为什么药品在印度如此便宜？药物定价中的经济学 [美国媒体]

Why are Medicines so Cheap in India? The Economics of Drug Pricing

为什么药品在印度如此便宜？药物定价中的经济学



India has been called the pharmacy of the world. Many generic drugs are made there and much of its drug production is exported internationally.

印度被称为“世界药房”。许多仿制药都是在那里生产的，而且它的大部分药品都出口到国际上。

Developing New Medicines is Risky and Expensive

（1）开发新药是有风险的而且成本高昂

Developing new pharmaceuticals is an incredibly complex, extraordinarily expensive, and a very risky endeavor. Unlike other innovative technologies, before the drug comes to the market it has to demonstrate safety and efficacy through remarkably expensive clinical trials.

开发新药是一项极其复杂、极其昂贵的工作，而且是一项非常冒险的尝试。与其他创新技术不同的是，在药物进入市场之前，它必须通过非常昂贵的临床试验证明其安全性和有效性。

To put things into perspective the California Research Association estimates that “only five in 5,000 or 0.10 percent of the drugs that begin pre-clinical testing ever make it to human testing. Out of the 0.10 percent that make it to human testing, only 20% ever get approved for human usage. Of these, 2 out of 10 marketed drugs are able to match or exceed R&D costs.

为了客观地看待这个问题，加州研究协会估计“在临床使用之前测试中，只有五千分之五或0.10%的药物能用于人体测试。在进行人体测试的这0.1%中，只有20%最终获得批准用于人体。而获批的这些药物中，只有1/5能够覆盖或者超过研发成本。（译者注：最终能够回收成本的只有十万分之四）。

Based on these statistics it is not surprising that failure is the expected outcome for most potential drugs. To make things more convoluted believe it or not the average research and development (R&D) cost of developing a new drug is estimated to be $5.5 billion over 15 years.

基于这些统计数据，预期大多数潜在药物会失败，也就不足为奇了。更复杂的是，不管你信不信，在过去15年的时间里，开发一种新药的平均研发（R&D）成本估计为55亿美元。

Potential Dilemma of Drug-Pricing

（2） 药品定价的潜在困境

The cost of developing a new drug is very expensive however the cost of manufacturing a drug that has already been invented is relatively cheap. For example, Lipitor one of the top-selling drug that lowers cholesterol costs $5.80 per 100 tablets to manufacture however the cost of inventing Lipitor was still in billions.

开发一种新药的成本非常昂贵，但是药物研发成功后，生产药品的成本相对较低。例如，立普妥（Lipitor）是最畅销的药物之一，它能降低胆固醇，生产成本为每100片售价为5.80美元，然而普妥的研发成本仍然高达数十亿美元。

The existence of high R&D costs and low manufacturing costs creates a huge problem for the overall drug development process. Due to low manufacturing costs, a pharmaceutical company that invests billions to develop a new drug faces immediate competition. Potential competitors without investing anything in R&D could manufacture the drug, enter the market, and sell a generic copy of the drug at a very low price. Because of this, the company that invested billions to develop the new drug can never recoup its R&D costs. Thus, this situation provides no incentive for anyone to invest in an already risky drug invention process.

高研发成本和低制造成本的并存，给药品的整个研发过程带来了巨大的问题。由于制造成本较低，一家投资数十亿美元开发新药的制药公司面临着直接竞争。没有在研发上投入任何资金的潜在竞争对手可以生产这种药物，进入市场，并以极低的价格出售仿制药。正因为如此，投资了数十亿美元开发新药的公司，永远无法收回研发成本。因此，这种情况导致不会有人投资于风险巨大的药物研发过程。

To incentivize drug invention pharmaceutical companies that innovate new drugs are provided patents i.e. market exclusivity. The market exclusivity provides an opportunity for the company to recover its R&D costs and make profits thus incentivizing innovation. The company however is given exclusivity only for a limited time (usually 10-12 years) after which the patents expire and generic companies can copy the medicine and enter the market. This process will eventually bring the prices down and provide treatments for life threatening diseases at extremely cheap costs.

为鼓励制药公司研发新药，政府授予药企专利，即垄断地位（译者注：原文意思是“市场排他性”）。垄断地位为公司提供了一个机会，使其能够收回研发成本并获得利润，从而激励创新。然而，公司的垄断性地位时间是有限的（通常是10-12年），专利到期后，药品仿制公司可以仿制药品并进入市场。这最终将降低药品价格，并以极低的价格为一些致命的疾病提供治疗。

The patent procedure allows the innovator pharmaceutical company to charge a high price for their drug to recoup their original R&D costs and report profits. For example, when Lipitor was still covered by a patent, the consumer cost was $272.37 for a 100 tablets, which provided Pfizer (the innovator company) a % markup of 4,696. Thus, it is not surprising that Lipitor generated more than $100 billion in revenue for Pfizer since it was approved in 1997.

专利权允许创新的制药公司对他们的药品收取高昂的费用，以收回他们最初的研发成本并获得利润。例如，当立普妥的专利权仍在有效期时，价格是100片272.37美元，这为辉瑞（药品研发公司）带来了4696%的溢价。因此，自1997年获得批准以来，立普妥为辉瑞公司创造了1000多亿美元的收入，这并不奇怪。

What makes medicines in India cheap?

（3）什么使得印度的药品如此便宜？

The patent system works well in countries where most people are covered by health insurance. This is the case in the west. Consumers pay a monthly or annual premium to insurance companies in exchange for coverage. By doing so the consumers do not incur the exorbitant cost of medication that the pharmaceutical company seeks to recoup its R&D costs.

绝大多数国民都被医疗保险覆盖的国家中，专利制度运行良好。这是西方的情况。消费者每月或每年向保险公司支付保险费，以换取保险。通过这样做，消费者不用承担制药公司为收回研发成本而收取的高昂的药物价格。

Things are very different in developing and underdeveloped countries. Most people in such countries are not covered by health insurance. Imagine a patient in India, a country with 276 million people living below $1.25 per day on purchasing power parity paying $272.37 for a 100 tablets of Lipitor. Hence it is not surprising that Lipitor was sold at a much lower cost in India than some of the western countries.

发展中国家和欠发达国家的情况则大不相同。在这些国家，大多数人没有医疗保险。想象一下，印度—— 一个有2.76亿人每天生活费低于1.25美元的国家——的一个病人（如何支付的起）每100片272.37美元的立普妥（按购买力平价计算）。因此，在印度，立普妥的售价比一些西方国家低得多，这也就不足为奇了。

To keep the costs of medications cheap, India has has made a series of policy decisions. For example, until 2005, India offered no patent protection for pharmaceutical products, which made the generic pharmaceutical industry thrive. When India became a part of World Trade Organization (WTO) it passed patent laws in 2005, however the laws only offered weak protections to pharmaceuticals. Hence, when new drugs come to the Indian market, they typically face generic competition pretty much right after their launch. The result is that medication in India is ridiculously cheap and generic pharmaceutical industry continues to thrive.

为了降低药物成本，印度已经做出了一系列的政策决定。例如，在2005年之前，印度不为药品提供专利保护，这使得仿制药产业蓬勃发展。当印度成为世界贸易组织（WTO）的一员时，它在2005年通过了专利法，然而法律只对药品进行了微弱的保护。因此，当新药物进入印度市场时，它们通常在上市后就面临仿制药的竞争。其结果是，印度的药物价格便宜得离谱，仿制药行业继续蓬勃发展。

However there is a less obvious downside to this approach. By offering pretty much no patent protection to drugs it delays entry of new pharmaceutical products into the Indian market. If companies that have incurred huge R&D costs cannot recoup their profits it is not surprising that this will be the case. A new drug comes to the US market one or two years after being approved by the FDA however it takes 5-7 years for the same drug to come out in the Indian market. Hence the low prices arguably come at the cost of significant delays in the availability of new drugs. Apart from delayed availability of drugs another downside comes in the area of R&D of new drugs.

然而，这种做法有一个不太明显的弊端。由于对药物几乎不提供什么专利保护，这也推迟了新药品进入印度市场的时间。如果那些研发成本巨大的制药公司无法收回成本，那么发生这种事情就不奇怪了。在美国，一种新药获得食品及药物管理局批准1到2年之后会进入美国市场，但同样的药物，进入印度市场通常需要5到7年的时间。因此，低价格的代价可能是新药的供应出现严重推迟。

Innovation of new drugs is bare minimum in India and without patent protection it is not surprising that is the case. If India desires to grow into its role as a scientific and technological powerhouse then it must come up with a way to provide some sort of patent protection to drugs thus incentivizing drug development and innovation.

除了药物的延迟供应，新药物的研发领域也出现了另一个不利因素。在印度，几乎没有药物方面的创新并且对于新药没有专利方面的保护。如果印度想要发展成为一个科学和技术强国的角色，那么它必须想出一种方法，为药物提供某种专利保护，从而激励药物研发和创新。