Publication date: October 15, 2024
Parallel import of medicinal products is an institution that has its source in the EU law, resulting from the free movement of goods (Articles 34-36 TFEU), consisting in importing medicinal products from the European Union countries or a Member State of the European Free Trade Agreement. According to Article 21a of the Pharmaceutical Law, the medicinal products subject to parallel import must have “the same active substance or the same combination of active substances, at least the same indications up to level 3 of the ATC/ ATCvet code […], the same strength, the same route of administration and the same form as a medicinal product authorized for marketing in the territory of the Republic of Poland or a similar form that does not cause therapeutic differences in relation to a medicinal product authorized for marketing in the territory of the Republic of Poland.”[1]
Medicinal products very often differ depending on the country in which they are sold, so this solution allows for significant savings for the patient, thanks to the possibility of buying the medicine at a lower price. It is worth mentioning that this also applies to products requiring a prescription.
Unlike parallel import, target import differs in that it does not require a marketing authorization, but the use of this medicinal product must be necessary to save the life or health of the patient. Moreover, target import does not limit us to importing a drug from European Union countries or a member state of the European Free Trade Agreement, because Article 4 of the Pharmaceutical Law refers to “medicinal products imported from abroad”. In addition, target import is used in emergency situations, when a given drug is needed for an individual patient, in particular in cases of threat to life or health, and this procedure does not require a change in packaging or leaflet. The situation is different with parallel import, which is intended for general use, where it is required to adapt the packaging and leaflet to Polish regulations.
To obtain a permit for parallel import of medicines, an application must be submitted to the Polish President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Polish “URPL”), however, this permit is issued for a single product, not the activity of parallel import itself. It should also be noted that obtaining such a permit is not required in the case of medicinal products authorized for marketing under the central procedure, i.e. medicines approved for sale in all European Union countries. What is more, “According to the definition of parallel import contained in art. 2 item 7b of the Pharmaceutical Law, parallel import is a form of wholesale trade. Although it does not result directly from the regulations, it must be stated that the condition for conducting such activity is to have a permit to run a pharmaceutical wholesaler”.[2]
The following must be attached to the submitted application for a parallel import permit:[3]
At the beginning, the formal assessment of the application and the documentation attached to it takes place in terms of the completeness of the documents. If any deficiencies are found, the applicant will be requested to supplement them within 7 days. Subsequently, the office analyses the application in terms of the correctness of the information provided and compliance with the requirements of parallel import. In the event of any comments on the submitted documentation, the person submitting the application will be informed about them via e-mail.
In the procedure for issuing a permit for parallel import of medicinal products, an analysis of the similarity of the imported drug is carried out in relation to its equivalent admitted to trading on the Polish pharmaceutical market. The President of the Registration Office (URPL) takes into account in particular the criteria mentioned in art. 2 item 7b of the Pharmaceutical Law, whereas the failure to meet the latter may lead to refusal to obtain the permit. This refers to situations in which “the differences between these products are significant and may pose a threat to the life and health of humans or animals. […] The current practice of the Polish Office (URPL) shows that obtaining a permit for parallel import may be permissible even in the event of such differences as: the size of the packaging (even twice as large), the composition of excipients, differences in the origin of the active substance (i.e. the active substance of the imported drug comes from a different manufacturer than the substance of the drug in Poland), differences in the pharmaceutical form (e.g. coated tablet vs. prolonged-release tablet)” [4]. In the case law of administrative courts, one can also encounter cases in which the criterion of the identity of the medicinal product is understood by the President of the URPL as “single-element drug”. More specifically, this concerns a situation in which a product authorized for marketing in Poland was a single drug, while in the exporting country it consisted of two separate products (case reference number: VI SA/ Wa 1730/16 and II GSK 4222/17). As a result, the President of the URPL refused to issue consent and the case was appealed only in the Voivodship Administrative Court (completed successfully for the appellant). Another example encountered in case law is a case concerning a company that applied for a permit for parallel import of a drug that was authorized for marketing in the exporting country as a generic drug, while the equivalent in Poland was a reference medicinal product. In this case (reference number VI SA/ Wa 2256/17), the President of the URPL found that the difference in the registration category was significant enough to pose a potential threat to public health. In this case, even though the active substances were identical, the authority found that the lack of sufficient documentation on the safety and efficacy of the generic medicine prevented its authorisation for the Polish market.
The fee for submitting an application for a permit for parallel import of a medicinal product is PLN 6,132, and the permit itself is issued for a period of 5 years. It is also possible to extend the validity period for another 5 years on the basis of an application submitted by the parallel importer at least 6 months before the expiry of the permit’s validity period (Article 21a). In the case of submitting an application for extension, the fee will be PLN 5,250. The application process is identical to that for obtaining the original permit for parallel import.
Required documents: [5]
However, in certain circumstances the authorisation may lapse before its expiry date in the following cases:
Since the exported products are labelled in foreign languages, the parallel importer must make some changes to the packaging before they are placed on the Polish market. This involves repackaging the goods, which may involve replacing the original box with a new one or putting a new label on the original packaging and replacing the leaflet with a Polish version.
In connection with parallel import, the packaging of the product may be changed, including placing on it markings that interfere with the trademark used by the manufacturer. Such action by the parallel importer is subject to assessment from the point of view of infringement of the exclusive rights of a third party. Case law has developed criteria which, when met cumulatively, preclude the assumption that there has been unlawful infringement of a trademark (see the judgment of the ECJ of 11 July 1996 in joined cases C-427/93, 429/93 and 436/93 Bristol-Myers Squibb vs Paranova). Repackaging a product using another person’s trademark is permissible if it meets the conditions indicated in the aforementioned judgment (so-called BMS conditions), i.e. when
(1) it constitutes a condition for introducing the product to the market (objective necessity condition),
(2) it does not affect the condition of the product,
(3) the new packaging clearly indicates the manufacturer and importer,
(4) the appearance of the new packaging does not damage the reputation of the manufacturer and the product,
(5) the manufacturer was notified of the parallel import before the medicinal product was introduced to the market and, if such a request was made, received a sample of the product.
In light of the applicable regulations, a parallel importer has a considerable scope of freedom in using the names of medicinal products originating from parallel import. One possibility is to change the name of the medicine, under the one used in Poland. In a sense, this procedure may raise a lot of controversy, because it is an interference with trademarks, the right to which is vested only in the entitled party, however, this action is permitted, as has been repeatedly stated in the case law of the CJEU (case C-379/97 Pharmacia & Upjohn SA v. Paranova A/S).
The second option is to use the original name of the product from the exporting country. In other words, this is an option that allows the parallel importer to leave the original name of the product, used in the country of origin.
The third option provided by the Polish legislator is to use a scientific or commonly used name in addition to a trademark or the name of an entity authorized to parallel import. “In practice, this means that a parallel importer may use a generic name – INN (International Nonproprietary Name) – together with its name, which may also be a trademark.”[6]
After obtaining the authorization, but before introducing the product to the market, the parallel importer is obliged to carry out two types of notifications. First, in accordance with Article 21a, paragraph 8a of the Pharmaceutical Law Act, the parallel importer must inform the Chief Pharmaceutical Inspectorate (GIF), the President of the URPL and the responsible entity in Poland about the planned date of introducing the product to the market, at least 30 days in advance. Second, the importer who carried out the repackaging of the drug is obliged to inform the entity entitled to the trademark about this. This notification should also include a sample of the repackaged product. Interestingly, this obligation is based on the case law of the CJEU. The lack of such notification results in the fact that the product introduced to the market may be treated as a counterfeit product under the provisions of the Industrial Property Law Act. The trademark owner may then seek a court order prohibiting the introduction of the product to the market and compensation under Article 296 of the aforementioned Act. When making this notification, it has to be remembered that the entity entitled to a trademark registered in Poland does not have to be (and usually is not) identical to the responsible entity in Poland.
Summary
Parallel import of medicines is an important mechanism operating within the framework of EU law, which takes advantage of the free movement of goods in the European Union. Thanks to this institution, it is possible to import medicines at lower prices from other EU or EFTA countries, which contributes to the greater availability of cheaper medicinal products on the Polish market. For patients, this means real financial benefits, especially in the case of long-term treatment, while maintaining high standards of quality and safety. It is important that despite differences in the origin of the products, medicines imported under parallel import must meet the requirements specified in the law regarding active substances, strength, indications and pharmaceutical form, which guarantees their compliance with equivalents approved for marketing in Poland.
The process of obtaining a parallel import permit, although formally complicated, ensures transparency and control over products introduced to the market. It requires the completion of a number of formalities, including the provision of appropriate documents regarding the characteristics of the drug, packaging, leaflets and permits for the production and repackaging of medicinal products. These stringent requirements are intended to ensure the safety of patients who use products from other markets. Also, the provisions on the repackaging of products, known as BMS conditions, protect the rights of trademark owners, while allowing for the legal adaptation of packaging and leaflets to the requirements of the Polish market.
Another important aspect of parallel import is the need for appropriate notifications before the product is placed on the market. This procedure requires notification to both the Chief Pharmaceutical Inspectorate, the President of the Office for Registration of Medicinal Products, and the entity responsible for the trademark. This is important from the point of view of protecting intellectual property and preventing infringements of trademark rights.
The introduction of parallel imported medicines to the Polish market is also an important element in promoting competition in the pharmaceutical sector. It allows for lower prices of medicines, which in the long term benefits both patients and the healthcare system. Additionally, these procedures allow patients to access medicines that may be less available or more expensive on the local market at a given time.
Despite numerous formal requirements and procedures related to obtaining permits, parallel import remains one of the key tools supporting balance in the pharmaceutical market. Thanks to appropriate legal regulations, both patients and the pharmaceutical market benefit from greater availability of medicinal products, while maintaining high standards of health protection. In the long term, the institution of parallel import supports competition, innovation and provides patients with a wider choice of available therapies, which is crucial for effective and efficient treatment in Poland.
Sources:
https://www.e-medest.pl/artykuly/import-rownolegly-lekow-co-to-jest-i-na-czym-polega.html
Procedura centralna – Ministerstwo Zdrowia – Portal Gov.pl (www.gov.pl)
Prawo farmaceutyczne. Komentarz – Komentarze – LEX (uek.krakow.pl)
https://www.gov.pl/web/urpl/przedluzenie-okresu-waznosci-pozwolenia-na-import-rownolegly2
EU regulations:
a/ TFEU (Articles 34 and 36)
b/ Directive 2001/83/EC
Polish law:
a/ Pharmaceutical law
b/ Regulation of the Minister of Health of 3 June 2014 on the template of the application for issuing a permit for parallel import and making changes to this permit
c/ Regulation of the Minister of Health of 16 June 2015 on the method of determining and paying fees related to the marketing authorisation of a medicinal product
d/ Parallel import permit (issued by the President of the Office for Registration of Medical and Medicinal Products, Medical Devices and Biocidal Products)
[1] Journal of Laws 2024.686, unified text of 2024.05.06.
[2] W.L. Olszewski [in:] R. Dybka, Z. Ignatowicz, K. Miłowska, B. Nowak-Chrząszczyk, P. Sosin -Ziarkiewicz, Z. Ulz, P. Zięcik, M. Żarnecka, W.L. Olszewski, Pharmaceutical Law. Commentary, Warsaw 2016.
[3] Requirements taken from: https://www.gov.pl/web/urpl/pozwolenie-na-import-rownolegly
[4]W.L. Olszewski [in:] R. Dybka, Z. Ignatowicz, K. Miłowska, B. Nowak-Chrząszczyk, P. Sosin -Ziarkiewicz, Z. Ulz, P. Zięcik, M. Żarnecka, W.L. Olszewski, Pharmaceutical Law. Commentary, Warsaw 2016, art. 21(a).
[5]Requirements taken from: https://www.gov.pl/web/urpl/przedluzenie-okresu-waznosci-pozwolenia-na-import-rownolegly2
[6]M. Kondrat [in:] W. Masełbas, J. Stefańczyk-Kaczmarzyk, W. Zieliński, M. Kondrat, Pharmaceutical Law. Commentary , 2nd edition, Warsaw 2016, article 21(a).