Good Day BIO: China's regulations could restrict access and use of human genetic resources by foreign entities

China's proposed human genetic resources regulation may significantly impact global R&D efforts coordinated by foreign entities—here’s why it matters and what BIO’s doing about it. Plus, April is National Minority Health Month and National Limb Loss and Limb Difference Awareness Month—we tell you more about them and the role for biotech. (759 words, 3 minutes, 47 seconds)

China wants to ban use of human genetic resources abroad

BIO recently filed comments on a few biotech issues in Asia—including China’s proposed rules on human genetic resources (HGR), which would significantly restrict how foreign entities are able to access and use Chinese HGR to drive global R&D initiatives. We spoke to Justin Pine, BIO’s Senior Director of International Affairs, to get the details.

The 2019 Regulation on the Management of Human Genetic Resources (HGR) has already “posed unnecessary and onerous barriers for the global biopharmaceutical industry, resulting in delays in global clinical trials and R&D initiatives,” due to requirements to obtain permission from the State Council to share, access, or use HGR.

The new proposal goes further and aligns with the 2020 Biosecurity Law, which broadened the definition of “human genetic resources” to include physical specimens (like tissue) as well as data and requires foreign companies to partner with local firms in R&D, raising questions about ownership of IP.

Of particular concern: foreign entities are prohibited from collecting China’s HGR within China, requiring local partnerships to fully realize R&D projects, and subject to onerous government oversight and approvals to transfer data abroad. 

“When taken together, these provisions on IP, data sharing, and benefit sharing do not accelerate global R&D efforts but, rather, create challenges to cultivate long-term collaborative scientific relationships and deter global partnerships,”explain BIO’s comments to China’s Ministry of Science and Technology (MOS).

The bottom line: This would “unnecessarily restrict research and development efforts in the life sciences in both China and abroad, impeding the development of scientific advancements for the benefit of Chinese citizens and mankind,” explains BIO.

BIO also filed comments with USTR and the U.S. Department of Commerce on the Indo-Pacific Economic Framework—read more about how an Indo-Pacific strategy can support biotechnology.

More News: 

The Atlantic: A tick bite made them allergic to meat – and an organ-transplant company has an unexpected solution
“To make a pig whose organs could be harvested for transplant, Revivicor first had to make an alpha-gal-free pig. And when it did, the company realized that transplant surgeons weren’t the only ones interested. Since last fall, Revivicor has been quietly sending refrigerated packages of alpha-gal-free bacon, ham, ground pork, chops, and pork shoulders to people in the alpha-gal-syndrome community.” 

2 health awareness months – and the role for biotech

April has been full of important health awareness days, weeks, and months—here are two we don’t want to forget, because they touch upon critically important issues for BIO.

1. National Minority Health Month

The past two years have shined a bright light on health inequities in America,with COVID infection and death rates disproportionately higher among people of color. But disparities go far beyond COVID, present in diseases from cancer to heart disease.

Biotech can close the gaps: “Quite often we think about innovation with respect to perhaps rare or severe diseases, but actually innovation is a tool that we can use to really close the gaps that we have, from a health equity perspective,” Alnylam CEO Yvonne Greenstreet told us.

What BIO’s doing about it: The BIOEquality Agenda is addressing inequities in health care and the industry, starting with diversity in clinical trials, which will allow us to “develop medicines that address the needs of the whole population,” as Greenstreet said. 

More than 500 people in the U.S. lose a limb every day—and by 2050, the number of people living with limb loss will nearly double to 3.6 million, says the Amputee Coalition.  

These individuals face a number of health challenges—including mental health challenges, which were exacerbated during the pandemic, as well as high risk of developing drug-resistant infections, we reported last year.

What BIO’s doing about it: BIO advocates for legislation that would address the challenges in the antimicrobial marketplace to ensure we can stop this “silent pandemic” that disproportionately affects at-risk patients. 

President Biden’s Thursday: Delivering a speech about support for Ukraine. Biden will also ask Congress for more funding to send aid to Ukraine today, according to The Washington Post. Later, hosting his first official White House film screening to show HBO’s “The Survivor” in honor of Yom HaShoah and Holocaust Remembrance Week.

What’s Happening on Capitol Hill: A Senate Appropriations subcommittee will hold a hearing on the 2023 budget request for the FDA, with FDA Commissioner Dr. Robert Califf scheduled to testify, while a House Appropriations subcommittee will hold a hearing on the 2023 budget request for USDA. The House Committee on Science, Space, and Technology will hold a hearing on “The Urgent Need for Ambitious Climate Action.”