Beijing Life Sciences and Healthcare Roundtable 2018

In May, The Legal 500 and GC magazine, in partnership with CMS Beijing, hosted a roundtable to consider the changing regulatory frameworks for the pharmaceutical and life sciences sector in China.

Life sciences and pharmaceuticals have been major areas of growth for China in recent years. With pending regulatory reform likely to stoke further investment and heighten interest, The Legal 500 and GC magazine, in partnership with CMS Beijing, hosted a roundtable to consider the role of Legal in promoting further growth.

A shift in China’s approach to drug review and approval was first on the agenda, as the impact of its implementation was discussed. Under the new system, drugs with ‘apparent clinical value’ – those which are innovative and unique, or innovative and their manufacturing will be transferred to China – are eligible for prioritised review and a smoother, faster path to market.

The shift required close interaction between Legal and business, but representatives working directly in the sector – as well as those from firms specialising in life science investment – agreed that a streamlined process would increase the attractiveness and competitiveness of the domestic market.

Of particular importance was a change to the requirements imposed on foreign producers, who previously were only able to begin testing their drugs in China after they had entered phase two somewhere else internationally. This was previously seen as a prohibitive measure for a number of producers, which has resulted in a number of drugs not making it to China without lengthy delays – if at all. Consensus from the international players in attendance was that this was a game-changing development – one likely to prompt major changes to investment structures and strategies.

Changes to regulation are part of a broader trend evident in China – already the world’s second-largest market for pharmaceuticals, with biotechnology and life sciences target industries for government growth. This was spelled out when biotechnology was committed to in the 12th Five Year Plan – the national plan and blueprint for the impending government term.

A rise in startups has been symptomatic of changes to government policy promoting moving up the value chain – diversifying away from manufacturing and further into the innovation space – with a host of new challenges presented to Legal as a result. Those in attendance pointed to a lack of adequate regulation, particularly where it came to data use and investor protection, as potential roadblocks to future growth and areas of concern for counsel.

If China is to meet the lofty goals set out for the life sciences and pharmaceutical sectors, those in attendance pointed to intelligence regulatory policy and processes, transparency, development of R&D infrastructure and certainty around technology transfer and commercialisation as key elements for success.