China speeds up legislation to break the chronic diseases of drugs, vaccines and "medical troubles"

  Xinhua News Agency, Beijing, October 27th Title: Eliminate the pain of medication, the worry of vaccine and the trouble of "medical trouble" — — China speeds up medical and health legislation to "prescribe medicine" for chronic medical problems.

  Xinhua News Agency reporter Tian Xiaohang

  The problem vaccine cases are shocking. Fake drugs and high-priced drugs make patients look forward to "medicine", and frequent "medical troubles" hurt "doctors" and "patients". In order to get rid of these persistent medical problems, the draft law on basic medical care and health promotion, which was submitted to the National People’s Congress Standing Committee (NPCSC) for the second review a few days ago, puts forward that the personal safety and personal dignity of medical and health personnel should not be violated, a whole-course drug traceability system should be established, and a planned vaccination system &hellip should be implemented; … Safeguarding the rights and interests of doctors and patients with the rigid constraints of law.

  Crack down on "medical trouble": the practice place of medical and health institutions is a public place.

  On September 22nd, three obstetricians and gynecologists in Peking University First Hospital, including He Yingdong, were beaten by the patients’ families while on duty, and the problem of "medical trouble" was once again pushed to the forefront of public opinion.

  According to the White Paper on Physicians’ Practice in China released by the Chinese Medical Doctor Association in early 2018, only 34% of physicians have never personally experienced violent medical injuries. In recent years, from "medical trouble being punished" to multi-department joint punishment, the state has frequently cracked down on "medical trouble", but it is still difficult to eliminate the phenomenon of violent injury to doctors.

  The second draft of the draft law on basic medical care and health promotion proposes that the personal safety and personal dignity of medical and health personnel are inviolable and their legitimate rights and interests are protected by law. The practice place of medical and health institutions is a public place providing medical and health services, and no organization or individual may disturb its order.

  "In order to maintain the normal medical order and the professional rights and interests of medical and health personnel, and ensure that patients have a good medical environment and medical rights, it is necessary and urgent to clarify the legal attributes of medical and health institutions." Deng Yong, an associate professor in the Department of Law of Beijing University of Chinese Medicine, believes that defining the practice places of medical and health institutions as public places is conducive to the better connection between the law and the punishment law for public security administration, and the public security organs can enforce the law more effectively to crack down on "medical troubles" according to law.

  To reduce violent injuries to doctors, in addition to protecting the rights and interests of medical and health personnel, it is necessary to reduce the contradiction between doctors and patients in a multi-pronged manner to prevent problems before they occur.

  Protect the rights and interests of patients. The second draft of the draft puts forward that citizens have the right to informed consent on matters related to illness, diagnosis and treatment plan, medical risks, medical expenses and so on when receiving medical and health services. Citizens have the right to voluntarily participate in clinical trials of drugs and medical devices and other experimental medical research according to law and enjoy informed consent.

  Strengthen the management of medical institutions. The second draft of the draft proposes that the state should establish a medical dispute prevention and handling mechanism to properly handle medical disputes and maintain medical order. Medical and health industry organizations and medical and health institutions shall strengthen the education of medical ethics for medical and health personnel. Medical and health personnel shall not take advantage of their positions to ask for, illegally accept property or seek other illegitimate interests.

  "It is necessary to really get rid of profit-seeking factors such as taking medicine to support doctors, over-medical treatment, over-examination and setting income-generating indicators for hospitals, so that public medical care can return to public welfare." Deng Yong said that the fundamental solution to the problem of "medical troubles" depends on continuously deepening the reform of the medical and health system, effectively solving the problems of difficulty and high cost of medical treatment, and improving the salary and treatment of medical and health personnel and patients’ medical experience.

  Let the masses use the rest assured drugs: establish the whole process traceability system of drugs

  Selling more than 30 kinds of fake anticancer drugs to 30 provinces in China, a box of drugs can make a maximum profit of 10 thousand yuan, and the amount involved exceeds 10 million yuan … … A huge case of manufacturing and selling counterfeit drugs in Shenzhen exposed the defects in the field of drug quality and safety supervision in China.

  In order to let the people use the rest assured drugs, the second draft of the Basic Medical Care and Health Promotion Law has a special chapter, which makes detailed provisions on the related issues of "drug supply guarantee".

  It is clear from the second draft that the state will improve the supply capacity of essential drugs, strengthen the quality and safety supervision of essential drugs, and ensure the fair, accessible and rational use of essential drugs. The state improves the drug supply guarantee system, establishes a coordination mechanism for drug guarantee, and coordinates the research and development, production, circulation, use, evaluation and supervision of drugs to ensure the safety, effectiveness and accessibility of drug use by citizens.

  Enterprises produce "medicine for conscience" and pharmacies don’t sell "medicine for black heart", so people can use "medicine for rest assured". The risk of drug quality and safety exists in the whole life cycle of drug research and development, production, circulation, management and use. To this end, the second draft of the draft proposes that the state should strengthen the management of drugs and establish a whole-course traceability system for drugs to ensure the quality and safety of drugs.

  "The whole process of traceability can realize that the source of drugs can be traced, the destination can be traced, and the responsibility can be investigated." Yan Jianzhou, a project researcher at the National Drug Policy and Pharmaceutical Industry Economic Research Center of China Pharmaceutical University, said that in the event of drug quality and safety problems, the whole traceability system can also control the scope of influence, recall related products, find out the reasons in time, and protect the rights and interests of the people.

  The phenomenon of winning the bid at ultra-low price in the bidding of essential drugs also brings hidden dangers to the quality of drugs. Experts generally believe that this kind of behavior seriously affects the normal supply of clinical drugs and has a greater degree of social harm. Therefore, we should increase the punishment and increase the illegal cost.

  To this end, the second draft of the draft clearly States that the state strengthens the supervision and management of centralized drug procurement, and bidders participating in drug procurement bidding shall not bid at a price lower than the cost. The second draft review also strengthened the legal responsibility of bidders who participated in drug procurement bidding at a price below the cost in violation of the law.

  In recent years, there are frequent local and structural shortages of clinically necessary drugs such as protamine and mitomycin. How to eliminate the pain of "waiting for medicine to save lives"

  The second draft of the draft proposes that the state publishes the list of essential drugs, and dynamically adjusts the list of essential drugs according to the clinical application practice of drugs, changes in drug standards, and the new listing of drugs.

  "Dynamic adjustment can make the newly approved drugs with significantly improved efficacy and reasonable price enter the catalogue in time to ensure the accessibility of patients." Yan Jianzhou said that drugs whose clinical effects no longer have comparative advantages or have quality and safety problems can also be transferred out of the catalogue in time through dynamic adjustment, so that the safety of patients’ medication is guaranteed.

  Resolving vaccine anxiety: the state implements a planned vaccination system.

  Changchun Changsheng Biotechnology Co., Ltd. illegally produced rabies vaccine and other vaccine cases, which exposed loopholes and potential risks in the supervision of vaccine production and use, and caused continuous concern of public opinion.

  In order to dispel the public’s doubts and worries, the second draft of the Basic Medical Care and Health Promotion Law proposed that the state implements a planned vaccination system, and citizens have the right and obligation to receive the national immunization program vaccine according to law. Vaccines used for vaccination should be produced in strict accordance with good manufacturing practice, meet the national drug standards, and ensure safety and effectiveness.

  The second draft of the draft also proposed that the state should implement a vaccination certificate system for children. When children enter nursery schools, nursery institutions and schools shall examine vaccination certificates, and if they find that they have not been inoculated according to the national immunization plan, they shall report according to law, and cooperate with relevant units to urge their guardians to replant in time after children enter nursery schools and schools.

  Deng Yong believes that raising some contents of vaccine-related administrative regulations and rules into law can realize the scientificity, completeness and rationality of legislation; Defining the responsibilities of all parties in the process of vaccine use in law will also help to avoid the occurrence of vaccine fraud and adverse reactions.

  The reporter learned that the revised draft of the Drug Administration Law, which was submitted to the National People’s Congress Standing Committee (NPCSC) for deliberation for the first time a few days ago, also listed separate provisions to strengthen the supervision of vaccines and other special drugs. For example, in the process of vaccine development, production, circulation and vaccination, information technology should be used to collect and retain traceability information. The holder of the marketing license of the vaccine shall be insured in accordance with the relevant provisions of the state.

  Vaccines are involved in many places in the revised draft of the Drug Administration Law. For example, vaccines, blood products, narcotic drugs, psychotropic drugs, and toxic drugs for medical use may not be commissioned for production, except in cases where the drug supervision and administration department of the State Council stipulates that the production can be commissioned. The pharmaceutical supervisory and administrative department shall focus on supervision and inspection of biological products such as vaccines. In addition, the revised draft comprehensively increases penalties, and clarifies that six types of illegal acts, such as the production and sale of vaccines belonging to counterfeit drugs and inferior drugs, will be severely punished within the statutory scope.