United Nations' final report on medicine access deeply flawed
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On September 14, the United Nations’ High Level Panel on Access to Medicines released its long-anticipated final report, which purports to provide recommendations for improving global access to health care. Amidst murmurings that the Panel was poised to focus on intellectual-property rights, experts urged the group to consider real barriers to access such as weak infrastructure and a dearth of skilled healthcare workers. But the Panel chose not to heed their advice. Although the Panel acknowledged numerous factors that stop people from getting the life-saving medicines they need, it explained that it had a narrow mandate to focus on a perceived incoherence between intellectual-property rights and access to health care.
As predicted, the report recommends massively scaling back intellectual property rights. Among its most contentious recommendations, the Panel encourages countries to implement legislation that would force drug companies to license their patented-protected drugs to governments. The Panel also recommends sanctions for countries or companies that seek to protect their patent inventions against a compulsory licensing system. The Panel further calls on countries to discourage universities from exclusively licensing their inventions. And the Panel encourages countries to spend more on research and development of drugs so as to “delink” research and development from drug prices.
In issuing these recommendations, the Panel ignored its only member with drug development experience—Andrew Witty of GlaxoSmithKline. Buried toward the end of the report is his statement expressing concern regarding the Panel’s recommendations. As to compulsory licensing, Witty explains, “innovations would be endangered for patients around the world” given that companies would be less willing to invest in research and development if they cannot protect their profits. Witty also points out that de-linkage between research and development and drug prices could also “damag[e] innovation.”
Unsurprisingly, many experts and institutions—including the U.S. State Department—have heavily criticized the report. The State Department expressed its “dee[p] disappoint[ment]” in the report; the Department opined that it was “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.” As the State Department aptly put it: “Intellectual property rights and trade are essential to medical innovation, which is fundamental to promoting global health.”
The UN had a real opportunity to address a global crisis. Unfortunately, it not only missed that opportunity, but has offered proposals that may entrench access problems even further
Partner, King & Spalding LLP
A partner in the FDA and Life Sciences practice at King & Spalding LLP, Marisa Maleck focuses on litigation, regulatory matters and public policy, with a focus on consumer products. As a former senior counsel at a bio-tech company and in private practice, Marisa has substantial experience with and is skilled in providing creative solutions in the face of uncertainty.
Marisa represents clients in a variety of matters with a focus on FDA-regulated products like food, beverages, pharmaceuticals, medical devices, wellness products, cosmetics, tobacco and cannabis. As a former senior counsel at an FDA-regulated biotech company and as a former partner in King & Spalding’s Litigation and Global Disputes practice group, she handled hundreds of suits in a multi-district litigation, multiple agency inquiries, an FTC lawsuit and 10+ state Attorney Generals actions. With a special focus on consumer fraud, social-media marketing and personal injury/wrongful death lawsuits, Marisa has successfully drafted and/or argued appellate briefs and critical motions in numerous cases—including class actions and complex litigation—before the U.S. Supreme Court, federal and state courts of appeals, and federal and state trial courts. She has also advocated tirelessly for her clients through engagement with agencies and policy-makers. She also advises her clients about legal risk (and how to avoid it) in investigations, enforcement actions, private litigation and private-equity investments.
Marisa also advocates for her clients’ interests in the court of public opinion. She is often solicited for her balanced legal analysis by members of the media. Marisa has appeared on (tv/radio) MSNBC, MSN, CNBC and NPR, and in (print) Newsweek, the National Law Journal, The Wall Street Journal, The Washington Post and Politico.
In addition, Marisa has an active pro-bono practice representing indigent defendants through federal appellate appointments as part of the Criminal Justice Act program and as a screener for the Mid-Atlantic Innocence Project.