"4+7" effect: drug price dropped by 52%, 22 varieties replaced original research

Source: China Net

Medical Network April 26th On April 25th, the National Health and Health Commission held a press conference to introduce the overall progress, effectiveness and typical experience of deepening the reform of the pharmaceutical sector in the name of the Secretariat of the State Council's Medical Reform Leading Group.

“4+7” changes the industry pattern
National organizations have conducted pilot projects for centralized drug procurement and use in 11 cities including Beijing and Shanghai. The State Food and Drug Administration, the State Health Care Commission and the National Medical Insurance Bureau respectively issued supporting measures, and put forward specific requirements from the aspects of ensuring the quality of the winning drugs, the use of the winning drugs, and the implementation of medical insurance. The 11 pilot cities have successively released implementation plans since March, and all pilot projects were launched before April 1.
Xue Haining, deputy director of the Department of System Reform of the National Health and Health Commission, said that overall, the pilot work was implemented steadily, and the expected reform effect was initially revealed: First, the price of medicines was effectively reduced. Taking advantage of the price-changing price, the average price of the winning drugs in the pilot areas dropped by 52%. The price of non-pilot areas was linked. Some unselected varieties of enterprises actively cut prices and strived for markets other than the pilot. The overall price of medicines showed a significant downward trend. Second, the process of replacing generic drugs with generic drugs is accelerating. Twenty-two of the 25 selected varieties were generic drugs, and the market share of generic drugs increased rapidly, while the consistency evaluation continued to advance. Third, the pattern of the pharmaceutical industry has changed. With quantity procurement, the low-level homogenization competition is further eliminated, and the enterprise is transformed and upgraded, and the market order is increasingly standardized.
Then, whether it is the development of new drugs or the production of generic drugs, is it necessary for enterprises to join the “4+7” queue in order to keep up with the pace of new medical reform?
Taking Jiangsu as an example, Wang Yue, director of the Jiangsu Provincial Drug Administration, said that the scale of Jiangsu's pharmaceutical industry in 2018 was 408 billion yuan, on the one hand, the contribution of new drugs. In 2018, there were 10 varieties of domestically produced innovative drugs approved by the State Food and Drug Administration, of which 6 were settled in Jiangsu. On the other hand, the consistency evaluation of generic drugs was rapidly advanced. In Jiangsu Province, 131 products have been completed and officially accepted, and 40 products of 17 companies have passed the consistency evaluation. Therefore, the goal is to realistically “push new” to ensure clinically urgent needs, while encouraging generic products to replace the original research through consistency evaluation, and further reduce drug prices.
According to Wang Yue, in order to ensure the smooth progress of the “4+7” pilot, the State Food and Drug Administration has recently held a meeting specifically for the “4+7” variety supervision, and unified deployment has been carried out nationwide. In the next step, Jiangsu Provincial Food and Drug Administration will carry out the implementation in three aspects:
The first is to implement the main responsibility of the winning bidder. In this centralized procurement, 5 enterprises and 6 varieties in Jiangsu Province won the bid. On April 9th, Jiangsu Province held the province's centralized procurement of varieties and passed the consistency evaluation of the production enterprise management meeting, regulatory analysis and judgment meeting, organized the company to sign a letter of commitment, this commitment includes commitment to quality and safety and supply; It is strictly implementing regulatory responsibility. Being able to purchase the winning bid in the “4+7” concentration means that the company's initiative and quality and safety management are better, and it is upstream in the whole industry. Regulators need to improve efficiency rather than increase duplication and invalid regulation. For example, the clinical use of ADR status, problems found in past inspections, as well as complaints and reports, supervision and sampling. Then comprehensively judge all factors, scientifically assess the degree of enterprise risk, formulate inspection plans on a quarterly basis, and incorporate them into the annual supervision plan; third, cooperate with health and other departments to ensure supply security, strengthen communication and coordination, and timely interoperate with relevant supervision. information.
"Two-vote system" regulates circulation order
In addition, it is aimed at regulating the order of drug circulation. Xue Haining said that in 2017, the “two-vote system” will be implemented in the procurement of pharmaceuticals in public medical institutions, which will be fully promoted in 2018. Due to the compression of the drug circulation link, the circulation order was gradually standardized, and the industry concentration was improved. Promote "Internet + drug circulation", promote online and offline collaborative development, and encourage the provision of "net-order store take" and "net-order store delivery" services. Some large-scale drug circulation companies rely on third parties to provide high-quality and efficient services such as drug storage and distribution. It is more convenient to buy medicines with medicine.
At present, the State Food and Drug Administration has issued guidance on the construction of drug information and traceability system, emphasizing the implementation of the main responsibility of enterprises, realizing the drug “one thing, one yard, the same code”, and guiding the industry to trace the whole process. The Ministry of Commerce organized the construction of a traceability system for the circulation of Chinese herbal medicines, and initially established a traceability system covering the production, operation, and professional markets of Chinese herbal medicines, as well as the production, management and use of Chinese herbal medicines, to provide a retrospective basis for the safety of public medication.