Published July 19, 2022
| Version v1
Book chapter
Open
Pharmaceutical crime in the European Union - selected issues
Creators
Description
The aim of the study is to analyse the main directions of the dynamically developing pharmaceutical crime that the European Union and all its Member States have to deal with, as well as to attempt to indicate further necessary systemic solutions to prevent this type of crime. The author presents the most common types of pharmaceutical crimes in the European Union, analyses the normative activity of its organs aimed at preventing this type of crime and the harmonisation of the laws of the Member States in this area. She also tries to identify the causes of the current problems with effectiveness in the fight against this type of crime in the European Union. In conclusion, the author presents proposals for considering the introduction of further pan-European legal regulations and formulates appropriate de lege ferenda conclusions in this regard.
Files
12 Komar Nalepa Pharmaceutical crime.pdf
Files
(244.7 kB)
| Name | Size | Download all |
|---|---|---|
|
md5:d891c2ed6a054053186ec86e72a88d37
|
244.7 kB | Preview Download |
Additional details
References
- Pharmaceutical law (2001), Dz.U. 2001, No 126, item 1381 with subsequent amendments
- 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 [2001] OJ L 311/67, as amended
- Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending
- Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products [2011] OJ L 174/74
- Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (2011), CETS 211
- Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use [2016] OJ L 32/1
- Report from the Commission to the European Parliament and the Council on the Member States' transposition of Article 118a of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2011/62/ EU of the European Parliament and of the Council of 8 June 2011, Brussels, 26 January 2018, COM(2018) 49 final, <https://eur-lex.europa.eu/legal-content/ EN/TXT/?uri=CELEX%3A52018DC0049> accessed 22 March 2022
- European Commission, Directorate General for Health and Food Safety, Möller U, Maly S, Rennoch, J, et al., Study on the transposition measures of Member States in relation to the pharmaceutical legislation (Art. 118a of Directive 2001/83/EC): final report, Publications Office 2018 <https://data.europa.eu/doi/10.2875/41105> accessed 22 March 2022
- Bird R C, 'Counterfeit drugs: a global consumer perspective' (2007–2008) 8 Intellectual Property Law Journal
- Dworzecki J, Nowicka I, 'Organized crime in the production and distribution of falsified medicines in Poland: outline the problem' (2019) 6 Entrepreneurship and Sustainability Issues <https://doi.org/10.9770/jesi.2019.6.4(15)>
- Fijałek Z, Sarna K, 'Fałszowanie leków i inne przestępstwa farmaceutyczne' (2009) 263 Problemy Kryminalistyki [Issues of Forensic Sciences]
- Fijałek Z, Sarna K, 'Wybrane aspekty jakości produktów leczniczych i suplementów diety – produkty substandardowe, nielegalne i sfałszowane' (2009) 65 Rynek Farmaceutyczny
- Kohli V P, Combatting Falsification and Counterfeiting of Medicinal Products in the European Union – A Legal Analysis (Copenhagen Business School 2018)
- Mages R, Kubic T T, 'Counterfeit medicines: Threat to patient health and safety' (2016) 18 Pharmaceuticals, Policy and Law <https://doi.org/10.3233/PPL-160441>
- Młynarek M, Zjawiska patologiczne na rynku farmaceutycznym (Instytut Wymiaru Sprawiedliwości 2019)
- Pashkov V, Soloviov A, Olefir A, 'Legal aspects of counteracting the trafficking of falsified medicines in the European Union' (2017) 70 Wiadomości Lekarskie
- Świeczkowski D, Zdanowski Sz, Merks P, Jaguszewski M J, 'Leki sfałszowane jako wyzwanie dla zdrowia publicznego – próba definicji pojęcia i skali zjawiska na świecie oraz ujęcie prawne i socjologiczne' (2019) 75 Farmacja Społeczna <https:// doi.org/10.32383/farmpol/115755>
- Europejska Akademia Pacjentów, Sfałszowane leki, <https://www.eupati.eu/pl/ bezpieczenstwo-stosowania-lekow/sfalszowane-leki/> accessed 22 March 2022
- Interpol 'Operation Pangea – shining a light on pharmaceutical crime', 21 November 2019 <https://www.interpol.int/News-and-Events/News/2019/Operation- Pangea-shining-a-light-on-pharmaceutical-crime> accessed 22 March 2022
- Krajowa Organizacja Weryfikacji Autentyczności Leków (KOWAL) 'Serializacja i Dyrektywa Antyfałszywkowa', 11 February 2019 <https://www.nmvo.pl/pl/ aktualnosci/serializacja-i-dyrektywa-antyfalszywkowa/> accessed 22 March 2022
- Polityka Zdrowotna, 'Komisja Europejska chce skuteczniejszej walki z fałszowaniem leków', Polityka Zdrowotna, 3 April 2018 <https://www.politykazdrowotna. com/30298,komisja-europejska-chce-skuteczniejszej-walki-z-falszowaniem-lekow> accessed 22 March 2022
- Słowik P, Styczyński J, 'Nasze zdrowie w rękach bandytów', Dziennik Gazeta Prawna, 22 stycznia 2021 <https://www.gazetaprawna.pl/magazyn-na-weekend/ artykuly/8074698,przestepczosc-farmaceutyczna-koronawirus-falszywe-lekiwyroby- medyczne.html> accessed 22 March 2022
- Stowarzyszenie Leki Tylko z Apteki, raport 'Pozaapteczny obrót lekami OTC bezpieczeństwo, ekonomia i oczekiwania pacjentów' (2018) <https://lekitylkozapteki. pl/uploads/raport.pdf> accessed 22 April 2022
- Warszawski Uniwersytet Medyczny (WUM), Wywiad z profesorem Zbigniewem Fijałkiem na temat fałszowanych leków [Interview with professor Zbigniew Fijałek about counterfeit medicines] <https://www.wum.edu.pl/node/13622> accessed 29 April 2022.