Supervision Paired with Innovation: The New Vaccine Administration Law

• Author: Song Jinyang
• Pages: 416-426

416 TSINGHUA CHINA LAW REVIEW [Vol. 11:415

SUPERVISION PAIRED WITH INNOVATION:

THE NEW VACCINE ADMINISTRATION LAW

SONG Jinyang

I. INTRODUCTION

After the recent vaccine scandal, where Changchun Changsheng,

a Jilin-based biotechnology company produced nearly 500,000

substandard diphtheria, pertussis and tetanus (DPT) vaccines 1

rendered the country in the grip of nationwide concern for vaccine

safety, the central government proposed a separate legislation for

vaccine administration to ensure the authority and stability of

vaccine supervision.2 The Vaccine Administration Law (hereinafter

referred to as VAL) has recently been promulgated at the 11th

meeting of the Standing Committee of the 13th Session of the

National People’s Congress.3

Before this separate vaccine administration law was enacted, the

administration and supervision of vaccines are largely dependent on

general drug administration laws such as Drug Administration Law4

and product standards such as Good Manufacturing Practice for

Drugs (2010 Revision). The State Council amended the Regulation

on the Administration of Circulation and Vaccination of Vaccines

(hereinafter referred to as “2016 Vaccine Regulation”)5, in response

to the 2016 vaccine scandal where the vaccine delivery in several

provinces failed to meet the low-temperature requirements. 6

1 Reuters Edit orial, Chinese vaccine maker made 500,000 substandard b aby vaccines , REUTERS

(Aug. 15, 2018), https://www.reuters.com/arti cle/us-china-vaccines-idUSKBN1L014D.

2 Zhao Wenjun ( 赵文君) & Yang Weihan (杨维汉), Wo guo Nidui Yimiao Guanli Dand u Lifa (我

国拟对疫苗管理单独立法) [China Plans to Enact Separate Dru g Administration La w], XINHUA NET

(Dec. 23, 2018), http://www.xinhuanet.com/politi cs/2018-12/23/c_1123892044.htm.

3 Draft law stipula tes heav y penalites for fake vaccines, XINHUA NET (Apr. 2 3, 2019 ),

http://www.xinhuanet.com/english/2019 -04/23/c_137999254.htm.

4 Yaopin Guanli Fa (药品管理法) [Drug Admi nistration Law] (promulgated by the Stan ding

Comm. Nat’l People’s Cong., Sep. 20, 1984, effe ctive Jul. 1, 1985) (2015) (Chinalawinfo).

5 Yimiao Liutong he Yufangjiezhong Guanli Tiaoli (疫苗流通和预防接种 管理条例) [Regulation

on the Administration of Circulatio n and Vaccination of Vaccines] ( promulgated by St . Council, Mar.

24, 2005, effective Jun. 1, 2005) (2016) (Chinala winfo).

6 Feifa Jingying Yimiao Ansuo She 24 Shengshi Gonganbu: Jiang Quanli Zhenban ( 非法经营疫苗

案索涉24省市 公安部：将全力侦办) [I llegal Vaccine Business Involves 24 Provinces and Cities

Ministry of Public Security: Will Work it s Best on the Case], IFENG (Mar. 20, 2016), http://finance.ifen

g.com/a/20160320/14278702_0.shtml.