查看原文
其他

Investing in the "beauty economy"

张露 戴静宇 北京市竞天公诚律师事务所 2022-07-23

Authors: Zhang Lu / Dai Jingyu

(This article was first published on China Business Law Journal column "Life sciences & healthcare", authorised reprint)


Chinese authorities have started a crackdown on illegal medical cosmetic services, with a number of ministries and departments issuing a joint special plan of general rectification from June to December. While this heralds an era of tightened regulation for medical cosmetic companies, the sector remains an alluring one for investors keen to ride the wave of the “beauty economy”.


QUALIFICATIONS


First and foremost, it is important to understand that there is a world of difference between cosmetic hospitals and beauty salons. According to the Regulation of Medical Beauty Treatments, medical cosmetology refers to the repair and reconstruction of facial appearance or of various parts of the body through surgery, medicine, medical devices or other traumatic or invasive medical technologies. Life cosmetology, on the other hand, according to the National Medical Products Administration (NMPA), refers to non-invasive healthcare using cosmetics, health products and non-medical devices, such as skin and hair care, and massage. Cosmetic hospitals providing medical cosmetology services require a Medical Institution Practice Licence; beauty salons providing lifestyle cosmetology services require a Sanitary Permit for Public Places.


Cosmetic hospitals are only one type of cosmetic institution. According to the List of Reforms Related to Enterprise-Related Operation-Permitting Matters Established at Central Level (2021 National Version), since 1 July 2021, the permit entry management of clinics has been replaced nationwide with filing management. For the medical cosmetology industry, this marked the further relaxation of restrictions on individuals or organisations establishing cosmetic plastic surgery clinics and medical beauty clinics.


SERVICES


Under the Hierarchical Management of Medical Cosmetic Services, cosmetic surgeries are classified into four categories based on technical difficulty, probability of medical accident and degree of risk. Investors may refer to an institution’s practice licence for the medical subjects it may undertake, which helps understand its scope of service.


Unfortunately, finding out about every medical cosmetic item is not a simple matter of looking it up in the relevant laws and regulations, and investors often have to make up their own minds on whether the institution is operating outside of its permitted scope.


We suggest that investors become familiar with the specific procedures in order to determine if the instruments and devices involved have been properly registered and all the appropriate filings made;

And to determine if the procedures fall under physical or other traumatic or invasive cosmetic treatment using medicine, medical device or surgery, based on how the instruments and devices are actually used.


For example, the current popular "Thermagi" and "ThermoLift"  are radiofrequency therapy in the category of invasive treatment projects of beauty Dermatology; "Fotona4d" uses a medical laser instrument, which belongs to laser therapy. If an institution uses such words as "laser treatment" to promote "Thermagi", but it does not have the Medical Institution Practice Licence or its diagnosis and treatment subjects do not include the department of beauty and dermatology, such  circumstance  shall consititute operation beyond the business scope, and the institution may be fined or have its Medical Institution Practice Licence revoked.


PRICING AND MARKETING


In terms of pricing, non-governmental medical institutions may adopt the market regulation price – in other words, independent pricing, while public medical institutions must file with the competent authority for price announcement. A medical cosmetic institution must publicly display its physicians, items and prices at its premise, so consumers can make a thorough price comparison.


It is worth noting that cosmetic marketing suffers from rampant price frauds such as “falsified original price” and “inconsistent fees”. Regulators nationwide have made many attempts to counter the problematic pricing of cosmetic services in recent years.


Medical cosmetology is simultaneously a type of medical treatment and consumer product. Medical cosmetic institutions may only publish advertisements after obtaining the Examination Certificate for Medical Advertisements. They are further prohibited from disguising advertisements under the form of news or features or committing any false publicity.


In line with the media trends, many medical cosmetic institutions have opted for live streaming and short video as new outlets, featuring influencer demonstrations of the whole procedure or real-time Q&A sessions with a doctor. For the most part, such programs are individual creations in name only and are in fact coordinated with the institutions with the ultimate goal of soliciting purchases and generating user traffic.


To enhance regulation and supervision in medical cosmetology advertisement, the State Administration for Market Regulation issued the Guidelines for the Enforcement of Medical Cosmetology Advertisement on 2 November. Depending on its exact content or form, such thinly veiled promotion may still be recognised by regulators as disguised advertisements. Novelty notwithstanding, institutions must always comply with advertising laws and regulations when promoting their products. This includes avoiding any advertisements promoting “appearance anxiety”, or disguised as healthcare public service announcements (PSA), interviews or news reports.


MEDICINE & MEDICAL DEVICES


Medicine and medical devices used during medical cosmetic treatment ar medical cosmetic products, which can only be operated by a qualified practising physician with relevant clinical experience in a qualified medical cosmetic institution. Other than the required qualifications, investors should also note whether the products used have been legally procured.


Medical cosmetic institutions should only purchase legally registered/file medicine and medical devices from companies with production andJane Zhang operating qualifications. They should also establish an internal inspection system for all incoming products and avoid buying anything of unknown origin or ingredients through online, social media or cross-border channels.


Taking the example of hyaluronic acid injection, a popular form of facial cosmetic treatment, investors may refer to the NMPA website to determine if the Registration Certificate for Medical Device, or the approval for domestic sale, have been obtained for the domestic or foreign brands of hyalu-ronic acid, respectively.


The medical cosmetic industry is at a critical juncture, with both intensified regulation and strong capital inflow looming. Lowering investment risks and ensuring compliance with the complex regulations are matters of high priority in joining medical cosmetic institutions with the capital market in a healthy and productive manner.



医药医疗专栏往期文章

1. 医疗器械追溯制度及企业上市重点关注问题

2. Medical Device Tracking System and Key Issues for Listing

3. 中国药品专利纠纷早期解决机制概览

4. Early resolution mechanism for drug patent disputes in China

5. 医疗数据合规三问

6. Three questions on medical data compliance

7. Highlights of New Rules on Medical Devices Regulation

8. 管中窥豹读新《医疗器械监督管理条例》

9. Cross-border Use of Medical Products in the Greater Bay Area

10. 细胞治疗监管政策——基础篇

11. 互联网医疗:医疗行业企业之数字化营销——春潮涌动,乘风破浪

12. 说一说互联网“医+药”里的那个“药”

13. 民营医疗机构:赴港IPO之合规注意事项探析

14. 互联网医疗:跨境线上诊疗与咨询

15. 互联网医疗:新冠疫情背景下的法律准入与监管发展

16. 药械应急审批助力疫情防控——8问小科普

17. 临床基因检测行业的监管与挑战(上篇)

18. Highlights of China’s 2019 Drug Administration Law

19. 与时俱进,焕然一新——喜迎《药品管理法》新修订版

20. 疫苗管理法正式出台,新法亮点几何?

21. 《人类遗传资源管理条例》亮点初析

22. “药品4+7带量采购”之小白十问

23. 我国医疗行业上市许可持有人(MAH)制度初探(下篇)

24. 重典治乱,监查并举,制度创新——从疫苗管理单独立法说起

25. 我国医疗行业上市许可持有人(MAH)制度初探(上篇)


作者介绍
 张露  

合伙人

010-5809 1150

zhang.lu@jingtian.com


张露律师的执业领域为证券与资本市场、私募股权与风险投资、公司合规、兼并与收购等。


张律师2013年加入竞天公诚,擅长新消费、医疗健康、TMT等领域的法律服务,曾为多家知名民营企业、大型国有企业和跨国企业提供上述领域的法律服务。张律师于2019年获评“LEGALBAND中国律届俊杰榜三十强”,并入选“北京市律师协会涉外人才库”。



张露律师历史文章

1. 民营医疗机构:赴港IPO之合规注意事项探析
2. 沉者为金!一文读懂网络剧、网络大电影监管全流程3. 互联网文化行业法律监管要点观察4. 新三板转板上市指导意见“征求意见稿”八大看点




戴静宇

010-5809 1255

dai.jingyu@jingtian.com


戴静宇先后毕业于中国政法大学、美国南加州大学,分别获得法学学士学位、法学硕士学位。戴静宇作为主要成员之一参与了多个香港联交所上市项目、境外债券发行项目、投资及常年法律顾问项目,涉及TMT、大消费、医疗与生物科技等行业。



您可能也对以下帖子感兴趣

文章有问题?点此查看未经处理的缓存