Publication date: October 15, 2024
The need for doctors to use a medicinal product not approved for marketing in Poland raises the question of whether the lack of registration of the drug in Poland is equivalent to a ban on its use.
The solution to this problem can be found in Article 45 paragraph 3 of the Act of 5 December 1996 on the professions of physician and dentist (Journal of Laws of 2024, item 1287), which indicates that in justified cases, a physician may prescribe medicines admitted to trading in other countries, with a detailed justification in the medical documentation.
This provision can be interpreted in divergent ways. In order to take advantage of this possibility, one should follow the recommendations indicated in art. 4 sec. 1-4 of the Act of 6 September 2001 – Pharmaceutical Law (consolidated text: Journal of Laws of 2024, item 686). These conditions include:
In the case of targeted import, direct prescription by a doctor may occur if he/she provides treatment outside the hospital, and must also be confirmed by a consultant from a given field of medicine. In other cases, the basis for import is the hospital’s demand, also confirmed by a consultant.
There are also different views, namely that “an exception to the principle of prescribing medicines admitted to circulation in the country is established by art. 45 sec. 3 of the Act, which allows a doctor to prescribe medicines admitted to circulation in other countries. The Act does not provide for restrictions similar to those in art. 4a of the Pharmaceutical Law regulating target import”.
It can be noted that the subject of the admissibility of using medicinal products that do not have a marketing authorization in the national procedure is extremely broad and insufficiently explained. Commentaries indicate that ultimately one should opt for a broad understanding of the consent contained in art. 45 sec. 3 of the Act of 5 December 1996 on the professions of physician and dentist (consolidated text: Journal of Laws of 2024, item 1287).
In terms of the possibility of using medicinal products not authorized for marketing in Poland[1], one can also cite the functions of cross-border prescriptions, which have been defined as prescriptions for a medicinal product or medical device issued by a person authorized to issue prescriptions in accordance with the law of a Member State of the European Union or a Member State of the European Free Trade Agreement (EFTA) – a party to the Agreement on the European Economic Area in which the prescription was issued, subject to fulfillment in another Member State of the European Union or a Member State of the European Free Trade Agreement (EFTA) – a party to the Agreement on the European Economic Area in accordance with the law of that country. The fulfillment of a cross-border prescription is presented in the Regulation of the Minister of Health of 23 December 2020 on prescriptions (consolidated text: Journal of Laws of 2023, item 487, as amended). This legal act indicates that a cross-border prescription may be filled in the Republic of Poland only if it has not been filled in a Member State of the European Union or a Member State of the European Free Trade Agreement (EFTA) other than the Republic of Poland – a party to the agreement on the European Economic Area and is filled for full payment. In the event that the prescription is issued in electronic form, the Medical Information System is to transfer the Prescription Filling Document to the National Contact Point, which should include the appropriate data indicated by the Regulation, numbers regarding the filled prescription received from the country providing the prescription, a detailed verbal description of the medicinal product and the contents of the package, the form of the internal packaging of the medicinal product, the code assigned to the medicinal product and the code description specified according to the anatomical-therapeutic-chemical (ATC) classification of the World Health Organization (WHO), active substances contained in the medicinal product (name of the active substance, quantity of the active substance), the name of the entity responsible for the medicinal product and the route of administration of the medicinal product.
A cross-border prescription issued in a given country becomes a cross-border prescription when it is redeemed in another EU or EFTA Member State. This means that the patient must redeem the prescription issued in their country in another country where the medicinal product is available. It should be emphasized that the prescription will be redeemed in accordance with local law. On the other hand, the procedure described in Article 45 paragraph 3 of the Act of 5 December 1996 on the professions of physician and dentist (Journal of Laws of 2024, item 1287) gives the physician the possibility of prescribing a medicine, which means that they have the right to recommend, administer or prescribe medicines approved for marketing in other countries. Prescribing medicines and medical devices occurs in two forms – independent purchase by the patient (use is formalized and takes place through issuing medical prescriptions) or in the conditions of providing constant care to the patient (as part of medical orders). The concept of a cross-border prescription covers only prescriptions issued within the EU or EFTA countries; a doctor using the procedure of Article 45 paragraph 3 of the Act on the Medical and Dental Professions is not obliged by this area.
Bibliography:
[1]Act of 6 September 2001 – Pharmaceutical Law (consolidated text: Journal of Laws of 2024, item 686).