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Borrow Lilac Garden Insight
On the occasion of the ninth anniversary of the database, Lilac Garden specially invited Professor Shao Rong, Executive Dean of the Institute of Drug Regulatory Science, China Pharmaceutical University and Executive Deputy Director of the National Drug Policy and Pharmaceutical Industry Economic Research Center of China Pharmaceutical University, to have an in-depth dialogue on the current situation and problems of China's pharmaceutical reform.
Lilac Garden Insight
Database: You have been engaged in the research of pharmaceutical regulations for a long time, and the revision of the "Drug Administration Law" has greatly alleviated the social phenomenon reflected in the movie "I Am Not the God of Medicine", but not long ago, the rare epilepsy drug clobazan is involved in psychiatric and rare diseases, and its purchasers are suspected of drug trafficking, so it has attracted widespread concern in the society.
Professor Shao Rong: The common problem reflected in the movie "I Am Not the God of Medicine" and the "Clobazan Incident" is the overseas purchase
of drugs.
The special feature of the "clobazam incident" is that at the time of the incident, the drug was already on the market abroad, but it was not marketed in China (there are already generic drugs on the market in China) and it was a drug
that was urgently needed for children with the disease.
The procurer of chlorbazam was prosecuted on suspicion of drug trafficking because the drugs involved were specially controlled drugs and were left alone
.
However, the mother (guardian) of the child of the user of clobazam was also found by a county people's procuratorate to constitute an aider in the crime of drug smuggling and trafficking, and was given a lighter punishment and not prosecuted
.
This characterization involving guardians is debatable and should be analysed on a case-by-case basis, the key points of which are the size of their purchases and the presence or absence of distribution
.
The former can be judged based on the purpose of purchase, course of use, frequency of use, and expiration date of the drug, while the latter can be judged
based on the motive, purpose, whether there is profit, whether it is distributed to uncertain people, etc.
If it is only mutual adjustment between children, it is really human
.
In view of this, when it comes to this special situation of both rare disease drugs and psychotropic drugs, the drug administration department and the judicial department should analyze it according to the specific scenario, and consider comprehensively from the perspective of the health of children with benefits, and from the perspective of improving the accessibility of drugs, rather than a one-size-fits-all determination
.
What makes this case reflect on how to continuously improve patients' access to medicines based on the interests of patients
.
.
Lilac Garden Insight Database: Drug Marketing Authorization Holder System (MAH) from 2016
It began to be piloted in all ten provinces (cities), and was once known as a system
to reform the domestic pharmaceutical industry.
After 6
Years of practice, the new drug industry because of MAH
What has changed? Are there any new situations and problems that require further improvement of the system?
to reform the domestic pharmaceutical industry.
After 6 Years passed 6 Years of practice, the new drug industry because of MAH What has changed? Are there any new situations and problems that require further improvement of the system?
Professor Shao Rong: MAH from pilot to 2019
It has been six years since the new drug law rose to full implementation and is now in full force
.
This system has played an indispensable role in the integration and optimal allocation of drug R&D and production resources, and has also effectively promoted the upgrading and progress
of China's pharmaceutical industry.
After a period of operation, some new situations and new problems
that need to be further opened up are indeed observed.
The first is the problem of
resource optimization within the group.
Relevant enterprises within the group generally operate under the same set of quality management system framework, but when the group company or subsidiary is the holder, the resources are integrated within the group, including production resources, management resources, etc.
, and in practice, it feels that the policy is still not smooth, and the effective allocation of resources and innovation elements needs to be improved
.
resource optimization within the group.
The second is the problem of segmented production of
drugs.
Under the existing legal conditions, the segmented commissioned implementation of drugs faces difficulties, and it is difficult to realize the segmented and multi-site commissioned production of biological products.
drugs.
The third is the issue of cross-border production, as the integration of resources crosses national borders, can foreign holders who intend to produce at home and abroad at the same time, can they entrust domestic production? Similarly, can a domestic drug MAH entrust overseas production? These problems need to be solved in in-depth research based on China's national conditions and the current situation of the industry;
The third is the issue of cross-border production.The fourth is the issue of cross-regional supervision, due to the differences in local regulatory capabilities and supervision levels, the formation of supervision may not be coordinated, such as in the change of holders and trustees, the transfer in is relatively convenient, but the transfer out will face various obstacles
.
The consequences of these thorny problems have attracted the attention of all circles of government, industry, academia and research, and systematic research and exploration practice are underway, which is expected to lay a good foundation
for thoroughly breaking through the blocking points in the future.
Lilac Garden Insight Database: 2022
Since then, innovative drugs seem to be entering a "cold winter", and several leading Chinese companies have frequently failed in the process of exploring the path of internationalization.
Professor Shao Rong: As an academician, I may not be able to provide valuable opinions and suggestions for the industry to refer to, but here I am also willing to share some of my observations and experiences
.
The "cold atmosphere" faced by the "innovative drug" industry is indeed very obvious, only two or three years ago, the vigorous spirit of the entrepreneurial team can be described by the saying "chicken blood", whether it is innovation or imitation, all of them are full of hope and confidence
for the future development.
But today, such "spirit" has been deflated to a worrying point
.
From a policy point of view, the fund pool of basic medical insurance is so large, how to use the least amount of money as possible to talk about the maximum benefit is the proper meaning
of the medical insurance department.
After thousands of efforts to make innovative drugs successfully marketed, it is unrealistic to hope that the problem of patient payment will be solved through basic medical insurance, and medical insurance focuses on the clinical value of innovative drugs and explores how to achieve value payment
.
The premise of innovative drugs entering the medical insurance catalogue is to form drug prices (payment standards)
through negotiation and transfer of expected market revenues.
Judging from the results of national talks in recent years, the market revenue of innovative drugs is expected to be greatly reduced; The same is true for the benefits of the generic drug market, many local companies use the profits obtained by generic drugs to support the research and development of innovative drugs, but after the evaluation of generic drugs into the national centralized procurement, generic drugs have entered the era of thin profits, which have a greater impact
on the enthusiasm of entrepreneurs and investors.
Although the development of the industry is facing great difficulties, we should see that entrepreneurs are still persevering and have not given up the industry, but the difficulty of survival will undoubtedly slow down the pace
of development of the industry.
In view of this, if in the process of policy formulation and implementation, more attention can be paid to gradual, coordinated, balanced interests, and the establishment of a benign ecology, it is bound to help fundamentally protect the interests of patients and the sustainable development of
the industry.
the industry.
Lilac Garden Insight
Database: At present, centralized procurement is being fully and deeply implemented in China, and the important purpose of centralized procurement is not only to reduce costs, help promotion, and stabilize demand, but also to promote research and development
.
In order to achieve the goal of promoting the development of innovative drugs, what incentives do you think should be taken in parallel?
.
In order to achieve the goal of promoting the development of innovative drugs, what incentives do you think should be taken in parallel?
Professor Shao Rong: The national centralized procurement policy has innovated the centralized procurement mechanism for drugs, truly implemented the procurement with quantity and linked to the quantity and price, and also truly reduced the price of drugs and reduced the burden
of drugs on the masses.
The in-depth implementation of centralized procurement has also changed a lot
to the industry ecology.
For example, the profit margins of generic drugs have been sharply compressed, which in turn has led to the downward adjustment of original drugs (although limited).
Previously, in China, the price of original research drugs that had passed the patent period was still high, which was actually very abnormal
.
of drugs on the masses.
As far as drug innovation is concerned, in the future, generic drugs enter the era of thin profits, entrepreneurs with strategic vision will focus on and resources to innovative drugs, which undoubtedly plays a huge role in promoting procurement, but innovation is not easy, its basis is the long-term accumulation of basic scientific research in life sciences, China's innovative drug industry is more follow-up innovation, PD-1
The crowded race track with hundreds of drug candidates is a case in point
.
Innovative drugs are a high-risk and high-investment industry, and it is difficult for a smart woman to cook without rice, and there is no way to talk about it without money
.
The source of funds for China's innovative drug enterprises is nothing more than two categories, one is the investment of social capital, the investment and financing of the biomedical industry in the first two years is extremely hot, but with the change of the environment and the exposure of risks, the "lonely" funds gradually withdrawn
.
The other category is the past accumulation generated by the generic drug business, but the more generic drugs included in the centralized procurement, the corresponding decrease in this source
.
In addition, the prosperity of the industry will attract a large number of sea "turtle" talents to return to China to start a business, and now that the "cold air" has hit, it will be uncertain whether there will be a steady stream of talents coming back
.
These are all areas
that need attention and need to be improved.
Lilac Garden Insight
Database: After a series of measures such as centralized procurement, the inflated drug prices have been improved to a certain extent, but at the same time, the reform of public hospitals and the reform of the medical insurance payment mechanism have not kept pace
.
In your opinion, in terms of pharmaceutical reform, what is the important next step?
.
In your opinion, in terms of pharmaceutical reform, what is the important next step?
Professor Shao Rong: I think the next step is to clarify the payment standards for drugs and reform the payment methods
.
If the clinical efficacy and clinical value of innovative drugs are not significantly better than the existing treatment standards, it is difficult to be adopted by medical insurance, which requires the research and development of innovative drugs to focus on innovation that is truly in demand and clinically valuable in the clinic
.
.
In addition, the early start of several batches of national centralized procurement has expired one after another, the next continuation work should be considered at the provincial level, how to do a good job of continuation, whether to appropriately introduce new competitors, how to implement the volume and price linkage, the solution of these problems are related
to the determination of the payment standard of drugs.
At the end of the dialogue, Professor Shao mentioned that pharmaceutical reform is related to people's lives and health, and the rise and fall of the industry, so it must be supported by solid data and evidence
.
Lilac Garden Insight Database Build 9
Over the years, a large amount of data has been deposited, which is undoubtedly a great asset
.
Making full use of these data not only facilitates tracking and reporting, but also facilitates relevant research in academia and helps improve the scientific nature
of regulatory policies.
It is recommended that more data display dimensions can be mined in the future to further release the value of
data.
Professor Shao Rong
Professor Shao RongSecond-level professor, doctoral supervisor, practicing lawyer
.
He is currently the Executive Dean of the Institute of Drug Regulatory Sciences of China Pharmaceutical University and the Executive Deputy Director of the National Drug Policy and Pharmaceutical Industry Economic Research Center of
China Pharmaceutical University.
.
He is currently the Executive Dean of the Institute of Drug Regulatory Sciences of China Pharmaceutical University and the Executive Deputy Director of the National Drug Policy and Pharmaceutical Industry Economic Research Center of
China Pharmaceutical University.
Engaged in the research of pharmaceutical policies and regulations, presided over and completed more than 100 projects of the National Social Science Fund (including major projects and aspects), the State Food and Drug Administration, the State Medical Insurance Administration, the Ministry of Industry and Information Technology and other ministries and commissions and industrial research projects, etc.
, and is a member of the State Food and Drug Administration Law Revision Expert Group, a member of the "Two Laws" publicity team, an expert of the State Food and Drug Administration Expert Committee for the Consistency Evaluation of the Quality and Efficacy of Generic Drugs, a member of the Safety Production Expert Group of the Ministry of Industry and Information Technology, a review expert of the National Evaluation Committee for the Protection of Traditional Chinese Medicines, and an expert in the work of national licensed pharmacists
。
The research results have played an important role in the field of national regulatory policies and regulations, and have been widely recognized by pharmaceutical administrative departments, pharmaceutical associations and pharmaceutical companies, and have been invited to be interviewed by CCTV, People's Daily and Central Radio Network for many times
.
He is also the director of the Chinese Pharmaceutical Association, the second vice chairman of the Pharmaceutical Affairs Management Professional Committee of the Chinese Pharmaceutical Association, the standing director of the Jiangsu Pharmaceutical Association, the second chairman of the Pharmaceutical Affairs Management Professional Committee of the Jiangsu Pharmaceutical Association, the director of the China Drug Supervision Research Association, the chairman of the Drug Regulation and Policy Research Committee, the vice chairman of the Drug Regulatory Talent Training Committee, the supervisor of the China Pharmaceutical Promotion Association, the chairman of the Enterprise Compliance Committee, and the vice chairman of the Regulation and Policy Committee
.
He is the deputy editor of the Chinese Medical Encyclopedia Compilation Committee, and the editorial board member
of many journals such as "Chinese Pharmaceutical Affairs", "China New Drug Journal", "Chinese Drug Evaluation", "China Health Policy Research", "Chinese Journal of Chemical Industry", "Journal of China Pharmaceutical University", "World Clinical Drugs", "Modern Application in China", "Chinese Pharmacy", "Modern Chinese Medicine", "Pharmaceutical Education", "Progress in Pharmacy", "Pharmaceutical Research", "Pharmacy and Clinical Research" and other journals.
