Sihaiwang: I'm not the God of medicine. A medicine named Gleevec is called "the God medicine", which has become the focus of hot discussion. It has caused a lot of repercussions to the society, but why are imported drugs still higher than foreign countries after tax exemption? Let's look at it in detail.
'I took the medicine for three years, ate the house and ruined my family. 'the patient's sad words make many people cry. The price gap between the well-known imported patent drugs and Indian generic drugs is also shocking.
In the hot debate, whether China should follow India's example and carry out 'patent compulsory licensing' for imported high-priced drugs is the most controversial topic.
It's a last resort to use compulsory licensing of 'nuclear weapons'
Gleevec is a life-saving drug in the treatment of CML. But the price of life-saving drugs is unacceptable.
Why is greavel so expensive? There's a classic answer: "the reason why it's so expensive is that it costs tens of thousands of yuan, because what you can buy is the second drug, the first one costs billions of dollars. '
The R & D cycle of the original research drug is long, the investment is huge and the risk is very high. During the patent protection period, in order to recover the cost as much as possible and earn enough profits, it will not be cheap to sell in any country. For example, from the discovery of the target to the approval of listing in 2001, it took 50 years and invested more than 5 billion US dollars.
At this time, some people may say, 'if China, like India, carries out compulsory patent licensing and drug imitation without the consent of the patentee, the drug price will not be so expensive. '
'this understanding is wrong. "Professor Wu Guanghai of Nanjing University of technology explained that in 1993, before China's accession to the WTO, the patent law was revised to meet the relevant provisions of the TRIPS Agreement and the Paris Convention. Among them, the provision that no patent is granted to drugs is deleted.
When India joined the WTO in 1995, the patent law was revised, but the drug patents before 1995 were not protected, and India also made full use of the 10-year transition period of developing countries, so the living space of generic drugs increased greatly. At the same time, India will also exercise the privilege of "patent compulsory license" to produce the original research drug that is still under patent protection. For example, the Patent Office of India issued a 'compulsory license' to NATCO to produce generic drugs of Bayer's liver cancer drug 'dogimes' on the grounds that' Bayer drugs are too expensive for ordinary people to afford '.
'there is also a system of compulsory (forced) drug imitation in China, but it has not been started for so many years. According to Wu Guanghai, China's patent law has special provisions on 'compulsory licensing of patents', involving articles 48-58. For drugs, whether to start compulsory patent licensing can only be considered under the four states of 'no enforcement of' antitrust ',' emergency 'and' public interest '.
"Patent compulsory licensing is like nuclear weapons, which has a great deterrent effect, but has a greater negative effect, and will not be used until it is a last resort," Wu said. "And some countries can only start it when they can't afford patent medicine and can't guarantee national basic medical care and national security. For example, Thailand and South Africa also used it in the outbreak of AIDS.
Patent system as a chip in drug price negotiation
'these pharmaceutical factories live by eating human blood steamed bread. "The reporter also heard a middle-aged woman gnashing her teeth.
Ordinary people who need special drugs will hate Novartis if their emotional control is not rational. Of course, the weak need sympathy, but in specific cases, it mainly depends on the social security system to achieve. The value of patent compulsory licensing system in medicine is more used to play an important role in the price negotiation.
As mentioned above, when domestic generic drugs are not expected for a while, patients have another life-saving straw: national drug price negotiation, in which the government comes out to lower the price of the original drug companies.
Sun libing, director of the intellectual property operation center of China Pharmaceutical University, said that because of the deterrent force of the patent compulsory licensing system, the first national negotiation on drug access to the medical insurance catalog made positive progress in 2017: 36 new drugs were finally included in the catalog, 15 of which were cancer drugs, with an average price reduction of 44%. For example, Herceptin, a life-saving drug for breast cancer, is cheaper than India's generic drugs after being reimbursed by medical insurance.
But in reality, many patients' families still have doubts: Why are the prices of some imported original research drugs still higher than those of other countries after the removal of tariff and value-added tax?
"This shows that the bargaining power of China's pharmaceutical industry is not enough. Sun libing believes that if China can develop "me too" drugs (referring to the drugs with independent intellectual property rights, whose efficacy is equivalent to the breakthrough drugs of the same kind), there will be no high-priced drugs. 'frankly, we still can't get competitive things. '
For example, after the patent protection period of Gleevec expired in 2013, three domestic generic drugs quickly obtained the production approval. The emergence of generic drugs has halved the price of Gleevec. Recently, 'Xinwei' produced by Jiangsu Haosen Pharmaceutical Co., Ltd. has become the first imatinib to pass the consistency evaluation, which also means that the domestic generic drugs of Gleevec have been proved to have the same efficacy as the original research drugs, and experts expect that it will further seize the market share of Gleevec.
In the face of major diseases, generic drugs can solve the urgent need for a while, but in the long run, they will not contribute to a country's pharmaceutical industry and national health. China is a big country of generics, and more than 95% of Western medicines are generics. For China, with a population of 1.3 billion, it is unrealistic and dangerous to rely on generic drugs to protect the health of the whole people.
It is not only a safeguard system but also a means of game
'patent is a kind of intangible property right, and the essence of patent system is to protect innovation. "Wu Guanghai said that the biggest problem of Chinese pharmaceutical companies is that they are lack of innovation and copy into fashion." if the hard-earned property is easily taken away by a robber logic, then who will work hard in the future? "
The lack of innovation ability is a long-standing weakness in China, and accelerating the construction of an innovative country has become the basic strategy of China. Therefore, according to the experts interviewed, it is impossible for China to reverse the patent system. However, the existing laws and policy documents still have room for full use.
"The State Council's newly released policy document on improving generic drugs has released new signals and greatly activated the strong generic system. "Wu Guanghai said that the general office of the State Council issued the opinions on reforming and improving the supply guarantee and use policy of generic drugs (hereinafter referred to as the opinions) on April 3, which clarified the path of compulsory license for drug patent implementation." this is to authorize relevant departments, which is equivalent to the sword of Shangfang. '
According to the opinion, it is necessary to 'implement compulsory licensing of drug patents by categories according to law, improve the accessibility of drugs', and' encourage patentees to implement voluntary licensing '.
'most manufacturers are reluctant to be adjudicated as patent compulsory licensing. Compared with patent voluntary licensing, the patentee's initiative to determine the amount of royalties will be weakened in the case of compulsory licensing. 'according to Wu Guanghai, the introduction of this document further increased the chips in drug price negotiation, and promoted the price reduction effect of patented drugs through negotiation by exerting pressure on patentees.
Experts said that the patent system not only protects the invention and creation from infringement, but also checks and balances the patentee to a certain extent, and plays a huge role in the game between countries.
"If the price of a patented product in the overseas market is much lower than that in the domestic market, it can be purchased by a third party from overseas and then sold to the domestic market through & lsquo; Parallel Import & rsquo;, thus breaking the manufacturer's price strategy. Wu Guanghai said that China's patent law has been amended for the third time in 2008, which has established the exhaustion of patent rights in parallel import, laying a foundation for China to take the initiative in international trade.
The experts suggested that domestic enterprises should carefully study and flexibly use patent weapons, so as to take the initiative in foreign trade and market competition.