Since the very beginning of the COVID-19 outbreak, AmCham China has done its best to provide support to members, from assisting and enabling donation channels to securing much-needed equipment, and helping member companies navigate the raft of new government policies designed to mitigate the impact of the epidemic.
Much of this work has been done through our industry-specific Forums & Committees, the working groups often described as “the engine of the Chamber”, which advocate for the most pressing industry needs of our members. One such story from our Healthcare Forum provides an example of this.
Last month when the COVID-19 epidemic was at its peak in Wuhan, the National Medical Products Administration, or NMPA, had its hands full with approvals for urgent medical devices needed by healthcare professionals dealing with the epidemic. However, lost in the mix, was attention on all the hundreds of other medical devices needed for everyday healthcare matters, for which the license renewal process had been severely impacted due to the urgent attention on COVID-19.
Several other organizations had tried to lobby the NMPA to push through approval of these other equally critical devices – but to no success. However, the AmCham China Healthcare Forum had other ideas.
Under the leadership of the Forum’s three co-chairs – Roberta Lipson, CEO & Founder, United Family Healthcare; Jeffrey Que, VP for Government Affairs and Policy, Johnson & Johnson China; and Alice Xu, VP for Health Economics and Government Affairs and Public Relations, Boston Scientific – AmCham China’s submission to NMPA referenced a recent joint policy announcement by NMPA, the State Administration for Market Regulation (SAMR), and the China National Intellectual Property Administration (CNIPA) to support the argument and focused on specifics areas, instead of attempting to request a wide-ranging approval.
The co-chairs raised this issue with AmCham China staff during a call early on in February, with the wider Healthcare Forum membership resolving to take further action during the Forum’s monthly meeting later that month. Following a call for comments to our members, the Chamber compiled all the necessary information working closely together with the Forum’s leadership. AmCham China was in close contact with the relevant government authorities throughout this time, and the Chamber submitted an official letter on February 20.
On February 26, the Center for Medical Device Evaluation under the National Medical Products Administration, or NMPA, announced that an extension of the license renewal procedure on these medical devices had been approved, providing critical underpinning of the medical device supply chain, and relief for businesses, patients, and healthcare personnel in need. The text of their announcement mirrored extremely closely to the petition that AmCham China had submitted one week previously.
To get into the details, devices that had been issued a technical review and revision notification from February 12, 2019 to the date when the epidemic is resolved, had the period for the revision of information extended for one year, while devices valid from the end of the epidemic to December 31, 2020, will have their period for the revision of information extended for six months.
From a company perspective, this means that our members can continue to provide all the best devices provided to hospitals and facilities across the country. Had these licenses expired, not only would our member companies be faced with huge financial losses and worthless stock, but healthcare providers across China would lose access to much-needed medical equipment.
While notable, this was just the latest in a long list of advocacy successes championed by our Forums & Committees, and achieved the dual purpose of both taking action that benefited our member companies and driving forward the healthy and sustainable development of China’s healthcare industry.
In the coming months, the Healthcare Forum will turn its focus to the industry’s need for post-epidemic development, while issues related to the implementation of the US-China Phase One trade deal will once again return to the fore once things begin to return to normal.
To learn more about the AmCham China Healthcare Forum, please contact Lu Li at lli@amchamchina.org