Recently, the movie "I am not the God of medicine" has set off a drug price war. India's "strong imitation" mode has increased the price of Chinese drugs by ten times. If our country does not follow the Indian drug imitation route, what should China do? On the one hand, it is the protection of intellectual property rights, on the other hand, it is the people's livelihood problems caused by high drug prices, which is really a dilemma.
'I used to help people buy cosmetics on behalf of others when I went to India. My friend sent me descriptions and pictures. I went directly to the drugstore to buy cosmetics. The process was no different from that of buying cosmetics on behalf of others, but the price was 10 times higher than that in China, which was really a surprise. '
Recently, after the film "I am not the God of medicine" became a hot topic, Li Wei (pseudonym), who had the experience of purchasing the film's hero Cheng Yong, told the surging news that he had worked in a multinational pharmaceutical company for many years, and the high drug price problem presented in the film did exist, but friends in the pharmaceutical industry around him expressed another view on the evaluation of the film, believing that the film just showed the current situation of high drug price But it doesn't say why. It seems to be biased.
The CML targeted drug, Gleevec, was listed in China for more than 10 years, and was included in the medical insurance catalog in 2017. In that year, 36 kinds of drugs, including Herceptin, were also included in the medical insurance through direct negotiation between the State Bureau of human resources and social security and pharmaceutical companies, most of which were anti-cancer drugs, and became one of the effective means in drug accessibility at the national level.
According to an analysis by a person related to the centralized purchase of government drugs, the release time of the film coincides with the new establishment of the National Medical Insurance Bureau. "Before the meeting of the State Council, it was very clear to solve the accessibility problem of anti-cancer drugs. Next, we can expect the medical insurance Bureau to issue the top-level design and specific measures. '
On July 5, the above-mentioned personage who did not want to sign said that the first symposium will be held after the establishment of the National Health Insurance Bureau, and it is expected that there will be discussions on the drug price negotiation and medical insurance access. The '36 varieties are certainly not enough, and the drug price negotiation of anti-cancer drugs is expected to be normalized, but the negotiation at the national level is also very limited, and it is expected that these issues will all be in the deed established by the health insurance bureau Off board solution. '
Although there are many expectations for the newly established medical insurance bureau, Wang Zhen, deputy director of the public policy research center of the Chinese Academy of Social Sciences and researcher, analyzes that the fundamental problem of high price of domestic anti-cancer drugs lies in the lack of innovation in the domestic drug industry.
"The pricing of drug companies follows the law of pharmacoeconomics. When there is no other treatment plan for the disease in a region, the drug is irreplaceable, and patients have no choice, so the price will naturally be high. Wang Zhenxiang's surging news analysis shows that compared with Europe, America and Japan, it is difficult for China to develop more advantageous and independent intellectual property rights of the same disease drugs after the import of new drugs.
In Wang Zhen's view, the only advantage of our negotiation at present is to 'exchange quantity for price'. But to solve the problem fundamentally, we can only steadily encourage drug innovation, and optimize the utilization of existing social security funds and resources. The goal of medical reform has never changed, that is, we should make rational diagnosis and treatment, and do not waste money on unnecessary drugs. '
Pharmaceutical companies: India's "strong imitation" model is not the fundamental solution
In the film, Xu Zheng plays Cheng Yong, whose prototype is Lu Yong, a private enterprise boss in Wuxi, Jiangsu Province. After suffering from CML, he has to take the targeted drug Gleevec produced by Novartis, a Swiss pharmaceutical company, for a long time.
The initial listing of Gleevec was known as "magic medicine". Even in the United States, the price was converted into RMB 17500. After the introduction into China, plus tariff and other pricing, it was RMB 24800. Before it was included in the national medical insurance catalog in 2017, patients had a heavy burden of medication.
In the process of taking it, Lu Yong bought India's "Gleevec" produced by India's imitation pharmaceutical factory through a friend's introduction. The difference between the efficacy and the original research is not big, but the price is only one tenth or even lower than that of domestic Gleevec.
Not only Greaves. Under the background of government's intervention in intellectual property rights, Indian pharmaceutical companies have rapidly developed into "world pharmaceutical companies" in recent decades. Almost all innovative drugs that are first listed in the United States, Japan and other places can quickly find low-cost generic drugs in India.
For the targeted drugs represented by Gleevec, the original research and development plant needs to invest a lot of money in the early stage, and it takes decades to find accurate targets and develop drugs, which is a high cost process; compared with that, the generic pharmaceutical plant has to do a lot of simple things.
On July 6, a person in charge of a global well-known multinational pharmaceutical company, who did not want to be named, replied to the surging news that, in addition to the pricing factors in line with the government's price policy, enterprises need to take into account the previous research and development costs as well as the subsequent production process, transportation and storage costs.
Based on this, the protection of intellectual property rights is clearly included in international trade agreements.
However, through the "strong imitation" system, India supports domestic pharmaceutical companies to carry out drug imitation.
The so-called "strong imitation", that is, the patent compulsory licensing system, allows restrictions on patent ownership in special circumstances. In international law, it was first established in the Paris Convention for the protection of industrial property.
In China, the current patent law also includes this article. In addition, in the opinions on reforming and improving the supply guarantee and use policy of generic drugs issued by the State Council in 2017, the licensing path is further clarified, pointing out that 'in the country, there is a serious epidemic situation of infectious diseases and other public health emergencies or a shortage of drugs for the prevention and control of serious and serious diseases, which has a negative impact on public health safety or When public health causes serious threat and other unusual situations', compulsory license can be implemented to maintain public health.
Although it is feasible to carry out "strong imitation", China has no precedent. Even from a global perspective, only a few countries have launched "strong imitation".
(strong imitation) in fact, it is the practice of backward countries. As the second largest economy in the world, China's intellectual property protection is a national policy, and India's practice is not applicable to us. "Wang Zhen said.
In the long run, the development of the generic drug market in India will inevitably restrain the impetus of new drug research and development, "and it is not the fundamental solution to the drug problem," said the aforementioned well-known multinational drug enterprise personage.
Liu Peng, a professor at the school of public administration of Renmin University of China and researcher at the National Development Institute, suggested in an interview with surging news that the patent protection system for patented drugs could be reformed, the patent protection period should be appropriately shortened, and at the same time, imported pharmaceutical enterprises should be encouraged to sell the patent drug royalty, or exchange the old technology for the market, and joint production with domestic pharmaceutical enterprises should be encouraged to effectively reduce costs.
In fact, surging news also learned that even in countries and regions with a sound intellectual property system, pharmaceutical companies have a large space in the pricing process.
The head of the multinational pharmaceutical enterprise also mentioned that another factor affecting the pricing is' the comparison with the existing standard therapies, not only in terms of price, but also in terms of effect, as well as the assessment of how much the overall medical cost can be reduced by the new drugs'.
In other words, the price of new drugs is also related to the current medical level of the country and the overall medical cost expenditure of the country. Compared with the United States and Japan with more advanced R & D technology, the demand elasticity of our country is lower. A large number of patients become the rigid demand group of new drugs, and drug companies will not take the initiative to reduce prices due to fierce competition.
Wang Zhen believes that China's drug innovation ability has been insufficient, so for some imported drugs, especially new anti-cancer drugs, the dependence is very high. "Some countries will soon develop new drugs or treatment programs, and in the competitive situation, drug companies will naturally reduce prices, but the level of research and development of domestic drug companies is low, and patients can only pay for the drugs that want to survive and are expensive. '
Apart from respecting patents, what else can China do?
In 2002, Gleevec entered the Chinese market for the treatment of patients with chronic myeloid leukemia in the acute stage, accelerated stage or after the failure of interferon treatment, and patients with malignant gastrointestinal stromal tumors who can not be surgically removed or metastasized.
Although the effect is outstanding, but the high price makes patients unable to afford it, so there is the movie's hero prototype, Lu Yong, who buys generic drugs in India on behalf of others.
In recent years, the central government has been deeply involved in the suffering of many patients with cancer drugs.
At the two executive meetings of the State Council in April and may this year, it was specially mentioned to speed up the price reduction of anti-cancer drugs. In addition to the implementation of zero import tariff from May 1, the government also adopted centralized procurement, including anti-cancer drugs into the medical insurance reimbursement catalogue, and accelerated the import and listing of innovative drugs. Imported chemical drugs will no longer be subject to batch by batch compulsory inspection.
As for the hot discussion of the film, the aforementioned anonymous people from the relevant aspects of drug procurement of the government's health department said that, in fact, from the relevant meetings of the national level and the State Council, we can see the determination of the government to solve the problems related to anti-cancer drugs, etc., "the release time of the film is also very correct, which coincides with the opportunity of the establishment of the National Health Insurance Bureau, and we should say that there are many expectations.".
After the institutional reform of the State Council in 2018, the National Medical Insurance Bureau was established, merging the links of medical insurance reimbursement service pricing, bidding procurement, medical insurance fund payment and so on, which were originally scattered in the Ministry of human resources and social security, the Ministry of health, the national development and Reform Commission and other departments, into one department.
According to the above-mentioned government sources, recently, the National Health Insurance Bureau will hold the first thematic Symposium on drug procurement after its establishment, which will be attended by relevant government personnel from some provinces and cities. "How to implement Premier Li Keqiang's speech, including how to purchase, specific operation of new drugs into the medical insurance, dynamic update of the medical insurance catalog and other issues, will be discussed in the conference. '
In 2017, the Ministry of human resources and Social Security launched the first national negotiation on drug access to the medical insurance catalogue. After four months of preparation and negotiation, 36 new drugs were finally included in the catalogue, with an average price reduction of 44%.
The Financial Times reported that the outcome of the negotiations highlighted the cooperation of the world's major pharmaceutical companies with the Chinese government's action to reduce drug prices, although this slowed down the revenue growth of some products.
Before that, due to the fact that the medical insurance catalogue hasn't changed for many years, only a few provinces and cities have made fine adjustments to the catalogue within their own scope, including some new drugs with high demand for patients, and even fewer varieties have been included. After all, there is no big data to support the provincial drug economy, and the cost survey is also difficult to do, so whether the provincial linkage will be formed after the establishment of the medical insurance bureau is also the focus of attention. '
The source also said that the list of basic varieties of medical insurance, which has been criticized for many years, is expected to be a dynamic update. The news was also mentioned in the recent China Medical Health Summit Forum.
Kang Wei, executive director of the pharmaceutical research and development industry committee (rdpac) of the China Association of foreign funded enterprises, said in a speech at the meeting that "in view of the access of innovative drugs, the Ministry of human resources and social security once proposed a dynamic adjustment plan for the medical insurance drug catalog, which is of great concern to all. I expect that this policy will be introduced next year. As far as I know, the biggest change of dynamic adjustment policy in the future is the application system. New products can be applied and negotiated actively, which is a huge progress. '
However, according to Wang Zhen's analysis, although the establishment of the medical insurance bureau can let some drugs enter the medical insurance, it can't fundamentally solve the problem. "Although the original decentralized departments are merged, there is little difference between what can be done and what before, because there are only so many social security funds. '
Communist military guerrilla leader and political commissar