The business club reported on January 5 that Obama had won the medical reforms. One of the important factors was that the US pharmaceutical industry favored his proposal.
In 2010, the harsh new economic realities dominated the decisions of the U.S. and European authorities, and the pharmaceutical industry took full advantage of the opportunities in emerging markets to maintain steady growth in performance.
American Medical Reform Victory
Although the Republican Party strongly opposed, the reform of the U.S. healthcare system was finally passed in March. The new medical reform is the largest reform of the U.S. healthcare system since the 1960s. It has expanded the coverage of U.S. medical insurance to another 32 million Americans. One of the important factors for Obama’s victory in medical reform is that the U.S. pharmaceutical industry favored his proposal. The American Institute of Pharmaceutical Research and Manufacturers (PhRMA) has spared no effort to promote the new healthcare reform.
In pharmaceutical pricing, the pharmaceutical industry has secured 12 years of exclusive sales rights in biological products. The industry agreed to provide US$80 billion in concessions over the next 10 years to contribute to reducing the cost of health insurance. The part of the offer will be reflected in the discount on drug prices, so that Americans over the age of 65 can purchase cheaper brand drugs.
European drug price storm
In recent years, the growth of the European pharmaceutical market has been weak, but this area is still very important for the pharmaceutical industry. In 2009, Europe accounted for more than 30% of global pharmaceutical revenue. The terrible economic conditions in Greece caused the country to drastically cut its drug prices by 27% in March 2010. Spain reduced its brand drug prices by 7% and lowered the price of generic drugs by 25%. France launched a €2.4 billion cost-saving plan in November, saving 860 million euros in medicines and medical devices.
Germany reduced the cost of new prescription drugs by reducing the drug price by more than 2 billion euros (US$2.76 billion).
Italy cuts its health care costs by 24 billion euros, of which 1.35 billion euros will come from reductions in drug costs. In 2011, Italy will also lower the price of anti-cancer drugs because it will adopt a "pay-for-performance" approach to drug prices.
China promotes global growth
In March, IMS Health released a research report titled "Reshaping the New Order in the World Pharmaceutical Market: A Reclassified World." The report proposes that in 2011 China's pharmaceutical sales will exceed France and Germany, becoming the world's third largest pharmaceutical market after the United States and Japan; in 2013, nearly half of the sales growth came from emerging markets.
In 2010, the total drug sales in these countries reached US$123 billion, accounting for approximately 16% of the US$770 billion in global drug sales. Sales in emerging markets contributed 37% to the growth of the global pharmaceutical industry. It is estimated that by 2011, the global pharmaceutical market will reach 880 billion U.S. dollars, and the growth of the Chinese market will make a greater contribution. IMS Health predicts that China's pharmaceutical sales, which is currently the third largest market in the world, will grow by more than 25% over the next year, exceeding US$50 billion. At the same time, 17 emerging pharmaceutical countries are expected to grow at a rate of 15 to 17% in 2011, reaching 170 billion to 180 billion US dollars. Drug sales in 17 emerging markets are expected to increase significantly. According to the decreasing order of market value growth, the report classifies these countries (IMS is called the emerging pharmaceutical market) into three levels. China alone occupies the top floor.
European generic pharmaceutical vision
In February, the European Generic Drugs Association (EGA) proposed the "Generic Drug Vision 2015", which aims to establish a globally competitive generics industry with the goal of increasing the availability and affordability of high-quality drugs for patients. To ensure the sustainable development of the entire European medical market.
EGA gives incentives to generic pharmaceutical companies in terms of R&D and taxation, and encourages innovation in biosimilars and clinical trials throughout the industry, while strictly following the principles of mutual recognition and strengthening the coordination of single markets.
According to the IMS MIDAS market survey data, the European generic market ranks eighth in the global market, with a value of 57 billion euros, and it has grown by 8% in 2009, and the growth rate in 2008 was 3%. According to estimates by EGA, the value of the generic market in Europe is 31 billion euros, and the annual growth rate is 6%. Price policies, reimbursement levels, and substitutes for generic drugs are the main drivers for the development of generic drugs markets.
Avandia exposes regulatory vacuum
In September, GSK’s diabetes treatment drug, Avandia, was evacuated from the European market because the drug caused a greater chance of heart attack, heart failure, and stroke in patients.
In the United States, the FDA has taken an approach that does not completely require the product to be withdrawn from the market. Many critics say that the actions taken by the regulators are too slow and they have not given sufficient vigilance in monitoring the safety of Avandia.
In another incident, the German Drug Evaluation Agency unearthed data from Pfizer's trial of the antidepressant reboxetine. These data show that reboxetine is an anti-depressant that is not effective and potentially harmful. Analysts believe that there is a “regulatory vacuum†in the EU: Pharmaceutical companies are not legally required to publish all test data.
Pharmaceutical promotion costs filing
In April, Pfizer announced in detail the costs it paid to American doctors. The reason for being forced to disclose the costs in detail is that the U.S. government has sued the company for its illegal marketing activities. Data show that from July to December 2009, Pfizer paid $35 million to approximately 4,500 healthcare professionals. Pfizer was the first pharmaceutical company to publish fees for doctors to carry out Phase I-IV clinical trials in addition to doctors' speeches and consultations. New medical regulations in the United States require that all pharmaceutical companies must submit fees for doctor consultation, lectures, meals, and other allowances.
Manufacturers and government war of words
The Danish diabetes company Novo Nordisk had a verbal battle with the Greek government in May, threatening to withdraw its modern insulin products from the Greek market to protest the country’s drug price cut by 25%. Afterwards, the Greek government agreed to only lower the price of the company’s products by 10%. In the past few years, Greek hospitals have owed large amounts of debt to pharmaceutical companies and medical device manufacturers.
In December 2009, a total of 1.2 billion euros of funds was repaid to pharmaceutical companies and medical device manufacturers. However, in the next few years, 5.6 billion euros of arrears will need to be paid through the government bond system.
These actions have created a dangerous precedent: If pharmaceutical companies believe that cost control measures are too harsh, they can effectively fight the government by evacuating products.
Reduced capital development line
The multinational pharmaceutical companies represented by Pfizer have reduced the number of drugs in the product development line in 2010 in order to renew extensive attention to its R&D efforts. Taking Pfizer as an example, Phase I R&D projects will bear the brunt of the reduction. Among the 31 R&D projects, Phase I R&D projects accounted for 15 cases. Pfizer needs to carefully study which drugs will help it reduce the impact of imminent patent failures.
In addition to Pfizer's streamlining of its R&D team, major multinational pharmaceutical companies have closed Europe and the US R&D centers, cut projects, and moved more R&D activities to emerging markets in the Asia Pacific region. In the treatment of cancer, multiple sclerosis, and autoimmune diseases in 2010, the pharmaceutical industry has achieved some breakthroughs, and more inventions will be born to bring more choices and solutions to patients.
In 2010, the harsh new economic realities dominated the decisions of the U.S. and European authorities, and the pharmaceutical industry took full advantage of the opportunities in emerging markets to maintain steady growth in performance.
American Medical Reform Victory
Although the Republican Party strongly opposed, the reform of the U.S. healthcare system was finally passed in March. The new medical reform is the largest reform of the U.S. healthcare system since the 1960s. It has expanded the coverage of U.S. medical insurance to another 32 million Americans. One of the important factors for Obama’s victory in medical reform is that the U.S. pharmaceutical industry favored his proposal. The American Institute of Pharmaceutical Research and Manufacturers (PhRMA) has spared no effort to promote the new healthcare reform.
In pharmaceutical pricing, the pharmaceutical industry has secured 12 years of exclusive sales rights in biological products. The industry agreed to provide US$80 billion in concessions over the next 10 years to contribute to reducing the cost of health insurance. The part of the offer will be reflected in the discount on drug prices, so that Americans over the age of 65 can purchase cheaper brand drugs.
European drug price storm
In recent years, the growth of the European pharmaceutical market has been weak, but this area is still very important for the pharmaceutical industry. In 2009, Europe accounted for more than 30% of global pharmaceutical revenue. The terrible economic conditions in Greece caused the country to drastically cut its drug prices by 27% in March 2010. Spain reduced its brand drug prices by 7% and lowered the price of generic drugs by 25%. France launched a €2.4 billion cost-saving plan in November, saving 860 million euros in medicines and medical devices.
Germany reduced the cost of new prescription drugs by reducing the drug price by more than 2 billion euros (US$2.76 billion).
Italy cuts its health care costs by 24 billion euros, of which 1.35 billion euros will come from reductions in drug costs. In 2011, Italy will also lower the price of anti-cancer drugs because it will adopt a "pay-for-performance" approach to drug prices.
China promotes global growth
In March, IMS Health released a research report titled "Reshaping the New Order in the World Pharmaceutical Market: A Reclassified World." The report proposes that in 2011 China's pharmaceutical sales will exceed France and Germany, becoming the world's third largest pharmaceutical market after the United States and Japan; in 2013, nearly half of the sales growth came from emerging markets.
In 2010, the total drug sales in these countries reached US$123 billion, accounting for approximately 16% of the US$770 billion in global drug sales. Sales in emerging markets contributed 37% to the growth of the global pharmaceutical industry. It is estimated that by 2011, the global pharmaceutical market will reach 880 billion U.S. dollars, and the growth of the Chinese market will make a greater contribution. IMS Health predicts that China's pharmaceutical sales, which is currently the third largest market in the world, will grow by more than 25% over the next year, exceeding US$50 billion. At the same time, 17 emerging pharmaceutical countries are expected to grow at a rate of 15 to 17% in 2011, reaching 170 billion to 180 billion US dollars. Drug sales in 17 emerging markets are expected to increase significantly. According to the decreasing order of market value growth, the report classifies these countries (IMS is called the emerging pharmaceutical market) into three levels. China alone occupies the top floor.
European generic pharmaceutical vision
In February, the European Generic Drugs Association (EGA) proposed the "Generic Drug Vision 2015", which aims to establish a globally competitive generics industry with the goal of increasing the availability and affordability of high-quality drugs for patients. To ensure the sustainable development of the entire European medical market.
EGA gives incentives to generic pharmaceutical companies in terms of R&D and taxation, and encourages innovation in biosimilars and clinical trials throughout the industry, while strictly following the principles of mutual recognition and strengthening the coordination of single markets.
According to the IMS MIDAS market survey data, the European generic market ranks eighth in the global market, with a value of 57 billion euros, and it has grown by 8% in 2009, and the growth rate in 2008 was 3%. According to estimates by EGA, the value of the generic market in Europe is 31 billion euros, and the annual growth rate is 6%. Price policies, reimbursement levels, and substitutes for generic drugs are the main drivers for the development of generic drugs markets.
Avandia exposes regulatory vacuum
In September, GSK’s diabetes treatment drug, Avandia, was evacuated from the European market because the drug caused a greater chance of heart attack, heart failure, and stroke in patients.
In the United States, the FDA has taken an approach that does not completely require the product to be withdrawn from the market. Many critics say that the actions taken by the regulators are too slow and they have not given sufficient vigilance in monitoring the safety of Avandia.
In another incident, the German Drug Evaluation Agency unearthed data from Pfizer's trial of the antidepressant reboxetine. These data show that reboxetine is an anti-depressant that is not effective and potentially harmful. Analysts believe that there is a “regulatory vacuum†in the EU: Pharmaceutical companies are not legally required to publish all test data.
Pharmaceutical promotion costs filing
In April, Pfizer announced in detail the costs it paid to American doctors. The reason for being forced to disclose the costs in detail is that the U.S. government has sued the company for its illegal marketing activities. Data show that from July to December 2009, Pfizer paid $35 million to approximately 4,500 healthcare professionals. Pfizer was the first pharmaceutical company to publish fees for doctors to carry out Phase I-IV clinical trials in addition to doctors' speeches and consultations. New medical regulations in the United States require that all pharmaceutical companies must submit fees for doctor consultation, lectures, meals, and other allowances.
Manufacturers and government war of words
The Danish diabetes company Novo Nordisk had a verbal battle with the Greek government in May, threatening to withdraw its modern insulin products from the Greek market to protest the country’s drug price cut by 25%. Afterwards, the Greek government agreed to only lower the price of the company’s products by 10%. In the past few years, Greek hospitals have owed large amounts of debt to pharmaceutical companies and medical device manufacturers.
In December 2009, a total of 1.2 billion euros of funds was repaid to pharmaceutical companies and medical device manufacturers. However, in the next few years, 5.6 billion euros of arrears will need to be paid through the government bond system.
These actions have created a dangerous precedent: If pharmaceutical companies believe that cost control measures are too harsh, they can effectively fight the government by evacuating products.
Reduced capital development line
The multinational pharmaceutical companies represented by Pfizer have reduced the number of drugs in the product development line in 2010 in order to renew extensive attention to its R&D efforts. Taking Pfizer as an example, Phase I R&D projects will bear the brunt of the reduction. Among the 31 R&D projects, Phase I R&D projects accounted for 15 cases. Pfizer needs to carefully study which drugs will help it reduce the impact of imminent patent failures.
In addition to Pfizer's streamlining of its R&D team, major multinational pharmaceutical companies have closed Europe and the US R&D centers, cut projects, and moved more R&D activities to emerging markets in the Asia Pacific region. In the treatment of cancer, multiple sclerosis, and autoimmune diseases in 2010, the pharmaceutical industry has achieved some breakthroughs, and more inventions will be born to bring more choices and solutions to patients.
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