A United Nations panel has released a much-anticipated report that expresses concern about how misdirected intellectual property laws and economic incentives may be affecting worldwide access to drugs and devices.
The U.N. Secretary-General's High-Level Panel on Access to Medicines said in its report (PDF) Tuesday that the current model of medical innovation is “ill-equipped” to respond to emerging infectious disease threats like Zika and Ebola and doesn't serve millions of people around the world who die from treatable conditions because they couldn't access the proper drugs.
Excessive intellectual property rules in nations like the U.S. may impede access to health technologies, the panel said. At the same time, companies aren't incentivized to make drugs that could improve public health, like antibiotics, which come at a significant cost to develop but yield low rewards.
Patent protection needs to be measured against the value of the drugs, giving high-value drugs like Solvadi, the hepatitis C “cure,” more protection than “me-too” drugs that are easier to develop or more common, said Dr. Mark Fendrick, a primary-care physician and director of the University of Michigan's Center for Value-Based Insurance Design.
The U.N. panel says government leaders must reform intellectual property rules and mechanisms to reward development of medicines that are of high-value to public health. Change is needed to “address the misalignment between profit-driven innovation models and public health priorities,” the panel said.
The panel goes as far as to say that more governments should allow compulsory licenses, which grant a company the ability to produce a patented product without the consent of the patent holder. The panel notes, however, that those licenses should be predictable, fair and take public-health needs into consideration.
The U.S. in particular has incentivized groundbreaking research by allowing universities to patent the results of federally funded research, but it needs to ensure that data from publicly funded drug research is accessible, the panel said. Leaders should put in place policies that require significant data sharing and access when academics or companies receive public grants for developing health technologies. That shared information would include clinical trial data so that they don't “force taxpayers to pay twice for the benefits of publicly funded research,” according to the report.
In general, companies should have to disclose the costs of research and development, production, marketing and distribution of health technology, as well as any public funding or subsidies, the panel said. But that's easier said than done, Fendrick said.
While it's easy to agree to added transparency, “defining what goes into the costs of R&D, production, marketing and distribution,” is very difficult and hard to agree upon, Fendrick said.
“The world is very variable in its innovative capabilities,” Fendrick said. “There are really great opportunities and challenges that come with those that push the envelope … we have to make sure there are incentives to continue to innovate.”
