Diagnostic laboratory tests play a central role in the implementation of precision medicine. It is essential that FDA regulation strike the right balance between protection of patient safety, and encouragement of advancement and innovation in testing. Read an original approach to FDA regulation that Professor David Hyman and I published in Investor’s Business Daily.
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. [Read More]
In America and across the globe, about 7,000 new medicines are in development. There's no question that many of them will save lives. Unfortunately, the United Nations is working to degrade the innovation ecosystem that makes such breakthroughs possible.
In 2015, UN officials convened a powerful new panel to study ways to improve impoverished countries' access to lifesaving medicines. By all indications, that panel will soon push to weaken intellectual property protections on medicines.
That would be a huge mistake. Such a policy shift would surely slow and possibly stop the creation of new diagnostic tests and drugs, depriving patients all over the world of treatments like immune therapies and gene editing — the biggest medical breakthroughs in a century.