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【两会】今年,代表委员们关心这些“药”事

医药魔方 医药魔方 来源:医药魔方
2019-03-09
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宪法规定,全国人民代表大会和地方各级人民代表大会是人民行使国家权力的机关;中国人民政治协商会议是有广泛代表性的统一战线组织。全国人民代表大会和中国人民政治协商会议统称“全国两会”。


3月初,春暖花开。来自全国各地、各族各界的代表委员近日齐聚北京、共商国是。两会是这些代表委员们政治生活中最重要的事件之一。小编就结合已有报道,来听听这些代表委员们今年所关心的“药”事。


国家医疗保障局局长胡静林:

——预计9月份完成医保目录调整工作

✔改革现行目录管理办法,建立医保目录动态调整机制。

✔启动2019年目录调整工作,预计工作9月份完成。

✔重点考虑基本药物、癌症和罕见病重大疾病用药,慢性疾病用药和儿童疾病用药,同时对于专家严格审定不具备条件的药品,也要调出目录。


全国人民代表、恒瑞医药董事长孙飘扬:

——建议改善政策环境,支持医药创新

✔ 加强创新药的知识产权保护,延长专利保护期,加强对新药数据的保护。 

✔仿制药政策应该要稳妥地推进,确保仿制药的质量可靠、价格合理、供应充足。

✔应鼓励和支持名优品牌的仿制药走出去,参与国际市场。

✔应制定产学研的政策,推动高校做基础研究,然后企业进行转化。

✔《药品管理法》的修改,要让企业参与进去,使其更符合创新药的发展规律。

✔发展商业保险迫在眉睫。医保政策不发展,行业下一步创新的发展就有很大问题。


全国人民代表、华海药业董事长陈保华:——推动医药行业高质量发展,建设制药强国

✔按照既定的仿制药一致性评价的质量要求和时限要求,加快推进仿制药一致性评价工作。

✔进一步完善通过一致性评价的仿制药的医院准入机制,让国产优质仿制药和原研药在一个平台上公平竞争。

✔完善医务人员考核和薪酬体系,切实让老百姓用上质优价廉的国产优质仿制药,降低老百姓用药负担。

✔完善药品生产工艺变更机制,确保新技术、新设备在提高药品质量、环境保护等方面发挥积极作用。


全国人民代表、贝达药业董事长丁列明:

——对首次在我国上市的专利创新药实施专利期补偿

✔对首次在我国上市的专利创新药实施专利期补偿。

✔进一步优化国家集中采购制度,通过竞标确定合理的中标价,采取多品种中标的模式。

✔在研发端上,加强与优化人类遗传资源审批流程。


全国人大代表、好医生药业集团董事长耿福能:

——聚力品牌价值链升级 助推中医药产业发展

✔建议国家加大知识产权生态链的保护

✔加强制定中药材种养殖标准

✔切实保障乡村医生合法权益

✔调整中药质量标准制定思路

✔促进第三方医疗服务发展

✔强烈呼吁设立彝医药标准


全国人大代表、扬子江药业董事长徐镜人:

——仿制药一致性评价是药企竞争的门槛

✔让贫困地区的人看得起病、看得好病、少生病,

✔未来仿制药市场的竞争,通过一致性评价是准入门槛,产品的价格是胜败的关键。


全国人大代表、齐鲁制药集团总裁李燕:

——将临床研究开展能力评价纳入医疗机构等级评审

✔由国家卫生健康委员会和相关部门牵头,对全国医疗机构,特别是大学附属医院进行一次摸底调查。根据调查结果,有针对性地加大临床研究管理经费、人员等的投入力度,设立独立、专职临床研究管理部门,开展临床研究各项事务管理。

✔对开展临床试验的医疗机构建立单独评价考核体系,有步骤、有计划地将新药、新医疗器械等注册类临床试验的承接数量和质量,以及开展研究者发起临床研究的数量和研究产出评价纳入医疗机构等级评审中。

✔加强伦理委员会分级管理,将伦理委员会的审查能力和效率也作为医疗机构等级评审的考核指标之一。

✔提高临床医学人员的科研设计水平和科研素养。

✔鼓励医务人员积极开展和参与各类临床研究,进一步改善医务人员创新环境。


全国人大代表、华兰生物董事长安康

——建立流感疫苗国家收储机制

✔在看到问题、加强监管的同时,支持疫苗的发展,树立社会各界对国产疫苗的信心。

✔加强相关科普教育工作,减少不必要的顾虑,增强各界对国产疫苗的信任。

✔扶持企业进行科技创新,开展新型疫苗的研发和开发,支持疫苗企业不断兼并重组做大做强,培育民族品牌,参与国际竞争。

✔进一步健全政府采购机制,加大对部分疫苗的采购力度。为有效地应对突发疫情,政府部门应该进一步出台应急预案和措施,对重点人群和疾病建立长期的预防机制。

✔建议国家卫健委统一60岁以上老人流感疫苗的需求数量,由工信部向企业下放生产计划,地方政府出资,国家卫健委统一调拨,并由疾控中心统一实施,最大程度上满足我国60岁以上老人对流感疫苗的接种需求。

 

全国人大代表、康恩贝集团有限公司董事长胡季强:

——建立协调机制,推动中医药事业发展

✔建议在国务院层面建立协调机制,在“一法一纲二规划”的大框架下,提出“中医药传承发展顶层设计”,合理调配涉及中医药全产业链管理的部门职能,最大限度减少“九龙治水”带来的监管空档和低效,提高监管的协调性和科学性。  

✔督促国家中医药局履行主管中医药工作的法定职责,依照《中医药法》给予其开展相关工作的充分授权,必要时可成立“国务院中医药发展领导小组”。 

✔督促卫健委、中医药局真正落实“中西医并重”的国家大政,充分认识中医药的临床价值,推进中医药临床路径制定工作,加强合理用药管理,严厉纠正粗暴对待中药的做法。 

✔督促国家药监局尽快研究制定符合中医药特点的中药审评审批体系,把制订《中药注册管理办法》纳入修法计划,启动中药上市后再评价工作。 

✔督促市场监管局牵头,协调农业农村部、商务部、自然资源部、工信部、林业和草原局、药监局、中医药局、卫健委等部门开展“中药材生产流通使用整顿”工作,形成长效机制,切实从源头上保障中药的质量安全和疗效。 

✔将3月17日定为中医药节,同时加强对中医药传统文化的宣传推广,增强14亿中国人的中医药文化自信,中医药走出国门才有底气。


全国人大代表、步长制药总裁赵超:

——建议加快中药注射剂再评价

✔中西医联合用药是临床必须,不存在主次之分。需科学对待临床用量大的中药大品种,避免中药大品种因临床疗效确凿、用量大,而被辅助用药误伤。

✔中西医医师比例失调,需要增强中医医师人才培养,提高他们的临床地位。

✔科学评价理性对待中药注射剂,加快中药注射再评价。

✔建立中药的独立评价体系。当前的中药创新临床药物评价体系没有充分尊重中医药的理论体系和重要的特点,而是基本参考了西医的临床评价体系与指导标准。

✔建立中医临床症候的诊断标准、疗效评价技术与方法、应用与中医药药学的研究,设立符合中药临床辩证特征的动物模型,建立动物模型中的医药症候评价的技术与方式,构建反映中医药临床疗效与作用特点的中药药学独特的评价体系。


全国政协会员、中国医院协会副会长方来英:

——建议三年内建立国家药品追溯体系

✔建立一个覆盖生产厂家、流通环节、零售药店的药品全过程追溯系统能够让“召回”效率得到指数级提升。

✔建立一套药品赋码系统和追溯体系,通过信息化的“加持”、电子码的“赋能”,未来的问题药品将越来越难混入市场。

✔建议医药行业机械、重复的劳动统一编码,交给能快速识别电子码的机器完成。


全国政协委员、辉瑞制药中国企业事务部总监冯丹龙:

——尽快出台《药师法》,制定统一药师制度和准入标准

✔尽快制定并颁布《中华人民共和国药师法》,制定统一的药师制度和准入标准,明确药师的法律地位和责任、权利、义务。

✔从国情出发,统筹发展学历教育和继续教育,以高层次药师人才队伍建设和基层药师队伍建设为重点,在医疗卫生机构和社会药房建设一支道德高尚、技术精良、专业扎实、结构合理、依法执业的药师队伍。

✔优化药师队伍配置结构,实现城乡之间、区域之间、各类医疗机构之间药师人才配置的基本公平。

✔通过立法统一药学服务规范和标准,不断提高药师的服务水平和质量,满足人民群众多层次、多样化的药学服务需求。


全国政协委员、中国疾控中心主任高福:

——狂犬病预防应以犬类接种狂犬疫苗为主

✔建议彻底控制传染源,解决狂犬病病毒传播问题。

✔建议通过给健康犬只接种狂犬病疫苗,使其体内能够产生抗狂犬病毒的特异性抗体,主动中和、消除入侵体内的狂犬病毒,从而达到预防狂犬病的目的。


机器翻译

The Constitution stipulates that the National People's Congress and local people's congresses are the organs for the people to exercise state power. The Chinese People's Political Consultative Conference is a broadly representative united front organization. The National People's Congress and the Chinese People's Political Consultative Conference Collectively referred to as "National Two Sessions".

In early March, spring blossoms. From all over the country. Representatives from all walks of life gathered in Beijing recently. The business is the same. The two associations are the most in the political life of these representatives. One of the important events. Xiao Bian combined with the existing reports to listen to the "medicine" things that these deputies are concerned about this year.

The Director of the National Health Protection Bureau Hu Jinglin:

< p>—It is expected that the medical insurance catalogue adjustment work will be completed in September

✔ Reform the current catalogue management method and establish a medical insurance catalogue dynamic adjustment mechanism.

✔Starting the 2019 catalogue adjustment work, it is expected that work 9 Completed in the month.

✔ Focus on essential medicines. Cancer and rare diseases, chronic diseases and childhood diseases, and strict calibration of unqualified drugs for experts. /p>

All Representative of the People's Republic of China. Sun Feiyang, Chairman of Hengrui Medicine:

-Recommended to improve the policy environment and support medical innovation

✔Strengthen the intellectual property protection of innovative drugs, extend the patent protection period, and strengthen Protection of new drug data.

The generic drug policy should be steadily promoted to ensure the quality of generic drugs is reliable. The price is reasonable. The supply is sufficient.

We should encourage and support famous brands. The generic drugs go out and participate in the international market.

The company should formulate policies for production, education and research, promote basic research in universities, and then transform enterprises.

✔《Drug Administration Law》 To modify, we must let enterprises participate in it, so that it is more in line with the development of innovative drugs.

The development of commercial insurance is imminent. The medical insurance policy does not develop, and the next step of innovation in the industry has great problems.

National People's Representative. Chen Baohua, Chairman of Huahai Pharmaceutical: Promote high-quality development of the pharmaceutical industry and build a strong pharmaceutical industry

✔Qualified and time-bound requirements in accordance with established generic drug conformity assessment , speed up the evaluation of the consistency of generic drugs.

✔ further improve Through the consistency evaluation of the generic hospital access mechanism, the domestic high-quality generic drugs and the original research drugs compete on a platform fairly.

✔ Improve the medical staff assessment and compensation system, and let the people use the quality Good quality and low-cost domestic high-quality generic drugs, reducing the burden of medicine for the people.

To improve the drug production process change mechanism and ensure new technology. New equipment plays an active role in improving drug quality and environmental protection.

National People's Representative. Ding Lie Ming, Chairman of Beida Pharmaceuticals:

-Compensation of Patent Period for Patent Innovative Drugs Listed in China for the First Time

✔For the first time in China The listed patented innovative drugs will be compensated for the patent period.

✔ Further optimize the national centralized procurement system, determine the reasonable bid price through bidding, and adopt the model of winning multiple varieties.

✔R&D On the end, strengthen and optimize the human genetic resources approval process.

National People's Congress representative. Good doctors pharmaceutical group chairman Fu Fu Neng:

-Gui Li brand value chain upgrade to promote Chinese medicine Industry Development

✔Proposal to increase the intellectual property chain of the country Protection

✔Strengthen the standard of Chinese herbal medicine breeding

✔Protect the legitimate rights and interests of rural doctors

✔Cultivate the development of Chinese medicine quality standards

✔Promoting the development of third-party medical services

✔ Strongly calling for the establishment of medical standards

National People’s Congress. Chairman of Yangzijiang Pharmaceuticals Xu Jingren:

—Generic Pharma Consistency evaluation is the threshold for competition among pharmaceutical companies

✔People in poor areas can see the disease. Seeing good disease. Less sick,

✔The competition in the future generic drug market is consistent Sexual evaluation is the entry barrier, and the price of the product is the key to success or failure.

National People's Congress. Li Yan, President of Qilu Pharmaceutical Group:

-Incorporate clinical research capacity assessment into medical treatment Institutional level review

The National Health and Health Commission and relevant departments take the lead in conducting a survey of national medical institutions, especially university affiliated hospitals. According to the survey results, targeted clinical research management funding The input of personnel, etc., set up an independent. Full-time clinical research management department, carry out clinical research management.

Establish a separate evaluation and evaluation system for medical institutions conducting clinical trials, and have steps. Plan to introduce the quantity and quality of new clinical medicines, new medical devices, and other clinical trials, as well as the number of research and clinical research initiated by researchers. The evaluation is included in the medical institution level review.

Enhance the ethics committee's hierarchical management, and the ethics committee's review ability and efficiency are also used as one of the evaluation indicators of the medical institution level review.

✔ Improve the scientific research design level and scientific research of clinical medical personnel.

✔Encourage medical staff to actively carry out and participate in various clinical research to further improve the innovation environment of medical personnel.

National People's Congress. Hualan Biological Chairman Ankang

-establishing a national flu vaccine mechanism

✔Seeing problems. Strengthening supervision while supporting the development of vaccines and establishing domestically produced vaccines Confidence.

Enhance relevant science education work, reduce unnecessary concerns, and enhance trust in domestic vaccines.

✔Support enterprises to carry out technological innovation and develop new vaccines And development, support vaccine companies to continue to merge and reorganize to become bigger and stronger, cultivate national brands, and participate in international competition.

✔ Further improve the government procurement mechanism and increase the procurement of some vaccines. In the case of an outbreak, the government departments should further introduce emergency plans and measures to establish a long-term prevention mechanism for key populations and diseases.

✔Proposal to the National Health and Health Commission to unify the number of influenza vaccines for people over 60 years old, by the Ministry of Industry and Information Technology The production plan is decentralized to the enterprise, and the local government funds the funds. The National Health and Health Commission is uniformly allocated and implemented by the CDC to meet the needs of the vaccination of influenza vaccine for the elderly over 60 years old.

National People's Congress Representative. Hu Jiqiang, Chairman of Kangenbei Group Co., Ltd.:

—Building a coordination mechanism to promote the development of Chinese medicine

✔ It is recommended to establish a coordination mechanism at the level of the State Council. Under the framework of the “Shortage 2 Plan”, the “Top Design of Inheritance and Development of Traditional Chinese Medicine” was proposed, and the functions of the departments involved in the management of the whole industry chain of Chinese medicine were rationally allocated to minimize the “Jiulong Water Control”. Bringing regulatory gaps and inefficiencies, improving the coordination and scientific nature of supervision.

Promoting the State Administration of Traditional Chinese Medicine to perform its statutory duties in charge of Chinese medicine work, and granting it according to the Chinese Medicine Law. Full authorization of related work, if necessary, the “Leadership Group for the Development of Traditional Chinese Medicine of the State Council” may be established.

The Ministry of Health and Medicine will implement the National Government of the Chinese and Western Medicines and fully understand Chinese medicine. The clinical value, promote the development of clinical pathways for Chinese medicine, strengthen the rational use of drug management, and severely correct the practice of rude treatment of Chinese medicine.

✔ urged the State Food and Drug Administration to study and formulate the approval of Chinese medicine evaluation in line with the characteristics of traditional Chinese medicine. The system will formulate the "Regulations on the Registration of Chinese Medicines" into the revision plan, and start the evaluation of Chinese medicines after listing.

✔Supervise the Market Supervision Bureau to take the lead and coordinate the Ministry of Agriculture and Rural Affairs. Ministry of Commerce. Department of Natural Resources. Ministry of Industry and Information Technology. Forestry and Grassland Bureau. The State Food and Drug Administration. The Chinese Medicine Bureau. The Health and Welfare Committee and other departments carry out the work of “recycling and rectifying the use of Chinese herbal medicines” to form a long-term mechanism to ensure the quality and safety of Chinese medicine from the source. And curative effect.

The March 17th will be designated as the Chinese Medicine Festival. At the same time, it will strengthen the promotion and promotion of traditional Chinese medicine culture and enhance the self-confidence of Chinese medicine culture of 1.4 billion Chinese.底 气.

National People's Congress. Zhao Chao, President of Buchang Pharmaceutical:

-Recommended to re-evaluate Chinese medicine injection

The combination of Chinese and Western medicine is clinically necessary. There is no distinction between primary and secondary. It is necessary to scientifically treat large varieties of traditional Chinese medicine with large clinical doses, and avoid the large-scale Chinese medicines due to the clinical curative effect. The dosage is large, and it is accidentally injured by auxiliary medication.

The proportion of Chinese medicine practitioners is imbalanced. It is necessary to strengthen the training of TCM physicians and improve their clinical status.

✔Scientific evaluation of rational treatment of traditional Chinese medicine injections, speed up the re-evaluation of traditional Chinese medicine injections.

✔ Establish an independent evaluation system for traditional Chinese medicine. Currently The innovative clinical drug evaluation system of traditional Chinese medicine does not fully respect the theoretical system and important characteristics of traditional Chinese medicine, but basically refers to the clinical evaluation system and guiding standards of Western medicine.

✔ Establish diagnostic criteria for clinical symptoms of traditional Chinese medicine. Efficacy evaluation techniques and methods. Application and traditional Chinese medicine Studying, establishing an animal model that conforms to the clinical dialectical characteristics of traditional Chinese medicine, establishing techniques and methods for evaluation of medical symptoms in animal models, and constructing a unique evaluation system for traditional Chinese medicine pharmacy that reflects the clinical efficacy and action characteristics of traditional Chinese medicine.

Member of the National Political Association. Fang Laiying, Vice President of the Chinese Hospital Association:

-It is recommended to establish a national drug traceability system within three years

✔Create a cover manufacturer. Circulation links. Drugs in retail pharmacies The whole process traceability system can make the “recall” efficiency increase exponentially.

✔Create a set of drug identification system and traceability system, through the “blessing” of informationization. Future problems Drugs will become more and more difficult to mix into the market.

✔Recommended for the pharmaceutical industry machinery. Repeated labor uniform coding, handed over to machines that can quickly identify electronic codes.

National CPPCC member. Feng Danlong, Director of Pfizer China Corporate Affairs Department:

-Provide the "Pharmacist Law" as soon as possible to formulate a unified pharmacist system and access standards

✔ Develop and promulgate the Chinese people as soon as possible Republic Pharmacist Law Uniform pharmacist system and access standards, clarifying the legal status and responsibilities of pharmacists. Rights. Obligations.

From the national conditions, coordinating the development of academic education and continuing education, with a high-level pharmacist talent team and grassroots The construction of the pharmacist team focuses on the construction of a high morality in medical and health institutions and social pharmacies. Excellent technology. Professional and solid. Reasonable structure. Pharmacist team practicing according to law.

✔Optimize the configuration of pharmacists and realize urban and rural Between the regions. The basic equivalence of pharmacist talent allocation among various medical institutions.

✔Enhance the pharmacy service standards and standards through legislation, continuously improve the service level and quality of pharmacists, and meet the needs of the masses. Level. Diversified pharmaceutical service needs.

National CPPCC National Committee. Director of China CDC Gao Fu:

-Rabies prevention should be based on dog vaccination rabies vaccine

>

✔It is recommended to completely control the source of infection and solve the problem of rabies virus transmission.

✔ It is recommended that rabies vaccine can be given to healthy dogs to produce specific antibodies against rabies virus. with Eliminate rabies virus invading the body to prevent rabies.

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