Upcoming Berkeley Law Privacy Conference

China is developing a robust commercial privacy and cybersecurity framework. A cybersecurity law took effect in 2017, multiple agencies are issuing guidelines, and a new e-commerce law with privacy and cybersecurity provisions just entered into force on January 1, 2019.  Further privacy legislation is being drafted, as China may be looking to develop a companion to the comprehensive privacy law of Europe. (Meanwhile, the US has no comprehensive privacy or cybersecurity law; Congress will debate the issue this year, but the outcome is quite uncertain.)

This raises a number of provocative question: In terms of the relationship between consumers and corporations, is China becoming more privacy-protective than the US? How should we understand the overall privacy and cybersecurity trends in China? How well does China’s overall legal environment support the implementation of the new and proposed laws?

To try to answer some of these questions, the Berkeley Center for Law & Technology is organizing a one-day conference in San Francisco on March 1.  The agenda is here; registration is here.

Much of the focus will be comparative, with an emphasis on interoperability and cross-border compliance: Given the rapid developments in privacy and cybersecurity law in China and Europe, how can innovative companies that want to offer their goods and services worldwide comply? Topics will include the definition of reasonable cybersecurity standards under the laws of China, the EU and the US; corporate data governance strategies in the face of overlapping requirements; and enforcement.

The event is co-sponsored by Peking University, The EastWest Institute, The United States Information Technology Office (USITO), The Asia Society, JD.com, and New America.

Draft of Data Exclusivity Rules Released by CFDA

CFDA just released on April 25, 2018 its Public Comment Draft of Pharmaceutical Data Exclusivity Implementing Rules  (provisional)  药品试验数据保护实施办法(暂行)征求意见稿 , available here (the web version is here) .  Comments are due by May 31, 2018 at yhzcszhc@cfda.gov.cn.

Article 5 proposes six-year data protection (which was China’s WTO commitment) for “innovative new drugs”.  “Innovative therapeutic biologics” are eligible for 12-year data protection (the previous May 2017 CFDA circular said 10 years).  The draft clearly encourages MNCs to include China in international multicenter clinical trials and to concurrently apply for market introduction in China (which can include other countries).  Full-term protection (6/12 years) is only available in this scenario.  Reduced Chinese data protection terms of one to five years may occur due to delays in introduction in China.  As a policy matter, this draft appears intended to help encourage conducting clinical trials in China as well as new product introduction into the Chinese market

Thanks to my friend and former student Jill (Yijun) Ge at Clifford Chance for bringing this to my attention and providing an initial review.  I welcome readers to submit English translations of this draft for me to post.

This is one of several exciting new developments in the pharma IP sector in China.  To help better understand the business implications of these changes, the Berkeley Center for Law and Technology is planning on hosting a half day roundtable discussion on pharmaceutical IP developments in China on May 30, one day before the comment period closes.  Seats are limited.  Please contact chinaipr@yahoo.com or mark.cohen@law.berkeley.edu for further information.