Analytical Assessment of Institutional Mapping of Iran’s Biotechnology Regulatory System Case Study: Biological Food and Drug

Document Type : Research Article

Authors

1 Ph.D. Public Management, Tehran University

2 Professor. Baqiyatallah University of Medical Sciences

3 Ph.D. Student of Public Management, Allameh Tabataba’i University

Abstract

Products regulation based on emerging technologies such as biotechnology has seized attention in the recent years. Thus the functional and structural analysis of Iran’s biotechnology regulatory system in the field of biological food and drug is presented in this study. So in the first step, Institutional mapping of biological drug and food sector is drawn, then based on Investigation of other countries biotechnology regulatory system and Conducting fourteen in-depth interviews and nine group interviews with experts, The existing weaknesses and challenges in this field identified and the appropriate solutions and strategies to deal with them are also presented in this article.
The findings of this study shows that the structural requirements are: to strengthening the national coordinator institutions and reforming the arrangement of regulator institutions, and functional requirements are: to presenting some strategies and solution for the functions such as regulation, monitoring, awareness and law enforcement.

Keywords


الف- کتب، گزارش و مقالات
1 - زمانیان مرتضی، 1395، درآمدی بر دولت تنظیم­گر، پژوهشکده سیاستگذاری علم و فناوری دانشگاه صنعتی شریف (اندیشکده مطالعات حاکمیت و سیاستگذاری)، تهران.
2 - زمانیان مصطفی، 1389، نقش تنظیم گری در نظام توسعه، شرکت مشاوران مدیریت توسعه عمید، تهران.
3 - زمانیان مصطفی، 1395، بررسی و تحلیل نقش ستاد توسعه زیست فناوری در نظام نوآوری زیست فناوری ایران، شرکت مشاوران مدیریت توسعه عمید، تهران.
4 - طباطبائیان، سید حبیب­الله، انتظاری، محمد، 1387، ﻣﻄﺎﻟﻌﻪ ﻣﻮردی ﻧﮕﺎﺷﺖ ﻧﻬﺎدی ﻧﻮآوری در ﺻﻨﻌﺖ ﺑﺮق ﻛﺸﻮر، فصلنامه سیاست علم و فناوری، سال اول، شماره 1.
5- Anantharaman, Divya, 2012, Comparing self-regulation and statutory regulation: Evidence from the accounting profession, Accounting, Organizations and Society, 37, 55-77.
6- Aligica, Paul Dragos, 2006, Institutional and Stakeholder Mapping: Frameworks for Policy Analysis and Institutional Change, Public Organization Review, 6, 79–90.
7- Baldwin Robert, Cave Martin, Lodge Martin, 2012, Understanding Regulation: Theory, Strategy, and Practice, OUP Oxford, UK, 2.
8- Belson, Neil A., 2000, US Regulation of agricultural biotechnology: an overview, Agrobiotechnology management & economics, Volume 3, 268-280.
9- Black Julia, 2001, Decentring regulation: understanding the role of regulation and self-regulation in a post-regulatory world, Current Legal Problems, Volume 54 (1), 103-146. ISSN 0070-1998
10- Cantley, Mark, 2007, OECD International Futures Project on “The Bioeconomy to 2030: Designing a Policy Agenda” An Overview of Regulatory Tools and Frameworks for Modern Biotechnology: A Focus on Agro-Food, OECD.
11- Chopyak Jill, Levesque Peter, 2002, Public participation in science and technology decision making: trends for the future, Technology in Society 24 (2002) 155–166.
12- Den Hertog, Johan, 2010, Review of economic theories of regulation, Utrecht School of Economics Utrecht University, Discussion Paper Series 10-18.
13- Engeli Isabelle, Rothmayr Allison Christine, 2015, When doctors shape policy: The impact of self-regulation on governing human biotechnology, Regulation and governance, Volume 10, Issue 3, 248-261.
14- Fernandez Diez, Ma. Carmen, Corripio Gil-Delgado, Ma. Reyes, 2004,  Regulatory Factors Affecting the Agri-Food Biotechnology Sector in the European Union, International Journal of Biotechnology, Volume 6, Issue 2-3.
15- France Agricultural Biotechnology Annual, 2016, Global agricultural information network, Report Number: FR1614.
16- Glowka, Lyle, 2003, Law and modern biotechnology: Selected issues of relevance to food and agriculture, Food and agriculture organization.
17- Goldstein, W., Kempen, P.P.v., Dela, T.G.a.J., 2006. Communication, Education and Public Awareness (CEPA).
18- Kagan, Robert A, 1989, Understanding Regulatory Enforcement, Berkeley Law, Kinderlerer J., 2002, Regulation of Biotechnology: needs and burdens for developing Countries, University of Sheffield, Sheffield Institute of Biotechnological Law and Ethics, UK. 
19- Mandel, Gregory, 2009, Regulating emerging technologies, Temple university Beasly school of law, Research Paper No. 2009-18
20- Malyshev, Nick, 2014, Regulatory enforcement and inspections: OECD best practice principles, OECD.
21- Patterson, Lee Ann, Josling, Tim, 2002, Regulating biotechnology: comparing EU and US approaches, European Policy Papers #8
22- Posner, R.A., 1974, Theories of Economic Regulation. Bell Journal of Economics and Management Science 5(2), 335-358,
23- Rakar, Iztok, Tičar, Bojan, 2015, The Rulemaking Procedure – Definition, Concepts and Public Participation, DANUBE: Law and Economics Review, 6 (2), 109–119.
24- Rowe, Gene, Frewer, Lynn J., 2000, Public Participation Methods: A Framework for Evaluation, Science Technology Human Values 2000 25: 3.
25- Shleifer Andrei, 2005, Understanding Regulation, European Financial Management, Vol. 11, No. 4, 439–451.
26- Singapore Agricultural Biotechnology Annual, 2015, Global agricultural information network, Report Number: SN500.
27- Uchtmann, D. L, 2002, A case study of agricultural biotechnology regulation, Drake Journal of Agricultural Law, Vol. 7. 
28- UNECE, Working Party on Regulatory Cooperation and Standardization Policies, 2009, Nineteenth session, Market surveillance, 23 – 26.
29- van Heesen-Laclé, Z.D, Meuwese, A.C.M., 2007, The legal framework for self-regulation in the Netherlands, Utrecht Law Review. 3(2), 116–139.
30- Wozniak, Chris A., McHughen, Alan, 2012, Regulation of Agricultural Biotechnology: The United States and Canada, US.
31- [32] Wiener, Jonathan B, 2004, The regulation of technology, and the technology of regulation, Technology in Society 26, 483–500.
ب اسناد و مقررات
32 - قانون ایمنی زیستی جمهوری اسلامی ایران، مصوب 26/5/1388
33- Memorandum for heads of food and drug administration, environmental protection agency, and department of agriculture of United States of America, 2015.