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After the evaluation of generic drugs after the original research or will face price cuts?

  • Author:Jane
  • Source:YAOZHI
  • Release on :2017-05-11
At present, China's generic drug consistency evaluation of the relevant policies are in full swing and vigorously pursued, which for our country to imitation-based pharmaceutical industry, its significance is self-evident, but what does the original research drug mean?

Now there are two kinds of argument: First, the original drug efficacy has been recognized by the public and the market, generic drug consistency evaluation will not affect the original research drugs; Second, the consistency of generic drug evaluation of the original drug is not good, and even may become Life and death challenges. Which do you agree with? Let us listen to how experts say.

April 27, in the "China Medical Insurance" magazine hosted the fifth phase of the Youth Pharmaceutical Forum, the Chinese foreign-invested enterprises Association of drug research and development industry committee Yang Dongsheng director, from the original drug manufacturers point of view, the consistency of evaluation The effects were analyzed.

1 explain the concept of two

Consistency evaluation: refers to the already approved generic drugs, according to the original study of drug quality and efficacy consistent with the principle of sub-batches of quality consistency evaluation, is the generic drug to be in the quality and efficacy to achieve consistent with the original drug Level.

Reference preparation refers to a control drug for the evaluation of the quality of the generic drug and the efficacy of efficacy, usually by imitation of the object, such as the original drug or internationally recognized homologous drugs. Reference preparation should be the prescription process is reasonable, stable quality, the exact effect of drugs.

2 three pressures

First Drug Purchase Group Auction

When the generic drug is evaluated for consistency, the original drug is usually used as a reference formulation. Public hospital drug centralized procurement is currently required group bidding, consistent evaluation after the adoption of the original drug as a reference preparation, it is necessary and through the consistency of the generic group of the same tender bid. And centralized procurement of the current rules is mainly than the price, so for the original research medicine, the policy will have a very large price pressure.

The second Medicare payment standard refers to generic drugs

Generic drugs through the consistency of the evaluation, the current popular argument is based on its retail price as a health insurance payment standards. This means that the original a generic drug if the evaluation before the sale of 20 dollars, through the consistency of evaluation, if the sale of 30 dollars, then no matter how much money the original research drug, the fund may only be reimbursed according to 30 dollars. Which is much higher than the current price of generic drugs, the original may be a heavy blow.

The third reasonable price control fee is the main tone of the medical reform

Generic drug consistency evaluation is a cost, to spend a lot of money, these costs want to be reflected through the public hospital drug procurement to the drug price, that is, price increases. But now the focus of public hospital drug procurement policy is the price, lower than the price, not higher than the lowest in history. For example, this year to sell the drug is 80 dollars, next year would like to mention 100, the current policy is impossible. Can only go down, can not go up.

Reasonable price control is the main tone of health care reform, so generic drugs even through the consistency of the evaluation, whether it can significantly increase the price or unknown, the original drug may not be the price of generic drugs Dongfeng to ease the pain of the price.

3 reaffirm policy implications

China 's pharmaceutical industry to imitate the main. The generic drugs have important economic and social benefits such as reducing medical expenses and improving drug availability. However, due to the relatively weak basis of the early approved generic medicine research, the quality of some generic drugs is quite different from that of generic drugs. The clinical efficacy of generic drugs, improve the quality of generic drugs to safeguard public health is of great significance.

Previously, Song Ruilin, president of the China Association for the Promotion of Medicine Innovation, said in an interview with Xiaobao: "Before the country did not require generics to do consistency evaluation, like no test, Or did not meet the definition of generic requirements, so now do the consistency evaluation .After evaluation, confirm the same to continue to agree; inconsistent is out of the market. Need to clarify is that these products are not qualified to do consistency evaluation , But the country did not provide the original.

4 deal with a contradiction

As we all know, the original research and development of a large investment, risk, difficulty and long cycle characteristics. From the discovery of possible new drugs into the pilot compounds, patent applications began to carry out a long research work in order to eventually put a new drug to the market.

If the original research drug companies can not get enough drug R & D returns, resulting in huge investment in R & D costs are not compensated by the market, will greatly dampen the enthusiasm of pharmaceutical companies to study new drugs, which may hinder the national pharmaceutical industry development level.

On the other hand, because the original drug through patent protection to obtain a monopoly of the market, its price is too high, resulting in excessive expenditure on medical expenses. Promote the listing of generic drugs as soon as possible, will control the price of drugs, reduce the cost of medical expenses has a very important role.

So generic drugs and the original research has a unified relationship between the opposition. The relevant aspects and policies should be considered is how to promote the consistency evaluation of generic drugs at the same time, promote China's pharmaceutical industry innovation and development, enhance the level of research and development and international competitiveness. At the same time should also take into account the choice of different patients medication.