Review 2020: Top 10 Noteworthy Changes in Pharmaceutical Policy

1. Changes in Key Pharmaceutical Policies The Basic Health Care and Health Promotion Act was promulgated on December 28, 2019; The Measures for the Administration of the Filing of Medical Representatives (Trial) were issued on September 30, 2020, the revised Version of the Appendix on Blood Products on December 1, 2020 was issued on June 30, 2020, and the 10th of 2020 The 2020 edition of the Pharmacopoeia of the People's Republic of China was issued on July 2, 2020; The Measures for the Administration of the Approval of Biological Products were issued on December 11, 2020, and the Measures for the Implementation of the Early Settlement Mechanism for Drug Patent Disputes (Trial) on March 1, 2021 were issued on September 11, 2020. Chemical injection consistency evaluation On May 14 this year, the State Drug Administration issued an official document "on the implementation of chemical injection generic drug quality and efficacy consistent evaluation of the work of the official document", requiring that listed chemical injection generic drugs are required to carry out consistent evaluation in accordance with the principle of consistency with the quality and efficacy of the original drug.
many of china's major domestic products are chemical injections, involving more than 350 billion markets, so it has been a lot of attention.
evaluation of the consistency of the injection of this chemical drug will bring great variables.
from the current consistent evaluation work and the situation of provincial networks, in the next few years injections may usher in a batch of phase-out.
recommended reading: chemical injection enterprises and varieties TOP50 latest! Injection Consistency Evaluation Ranking 3, Real World Data Guidelines (draft for comments), And Guidelines for Real World Evidence-Backed Drug Research and Review (Trial) were published, which compared 2020 to "the first year of real-world research in China" because the National Drug Administration awarded "Real World" no. 1 of 2020.
January 2020, the Drug Review Center (CDE) of the State Drug Administration issued the Guiding Principles for Real-World Evidence-Backed Drug Development and Review (Trial) (hereinafter referred to as the Guiding Principles), following the release in May 2019 of the "Basic Considerations for Real-World Evidence-Supported Drug Research and Development" (draft for comments) After the Draft for Comments, the real world evidence (RWE) to support drug research and development and market rules to further clarify and refine, and clear real-world research in drug regulatory decision-making status and scope of application, the promulgation of this principle by the industry as a "milestone event", real-world research in the industry caused by the discussion and attention is getting hotter.
under the circumstances of both opportunities and challenges, and with the promotion model of innovative drugs gradually shifting from commercial promotion to academic promotion, real-world research is likely to become the next battleground for innovative drugs PK.
recommended reading: Innovative drug PK's next battlefield official release! The Guiding Principles for Real-World Data (Draft for Comments) The Guiding Principles for Real-World Evidence Support drug Development and Review (Trial)are here! 4,500 varieties with the volume of procurement list spread, local collection everywhere flowering in July this year, the industry process out of the National Drug Collection Conference related content, which involves one point: according to the purchase amount of order, covering the first 80% of the drug about 500 (locally determined according to the specific circumstances of the number), by 2021 to cover 250, 2022 to be fully covered.
not carried out by the State, it is organized by the provinces.
this year, local harvests in various provinces and cities began to blossom everywhere.
This year, the provincial level joined forces to form four major alliances to purchase different varieties, including Sichuan, Shanxi, Inner Mongolia, Liaoning, Heilongjiang, Jilin, Hainan, Tibet;
only four coalitions already cover 21 provinces and municipalities in the country.
Other provinces have adopted the strategy of carrying out volume procurement alone, Shandong, Jiangxi, Zhejiang, Jiangsu, Fujian, Henan, Shanxi, Guangxi, Hubei, Hunan, Qinghai, Anhui and other provinces have launched volume procurement this year, and in the rules to give varying degrees of innovation.
recommended reading: provincial collection, where will go? Chemical drugs, biologics, auxiliary drugs full coverage, 500 varieties or will be with the volume of procurement (with list download) 5, the national crown stent belt procurement October 16, the national high-value medical supplies joint procurement The Office issued the "National Organization Coronary Bracket Centralized Band Purchase Document", for cobalt chromium alloy or platinum chromium alloy material, the type of drug-carrying repatin and its derivatives of the coronary stent for the volume procurement, and on November 5 in Tianjin opened the bid.
the final 10 products to be selected, involving 9 enterprises, procurement cycle of 2 years.
compared with 2019, the average price reduction of the same products of the same enterprises was 93%, the average price reduction of domestic products was 92%, and the average price reduction of imported products was 95%, which is expected to save 10.9 billion yuan according to the amount of intentional purchases.
other categories of high-value consumables collection will also be carried out in the near future.
second batch of high-value medical supplies national collection is also in the pipeline.
days ago, the relevant departments issued "on the implementation of high-value medical supplies, the second batch of centralized procurement data rapid collection and price monitoring notice", the second batch of medical supplies collection of data collection categories will be increased, involving 6 categories: artificial hip joint, artificial knee joint, defibrillator, blocker, orthopaedic materials, matching six high-value consumables.
, the first batch of data collection of vascular intervention, non-vascular intervention, pacemaker, ophthalmology products to supplement.
recommended reading: "National organization crown stent centralized belt procurement document" released the results of the crown stent collection, the maximum price reduction of more than 96% June, 2020 health care negotiations ended in December low, national health insurance The bureau announced the results of the 2020 health care catalog transfer, the adjustment, a total of 162 drugs negotiated, 119 successful negotiations, including 96 exclusive drugs, the success rate of negotiations as high as 73.46 percent.
it is worth mentioning that this adjustment for the first time set up a catalog of drug price reduction negotiations.
14 exclusive medicines with higher prices or higher costs and a higher fund footprint.
the annual sales of these drugs alone amounted to more than 1 billion yuan.
, the drugs were not only successfully left on the list, but the average price fell by 43.46 per cent.
recommended reading: health care negotiations results announced: domestic PD1 all successful 2020 health insurance negotiations exclusive variety information summary (with part of the decline in varieties) into the fastest innovative drug health insurance TOP2010 single anti-first medical insurance negotiations successful, 13 renewal battle! On March 5, the State Council of the CPC Central Committee issued the Opinions on Deepening the Reform of the Medical Security System, which contains 6 GLP-1 subject agitants in the medical insurance catalogue 7 and the Opinions on deepening the reform of the medical security system.
"1" is to strive to 2030, the comprehensive completion of basic medical insurance as the main body, medical assistance as the base to supplement medical insurance, commercial health insurance, charitable donations, medical assistance and common development of the multi-level medical security system.
"4" is a sound treatment protection, fund-raising operation, medical insurance payment, fund supervision four mechanisms.
"2" is to improve the supply of medical services and medical security services two support.
also responded to some people's livelihood concerns, including improving the cost guarantee mechanism for medical treatment in major outbreaks, improving the direct settlement system for off-site medical treatment, vigorously promoting the application of big data, accelerating the development of commercial health insurance, and the promotion of DRG.
recommended reading: "1 plus 4 plus 2" reform framework, a detailed number of deepening the health care system reform opinions related to the industry hot spots 8, CDE Yangtze River Delta, Dawan Division listed December 22, 23 On the same day, the State Drug Administration held a listing ceremony for the Yangtze River Delta Sub-center for Drug Review and Inspection, the Yangtze River Delta Sub-center for Technical Review and Inspection of Medical Devices, the Great Bay Division Center for Drug Review and Inspection, and the Great Bay Division Center for Technical Review and Inspection of Medical Devices in Shanghai and Shenzhen, Guangdong Province.
four review and inspection sub-centers are mainly responsible for assisting the Drug Review Center of the State Drug Administration and the Medical Device Technical Review Center in carrying out the communication guidance and related inspections in advance of the review of drugs and medical devices.
designated medical institutions opened in 9 cities in the Mainland of Guangdong, Hong Kong, Macao and the Bay Area shall use drugs that are clinically urgently needed and have been listed in Hong Kong and Macao, and shall be approved by the State Drug Administration and approved by the Guangdong Provincial People's Government authorized by the State Council.
According to the cooperation agreement, the State Drug Administration will work with the local government to strengthen the top-level design, establish a scientific and efficient professional regional review and inspection system, provide quality services for drug medical device enterprises research and development innovation, and build four sub-centers into a practical platform to promote the high-quality integrated development of the Yangtze River Delta region, Guangdong, Hong Kong and Macao Bay Area, deepen the reform of the drug medical device review and approval system cooperation platform, service pharmaceutical industry innovation and development incubation platform.
9, the third batch of clinical urgent need for foreign new drugs announced october 29, CDE announced the third batch of clinical urgent need for new drugs abroad, a total of 7 new drugs in this batch;
nearly 10 new drugs approved in China by 2020.
recommended reading: Clinically in urgent need of overseas new drug list update! 7 new drugs shortlisted 10, the establishment of pharmaceutical prices and recruitment credit evaluation system On December 25, the official website of the State Health Insurance Administration issued "on the accelerated implementation of pharmaceutical prices and recruitment credit evaluation system notice", the notice clearly, the provincial medical security bureaus, It is imperative that centralized purchasing agencies establish a system for evaluating pharmaceutical prices and credit for recruitment by the end of 2020, formulate and issue relevant policy documents, and publish the List of Medical Prices and Recruitment And Loss of Trust (2020 edition) on the official website of the Medical Security Administration and on the centralized procurement platform.
The provincial centralized procurement agencies as soon as possible to organize the province's bidding network enterprises as required to submit "pharmaceutical enterprise prices and marketing behavior credit commitment", to improve service awareness, online and offline parallel, convenient for pharmaceutical enterprises to submit trustworthy commitments, report relevant information.
December 28-30, Hainan, Shaanxi, Shanghai, Shaanxi, Chongqing, Qinghai, Liaoning, Hubei, Fujian, Anhui, Beijing, Shanghai, Yunnan, Guangxi, Jiangxi, Guizhou, Guangdong, Henan, Inner Mongolia and other places issued a comprehensive implementation of the State Health Insurance Administration on the implementation of the medical price and credit evaluation system.
The long-standing problems such as rebates and monopoly price increases in the field of medicine are important reasons for inflated prices, and lead to excessive growth in medical expenses, large loss of medical insurance funds, overburdening the masses, inducing excessive medical treatment, harming the health rights and interests of the masses, distorting the business environment and industry ecology, and weakening the innovation drive of the industry.
Taking the issue of drug rebates as an example, according to publicly available court decision documents, more than half of the country's 100 compulsory drug companies were found to have given or indirectly given kickbacks between 2016 and 2019, with the most frequently involving more than 20 cases in three years and more than 20 million yuan in a single case.
average sales expense rate of listed companies in China is more than 30%.
The purpose of establishing the credit evaluation system is to give full play to the guiding and normative role of the centralized procurement market for pharmaceutical products, to take appropriate measures to give rebates, monopoly price increases and other outstanding problems of disreenced pharmaceutical enterprises, to promote pharmaceutical enterprises in accordance with the principle of "fairness, reasonable and honest credit, quality and price in line" to set prices, to promote the reasonable return of pharmaceutical products prices, to safeguard the vital interests of the people.