| 来源类型 | Article |
| 规范类型 | 评论 |
| When fools march in | |
| Thomas Peter Stossel; Joel M. Zinberg | |
| 发表日期 | 2016-03-16 |
| 出版年 | 2016 |
| 语种 | 英语 |
| 摘要 | National Institutes of Health officials just wisely rejected a petition, supported by 51 congressmen, to exercise “march-in” rights to discourage drug “price-gouging.” The proposal didn’t merely violate the explicit intent of a decades-old statute — the Bayh-Dole Act — it also revealed the legislators’ ignorance of drug development and would have devastated medical innovation, while doing nothing to bring down drug costs. NIH officials must continue to reject similarly misguided and politicized petitions. The future of American medicine depends on it. While NIH funds some basic research that sometimes suggests drug candidates, only private companies can manage the lengthy and costly process of turning discoveries into usable products. Sens. Birch Bayh and Bob Dole’s bipartisan 1980 legislation allowed universities, non-profits, and small businesses to retain ownership of patents for inventions discovered with the aid of federal funding. The economic rationale was simple. Previously, the government owned inventions made with federal funding and granted only nonexclusive licenses to developers. Few companies were willing to invest the money and time to develop an invention into a practical product unless they could own and exclude others from exploiting it. As a result, the federal government sat on tens of thousands of patents that languished unlicensed and undeveloped. America’s publicly funded research was not benefiting the public. Bayh-Dole allowed the discovering institutions to retain titles and negotiate license terms with private companies to develop inventions into practical products, such as new drugs. The act has been highly successful. Universities created offices of technology licensing, and the number of patents, licenses, and technology development exploded. The act was crucial to developing America’s biotechnology sector. The act allows the federal government to “march in” and seize the intellectual property rights of the inventor and grant a license to “a responsible applicant or applicants” under two highly unlikely conditions. First, if the patentee and its licensee have not taken effective steps to achieve “practical application” of the subject invention — in other words, if they’re just sitting on it — the government can license the patent to someone who will develop it. The statute defines “practical application” as the benefits of the invention being made “available to the public on reasonable terms.” The second condition is met when government action is necessary to alleviate health or safety needs that are not being satisfied by the rights holder — think of a small company that invents a vaccine against a superbug but can’t produce it fast enough during a global pandemic. In Bayh-Dole’s 35-year history, the NIH has rejected all six petitions it received to exercise march-in rights. The 51 congressmen claimed march-in rights were intended to combat high drug prices that make drugs “[un]available to the public on reasonable terms.” In fact, nothing in the act or its legislative history supports this view. Sens. Bayh and Dole themselves wrote that “the law makes no reference to a reasonable price that should be dictated by the government,” that march-in rights are “not contingent on the pricing of a resultant product or tied to the profitability of a company that has commercialized a product that results in part from government-funded research,” and that government should march in “only when the private industry collaborator has not successfully commercialized the invention as a product.” Moreover, march-in rights would not necessarily lower drug prices. March-in rights do not empower the government to control prices — they only allow the NIH to increase competition by giving additional companies the right to utilize drug patents that were directly derived from the government-funded research. That accounts for less than 10 percent of new drugs approved by the FDA. And nothing guarantees that anyone would step up to undertake the risky and expensive process of developing and producing a competing drug — it costs $2.6 billion to introduce a new medicine, because 90 percent of drug candidates fail in clinical trials. Even if march-in powers could lower prices for this fraction of drugs, this congressional intervention risks chilling all drug development regardless of whether government funding played a direct role. Encouraging the government to seize patent rights in a non-emergency situation is a great way to discourage firms from developing and producing any new drugs. Congress’ failed political ploy asking NIH to employ march-in rights to control drug prices disregarded the spirit of the law, the best judgment of NIH officials and the interests of patients. Thankfully, Health and Human Services Secretary Sylvia Mathews Burwell understood the purpose of the law. Let’s hope future petitions meet the same fate. |
| 主题 | Health Care ; Health Economics |
| 标签 | drug industry ; Intellectual property ; Pharmaceuticals ; Pharmaphobia |
| URL | https://www.aei.org/articles/when-fools-march-in/ |
| 来源智库 | American Enterprise Institute (United States) |
| 资源类型 | 智库出版物 |
| 条目标识符 | http://119.78.100.153/handle/2XGU8XDN/260266 |
| 推荐引用方式 GB/T 7714 | Thomas Peter Stossel,Joel M. Zinberg. When fools march in. 2016. |
| 条目包含的文件 | 条目无相关文件。 | |||||
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