Ding Lieming, Chairman Of The National People'S Congress And Chairman Of Beida Pharmaceutical Co., Ltd.: To Open Up The Last Mile Of Clinical Application Of Innovative Drugs.

Health care has always been the focus of attention in the NPC and CPPCC sessions, which was particularly prominent in 2020.

On May 24th, Xi Jinping, general secretary of the CPC Central Committee, chairman of the CPC Central Committee and chairman of the Central Military Commission, participated in the thirteen session of the three session of the National People's Congress of Hubei. General secretary Xi Jinping pointed out that the public health system and medical service system played an important role in the epidemic, but there were some shortcomings and shortcomings. We should face up to the existing problems, intensify reform, and step up the short board, plug loopholes, and strengthen the weak.

How can health care reform be more efficient when the epidemic becomes normal? To this end, in twenty-first Century, the economic report reporter interviewed Ding Lieming, chairman of the National People's Congress and chairman of the pharmaceutical company of Beida.

Promoting the construction of public health emergency system

Twenty-first Century: against the epidemic prevention and control, general secretary Xi Jinping mentioned eight "mechanisms" when he participated in the deliberations of the Hubei delegation. What do you think?

Ding Lieming: the eight "mechanism" is a timely summary and deployment of epidemic prevention and control, which is critical to the present and future.

As a representative of the National People's Congress from the field of pharmaceutical enterprises, I am more concerned about the new situation and new problems of cancer patients during the epidemic period, such as medical treatment, drug purchase, diagnosis and treatment.

I suggest that the leadership of the State Council take the lead in setting up the National Cancer Prevention and control committee, and strengthen overall coordination and comprehensive guidance. Especially in the event of major public health events, the cancer treatment drugs can be integrated into the whole emergency rescue system, so as to ensure timely treatment for cancer patients.

At present, most of China's stockpile drugs are antibiotics, anti-virus and other emergency drugs and medical equipment. It is suggested that a sound national public health emergency management system should be combined with the promotion of national cancer prevention and control actions to screen a number of therapeutic drugs, such as targeted anticancer drugs, which are effective and urgently needed.

In my research, I learned that in order to avoid cross infection, many non epidemic patients are facing difficulties in seeing a doctor. Therefore, it is suggested that Internet hospitals should be implemented and the implementation of "long prescription" (prescription can be extended to no more than 12 weeks), and the policy of first purchasing drugs and reimbursement for patients who are not convenient to go to hospital prescriptions should be reimbursed by pharmacist purchase invoices within the prescribed time.

Twenty-first Century: the epidemic also has an impact on the clinical research of new drugs. What do you think?

Ding Lieming: the epidemic has a more far-reaching impact on the development of new drugs that are being pushed forward. In particular, the new drug clinical trials can not be carried out in an orderly way according to the plan, and the enterprises bear greater risks and affect the process of national independent innovation.

I suggest that in view of the new problems in clinical research during the epidemic period, special data processing rules can be issued, and a green channel should be established for clinical research projects of major diseases, so as to guide clinical trials in an orderly way.

Twenty-first Century: what advice do you have for optimizing the drug review and approval system?

Ding Lieming: the industry highly appraised the reform of the drug review and approval system in recent years. At the same time, there is room for improvement.

In the survey, some enterprises reflected to me. In 2019, from the application for IND meeting to get the reply for the longest 70 working days, it was 2.5 times that of the 2018 meeting communication system.

From the perspective of the development of the pharmaceutical industry, I suggest that applicants who are eligible can directly submit clinical trial applications without communication. They must conduct IND communication meetings. They also follow the practice of 2018. They are allowed to apply for pre clinical research meetings and submit full formal non clinical reports when IND is requested.

Second, it is recommended to implement the "drug registration management measures" and change "tandem" as a "parallel connection". The serial reviews between the various audits will be changed to parallel reviews, that is, after the new drug registration is accepted, CDE will communicate with the inspection center and the central inspection office as soon as possible, and the relevant audit, inspection and inspection tasks shall be communicated. Through the early communication between the various evaluation bodies, the time limit for the completion of the tasks will be clearly defined, and a number of work will be carried out in parallel with each other in order to ensure mutual cooperation. All tasks are completed within the time limit stipulated by the regulations.

In addition, during the IND data technology review, enterprises have limited access to information and can only contact the project managers of the business management department. It is suggested that we should further improve the project manager system and the communication system of technical review information, expand communication channels and enhance communication efficiency, especially the direct communication channels between enterprises and professional assessment teachers.

Open up the last mile of innovative drug clinical application

Twenty-first Century: the state attaches great importance to the problem of drug use by the ordinary people, and how to further reduce the burden of drugs on the common people.

Ding Lieming: in April this year, the Provisional Regulations on Administration of drug use for basic medical insurance made public comments to the public, reflecting the state's attention to the administration of medication in basic medical insurance.

As the NPC deputy, I learned from the survey that we believe that the support for independent innovation drugs should be further strengthened.

First, in the management of Drug Administration for basic medical insurance, it is recommended to appropriately adjust the requirements of enterprise declaration and the time limit for submitting materials, and allow materials to collect all the drugs that have been obtained before the deadline for new drugs to be included in the scope of dynamic adjustment, so as to speed up the access of new drug insurance for new listing and allow patients to use the new drugs with the right price earlier.

Two, it is suggested that medical institutions at all levels should not negotiate two times to ensure the authority of national negotiations. This is because the renewal negotiation is again calculated on the basis of the first big price negotiation. In order to continue to enjoy the medical insurance treatment, the entry form of the payment standard should be agreed on the premise that the price should be changed. The price of the medicine should be protected. If the price negotiation is allowed, the price of drugs will be too high, which will not conform to the principle of fair application of medical insurance and the trend of drug reform.

Third, it is recommended that the independent innovation drugs in the national medical insurance directory in the patent period, especially those on the basis of negotiations, be included in the national health insurance directory and the national essential medicines list, and be purchased and used first. We need to formulate better supporting measures, explicitly require medical institutions to give priority to procurement and use, and then open up the "last mile" of clinical application of innovative drugs.

Fourth, it is suggested that drugs should be approved under the same general name, such as bidding, so as to ensure the entry of domestic innovative drugs into medical insurance catalogues, so as to encourage the development of local innovative medicines in China.

Finally, I suggest that we increase the number of cancer gene detection products in the medical insurance directory, allowing enterprises to apply for entry into the medical insurance directory, effectively reduce the medical burden of patients, and improve the efficiency of medical insurance funds. (Editor: Lin Hong)

(author: Southern finance and Economics National two sessions report group Wang Haiping)

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