The price is down and the effect remains the same!

In order to alleviate the problems of difficult medical treatment, expensive medication, and heavy burden for patients, the National Medical Insurance Administration has successively carried out four batches of national drug centralized procurement since 2018, involving a total of 157 varieties and 533 selected products
.

The average price of selected drugs fell by more than 53%, and generic drugs accounted for most of the drugs included in the national drug collection list

On the 9th, the National Medical Insurance Bureau held a press conference to introduce the relevant situation
.

In this program, we will focus on issues related to generic drugs in centralized procurement:

First, what is a generic drug?

Second, are the therapeutic effects of generic drugs "the same" as the original drugs?

Third, how to ensure that patients use high-quality generic drugs?

Generic drugs are not "counterfeit drugs" or "fake drugs"

Let's first look at the first question, what is a generic drug?

Many people may not know much about generic drugs.
Generic drugs are not "counterfeit drugs" or "fake drugs".
Generic drugs are alternative drugs that have the same active ingredients, dosage forms, routes of administration, and therapeutic effects as the original drugs
.

According to international practice, once the protection of patented drugs expires, other countries and pharmaceutical factories can produce generic drugs.
This has also become an important way for countries to control treatment costs and improve the level of drug protection for patients
.

Generic drugs and original drugs are clinically equivalent

When the cost has come down, the price of medicine has naturally come down, but patients are also worried: If the price has come down, can the effect of the medicine be guaranteed? The second question is also a concern of many patients.
Are the therapeutic effects of generic drugs "the same" as the original drugs?

Prior to this, the relevant departments of medical insurance and health care jointly organized 20 medical institutions in Beijing to jointly carry out real-world research on the clinical efficacy and safety of the selected products in the centralized procurement of 14 representative generic drugs among the selected drugs
.

After two years of tracking more than 110,000 cases, the research team conducted research on the effectiveness indicators and adverse reactions of the drugs

At the press conference on the 9th, relevant experts introduced the research results
.

Zhang Lan, Director of the Department of Pharmacy, Xuanwu Hospital, Capital Medical University: Compared with the original drugs in the 14 centralized procurements we evaluated, there was no significant difference (statistical difference) in clinical effects and use (statistical differences), for example, in the treatment of virality.
In the case of hepatitis B patients, there was no statistical difference in the virological response rate between the two groups, and there was no statistical difference in the lipid-lowering drug's blood lipid compliance rate and the percentage of lipid-lowering drugs compared with the original drug
.

In terms of adverse reactions, that is, in terms of safety, we evaluated the safety of the 14 selected generic drugs compared with the original drugs, and there was no significant difference (statistical difference)

In the field of drug research and development, there is a professional term called "real world research", that is, in real clinical situations, in a non-experimental environment, collect relevant data on the use of the drug by patients for analysis and research
.

In this follow-up study, the 14 collectively-sourced generic drugs are clinically equivalent to the original drugs based on the data of "real world research"

The study focused on five major categories of drugs, including cardiovascular disease treatment drugs, drugs neuropsychiatric disorders, chronic hepatitis B drugs, anticancer drugs and injections
.

According to the indications and pharmacological characteristics of each drug, the research team selects targeted clinical efficacy and safety evaluation indicators, and verifies the clinical effects of the drug through multiple dimensions

Chang Feng, Professor of International Medicine Business School of China Pharmaceutical University: "Real-world research" is a very important, new and very important evidence for the equivalence between generic drugs and expired patent drugs
.

So for us in the future, we can return to international practice and be able to replace the original research drugs with a large number of high-quality generic drugs, which can reduce our medical insurance and patient expenditures, and then enable our medical insurance to cover more diseases and expand our coverage.

The state issued a document to ensure that patients use "relaxed medicine"

We see that generic drugs are not only cheap, but also clinically equivalent to the original research drugs
.

Next, there is the third question, how can we ensure that patients use high-quality generic drugs?

In 2016, China issued relevant documents requiring consistency evaluation of the quality and efficacy of all marketed generic drugs
.

Pave the way for high-quality generic drugs to replace original research drugs, and ensure that the masses can use "reasonable drugs"

Jiang Changsong, Associate Researcher of the National Institute of Medical Security, Capital Medical University: Generic drugs that can pass the consistency evaluation, in fact, we can actually call them high-quality drugs.
Medical staff and friends of patients are also welcome to use them
.
Over-rated generic drugs and original research drugs are actually equivalent, not only bioequivalent, but also clinically equivalent
.