What opportunities and challenges does the development of the pharmaceutical industry face in the 21st century?

Huicong Medical News: In May 2006, two translated books related to the pharmaceutical industry were released almost at the same time. One is "Shaping the Industrial Age: The Extraordinary Journey of the Modern Chemical and Pharmaceutical Industries" by Alfred Chandler Jr., a famous master of business and economic thinking (Huaxia Publishing House), and the other is "New England Medicine" "The Truth About the Pharmaceutical Industry" by Marcia Angell, former editor-in-chief of "Magazine" (Beijing Normal University Press).

The book "Shaping the Industrial Age: The Extraordinary Journey of the Modern Chemical and Pharmaceutical Industries" reflects Chandler's unique historical description and analysis of the chemical and pharmaceutical industries, painting a complete picture of Industrial development picture. Judging from the master's choice of modern chemical industry and pharmaceutical industry for summary and analysis of the 20th century industrial era, he, a business historian, has given high recognition to the chemical industry and pharmaceutical industry.

As for Angell’s book, as long as you see the fine print under the title: “How a $200 Billion Industry Scammed Us.” you will know that this is a book that is very critical of the current situation of the pharmaceutical industry. book. In comparison, Angel's book has the characteristics of a best-seller, with sharper words and very pointed views. It reveals the inside story of the pharmaceutical industry layer by layer and exposes the hidden rules of the industry.

But has the pharmaceutical industry really become a "liar" and a "pest" in the 21st century? Is the pharmaceutical industry a high-tech industry that creates products that save human lives, or is it a profiteering industry that relies on marketing methods to promote drugs?

Angel said: "Drugs are extraordinary. Human health and even life require drugs to maintain. But the pharmaceutical industry makes us uneasy."

The book "The Truth about the Pharmaceutical Industry" Discusses seven major problems that have existed in the U.S. pharmaceutical industry (mainly large pharmaceutical companies) since 1980: pharmaceutical companies have produced too many imitation innovative drugs and too few innovative drugs; the U.S. FDA has been too obedient to the industries it regulates ;Pharmaceutical companies have too strong control over the clinical research of their own products; patent and market monopoly periods are too long and too flexible; pharmaceutical companies have too strong influence over the medical education of their own products; regarding research and development, sales promotion and pricing The information is not transparent; the price is too high and the price difference is too large. To sum up, the U.S. pharmaceutical industry faces three major difficulties:

First, technological innovation is weak. After the revolution in prescription drugs during World War II, a large number of new drugs were introduced. In the 1940s, an average of 20 new drugs were launched each year, and in the 1950s, an average of 50 new drugs were launched each year. From 1998 to 2002, the average number of innovative drugs approved by the US FDA was less than 12. Among the 78 new drugs approved by the FDA in 2002, only 17 contained new active ingredients, and only 7 were improvements on old drugs. Most of the new drugs were what Angel defined as "imitation innovative drugs." But the pharmaceutical industry claims to be investing ever-increasing amounts of money in research and development. The Pharmaceutical Research and Manufacturers of America (PhRMA) claims that the U.S. pharmaceutical industry invested US$30 billion in R&D in 2001. As Tuft Center President Kenneth I. Kaitlin said: "Bringing new drugs to market is always a very expensive and risky endeavor, and our recent research shows that costs are still skyrocketing."

When technological innovation is so difficult, how does the pharmaceutical industry respond? That is to produce imitative innovative drugs and formulate favorable patent and market monopoly term protection policies. The pharmaceutical industry is not innovating, Angel said. They are enjoying the leftovers of a feast from the distant past.

The second is the marketing problem. The top ten pharmaceutical companies disclosed in their annual reports to the U.S. Securities and Exchange Commission and shareholders that in 1990, 36% of the company's sales revenue was spent on "selling and administrative expenses" (this expense is 2.5 times the research and development expenses). This proportion will be discussed next. remained almost unchanged for 10 years.

Where did the huge sales expenses go? Interpretations from the pharmaceutical industry, the U.S. General Accounting Office (GAO), and many media outlets differed from Angell's version.

But Angell’s revelations, I think, will definitely make pharmaceutical companies and many doctors feel a thorn in their backs.

As Angel said, the main sales target of pharmaceutical companies is not the public but doctors, and pharmaceutical representatives are in and out of doctors' lives. Since 2000, the American Medical Association and government departments have taken actions to regulate the behavior of medical representatives. But companies don’t have only one channel to influence doctors. They can also let doctors use their drugs through medical education, medical conferences and even clinical trials.

The third is the absence of social responsibility. When people get sick, do they have the right to receive medical treatment? As an industry that produces life-saving products, does the pharmaceutical industry have the right to charge high prices? Should the pharmaceutical industry directly influence the decisions of Congress and regulators (the FDA) in order to safeguard their own interests?

It is true that people can tolerate expensive Hermès scarves, Louis Vuitton handbags and Armani suits, but it is difficult to accept that they cannot afford medicine when they need it. This is because there are a large number of alternatives behind those luxury goods that can satisfy the needs of different groups of people. The substitutability of medicines is very small. If poor people and rich people suffer from the same disease, the symptomatic medicines are the same. At this time, price will directly affect the availability of the drug. At present, the pharmaceutical industry has not been given the responsibility to ensure the availability of drugs, but the industry should really reflect on its behavior, at least not to let society think that they are "troublemakers" who do not assume social responsibility.

Although "The Truth about the Pharmaceutical Industry" is written about the situation in the United States, who can say that Chinese companies are not also struggling with these problems? (The author is a Ph.D. from the Guanghua School of Management of Peking University and a postdoctoral fellow from the School of Economics and Management of Tsinghua University. He currently works in the Policy and Regulation Department of the State Food and Drug Administration.)

Economic Daily, August 4, 2004: With the rapid advancement of genetic technology, the 21st century has been considered the century of biotechnology. However, the biotechnology industry has not been smooth sailing, and the investment community's attitude towards biotechnology has been hot and cold. According to an analysis by the British "Economist" magazine, the main reason why ordinary people are skeptical of the biotechnology industry is that they confuse short-term problems with long-term potential.

Unlike the information industry, the biotechnology industry is hardly affected by the economic boom cycle. It is full of huge global business opportunities in the fields of medical care, agriculture and industry. The recent successful development of a new drug for colon cancer by a well-known American pharmaceutical company once again proves the strong vitality of the biotechnology industry. As long as the biotech industry survives the long research and development period, it can reap huge rewards once its products hit the market. Relevant experts predict that the new colon cancer drug will earn the company at least US$20 billion. Looking at the global biotechnology industry, its three gold mines have become increasingly prominent.

Gold Mine 1: Gene Technology

According to expert analysis, in the history of biotechnology development, the three major technological breakthroughs that won the Nobel Prize were all gene technologies, and they all have billions of dollars. of commercial value. The first is the gene recombination technology in the 1970s. Amgen, the world's largest biotechnology company, used this technology to develop new anti-anemia drugs and earned sales of US$6.3 billion.

The second is also the single-cell antibody technology of the 1970s. Genentech, the oldest biotechnology company in the United States, earned US$2.8 billion in sales revenue in 2002, mainly from the application of this technology. .

The latest one is RNA interference technology, which was rated as the greatest breakthrough in biotechnology by the authoritative scientific magazine "Science". It also has huge commercial application value. "Fortune" magazine commented that it is a new biotechnology drug. the next hot spot.

In addition, the use of genetically modified technology is creating new miracles. According to statistics from the International Agricultural Biotechnology Application Service Agency, more than 7 million farms in 18 countries around the world planted genetically modified crops in 2003, with a planting area of ??tens of millions of hectares, an increase of 40 times in the past seven years. China's genetically modified technology has developed rapidly, and genetically modified cotton has accounted for half of the total area, increasing farmers' income by 5 billion yuan every year. More than 400 other varieties, such as genetically modified rice, corn, soybeans, and vegetables, have entered the safety evaluation stage, and several varieties have met the conditions for industrialization.

Gold Mine 2: New Drug Development

The use of biotechnology to develop new drugs is currently one of the most popular and profitable fields. The year before last, global sales of new biotech drugs reached US$20 billion, a year-on-year increase of 23%. A survey of global pharmaceutical companies conducted by a professional pharmaceutical magazine in the United States shows that the world's top 25 large companies have developed 1,932 new drugs, of which 59 were developed by the companies themselves and 41 were obtained through patent acquisitions. GlaxoSmithKline alone, ranked first in the world, has developed 176 new drugs. According to estimates by the US "Business Week", new colon cancer drugs will generate annual sales revenue of US$1 billion after they are launched this year.

It is reported that humans have been able to produce more than 500 biological drugs for more than 200 diseases, and more than 300 million people around the world have benefited from this. Currently, there are more than 200 biological drugs in clinical trials around the world, of which 1/3 are Class I new drugs. Medical biotechnology will comprehensively improve the level of medical and health science and technology in terms of prevention, disease diagnosis, drug manufacturing, and biological treatment, and promote the fourth medical science and technology revolution.

Gold Mine Three: Industrial Field

The application of biotechnology in industry is called the "new industrial revolution" by the industry. A report by McKinsey & Company states that by 2010, one-fifth of the global chemical product output will be biomanufactured products. In the global market share of 280 billion US dollars in chemical products, chemical products manufactured by biotechnology will occupy a large part.

The British "Economist" magazine pointed out that the technology of using enzymes to produce chemicals in large quantities is very mature. In the next 10 years, new enzymes are expected to be applied in the production of plastics and fuels. A small niche company in the United States is expected to be able to use bacteria to mass-produce plastic by the end of this year. Its price can even compete with petrochemical compounds currently produced chemically. In addition, some companies are experimenting with extracting glucose from corn and other plants for use in the production of plastics and ethanol. Some experts predict that energy biotechnology is expected to replace "black gold" with "green gold" and alleviate the pressure of energy shortages.

According to statistics, the global biomass energy reserves are 1.8 trillion tons, equivalent to 64 billion tons of oil. The development of biomass energy has a very bright future. At present, major breakthroughs have been made in the production processes of fuel alcohol technology and biodiesel technology, and biohydrogen production technology is also in the research and development stage. In the near future, people will eventually be able to drive safe and energy-saving cars and airplanes that use bioenergy.