The reform of the pharmaceutical industry is focused on stimulating innovation

Xinnuo Medicine 2018-09-27

While accelerating the review and approval, it is necessary to unblock the channels for innovative medicines to be included in medical reimbursement. At the same time, relevant departments should encourage enterprises to increase R&D investment and improve the standards and quality of drugs.

The State Council recently issued the "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval" and clarified 12 reform tasks. As the first major adjustment in the review and approval system for the pharmaceutical industry in China in the past five years, this reform has also focused on improving the standards for drug evaluation and achieving drug safety, effectiveness and quality while addressing the large backlog of new drug applications that have been criticized. Controlling and promoting the structural adjustment and transformation and upgrading of China's pharmaceutical industry is by no means a simple "headache."

Some insiders pointed out that "slow" has become the biggest feature of China's current drug and medical device review and approval system. The long approval cycle has caused a serious imbalance between the number of drug registration applications and the number of approved approvals. Many new drugs have been blocked on the road of approval and cannot form economic and social benefits.

For pharmaceutical companies, whether innovation depends on the judgment of the benefits of innovation. Most companies prefer to grab the market in the highly competitive generics sector and are reluctant to invest in research and development to create new drugs. This reform starts from many aspects and focuses on building a review and approval system that is conducive to innovation. It will create an innovative environment for the pharmaceutical industry and stimulate the innovation vitality of pharmaceutical companies. In addition, through the pilot of the drug listing license holder system, exploring the separation management model of drug marketing license and production license will help developers to concentrate funds and technology on new drug research and development, and reduce the “repetition” caused by multiple transfers or segment transfers. R & D "problems, and then stimulate the innovation enthusiasm of drug research and development institutions and researchers from the source, and improve the quality of innovation.

The reform also adheres to the principle of decentralization and decentralization, strictly regulates and restricts the examination and approval authority for drugs and equipment, clarifies the contents and standards of examination and approval, and publicizes the information on the approval process, forming a public supervision of the examination and approval.

At the same time of industry reform, it should also be noted that although the current review and approval system has many drawbacks, it also has a positive side in ensuring drug safety. The examination and approval of drugs and devices has its inherent laws. The pursuit of approval speed and the inability to guarantee its quality are no different from the growth of seedlings. Therefore, how to speed up the examination and approval, improve the effectiveness and safety controllability of listed drugs, and solve the demand for drug use by the public on the premise of ensuring the quality and safety of drugs is the ultimate goal of this reform.

In the process of reform, the application channel of domestic medicines should also be unblocked. Accelerating the review and approval is conducive to the expansion of the production capacity of domestically produced drugs, especially innovative drugs. However, many innovative drugs entering the terminal market are currently constrained by some factors, especially in the mainstream medical market such as entering the medical insurance catalogue, which is subject to the listing period, the medical insurance catalogue adjustment time limit, and various localities. Various factors such as the medical insurance catalogue review system are limited. Therefore, while accelerating the examination and approval, it is necessary to unblock the channels for innovative medicines to be included in medical reimbursement.

At the same time, relevant departments should encourage enterprises to increase R&D investment and improve the standards and quality of medicines: on the one hand, they should increase financial support for high-tech enterprises; on the other hand, they should reduce the tax burden of biomedical enterprises, and The cost of clinical trial fees, the purchase of intangible assets, and the use of expenses are included in the scope of the deduction of research and development expenses. (Li Jialin)