If the UN Secretary General and the members of his “High Level Panel on Access to Medicines” thought the State Department was bluffing when it warned against their attempt to make intellectual property the fall guy for the lack of health care in poor countries, they were rudely awakened Friday afternoon. Disdaining diplomatic niceties, less than two days after the UN report issued, State bluntly replied in a statement titled “U.S. Disappointed Over Fundamentally Flawed Report of the UN Secretary-General’s High-Level Panel on Access to Medicines.” Compounding the pain, the same day five prominent university associations issued a joint paper taking the report apart. Being directly and publicly rebuked in this manner is a new experience for the Secretary General and his minions– but one they richly deserve.
When setting up his Panel, the Secretary General directed it to focus on the “policy incoherence” between intellectual property rights, international trade liberalization and human rights. The Department of State warned that such a limited mandate ignored critical factors documented to be causing health care problems in developing countries. State added that the Secretary General’s directive ensured that the Panel would reach “predetermined outcomes” against the patent system. While preliminary drafts indicated the Department’s warnings were being ignored, as the report was delayed months beyond its expected issue date a flicker of hope arose that perhaps the Panel was reconsidering its direction. The release of the final report last Wednesday dashed any illusions.
The UN report encouraged expanded use of compulsory licensing to seize patented drugs while recommending sanctions for countries and companies that dare resist having their intellectual property taken, called for governments to discourage exclusive licensing of university inventions, weakening of the patent laws, and for international governments to dominate life science research to “delink” it from the profit motive, among other similarly inclined ideas. The Panel ignored warnings of the only member with actual drug development experience, Andrew Witty, CEO of GlaxoSmithKline, that its recommendations would harm the development of new drugs, thus increasing human suffering. It appears the unstated goal of the report was placing the U.S. life science industry under UN control.
After expressing deep disappointment that the UN report “detracts from, rather than advances” efforts to develop and disseminate life saving medicines, State honed right in:
As the United States made clear in its submission to the Panel in February 2016, the narrowly- focused mandate of the Panel was flawed and unlikely to lead to outcomes that adequately address this complex issue. The result includes conclusions that further this narrow perspective, raising fundamental questions regarding the legitimacy of those conclusions.
It is equally regrettable that the Panel worked under the presumption of “policy incoherence” between intellectual property rights, international trade liberalization, and human rights, while failing to properly recognize the important role that these systems play in incentivizing drug development and expanding access to medicines around the world. Intellectual property rights and trade are essential to medical innovation, which is fundamental to promoting global health.
The statement continues:
We believe that we can both increase access to medicines and support innovation for the development of new and improved drugs for the world’s most critical health challenges. Indeed, there can be no access to drugs that have not been developed: support for innovation is essential. In this respect, we note the concerns raised by the several Panelists who have practical experience in managing medicine research and development that taking forward the recommendations of the Panel could have significant unintended negative consequences.
The Department concludes:
Regrettably, the Report’s narrow focus has caused it to overlook the advancements made by innovative economies around the world. Robust intellectual property policies found in the United States and other economies support the development of innovative new treatments that save and improve lives around the world. The rules-based international trade system eliminates trade barriers that drive up costs of medicines for governments and patients. Efforts to fund drug development and patient treatment programs in developing countries, including those sponsored by the United States, have made significant contributions.
The United States Government remains committed to advancing access to existing and new medicines, including by supporting innovation through robust intellectual property protections and working with public and private partners to find new solutions to the world’s pressing public health challenges.
The joint letter by the Association of American Medical Colleges, the Association of American Universities, the Association of Public and Land-grant Universities, the Association of University Technology Managers and the Council on Governmental Relations is remarkably blunt:
We believe strongly that the September 14 Report of the United Nations High-Level Panel on Access to Medicines misguidedly singles out intellectual property rights – particularly patents – as responsible for hindering equitable access to medicines, vaccines, diagnostics, and other health technologies. In fact, intellectual property rights make the existence of, and access to, these critical drugs and technologies more likely, not less.
The letter discusses policies in place insuring that university technology transfer efforts foster innovation and access to life saving medicines. It addresses the report’s call for government control over university licensing:
A strong patent system is what allows universities and related technology transfer organizations to transmit the knowledge and innovations they produce for the public good and broader societal benefit. In the U.S., the Bayh-Dole Act allows universities to hold title to intellectual property derived from federally-funded research. Before Bayh-Dole was enacted in 1980, the U.S. government held patent rights to federally funded university inventions. Consequently, university inventions almost always languished on laboratory shelves, failing to attract the investment from private companies needed to bring those inventions to fruition and, ultimately, to underserved populations in the U.S. and developed and developing nations around the world. Undermining Bayh-Dole and related patent protections would result in fewer novel medicines and medical technologies, not more.
It goes right after the contention that patents and licensing restrict the advancement of science as the UN alleges:
The U.N. Report erroneously suggests that the patenting of university research somehow limits access to academic discoveries and obstructs follow-on innovation. This conclusion is wrong on at least three counts. First, the U.S. patent system requires full disclosure of innovations for which protection is sought and our federal funding agencies increasingly require grantees to make peer-reviewed manuscripts and data publicly available at no cost. Second, scholarly norms inherently motivate academic researchers to publish their findings and/or use those findings in grant applications. Third, there is scant fact-based evidence – including in the U.N. Panel’s Report – that access and follow-on innovation are undermined by patenting; rather, if patent rights are restricted, innovators will rely more and more on trade secrets and fewer open disclosures will occur. In addition, U.S. law provides numerous checks and balances to ensure that patents do not impede further research, such as the safe harbor for patent infringement for those working to obtain FDA approval of a drug or medical device.
The conclusion provides no solace to the Secretary General or the panelists doing his bidding:
Universities stand unified in our commitment to ensure that university research advances worldwide public health. We believe that the proposals in the U.N. Panel’s Report would stymie rather than support that goal; accordingly, we hope that those proposals will not serve as the basis for further work within the United Nations. Instead, universities, the federal government, NGOs and the private sector must cooperate to find innovative ways within the current system to optimize global access to new and extant drugs, therapies, and other health technologies and scientific advances.
While the State Department and the university associations knocked the stuffing out of the UN report, efforts will be made to patch it back together for its propaganda value in the continued assault on patents and technology transfer. Still it’s refreshing to see such direct, unapologetic defenses of the contributions the patent system has made to world health. It makes you realize what can happen when the critics are no longer handled with kid gloves. That must have been a new experience for the UN. Let’s hope it’s just the beginning of a refreshing new trend.
And kudos to the U.S. Department of State and the university associations. You couldn’t have delivered a whoopin’ to a more deserving bunch.