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.