The two envelope bidding system for the procurement of national essential drugs under the two enve

In the process of the operation of the essential drug system, some places in the bidding process "for the low price is taken", causing the society to worry about the quality of essential drugs, in this regard, the "procurement mechanism" reiterates that the procurement of essential drugs should follow the principle of quality priority and reasonableness.

The "two-envelope" bidding system adopted in the bidding of essential drugs in Anhui Province has been recommended in the "Procurement Mechanism" and "all localities are encouraged to adopt it". This bidding system requires the preparation of economic and technical bids and commercial bids separately when preparing bids, and enterprises submit two bids at the same time.

The economic and technical bidding mainly reviews the production scale, distribution capacity, sales, industry ranking, market reputation, as well as GMP (GSP) qualification certification, drug quality sampling and random inspection history, electronic supervision ability and other indicators to ensure the quality of essential drugs. Only enterprises that pass the economic and technical bid review can enter the commercial bid review, and the business bid review is won by the lowest bidder.

In addition to strengthening quality management through system design, the essential medicines system will also improve electronic supervision and information systems. The SFDA will improve the national unified barcode of essential drug information and the drug electronic supervision platform, and carry out electronic supervision of all varieties of essential drugs. The "Procurement Mechanism" requires that from April 1, 2011, all provinces and municipalities (autonomous regions and municipalities) shall not purchase essential drugs that have not been included in the drug electronic supervision network and have not used the unified barcode of essential drug information.

In addition, the procurement of essential drugs has also established a "blacklist system", and the relevant departments will take punishment measures to clear out the national drug bidding and procurement market for enterprises that maliciously suppress and substandard drugs.

After the 2012 edition of the National Essential Medicines List, the focus of the next step of the essential drug system is still to continue to consolidate the centralized procurement mechanism of essential drugs, adhere to the provincial (autonomous region, municipal) unit of online centralized procurement, and implement the recruitment of production enterprises and procurement cooperation.

1. Policies and measures such as quantity and price linkage, two-envelope system, centralized payment, and whole-process monitoring.

Not all essential medicines can only be procured through two-envelope tenders. According to the classification and analysis of varieties in the 2012 edition of the catalogue, most essential drugs should be purchased online in a centralized manner by province (autonomous region, municipality), but for some varieties in the catalogue, different situations should be distinguished and different procurement methods should be adopted. For example, for exclusive varieties and essential drugs that have been basically stabilized and the market is sufficient after multiple centralized procurements, the national unified pricing will be piloted; For exclusive varieties, we can also explore the province (autonomous region, municipality) as a unit, according to the purchase quantity, regional distribution conditions, etc., directly with the manufacturer to negotiate the purchase quantity and **.

The quality threshold should be raised in the procurement of essential medicines.

With the launch of a new round of centralized procurement of essential drugs in some areas, the controversy about quality and quality in the double envelope has once again become a hot topic of social concern.

The double-envelope bidding system is a mechanism that organically combines the recruitment of enterprises, quantity, quality and quality in the centralized procurement of drugs, that is, the drugs participating in the bidding first pass the technical standard review of the assessment quality, and then enter the commercial bid review after passing the examination, and then determine the winning bid by bidding in the commercial bid evaluation. Through the two-envelope bidding system and other methods, make full use of market competition to form a reasonable procurement**.

Reducing the quality of drugs does not mean lowering the quality threshold, but it is still necessary to adhere to the quality priority and reasonableness. In 2021, the former State Food and Drug Administration and other 4 departments clearly required that enterprises pass the "Good Manufacturing Practice (2010 Edition)" (GMP) certification as an important indicator of quality evaluation, and stipulate that in the centralized procurement of essential drugs, if there are products from manufacturers that have passed the newly revised drug GMP certification to participate in the bidding, other products of the same kind that have not passed the newly revised drug GMP certification enterprises will no longer enter the commercial standard review stage.

This is an important measure to further standardize the centralized procurement mechanism of essential drugs, which is conducive to encouraging the concentration of essential drug production to advantageous enterprises; It is conducive to encouraging advantageous enterprises to pass the newly revised drug GMP certification as soon as possible to improve the quality of essential drugs; It is conducive to promoting the structural adjustment, optimization and upgrading of the pharmaceutical industry.

All localities should implement the spirit of the relevant documents in the new round of essential drug procurement, strictly follow the relevant regulations, further refine the procurement plan, adhere to the quality priority, the most reasonable, improve the "quality threshold" of the economic and technical standard evaluation, and give full play to the important role of the newly revised drug GMP in the two-envelope evaluation method. Adhere to the economic and technical standard review of qualified enterprises can enter the commercial standard review. At the same time, in the evaluation of commercial bids, a comprehensive evaluation of drugs with significantly low bids is carried out to avoid vicious competition and ensure that essential drugs are safe, effective and timely.

The views expressed below are those of individuals.

Since Anhui Province carried out the "double envelope" bidding system for the first time, all provinces across the country have begun to implement the evaluation mode of using double envelopes, that is, according to the production scale of the enterprise, the sales of drugs and the sales of drugs participating in the bidding, industry ranking, the integrity of enterprises and drug quality in each province, as well as GMP (GSP) qualification certification, drug quality sampling and random inspection history, electronic supervision capabilities and other indicators for review, in order to ensure the quality of essential drugs, Only the economic and technical standard review qualified enterprises can enter the review of the commercial standard, and the shortlisted enterprises will then bid for the product, the review, that is, the commercial standard review, in principle, by the lowest bidder.

It is true that the original intention of the two-envelope system is good, and it is hoped that under the premise of ensuring the quality of drugs, the quality of drugs will be reduced and the people will be benefited. However, as far as the current bidding form is concerned, the evaluation of economic and technical targets cannot open a large gap in the scores of shortlisted pharmaceutical companies, and the bidding for basic drugs no longer refers to the quality level of drugs, and the lowest one wins the bid. Those original products with high quality level and good drug effect cannot compete with domestic textiles, and naturally fail the bid.

In this case, the evaluation of economic and technical targets has become a virtual reality, and only the price is important!

Since the implementation of the "double envelope" system, feedback has been mixed, and the implementation of the zero difference rate of basic drugs has indeed made the people in some areas feel the benefits, but for some commonly used drugs because of manufacturing costs, zero profits and other reasons, they have gradually withdrawn from the market, and many people have complained bitterly. At the same time, the quality and efficacy of the standard drugs have also been questioned by all parties. As far as the current situation is concerned, the Ministry of Health of the People's Republic of China has begun to pay attention to it.

Since its implementation in 2009, the essential medicines system has entered a three-year adjustment period. The Ministry of Health of the People's Republic of China stated in the regular meeting in October that in the next work, it will continue to strengthen the comprehensive reform at the grassroots level, improve the construction of systems and mechanisms, guide and urge local governments to study and formulate implementation plans for the procurement of essential drugs, and further improve the "double envelope" bidding system. It is believed that for the bidding of basic drugs, the country will still make appropriate adjustments according to the current situation.

However, as a pharmaceutical company, it is not possible to blindly follow the requirements of the state and reduce the price of drugs to an unbearable level, because it has its own bottom line, on the other hand, it can affect the bidding office as much as possible, and some products can be selected into the bidding of essential drugs to ensure the clinical use of hospitals above the second level.

Same upstairs, embarrassing.

Well, I'm waiting for the day when the safety accident of winning the bid for the basic drug will cause everyone to reflect on the double envelope.

The original intention of the double envelope is also to reduce ** on the basis of quality assurance. When the economic and technical standards have reached a certain level of enterprises, can ensure the quality of the case, the competition.

But drugs are not ordinary things, and quality is difficult to measure with data. Taking the best as the main competitiveness will inevitably lead to the strategic focus of the enterprise on the first, which is definitely not a good trend.

When the rules cannot be changed, we can only wait for the results to change the rules.

I saw that it was a 50-point question, and I was very excited, and I was ready to recommend you, but I looked at the questioner.

In the bidding and bidding, there must be encountered the double envelope evaluation method, that is, before the bid opening, two envelopes submitted to the tenderer at the same time, if you do not understand its characteristics, can not carry out a good work, then today and the bid to see what is the double envelope evaluation method, what are the characteristics of the double envelope evaluation method?

1. What is the two-envelope bid evaluation method?

The two-envelope evaluation method refers to the bidder's bid evaluation method of sealing the bid and the bill of quantities in a separate envelope, and other business and technical documents in another envelope, and opening the bid in two times.

2. Precautions for the double-envelope bid evaluation method.

The bid evaluation procedure using this method is more complex and takes a long time, but it can eliminate the interaction between the technical part and the bidding, and it is more fair. Special attention should be paid to the confidentiality of information during the technical evaluation and the custody of the envelope.

3. Bid evaluation procedures for the two-envelope bid evaluation method.

1. When the bid is opened for the first time, the tenderer first opens the envelope of business and technical documents, and the letter is sealed and stored by the supervision authority or notary public.

2. The bid evaluation committee conducts a preliminary review of the business and technical documents

1) If the reasonably low bid method or the lowest bid evaluation method is adopted, the bid evaluation committee shall determine the list of bidders who have passed and failed the commercial and technical evaluation.

2) If the comprehensive evaluation method is adopted, the bid evaluation committee shall determine the list of bidders who have passed and failed the commercial and technical evaluation, and score the technical part of these bidding documents.

3. The tenderer shall issue a notice to all bidders, which shall indicate the time and place of the second bid opening. The tenderer will first announce the list of those who have passed the commercial and technical review at the bid opening meeting and read out their ** envelopes. For bidders who have not passed the business and technical review, their ** envelopes will not be opened and returned to the bidders on the spot.

4. After the second bid opening, the bid evaluation committee shall evaluate the bid in accordance with the bid evaluation methods specified in the bidding documents and recommend the winning candidates.

Fourth, the scope of application of the two-envelope bid evaluation method.

It is suitable for large-scale, technically complex or particularly complex projects, but according to the different characteristics of these Guiding Opinions and projects, the reasonable low price method, the lowest evaluation price method or the comprehensive evaluation method should be adopted.

The use of this method to evaluate the process is more complex and takes a long time, but it can eliminate the interaction between the technical part of the calendar and the bidding mu, which is more fair. Special attention should be paid to the confidentiality of information and the custody of envelopes during the bid evaluation of technical pants search.

The method requires the bidder to seal the bid, the bill of quantities and the contract estimate form separately in the first envelope, and other business and technical documents in another envelope, and submit them to the tenderer at the same time before the bid is opened. The tenderer first carries out the opening and evaluation of the commercial and technical bids, and then evaluates the bids according to the pass and disapproval, and then conducts the opening and evaluation of the envelope, in accordance with the relevant provisions of the bid evaluation measures, the bidders who have passed the business and technical bidding review are scored according to the 100-point system, and the winning candidates and reserve winning candidates are recommended in order from high to low. The implementation of the two-envelope bid evaluation method without a bid base has played a positive role in further standardizing the order of the bidding market and ensuring that the bidding activities are carried out openly, fairly and justly.