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Overview

Healthcare funding

In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors.

Healthcare in Poland is delivered through a publicly funded healthcare system, which is free for all citizens. Free medical care is provided within the range of guaranteed benefits. Detailed conditions for granting those benefits have been included in the Publicly Funded Healthcare Benefits Act and a series of decree acts. The entity established to carry out the above tasks is the National Health Fund (NHF), which also funds these benefits.

In the system of guaranteed benefits, an increasingly significant role is played by private entities. They are smaller, better managed and therefore more competitive than the public entities with whom they compete while under the auspices of the NHF.

With regard to drugs and medical devices, patients have access to reimbursed medicines; in other words, this aspect is partly or entirely publicly funded.

Delivery

In general terms, how is healthcare delivered in your jurisdiction? Outline the roles of the public and private sectors.

Access to healthcare is provided by the NHF by allowing free-market competition in order to grant specific health benefits.

Contests are announced separately on a top-down basis, according to the type and range of services. Patients may receive benefits from institutions that have entered into an agreement with the payer.

Benefits are granted in order of request, taking into account the date of filing and the health of the patient. Public and private entities use identical rules for granting benefits.

Key legislation

Identify the key legislation governing the delivery of healthcare and establishing the regulatory framework.

The most significant acts that regulate the functioning of the healthcare system in Poland are:

  • the Medical Activity Act 2011;
  • the Publicly Funded Healthcare Benefits Act 2004;
  • the Reimbursement Act 2011; and
  • the Patient Rights Act 2008.

Responsible agencies

Which agencies are principally responsible for the enforcement of laws and rules applicable to the delivery of healthcare?

The NHF oversees the providers of healthcare services that are financed from public funds. The NHF is also involved in the execution of duties against these providers. In addition, specific powers are granted to the Ministry of Health and to civil and administrative courts.

Scope of enforcement

What is the scope of their enforcement and regulatory responsibilities?

Within the law, the NHF defines the conditions applied to healthcare providers, and establishes standard form contracts.

Through the auditing process, the NHF verifies the correct implementation of these agreements. If any irregularities are found, depending on their nature, the NHF may exact the reimbursement of improperly granted benefits. The NHF may also impose penalties on the provider or may terminate their contract with immediate effect.

The NHF has tools to independently enforce these financial sanctions. Any disputes between the NHF and healthcare providers are subject to the administration of the courts of general jurisdiction.

Regulation of pharmaceutical products and medical devices

Which agencies are principally responsible for the regulation of pharmaceutical products and medical devices?

Regulation in the field of medicinal products is a matter for the legislature and, when required, the Minister of Health.

Executive powers of supervision and control over medical devices are entrusted to the Office for Registration of Medicinal Products, Medical Devices and Biocides. When it comes to control over the quality of medicinal products, special powers are granted to the State Pharmaceutical Inspectorate.

Insofar as the medicinal products and medical devices are financed or co-financed using public funds, special powers are granted to the NHF, which supervises the fiscal issues associated with refund.

Scope of enforcement

What is the scope of their enforcement and regulatory responsibilities?

The legislature lays down the principles and procedures for the marketing authorisation of medicinal products, including:

  • requirements for quality;
  • safety and efficacy of use;
  • conditions for conducting clinical trials;
  • production; and
  • trade.

The Minister of Health has the power to decide the principles of individual refunds of medicinal products and medical devices. Proper implementation of these principles has been assured by specialised institutions such as the State Pharmaceutical Inspectorate and the Office for Registration of Medicinal Products, Medical Devices and Biocides, which has the power to authorise individual medicinal products on the market.

When it comes to financing medicinal products or medical devices, the NHF oversees the appropriate implementation of the applicable rules.

Other agencies

Which other agencies have jurisdiction over healthcare, pharmaceutical and medical device cases?

The Office of Competition and Consumer Protection is the authority that has jurisdiction in matters relating to medicinal products or medical devices within the framework of oversight practices that restrict competition. The president of the Competition Office may render decisions that require the termination of competition that causes infringement for both producers and distributors of medicinal products and medical devices.

Simultaneous investigations

Can multiple government agencies simultaneously conduct an investigation of the same subject? Does a completed investigation bar another agency from investigating the same facts and circumstances?

It is possible that several independent agencies may lead proceedings concerning the same facts and the same entities. Each of them, within the limits of its own powers, examines another aspect of the case and evaluates it in the context of compliance with various laws. For example, the NHF may assess the correct execution of the agreement and possibly impose financial sanctions while enforcement authorities simultaneously investigate whether any crime took place during the execution of the agreement.

Regulation of pharmaceutical products and medical devices

Monitoring powers

What powers do the authorities have to monitor compliance with the rules on drugs and devices?

The most significant legal act that regulates aspects of production and marketing of medicinal products and medical devices is the Pharmaceutical Law of 6 September 2001, and its subsequent acts.

In addition, there is:

  • the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Use and Medical Devices Act 2001; and
  • the Office for Registration of Medicinal Products, Medical Devices and Biocides Act 2011.

There are three levels of control exercised by the competent authorities:

  • supervision of the quality of medicinal products and the process of their distribution in the retail market falls under the competence of pharmaceutical inspectors;
  • the pharmacovigilance system falls under the supervision of the president of the Office for Registration of Medicinal Products, Medical Devices and Biocides (president of the Office); and
  • supervision of the quality of veterinary medicinal products and the process of their distribution falls under the competence of the Chief Veterinary Officer.

The medical devices area is also under the control of the president of the Office. Regulation is carried out regarding:

  • manufacture;
  • marketing and use; and
  • performance evaluation.

Supervision of medical devices is based on collecting and analysing information on the safety of products and control of all entities that have a direct or indirect impact on the shape of a medical device (such as manufacturers, authorised representatives, importers, distributors or subcontractors). Control of these entities covers all stages, from design and manufacture of medical devices, to their entry on the market or use. It may also include the presentation of the product at trade fairs, exhibitions, demonstrations and scientific and technical symposia.

In some situations, justified by the need to protect the life or health of patients or to protect public health, the president of the Office may inspect the device, its documentation and conditions of use.

Investigation time frames

How long do investigations typically take from initiation to completion? How are investigations started?

Anyone who has information about the circumstance of a medical incident may report it to the president of the Office.

In the event of a medical incident, the healthcare provider is obliged to report it immediately to the manufacturer or an authorised representative, and to send a copy of the report to the president of the Office. The same duty to notify also applies to any manufacturer that has been informed of an incident relating to a product they have produced.

A similar procedure exists for medicinal products. In the case of justified suspicion of any irregularities that could threaten the safety or quality of medicinal products, the chief pharmaceutical inspector (PCI) may order the immediate inspection of the manufacturer of the active substance, and any distributors established in a third country.

Access to investigation materials

What rights or access does the subject of an investigation have to the government investigation files and materials?

Any procedural acts concerning control or inspection of medicinal products or medical devices are carried out in the presence of a controller or a person authorised by a controller. The controller may waive the right to participate in these proceedings. In such cases, control proceedings are performed in the presence of an appointed witness. The witness does not have to be present during acts related to obtaining evidence from books, records or other documents.

Following the correct procedures, various parties’ involvement in the production process is established. Once the proceedings are complete, a protocol of control is drawn up.

The controlled entity can file reasonable objections, which are subject to examination by the inspection body.

Investigations abroad

If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?

The PCI may also inspect the manufacturing conditions of medicinal products that are manufactured abroad. Such inspections are carried out by the inspector of producing affairs.

Inspection of the manufacturing conditions of a medicinal product in a third country is intended to confirm the compliance of these conditions with the requirements of good manufacturing practice (GMP) within the meaning of EU pharmaceutical law.

The PCI also considers as equivalent inspections carried out by:

  • a competent authority of a member state of the European Union or member states of the European Free Trade Association (EFTA) (parties to the European Economic Area or a state that has an agreement on mutual recognition of inspections of EU member states or is a member state of EFTA);
  • a party to the Agreement on the European Economic Area; and
  • countries with the equivalent of the European Union GMP requirements and an equivalent inspection system.

In such cases, foreign inspection is not carried out.

The PCI may request that a producer established in a non-member state or a non-EFTA state submit to inspection of manufacturing conditions.

However, unlike manufacturers of medicinal products or manufacturers of active substances established in Polish territory, the third-country manufacturer has no obligation to submit to such an inspection.

The PCI does not have any legal instruments that would oblige producers outside the European Union or EFTA to submit to an inspection.

In addition, under the regulation of good distribution practice, if there is justified suspicion that irregularities are causing a threat to the safety or quality of an active substance, the PCI may order the immediate inspection of the active substance manufacturer or distributor of the active substance who is established in a third country.

Regarding the medical devices area, the president of the Office has no authority to inspect third-country producers. In such cases, control may be exercised only towards the manufacturers, authorised representatives of the importers, distributors and subcontractors who are domiciled or established in Polish territory.

Enforcement proceedings

Through what proceedings do agencies enforce the rules?

The Pharmaceutical Law and the Law on Medical Devices Acts contain detailed regulations concerning audit and inspection procedures within the competence of the PCI and the president of the Office.

They may impose appropriate sanctions on producers. This proceeding is administrative in nature. Controlling authorities may also impose subsidiary criminal sanctions.

The Pharmaceutical Law Act and the Medical Devices Act contain provisions that specify the punitive sanctions imposed in criminal proceedings. In addition, the Pharmaceutical Law Act provides certain administrative sanctions.

Sanctions

What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?

As part of its administrative sanctions, the PCI has the authority to grant or revoke permission to produce or import a medicinal product if the producer or importer of the medicinal product has ceased to fulfil their duties as required. If there is any question that a medicinal product or active substance does not meet established quality requirements, the PCI gives a decision regarding a ban on its introduction, or regarding withdrawing the medicinal product or active substance from the market. After examining the circumstances, the PCI:

  • orders that the responsible entity or parallel importer destroy the medicinal product or active substance; or
  • allows use or consumption of the medicinal product or active substance for another purpose.

The legislature recognises that measures and non-penalty sanctions are not sufficient for enforcing correct standards regarding medicinal products. Pharmaceutical law also contains penal provisions, where the following sanctions are recommended:

  • restriction of liberty and imprisonment; and
  • fines of an administrative-disciplinary character.

In the Medicinal Products Act, it is indicated that the president of the Office can give an administrative resolution regarding forbidding, stopping or introducing restrictions for the use of a medicinal product or group of products, withdrawing them from the market or from use or obliging those in charge of safety to take field safety correction action or to issue a safety note.

This can be done with the aim of protecting life, health or safety of patients, users or other persons and also for the counteraction of a threat to health, safety or public policy. There are also penal measures such as fines restricting liberty and imprisonment. These are classified as being part of criminal proceedings.

Actions against employees

Can the authorities pursue actions against employees as well as the company itself?

Polish provisions regarding test proceedings and the surveillance of medicinal products, which are led by the PCI or the president of the Office, do not provide for closely controlled activities against employees of enterprises. Judgment of employee responsibility can result from special provisions involved in disciplinary proceedings. It can also result from observations regarding contractual character, in other words on the basis of the agreement between employee and employer. Moreover, the responsibility for non-performance or an unsatisfactory performance of employee duties is determined in the Labour Code of 26 June 1974. The employee bears responsibility for any loss and damage incurred by the employer based only on actions from which the loss or damage resulted. Obviously, any illegal behaviour by an employee may also be prosecuted under the Polish Criminal Code. Based on these provisions, the employee does not bear responsibility for any resulting damage in relation to acting within the limits of acceptable risk.

Defences and appeals

What defences and appeals are available to drug and device company defendants in an enforcement action?

Companies are able to appeal for the discontinuation of enforcement actions following a pharmaceutical inspection in matters concerning their competence. In the event that a provincial pharmaceutical inspector is the body of the first instance, a PCI acts as the appeal organ. If the PCI is a central government administration authority, there is no entitlement to an appeal from a PCI decision if it is given in the first instance. However, the case can be reviewed as a result of an application to the PCI for re-examination. The rules of the Code of Administrative Procedure are then applied. Decisions given by the PCI as the organ of second instance and given by way of proceedings for the re-examination of the case could be challenged before the administrative court. The Provincial Administrative Court in Warsaw is the competent body for hearing an administrative complaint against a decision of the PCI.

There are similar procedures regarding submitting a complaint to the president of the Office. Moreover, during control proceedings the controlled entity can submit reservations about the protocol of the inspection.

Minimising exposure

What strategies should companies adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

The possibility of enforcement actions is minimised when the company is functioning correctly; in other words, based on procedures or internal regulations and in accordance with generally applicable provisions of the law. It is important that every entity maintain the quality level of medicinal products and the safe means of applying them. This will help to avoid adverse effects in the event of a control situation. Keeping reliable documentation and taking effective advance action is essential. If the controlling action is already in motion, the company should provide controllers with access to documentation, rooms and the equipment and products that are the object of the control. If a controlled entity has submitted a control protocol ahead of the control action, it should then follow recommendations submitted after the control action has taken place.

Recent enforcement activities

What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?

Recently, when inspecting medicinal products, the authorities have emphasised meeting quality requirements and safety measures when applying the products. As a result of inspections and the detection of irregularities, the PCI has placed sanctions by stopping trade over the entire country or by withdrawing the products from the market.

Self-governing bodies

Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organisations police members’ conduct?

There are many self-governing bodies and organisations in charge of the sale of pharmaceutical products and medical devices in Poland. They include, among others, the Polish Association of Self Medication Industry (PASMI) and the Polish Chamber of Commerce of Medical Devices, which is the largest and most representative organisation of producers and distributors of medicinal products in Poland. Moreover, a self-governing pharmaceutical company functions as part of the Principal Pharmaceutical Chamber and Provincial Pharmaceutical Chambers. Such a body is able to conduct disciplinary proceedings concerning its members. It also has an advisory voice in matters of revocation of a permit for a pharmacy or pharmaceutical wholesaler.

Relationships between healthcare professionals and suppliers

Relationship rules

What are the rules prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services?

No general rules apply to such relationships. Only a small number of entities that finance their activities with public funds are obliged by the legislature to carry out open competition for providing healthcare services. However, in general, breach of this rule does not result in sanctions. There is one binding ban for advertising medicinal products and medical devices.

Enforcement

How are the rules enforced?

The obligation to conduct a competition for delivery of healthcare by entities specified in the Healthcare Delivery Act 2011 is not enforced. Legislation does not provide appropriate procedures in this regard. Compliance with the advertising ban is subject to inspection conducted by the PCI, and by the main veterinarian in relation to veterinary products.

Reporting requirements

What are the reporting requirements on such financial relationships? Is the reported information publicly available?

The sole regulation for sustaining transparency in financial relationships between healthcare providers and suppliers of services, medicinal products or medical devices is contained in the Access to Information Act 2001. However, entities that do not use public funds are not bound by this regulation.

Entities that use public funds for the delivery of healthcare on the basis of contracts with the NHF are obliged to place subcontractors’ data in the portal that is dedicated to detailing contracts that are being performed.

Regulation of healthcare delivery

Authority powers

What powers do the authorities have to monitor compliance with the rules on delivery of healthcare?

The NHF is entitled to carry out inspections in order to verify healthcare entities’ compliance with the provisions of the law and orders of the President of the NHF. For this purpose, the authority has been empowered to carry out inspections and, depending on the outcome, may:

  • demand fund reimbursement if it finds that funds were unduly transferred to the entity; or
  • impose a contractual penalty if it finds that the entity performed inappropriately or did not complete the contract.

The NHF may also terminate the agreement without notice.

Investigation time frames

How long do investigations of healthcare providers typically take from initiation to completion? How are investigations started?

A healthcare provider inspection lasts from several days to a few years and is initiated by delivery of a notice of initiation to the entity being subjected to such inspection.

Access to investigation materials

What rights or access does the subject of an investigation have to the government investigation files and materials?

The entity subjected to an inspection is entitled to provide the authority with evidence supporting its assertions at any stage of inspection. The entity may also demand access to files at any stage of inspection proceedings. However, this right is rarely used.

Enforcement agencies

Through what proceedings do agencies enforce the rules?

The NHF enforces the law concerning provisions of healthcare services with its own procedures, set out in the Health Care Services Financed with Public Funds Act 2004. This is not a civil or criminal procedure and does not specifically provide for the hearing of the case by a civil court. However, such conclusion should be drawn from the fact that the NHF is bound to the healthcare provider by a civil agreement.

Sanctions

What sanctions and other measures can the authorities impose or seek in enforcement actions against healthcare providers?

Depending on the outcome of an inspection, healthcare providers may be subjected to following sanctions:

  • reimbursement of funds, if the NHF finds that the funds were unduly transferred to the entity;
  • imposing a contractual (financial) penalty, if the NHF finds that the entity performed inappropriately or has not performed the contract. However, the total amount of contractual penalty imposed during the term of the contract cannot exceed 4 per cent of the amount of the NHF’s obligation towards the healthcare provider, resulting from the contract; or
  • in the event of material infringements, the NHF may also terminate the contract without notice. Additionally, in consequence of such termination, the healthcare provider would be excluded from the competition for a new contract for the next five years.

Defences and appeals

What defences and appeals are available to healthcare providers in an enforcement action?

Healthcare providers are entitled to submit objections to the inspection authorities (within seven days) and, in the subsequent phase of inspection proceedings, objections to the post-inspection statement issued by the inspecting authority after evaluating the objection to the protocol. The second objection must also be submitted within seven days. Notwithstanding the above, the healthcare provider is entitled to file a complaint with the President of the NHF about the activities of the Director of the regional branch of the NHF.

Minimising exposure

What strategies should healthcare providers adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

As a rule, the risk of being subjected to an inspection cannot be minimised. Inspections are conducted in accordance with a plan accepted by the NHF. Aside from this, ‘problem inspections’ are conducted as a consequence of complaints against healthcare providers submitted by patients to the NHF. In order to prevent inspections of this kind, the entity should comply with the rules, contractual provisions and procedures currently binding healthcare providers.

Minimising the risk of potential responsibility at the ongoing proceedings stage is limited to active participation in the inspection; in particular, by means of initiating evidence and exercising appeal rights.

Healthcare providers should implement internal quality procedures and supervision of compliance with the provisions of law and contract provisions, as well as ensuring the constant education of their personnel in this respect.

Recent enforcement activities

What have the authorities focused on in their recent enforcement activity and what sanctions have been imposed on healthcare providers?

The NHF increasingly focuses on:

  • evaluation;
  • whether the procedures for which the NHF pays were correctly qualified and presented for payment;
  • whether medical grounds for conducting these procedures were present; and
  • whether another similar, less expensive procedure was available.

In such case, the NHF demands reimbursement for the healthcare provision that was contested.

Moreover, the inspection involves particular evaluation of whether medical documents are correctly maintained, whether the services are provided at the time and place specified in the contract and whether the personnel schedule reported to the NHF is observed. Infringements in this respect are the most common accusations against the healthcare providers. For such infringements, financial penalties are imposed on the healthcare provider for each infringement.

Self-governing bodies

Are there self-governing bodies for healthcare providers? How do those organisations police members’ conduct?

There are no formal self-governing bodies for healthcare providers in Poland, except for the Chamber of Physicians and Dentists and the Supreme Chamber of Nurses and Midwives. However, voluntary bodies represent various entities, such as a national association for private hospitals, or bodies that unite entities providing primary healthcare services. These organisations do not have far-reaching competencies over their members.

Remedies for poor performance

What remedies for poor performance does the government typically include in its contracts with healthcare providers?

Recently, in its contracts with healthcare providers, the government included some obligations regarding financing individual treatments within an approved period of time. This resolution should lead to a faster route to oncology diagnosis and treatment.

Negative quality assessment of granted benefits, which could be the result of an inspection by the NHF, negatively influences the immediate competition proceedings, resulting in a lower spot-price offer. It also reduces the chances of entering into another agreement.

Most agreements with service providers contain regulations providing for sanctions, such as making the level of remuneration of service providers conditional on results achieved by them and the effectiveness of their action. Sanctions may only be imposed if provisions of law or provisions of contracts concluded with the NHF are infringed while performing medical benefits.

Private enforcement

Causes of action

What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?

In order to enforce healthcare system rules, citizens and other private entities can primarily apply to the court with a civil lawsuit proceeding to obtain proper compensation for the violation of the patient’s rights.

This procedure is regulated in the Code of the Civil Procedure. There is also a nonjudicial remedy based on a claim to the Provincial Commission for deciding on medical events. The injured party must submit a request to establish the medical event. The amount of compensation or proposed compensation depends on the discretion of the insurance company (the total amount of compensation is up to 300,000 zlotys).

Other nonjudicial remedies are:

  • a complaint against a violation of patient rights to the patient ombudsman; or
  • a complaint against a doctor or nurse to the Supreme Medical Council or the Supreme Chamber of Nurses and Midwives.

Framework for claims

What is the framework for claims of clinical negligence against healthcare providers?

The patient, or his or her heirs (in case of a patient’s death), have the right to appear against the perpetrator of the mistake of clinical negligence with a civil action, or before the court, or before the Regional Commission for Evaluation of Medical Events.

Infecting a patient with a biological pathogen, inflicting bodily harm, causing disturbance to the health of a patient or causing the death of a patient can be an undesired medical event resulting in variance with current medical knowledge on:

  • diagnoses, if it caused the improper treatment or delayed the due treatment, contributing to the progression of the disease;
  • cure, including the performance of the operation treatment; and
  • applying the medicinal product or the medical devices.

In the lawsuit, the patient must show:

  • the type of medical negligence and the circumstances deemed to be unacceptable, causing complications after the treatment;
  • that medical negligence occurred as an effect of the actions of the medical staff or the service provider;
  • the existence of the causative connection between the medical negligence and the just functioning of the medical staff or service provider; and
  • the extent of injustice (the kind and the length of psychological suffering) experienced in relation to medical negligence, and the amount of extra costs incurred in relation to the medical event or in connection with the total or partial loss of paid work, or with the accretion of his or her needs or reducing views of success for the future.

It is possible to repair damage to the patient through the payment of compensation, damages or disability pension paid for the future.

During the statement, courts do not monitor whether the provider is a public or private entity. If, in the course of judicial proceedings, the expert opinion of a specialist judging the process of treating of the patient confirms the appearance of a medical event, these courts punish such infringements vigorously.

Seeking recourse

How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?

There are no detailed provisions based on which purchasers or users of medicinal products can pursue their laws for infringements. They can initiate a civil action based on the general rules and demand compensation depending on the actual state of affairs, the character of the infringement and its effects. For example, in a case of misleading advertisement of a medicinal product, the consumer can demand a return of benefits or decide the appropriate amount of money to achieve the determined social objective associated with supporting Polish culture, protecting the national legacy or providing consumer protection. This will be achieved during the civil proceedings.

Compensation

Are there any compensation schemes in place?

The injured party may seek damages before a civil court on general principles. As a rule, the party must demonstrate the cause of damage and that the damage is caused by the culpable behaviour of the perpetrator (eg, the medical or therapeutic entity).

If damage was caused by a drug or a medical device used in accordance with the manufacturer’s instructions, then it may incur the strict liability of the manufacturer. In such cases the patient does not have to prove that the manufacturer is to blame for the deliberate release of a dangerous product on the market.

For some of the damages caused during the granting of health benefits (medical events), legislation provides a simplified compensation procedure in extrajudicial proceedings before the special committees. However, there are certain limitations on the maximum amount of compensation that can be achieved this way.

Class and collective actions

Are class actions or other collective claims available in cases related to drugs, devices and provision of care?

There is no regulation for the possibility of rolling out a class action or appearing as part of a collective pursuing a claim in a matter concerning medicines and medicinal products. The same goes for cases that are closely linked to the healthcare service. However, it is possible to instigate a class action against an entity violating patients’ rights or disturbing the protection of personal data in relation to granted benefits of healthcare. The rules of such a class action are regulated by the following acts: the Pursuing Claims in Group Proceedings Act 2009; and the Code of Civil Procedure Act.

Review

Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?

An act, omission or decision of a publicly acting entity in the healthcare sphere can become the object of administrative or judicial-administrative control as a result of filing a complaint. In the framework of administrative proceedings combined with appropriate remedies against given decisions, the entity that is dissatisfied with the bodies mentioned above, is entitled to file a complaint to the competent authority to recognise this complaint. Positive recognition can result in resuming proceedings, repeal or a change in the decision. Settling the matter should take place with no unnecessary delay and should take no longer than one month.

Court-administrative initiations of proceedings are aimed at judicial control of the decision given by the public agency, possibly taking place only after exhausting the appeal route envisaged in special provisions. For example, a complaint to the provincial administrative tribunals about the decision of the PCI can be ended only after prior recognition by the PCI of the application and to look at the matter again. In such proceedings, the party can only be an entity connected to the decision.

The actions or failure to act by private entities in the healthcare sphere are subject to a control that can be started, both ex officio, and as the result of a complaint filed by third parties to competent bodies (eg, to the NHF). The NHF investigates complaints concerning the improper completion of a contract by service providers who have agreements with the NHF. The NHF should recognise the complaint within a month. The person who submitted the complaint must be notified in writing about the way in which the matter is settled. If the NHF states that suspicions of irregularity are justified, inspection proceedings can be initiated.

Whistleblowers

Are there any legal protections for whistleblowers?

There is no regulation regarding the protection of persons detecting malfunctions within the healthcare system. The sequence of notifications is anonymous, so there is no need for whistleblower protection. Irrespective of the above, if the disclosed information is detrimental to the whistleblower, appropriate regulations provide further anonymity for the informer.

Does the country have a reward mechanism for whistleblowers?

The only mechanism that awards informers is found in the area of protection of competition, known as the ‘leniency programme’ and the ‘leniency programme plus’. A company conducting activities in healthcare, medicinal products or medical devices and participating in practices limiting competition may submit an application or information to the president of the Office of Competition and Consumer Protection. The president of the Office can impose or reduce a fine for the company. The leniency programme also encompasses company managers.

Moreover, within the framework of the leniency plus programme, the entrepreneur or managing persons who fulfil the conditions for applying the decrease of the fines can benefit from additional fine reduction if certain conditions are met (‘plus’).

Other provisions referring directly to medicinal products, medical devices or healthcare have no award systems for informers.

Are mechanisms allowing whistleblowers to report infringements required?

There is no detailed regulation that provides possibilities for informers to report infringement. They can only file a motion or a complaint with the relevant organisation. The procedure takes place according to the administrative rules. Settling the matter should take place without delay and should take no longer than one month.

Cross-border enforcement and extraterritoriality

Cooperation with foreign counterparts

Do prosecutors and law enforcement authorities in your country cooperate with their foreign counterparts in healthcare cases?

The Department of Health performs assignments regarding Poland’s membership of the European Union. Representatives of the Ministry of Health and experts in the work of EU institutions, among others, the councils of the European Union, take an active role in working parties (eg, parties of public health, pharmaceutical products, medical products and food centres), of the European Commission and of the European Parliament.

Beside EU healthcare cooperation, bilateral and direct cooperation is also important, as is direct cooperation between Poland and its partners.

The Department of Health cooperates with Europe, Asia, Africa and the Middle East, and the Americas. Most active cooperation takes place between Poland and its neighbours: the Czech Republic, Germany, Lithuania and Slovakia. Further, Poland has special cooperation agreements in healthcare and medical sciences with many other countries. Thanks to those agreements, a regular exchange of knowledge and experience in medicine is possible. The bilateral cooperation is most often carried out in the form of meetings between health ministers and experts and exchanges of information.

Triggering investigations

In what circumstances will enforcement activities by foreign authorities trigger an investigation in your country?

Enforcement authorities and institutions in other EU member states mutually ensure that the producers and distributors of medicinal products and active substances act in accordance with principles of the GMP and good production practice. Within that framework, it is possible for the relevant EU member state institutions to conduct an audit or inspection of producers and distributors.

However, within the confines of healthcare, there is no provision or pharmaceutical law that would directly allow proceedings to be brought by overseas institutions in Poland - proceedings are only conducted by Polish bodies. However, proceedings could be initiated by Polish authorities following information about irregularities received from a foreign institution.

Pursuing foreign entities for infringement

In what circumstances will foreign companies and foreign nationals be pursued for infringements of your country’s healthcare laws?

As a rule, a foreign entity and foreign people can perform business activities in Poland following the same principles that apply to Polish nationals. This means that provisions of Polish law apply to every entity on Polish territory. The responsibility of these entities is similar to that incurred by Polish nationals. Moreover, special provisions contain additional regimes for such persons. For example, the Polish Border Guard (BG) can conduct legal control of foreign business activity in Poland. The controlled entrepreneur, at the request of BG officers, must present documents concerning the legality of the conducted business activity within seven days. These documents are, for example:

  • the confirmation of entry in the central register and information on the business or the entry in the National Register of Court;
  • entry in the Regulator Activity Register;
  • a specified licence; or
  • permission.

Foreigners who conduct a business activity in Poland without an entry in the Register of Business Activity, which is required by law, are punishable by a fine or restrictions on liberty.

Update and trends

Current developments

What are the authorities’ enforcement priorities likely to be in the coming year? Are there any noteworthy cases pending? Are there any current developments or emerging policy or enforcement trends that should be noted?

No updates at this time.