Ten thousand words interview! The head of the price collection department of the National Health Insurance Administration explained in detail: 14 questions about collection.

The third batch of national centralized drug procurement (here is: collection) has been officially launched, will be opened in Shanghai on August 20.
56 varieties, 82 product regulations, tens of billions of procurement scale involving 184 pharmaceutical companies, affecting the attention of the entire pharmaceutical industry.
since 2019, in 11 pilot cities to implement the "4 plus 7" volume procurement, the collection gradually towards institutionalization, normalization, enterprises also from doubt and wait-and-see to full competition.
as a "super-buyer" with a $2 trillion health-care fund, the National Health Insurance Administration spends about $800 billion a year to pay for drugs, nearly half of the total end-of-life sales.
in order to improve the efficiency of the use of health insurance funds, the Health Insurance Bureau to centralized procurement as a breakthrough in reform, trying to price drugs with gold sales part of the squeeze, to ensure that people can afford medicine, eat good medicine.
in the volume of procurement, the provinces to implement tender collection for many years, but because of the decoupling of the volume price, drug "price reduction death" frequent occurrence, drug prices are still inflated.
new collection of strip procurement, indeed through price-for-volume incentives for enterprises to reduce prices.
In addition to the "soul cut price" of 1-2 fold, there is a lot of discussion in the industry: whether collecting and compressing corporate profits will curb innovative research and development;
face of industry questions, the head of the medical price and tender procurement department of the State Health Insurance Administration was interviewed by Caijing to analyze and demystify from the bottom logic of policy design.
because of the complex interests of the field of medicine, there will be a lot of "smoke bombs", the person in charge said, "can not just listen to what others say, the key depends on how he does."
"1 by the gold sales steady money has been the past ask: before the joint procurement (drug centralized procurement and use of joint procurement office) organized an online collection symposium, to find out the intention of enterprises.
this year to face the collection, the overall attitude of enterprises, which reflects the main challenges faced? A: This year, enterprises generally support the policy of collecting, there are few objections, some of the differences mainly focus on the inclusion of varieties.
our analysis, the different ideas of the enterprise are mainly related to the market structure.
For example, the original research drug market share is high, over-evaluation of generic drugs accounted for a low proportion of varieties, imitation enterprises hope to rapidly expand market share through inclusion in the collection, to help promote, while the original research drug companies try to fight generic drugs through patents, quality standards and other disputes to protect the existing market share.
we fully listen to the advice of clinical experts, from a clinical point of view, the quality and efficacy of generic drugs is no problem, can replace the original research drugs, will be included in the collection.
in the collection rules, enterprises also have different views, such as the length of the contract.
that have been evaluated consistently want longer contract periods, while those that have not been evaluated tend to have shorter contract periods so that they can compete in the next round.
addition, how many companies should be winning? The second batch of national collection, a variety of up to 6 selected, some enterprises think that 6 is not enough, should be expanded to 10;
These are the interests of enterprises, the position of the Health Insurance Bureau is that we must adhere to the quality as the bottom line, according to clinical needs to decide to include the drug varieties collected;
has now formed a better multi-sectoral coordination mechanism.
(Note: the third batch of national collection of a variety can have up to 8 enterprises selected) Q: from the "4 plus 7" volume procurement pilot to the third batch of collection, more than a year, pharmaceutical enterprises on the attitude of collection has undergone a great change, collection to the pharmaceutical industry to bring about the impact of what? A: To do the bidding and procurement policy, we need to consider the interests of three subjects: ordinary people, doctors and medical institutions, pharmaceutical enterprises.
for pharmaceutical enterprises, the collection has four aspects of the effect: cost reduction, promotion, stable demand, promote research and development.
to reduce costs, through three mechanisms to achieve: first, crowding out sales costs, second, to reduce the financial costs of enterprises, the previous hospital repayment cycle to six months, a year, or even two years, "4 plus 7" collection of drugs within a month of the proportion of repayment reached more than 97%;
help promote, drug sales in China is more difficult, on the one hand, medical institutions are in a strong position, many pharmaceutical companies in order to be admitted to the hospital to do a lot of marketing work, including many "grey" or even illegal transactions.
if the drug into the collection, this part of the investment can be completely saved, the more enterprises into the collection of products, the more obvious the cost savings in sales.
from the industry level, the sales cost of pharmaceutical companies accounted for about 40% of revenue, enterprise feedback into the collection of varieties sales costs reduced to less than 10%.
stable demand, before the hospital scattered procurement, the entire market is highly unstable, collection after at least 1-3 years after the demand is clear and stable, enterprises can rest assured to do a good job of production scheduling arrangements.
promote research and development, there is widespread concern that the collection squeezes corporate profits and affects research and development, but it does not.
we're going to squeeze out over-inflated sales, not research and development costs, and we're very supportive of the increase in research and development costs.
: How can volume procurement promote research and development? Because pharmaceutical companies judge the future of generic drugs out of the way is not big, must be transformed to do the original research? A: According to the data, the research and development expenditure of a well-known domestic enterprise leading in drug research and development increased to 3.9 billion yuan in 2019, up 46% YoY.
is not that generic drugs have a big way out, but that generics alone are not enough.
the future development of generic pharmaceutical enterprises must also rely on quality control, process transformation, cost control, relying on gold sales, steady money is a thing of the past.
China's pharmaceutical industry in the past was "locked up" in the low-end state, is because of long-term unfair competition, not innovation, quality competition, but rebate competition, leading to the expulsion of good currency.
so many entrepreneurs understand: collecting to provide a level playing field, value competition platform, can help you out of the quagmire.
expert evaluation, in the past 20 years, there are two points on the industrial transformation and upgrading of the greatest impact: First, drug consistency evaluation, set up quality standards;
so that the volume of procurement did not curb research and development, but to promote enterprises to pay more attention to research and development.
: Will future policies give some room for support for generic drugs that cost a lot of research and development? A: For the first generic drug, the market itself will be "rewarded".
lack of competition, the first generic drug companies can follow the pricing, the price is slightly lower than the original drug, but still can get a higher price.
Centralized volume procurement also inspired enterprises to strive for the first imitation or first over-consistent evaluation, before, the first imitation of drugs even if over-evaluated, the share is generally lower;
2 National organizations with the volume of medicines exceeded the expected completion of the agreed procurement volume question: At the end of 2019, the "4-7" drug belt procurement pilot areas of 25 selected drugs completed an average of 183% of the agreed procurement volume, some drugs exceeded the amount of several times.
for over-procurement, what kind of attitude does the health insurance bureau have, what measures will be taken to encourage medical institutions to report more accurately? A: Over-procurement is expected, but the exact amount exceeded is determined by a variety of factors.
According to our monitoring and analysis, there are at least 12 reasons for the oversized, the main reasons are three: First, the release of demand, the original drug-free patients, the price came down, the demand was released.
such as the treatment of hepatitis B of the tinofove, Entikave, the annual per capita cost from 5000 yuan, 3000 yuan to 200 yuan, after the price reduction of these two drugs increased by 3-5 times.
followed by demand migration, which used to be used in other drugs, and now to relatively inexpensive collection of medicines.
third there is a depression effect, such as the "4 plus 7" pilot in Xi'an, the surrounding more than a dozen cities, many patients to Xi'an to open drugs, but also increased the demand for collected drugs.
the actual procurement volume substantially exceeds the agreed purchase volume, there is indeed a situation of insufficient reporting by some medical institutions.
Next we will further improve, for example, strengthen the main responsibility of the hospital, urge the pharmaceutical department to refine the statistical audit of the reported amount, the hospital leadership audit clearance;
addition to perfecting the process and making full use of information technology to ensure accurate reporting, we have also established an interest guidance mechanism and implemented a retention mechanism for the balance of medical insurance funds.
if medical institutions report less, it means that the budget space it can save will be reduced.
: Just mentioned that the collection of enterprises can stabilize demand, but will the excess exceed the capacity and budget constraints of enterprises, resulting in insufficient supply? If a pharmaceutical company in the second year of a winning bid standard, but the production line, workers, etc. have been prepared in place, will lead to the production line empty, overcapacity? A: We all understand support for the reasonable overstaying of demand release and demand transfer.
in the capacity guarantee range, the supply is enlarged, the vast majority of enterprises are also welcome, because the scale of production expanded, the cost of allocation is lower.
but there are some enterprises can not meet the excess demand, then will use other selected pharmaceutical companies to ensure supply.
there is very little supply because of the amplification of demand, the production elasticity of chemicals is very large, some production lines open for a month, can produce a year's supply, so most enterprises can meet the requirements.
a small number of enterprises are not in their own hands, expanding supply may not have a cost advantage, capacity will be limited.
We have observed that the first batch of "4 plus 7" of the selected enterprises can supply their own raw materials, can not be self-seism of a small number of enterprises are also in the pre-harvest strategic reserves for several years, which is precisely the embodiment of market competitiveness.
Based on the information we have on international drug prices, there are still some collected drugs at higher prices than international generics, and some are priced at or slightly lower than international prices, but not at a loss.
we still have to believe in the economic rationality of enterprises, if the whole country is losing money, enterprises will not do such a loss-making business.
In fact, pre-harvest pharmaceutical companies for tens of thousands of hospitals across the country, some drugs as many as hundreds of peer competition, many enterprises in the production line is unsaturated operation, the enterprises to participate in the collection is basically relying on the existing production line capacity, very few enterprises in order to collect the construction of new production lines, overall, after the collection of market certainty significantly improved.
Q: In April this year, Shanghai Sunshine Pharmaceutical Procurement Network (this network is responsible for the implementation of the volume procurement landing) issued a message suggesting that the second batch of national collection of selected varieties, there are 4 varieties in the initial implementation of the possible supply constraints, delivery delays, etc. , causing the market to take the purchase of some drugs out of supply concerns, what is the reason for this situation? A: Shanghai is sent to prompt medical institutions to purchase in an orderly manner, not to buy.
In fact, according to the normal pace and cycle of hospital procurement, the supply of medicines is sufficient, but some hospitals will buy - the purchase of half a year's volume, hoarded on the shelves, which will artificially lead to a shortage of market supply."
, during the outbreak, enterprises are gradually resumed work, before mainly relying on the original inventory, in accordance with the normal progress of procurement, followed by production scheduling, can be fully supplied.
so Shanghai tips to be based on the actual clinical needs of reasonable procurement.
it is precisely because of the timely prompt of recruitment agencies, rational procurement of medical institutions, enterprises have sufficient stock, Shanghai's second batch of collection and collection officially implemented, there is no shortage of selected drugs.
3 How are unre assessed drugs tried? While waiting to do Q: drug consistency evaluation costs up to millions of dollars, at present, unestabilized drugs can also participate in the collection of competitive bidding, which will weaken the enterprise input consistency evaluation momentum? A: There is a serious "information asymmetry" in the supply of medicines, and it is difficult for both patients and doctors to determine their effectiveness before the drugs are used.
, drugs are the most tightly regulated special commodities worldwide, requiring access approval and quality control by the drug regulatory department.
developed countries, through consistent evaluation, is the premise of generic drug market.
The State Drug Administration has vigorously promoted consistent evaluation, which has led to the overall upgrading of the domestic pharmaceutical industry.
for the recruitment sector, the ideal state is that the quality of the drug can be ensured through the supervision of the drug regulatory department, the recruitment process only need to consider the price factor.
drug regulatory commission to speed up the evaluation of consistency, will help to clear obstacles and create conditions.
from the perspective of medical insurance, we are also studying the introduction of price, recruitment policies, in line with the drug regulatory departments to support the evaluation of generic drug consistency.
there are already two policies on the ground: First, generic drugs as long as the evaluation, you can compete with the original drug, to give domestic pharmaceutical companies equal opportunities to compete.
before the local will be divided into 3, 4 levels: the original research drug is the first level, the evaluation of generic drugs is the second level ... Lead to the original drug is always exclusive, no competition.
through this change, the situation of high prices and high market share of the original drug, historically does not exist.
second, as long as a variety of over-evaluation enterprises more than 3, and these 3 can guarantee the market supply, will no longer collect un-evaluated drugs.
from international experience, consistency evaluation is a long-term process, such as the completion of the drug quality re-evaluation (equivalent to consistency evaluation) project in Japan, which took nearly 20 years.
In my observation and judgment, the CPC Central Committee and the State Council, the people are afraid that the health care sector will not give such a long time to complete the task of collection and reform, so, the health care system on the one hand, hope that the drug regulatory departments to speed up the pace of consistent evaluation, "doing side by side", on the other hand, we must also meet the difficulties, research and explore the collection rules for drugs that have not been evaluated.