مبارزۀ کیفری با تقلب در فراورده ‏های پزشکی در اسناد بین‏ المللی و حقوق ایران

نوع مقاله : مقاله علمی - پژوهشی

نویسنده

دانشیار گروه حقوق جزا دانشکدۀ علوم اجتماعی دانشگاه بین ‏المللی امام خمینی (ره)

چکیده

تقلب در فراورده‏های پزشکی، شامل داروها و تجهیزات پزشکی، رفتاری نامشروع و زیان‌بار است که بهداشت عمومی و سلامت شهروندان را تهدید می‌کند و پیامدهای خطرناک این پدیدۀ جناییِ رو به رشد، این پرسش را مطرح می‌کند که جامعۀ جهانی در سطح اسناد بین‌المللی در مقابل این پدیدة جنایی چه واکنشی داشته و مبارزة کیفری ضد آن را به مدد کدامین تدابیر پیگیری کرده است؟ و وضعیت موضوع در حقوق ایران چگونه است؟ یافته‌های این پژوهش که از روش توصیفی- تحلیلی بهره گرفته است، نشان می‌دهد که با وجود اهتمام سازمان بهداشت جهانی و ایجاد ساختارهای ویژه برای مبارزه با پدیدۀ یادشده، انعقاد یک سند در قامت جهانی آن ناکام مانده است. اما شورای اروپا با تمرکز بر بهداشت عمومی و تفکیک آن از مالکیت فکری، با تصویب کنوانسیون مدیکرایم و تدوین راهبردهای پیشگیری، استفاده از حقوق کیفری، حمایت از بزه‌دیده و همکاری بین‌المللی، مبارزه با این پدیده را سامان داد و با تعریف مفاهیم ضروری، دولت‌های عضو را به جرم‌انگاری برخی رفتارها ملزم کرد و با پیش‌بینی مجازات و برخی تدابیر مؤثر، مناسب و بازدارنده، مبارزۀ کیفری با تقلب و جرایم مشابه متضمن تهدید سلامت عمومی را پی‌ریزی کرد و ضمن ایجاد هماهنگی بین دولت‌های عضو، تحولی مهم را در مبارزه با پدیدۀ تقلب در فراورده‌های پزشکی ایجاد نمود، ولی تصویب یک سند بین‌المللی جدید می‌تواند برخی کاستی‌های آن را جبران کند. در ایران، قوانین مختلف و ناهماهنگی مبارزۀ کیفری با پدیدة یادشده را برعهده دارد و جرم‌انگاری ناقص، مانند غفلت از تجهیزات پزشکی و برخی اقلام مرتبط، وضع قانون جدیدی را که به موضوعات پزشکی و دارویی اختصاص یابد و از تمامی راهبردهای مبارزه با این پدیدۀ ضد بهداشت عمومی بهره ‌گیرد، ضروری می‌نماید.

کلیدواژه‌ها

عنوان مقاله [English]

Criminal Combating the Counterfeiting of Medical Products in International Instruments and Iranian Law

نویسنده [English]

  • Mohsen Eini
Associate professor, Department of Law, Faculty of Social Sciences, Imam Khomeini International University, Qazvin, Iran
چکیده [English]

Counterfeit in medical products, including medicine and medical devices is an illegal and harmful behavior that threatens public health and well-being of citizens. The dangerous consequences of this growing criminal phenomenon raise the question of how the international community has reacted to the phenomenon at the level of international instruments and with what measures has it pursued a criminal combat against it? What is the status of the issue in Iranian law? The findings of this study, which uses a descriptive analytical approach, show that despite the efforts made by the World Health Organization and special structures created to combat this phenomenon, concluding an instrument in its global status has failed. However, the Council of Europe by focusing on public health and separating it from intellectual property, by ratifying the MEDICRIME Convention and developing prevention strategies and by the use of criminal law, protection of victims and international cooperation organized a combat against this phenomenon; and by defining the necessary concepts committed member states to criminalize certain behaviors. The Council also established a criminal combat against counterfeits and similar crimes involving threats to public health by anticipating punishment and some effective, proportionate and dissuasive sanctions, and while building coordination between member states, significantly revolutionized the combat against counterfeits in medical products. Nonetheless, the ratification of a new international instrument could make up for some of its shortcomings. In Iran, different and uncoordinated laws are responsible for the criminal combat against the phenomenon, and incomplete criminalization, such as neglect of medical devices and some related materials necessitates the enactment of a new law dealing with medical and medicinal issues, taking advantage of all strategies in combating against this public health phenomenon.

کلیدواژه‌ها [English]

  • counterfeit in medical products
  • crimes against public health
  • falsified medicines
  • MEDICRIME convention

مراجع

  1. الف) فارسی

    1. ابراهیمی، شهرام و دانش، مصطفی (1398)، «تحلیل شکلی و ماهوی قانون مبارزه با قاچاق کالا و ارز»، مطالعات حقوق کیفری و جرم‌شناسی ،ش 2، دورۀ پاییز و زمستان.
    2. بیابانی، غلامحسین و نظری، غلامحسین (1391)، «بررسی ابعاد قاچاق کالا و روش‌های مبارزه با آن»، دوفصلنامۀ بررسی‌های حقوقی، ش 3، دورۀ بهار و تابستان.
    3. پایگاه خبری- تحلیلی فرارو (1397)، «پروتز تقلبی در ستون ‌فقرات بیماران واقعی»، 27 بهمن 1397، کد خبر: 390932 ، به آدرس:https://fararu.com/fa/news/390932 : آخرین بازدید 12 آذر ماه 1399.
    4. توکلی، احمدرضا و حق‌شناس، محمدرضا (1393)، «جرائم علیه سلامت عمومی از منظر فقه مقارن و حقوق جزا با تأکید بر جرم تقلب در کالاهای خوراکی»، دوفصلنامۀ فقه مقارن، ش 3، دورۀ بهار و تابستان.
    5. جاوید، احسان و نیاورانی، صابر (1392)، « قلمرو حق سلامتی در نظام بین‌المللی حقوق بشر»، فصلنامۀ پژوهش حقوق عمومی، ش 41، دورۀ پاییز.
    6. دیده‌بان شفافیت و عدالت- اخبار دیده‌بان (1398)، «پرونده‌های فساد ... »، 13 مرداد 1398، به آدرس: 2019/08/04 http://daad.ir : آخرین بازدید 12 آذر 1399.
    7. 7. عباسی، محمود؛ رضایی، راحله؛ دهقانی، غزاله (1393)، «مفهوم و جایگاه حق بر سلامت در نظام حقوقی ایران»، فصلنامۀ حقوق پزشکی، ش30، دورۀ پاییز.
    8. متقی، سمیرا؛ سیفی، آناهیتا؛ درودیان، مجید (1396)، «ماهیت حق بر سلامت و جایگاه دولت در تحقق آن»، پژوهشنامۀ حقوق اسلامی، ش 2 (پیاپی 46)، دورۀ پاییز و زمستان.
    9. نظریۀ مشورتی شمارۀ 376/94/7 ادارۀ کل حقوقی قوۀ قضائیه، 14/2/1394.
    10. نظریۀ مشورتی شمارۀ 316/93/7 ادارۀ کل حقوقی قوۀ قضائیه، 15/2/1393.

     

    ب) خارجی

    1. Abiri, Armaghan (2018), A critical analysis of the reform of the pharmaceutical sector in Iran, with specific reference to the regulatory framework, PhD thesis, Southern Cross University, Lismore.
    2. Abbing, Henriette D.C. Roscam (2018), “European Governance of Health Systems. It Takes Two to Tango: The Council of Europe and the European Union”, European Journal of health law, 2018, Vol. 25, Issue. 2, pp. 121-131
    3. Altavilla, Annagrazia (2018), Safe, “Innovative and Accessible Medicines in Europe: A Renewed Strategy for Patients and the Pharmaceutical Sector”,European Journal of Health Law, Vol. 25 , pp. 133-156.
    4. Alwon ,Bassam Mohammad (2015), Developing a national strategy for combating counterfeit medicines, thesis, School of Pharmacy ,University of East Anglia.
    5. Ambos, Kai (2018), European Criminal Law,United Kingdom,Cambridge university press .
    6. Attaran, Amir (2015), “Stopping Murder by Medicine: Introducing the Model Law on Medicine Crime”, The American Journal of Tropical Medicine and Hygiene , Vol. 92 (Suppl 6), pp. 127–132.
    7. Attaran,Amir; Bate, Roger; Megan, Dall (2011), “Why and How to Make an International Crime of Medicine Counterfeiting “ , Journal of International Criminal Justice, Vol. 9, pp. 325-354.
    8. Babar, Zaheer-Ud-Din (2017), Pharmaceutical Policy in Countries with Developing Healthcare Systems, Springer International Publishing AG, Cham.
    9. Bate ,Roger ; Attaran, Amir (2010), “A Counterfeit Drug Treaty: Great Idea, Wrong Implementation “,The Lancet, Vol. 376, No. 9751, pp. 1446-1448.
    10. Buckley, Gillian J. and Gostin, Lawrence O.(2013), Countering the Problem of Falsified and Substandard Drugs, Washington, D.C., the National Academies Press.
    11. Calderoni, Francesco (2010), Organized Crime Legislation in the European Union, Berlin Heidelberg, Springer.
    12. Card, Richard (2006), Criminal Law, 17 ed., New York, Oxford University Press.
    13. Casabona, Carlos M. Romeo; Mora, Asier Urruela; Jiménez, Pilar Nicolás; Jiménez. Óscar Alarcón (2017), “International strategies in fighting against medicaments fraud and other similar offences,The MEDICRIME Convention”, Crime Law and Social Change,68, Issue. 1-2, pp. 95-122.
    14. Chika,A; Bello, SO; Jimoh, AO;Umar, MT (2011), “The menace of fake drugs: consequences, causes and possible solutions”, Research Journal of Medical Sciences ,Vol. 5, Issue. 5 , pp. 257-261.
    15. Council of Europe (2015), Handbook For Parliamentarians (MEDICRIME Convention, CETS No. 211), Strasbourg, Council of Europe .Avilable at:20/06/2020: https://www.edqm.eu/sites/default/files/handbook-for-parliamentarians-medicrime.pdf
    16. Council of Europe (CoE), Explanatory Report to the Council of Europe Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and on the Financing of Terrorism, Strasbourg , Council of Europe, Treaty Office. Avilable at: 20/06/2020: https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=09000016800d3813
    17. Council of Europe (CoE)(2012) Explanatory Report to the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health, Strasbourg , Council of Europe ,Treaty Office. Avilable at: 20/06/2020: https://rm.coe.int/CoERMPublicCommonSearchServices/DisplayDCTMContent?documentId=09000016800d383b
    18. Council of Europe ,Treaty Office- Chart of signatures and ratifications of Treaty 211 ( Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health )

    Status as of 20/03/2020. Avilable at: 04/04/2020:

    https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/211/signatures? p_auth=8kLrbMfB

    1. Cvetanovski, Filip; Brezovska ,Katerina; Panovska, Ana Poceva; Acevska, Jelena; Ribarska, Jasmina Tonic; Sterjev, Zoran; Grozdanova, Aleksandra; Netkovska, Katerina Ancevska (2016), “Counterfeiting of medicines as an infringement of the intellectual property rights”, Macedonian pharmaceutical bulletin, Vol. 62, Issue. 1, pp. 85-89.
    2. Dégardin, Klara; Roggo, Yves; Margot, Pierre (2014), “Understanding and fighting the medicine counterfeit market”, Journal of Pharmaceutical and Biomedical Analysis, 87, pp. 167-175.
    3. European Commission (2017), Handbook on How to Issue and Execute a European Arrest Warrant, Brussels, 28.9.2017 C(2017) 6389 final, Available at : 16.08.2109

    https://e-justice.europa.eu/fileDownload.do?id=db28c045-9f92-472e-9452-518b4ce84712

    1. European Directorate for the Quality of Medicines & HealthCare (EDQM)(2018), the Edqm on the Move, Annual Report, Strasbourg, Council of Europe, Available at: 16.01.2020: https://www.edqm.eu/sites/default/files/medias/fichiers/AboutUs/annual_report_2018.pdf
    2. European Medicines Agency ( 2015), European Medicines Agency: Celebrating 20 Years (1995-2005), The editors: Sir Kent Woods & Pharm. Noël Wathion ,Designed & Published by Core Media Services UK Ltd. & Service Point.
    3. European Parlement (2012), Everything you need to know about ACTA, Focus, Directorate for the Media ,Director - Spokesperson: Jaume DUCH GUILLOT, Reference No:20120220FCS38611. Available at: 11.01.2020

    https://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+IM- PRESS+20120220FCS38611+0+DOC+PDF+V0//EN&language=EN

    1. Fayzrakhmanov, N.F.(2015), “Fighting trafficking of falsified and substandard medicinal products in Russia”, International Journal of Risk & Safety in Medicine,Vol. 27, pp. 37–40.
    2. Gadinis, Stavros; Mangels, Colby (2016), “Collaborative Gatekeepers”, Washington and Lee Law Review, Vol. 73, Issue. 2, pp. 797-914
    3. Hamilton, William L; Doyle ,Cormac, Halliwell-Ewen, Mycroft;Gabriel ,Lambert (2016), “Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies”, Health Policy and Planning, Vol. 31, No. 10, pp.1448-1466.
    4. IMPACT (2006), Counterfeit Medicines: an update on estimates 15 November 2006, World Health Organization. Available at: (08.01.2020)

    https://www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf

    1. IMPACT (2011), IMPACT: International Medical Products Anti-Counterfeiting Taskforce: Facts| Activities| Documents Developed by the Assembly and the Working Groups 2006–2010, Milan: IMPACT Secretariat.
    2. INTERPOL (2017), Millions of Medicines Seized in Largest INTERPOL Operation against Illicit Online Pharmacies, News and Events, Available at (25.09.2019): https://www.interpol.int/News-and-Events/News/2017/Millions-of-medicines-seized-in-largest-INTERPOL-operation-against-illicit-online-pharmacies
    3. INTERPOL (2019). Operation Pangea – shining a light on pharmaceutical crime, Available at: (08.01.2020)

    https://www.interpol.int/en/News-and-Events/News/2019/Operation-Pangea-shining-a-light-on-pharmaceutical-crime

    1. Isles , Mike (2017), “What's in a Word? Falsified/Counterfeit/Fake Medicines - The Definitions Debate”,Medicines Access @ Point of Care, Vol. 1, pp. 40-48.
    2. Jalili ,Ronak; Miraghaei, Shahram; Mohamadi, Bahareh; Babaei, Atefeh; Bahrami, Gholamreza ( 2015), “Detection of corticosteroid compounds and phosphodiester inhibitors (PDH-5) as counterfeit in herbal products available in Iranian market by HPLC method”, Journal of Reports in Pharmaceutical Sciences, 2015, Vol. 4, Issue. 1, pp.75-81.
    3. Johansson, Monika; Fransson ,Dick; Rundlöf ,Torgny ; Huynh ,Ngoc-Hang; Arvidsson , Torbjörn (2014). “A general analytical platform and strategy in search for illegal drugs”, Journal of Pharmaceutical and Biomedical Analysis ,100, pp. 215–229.
    4. Keitel,Susanne (2012), “The MEDICRIME Convention: criminalizing the falsification of medicines and similar crimes”, Generics and Biosimilars Initiative Journal, Vol. 1, Issue. 3-4, pp. 138-141
    5. Kohli ,Vishv Priya (2018), Combatting Falsification and Counterfeiting of Medicinal Products in the European Union - A Legal Analysis, Doctoral School Of Business And Management,Copenhagen Business School.
    6. Le, Phuong; Grund, Laurie; Marwa, John; Ojo ,Wuraola; Otts Jr., John; Arab, Farhia (2018), “Combating Substandard and Counterfeit Medicines by Securing the Pharmaceutical Supply Chain: The Drug Supply Chain Security Act (DSCSA) of 2013”, Innovations In Pharmacy,Vol. 9, No. 2, Article. 13, pp. 1-11.
    7. Lee ,Kah Seng ; Yee ,Siew Mei; Razi Zaidi , Syed Tabish; Patel , Rahul P. ; Yang, Quan ; Al-Worafi ,Yaser Mohammed and Ming, Long Chiau (2017). “Combating Sale of Counterfeit and Falsified Medicines Online: A Losing Battle”, Frontiers in Pharmacology,Vol. 8 , pp. 1-4.
    8. Liberman , Jonathan (2012 ), “Combating Counterfeit Medicines and Illicit Trade in Tobacco Products: Minefields in Global Health Governance”, journal of law, medicine & ethics, Vol. 40, Issue. 2, pp. 326-347.
    9. Mackey,Timothy Ken (2014), Global Governance and Diplomacy Solutions for Counterfeit Medicines, PhD thesis, San Diego,University of California, San Diego State University.
    10. Mydin , Helmy Haja; Stevens, Philip (2013), fake medicine in Asia, EMHN BRIEFING No.1, The Institute for Democracy and Economic Affairs Institute, Avilable at 20/10/2019: https://www.researchgate.net/profile/Helmy_Haja_Mydin/publication/235912758_Fake_medicines_in_Asia/links/02bfe51410e45883f2000000/Fake-medicines-in-Asia.pdf
    11. Nayyar, Gaurvika M. L.; Attaran ,Amir; Clark, John P.; Culzoni , M. Julia; Fernandez, Facundo M.; Herrington, James E.; Kendall, Megan; Newton, Paul N.; Breman, Joel G. (2015), “Responding to the Pandemic of Falsified Medicines”, The American Journal of Tropical Medicine and Hygiene ,Vol. 92 (Suppl 6), pp. 113–118
    12. Negri ,Stefania (2016), “The Medicrime Convention Combating Pharmaceutical Crimes through”.

    European Criminal Law and Beyond”, New Journal of European Criminal Law, Vol. 7, Issue. 3, pp. 350-367.

    1. Newton,Paul N.; Green, Michael D; Fernandez, Facundo M. (2010), “Impact of poor-quality medicines in the ‘developing’ world”, Trends in Pharmacological Sciences,Vol. 31, No. 3, pp. 99-101.
    2. O’Hagan, Andrew ; Garlington , April (2018), “Counterfeit drugs and the online pharmaceutical trade, a threat to public safety”, Forensic Research & Criminology International Journal, Vol. 6, No. 3 , pp. 151-158 .
    3. Parliamentary Assembely - Report Committee on Economic Affairs and Development Rapporteur (2007), Need for a Council of Europe convention on the suppression of counterfeiting and trafficking in counterfeit goods , Doc. 11227, Available at: 16.08.2109

    http://www.assembly.coe.int/nw/xml/XRef/X2H-Xref-ViewHTML.asp?FileID=11474&Lang=EN

    1. Pashkov,Vitalii; Soloviov,Aleksey; Olefir, Andrii (2017), “Legal Aspects Of Counteracting The Trafficking Of Falsified Medicines In The European Union”, Wiad Lek, 71, 4, pp. 843-849.
    2. Rebiere, Hervé; Guinot ,Pauline; Chauvey, Denis; Brenier, Charlotte (2017), “Fighting falsified medicines: The analytical approach”, Journal of Pharmaceutical and Biomedical Analysis ,Vol. 142 , pp. 286–306.
    3. The lancet (2011), Fighting fake drugs: the role of WHO and pharma, Elsevier,p.1. Available at: (08.01.2020)

    https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(11)60656-9.pdf

    1. Valverde, José Luis (2017), “Illegal medicines as threats to public health”, Pharmaceuticals Policy and Law, 19, pp. 1–16.
    2. Vermeulen , G.; Beken, T. Vander (1997), “New Conventions on Extradition in the European Union: Analysis and Evaluation”, Penn State International Law Review , Vol. 15: No. 2, pp. 265-300.
    3. Warman, Matt (2012), “European Parliament rejects ACTA piracy treaty”, The Telegraph, Available at: (08.01.2020)

    https://www.telegraph.co.uk/technology/news/9375822/European-Parliament-rejects-ACTA-piracy-treaty.html

    1. World Health Organization- Department of Essential Drugs and Other Medicines Counterfeit Drugs (1999), Counterfeit Drugs: Guidelines for the Development of Measures to Combat Counterfeit Drugs, Switzerland, World Health Organization.
    2. World Health Organization (2018), WHO Global Surveillance and Monitoring System for substandard and falsified medical products, Switzerland, World Health Organization.
    3. World Health Organization (2017), WHO Member State mechanism on substandard/spurious/falsely-labelled/falsified/ counterfeit medical products , Switzerland , World Health Organization.
    4. World Health Organization (2017), WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices, Geneva, World Health Organization.
    5. World Health Organization (2006), “Fact sheet N°275, Counterfeit Medicines”, Available at: (27.08.2019) www.who.int/mediacentre/factsheets/fs275/en/print.html
مطالعات حقوق تطبیقی
دوره 12، شماره 1
بهار و تابستان
فروردین 1400
صفحه 263-289

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