A Comparative Study on the Regulation of Advertising Pharmaceutical and Medical Products: The Case of Iran, China, and Turkey
Original Article | Pages: 95 - 110
- Hoda Ghafari - Department of Public and International Law, Faculty of Law and Political Sciences, Allameh Tabatabai University, Tehran, Iran
- Zahra Ebrahimi - Ph.D., Candidate of Public Law, Faculty of Law and Political Sciences, Allameh Tabatabai University, Tehran, Iran [Zahra_ebrahimi@atu.ac.ir]
Abstract
Background: Regulatory authorities in each country strive to protect public health through legislation, regulation, and standardization to ensure the quality, safety, effectiveness, labeling, marketing, and proper advertising of pharmaceutical products throughout the life cycle of the product. Regulation in the field of advertising pharmaceutical and medical products is the supervision of all informative and persuasive promotional activities of the pharmaceutical industry with the aim of influencing the prescription, supply, purchase, and use of drugs.
Methods: Having conducted the comparative analysis as the methodology of the current research, the regulations and structures for monitoring the advertising of pharmaceutical and medical products in China and Turkey were compared with the established ones in Iran.
Results: According to this study, the advertising regulation mechanism of pharmaceutical and medical products in Iran, comparing with China and Turkey, faces four main problems including: 1) lack of a single administrator in monitoring the advertising of pharmaceutical and medical products, 2) ambiguity in the licensing or non-licensing of medicine advertised to the public in Iranian law, 3) non-transparent regulations on how to advertise to physicians, and 4) the lack of a self-regulatory body with the membership in pharmaceutical companies and distributors in order to develop codes of practice for the trade union to create healthy competition and prevent advertising violations.
Conclusion: In Iran, it is necessary to codify and approve a comprehensive and transparent law in the field of marketing and advertising of pharmaceutical and medical products by designating a supervisory body and promulgating advertising standards (Both to the general public and to the professional audience).
Keywords
Government regulation, Medicine, Equipment and supplies, China, Turkey, Iran
References:
- Rägo L, Santoso B. Drug regulation: history, present and future. In: Van Boxtel CJ, Santoso B, Edwards IR, editors. Drug benefits and risks: international textbook of clinical pharmacology. The Netherlands: Ios Press; 2008. p. 65-77.
- Praneeth P. Regulatory affairs and its role in pharmaceutical industry. Int J Pharm Biomed Eng. 2016;3(1):1-2.
- Alastair J, Wood AJ, Cuff PA. Regulating medicines in a globalized World with increased recognition and reliance among regulators: a national academics report. JAMA. 2020;324(2):145-6.
- Chamelon pharma consulting. Pharma regulatory & registration [Internet]. Germany: a business unit of mammut pharma GmbH. 2020 Jan 26 [cited 2020 Jan 26]; [about 5 screens]. 2020. Available from: https://www.chameleonphar-ma.com/services/regulatory-registration.
- Yeh W. Becoming Chinese-passages to modernity and beyond [Internet]. California: University of California Press; 2000 Jan 15 [cited 2000 Oct 23]; [about 10 screens]. 2000. Available from: https://publishing.cdlib.org/ ucpres-sebooks/view?docId=kt5j49q621&chunk.id=bm02&toc.depth=1&toc.id=&brand=ucpress.
- Semin S, Aras S, Guldal D. Direct‐to‐consumer advertising of pharmaceuticals: developed countries experiences and Turkey. Health Expect. 2006;10(1):4-15.
- Alves TL, Lexchin J, Mintzes B. Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethic. 2019;25(4):1167-92.
- U.S. Food & DRUG administration. Drug advertising: a glossary of terms [Internet]. USA: FDA. Available from: https://www.fda.gov/ drugs/prescription-drug-advertising/drug-adver-tising-glossary-terms.
- 9. Tabatabaii Motameni MA. [Look at the con-stitutional rights of the people's republic of China]. J Constitutional Right. 2005;3(5):167-176. Persian.
- Cheng H, Zhung S, Zhang K. Pharmaceutical advertising 2020-China: Trends and developments [Interrnet]. China: East & Chamber Parents. 2020. Available from: https://practic egu-ides.chambers.com/practice-guides/pharma-ceutical-advertising-2020/china.
- Yalcin D, Abra S. Pharmaceutical advertising regulation and medical device advertising in turkey [Internet]. Turkey: CMS. Vailable from in: https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/turkey.
- Atılgan Karakulak Ö, Doğan D. The international comparative legal guide to: pharmaceutical advertising 2018. 15th ed. London: Published by Global Legal Group; 2018. 16 p.
- Ratanawijitrasin S. Effective drug regulation: a multi country study. 1st ed. Geneva: WHO; 2002. 100 p.
- Ma F, Lou N. Regulation of drug promotion in China [Internet]. China: Food and drug law institute. may/jun 2013. Available from: https: //www.cov.com/~/media/files/corporate/publications/2013/05/regulation_of_drug_promotion.pdf.
- Chan K, Chan F. Information content of television advertising in China: An update. Asian J Commun. 2005;15(1):1-5.
- Laing Buisson. China introduces tough new advertising laws on medical treatment. Lon-don: IMTJ-International medical travel jour nal. 2015. Available from: https://www.imtj. com/news/china-introduces-tough-new-adver-tising-laws-medical-treatment.
- Kavcar G, Ozkahraman D. Turkey: Advertisement on cosmetic and pharmaceutical industry [Internet]. Turkey: Kilinc Law & Consulting. 2020. Available from: https://www.mondaq. com/turkey/advertising-marketing-branding/ 929214/advertisement-on-cosmetic-and-phar maceutical-industry
- Çeli̇k H, Güney B, Turkey: Health claims For anti-coronavirus products in advertising [Internet]. Turkey: Gun Partners. 2020. Available from: https://www.mondaq.com/turkey/adver-tising-marketing-branding/910742/health-cla-ims-for-anti-coronavirus-pro-ducts-in-adver-tising.
- Gürkaynak G, Yıldız C, Gürün N. Turkey: Turkish medicine and medical devices agency announces draft amendment regulation on sales, advertising and promotion of medical devices [Internet]. Turkey: ELIG Gürkaynak Attorneys-at-Law. 2020. Available from: https ://www.mondaq.com/turkey/life-sciences-bio technology-nanotechnology/893200/tur-kish-medicine-and-medical-devices-agency-anno unces-draft-amendment-regulation-on-sales-advertising-and-promotion-of-medical-devices
- Standards for the examination and publication of drug advertisements [Internet]. China: China’s leader in online legal research, 2020, Available from: http://www.lawinfochina. com/display.aspx?id=5944&lib=law&SearchKeyword=&SearchCKeyword.
- Üçer K, Ekim H. Medicinal product regulation and product liability in Turkey: overview. Canada: Thomson Reuters. 2019. Available from: https://uk.practicallaw.thomsonreuters. com/0-617-2716?__lrTS=202101051059295 38&transitionType=Default&contextData=(sc. Default)&firstPage=true.
- Yu F. Pharmaceutical policy in China. In: Zaheer-Ud-Din B, editor. Pharmaceutical policy in countries with developing healthcare systems. Switzerland: Springer; 2017. p. 169-91.
- Wang K. Medicinal product regulation and product liability in China: overview. Canada: Thomson Reuters. Available from: https://con tent.next. westlaw.com/Document.
- Abel-Smith B. Value for money in health services. 1st Engl. ed. Pourreza A, translator. Tehran: Samt publisher; 2013. 314 p.
- Jiang J. China's pharmaceutical marketing authorisation holder mechanism. McDermott Will & Emery International News, 2019. Available from: https://www.natlawreview. com/article/china-s-pharmaceutical-marketing -authorisation-holder-mechanism
- Wang Y, Chen D, He J. A brief introduction to China's new drug administration law and its impact on medications for rare diseases. Intractable Rare Dis Res. 2019;8(4):226-30.
- Beckett N, He D. China announces major changes to its drug regulatory regime [Internet]. China: CMS. Available from in: https: //www.lexology.com/library/detail.aspx?g=f8b5a9a5-95cc-492d-918b-6ebd22423e39
- Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish medicines and medical devices agency: comparison of its registration process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharm. 2018;25;9:9.
- The R&D-based Pharmaceutical Association Committee (RDPAC): Overview [Internet]. China: RDPAC. 2021. Available from: http:// en.rdpac.org/index.php?r=site%2Fabout.
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Ghafari H, Ebrahimi Z. A Comparative Study on the Regulation of Advertising Pharmaceutical and Medical Products: The Case of Iran, China, and Turkey. Iran J Biomed Law Ethics. 2020;1(2):95-110.