After the conclusion of the negotiation of the National Medical Insurance Drug List in 2022, an antiviral drug called Paxlovid has attracted widespread attention. This is an oral drug developed by Pfizer for mild to moderate COVID-19, consisting of nirmatrelvir tablets and ritonavir tablets. However, negotiations for the drug failed in China, resulting in it not being included in the medical insurance,** up to 2,980 yuan a box. At the same time, the purchase price of the United States, Europe and other countries is about 500 US dollars (about 3500 yuan), while the generic drugs in India and other countries are only about 400 yuan. This is reminiscent of the movie "I Am Not the God of Medicine", which tells the story of an ordinary man who smuggles low-cost generic drugs from India in order to treat leukemia patients. This article will start with this movie, the concept, role and problems of drug patent pools and generic drugs, and why Paxlovid is difficult to reduce in price in China.
I Am Not the God of Medicine" protagonist Cheng Yong (played by Xu Zheng) is a vendor who sells Indian god oil, and in order to help his friend with chronic myeloid leukemia, he bought a generic drug called Gleevec from India. This drug is an innovative drug for leukemia developed by Novartis, but it is as high as 2 per box in China30,000 to 2580,000 yuan, and it needs to be taken for a long time. In comparison, generic drugs in India cost only 200 yuan per box. Cheng Yong began his ** career, bringing hope to countless leukemia patients and also bringing trouble to himself. He was eventually prosecuted for "obstructing credit card management" and "selling counterfeit drugs", but was acquitted with the support of many patients. The prototype of the film is the real leukemia patient Lu Yong, who is known as "the first person to be the first anti-cancer drug" because he bought a large number of generic drugs of Gleevec from India.
So, what is a generic drug?To put it simply, generic drugs are drugs that are produced by other pharmaceutical companies in accordance with the quality standards and specifications of the original drug after the patent of the original drug expires. The active ingredient, dosage form, route of administration, efficacy and safety of the generic drug should be consistent with the original drug, but the name and packaging of the drug may be different. The biggest advantage of generic drugs is that they are cheap, usually only one-tenth or one-hundredth of the original drug. For example, Gleevec in "I Am Not the God of Medicine" is a targeted drug that can inhibit the proliferation of leukemia cells, and is known as the "miracle drug". Its emergence has turned leukemia from a deadly malignancy into a chronic disease that can be controlled with drugs, with a five-year survival rate of up to 90%. However, it is also very expensive, costing about 300,000 yuan per year, and it has to be taken for life. In comparison, generic drugs in India cost only 200 yuan per box, and the cost is less than 1,000 yuan a month.
Why is there such a big gap between the original drug and the generic drug?This is mainly due to the fact that the R&D cost of the original drug is very high, and the risk is also very high. According to statistics, it takes 10 to 15 years for a new drug to go from R&D to marketing, with an average investment of $2 billion to $4 billion, and less than 10% of drug candidates can pass various stages of clinical trials and finally be approved. In order to improve R&D costs and obtain profits, original drug companies will apply for patent protection, so as to enjoy a monopoly position in the market for a certain period of time and set prices independently. In addition to R&D costs, the first grade of original drugs is also affected by the supply and demand of the pharmaceutical market, the cost of circulation, and policy factors. Generic drugs do not need to bear R&D costs, and only need to be produced and quality controlled according to the standards of the original drug, so they can greatly reduce ** and improve the accessibility and affordability of drugs.
Why can the Indian generic drugs in I Not the God of Medicine be legally produced and sold?This involves an important concept, which is the Medicines Patent Pool (MPP). MPP is a United Nations-supported public health programme established in 2010 in Geneva, Switzerland. Its purpose is to negotiate with innovator companies to put their drug patents into the patent pool, and then the MPP will license the patents to the generic drug companies, so that the generic drug companies can produce and sell low-cost drugs in authorized low- and middle-income countries, so as to improve the access of people in these countries to innovative drugs.
MPP mainly involves drugs for major infectious diseases such as AIDS, hepatitis C and tuberculosis, and has signed license agreements with 23 original drug companies, authorizing 24 drugs, covering 139 countries and regions, and benefiting more than 1 billion people around the world.
The operation mode of MPP is as follows: first, MPP will negotiate a voluntary license with the original drug company, and the original drug company can choose to put all or part of its drug patents into the patent pool, or it can set some restrictions, such as the scope of the country, the time limit of the authorization, and the fee of the authorization.