المنظور القانوني للجرائم البيولوجية في صناعة الأدوية الحيوية: دراسة حول أمن الأدوية / The Legal Perspective on Biocrimes in the Biopharmaceutical Industry: A Study on Drug Security
دياب, . (2025). المنظور القانوني للجرائم البيولوجية في صناعة الأدوية الحيوية: دراسة حول أمن الأدوية / The Legal Perspective on Biocrimes in the Biopharmaceutical Industry: A Study on Drug Security. EKB Journal Management System, 45(45), 2861-2924. doi: 10.21608/mawq.2025.372374.1158
محمدفتحي شحته دياب دياب. "المنظور القانوني للجرائم البيولوجية في صناعة الأدوية الحيوية: دراسة حول أمن الأدوية / The Legal Perspective on Biocrimes in the Biopharmaceutical Industry: A Study on Drug Security". EKB Journal Management System, 45, 45, 2025, 2861-2924. doi: 10.21608/mawq.2025.372374.1158
دياب, . (2025). 'المنظور القانوني للجرائم البيولوجية في صناعة الأدوية الحيوية: دراسة حول أمن الأدوية / The Legal Perspective on Biocrimes in the Biopharmaceutical Industry: A Study on Drug Security', EKB Journal Management System, 45(45), pp. 2861-2924. doi: 10.21608/mawq.2025.372374.1158
دياب, . المنظور القانوني للجرائم البيولوجية في صناعة الأدوية الحيوية: دراسة حول أمن الأدوية / The Legal Perspective on Biocrimes in the Biopharmaceutical Industry: A Study on Drug Security. EKB Journal Management System, 2025; 45(45): 2861-2924. doi: 10.21608/mawq.2025.372374.1158

المنظور القانوني للجرائم البيولوجية في صناعة الأدوية الحيوية: دراسة حول أمن الأدوية / The Legal Perspective on Biocrimes in the Biopharmaceutical Industry: A Study on Drug Security

مجلة الشريعة والقانون بالقاهرة
Volume 45, Issue 45, May 2025, Page 2861-2924  XML PDF (964.6 K)
Document Type: المقالة الأصلية
DOI: 10.21608/mawq.2025.372374.1158
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Author
محمدفتحي شحته دياب دياب email orcid
جامعة حائل - كُلِّيَّة الشريعة والقانون
Abstract
يشهد قطاع المستحضرات الصيدلانية الحيوية تطورات متسارعة، إلا أن ذلك يرافقه مخاطر متزايدة لإساءة استخدام التقنيات الحيوية في ارتكاب الجرائم البيولوجية، مما يهدد الصحة العامة والأمن القومي. تهدف هذه الدراسة إلى تقييم الإطار القانوني الجنائي المتعلق بالجرائم البيولوجية في صناعة الأدوية الحيوية، واقتراح إطار قانوني جديد أكثر فعالية. تكمن مشكلة البحث في قصور القوانين الجنائية التقليدية عن مواجهة تعقيدات هذه الجرائم، مما يستدعي تطوير استراتيجيات وقائية وعقابية متخصصة. تكمن أهمية الدراسة في حماية الصحة العامة، وتعزيز الابتكار في صناعة الأدوية، وضمان محاسبة مرتكبي الجرائم البيولوجية.
تعتمد الدراسة على منهجية بحثية متكاملة تجمع بين التحليل الوصفي والتحليلي النقدي، مع مراجعة الأدبيات الأكاديمية، والتقارير الحكومية، والاتفاقيات الدولية، ودراسات الحالات ذات الصلة.
أظهرت النتائج أن الإطار القانوني الجنائي التقليدي يفتقر إلى تعريفات واضحة للجرائم البيولوجية، ويواجه صعوبات في إثبات الجريمة، وتحديد الاختصاص القضائي، وتحقيق التوازن بين حماية الملكية الفكرية وأمن الأدوية.
بناءً على هذه النتائج، تقترح الدراسة إطارًا قانونيًّا جنائيًّا جديدًا يركز على الوقاية، والتعاون متعدد التخصصات، والمرونة، والتوازن بين المصالح، والتعاون الدولي. يتضمن هذا الإطار تعريفات قانونية واضحة، وتجريم الأفعال التحضيرية والمساعدة، وعقوبات رادعة ومتناسبة، وآليات فعالة للكشف والتحقيق، وحماية الشهود والمبلغين عن المخالفات. يهدف هذا الإطار المقترح إلى معالجة أوجه القصور في الإطار التقليدي، وتوفير استجابة فعالة وشاملة للتهديدات المتزايدة التي تشكلها الجرائم البيولوجية في صناعة الأدوية الحيوية.
 
The biopharmaceutical sector is witnessing rapid developments, yet this is accompanied by increasing risks of misuse of biotechnology to commit biological crimes, threatening public health and national security. This study aims to evaluate the criminal legal framework related to biological crimes in the biopharmaceutical industry and propose a new, more effective legal framework. The research problem lies in the inadequacy of traditional criminal laws to address the complexities of these crimes, which calls for the development of specialized preventive and punitive strategies. The importance of the study lies in protecting public health, promoting innovation in the pharmaceutical industry, and ensuring that perpetrators of biological crimes are held accountable.
The study relies on an integrated research methodology that combines descriptive and critical analysis, with a review of academic literature, government reports, international agreements, and relevant case studies.
The results showed that the traditional criminal legal framework lacks clear definitions of biological crimes and faces difficulties in proving the crime, determining jurisdiction, and balancing intellectual property protection with drug safety.
Based on these findings, the study proposes a new criminal legal framework that emphasizes prevention, multidisciplinary collaboration, flexibility, balancing interests, and international cooperation. This framework includes clear legal definitions, criminalization of preparatory and assisting acts, dissuasive and proportionate penalties, effective detection and investigation mechanisms, and witness and whistleblower protection. This proposed framework aims to address the shortcomings of the traditional framework and provide an effective and comprehensive response to the growing threats posed by biocrimes in the biopharmaceutical industry.
Keywords
الجرائم البيولوجية، أمن الأدوية الحيوية، الأدوية المزيفة، تعديل الجينات غير القانوني، الإرهاب البيولوجي. / Biological Crimes; Biopharmaceutical Security; Counterfeit Medicines; Illegal Gene Editing; Bioterrorism
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