289 catalog failed to do? Delay or elimination? Disposal plan is coming

At present, it is less than 5 months before 289 generic drugs quality and efficacy consistency evaluation is completed According to the latest data provided by the State Drug Administration, 15 batches of 1074 drug specifications of reference preparations have been published, and a total of 4 batches of 41 generic drugs have passed the consistency evaluation, which means that most generic drugs have not passed the quality and efficacy consistency evaluation Then, will the varieties that fail to complete the evaluation work according to the regulations be postponed or eliminated? Recently, the reporter learned from the seminar on "consistency evaluation in action and promotion of high-quality generic drugs" that from August to September, the relevant management departments will announce the disposal plan for the failed varieties Actively adjust the relevant review resources, coordinate the inspection and inspection resources, study and improve the relevant evaluation requirements and guidelines, classify and promote the evaluation of 289 varieties, and timely announce the varieties passing the evaluation Relevant person in charge disclosed that at present, relevant departments have started to link the catalogue of essential drugs and the catalogue of Medicare drugs, encouraged clinical drug use to replace imported original research drugs with domestic generic drugs that passed the consistency evaluation, and promoted the reduction of drug cost burden of the whole society At the same time, strengthen post listing inspection, urge production enterprises to continue to comply, and strictly prevent consistency evaluation from becoming "one-off evaluation" CDE released 9 non generic drugs in 2012-2016, with 631 patents of original research drugs expired in the world Due to information asymmetry, technical difficulties and the small scale of some rare disease drugs market, many patent expired drugs, and no enterprises applied for generic registration In January this year, the drug Examination Center released the list of the first batch of drugs with expired, terminated, invalid patent rights and no copy application, totaling 9 varieties 　　 According to the relevant persons of the Department of system reform of the national health and Health Commission, from the perspective of international experience, it needs a number of policies and measures to encourage the research and development of generic drugs: first, allow the enterprises of generic drugs to develop in advance before the expiration of the patent period; second, give the first generic drugs a certain period of market monopoly, and allow them to obtain excess profits; third, provide research and development information services to facilitate the enterprises The fourth is to implement strict standards for drug patent recognition to provide space and opportunities for research and development of generic pharmaceutical enterprises In addition, we need to strengthen the inspection of anti-monopoly behavior In view of the current situation that the original pharmaceutical research enterprises use their dominant position to manipulate the market, the United States, the European Union, South Korea and other countries pay attention to strengthen the inspection of unfair transactions and monopolistic behaviors, and create a fair market environment At the same time, we should support the development of generic pharmaceutical enterprises, including increasing government investment, supporting the establishment and operation of enterprises, and relaxing drug price control At present, China is also further improving its support policy, the person said For centralized drug procurement, the procurement catalogue shall be prepared according to the generic name of the drug, and generic drugs with the same efficacy shall compete with the original drugs equally For the newly approved generic drugs, the relevant departments shall timely prepare the drug purchase code of public medical and health institutions If the corresponding generic drugs have been listed in the drug purchase catalogue, the centralized drug purchase institution shall timely start the purchase procedure; if the corresponding generic drugs have not been listed in the drug purchase catalogue, the centralized drug purchase institution shall timely demonstrate from the date of approval for listing, It is actively included in the drug purchase catalogue The drugs with compulsory patent license by the State shall be included in the drug purchase catalogue of all regions unconditionally It has been revealed that at present, the health and Health Commission and the drug administration are cooperating to promote the alternative use of generic drugs, including generic drugs with the same quality and efficacy as the original research drugs into the directory of alternative drugs with the original research drugs, marking them in the instructions and labels, and timely releasing relevant information to the society, so as to facilitate the choice of medical staff and patients Strictly implement the requirements of prescribing according to the generic name of drugs Except for special circumstances, there shall be no trade name on the prescription At the same time, health and other departments should strengthen drug management, formulate policies and incentives to encourage the use of generic drugs, and strengthen the supervision of clinical drugs Strengthen the role of pharmacists in prescription audit and drug dispensing When providing AIDS and tuberculosis patients with drugs according to regulations, priority should be given to purchasing and using generic drugs At the conference of three medical linkage to promote generic drug research and development, the reporter learned that at present, medical insurance institutions are also speeding up the development of payment standards for medical insurance drugs, and generic drugs with the same quality and efficacy are paid according to the same standards as the original research drugs It is also in the process of establishing and improving the dynamic adjustment mechanism of the drug catalogue of basic medical insurance, and timely bringing eligible drugs into the catalogue The drugs in the catalogue of basic medical insurance drugs shall not be limited by the trade name or manufacturer The medical insurance information system shall be updated in time to ensure that the generic drugs approved for listing are equally included in the scope of medical insurance payment Through the incentive and restraint mechanism of medical insurance payment, medical institutions are encouraged to use generic drugs Some experts also revealed that China will soon implement compulsory licensing of drug patents according to law and encourage patent holders to implement voluntary licensing A unit or individual that meets the conditions for implementing the compulsory license may, according to law, submit a request for compulsory license to the State Intellectual Property Office Compulsory licensing shall be implemented in case of serious and serious infectious diseases and other public health emergencies or the shortage of drugs for prevention and control of serious and serious diseases, which pose a serious threat to public health and safety or public health Recently, the national health and Health Commission, together with the Ministry of industry and information technology, the State Drug Administration and other departments conducted evaluation and demonstration, and has proposed the implementation of compulsory license to the State Intellectual Property Office The State Intellectual Property Office has made the decision to grant or reject the implementation of compulsory license according to law Generic drugs play an irreplaceable role in any country At present, the United States is the country with the highest substitution rate of generic drugs In 1984, generic drugs accounted for 18% of the total prescription volume in the United States By 2016, it increased to 89% The average time to market of generic drugs was 3 years earlier, and the patent monopoly period of patent drugs was shortened by 3 years on average Denmark, Finland, France, Norway and Spain in Europe have also implemented similar alternative initiatives In 2002, Sweden announced the implementation of the lowest price generic substitution policy Relevant people from the Department of institutional reform of the National Health Commission also said that the development of generic drugs has four meanings: first, improving accessibility It has made up the blank and laid the foundation for solving the problem of whether high-quality drugs are available, good or not, and unused Second, promote the linkage of "three medical services" Through the improvement of drug supply security system, combined with the reform of medical insurance payment mode, promote the linkage of "three medical services" Third, more benefits to the people Through promoting the improvement of drug supply capacity, fair competition and encouraging the use of drugs, drug prices will be reduced Fourth, optimize the industrial structure Push forward the leapfrog development from a big pharmaceutical country to a powerful pharmaceutical country.