CHINA: An Introduction to Healthcare (PRC Firms)
Transactional Market Status: Cautious, Steady and Retrieving Value
市场交易现状：谨慎稳健，重塑价值
The transactional market of this year can be characterised as cautious, steady and retrieving value compared with the active market performance before 2021. The whole competitive landscape in licensing deals is increasingly fierce, gradually shifting from quantitative superiority to quality and strategic competitiveness, and the risk tolerance requirements on both parties of the transaction are getting higher and higher; on the other hand, cutting-edge and innovative technologies such as Artificial Intelligence (“AI”) are still highly favoured by investors.
相较于2021年以前积极活跃的市场表现，过往一年交易市场以谨慎稳健和重述价值为主风向标。一方面，许可交易的竞争越来越激烈，数量竞争格局逐渐转为质量和战略竞争，对交易双方风险承受能力的要求也越来越高；另一方面，前沿及创新技术（如人工智能AI等新技术）仍备受投资者青睐。
It should be noted that China's regulatory policies are still actively attracting premium pharmaceutical enterprises, constantly promoting the localisation of multinational companies, increasingly providing support for the introduction of high-quality products and steadily strengthening the governance of related regulatory areas. In return, pharmaceutical enterprises enter into a new era of compliance reorganisation under the evolving competitive situation.
需要注意的是，中国监管政策仍在大力吸引优质的医药企业、推进外资企业的本土化、增加引入优质产品的扶持力度，同时还强化医药行业相关监管领域的治理，这也促使医药企业在竞争格局持续演变的当下进入了新一轮的合规重整期。
Continuously Strengthening Foreign Investments' Protection and Encouraging Product Innovation
持续加强外资保护，鼓励产品创新
The State Council, in its opinions related to the continuous strengthening of foreign investment protection in 2023, proposed to reinforce the protection of intellectual property rights in the procurement of medicines and medical consumables, and to take timely measures such as ceasing procurement and cancelling the qualification for listing of products that are identified as infringing patents by administrative rulings of the intellectual property administrative department or by effective courts’ judgement. Meanwhile, one of the biggest highlights in the negotiation for 2023 national reimbursement drug list (“NRDL”) is its emphasis on encouraging innovation, with new target drugs emerging constantly in the list, the NRDL is incrementally enabling innovative drugs to benefit patients in China. It is reasonable to anticipate that the innovative characteristics (eg, the innovative drugs with patent value, or with new therapeutic effects) remain to be important factors in evaluating the competitiveness of products.
国务院在2023年持续加强外商投资保护相关的意见中，提出加强药品和医用耗材采购领域知识产权保护，对经知识产权部门行政裁决或人民法院生效判决认定为专利侵权的产品，及时采取不予采购、取消中选资格等措施。与此同时，2023年国家医保目录准入谈判的最大亮点之一是突出了鼓励创新的导向，新靶点药物逐步被纳入了目录范围，使得创新药快速惠及中国患者。合理预见，具有专利价值的原研属性和具备新疗效等的创新属性将依旧是衡量产品强竞争力的重要因素。
Regulatory Ideas That Are More in Line with Industry Needs
更贴合行业需求的监管思路
Refined human genetic resources administration and ethical review regulations came into effect
细化落地的人类遗传资源监管和伦理审查规则
In 2023, the human genetic resources administration embraced the revolution of supervising deregulation and service improvement. In addition to defining "human genetic resources information" in an enumerated manner and clarifying the definition of "foreign entities" in line with practical operation, these latest regulations facilitate and speed up the compliance management of human genetic resources and international collaboration through simplifying and refining administrative regulatory measures. In terms of ethical review, the new regulations implemented in 2023 place special emphasis on the activities related to "human" rather than "medical science", detail the requirements of informed consent, and clarify the ethical supervision of research activities in which biological samples are used. It is foreseeable that a well-developed ethical review system will be progressively established in China.
人类遗传资源监管在2023年迎来深化落实的 “放管服” 改革，除对 “人类遗传资源信息” 以列举的方式予以界定、并对管理实践中的关注焦点 “外方单位” 的情形予以明确外，监管新规通过对行政监管手段的简化和细化有利地推动了人类遗传资源的合规管理和国际合作。伦理审查层面，2023年发布实施的新规将审查对象重点聚焦于 “人” 而非 “医学” 、细化知情同意要求、并明确了涉及生物样本的研究的伦理监管，可以预见中国的伦理审查体系的日益完善。
Gradually clarifying the compliance pathways for cross-border transfer of personal information
逐步明晰的个人信息出境合规路径
The Cyberspace Administration of China has gradually clarified the compliance path for the exfiltration of personal information through a series of supporting regulations. In addition to passing the data exfiltration security assessment and obtaining personal information protection certification of the network information security authority, the "Measures for the Standard Contract for the Outbound Cross-Border Transfer of Personal Information" implemented in 2023 provides a clearer basis and improves the feasibility of contracts. At the same time, the authorities are also exploring "unrestricted" regulatory means to standardise and promote the orderly and free flow of data in accordance with the law through the draft for comments. This is also worthy of companies' continued attention.
互联网信息安全管理部门通过一系列的配套规定逐步明晰个人信息出境的合规路径，除了通过网络信息安全主管部门的数据出境安全评估、进行个人信息保护认证外，2023年实施的《个人信息出境标准合同办法》对于订立标准合同的个人信息出境路径提供了更加明确的依据、提高了合同实际履约过程中的可操作性。同时，主管部门也在通过征求意见稿的形式探索规范和促进数据依法有序自由流动的 “松绑式” 监管手段，值得相关企业持续关注。
Increasing Emphasis on the Compliance and Healthy Development of the Healthcare Industry
不断重视行业的合规且健康发展
With the refinement of governance rules and the strengthening of regulatory trends in traditional regulatory fields such as antitrust and anti-corruption, the introduction of new regulatory regulations such as corporate social credit has given pharmaceutical companies the opportunity to re-examine and optimise their own compliance management.
随着反垄断和反腐败等传统监管领域治理规则的细化和监管态势的加强，企业社会信用等监管新规的出台推动着医药企业迎来重审并优化自身合规管理的契机。
Ongoing enforcement in antitrust investigations
持续发力的反垄断调查
The pharmaceutical industry has always been a key area of focus for antitrust enforcement. Among the typical cases of special antitrust enforcement actions disclosed in 2023, five of the 23 cases were related to the pharmaceutical industry, and the types of violations mainly involved the implementation of monopoly agreements and abuse of dominant market positions, with fines of up to CNY100 million. Pharmaceutical companies should pay attention to the law enforcement measures of regulatory authorities and conduct regular compliance reviews on the company's market competition, product purchase and sales agreements, and distributors' performance, to properly mitigate the risk of violations.
医药行业向来是反垄断执法的重点关注领域，2023年披露的民生领域反垄断执法专项行动的典型案例中，23个案例中的5个就与医药行业相关，违法类型主要涉及达成并实施垄断协议和滥用市场支配地位，罚款金额高达亿元。医药企业应当关注监管部门的执法口径，并对企业的市场竞争情况、产品购销协议约定、经销商的履行情况等进行定期合规审查，以更好地降低垄断违法风险。
Nationwide anti-corruption campaign in the healthcare industry
全国医药领域反腐治理
The centralised rectification of corruption issues in the healthcare industry in 2023 emphasised systemic and comprehensive governance in all fields, all chains and all coverage. It aimed to restore a fair market environment for pharmaceutical and medical device purchase and sales activities, and further reduce and compress the sales expenses and costs of products. Complying with laws and regulations and internalising the healthcare industry's self-regulatory rules into enterprises' compliance management systems will safeguard the stability and long-term development of pharmaceutical companies.
2023年医药领域的腐败问题集中整治工作强调全领域、全链条、全覆盖的系统治理，旨在恢复药械购销领域的公平市场环境、进一步降低和压实产品的销售费用成本。在反腐治理常态化的当下，遵守法律法规并将行业自律性规则内化至自身合规管理体系的建设将为医药企业行稳致远保驾护航。
Social Credit System Is Taking Its Initial Shape
社会信用体系建设初见雏形
In order to solve the problem of "nothing to rely on" in credit construction in various industries and fields, China's social credit system and rules have entered the initial stage of construction in recent years. Untrustworthy pharmaceutical companies may face restrictions in terms of access to NRDL, centralised pharmaceutical procurement and listing and bidding qualifications. It is necessary and urgent to incorporate credit monitoring into companies’ daily legal and compliance risk management.
为解决各行业、各领域信用建设 “无法可依” 的问题，中国的社会信用监管制度规则在近年来迈入初期建设阶段。失信医药企业在医保目录准入、医药集中采购、挂网资格等方面将可能面临限制，将信用监控纳入公司日常法律和合规风险管理具有其必要性和迫切性。
Challenges And Opportunities Brought by Cutting-Edge Technology to the Healthcare Industry
前沿技术对于行业带来的挑战和机遇
Ethical review of science and technology activities promotes good development of the healthcare industry
科技伦理审查推动行业向上向善发展
In the context of the upward trend of the development of science and technology for good, the implementation of “Measures of Ethical Review of Science and Technology (Trial Implementation)” in 2023 gave direct guidance to enterprises in relevant industries and clarifies the scope of scientific and technological activities that require science and technology ethics review and the laws that are violated in the form of examples. It encouraged enterprises to self-regulate and comply with scientific and technological ethics regulatory requirements.
医疗健康领域作为科技伦理的重点监管对象，在科技发展向上向善的背景下2023年《科技伦理审查办法（试行）》的落地让企业有法可依，以例举的形式明确了需要进行科技伦理审查的科技活动范围和违反的法律责任，促使企业自主规范并遵循科技伦理监管要求。
Legal challenges continuously accompanying the application of AI
法律挑战时刻伴随着AI运用
As a technological application with the most commercial prospects, AI has gradually integrated and interacted with the multi-dimensional big data formed in the medical and healthcare industry. It has been used in multiple subdivisions such as target discovery, compound synthesis and clinical trial design optimisation. The industry brings new dynamics, but also raises ethical and legal challenges. Before engaging in AI application activities, pharmaceutical companies should focus on analysing legal factors such as open-source risks, operational/algorithm compliance, intellectual property infringement protection, personal information protection and attribution of output results.
AI作为最具有商业前景的技术应用，已逐步与医疗健康领域中形成的多维大数据进行交融和交互，在靶点发现、化合物合成以及临床试验设计优化等多个细分领域被运用，为医药行业带来了新动力的同时也引发伦理和法律挑战。医药企业在参与AI应用活动前应侧重分析开源风险、运营/算法合规、知识产权侵权保护、个人信息保护、输出成果归属等法律要素。