Is it against the law to buy Indian high imitation drugs on behalf of others
4hw.com.cn: recently "I am not the God of medicine" has brought the problem of high price medicine into the public's vision again. In addition, the film also focuses on the purchase of high generic drugs from India as the main line, and tells some contradictions between human feelings and laws. Many small partners are curious. Is it against the law to buy high generic drugs in India? Let's have a look.
Multiple price differences make Indian generic drugs popular in China
Generic sales in India have become an 'underground market'
Most of the Indian generic drugs that are popular in China are anti-cancer drugs. The reason why they are popular in China is simply that they are cheap. Because India does not strictly protect foreign patented drugs, the generic drugs in India are very cheap. The average price of generic drugs in India is only 20% - 40% of the patented drugs, and the difference of individual varieties is even more than tens of times.
In 2002, when Lu Yong was diagnosed with CML, he ate a box of Gleevec produced by Novartis, Switzerland, at 23500 yuan, and later found that the box of Gleevec produced by India was only 4000 yuan. Now, his group purchase price is only 200 yuan a box.
Due to the huge price gap, the purchase of Indian generic drugs has formed a huge 'underground market' in China: some of them will even provide formal purchase invoices, and then send them directly to China as the evidence of 'genuine drugs'. There are also local Indians who use rich resources to carry out direct mail purchase services. According to the reports of domestic media, there have been more than a dozen criminal cases involving the sale of 'Indian version of anti-cancer drugs' in recent years, and some of them have been worth more than 10 million yuan.
This kind of disorder has also attracted the attention of China's regulatory authorities. Lu Yong's detention is an example of the relevant Chinese authorities' efforts to crack down on the illegal sale of Indian generic drugs. After all, the quality of these drugs in circulation underground is not guaranteed. If you take fake drugs, you will delay your illness, and if you take them seriously, you will do more harm. But such a move is not only no one to cheer up, but also a cry for Lu Yong from leukaemia patients. The online debate is also fierce, so it can be seen that the fight against generic drugs in India by relevant departments is a very controversial move.
Discussion on the definition of fake medicine
According to the provisions of the drug administration law of China, imported drugs need to undergo clinical monitoring, and the drug import registration certificate number is the real drug. This means that in the case of Lu Yong, although the efficacy of the Indian generic Gleevec has been recognized by patients, and it is also produced legally in India, but because there is no certification license, they are fake drugs according to the law of our country. For this one size fits all rule, cancer patients who can't afford expensive imported drugs and use Indian generics as life-saving drugs won't pay. This is also an important reason why the purchase enthusiasm of cancer patients remains unchanged despite the constant emphasis of the drug regulatory department that about 75% of overseas anti-cancer drugs purchased online are fake drugs.
Ruan Qilin, a professor at China University of political science and law, believes that drugs that are licensed in some countries are regarded as fake drugs only because they do not have the approval number of China's drug regulatory authorities, which is actually an administrative violation. Hu Shizhi, an economist, asked: 'whether drugs are genuine or not and whether they are sold guilty depends not on the drugs themselves, but on whether they have been approved by the government departments. In this way, you can't understand whether the law is intended to protect the victims, or whether it is necessary to protect the approval rights of the government departments at the expense of manufacturing the victims? It can be seen that scholars have different views on whether such regulations are appropriate and how to really protect patients.
From the perspective of the law enforcement of the investigation and punishment of fake drugs, it only depends on whether there are approvals, which is reasonable. But from the perspective of many patients, these Indian generic drugs without approval are definitely life-saving drugs. How can we say they are fake drugs? Therefore, the general definition and attack of fake drugs will not only fail to protect consumers, but even damage the interests of consumers. Whether there is a flexible approach to really think about the needs of patients is something that the competent department needs to seriously consider.
Group purchase of generic drugs in India is indeed illegal, but whether to bear the penalty is questionable
According to the eighth amendment to the criminal law of China, as long as there is a subjective intentional production and sale of counterfeit drugs, no matter whether it is for profit or not, and no matter whether it is actually personal injury, it constitutes a crime. This regulation has undoubtedly increased the efforts to deter the manufacture and sale of fake drugs and protected the life safety of consumers, but it has ignored the special situation of Lu Yong, a kind of agent buyer. Before Lu Yong, there had been cases of punishment for purchasing Indian generic drugs.
Lu Yong's special case is that, according to the report, he is just helping the leukemia patients. From a broader point of view, Lu Yong's buying on behalf of others can't be said to have 'social harmfulness'. What's a crime?
Even in the case of conviction, the law of our country still has the stipulation of exemption from criminal punishment: a certain act constitutes a crime, but it is exempted from criminal punishment because of the minor circumstances of the crime. But Lu Yong's behavior is not only mild, without social harm, but also has great social public welfare. Even the local prosecutors believe that "from the perspective of ordinary people, Lu Yong's behavior is to some extent" heroic ". It can be seen that it is not only reasonable but also legal for 300 white blood patients to ask the judicial authorities to exempt Lu Yong from criminal punishment.
In November, the Supreme People's court and the Supreme People's Procuratorate jointly issued a new judicial interpretation: it is not a crime to sell a small amount of drugs processed privately according to folk traditional formulas, or to sell a small amount of foreign and overseas drugs imported without approval without causing harm to others or delaying diagnosis and treatment, if the circumstances are obviously minor and the harm is not serious.
Although Lu Yong buys thousands of patients on behalf of them, it's hard to say that it's a "small amount of sales" in such a situation, there are so many patients who need Indian generic drugs. Secondly, Lu Yong's purpose is not to make profits. Whether it should be considered as a crime or not should be considered as appropriate.
Lu Yong's story is regarded by many as the Chinese version of Dallas buyer's club. The Oscar nominated best picture is about how a patient in the late stage of AIDS struggles with the disease: the protagonist smuggles unapproved drugs from all over the world to prolong his life and that of his sick friends, which has been fighting with the FDA for a long time. In the film, the judge's speech is thought-provoking. The judge said to the FDA, "you directly interfere with the circulation of drugs that even the patients themselves think are harmless, and the court is deeply troubled; the establishment of the drug administration is to protect the people, rather than prevent them from getting help. "Sometimes our laws are unreasonable. If a person is confirmed to be critically ill, they should have the right to use the methods they think will help. '
There is still a lot that the country can do to change the situation of India's underground sales of generic drugs
Changing the situation of increasing the price of imported drugs can make cancer patients enjoy cheaper anticancer drugs
In this year's "New Oriental famous teacher Li Rui teaches students to receive red envelopes" video, famous teacher Li Rui once said frankly that each department only makes money from tumors, targeting drugs for treatment, a course of 100000 & hellip & hellip;
The "targeted drugs" here refer to the imported anti-cancer drugs produced by some multinational pharmaceutical companies. It is true that imported patent drugs are expensive, but especially in China. According to a 2012 survey, the average price of 31 imported drugs sold in the Chinese market is twice that of the UK. According to a 2013 report, 'Herceptin' with the same specification for breast cancer treatment costs 24500 yuan in the mainland, while the lowest price in Hong Kong pharmacy is only about 14800 yuan.
According to the insiders, the logistics and business expenses of pharmaceutical giants account for 7% ~ 8% of the drug price, and the dealers involved are generally about three, with a premium of 5% ~ 7% for each dealer, and a premium of 7% ~ 8% for the last level of dealer to hospital chain. In the case of GlaxoSmithKline bribery, 30% of the drug fee was used for bribery. Rapatinib, the targeted treatment drug for breast cancer, was produced by GlaxoSmithKline and sold for tens of thousands of yuan per box.
In addition, the value-added tax rate of drugs in mainland China is 17%, far higher than the average value of 8.8% in European countries, and 0% in the United States, Australia and other countries. If the expensive life-saving medicine can implement certain tax relief, it can also make the medicine cheaper.
India's' strict 'patent restrictions are also worth learning
Patent medicine has always been one of the most serious conflicts between developed and developing countries. Developed countries often think that the development of new drugs will be affected if drug patents are not protected. However, some developing countries believe that it is a moral responsibility to produce cheap drugs for their own people, and the patent rights of drugs need to be restricted. In this regard, India's practice is the most typical. Although under international pressure, India issued a patent law in 2005, which allows the first patent right to drugs, it is limited to drugs discovered after 1995.
As an example, as early as 2006, in order to protect its intellectual property rights, Novartis took the Indian government to court and appealed to the Supreme Court of India after losing the lawsuit. However, in 2013, Novartis was still defeated. The reason for the failure of the appeal was that the court thought that the new version of Gulliver was not innovative because it did not have much difference from the original version.
Compulsory licensing is a powerful tool for developing countries to break the barriers of pharmaceutical patents
India has very little patent protection for drugs, which is also a very special case in the world. If there is no reference, then "compulsory license" (without the consent of the patentee, other units or individuals are allowed to directly implement their invention and creation) may be a powerful tool for developing countries to break the barriers of pharmaceutical patents in developed countries, which is not uncommon in the world. In Thailand, for example, around 2006, in the face of the country's serious AIDS epidemic, Thailand carried out a "compulsory license" for anti AIDS drugs. In addition, Thailand has also implemented compulsory licensing of four cancer treatment drugs, including Gleevec, according to WTO rules. As a result, Novartis has promised to provide cancer patients in Thailand's national health insurance plan with the drug free of charge.
In addition to Thailand, Brazil, South Africa, Indonesia and other countries have similar cases of using WTO rules to bargain for patent monopoly drug companies for the right to health of patients with major diseases.
With the help of a huge market of 1.3 billion people, it is not impossible for China to negotiate with international pharmaceutical giants to reduce the prices of these patented drugs substantially. In 2005, China promulgated the measures for compulsory licensing of patent implementation involving public health issues. Although this is only for infectious diseases, the patent law of the people's Republic of China, which was revised at the end of 2008, has also clearly stipulated that "for the purpose of public health, a compulsory license can be granted to the patented drug & hellip. So far, however, the State Intellectual Property Office has not received an application for compulsory patent license. The reason is said to be that the purpose of public interest 'is very extensive, difficult to quantify, and the scope cannot be specifically measured'.