【观点】齐鲁制药总裁李燕：支持民族医药产业创新升级

2024年全国两会召开期间，第十四届全国人大代表、齐鲁制药总裁李燕准备了多份建议。其中，在《关于支持民族医药产业创新升级发展的建议》中，她建议坚持系统理念，持续优化药物研发环境；支持企业增强核心竞争力，切实奠定民族医药产业发展根基；构建协同创新转化机制，提高科研成果转化效率；进一步完善市场准入等政策，保障发展可持续。

李燕认为，当前我国医药产业发展进入新阶段，医药卫生体制改革深入推进，获批新药数量屡创新高。但中国医药产业发展是一项系统工程，行业“内卷”、创新能力不足、高质量创新成果少、整体国际竞争力偏弱等问题依然存在。需要在现有基础上，通过政策的系统性建构、体系性整塑，进一步发挥好政策的集中组合效应，充分释放民族医药产业和企业发展新活力。

“在进行国家药品监管制度顶层设计时，既要保证监管的科学性，也要统筹民众利益、产业发展。既鼓励创新，又正视我国制药产业发展阶段和实际，在规避低水平创新导致的‘内卷’和给低水平创新产品‘保护’的同时，对企业创新中遇到的问题给予指导和支持。”李燕说。 CXO UNION-CXO联盟（cxounion.cn）

为此，她建议国家有关部门加强政策会商和部际联动，综合性政策共同谋划，专门性政策相互衔接，密切配合推进医药卫生体制改革，加强医保、医疗、医药协同发展和综合治理。

“我国医药产业、头部医药企业目前处于‘仿转创’的爬坡过坎期，需要加大释放政策红利，不断培育巩固企业创新主体地位。”李燕建议在全国重点实验室等重大国家平台上，给予民营医药龙头企业单独申报通道，助力企业创新发展。在科技项目立项、评审过程中提升企业专家比例，提升产业化应用科技创新项目比例，探索建立重点科技型企业成果和科研项目直报渠道，给真正具有创新实力和能力的企业更多“阳光雨露”。

经过调查研究，李燕发现创新药自身还存在上市时间短、民众认知不足、价格相对偏高等不足，临床使用面临“入院难”“入医保难”及“支付结构单一”等问题。

对此，她建议医保部门规范明确新上市创新药的范围和价格规则，开通快速挂网通道，确保创新药上市后及时获得挂网准入资质。放宽“一品两规”限制，通过开展药品综合评价或药品价值评估等方式，盘活新上市、高品质药品的进院渠道。加强医疗机构对创新药合理配备使用的重视，必要时通过行政手段干预，要求医疗机构定期、系统开展新药准入工作，保证创新药市场准入。 CXO UNION-CXO联盟（cxounion.cn）

翻译：

Li Yan, President of Qilu Pharmaceutical: Support the innovation and upgrading of the ethnic medicine industry

During the National Two Sessions in 2024, Li Yan, a deputy to the 14th National People’s Congress and president of Qilu Pharmaceutical, prepared a number of proposals. Among them, in the “Suggestions on Supporting the innovation and Upgrading of the Development of Ethnic Medicine Industry”, she suggested adhering to the system concept and continuously optimizing the drug research and development environment; Support enterprises to enhance their core competitiveness and lay a solid foundation for the development of ethnic medicine industry; Establish a collaborative innovation and transformation mechanism to improve the transformation efficiency of scientific research results; We will further improve market access and other policies to ensure sustainable development. CXO UNION-CXO联盟（cxounion.cn）

Li Yan believes that the current development of China’s pharmaceutical industry has entered a new stage, the reform of the medical and health system has been further promoted, and the number of approved new drugs has repeatedly reached a new high. However, the development of China’s pharmaceutical industry is a systematic project, and problems such as “internal volume”, insufficient innovation ability, few high-quality innovation achievements, and weak overall international competitiveness still exist. It is necessary to further exert the concentrated combination effect of policies through the systematic construction and systematic consolidation of policies on the existing basis, and fully release the new vitality of the development of ethnic medicine industry and enterprises.

“In the top-level design of the national drug regulatory system, it is necessary to ensure the scientific nature of supervision, but also to coordinate the interests of the public and industrial development.” It not only encourages innovation, but also faces up to the development stage and reality of China’s pharmaceutical industry, and gives guidance and support to the problems encountered in the innovation of enterprises while avoiding the ‘internal volume’ caused by low-level innovation and ‘protection’ of low-level innovation products.” Li Yan said.

To this end, she suggested that the relevant departments of the state strengthen policy consultation and inter-ministerial linkage, jointly plan comprehensive policies, connect specialized policies with each other, closely cooperate to promote the reform of the medical and health system, and strengthen the coordinated development and comprehensive management of medical insurance, medical treatment and medicine. CXO UNION-CXO联盟（cxounion.cn）

“China’s pharmaceutical industry and head pharmaceutical enterprises are currently in the climbing period of ‘imitation transformation’, and need to increase the release of policy dividends and constantly cultivate and consolidate the main position of enterprise innovation.” Li Yan suggested that on major national platforms such as national key laboratories, private pharmaceutical leading enterprises should be given a separate declaration channel to help enterprises innovate and develop. In the process of science and technology project establishment and evaluation, increase the proportion of enterprise experts, increase the proportion of industrial application science and technology innovation projects, explore the establishment of key science and technology enterprises and scientific research projects direct reporting channels, and give more “sunshine and rain” to enterprises with real innovation strength and ability.

After investigation and research, Li Yan found that innovative drugs themselves still have shortcomings such as short listing time, lack of public awareness, relatively high price, and clinical use faces problems such as “difficult admission”, “difficult admission to medical insurance” and “single payment structure”.

In this regard, she suggested that the medical insurance department regulate and clarify the scope and price rules of the newly listed innovative drugs, open the fast hook network channel, and ensure that the innovative drugs get the hook network access qualification in time after the listing. Relax the restrictions of “one product and two regulations”, and activate the channels for newly listed and high-quality drugs to enter the hospital by carrying out comprehensive drug evaluation or drug value evaluation. Strengthen the attention of medical institutions to the rational allocation and use of innovative drugs, intervene through administrative means when necessary, and require medical institutions to regularly and systematically carry out new drug access work to ensure market access for innovative drugs. CXO UNION-CXO联盟（cxounion.cn）

由CXO UNION-CXO联盟（cxounion.cn）转载而成，来源于中中华工商时报；编辑/翻译：CXO UNIONCXO联盟小U。

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