Zhang Rui: The market shortcomings of Chinese generic drugs

Zhang Rui

"I'm Not the Medicine God" (hereinafter referred to as "Yaoshen") is now explosive in the domestic theaters in China. On the first day, it exceeded the 300 million yuan box office mark;The real gold and silver with a facial book of 2.2 billion yuan.

The play tells the pharmacy owner Cheng Yong, smuggling a relatively low generic drug from India, and then sold to Chinese chronic leukemia patients in China, and then the story of a lawsuit.The audience who walked out of the theater was immersed in the scene rendering of the movie while tearing the eyes, while asking and asking China why there were no quality and low -cost generic drugs like India?

Equity of generic drugs is generally considered to have the same active ingredients, dosage forms, dosage channels and therapeutic effects as the original drug.The original research medicine is also a new drug of the source. It must be determined before the formal use of the disease, target protein activity screening, molecular structure optimization, animal toxicity test, and clinical observation and effective evaluation.For the Gleevese in "Medicine God", it cost more than $ 1 billion from research and development to formally invested clinical clinic. After nearly 30 years.

That's why, after the original research medicine enters the market, there are often legal protection periods of patents ranging from more than six years.As soon as the protection period is expired, other pharmaceutical companies can follow the molecular structure of the original drug to launch generic drugs.Preliminary estimates that by 2020, 200 original drug patents in the world have expired each year, among them, there are many star varieties.

Because there is no need to go through the long search and discovery and clinical trial process as the original medicine, the overall cost of generic drugs is naturally much smaller than the original research drug, and the market price is also much lower.However, since the component substance that is different from the original drugs is added during the synthesis and purification process, the efficacy of generic drugs cannot be simply divided with the original research drugs, but at the same timeBiological equivalent may also exceed the original research medicine.

At present, only large multinational pharmaceutical companies have the ability to develop the original research drugs, and generic drugs have become indispensable medical resources for all countries.In the United States, 90%of the prescription drugs on the shelves are generic drugs, and more than 95%of Western medicines in China are generic drugs.

The existence of generic drugs not only increases the competition in the drug market, the most important significance is to reduce the treatment cost of patients.As far as China is concerned, although the current official chemicals batch number, more than 95%have been given generic drugs, more than 4,300 Chinese companies are generic drug manufacturing companies, but generic drugs have never been sought after by patients like India and the United States.As a result, the original drug (including the original medicine that has been full of patent protection period) in the market accounts for 80%, and domestic generic drugs are only 20%of the share, and this result still occurs in the price of domestic generic drugs.One -third, or even one -tenth.

Indeed, the price -high original drug is not affordable by any patient, but as long as he has a certain ability, most patients and their families will give up generic drugs and choose the original medicine. Especially when facing major illnesses, China is domestic in China.Patients often use the original medicine without hesitation.

On the one hand, the clinical use period of the original medicine is much longer than the generic drug. The word -of -mouth effect is naturally stronger than the generic drug, and the use of the patented market exclusive period.Agreement; more importantly, the domestic pharmaceutical market in China was once mixed with fish and dragons, lack of standards, fakes and inferiority, and consumers' credibility of the quality and efficacy of generic drugs has always been difficult to improve. In fact, some domestic imitation actually imitationsThe effect of pharmaceuticals from the original research medicine is far away, & ldquo; No one dares to buy & rdquo; & ldquo; No one wants to use & rdquo; as a & ldquo; curse & rdquo; therefore, it has been repeatedly strengthened, and it is also further strengthened.Stimulates people's trust and loyalty to the original medicine.

In addition to the differences and consumption psychology, it constitutes the exclusion of Chinese domestic generic drugs. Some people also vividly say that domestic drugs have fallen into the hospital door before they reach the patient's hands.Not to mention & ldquo; Drug bonus & rdquo; in the system with & ldquo; to nourish the medicine & rdquo;As a result of the domestic generic drugs entering & ldquo; Cold Palace & rdquo; at present, the public hospital's drug bidding and procurement system itself has an operation mechanism for domestic generic drugs.The original medicine during the protection period can be obtained through negotiations.

In addition, the province -oriented pharmaceutical bidding purchase traffic & ldquo; one product, two regulations & rdquo; that is, a variety chooses one domestic import, which actually means that when domestic generic drug companies played in groups, the original research medicine had won the finals in the finals.Tickets.

In order to push the domestic generic drugs into the hospital and get the recognition of both doctors and patients, the Chinese government decided to complete the consistency evaluation of 289 domestic generic drugs by the end of this year.The same varieties of other pharmaceutical manufacturers should be completed in principle within three years, and those who are not completed within the time limit will be canceled and re -registered qualifications.The consistency evaluation is to let domestic generic drugs and original drugs be properly benchmarked, and accept the market judgment and recognition in the benchmark. At the same timePharmaceutical market structure.

It is reported that, as a generic drug of Gleevec, Jiangsu Haosen Pharmaceutical's & ldquo; Imarinib & rdquo; has become the first domestic generic drug that has passed the consistency evaluation, and Imaidib does not belong to 289 base drugs.The consistency evaluation is proceeded by its company.Here, we need to point out that if there are more pharmaceutical companies in China, it can show the courage of extraordinary proves like Haosen Pharmaceutical, and I believe that its collective fans that have won the market for domestic generic drugs are not far from time to time.

While implementing consistency evaluation, the State Council of China also issued a special document recently, requiring that generic drugs must be incorporated into the procurement catalog in time, and at the same time emphasized that the need to consistent with quality and efficacy, incorporating the drug catalog with the original drugs.But from now on, even if domestic generic drugs can enter the local medical insurance directory, as long as the hospital ignores it, domestic generic drugs are still helpless to wander outside the ward.Therefore, in order to encourage the enthusiasm of the hospital to purchase domestic generic drugs, the author suggested that it is necessary to give preferential policy support in the fiscal taxation link; or by increasing the proportion of medical insurance reimbursement, encouraging patients to use domestic generic drugs to force the hospital to increase domestic production to domestic productionPurchase of generic drugs.

It is worth noting that the care of policy and the power of inclined are very limited. It is necessary to practice the merits of the city in the market.At present, there are more than 4,300 domestic pharmaceutical companies in China, but most of them are small and medium -sized enterprises. There are only three companies with a scale of 100 billion., Far lower than about 80%global.

If the enterprise is not available, the financing capabilities will not be able to talk about it. The funds required for scientific research and development will be stretched. Enterprises can eventually be hovering forever in the low -end imitation.Therefore, breaking the & ldquo; Chicken Head Culture & RDQUO; and seeking a strong combination and industry capital optimization configuration should become a consistent action of pharmaceutical companies.

It is also necessary to emphasize that generic drugs should become a wide springboard in the eyes of pharmaceutical companies. If Chinese domestic pharmaceutical companies can take the initiative to improve the preparation and upgrade of the original research drugs, not to mention all, but just to make a minority generic drug, to the original research drugs than the original research drugsA better level, domestic generic drugs do not worry about the day when wings are not soaring and vertical.Of course, it is also difficult to do medicine and generic drugs.From the selection of raw materials to synthetic and purifying, to equipped with drug accessories, the ultimate generation of generic drugs requires strong production, processing and technical capabilities.

For pharmaceutical companies, whether it is to upgrade the original drugs or strengthen the improvement of generic drugs, it undoubtedly require continuous increase in research and development investment. At the same time, the government must provide sufficient policy support in terms of fiscal, taxation, financing and other aspects.

The author is a director and professor of economics of the Chinese Market Society

At present, there are more than 4,300 domestic pharmaceutical companies in China, but most of them are small and medium -sized enterprises. There are only three companies with a scale of 100 billion., Far lower than about 80%global.