Life Sciences Spotlight - Issue 4, 2014

by DLA Piper

Since our last edition, there has been a number of developments in the Life Sciences sector across the Asia Pacific region and we are pleased to be able to update you on these recent trends.

It is evident that the focus on compliance in the region will continue for some time unabated and changes to the regulatory landscape are continuous and increasing. Those in the industry who have responsibility for legal and compliance have an ever increasing burden in this respect. Not only are the goal posts continually shifting but there are many, many more hurdles that need to be cleared. In short, ensuring compliance is getting much more difficult.

In this edition, Andrew Ball and Elizabeth Ticehurst discuss from an employment perspective, how best to achieve compliance from employees in Australia. Scott Thiel explains the new rules governing the collection, use and security of consumer personal information in China. This is a significant development given that the new rules significantly expand privacy protection for consumers in China. These changes follow a wave of privacy reform across the region. Given that Life Sciences companies routinely collect and handle personal data, these rules present significant changes for the industry.

In addition to increasing and changing regulation, regulators are keenly pursuing enforcement. In this issue, Sammy Fang and Sally Zhang consider the new wave of regulatory enforcement action by government authorities in China and ways to implement a proactive and effective regulatory and compliance program. In addition, Simon Uthmeyer discusses the ACCC’s recent action against Pfizer which has caught everyone’s attention in Australia. One has to ask, is this the first of a new wave of enforcement against patentee’s in Australia, similar to those in the United States and Europe?

Whilst the outlook for life sciences companies presents a number of challenges across the region, particularly in relation to compliance, it is clear that from the volume of recent transactions that there is an emerging trend in M&A activity. This activity is likely to provide opportunities for companies from some period of time.

In contrast to the increasing burden in relation to regulatory compliance, recent amendments to requirements relating to merger and acquisitions activities in a number of jurisdictions bring some welcome relief. In China, the new simplified merger regime will provide a fast track process for a broad range of transactions. Jingwen Zhu discusses this new regime which will potentially speed up the process for 60 percent of transactions (according to MOFCOM). Further, in this edition, Masahiko Ishida discusses changes to the law in Japan, which once effective may simplify the licence requirements for medical device manufacturers in the context of an acquisition.

In This Issue:

- Chinese Regulatory Enforcement Action Showing No Signs Of Slowing Down

- Patent Strategies And Loyalty Discounts

- Data Privacy Protection In New Prc Consumer Rights Law Effective From 15 March 2014

- Enforcing Compliance – How To Ensure That Employees In Australia Comply With Regulatory Codes

- China’s Simplified Merger Review Is Effective

- Australian New Zealand Therapeutic Products Agency – Will We Ever Get There?

- M&A’s, Manufacturing And Distributing Medical Devices In Japan

Please see full publication below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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