U.S.: UN report on health care access stems from a ‘biased mandate’

The U.S. isn’t likely to buy into several recommendations in a new report by the UN High-Level Panel on Access to Medicines that narrowly focuses on patents as the barrier to access to drugs and devices across the world.

Even before the report came out this week, the Obama administration voiced concerns about the expected recommendations and the panel itself. Testifying Tuesday in an oversight hearing before a House Judiciary subcommittee, Michelle Lee, director of the Patent and Trademark Office (PTO), said the administration wants to expand global access to drugs and devices, but it questioned the process used to appoint the 15-member international panel and the “narrow focus and biased mandate” the panel was given.

The panel was based on the “unjustified assumption of intellectual property policy incoherencies between the rights of the inventors, trade rules, human rights laws and public health,” Lee said.

That assumption of a misalignment between the right to health and intellectual property (IP) underlies the recommendations made in the report, namely that compulsory licensing should be encouraged, more public funding of R&D is needed and R&D costs should be delinked from the pricing of medical technologies. (See Key UN Panel Recommendations, below.)

The panel itself acknowledged that access to drugs and devices throughout the world is restricted by many factors that urgently need to be addressed, but it limited its report to the tension caused by patents due to the mandate it was given by the UN.

Patents on drugs and devices are a contentious issue at the UN, Rep. Mimi Walters (R-Calif.) said at the oversight hearing. Instead of challenging medical IP and trying to overturn standards set by the World Trade Organization, she said the UN should reinforce sound policies to encourage innovation to tackle unmet medical needs.

Lee said she appreciates a country’s desire to protect its public health, but access has to be balanced with the incentive to innovate so new treatments and cures can be developed. One way to do that is to ensure a fair and level playing field.

Meanwhile, the administration is monitoring attempts at compulsory licensing in various markets, she added, noting that voluntary licensing is always preferable. And the PTO is improving the quality of the patents it issues by expanding its global searches for prior art.

MISSED OPPORTUNITY

Industry groups in the U.S. see the UN report, with its one-eyed focus, as a missed opportunity.

“The ability of patients to obtain quality care depends on many factors – including health care infrastructure, government policies, adequacy of funding, the presence of trained health care providers, health literacy and stigma,” said Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America.

Because it fails to recognize and address the complexity of biopharma R&D and the work that’s already being done to expand access, Ubl dismissed the report, saying it is not a sound basis for further UN action.

Joseph Damond, senior vice president for international affairs at the Biotechnology Innovation Organization, agreed that the report ignored the real issues that impact access to innovative treatments and cures throughout the developing world. Instead, he said, its singular IP focus would “actually undermine ongoing research and development by hundreds of companies, universities and researchers.” Damond cited research that shows IP is not the issue. About 95 percent of what the World Health Organization has defined as essential medicines are off-patent, he noted, yet a third of the world’s population doesn’t have reliable access to those drugs. And a National Bureau of Economic Research study of 76 countries over a 20-year period showed that patients living in countries with strong IP rights have better access to new treatments, he added.

In making a case for its recommendations, the UN panel referred to the rising price of Epipen (epinephrine, Mylan NV), new outbreaks of diseases like Ebola and Zika, and growing problems with antimicrobial resistance.

While a safety cap covering the needle on the Epipen auto-injector is patented, IP is not the reason the product enjoys a near monopoly in the U.S. The device has competition in other markets, but its major U.S. competitor, Sanofi US’ Auvi-Q, was withdrawn last year because of potential device malfunctions. And earlier this year, the FDA rejected Teva Pharmaceutical Industries Ltd.’s ANDA referencing Epipen. (See BioWorld Today, Aug. 24, 2016.)

As for new disease outbreaks, the complexity of R&D, coupled with limited public and private resources, makes it difficult to have a new treatment already available before a need is recognized.

NEXT STEPS

To address the inequities in global access to treatments, the panel recommended a UN-led approach in which governments would form a working group to create an international code of principles for biomedical R&D. That code would be used to negotiate global agreements on the coordination, financing and development of health technologies, as well as a binding R&D convention run by the UN.

While U.S. lawmakers see room for improving the quality of patents granted to medical technologies, they have their own ideas about next steps. At Tuesday’s hearing, Judiciary Committee Chairman Bob Goodlatte (R-Va.) questioned whether the incremental innovation of features like the Epipen safety cap truly meet the level of patentability. “We’re not talking about the light bulb here,” he told the PTO’s Lee.

Although Mylan’s patent hasn’t been challenged via the inter partes review (IPR) process, Goodlatte said the Epipen dominance of the U.S. market shows how important the IPR is. “It’s paramount to ensuring strong patent quality,” he added.

However, some members of the committee remained concerned about IPR abuses, especially when it comes to short-sellers using the system to manipulate the market.

While the PTO is working to improve patent quality going forward, the IPR process is helping to weed out weak patents already granted, Lee said. Opening the process to the public, rather than just would-be competitors, is making the system work as Congress intended.

Grappling with the patent challenges facing biopharma and device companies as technology enters frontiers unimagined when the U.S. Constitution was framed more than 200 years ago, Rep. Darrell Issa (R-Calif.) pondered how Congress can encourage medical innovation but still comply with the founding fathers’ constitutional dictates on what is patentable.

“It is going to be, over a period of time, harder and harder for people to know whether or not they have an investable new technology,” Issa told Lee as they waited for the other committee members to return from a House vote.

Companies can’t wait for a patent to be granted before they begin the costly and lengthy process of developing useful drugs and devices, he said, noting that IPR challenges that can occur any time after a patent has been granted add more uncertainty for the biopharma and biotech sectors.

Drug and device companies must rely on their inventions in making an investment, not just in development, but in a “massive search of science” that includes expensive clinical trials, statistical analyses and, ultimately, proof that their invention is a useful advance of science, Issa said. An IPR challenge can erode that investment.

Issa also questioned the idea of obviousness when it comes to discovering and proving the unknown in medical advances. For instance, the very act of discovering whether something that’s not known to be safe and effective is, in fact, safe and effective should be patentable, he said, citing all the investment and work that must be done to demonstrate safety and efficacy.

Acknowledging that the current Congress doesn’t have time to address such issues, Issa said this is something the next Congress should consider. One suggestion he mentioned was the possibility of a different kind of patent that would have a shorter term.

Congress’ mandate isn’t to grant exclusivity, Issa said, but rather to promote advances in science.

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