Is the imported drug still higher than the foreign tax after tax exemption?

Medical Network July 10th Recently, the relevant ministries and commissions have speeded up the approval of new drugs listed overseas, strengthened the supply of shortage drugs, and implemented a series of combination punches in anti-cancer drug price reduction.

2. Recently, a drug called Gleevec was called ' magic medicine ' and became the focus of hot discussion.

'I ate the medicine for three years, ate the house, and ate the family.' The patient’s helpless words made many people cry. The well-known price difference between imported patented drugs and Indian generic drugs is also Shock.

In the hot debate, China should not follow the example of India, and the patent compulsory license for imported high-priced drugs is the most controversial topic.

Gleevec is a life-saving medicine for the treatment of chronic myelogenous leukemia. But life-saving drugs are sold at an unacceptable price.

Why is Gleevec so expensive? I know that there is a classic answer: 'The reason why it is expensive to sell tens of thousands of dollars, because you can buy a second drug, the price of the first drug is One billion dollars. '

The research and development cycle of the original research drug is long, the investment is huge, and the risk is extremely high. In the patent protection period, in order to recover the cost as much as possible and earn enough profit, it will not be cheap in any country. In the case of Gleevec, from the discovery The target was approved for listing in 2001. It took 50 years to complete and invested more than 5 billion US dollars.

At this time, some people may say, 'If China is also like India, carry out a compulsory license for patents, without the consent of the patentee. drug Imitation, the price of medicine will not be so expensive. '

'This understanding is wrong.' Professor Wu Guanghai of Nanjing University of Science and Technology explained that in 1993, before the accession to the WTO, China amended the patent law to meet the relevant provisions of the Paris Convention of the TRIPS Agreement. Removed the requirement that patents are not granted for drugs.

India also amended the patent law when it joined the WTO in 1995, but it did not protect the drug patents before 1995, and India also made full use of the 10-year transition period in developing countries, and the living space of generic drugs increased greatly. Meanwhile, India It will also exercise the 'patent compulsory license' privilege to produce the original drug that is still under the patent protection period. For example, the Indian Patent Office issued a 'compulsory license' to Natco to produce the generic drug of the Bayer company's liver cancer drug 'Doshimi'. The reason is that 'Bayer drugs are too expensive, ordinary people can't afford it'.

'The law of drug-enforced imitation (strong imitation) is also available in China, but it has not been activated for so many years. ' According to Wu Guanghai, China's patent law has special provisions for 'compulsory licensing of patents', involving Articles 48-58. For drugs, only In the four states of 'not implemented' 'antitrust' 'emergency' and 'public interest', it is only possible to consider whether to initiate a patent compulsory license.

Wu Guanghai said, 'Patent compulsory licensing is like a nuclear weapon. The deterrent effect is great, but the negative effect is even greater. It will not be used if it is not necessary.' And some countries cannot guarantee the national basic medical care and national security because they cannot afford the patented drugs. Will start, such as Thailand, South Africa was also used when the AIDS epidemic broke out.

'These factories are based on eating blood and licking their heads.' The reporter also heard a middle-aged woman gnashing her teeth.

Ordinary people who need special medicines, if the emotional control is slightly irrational, will hate the enterprises like Novartis, Switzerland. The weak people need sympathy, of course, but in specific cases, they still have to rely on the social security system to achieve. The value of the compulsory licensing system on drugs is more used to play a heavyweight role in drug price negotiations.

As mentioned above, when the domestic generic drug is not expected for a while, the patient has another life-saving straw: the national drug price negotiation, that is, the government has come forward to lower the selling price to the original drug company.

Sun Libing, director of the Intellectual Property Operation Center of China Pharmaceutical University, said that the deterrence of the patent compulsory licensing system has made positive progress in the first national negotiations for the 2017 medical insurance drug access: In the end, 36 new drugs were included in the catalogue. Among them, 15 are for the treatment of oncology drugs, with an average price reduction of 44%. For example, the treatment of breast cancer 'life-saving medicine' Herceptin, after reimbursement through medical insurance, the original research drug is cheaper than the Indian generic drug.

However, in reality, many families of patients still have doubts: Why do some imported original drugs are still higher than other countries after removing tariffs and value-added taxes?

'This shows China medicine The bargaining power of the industry is not enough. ' Sun Libing believes that if China can develop a 'me-too' drug (referring to drugs with independent intellectual property rights, its efficacy is comparable to similar breakthrough drugs), the price of drugs will not exist. 'That is white, or we can't find something competitive.'

Taking Gleevec as an example, after the patent protection period expired in 2013, three domestic generic drugs quickly obtained production approvals. The emergence of generic drugs has reduced Gleevec by half. Recently, Jiangsu Haosen Pharmaceutical produced '昕维' became the first imatinib to pass the consistency evaluation, which also means that Gleevec's domestic generics proved to be consistent with the original drug efficacy, experts expect this will further seize Gleevec's market share .

In the face of major diseases, generic drugs can solve the urgent need, but in the long run, it will not affect the pharmaceutical industry and the whole people of a country. health Contributing. China is a big drug-like country, and more than 95% of Western medicine is a generic drug. For China with a population of 1.3 billion, it is unrealistic to rely on generic drugs to protect the health of the whole people.

'Patent rights are an intangible property right, and the essence of the patent system is to protect innovation.' Wu Guanghai said that the biggest problem for Chinese pharmaceutical companies is the lack of innovation, which is like the wind. 'If you work hard to earn a family property, you can be confused by a robber logic. It’s easy to take away, then who will work harder in the future?

Insufficient innovation capability is a drawback of China. Accelerating the construction of an innovative country has become China's basic strategy. Therefore, the experts interviewed believe that it is impossible for China to reverse the patent system. However, the existing laws and policy documents still have full use of space. .

'The State Council issued the latest revised generic drug policy document, releasing new signals, and greatly activating the imitation system.' Wu Guanghai said that the General Office of the State Council issued the "Revision and Improvement of the Supply of Generic Drugs" on April 3 And the opinions of the use policy (hereinafter referred to as the "Opinions"), clarified the compulsory license path for the implementation of drug patents, 'this is the authorization to the relevant departments, equivalent to Shangfang Baojian.'

The "Opinions" stated that it is necessary to "classify and implement drug patent compulsory licenses according to law, improve the accessibility of drugs" and 'encour patent owners to implement voluntary licenses'.

'Most manufacturers are reluctant to be compulsory for patent compulsory licensing. Because compared to the voluntary licensing of patents, in the case of compulsory licensing, the patentee’s initiative to determine the amount of royalties will be weakened. ' Wu Guanghai believes that this The introduction of the document further added to the bargaining chip in the drug price negotiations, and exerted pressure on the patentee to promote the price reduction effect of the patented drug through negotiation.

Experts said that the patent system not only protects inventions from infringement, but also has certain checks and balances on patent holders. The game between countries is even greater.

'If the price of a patented product in overseas markets is much lower than the domestic price, then it can be purchased and re-sold by a third party from the third party through the 'parallel import' method, thus breaking the manufacturer's price strategy. 'Wu Guanghai said, China Through the third revision in 2008, the Patent Law has established the exhaustion of patent rights in parallel imports, laying the foundation for China to take the initiative in international trade.

Experts interviewed suggest that domestic enterprise The patented weapons should be carefully studied and used flexibly to take the initiative in foreign trade and market competition.

The patients who can't afford Gleevec have risked buying cheaper generic drugs from India. This is both the helplessness of the patients and the sorrow of the domestic drug market.

Recently, Jiangsu Haosen Pharmaceutical '昕维' became the first imatinib to pass the consistency evaluation, which also means that Gleevec's domestic generic drug '昕维' has been proved to be consistent with the original drug efficacy. The efficacy of generic drugs has been continuously proven and included in the scope of medical insurance, and cheaper generic drugs will usher in more market opportunities.

However, the current situation in the market is that patients have concerns about generic drugs, and the enthusiasm of domestic pharmaceutical companies for generic drugs is not too high. Deputy Director, Research Fellow, Institute of Economics, Chinese Academy of Social Sciences, Director of Public Policy Research Center, Chinese Academy of Social Sciences Zhu Hengpeng said that it is not difficult to do generic drugs, but pharmaceutical companies have no incentive to do high-quality generic drugs. This is because of strong publicity. hospital More like high-priced drugs. 'In the domestic pharmaceutical market, public medical institutions hold more than 75% of drug retail, whether for patients or pharmaceutical companies, they firmly occupy a monopoly position. 'Zhu Hengpeng analysis.

Zhao Heng, a partner of Latitude Health, a medical strategy consulting company, said: 'After the adoption of the conformity rating, the development of generic drugs has gained a huge market, because the future medical insurance payment price will be determined according to the price of generic drugs. The original drug does not cut prices, doctors And the hospital can't use it, because the part that exceeds the medical insurance payment price becomes the cost of the hospital, and the hospital can no longer go so much like using high-priced medicine.'