The seventh batch of countries organized centralized drug procurement officially kicked off. From February 18, the joint procurement office will carry out the filling of relevant drug information. After more than three years of speed-up, expansion and rule optimization, six rounds of national centralized procurement and dozens of regional alliances and provincial centralized procurement, the reform of pharmaceutical centralized procurement has entered a new stage of normalization and institutionalization.
The reporter of the Securities Times found that the whole chain of centralized procurement, including medical insurance negotiation, volume procurement, supply of pharmaceutical enterprises to front-line medical institutions, is running more and more closely and smoothly. At present, all links of centralized drug purchase have become more and more reasonable: medical insurance negotiation is no longer based on low price, hospital drug distribution is no longer uneven, and the capital market is no longer pale.
Three years ago, when the centralized purchase policy was freshly released, the relevant sectors howled, and all parties in the market believed that it was a major bad news for the whole pharmaceutical industry. But now looking back, the impact of centralized procurement on the whole pharmaceutical industry is not as great as expected. What's more surprising is that some enterprises benefit from it.
In the pharmaceutical sector, there is no eternal darkness, only the dawn that has not been reached. Under the remarkable effect of centralized purchase process optimization, the policy negative brought by medical insurance fee control has been basically digested by the market, the "policy bottom" of the pharmaceutical sector is gradually being built, and the dawn may be not far away
the process is tight and smooth
From the results of pharmaceutical enterprises and hospitals interviewed by the reporter, at present, the operation of all links of the centralized pharmaceutical purchase system has been very smooth, and the conflict situation has been significantly reduced. At the beginning of the first two batches of national procurement, the government, pharmaceutical enterprises, hospitals and other participants were not familiar with the specific implementation process. There were cases where the number of government procurement did not match the actual demand of the hospital, pharmaceutical enterprises did not distribute goods in time or even cut off supply, but now there are basically no similar problems, which can be solved quickly even if they occur.
Zhang Tao (a pseudonym), the person in charge of a large pharmaceutical enterprise, told reporters that there had been uneven distribution to medical institutions during the implementation of the first and second batch of national centralized drug procurement. At that time, it was because the medical institutions were not allowed to report the demand, but the provincial procurement platform directly captured the procurement data of the previous year from the platform. However, due to the inaccurate data and the inaccurate planned amount reported by medical institutions on the platform, the number of drugs provided to hospitals far exceeds their actual use needs, and some drugs are allocated too little, resulting in insufficient use of hospitals.
But now this kind of problem basically won't appear. Zhang Tao said that now the centralized procurement has been implemented to the fifth batch, and the inter provincial alliance procurement has been implemented during the period. The process has been significantly optimized and the allocation has become more and more reasonable. There will also be untimely supply, but it is mainly due to sudden factors, such as the cause of the epidemic. There are also shortages of some drugs due to insufficient production capacity, such as vitamin B6 tablets, ibuprofen sustained-release capsules, ethambutol, rivaroxaban, budesonide, celecoxib, linezolidine, calcium gluconate injection, betahistine, etc.
● it is understood that the current basic process of drugs from determining the purchase quantity to final distribution to the first-line medical institutions is: first, the medical institutions report the quantity on the centralized purchase platform with reference to the historical purchase data of the previous year; Then, the centralized purchase platform generates a purchase contract according to the corresponding purchase quantity and embeds it in the purchase platform; Finally, medical institutions, production enterprises and distribution enterprises selected by the production enterprises sign electronic contracts on the platform, and the distribution company starts to distribute drugs.
Generally, the reported volume of medical institutions shall be reported according to 50% - 80% of the historical procurement data of the previous year (it can be lower than 50% in case of special circumstances, but the reason shall be explained). In this case, the quantity of most centralized drugs can meet the actual clinical needs.
Wang Jie (a pseudonym), President of a class III hospital, told reporters that the hospital reported the planned purchase quantity according to the above process, which can basically meet the clinical demand. After the production enterprise selects the distribution enterprise according to the provinces selected by the National Medical Insurance Bureau, it will distribute the drugs to the first-line hospitals. Occasionally, there will be insufficient or uneven distribution, but basically, the distribution enterprise can make up within one week.
What if the actual demand exceeds the reported planned quantity? Zhang Tao explained that the purchase volume of medical institutions can exceed the contract volume, and production enterprises and distribution companies can be required to supply according to the centralized purchase price. Of course, the hospital can also buy the manufacturer's drugs purchased by the hospital before centralized purchase. However, after some drugs enter the centralized purchase, other manufacturers will no longer produce and supply them. At this time, there is a situation that hospitals can't buy drugs, such as chemotherapy drug paclitaxel.
In practice, Wang Jie suggested that the newly developed new drugs (quickly benefit Lbx Pharmacy Chain Joint Stock Company(603883) ), tumor drugs and cardiovascular and cerebrovascular drugs can increase the purchase volume. Zhang Tao suggested that chronic diseases and common diseases such as antihypertensive drugs, hypoglycemic drugs, lipid-lowering drugs and anti HBV drugs could increase the purchase volume. Adjuvant drugs, Medicare limited reimbursement scope, especially drugs with narrow indications and antibiotics, can appropriately reduce the purchase volume
continue to speed up and expand
From February 18, the joint procurement office will carry out the filling of drug information related to the centralized drug procurement organized by the seventh batch of countries. This means that the seventh batch of countries organized centralized drug procurement officially kicked off. The scope of this centralized collection includes 58 varieties and 208 specifications of drugs including afatinib oral normal release dosage forms (20mg, 30mg, 40mg, 50mg).
Looking back on the past rounds of collection, from the perspective of diseases, the first priority is to set up a variety of population that involves a large population, a large amount of consumption and a high purchase amount, but do not give up the use of small groups: initially, it mainly purchased medicines for common diseases and chronic diseases, such as hypertension, diabetes, digestive system diseases, and so on. Rare diseases, drugs and other fields.
● in terms of the number of varieties, each round of centralized procurement is gradually increasing: when the "4 + 7" pilot cities are centralized procurement in 2019, the procurement object is only 25 kinds of drugs, while the varieties of the second batch and the third batch of national procurement in 2020 are increased to 32 and 55 respectively, and the varieties involved in the fourth batch, the fifth batch of national procurement and the special procurement of insulin (the Sixth Batch of national procurement) in 2021 are 45, 61 and 16 respectively.
So when will the centralized purchase of medicine stop? Wang Jun (a pseudonym), a senior pharmaceutical industry analyst, believes that the principle followed by the centralized purchase of medicine is "to collect as much as possible", that is, all the drugs you can think of may be included in the centralized purchase. The people-friendly policy of centralized purchase and price reduction will be implemented to the end, and no small group will be left behind. For pharmaceutical enterprises, no one can avoid this storm, but in different order.
Zhang Fei (a pseudonym), a researcher in the pharmaceutical industry, once told reporters that except for a few varieties with high barriers and good competition pattern, most generic drugs will face the process of centralized purchase of sharply reducing prices, exchanging prices for quantities, and finally converting them into low gross profit products. If the evaluation system is not perfect, the centralized collection will be postponed. The evaluation system of non over evaluated chemical drugs, biological drugs and Chinese patent medicines is not perfect. Relevant departments may guide some regions to explore the rules of centralized collection and accumulate mature experience for national promotion.
Since most pharmaceutical varieties will be included in the centralized purchase, the next thing to do is to accelerate the development. Increasing speed and expanding area is the overall feature of the past few rounds of centralized mining, and it is also the key word of this year's centralized mining of medicine. The first six rounds of national centralized procurement involved a total of 234 kinds of drugs, and the latest requirement of the national medical insurance administration is to strive to cover more than 350 kinds of drugs in each province through national organization and provincial alliance procurement by the end of this year.
The development of insulin special procurement has expanded the scope of pharmaceutical centralized purchase from chemical drugs to biological drugs. In 2022, intensive mining will also be carried out in three sectors: chemical medicine, Chinese patent medicine and biological medicine. In addition, the successful collection of coronary stents, artificial joints and the upcoming collection of implant teeth also means that the collection of high-value medical consumables is also accelerating and expanding. The centralized purchase of high-value medical consumables in 2022 will also focus on orthopedic consumables, drug balloons and other varieties
continuous optimization of rules
The six rounds of national mining and several rounds of multi provincial alliance centralized mining carried out in the past three years have optimized the rules almost every time. The rule design of the number of shortlisted enterprises, quotation guidance and procurement cycle has been improved and improved.
In terms of shortlisting rules, it is stipulated that only one enterprise of each variety won the bid during the "4 + 7" centralized purchase. After the expansion, the number of winning enterprises expanded to 3. By the fifth round, the number of shortlisted enterprises has reached 10 at most. From the source, it eliminates the risk of quality decline that may be brought by the dominance of one market, and also ensures the reasonable competition pattern of multiple pharmaceutical enterprises in the industry.
The procurement cycle is also extended from the initial 12 months to 2 years, and then changed to determine the procurement cycle according to the number of selected enterprises. The maximum procurement cycle can reach 3 years, and the rule design is more reasonable.
The most obvious and satisfying thing about rule optimization is the gradual rationalization of the bid winning price, which breaks the "only low price theory". The initial rules of price competition and low price selection led many pharmaceutical enterprises to declare lower than the cost price, which brought hidden dangers such as the collapse of pharmaceutical enterprises and the interruption of drug supply.
Considering the different production costs of different pharmaceutical enterprises, starting from the second batch of centralized procurement, in addition to the reduction of "unit application quotation" by no less than 50%, an optional rule has been added: "unit comparable price" shall not be higher than 1.8 times of the lowest price of the same variety. In other words, the bid winning prices of different pharmaceutical enterprises are allowed to be different, and the gap can be up to 1.8 times.
The competition is still fierce: the average price of the first six batches of drugs for centralized procurement is 53%, the average price of cardiac stents is 93%, and the average price of artificial hip and knee joints is 82%. The rules of centralized purchase continue to be fine tuned and refined. In the subsequent centralized purchase, measures such as differentiated quotation of different groups and quotation with quantity (volume price linkage) have also been introduced.
Under the continuous optimization of the rules of centralized procurement, the competition of national centralized procurement is not as fierce as at first. The qualification of winning is no longer a simple "low price", but the few with the highest price do not win. For example, in the fifth batch of centralized purchase, the selection rate of enterprises has reached 74%. The quotation of pharmaceutical enterprises is also more rational. There is no need to worry about the existence of extreme quotation. They focus more on their own costs and production capacity, and declare on the premise of ensuring their reasonable profits.
In October last year, Nanjing Medical Insurance Bureau organized the alliance of medical institutions in Nanjing to carry out overall price negotiations with Shenzhen Mindray Bio-Medical Electronics Co.Ltd(300760) . The overall decline of Shenzhen Mindray Bio-Medical Electronics Co.Ltd(300760) some in vitro diagnostic reagents and orthopaedic consumables was only 35.51%. This may be the wind vane for the continuous change of centralized mining heading
promote industry reshuffle and upgrading
Purchasing with volume was once a term that changed the color of the market: the bid winner faced the challenge of sharp price reduction and reduced gross profit, and the bid loser faced the risk of declining market share and even losing the market. However, after three years of verification, the impact of centralized procurement on the whole pharmaceutical industry is not as great as expected, and even enterprises benefit from it.
● a typical case is Sichuan Huiyu Pharmaceutical Co.Ltd(688553) which has just appeared on the market. Benefiting from volume procurement, Sichuan Huiyu Pharmaceutical Co.Ltd(688553) continued to grow in performance: in 2019 and 2020, the operating revenue increased by 1201.68% and 92.94% respectively, and the net profit increased by 903.96% and 93.22% respectively. Mainly due to its fist product (accounting for more than 90% of the revenue), pemetrexed disodium for injection won the bid in the volume procurement of "4 + 7" pilot cities and later 25 provincial alliance regions. The sales revenue of the product increased significantly, from 29.0541 million yuan in 2018 (not benefiting from centralized purchase) to 1.236 billion yuan in 2020, with a cumulative increase of more than 40 times in the two years.
Its market share has also increased. According to the Milne database, Qilu pharmaceutical, which also owns pemetrexed disodium for injection, failed to purchase in pilot cities and the first batch of national procurement because it passed the consistency evaluation in December 2020, and its market share decreased from 29.63% in 2018 to 17.7% in the first half of 2020. The market share of Sichuan Huiyu Pharmaceutical Co.Ltd(688553) has increased significantly thanks to volume procurement.
The performance growth of Sichuan Huiyu Pharmaceutical Co.Ltd(688553) in 2021 is also related to volume procurement. According to its 2021 performance express, the growth rate of annual operating revenue and net profit is expected to reach 34.26% and 31.96%. The main reason for the performance growth is not only the continuous growth of the sales volume of pemetrexed disodium for injection mentioned above, but also the sales growth brought by the fifth batch of centralized purchase of the company's products oxaliplatin injection, docetaxel injection, Paclitaxel injection and bendamostine hydrochloride for injection.
Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) is also a typical representative of a beneficiary centralized purchase. From the historical bid winning list, it has always been a large bid winner in volume procurement, and there are multiple varieties on the list in each round of centralized procurement. In 2020, Zhe Jiang Hua Hai Pharmaceuticalco.Ltd(600521) operating revenue and net profit increased by 20.36% and 63.24% respectively year-on-year. It said that one of the reasons for the performance growth was that with the promotion of national centralized procurement, the market coverage of the company's products was rapidly improved, which affected the significant increase in the sales of preparations in China.
Of course, there are also enterprises with "tight hoop curse" brought by centralized mining. Taking Jiangsu Hengrui Medicine Co.Ltd(600276) as an example, the company has repeatedly said in its performance report that it is affected by the loss of bid, bid winning and price reduction of centralized mining. In the first half of 2021, Jiangsu Hengrui Medicine Co.Ltd(600276) performance growth pressed the pause button, and the share price has first fallen to respect.
Jiangsu Hengrui Medicine Co.Ltd(600276) said in the announcement that the sales of traditional generic drugs fell due to the influence of national and local volume procurement. For the six drugs involved in the third batch of centralized purchase, which began in November 2020, the sales revenue decreased by 57% month on month during the reporting period; On the other hand, the main product carrelizumab began to implement the medical insurance negotiation price since March 1, 2021, with a decrease of 85%. In addition, many problems, such as the difficulty of entering the hospital and the different implementation time of medical insurance in various places, caused the negative growth of carrelizumab sales revenue month on month.
In addition, Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) and Huadong Medicine Co.Ltd(000963) which once led to a significant decline in performance after losing the standard of core products are also the "victims" of centralized purchase.
Due to the loss of bids in centralized procurement for many times, in 2019, Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) ended the previous 14 consecutive years of performance growth, with both operating revenue and net profit declining, and continued to decline in the second year, from the annual profit of 1.458 billion yuan in 2018 to 50.13 million yuan in 2020. The sales of acarbose, the core product of Huadong Medicine Co.Ltd(000963) , reached more than 3 billion yuan in 2019, but after losing the bid, the company will not list this revenue separately in 2020.
Wang Jun told reporters that on the whole, the impact of centralized mining on the pharmaceutical industry is limited. This is because volume purchase only reduces unreasonable channel profits, but reduces the sales and operation costs of enterprises as much as possible. The form of volume for price is also conducive to accelerating import substitution and improving the market share of Chinese pharmaceutical enterprises. In the long run, it is conducive to the high-quality development of the industry, but the era of huge profits of pharmaceutical enterprises has gone forever. The industry has directly entered the era of competition between R & D and cost competition from the mode of channel competition driving sales.
● according to relevant statistics, in 2020, the sales expenses of A-share pharmaceutical listed companies decreased by 6% year-on-year, the first decline in recent five years; Meanwhile, R & D expenses increased by 22% year-on-year. The data gap between the two may continue to widen in 2021. The 132 enterprises in Shenwan chemical pharmaceutical sector spent 15.7 billion yuan on R & D in the first half of 2021, with an average investment of about 120 million yuan per enterprise in the first half of the year. In the same period of 2019 and 2020, the average investment is only 87 million yuan and 94 million yuan.
With the changes of sales expenses and R & D expenses, Jianzhi pharmaceutical enterprises have changed from focusing on sales mode to focusing on R & D as a whole. Generic pharmaceutical enterprises that rely on a single variety and lack subsequent varieties have significantly greater risks in the face of policy changes; The business model highly dependent on a single product cannot support the sustainable development of pharmaceutical enterprises. Innovation and transformation have become the consensus of pharmaceutical enterprises.
