of the validity period. In special cases, based on safety data, the Registration Office can issue a one-off decision extending the validity period for a subsequent five years.

Post-marketing commitments and pharmacovigilance obligations

The MAH must fulfil specific requirements, for instance:

  • Keeping a register of reported adverse reactions.

  • Sending reports on adverse reactions to the Registration Office President on specified dates.

  • Providing reports on studies regarding safety conducted after authorisation was obtained, and analysing the proportion of benefits to risk.

  • Notifying the need to make urgent changes to the Product Characteristic Summary.

 
9. 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 MAH 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.

 
10. Are foreign marketing authorisations recognised in your jurisdiction?

Foreign marketing authorisations can be recognised in Poland under the following procedures:

  • Centralised procedure. The European Medicines Agency in London can carry out this procedure. It enables a product to be marketed in all EU member states at the same time.

  • Decentralised procedure. This applies where a medicinal product is marketed in the EU and the applicant applies for it to be registered in another member state.

  • Mutual recognition procedure. Under this procedure, the product is registered in a member state which is specified as the reference state, and then registered in secondary member states where the applicant would like the product to be marketed. This procedure is used as an alternative to the centralised procedure (see above), and enables a product to be registered in selected member states at the same time.

 
11. What powers does the regulator have in relation to marketing authorisations?

Monitoring compliance

The Registration Office can control the systems used to monitor the safety of medicinal products, for example through the right to request documentation.

The Pharmaceutical Inspectorate can carry out inspections to monitor whether manufacturing and import comply with Good Manufacturing Practices and the marketing authorisation, for example, control methods used in the manufacturing process.

Imposing penalties

The Registration Office can withdraw a marketing authorisation in certain circumstances, including where:

  • There are serious unexpected adverse reactions to the medicinal product, endangering human life and health.

  • The declared therapeutic effect is absent, or there is a risk that its adverse effects are out of proportion to the therapeutic effect.

  • The medicinal product is marketed contrary to the authorisation or the law.

  • The fee for extending the authorisation validity term is not paid on time.

  • The Registration Office President is not notified of new information falling within the scope of the documentation which could limit the product's application.

  • The product is removed from the EU list of traditional herbal medicinal products, unless both:

    • the MAH, within three months of the date the product is removed from the list, supplements the product documentation;

    • the Registration Office issues a positive marketing authorisation decision as a result.

  • The conditions specified in a conditional authorisation are not met.

  • The MAH does not make the changes to the medicinal product documentation required by the Registration Office President.

Parallel imports

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

Application procedure

To obtain a parallel import licence, it is necessary to apply to the Registration Office President. The application usually requires the identity of the medicinal product marketed in Poland and in the member state from which the product is imported. The Registration Office President issues a decision on issuing the licence within 45 days of a complete application being filed. Parallel import licences are valid for five years.

Having received the licence, and no later than 30 days before the date the medicinal product is first planned to be marketed, the parallel importer must inform the following entities of the date the medicinal product is expected to be imported into Poland:

  • The MPI.

  • The Registration Office President.

  • The MAH that holds an authorisation to market the product in Poland.

Restrictions

All medicinal products can be brought into Poland by parallel import from countries inside the EU or EFTA, except Switzerland.

However, restrictions apply to products being imported into other EU member states from Poland.

Under the "specific mechanism" provided in the accession treaty under which Poland joined the EU, the holder of a patent or supplementary protection certificate (SPC) (see Question 20) can prevent the import from Poland of a medicinal product to member states in which the product benefits from patent protection, even where the product was marketed in Poland by that person or with his consent.

In relation to imports to Poland from the EU or EFTA (except Switzerland), the specific mechanism applies to medicinal products for which patent protection was applied in an EU or EFTA member state (except Switzerland) before 15 January 1993.

Certain restrictions apply to medicinal products imported from outside the EU or EFTA (except Switzerland) into Poland:

  • They cannot be marketed under a parallel import licence (the procedure to obtain an ordinary marketing authorisation must be followed (see Question 8)).

  • The import of patented products or goods bearing a protected trade mark from outside the EU or EFTA (except Switzerland) to the EU market without the holder's consent breaches that holder's intellectual property rights.

Restrictions

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

Medicinal product advertising which is based on the following is generally prohibited:

  • The giving, offering or promising of material benefits, presents and other incentives. This does not generally apply to items of a negligible material value (that is, a maximum gross value of PLN100) that both:

    • are related to medical or pharmaceutical practice;

    • bear the advertising logo of a firm or medicinal product.

  • The organising and financing of promotional meetings, conferences, trips and scientific congresses to promote medicinal products, during which the hospitality provided exceeds the main purpose of the meeting. This does not generally apply where the hospitality provided does not exceed the main purpose of the meeting.

Accepting these benefits is also prohibited.

These restrictions apply in relation to offering benefits and hospitality to persons authorised to write prescriptions or persons trading in medicinal products, including situations in which a loyalty programme is addressed to those persons. Donations made to public or private healthcare institutions are generally not prohibited or restricted.

New regulations that come into force on 1 January 2012 introduce a ban on any form of incentives relating to reimbursed products.

Violating the above prohibitions may in certain circumstances lead to criminal liability, in some cases also for acts that take place outside Poland.

 
14. What are the restrictions on marketing medicinal products on the internet, by e-mail and by mail order?

Only over-the-counter (OTC) medicinal products, which do not have to be prescribed by a doctor, can be sold by mail order. In addition, only general pharmacies and pharmacy outlets can carry out mail order.

Medicinal products can be obtained by mail order on the basis of orders placed:

  • In a pharmacy.

  • By telephone.

  • By fax.

  • By e-mail.

  • Using a form found on the outlet's website.

Medicinal products purchased can only be returned if the wrong item is sent or if they are of defective quality.

 

Advertising

15. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

Chapter 4 of the Pharmaceutical Law is the main legislation regulating the advertising of medicinal products.

The Ministry of Health Regulation of 21 November 2008 on the advertising of medicinal products (Advertising Regulation) governs, among other things:

  • The terms and conditions for medicinal product advertising.

  • The form of the advertisement and the data that it must contain.

  • How the advertisement will be circulated.

These provisions implement Directive 2004/27/EC on the Community code relating to medical products for human use (Code for Human Medicines Second Amendment Directive).

The general rules concerning advertising under the Act on Combating Unfair Competition 1993 also apply.

The MPI monitors compliance with the regulations on medicinal product advertising. Where the law is breached the MPI can order the recipient of its decision to:

  • Cease the medicinal product advertising.

  • Display the decision on the breach in the places where the advert was shown and publish a retraction.

  • Rectify the breach.

Restrictions

It is forbidden to advertise medicinal products that:

  • Are not authorised for marketing.

  • Are marketed without obligatory marketing authorisation, on the basis of specific regulations.

  • Contain information which is inconsistent with the summary of product characteristics.

If an advert is to be aimed at the public generally it cannot concern medicinal products that:

  • Are available only on prescription.

  • Contain psychotropic and intoxicating substances.

  • Are on the list of reimbursable medicines.

There are several categories of conditions that must be met for the advertising of a medicinal product to be admissible, including that:

  • The advertising cannot:

    • be misleading;

    • involve benefits being offered or promised in exchange for purchasing a medicinal product;

    • be aimed at children, or contain any element aimed at children.

  • The medicinal product must be presented objectively with reliable information about its application.

  • The advertising must contain certain data set out in the Advertising Regulation (this data must be given in wording that complies with the summary of product characteristics). Content requirements are regulated separately for the advertising of medicinal products aimed at persons authorised to write prescriptions and advertising aimed at the general public.

There are certain requirements that regulate the forms of advertising that are admissible and the content of mandatory warnings accompanying an advert.

Internet advertising

There are no specific regulations on advertising medicinal products on the internet.

 

Packaging and labelling

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

Legislation and regulatory authority

The packaging, labelling and patient information leaflet of a medicinal product is primarily regulated by the:

  • Pharmaceutical Law.

  • Minister of Health Regulation of 20 February 2009 on requirements for medicinal product packaging, labelling and patient information leaflets. The MPI enforces this regulation.

Information requirements

The packaging, labelling and leaflet of a medicinal product must correspond to the data contained in documents approved during the marketing authorisation procedure. The outer packaging of a medicine must bear the medicine name in Braille, although this does not apply to medicinal products:

  • Used solely in entities that provide stationary and 24-hour care (including for example hospitals and hospices).

  • Listed in the Minister of Health Regulation of 18 December 2009 on categories of medicinal products whose packaging does not have to bear the product name in Braille.

The information on the packaging must be readable, easy for users to understand and impossible to remove without destroying the packaging. The contents of the leaflet cannot contain any promotional elements or encourage readers to use the medicinal product contrary to indications.

The labelling and the leaflet must be written in Polish. The information can also be given in other official languages of the EU or EFTA member states, provided it corresponds to the Polish wording.

Other conditions

Applications for medicinal product marketing authorisations must include:

  • Samples of both outer and inner packaging, with a written and a graphic description.

  • The patient information leaflet, together with a readability test report.

See Question 8.

If a marketing authorisation is issued, the packaging and the labelling have been approved.

 

Traditional medicines

17. Outline the regulation of the manufacture and marketing of alternative or complementary medicinal products.

There is a simplified marketing authorisation procedure for traditional herbal medicinal products. However, this does not apply if a particular product can be marketed as a homeopathic product or under the general procedure.

Special requirements apply to the advertising of traditional herbal medicinal products (section 4, Advertising Regulation).

There are no other regulations relating to other alternative or complementary medicinal products.

 

Patents

18. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?

Conditions and legislation

The Industrial Property Act of 30 June 2000 regulates patent protection.

Patent protection is given for inventions that:

  • Are new.

  • Involve an inventive step.

  • Are capable of industrial application.

Scope of protection

Patents can currently be obtained for medicinal substances in various categories:

  • Product (for example, chemical compound and pharmaceutical category).

  • Method (for example, manufacturing, purification, and division).

  • Application (that is, the method by which the medicinal product must be administered to the patient).

Therefore, not only process (method) patents are available for medicinal products and related substances, but also product and application patents.

Patents cannot be given for:

  • Inventions, the use of which would be contrary to public order or morality.

  • Plant or animal varieties or essentially biological processes for the production of plants or animals. This does not apply to:

    • microbiological processes; or

    • the products obtained from those processes.

  • Methods for treatment of the human or animal body by surgery or therapy, or diagnostic methods applied on human or animal bodies. This does not apply to products, particularly substances or compositions applied in diagnostics or treatment.

 
19. How is a patent obtained?

Application and guidance

Patents are obtained from the Polish Patent Office (Patent Office) (www.uprp.gov.pl).

The Patent Office charges a single fee for the first three years of patent protection, and additional fees for subsequent years of patent protection up to 20 years.

Patent protection is granted on the provision that payment is made for the first protection period. Failure to pay the fee results in the Patent Office declaring that the decision to grant patent protection has lapsed.

Current fees for an invention application are:

  • PLN550 for an application in written form.

  • PLN500 for an application in electronic form.

Additional fees are charged for every page of the invention description above 20 pages, as well as for a declaration of priority over an earlier application.

Process and timing

The patent application process comprises the following stages:

  • The applicant files the invention with the Patent Office together with the required documentation.

  • The Patent Office:

    • carries out a formal examination of the application;

    • draws up a search report containing the citations of the documents which may be taken into consideration in evaluating the invention claimed in the application;

    • publishes the particulars of the patent application filed immediately after the expiry of 18 months from the application date;

    • carries out a substantial examination to check that the invention is patentable;

    • where the outcome of this examination is positive, decides to grant a patent and issues the patent document once the appropriate fee is paid.

From the date of publication of the particulars of the patent application, third parties can inspect the application specification. Until a decision on the grant of a patent is taken, those parties can submit to the Patent Office any observations as to the existence of grounds that may cause a patent to be denied.

Within six months from the publication of the intention to grant patent protection, any person can give reasoned notice of opposition to the Patent Office's final decision to grant a patent.

Deposit system

The Patent Office operates on a system where applications are subject to scrutiny, rather than a deposit system.

 
20. How long does patent protection typically last? Can monopoly rights be extended by other means?

Duration and renewal

By law a patent protection can last for a maximum of 20 years from the application date. Protection can only continue if:

  • All required fees for maintaining the patent are paid on time.

  • No proceedings were effectively carried out to invalidate the patent.

Extending protection

An SPC for medicinal products and plant protection products can extend the patent protection period. SPCs are regulated by:

  • Regulation (EEC) 1768/92 concerning the creation of a supplementary protection certificate for medicinal products.

  • Chapter 5(1), Part 2, Title 2 of the Industrial Property Act.

An application for an SPC is filed with the Patent Office, which will issue the certificate once the specified requirements are met.

SPC protection cannot be for longer than five years. However, an SPC can be extended to five and a half years, if the SPC relates to a human medicinal product for which data from clinical trials conducted according to an agreed paediatric investigation plan (PIP) have been submitted (as set out in Article 36 of Regulation 1901/2006 on medicinal products for paediatric use).

SPCs were introduced to compensate for the long time needed:

  • To obtain regulatory approval of these products (that is, authorisation to put these products on the market).

  • For the patent examination procedure (it can take five years for patent protection to be granted, and the SPC can be issued for this period).

 
21. How can a patent be revoked?

A patent can be declared invalid in whole or in part at the request of any person having a legitimate interest, who is able to prove that the statutory requirements for the grant of a patent have not been satisfied.

A patent also lapses on:

  • The expiration of the term for which it has been granted.

  • The patent holder's surrender of the patent before the Patent Office, with the consent of the parties having rights in the patent (other than the patent holder).

  • Failure to pay a renewal fee in the prescribed time limit.

  • The invention becoming irreversibly unfeasible for exploitation due to the lack of access to the biological material, which has become inaccessible and unfeasible for reproduction on the basis of the description.

 
22. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?

Conditions for infringement

A patent grants the exclusive right to use the invention for profit or professional purposes throughout Poland. This means that the patent holder can prohibit third parties that do not have the patent holder's consent from using the patent holder's invention by either:

  • Making, using, offering, or putting on the market a product that is the subject matter of the invention, or importing the product for those purposes.

  • Employing a process that is the subject matter of the invention, as well as using, offering, putting on the market or importing for those purposes the product directly obtained by that process.

Claim and remedies

The main type of protection for patent rights is civil protection. Common courts in Poland have the power to hear cases involving patent infringement. A patent holder whose rights under a patent are infringed can demand that the infringing party:

  • Cease the infringement.

  • Surrender the unlawfully obtained profits.

  • In the case of infringement caused by fault, redress the damage either:

    • under general rules concerning the calculation of damages in civil cases;

    • through paying a sum of money equal to either the licence fee or other reasonable compensation, which would have been due if the patent holder had given consent to exploit his invention.

When judging the infringement, the court can, at the patent holder's request, decide to publish the judgment in full or in part, or publish the fact of the judgment, in a manner and to the extent specified by the court (for example, a statement in the press).

The infringement of patent rights can also give rise to criminal liability (Articles 303 to 310, Industrial Property Act).

 
23. Are there non-patent barriers to competition to protect medicinal products?

There are time barriers for approving marketing of generic products connected with data exclusivity and marketing exclusivity (see Question 9).

Orphan medicinal products can receive certain protection, including:

  • A ten-year marketing exclusivity period.

  • A 12-year marketing exclusivity period for orphan drugs for paediatric use, that meet specific requirements.

  • Reduced fees during the marketing authorisation procedure.

The issues relating to the special status of orphan drugs are mainly regulated by Regulation EC/141/2000 on orphan medicinal products.

 

Trade marks

24. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?

Conditions and legislation

A medicinal product mark can be registered as a trade mark if it meets the relevant legal requirements. The sign must be capable of:

  • Being represented graphically.

  • Distinguishing the goods of one entrepreneur from those of other entrepreneurs.

To obtain trade mark protection, an application must be filed with either:

  • The Patent Office, based on the Industrial Property Act (for national protection), or the WIPO Madrid Agreement Concerning the International Registration of Marks 1891 (Madrid Agreement) and the Protocol Relating to the Madrid Agreement 1989 (for international protection).

  • The Office for the Harmonisation of the Internal Market, based on Regulation (EC) 207/2009 on the Community trade mark (for EU-wide protection).

Scope of protection

Protection is not provided for certain signs, for example signs that (Industrial Property Act):

  • Infringe third parties' personal or economic rights.

  • Are contrary to law, public order or morality.

  • May mislead the public, in particular as to the nature, properties of the goods or geographic origin.

  • Have been applied for in bad faith.

  • Incorporate certain national symbols.

 
25. How is a trade mark registered?

Application and guidance

Trade mark applications are filed with the Patent Office.

The Patent Office charges a single fee for the first ten years of trade mark protection, and renewal fees for subsequent periods of trade mark protection.

Trade mark protection is granted on the basis that payment is made for the first protection period. Failure to pay the fee results in the Patent Office declaring that the decision to grant trade mark protection has lapsed.

Fees for registering a trade mark in three classes of goods or services, according to the WIPO Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks 1957, are currently:

  • PLN550, for an application in up to three classes, in written form.

  • PLN500, for an application in up to three classes, in electronic form.

The Nice classification is a system of classifying goods and services for the purpose of registering trade marks. The latest version of the system groups products into 45 classes (classes one to 34 include goods, and classes 35 to 45 cover services). It allows users seeking to trade mark a good or service to choose from these classes, as appropriate.

Process and timing

The trade mark protection process comprises the following stages:

  • The applicant files the trade mark application with the Patent Office together with the required documentation.

  • The Patent Office:

    • carries out a formal examination of the application;

    • publishes a trade mark application immediately after the period of three months from the date of filing of that application;

    • checks that statutory requirements for obtaining the right to trade mark registration are met;

    • issues a decision to grant protection if it confirms that all statutory requirements are met.

From the date of publication, any third parties can acquaint themselves with the trade mark determined in the application, and with the list of the goods for which the mark is intended. They can also submit to the Patent Office their observations as to the existence of grounds that can cause a right of protection to be denied.

Within six months from the publication of the intention to grant trade mark protection, any person can give reasoned notice of opposition to a final decision of the Patent Office on the grant of a trade mark.

The time it takes to obtain protection has been shortened to about 12 to 18 months.

 
26. How long does trade mark protection typically last?

Duration and renewal

Trade mark protection is given for ten years from the application date. The protection period can be extended for further ten-year periods on the application of the trade mark holder and on payment of the appropriate renewal fee.

Extending protection

On lapse of trade mark registration protection, the Patent Office issues the right holder a notice to pay a renewal fee. Protection renewal fees should be paid in advance, no later than on the day of expiry of the preceding protection period. The renewal fees can also be paid within six months after expiry of the time limit, with a surcharge of 30% of the fee.

Protecting a trade mark for other classes of goods and services requires registering a new trade mark.

There is no other possibility of extending a trade mark.

 
27. How can a trade mark be revoked?

The right of protection for a trade mark can be invalidated in whole or in part at the request of any person with a legitimate interest, provided that the person is able to prove that the statutory requirements for the grant of that right have not been satisfied.

Trade mark protection also lapses:

  • When the period for which it was issued lapses.

  • When the right holder surrenders the right before the Patent Office, with the consent of the parties with rights to the trade mark (other than the right holder).

  • When the right holder fails to put to genuine use the registered trade mark for the goods covered by the registration for a period of five successive years after a decision on the grant of a right of protection has been taken, unless serious reasons for the non-use exist.

  • When a mark loses its distinguishing features if, through the actions or omissions of the holder, it becomes an ordinary mark used in trade.

  • As a result of actions of the holder, or third parties with the holder's consent, if the trade mark could mislead recipients, particularly as to the nature, properties or geographic origin of goods.

  • As a result of removal of the legal entity who enjoyed the right of protection for the trade mark from its relevant register (a legal entity can be deleted from a register, among others, for bankruptcy or because of its own application).

 
28. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?

Conditions

Infringement of the right of protection for a trade mark consists of unlawful use in the course of trade of:

  • A trade mark identical to a trade mark registered in relation to identical goods.

  • A trade mark identical, or similar, to a trade mark registered in relation to identical or similar goods, if a likelihood of misleading the public, particularly a risk of associating the trade mark with a registered trade mark, exists.

  • A trade mark identical, or similar, to a renowned trade mark registered for any kind of goods, if such use without due cause would bring unfair advantage to the user, or be detrimental to the distinctive character or the repute of the earlier trade mark.

Claim and remedies

The basic type of protection under a protected trade mark is civil protection. The common courts have jurisdiction over this type of claim. Anyone whose trade mark protection right has been infringed can demand that the infringer:

  • Cease the infringement.

  • Surrender the unlawfully obtained products.

  • In the case of infringement caused by fault, also redress the damage either:

    • under general rules concerning the calculation of damages in civil cases;

    • through paying a sum of money for using the mark equal to either the licence fee, or other reasonable compensation, which would have been due if the patent holder had given consent to exploit his trade mark.

When judging the infringement of a trade mark the court can, at the holder's request, decide to publish the judgment in full or in part, or publish the fact of the judgment, in a manner and to the extent specified by the court.

The infringement of trade mark protection rights can also give rise to criminal liability under the Industrial Property Act (Articles 305 to 309, Industrial Property Act).

Patent and trade mark licensing

29. Does a patent or trade mark licence agreement and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body?

There are no requirements for a patent or trade mark licence agreement to be approved by any government or regulatory body.

A licence can, at the request of the interested party (usually the licensee), be recorded in the Patent Register or Trade Mark Register, managed by the Patent Office. The holder of an exclusive licence recorded in either of the registers can, to the same extent as the patent or trade mark holder, enforce its claims in the event of infringement, unless the licence stipulates otherwise.

There are no requirements for payment of royalties under a patent or trade mark licence to a foreign licensor to be approved by any government or regulatory body.

Patent and trade mark conventions

30. Is your jurisdiction party to international conventions on patent and trade mark protection?

Poland is party to international conventions, including the WIPO Paris Convention for the Protection of Industrial Property 1883, as amended.

 

Product liability

31. Outline the scope of medicinal product liability law.

Legal provisions

Any manufacturer that does not observe good manufacturing practice can face administrative, criminal or civil liability.

Title VI(1) of the Civil Code regulates civil liability for damage caused by a dangerous product (including a dangerous medicinal product). It is considered tortious (ex delicto) liability.

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 dangerous traded product.

  • That there was a normal causal link between the damage and use of the product.

The burden of proof lies with the injured party, although 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 (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.

 
32. How can a product liability claim be brought?

Limitation periods

Claims for damages caused by a dangerous product become time-barred three years from the date on which the injured party was aware of, or could have been aware of if it had taken due care, of the damage and of the party responsible for the damage. In addition, all claims become time-barred ten years after the date on which the product was first traded. After the end of this period claims can be brought based on general rules, which require additional evidence of fault (an injured party must prove to the court the defendant's negligence, and that this negligence caused damage).

Class actions

On 19 July 2010 the Class Action Claims Act of 17 December 2009 came into force under which class actions are allowed for, among others, damage caused by a dangerous product.

Foreign claimants

To bring a claim on the basis of hazardous product liability (Article 449(1), Civil Code) it is irrelevant whether the claimant is a resident or not. The deciding factor is the status of the defendant. Generally, if the defendant is a resident, it is possible to bring a claim against him. It is also possible in some cases if the defendant is non-resident.

If the damage occurs in Poland the claimant can bring a claim. The claimant can also bring a claim if the damage occurs outside Poland, provided certain other conditions are met.

 
33. What defences are available to product liability claims?

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.

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

If a dangerous product causes damage to a person, the injured person can demand that the liable person cover the costs of the injured person's:

  • Treatment.

  • Preparation for taking up a new profession (where abilities are lost that are necessary to perform the old one).

  • Disability pension.

In addition, the injured person is entitled to non-compensatory damages (that is, damages that are not awarded to compensate financial injury but to compensate the injured person for non-financial harm).

If a dangerous product causes damage to property, the injured party cannot receive compensation for:

  • Damage to the product itself and the profits that the injured party may have received from using the product.

  • Damage to property caused by a dangerous product, unless the damage caused by the dangerous product exceeds the equivalent of EUR500 (as at 1 November 2011, US$1 was about EUR0.7).

Punitive damages are not allowed for product liability claims. 

 

Reform

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

After the parliamentary elections in October 2011 a new government was constituted in November 2011. It is difficult at this time to predict which proposals will become law. However, certain political statements have been made, indicating that new regulations relating to complementary health insurance, clinical trials, public health, quality in healthcare and pricing are likely to be considered.

 

The regulatory authorities

Ministry of Health

W www.mz.gov.pl

Main areas of responsibility. The Ministry of Health is responsible for:

  • Specifying lists of reimbursement decisions, reimbursed medicines and limits on medicine prices.
  • Deciding whether a medicinal product should be entered on the list of reimbursed medicines.
  • Developing state medicine policy.
  • Supervising the Main Pharmaceutical Inspectorate, the Registration Office President, and the NHF (in some respects the NHF is supervised by the Minister of Finance).
  • Issuing licences for clinical trials, marketing authorisations and parallel imports.

Main Pharmaceutical Inspectorate

W www.gif.gov.pl

Main areas of responsibility. The Main Pharmaceutical Inspectorate is responsible for:

  • Issuing licences to manufacture and import medicinal products.
  • Supervising conditions for the manufacture of medicinal products.
  • Compliance with the Pharmaceutical Law.
  • Issuing decisions to withdraw and stop the marketing of medicinal products.

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

W www.urpl.gov.pl

Main areas of responsibility. The Office is responsible for:

  • Taking steps leading to decisions being adopted by the Minister of Health on the marketing of a medicinal product.
  • Giving information about the documents and steps required for marketing medicinal products.
  • Issuing licences for clinical trials.
  • Issuing parallel import licences.
  • Issuing marketing authorisations.
  • Keeping the Register of Medicinal Products Marketed in Poland.


Contributor details

Marcin Matczak

Domański Zakrzewski Palinka Sp. k Law Firm

T +48 22 557 86 33
F +48 22 557 76 01
E marcin.matczak@dzp.pl
W www.dzp.pl

Qualified. Poland, 1999

Areas of practice. Pharmaceutical; biotechnology; regulatory advisory; administrative; advertising; business constitutional; competition.

Recent transactions

  • Advising on advertising law and competition law.
  • Advising the FMCG sector on admissible advertising and promotional activity in respect of alcohol products.
  • Advising the pharmaceutical sector on the rules for advertising and promoting medicinal products under the new Pharmaceutical Law.

For more details of recent transactions, publications, and so on, see full PLC Which lawyer? profile here.

Aleksandra Auleytner

Domański Zakrzewski Palinka Sp. k Law Firm

T +48 22 557 76 85
F +48 22 557 76 01
E aleksandra.auleytner@dzp.pl
W www.dzp.pl

Qualified. Poland, 2002

Areas of practice. Intellectual property law; IT, media and telecoms law; advertising; unfair competition; state aid.

Recent transactions

  • Intangible rights, as governed by copyright law, industrial property law and new technologies and e-commerce law.
  • Advising technology companies on implementation, maintenance and other agreements typical of the IT sector.
  • Advising advertising agencies, TV stations, food and clothes manufacturers, and e-shop operators.
  • Wideband network construction projects and e-health projects.

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