Publication date: October 10, 2024
The concept of a named patient concerns the access to the supply of a medicinal product that is excluded by a Member State from the provisions of Directive 2001/83/EC, in accordance with the applicable provisions and in order to meet special needs [based on Article 5(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ EU L 311, 2001, No. 311, p. 67, as amended)].
“The expression ‘special needs’ means that the medicinal product in question is necessary to meet a specific and identified need. The need must be felt by a specific patient. As regards the concept of ‘special’, it refers to circumstances that go beyond the usual cases. One can imagine, for example, the case of a patient suffering from a rare disease requiring treatment with medicinal products not covered by an authorisation on the national market. Similarly, the requirement that medicinal products be supplied in response to an ‘unsolicited order made in good faith’ means that the medicinal product must be prescribed by a doctor following an objective assessment of the health of his patients and based solely on therapeutic considerations. It follows from all the conditions set out in Article 5(1) of that Directive, read in the light of the essential objectives of that Directive, in particular the objective of protecting public health, that the derogation provided for by that provision can only concern situations in which a doctor considers that the health of his individual patients requires the administration of a medicinal product for which there is no equivalent authorised on the national market or which is unavailable on that market.” (Judgment of the Court of Justice of 29 March 2012, C-185/10, EUROPEAN COMMISSION v. REPUBLIC OF POLAND, ZOTSiS 2012, No. 3, item I-181).
In Polish law, the above issue is regulated in art. 4 of the Act of 6 September 2001 – Pharmaceutical Law (consolidated text: Journal of Laws of 2024, item 686). Based on art. 4 sec. 1 of the Pharmaceutical Law, medicinal products imported from abroad are exempt from the obligation to have a marketing authorization if their use is necessary to save the life or health of the patient, provided that the medicinal product in question is approved for marketing in the country from which it is imported and has a valid marketing authorization. Importing a medicinal product for the needs of an individual patient is referred to as “target import“. A medicinal product may be imported by means of target import based on the demand of a hospital or a physician providing treatment outside the hospital, confirmed by a consultant in a given field of medicine.
The wording in Article 4, Section 1 of the Pharmaceutical Law that a given product is “authorised for marketing without the need to obtain a marketing authorisation” seems erroneous – it suggests that this provision is not about creating the possibility of using a medicinal product not authorised for marketing by an individual patient, but about creating the possibility of marketing medicinal products outside the official, controlled market.[1]
Medicinal products imported from abroad are permitted for sale if they meet all of the following conditions:
Although the regulations do not use the term named patient, a named patient may be considered to be a person for whose individual needs a given medicinal product is introduced to the market. The right to authorize a medicine to be placed on the market, resulting from Article 4 of the Pharmaceutical Law, may be exercised only in necessary cases, taking into account the special needs of the patient.
Patient data are in the register of requests implemented as part of the target import, which also processes detailed data on the medical entity submitting the request, data on the physician issuing the request, data on the medicinal product, consultant data and data on the decision itself. Register of medicinal products admitted to trading without a permit is maintained in the IT system by the minister responsible for health.
The issuance of requests for the import of medicinal products necessary to save the life or health of a patient from abroad, referred to in art. 4 sec. 2 of the Pharmaceutical Law, as well as requests for the import of foodstuffs for special nutritional uses from abroad in accordance with art. 29a sec. 2 of the Act of 25 August 2006 on food and nutrition safety (Journal of Laws 2023.1448, unified text of 2023.07.28) is carried out electronically using the Target Import Service System. Target Import Service System enables the consideration of complex requests, obtaining by pharmacies and pharmaceutical wholesalers the information on the considered requests and communication with the minister responsible for health regarding this scope.
It should be noted that one marketing authorisation for a medicinal product may be issued to one marketing authorisation holder, i.e. only one person may be the addressee of the decision to grant a marketing authorisation for a medicinal product.
According to the regulation on target import, the treating physician or hospital issues a request with attached information about the patient’s illness. The issuance of such a request is recorded in the patient’s medical records, providing: the name, pharmaceutical form, dose and method of administration of the medicinal product, the period of treatment with the use of this product and the justification for the request. In the case of issuing a request for target import of a medicinal product by a physician, it should be additionally signed by the head of the medical entity running the hospital or a person authorized by him.
After the decision is issued, information about the consideration of the request is sent from the Target Import Service System to the email address provided when issuing the request. If the request was issued in paper form, this information is sent to the patient’s address (if the request concerns a product used at home) or to the address of the medical entity (if the product will be used in a medical entity).
After obtaining the consent of the Minister of Health, the patient has 60 days to submit the demand for fulfillment to the pharmaceutical wholesaler via the pharmacy (the demand will expire if it is not submitted to the pharmaceutical wholesaler within 60 days of confirmation, regardless of whether the patient applies for its reimbursement or purchases the drug at full cost). The pharmacy imports the drug via the pharmaceutical wholesaler.[2]
The marketing authorization holder is obliged to monitor adverse reactions to the medicinal product that it has placed on the market. According to Article 10, paragraph 2, point 5 of the Pharmaceutical Law, the application for a marketing authorization for a medicinal product for humans must be accompanied by a description of the adverse reaction monitoring system that will be implemented by the marketing authorization holder.
[1]M. Krekora, 3.3. Specific rules for admission to trading [in:] M. Krekora, M. Świerczyński, E. Traple, Pharmaceutical Law , Warsaw 2020.
[2]https://www.gov.pl/web/zdrowie/sprowadzac-leki-z-zagranicy-import-docelowy-