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In February 2014, the China Food and Drug Administration (“CFDA”) invited second-round comments from the public regarding proposed amendments to the China Drug Registration Regulations (“DRR”). One of the proposed amendments touches upon patent protection for drugs in China.
The National Development and Reform Commission ( NDRC ) released a new set of Management Measures for Approval and Filing of Outbound Investment Projects ( 境外投资项目核准和备案管理办法) ( New Measures ) on 8 April 2014. The New Measures take effect on 8 May 2014 and will replace the Interim Management Measures for Approval of Outbound Investment Projects ( 境外投资项目核准暂行管理办法) ( Original Measures ) which have been in force since 9 October 2004.
On 21 March 2014, CIRC issued the Administrative Measures on the Acquisition and Merger of Insurance Companies (the Insurance M&A Measures ) which will take effect from 1 June 2014. The Insurance M&A Measures apply to M&A activities whereby an insurance company is the target for a merger or acquisition. The target insurance company could be either a domestic or a foreign invested insurer. However, the Insurance M&A Measures will not apply to any equity investment by insurance companies in non-insurance companies in China or in overseas insurance companies.
The Regulations on Supervision and Administration of Medical Devices (in Chinese《医疗器械监督管理条例》, State Council Order No. 650) (the Medical Device Regulations) were amended by China's State Council on 31 March 2014 and will come into effect on 1 June 2014. This is the first amendment in more than a decade since the Medical Device Regulations were first promulgated in 2000, even though the amendment was initiated eight years ago in 2006. The 2014 amendment unveils reforms on the regulatory regime for medical devices market in China from various aspects.
Walking a fine line in China:Distinguishing between legitimate commercial deals and commercial bribeChina in the 21st century exemplifies an atmosphere of great opportunity and intense competition. Against this backdrop, it has become increasingly common for businesses to adopt a variety of practices in order to make their products and services competitive. Such practices may include paying middle-men to promote sales and giving incentives to buyers directly. However, whilst revenue spikes are undoubtedly welcome, businesses should bear in mind the potential backlash arising out of these commercial arrangements. The risk that such arrangements may not comply with anti-bribery and corruption laws and therefore cause business significant damage in the long term should not be underestimated.
As of 2013, China had 9,800 private hospitals, representing almost half of the total number of hospitals in the country 1 . However, private hospitals still severely lag behind their public peers due to low utilisation, talent shortages and incomplete social insurance coverage. As part of China's ongoing healthcare reform initiatives, the Chinese government has set a goal to increase the share of patients treated by private hospitals to 20% by the end of 2015 2 .
On 30 November 2014, the State Council of China released a draft Deposit Insurance Regulation (the Draft), to establish a deposit insurance system in order to "protect interests of depositors, prevent and mitigate financial risks and maintain a stabilised financial system". The public are invited to submit comments on the Draft by 30 December 2014.
Following earlier reforms of the PRC's anti-corruption rules (for further information, please see our previous briefings published in January 2013 and March 2011 ), the National People's Congress (NPC) has recently published a proposed amendment to the PRC Criminal Law in draft form for public comments (the Draft). The Draft expands the reach of official bribery offences, gives more autonomy to judges to inflict severe punishments, and generally increases the level and type of punishments that can be imposed on individuals who commit bribery offences. It further demonstrates the government's determination to tackle corruption in China.
The State Council of China recently released amendments to the Foreign Bank Administrative Regulations of China (the Amendments) with effect from 1 January 2015.
With a trend towards increasing investigation against administrative monopoly, there will probably be more cases against administrative monopolistic conducts in 2015. Companies may, as plaintiffs, sue local governments or its authorized institutions for administrative monopoly.