Best prices Special offers for members of the PWE book club The cheapest delivery
DOI: 10.33226/0137-5490.2023.12.1
JEL: I18, K14, K23
Katarzyna Banasik ORCID: 0000-0003-3693-0480 , e-mail: kbanasik|afm.edu.pl| |kbanasik|afm.edu.pl

Advertising of medicinal products in Polish law in the light of Directive 2001/83/EC on the Community code relating to medicinal products for human use

 The subject of the article is the advertising of medicinal products in Polish law in the light 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. The objective of this study is to evaluate the implementation of the Directive in the field of advertising of medicinal products by the Polish legislator. The author, using the dogmatic research method, makes the linguistic-logical analysis of the provisions of the Polish Act – Pharmaceutical Law, referring at the same time to relevant provisions of the Directive. The author presents Polish regulations regarding both advertising to the public and advertising directed to persons authorized to issue prescriptions or persons trading in medicinal products. After analysing the provisions of an administrative nature, the author analyses the criminal law regulations regarding the violation of the provisions on the advertising of medicinal products. During the analysis, the author points out the shortcomings of Polish regulations and makes de lege ferenda postulates. In the final part of the study, the author makes a final assessment of the implementation of the Directive by the Polish legislator, as well as indicates an example of carelessness of the EU legislator.

Keywords: advertising of medicinal products; Community code relating to medicinal products for human use; liability for violation of regulations concerning advertising of medicinal products; Polish law

References

 

Bibliografia/References

 

Literature/Literatura

Banasik, K. (2023). Bezprawne dostarczanie próbek produktów leczniczych. Przegląd Sądowy, (9), 5–17.

Czyżewska, K. (Ed.), Dziurowicz, J., Łoś, K., Łukawska, N., & Piekarczyk K. (2020). Reklama produktów leczniczych. Komentarz do art. 52–64 ustawy – Prawo farmaceutyczne. Lex.

Harasimiuk, D. E. (2011). Zakazy reklamy towarów w prawie europejskim i polskim. Lex.

Iwański, M. (2023). Dział II. Odpowiedzialność karna w prawie medycznym. Rozdział 15. Korupcja w systemie ochrony zdrowia. In: A. Barczak-Oplustil, & T. Sroka (Eds.), System Prawa Medycznego. Tom 6. Prawo farmaceutyczne. Legalis.

Raglewski, J. (2008). Kilka uwag w kwestii reklamy produktów leczniczych na gruncie ustawy Prawo farmaceutyczne. Prawo i Medycyna, (3), 132–139.

Stefańczyk-Kaczmarzyk, J. (2016). In: M. Kondrat (Ed.), Prawo farmaceutyczne. Komentarz. Lex.

Targosz, T. (2007). Część szósta. Międzynarodowe aspekty prawa reklamy. Rozdział XXII Reklama a wolności traktatowe. In: E. Traple (Ed.), Prawo reklamy i promocji. Lex.

Wilk, L. (2011). Korupcja w reklamie farmaceutycznej. Prokuratura i Prawo, (10), 21–36.

Wilk, L. (2017). In: M. Mozgawa (Ed.), Pozakodeksowe przestępstwa przeciwko zdrowiu. Komentarz. Lex.

Wilk, L. (2018). In: L. Ogiegło (Ed.), Prawo farmaceutyczne. Komentarz. Legalis.

 

Legal acts/Akty prawne

Act of 16 April 1993 on Combating Unfair Competition, Journal of Laws 1993 no. 47 item 211 as amended.

Act of 6 June 1997 – Penal Code, Journal of Laws 1997 no. 88 item 553 as amended.

Act of 6 September 2001 – Pharmaceutical Law, Journal of Laws 2001 no. 126 item 1381 as amended.

Act of 6 March 2018 – Entrepreneurs' Law, Journal of Laws 2018 item 646 as amended.

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. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02001L0083-20220101 (accessed: 26.08.2023).

Regulation of the Minister of Health of 21 November 2008 on the advertising of medicinal products, Journal of Laws 2008 no. 210 item 1327 as amended.

 

Other sources/Inne źródła

Decision of the Provincial Administrative Court in Warsaw of 29 March 2006, I SA/Wa 1270/04, Lex no. 806466.

Decision of the Chief Pharmaceutical Inspector of 19 February 2014, GIF-P-R-450/42-12/JD/13. https://archiwum.gif.gov.pl/pl/decyzje-ikomunikaty/decyzje/decyzje/503,Decyzja-z-dnia-19022014-znak-GIF-P-R-45042-12JD13.html (accessed: 26.08.2023).

Judgment of the European Court of Justice of 8 November 2007, C-374/05-Gintec, Lex nr 326063.

Summaries of EU Legislation. Dyrektywy Unii Europejskiej. https://eur-lex.europa.eu/PL/legal-content/summary/european-union-directives.html (acccessed: 26.08.2023).

Summaries of EU Legislation. European Union directives. https://eur-lex.europa.eu/EN/legal-content/summary/european-union-directives.html (accessed: 26.08.2023).

Article price
5.00
Price of the magazine number
17.00
Subscription
197.00 €
158.00
Lowest price in last 30 days: 158.00
get subscription