The state encourages innovation, why should it vigorously develop generic drugs?



In recent years, innovative anti-cancer drugs such as targeted drugs and biologics have emerged, and there are more accurate and effective ways to treat tumors in addition to traditional chemotherapy. However, because these innovative drugs are often imported patented drugs, the price is expensive, and the average patient can not use it or can not afford it, which is a pain point of widespread concern in society. Not long ago, The General Office of the State Council issued the Opinions on reforming and Improving the policy of generic drug Supply Security and Use, proposing to promote the research and development of generic drugs, improve the quality and efficacy, and improve the support policy, coupled with the subsequent introduction of the zero tariff policy of imported anti-cancer drugs, this internal and external change, so that people can reduce the cost of drugs and use more effective new drugs, there are more expectations.

Zhang Yuhui, chief physician of the respiratory and critical Care Medicine Department of Beijing Chaoyang Hospital, has worked in the respiratory department of Beijing Chaoyang Hospital for more than 20 years. In the past 20 years, she felt that the most difficult thing to face was patients who could not afford targeted drugs. One of Zhang Yuhui's patients, only 30 years old, is a terminal cancer patient, because the use of expensive targeted drugs, the family can only choose chemotherapy.

Zhang Yuhui said that targeted drugs are better than chemotherapy drugs, its safety is better than chemotherapy drugs, less toxic. Because the patient is very sick, she wants to give him some less toxic drugs. Clearly know that there is medicine can be saved, but there is nothing to do, as a doctor, Zhang Yuhui feels very helpless, very sad, but also very uncomfortable.

There is no medicine, not only the patient suffering, the doctor suffering, the country is also very anxious. In 2016, the national drug price negotiation was launched, and in two years, through two national negotiations, nearly 20 anticancer drugs have entered the national medical insurance catalog. A few days ago, The State Council held an executive meeting and decided to implement zero tariffs on imported cancer drugs from May 1. All these efforts are aimed at making good medicines available and affordable to the people. However, many serious diseases and special diseases are chronic diseases, although there are policy subsidies and charitable donations of drugs, patients still have to bear part of the cost, and they have to take drugs for a long time, and the accumulated burden is still very heavy.

How can we solve this problem? Let's start with an example. Gefitinib is a special drug for the treatment of lung cancer, which was first developed by an American company and successfully launched in China in 2005. Because there is no alternative medicine in China, the price of gefitinib in the domestic market has been high, as high as 5,000 yuan per box. In February 2017, gefitinib and tablets developed by a domestic pharmaceutical company were listed, with a price of less than 2,000 yuan per box, which not only broke the market monopoly of foreign pharmaceutical companies, but also reduced the price of imported gefitinib tablets by half.

Liu Jie, chief physician of respiratory Department of Shandong Cancer Hospital, told reporters: "For advanced non-small cell lung cancer, the use of domestic gefitinib treatment, the state bear about 20,000 yuan, patients bear about 20,000 yuan, you can get lifelong medication, so that for most patients can afford, many patients can get the best treatment, but also get the best survival."

It can be seen that the most fundamental way to solve this problem is to have alternative drugs that are consistent with the original patented drugs in terms of quality and efficacy. Therefore, many countries, including China, encourage the combination of imitation and innovation, that is, vigorously develop generic drugs while developing innovative drugs.

According to Fu Hongpeng, a researcher at the Health Development Research Center of the National Health Commission, generic drugs refer to a drug that is produced by a manufacturer that does not have a patent and can replace the original patented drug after its compound patent expires, and its research and development cost is low, which can meet patients well and can be affordable economically. All countries in the world have developed generic drugs, for some countries with relatively backward pharmaceutical industry, the development of generic drugs is a necessary way for the development of pharmaceutical industry.

On April 3, The General Office of the State Council issued the Opinions on reforming and Improving generic drug Supply Security and Use policies, which put forward 15 specific opinions from promoting research and development, improving quality to supporting policies. China is a major producer of generic drugs, nearly 5,000 pharmaceutical companies, 99% are generic drug companies, nearly 170,000 drug approvals, more than 95% are generic drugs. It is embarrassing that although there are some patented drugs, we have alternative generic drugs, but for safety reasons, doctors are still more willing to use patented drugs with a long time on the market and exact efficacy in clinical practice, and most patients will choose patented drugs if economic conditions allow.

Why do doctors and ordinary people have little confidence in domestic generic drugs? Shi Luwen, a professor at the School of Pharmacy of Peking University, was commissioned by relevant departments in 2014 to do some projects. Research shows that China's generic drug companies have been excessively competitive for a long time and repeated production at a low level, resulting in uneven drug quality and affecting public confidence.

Therefore, this "opinion" proposes to establish an inter-departmental information sharing mechanism, formulate and regularly publish the list of drugs to encourage imitation, formulate the list of drugs to encourage imitation, take the demand as the orientation, strengthen the technical research of generic drugs, and include some key common technology research in the relevant national science and technology plans; We will strengthen technological research on generic drugs, and guide enterprises to develop, register and produce high-quality generic drugs that are in short supply.

Fu Hongpeng said: "Mainly to encourage five categories of drugs, one is clinically necessary, effective but in short supply of varieties, the other is children's drugs, infectious disease drugs, and public health emergencies, and the last is the patent is about to expire within a year, there is still no enterprise to apply for imitation of this drug, the focus is to guide the development of such drugs."

To make people have confidence in generic drugs, the key is to improve the quality and efficacy of generic drugs. The development history of China's pharmaceutical industry is relatively short, and the regulatory approval of drugs has a gradual process. Foreign generic drugs are approved according to the same standards as the quality and efficacy of the original drug, and China only began to implement this work in 2015. This time, in the "Opinions" again emphasized that it is necessary to accelerate the evaluation of the quality and efficacy of generic drugs.

How do we understand this consistency? Domestic gefitinib is the first batch of products that passed the consistency evaluation announced by the country in December 2017, and it has three similarities compared with the original drug.

Zheng Xiaoqing, assistant director of the pharmaceutical preparation Institute of a pharmaceutical enterprise group, said: "The first consistency is that the prescription process is completely consistent with the original product, so as to ensure the consistency of clinical efficacy; The second consistency is the consistency of product quality test results; The third is the consistency of the clinical effect and the original product. This has also been well demonstrated in our three clinical trials."

It seems that it is not easy to make high-quality generic drugs. Innovation and imitation, it seems to be a contradiction, but in fact, high-quality generic drugs are definitely not a simple copy, it needs to thoroughly study the original drug, the same need for research and development and innovation. The research and development of domestic gefitinib lasted for 6 years and invested more than 100 million yuan.

Bao Haizhong, vice president of a pharmaceutical enterprise group, said: "To make a good generic drug, the first is research and development, in the research and development stage, the establishment of the production prescription process and the setting of quality standards have determined the innate quality of drugs; How to build a quality assurance system consistent with the international developed countries is also very key to the consistency of drug production quality, so only from the research and development, production, transportation and storage of all aspects of quality control, drug life cycle management, in order to ensure the quality of drugs in the final use process."

Therefore, in this "Opinion", from pharmaceutical excipients to packaging materials, process level, and then to the review and approval of drugs, quality supervision, a series of planning for the whole industry chain of generic drugs.

There are still many links between making high-quality generic drugs and actually using them by patients. Although some of our generic drugs are consistent with the original drugs in terms of quality and efficacy, their promotion in the market is not ideal. Statistics show that the original research drug gefitinib has entered more than 1,200 hospitals in China, while domestic gefitinib only entered more than 200 hospitals in China.

Xu Yuanling, vice president of a pharmaceutical enterprise group, said: "Even after entering the hospital, there are some restrictions on the use of, for example, some provinces and cities clearly stipulate that in the country's 36 negotiated varieties, the original drug does not account for the proportion of drugs, and generic drugs occupy the proportion of drugs, if it is the proportion of drugs, it limits the hospital's prescription."

Shi Luwen, director of the Department of Pharmaceutical Management and Clinical Pharmacy at Peking University's School of Pharmacy, said: "To really make this product play its role, the following policies need to be supporting, from bidding, procurement and the entire medical insurance reimbursement, to entering the hospital, we need to build corresponding supporting mechanisms."

Therefore, in this "Opinion", it is clearly proposed that generic drugs should be included in the procurement catalogue in a timely manner, and manufacturers and brands should not be restricted, so as to promote equal competition between generic drugs with the same quality and efficacy and original research drugs; The generic drugs with the same quality and efficacy should be included in the list of drugs that can be substituted with the original drugs, marked in the instructions and labels, guided and encouraged doctors to use, and strengthened the role of pharmacists in drug allocation; At the same time, it is necessary to speed up the formulation of payment standards for medical insurance drugs, and generic drugs and original drugs with the same quality and efficacy should be paid according to the same standards.

Liu Lihong, chief pharmacist of Beijing Chaoyang Hospital, said: "Put the drugs that have passed the consistency evaluation in the procurement catalog, so that doctors can better understand which drugs have passed the consistency evaluation, another point is to let doctors give priority when prescribing drugs, it has a system that gives priority to generic drugs." Another important thing is that Medicare pays for drugs that are evaluated in accordance with consistency, and the support of such a system is actually very beneficial to promote the use of our generic drugs."

Shi Luwen, director of the Department of Pharmaceutical Management and Clinical Pharmacology at Peking University School of Pharmacy, said: "The 13th article in 2017, also specifically talks about the role of pharmacists, that is, the (prescription) opening of the name, as long as the two are exactly the same, through the consistency evaluation, we should set a policy, there are pharmacists quality inspection, can be in the same general name, choose generic drugs, the price is relatively cheap, so as to increase the proportion of hospital use."

In Beijing Chaoyang Hospital, the reporter saw that they opened a precision medicine clinic, a morning of patients, which is the country's first pharmacist to visit the drug clinic. In this hospital, the prescription prescribed by the doctor must be reviewed by the pharmacist before it can be delivered to the patient, and the role of the pharmacist is increasingly prominent in the medical behavior. We should not only allow people to use affordable high-quality drugs, but also rational drug use and precision drug use, which is the future direction.

Whether the people can use and afford high-quality generic drugs is related to whether the burden of patients can be reduced, the choice of drugs can be increased, the national health level is related to the sustainable development of the pharmaceutical industry. In order to improve the level of generic drugs, we must start with the whole chain, not only to improve the quality and efficacy of drugs from the research and development and production, but also to pave the way for the market promotion and supply security of generic drugs from the system. This New Deal from the promotion of domestic generic drugs, expand the import of drugs at the same time, it can be said that the next is a set of forced drug companies reform and innovation, enhance the competitiveness of the chess.