A new round of medical fee reduction window period will create innovation and encourage imitation of both hands.
A new round of medical fee reduction window period is about to open. Recently, the relevant ministries and commissions have played a series of combination punches in speeding up the approval of new drugs that have been listed overseas, strengthening the supply of shortage drugs, and implementing the price reduction of anti-cancer drugs, so as to make Chinese residents use good drugs as soon as possible and afford good drugs. A reporter from the Economic Information Daily learned that there will be a package of supporting policies to speed up the landing in the future, including speeding up the listing process of new drugs abroad, encouraging drug innovation and imitation, and improving the medical insurance access mechanism, and so on. A larger space for medical fee reduction is worth looking forward. Multi-sectoral intensive deployment of domestic new drug market lag and high prices are expected to accelerate the break.
A new round of medical fee reduction window period is about to open. Recently, the relevant ministries and commissions have played a series of combination punches in speeding up the approval of new drugs that have been listed overseas, strengthening the supply of shortage drugs, and implementing the price reduction of anti-cancer drugs, so as to make Chinese residents use good drugs as soon as possible and afford good drugs. A reporter from the Economic Information Daily learned that there will be a package of supporting policies to speed up the landing in the future, including speeding up the listing process of new drugs abroad, encouraging drug innovation and imitation, and improving the medical insurance access mechanism, and so on. A larger space for medical fee reduction is worth looking forward.
multi-sector intensive deployment
domestic new drug market lag and high price of the stubborn disease is expected to accelerate the crack. The executive meeting of the State Council held on June 20 determined to speed up the approval of new drugs that have been listed overseas, implement price reduction measures for anti-cancer drugs, and strengthen the supply guarantee of shortage drugs. First, orderly speed up the approval of new drugs listed abroad in the domestic market. The simplified listing requirements for drugs for the treatment of rare diseases and some drugs for the prevention and treatment of serious life-threatening diseases can be submitted to all research materials obtained overseas for direct listing, and the regulatory authorities shall conclude the trial within 3 months and 6 months respectively. Two is to urge the promotion of anti-cancer drugs to speed up the price reduction. All provinces (autonomous regions and municipalities) should carry out special bidding and procurement of anticancer drugs in the medical insurance catalogue. Exclusive anti-cancer drugs outside the health insurance catalogue should be negotiated on health insurance access. To carry out the national drug centralized procurement pilot, to achieve a significant reduction in drug prices. Third, strengthen the national shortage of drug supply security monitoring and early warning, the establishment of shortage of drugs and raw materials to stop production filing system, increase reserves, to ensure that patients continue to supply drugs. Data
shows that at present, there are more than 3800 overseas listed drugs approved in my country, including more than 3400 chemical drugs, more than 300 biological products, and more than 70 traditional Chinese medicines, which basically cover anti-cancer, anti-virus, and anti-hypertension. And other major treatment areas. In the past 10 years, 415 new drugs have been listed in the United States, the European Union and Japan. Of these new drugs, 277 have been listed or declared in China, accounting for 66.7 percent. In terms of the number of approvals, an average of 336 clinical trials of imported drugs have been approved each year in the past five years, an increase of 7% per year; an average of 56 imported drugs have been approved for marketing each year, an increase of 16% per year; and in terms of the total time limit for clinical approval and marketing approval, the legal time limit for new drug approval in China is close to that of developed countries." At the State Council's regular policy briefing held by the State Council Information Office on June 22, Jiao Hong, director of the State Drug Administration, said.
Jiao Hong also said that for drugs that have been listed overseas for the prevention and treatment of serious life-threatening diseases with no effective treatment and rare diseases, and if there is no ethnic difference confirmed by research, the applicant does not need to apply for clinical trials, but can directly apply for listing with overseas test data and enter the Chinese market 2 years in advance.
The promotion of anti-cancer drug price cuts has also been mentioned many times this year. At the press conference of Premier Li Keqiang of the National People's Congress and the National People's Congress, it was clearly stated that "the import tax rate of anti-cancer drugs should be reduced to zero tax rate". On April 12, the executive meeting of the State Council decided to reduce the import tariff of all common drugs, including anti-cancer drugs, alkaloid drugs with anti-cancer effect and actual imported Chinese patent medicines to zero from May 1, and encourage the import of innovative drugs. At the press conference of the State Council Information Office on April 28, Zeng Yixin, deputy director of the National Health Commission, said that negotiations on medical insurance access for anticancer drugs that are not included in medical insurance are scheduled to start after May 1.
In terms of strengthening the supply guarantee of shortage drugs, the General Office of the Ministry of Industry and Information Technology recently issued the "2018 Key Work Arrangements for the" Three Products "Special Action in the Consumer Goods Industry", stating that it will guide local governments to cultivate centralized production bases for small varieties of drugs (shortage drugs), add 10 small varieties of drugs, and stabilize production and supply. Support pharmaceutical companies to carry out quality and efficacy consistency evaluation of generic drugs, and comprehensively improve the quality of generic drugs.
At the local level, related supporting initiatives are also accelerating the landing. Taking the shortage of drugs as an example, the Guizhou Provincial Health Commission recently issued the "Notice on Publicizing the First Batch of Shortage Drug List in Guizhou Province", and a total of 23 drugs were included in the shortage drug list. The shortage of drugs will implement fixed-point production, coordinate emergency production and import, and at the same time, improve the shortage of drugs reserves. Liaoning Province, on the other hand, proposed to establish a consultation and linkage mechanism for the guarantee of drug supply in shortage, incorporate the guarantee of drug supply in shortage into the government performance appraisal system, and strengthen supervision, supervision, incentive and accountability.
Domestic pharmaceutical companies face huge challenges
However, some people in the industry said that with the acceleration of the process of importing innovative drugs, domestic pharmaceutical companies will also face huge challenges.
China's drug market is still in a market pattern dominated by generic drugs. Previous data from the Food and Drug Administration showed that the total number of drug approval numbers in China is as high as 189000, and more than 95% are generic drugs.
"Research and development of new drugs takes a long time, costs a lot, and risks are high. In contrast, generic drugs have low investment, short time, and low risks. Therefore, most of China's local pharmaceutical companies cluster to produce generic drugs." Insiders said.
CICC's research report also pointed out that in terms of the number of pre-listing R & D and new drug listings, China is currently in the third tier, contributing about 2% to global innovation, and the first tier of the United States (about 60%) There is still a big gap between the countries in the second tier (Japan, South Korea and Western Europe).
To support the healthy development of innovative pharmaceutical enterprises in China. In recent years, China has introduced many related policies. The "Thirteenth Five-Year Plan" of medicine proposes to strive to achieve the goal of developing 30 new drugs in 2030 and rank among the forefront of innovative countries. Continuously strengthen patent protection, drug test data protection, innovative drugs and high-quality generic drugs that pass consistency evaluation can be adjusted in a timely manner into the health insurance catalog and drug collection.
"Due to the need for large capital investment and a fairly long R & D cycle, the profitability of many innovative drug manufacturers is worrying, and many have been in a state of loss for a long time." Industry insiders said that even if it is difficult to be approved for listing, it will still face the dilemma of unmatched market access such as the current medical insurance access, price formation mechanism, bidding mechanism and medical insurance reimbursement system. Hao Chunpeng, director of the Research Center of the China Medical Insurance Research Association, said that the medical insurance department has always had a correct attitude towards enterprises with significant innovative value, including giving enterprises reasonable benefits for compliance. It is believed that in the future, more drugs with greater economic benefits will enter the medical insurance drug list to provide services for more insured persons. Jiao Hong further said that there are still some difficulties in the reform, which need to be solved quickly. First, the bottleneck problem of insufficient resources in clinical trial institutions needs to be solved quickly, and the capacity building of clinical trial institutions needs to be strengthened urgently; second, the current drug regulatory system does not adapt to the requirements of reform and innovation, and the construction and ability level of professional review teams need to be improved. The construction of professional inspector team needs to be strengthened urgently; third, laws and regulations such as drug test data protection, patent linking, and patent term compensation are not yet perfect; fourth, the main responsibility of drug marketing license holders needs to be further consolidated, so as to strengthen the management of the whole life cycle of drugs.
More Policy Combination Fist Will Play
Encourage Innovation while continuing to encourage drug imitation is an important policy orientation for the development of China's pharmaceutical market.
According to Jiao Hong, in the next step, the State Food and Drug Administration will also introduce relevant policies and measures to further encourage the domestic listing of overseas new drugs. Adjust the registration and inspection procedures for imported chemicals, adjust the pre-market registration and inspection of all imported chemicals to post-market supervision and sampling, and speed up the process of listing new drugs abroad. Data protection will also be implemented. According to the clinical trials of overseas new drugs in my country, corresponding data protection periods will be given, and other applications for the same variety will not be approved during the protection period. On June 11, the national development and Reform Commission issued the notice on organizing and implementing the special project of biomedical contract R & D and production service platform construction, proposing to effectively support the R & D and industrialization of local innovative drugs, and strive to provide services for more than 100 new drugs per year. A brokerage report pointed out that innovative drugs will be the biggest investment opportunity in the next 10-20 years. China will surely produce several pharmaceutical giants with a market value of more than 100 billion US dollars and dozens of leading enterprises in various fields with a market value of more than 100 billion RMB.
However, it is worth noting that continuing to encourage the development of high-quality generic drugs will also remain an important starting point. On April 3, the "Opinions on Reforming and Improving the Supply Guarantee and Use Policy of Generic Drugs" issued by the General Office of the State Council clearly stated that it is necessary to promote equal competition between generic drugs and original drugs that are consistent with the quality and efficacy of original research drugs.
Jiao Hong made it clear that the State Food and Drug Administration will implement a drug patent link and patent term compensation system to promote innovators to have reasonable expected benefits, strengthen intellectual property protection, and encourage drug innovation while encouraging drug imitation.
On July 3, the Beijing Municipal Human Resources and Social Security Bureau issued a notice clarifying the payment of generic drugs for 36 negotiated drugs, and including generic drugs for 36 negotiated drugs in the Beijing Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List Class B Drug Scope. At the same time, the payment standard of generic drugs shall be the "price limit" of the corresponding negotiated drugs, and the maximum shall not exceed the corresponding negotiated drugs.
The relevant person in charge of the Beijing Municipal Human Resources and Social Security Bureau said that most of the 36 negotiated drugs are imported drugs. With the expiration of their patent period, similar generic drugs will be produced in China, and these generic drugs are also equivalent to Negotiated drugs are included in the medical insurance drug catalog. "Typically, the actual market selling price of a generic drug will be lower than the negotiated drug price." The relevant person in charge pointed out.
More space for medicine fee reduction is worth looking forward. "Usually the price of a generic drug can reach 70% of the original drug. With the increase of similar generic drug manufacturers, the drug price will continue to decline, reaching 30% of the original drug, or even lower." Drug wisdom network co-founder, senior engineer Li Tianquan said. According to industry insiders, if the current generic drug consistency evaluation varieties can replace the original research drugs, it can save the country tens of billions of yuan in medical insurance costs every year.
"At present, the national level has paid unprecedented attention to the quality improvement of generic drugs, hoping to speed up China's leap from a pharmaceutical power to a pharmaceutical power." Guo Yunpei, president of China Pharmaceutical Enterprise Management Association, said.