摘要：Objectives. We explored whether the United States, which does not regulate pharmaceutical prices, is responsible for the development of a disproportionate share of the new molecular entities (NMEs; a drug that does not contain an active moiety previously approved by the Food and Drug Administration) produced worldwide. Methods. We collected data on NMEs approved between 1992 and 2004 and assigned each NME to an inventor country. We examined the relation between the proportion of total NMEs developed in each country and the proportion of total prescription drug spending and gross domestic product (GDP) of each country represented. Results. The United States accounted for 42% of prescription drug spending and 40% of the total GDP among innovator countries and was responsible for the development of 43.7% of the NMEs. The United Kingdom, Switzerland, and a few other countries innovated proportionally more than their contribution to GDP or prescription drug spending, whereas Japan, South Korea, and a few other countries innovated less. Conclusions. Higher prescription drug spending in the United States does not disproportionately privilege domestic innovation, and many countries with drug price regulation were significant contributors to pharmaceutical innovation. In contrast with most other countries, the United States does not employ a form of drug price regulation to control spending on pharmaceuticals, 1 mainly because of concern that regulatory controls drive down profits and discourage the flow of capital to support the development of new molecular entities (NMEs). 2 Industry and government officials in the United States have targeted other countries for their implementation of national policies surrounding drug price regulation. For example, the Pharmaceutical Manufacturers Association of America has claimed that foreign governments are free riding on US innovation and are not paying for their fair share of drug development costs. 3 , 4 In addition, US government officials have stated that the United States is now covering most of the costs of developing a new drug. 3 The concern that regulatory controls in other countries may affect global pharmaceutical innovation has also affected US trade negotiations and domestic policy. 5 The US government has placed pressure on other countries to modify their current price regulation of pharmaceuticals or formulary structure. 5 In 2003, the US Congress inserted a ban on government negotiation of drug prices in the Medicare Modernization Act of 2003, presumably because of concerns over the impact of drug price regulation on innovation. 6 , 7 Several influential commentators have also voiced concern over the potential negative impact of US health care reform on pharmaceutical innovation. 8 On the other hand, patient advocates and researchers are concerned about the potential increase in costs, reduced access to medications, and threats to public health that a lack of drug price regulation in the United States or abroad may entail. 9 , 10 The statements of US government officials and industry representatives imply that the US market is paying for the development of most new drugs. There is ample evidence that domestic profits in several countries that have price or profit control cover research and development expenditures. 11 For example, in Canada, domestic sales on average are about 10 times the research and development costs. In the United Kingdom, the pharmaceutical industry invests more of its revenues from domestic sales in research and development than do companies in the United States. 11 Statements by US government officials and industry representatives also imply that the United States is becoming a dominant source of innovation because of its lack of drug price regulation. From a purely theoretical standpoint, these statements are troubling because they imply a country-specific source of innovation. The industry is private, however, not government owned, and operates in a worldwide market. 3 It is also doubtful that pure price considerations would affect where a drug was developed, and more strategic considerations such as the availability of drug-specific research resources and infrastructure in a particular country may be a more important consideration. Given the impact of these statements on domestic policy and trade relations, we sought to examine innovation from a country-specific vantage point and bring data to this discussion. We explored whether the United States, which does not employ a form of drug price regulation, is responsible for the development of a disproportionate share of NMEs, and also examined whether other countries, which do employ some form of price or profit control, contribute disproportionately less.
