Human Genome Editing Research Should Move Forward, Says Influential Hinxton Group

September 10, 2015
Press Release
For Immediate Release
Contact: Leah Ramsay, lramsay@jhu.edu, 202.642.9640

Human Genome Editing Research Should Move Forward, Says Influential Hinxton Group

Research involving editing the human genome, including research with human embryos, is essential to gain basic understanding of biology and germ cells and should be permitted, according to one of the first global meetings to debate the controversial new techniques.

The bold statement is published Thursday, September 10, by the Hinxton Group, a global network of stem cell researchers, bioethicists, and experts on policy and scientific publishing, who met in Manchester, England, September 3-4.

While firmly backing the need for gene editing research, the group makes a clear distinction between research and clinical application.

“We believe that while this technology has tremendous value to basic research and enormous potential for somatic clinical uses, it is not sufficiently developed to consider human genome editing for clinical reproductive purposes at this time,” the consensus statement reads.

According to Debra Mathews, a member of the Hinxton Group steering committee, discussions at the meeting focused on the use of gene editing in research and the most contentious aspects of these new technologies, primarily the implications for any children born with engineered genetic modifications, and also successive generations who would inherit those genetic changes; that is, the inheritable, or germline, nature of the modifications.

“While there is controversy and deep moral disagreement about human germline genetic modification, what is needed is not to stop all discussion, debate and research, but rather to engage with the public, policymakers and the broader scientific community, and to weigh together the potential benefits and harms of human genome editing for research and human health,” says Mathews, the Assistant Director for Science Programs at the Johns Hopkins Berman Institute of Bioethics.

The consensus statement addresses these ethical concerns, with the group agreeing that, “given all safety, efficacy and governance needs are met, there may be morally acceptable uses of this technology in human reproduction, though further substantial discussion and debate will be required”.

In the meantime, knowledge gained through basic science research is essential to human understanding of both ourselves and other life, the group says. “Much of our knowledge of early development comes from studies of mouse embryos, yet it is becoming clear that gene activity and even some cell types are very different in human embryos. Genome editing techniques could be used to ask how cell types are specified in the early embryo and the nature and importance of the genes involved,” says Robin Lovell-Badge, a member of the Hinxton Group steering committee and Group Leader, and head of the Laboratory of Stem Cell Biology and Developmental Genetics, The Francis Crick Institute.

The statement emphasizes the importance of “meaningful and substantial public engagement” to decision-making about genome editing. Policymakers are specifically addressed, stating that policy restraints on science should have justification that “that reaches beyond disagreements based solely on divergent moral convictions.”

“The relevant regulatory distinction should be not between using genome editing in somatic cells and using it in embryos, but between research and reproduction: whether those embryos are ever destined to be implanted, says Sarah Chan, another steering committee member and a Chancellor’s Fellow at the Usher Institute for Population Health Sciences and Informatics, University of Edinburgh.

“Restricting research because of concerns that reproductive application is premature and dangerous will ensure that it remains forever premature and dangerous, for want of better knowledge,” Chan says.

# # #

Hinxton Group Consensus Statement on Genome Editing Technologies and Human Germline Genetic Modification, published online:http://www.hinxtongroup.org/Hinxton2015_Statement.pdf

About the Hinxton Group: http://hinxtongroup.org/

For more information or commentary from Debra Mathews, contact:
Leah Ramsay, Johns Hopkins Berman Institute of Bioethics
lramsay@jhu.edu 202.642.9640

Other contacts:

For commentary from experts who are NOT members of the Hinxton Group, contact: Robin Bisson, Genetic Expert News Service
robin@geneticexperts.org +1 (202) 833-4613

The Science Media Centre (UK)
fiona@sciencemediacentre.org +44 (0)20 7611 8300

Professor Robin Lovell-Badge, Hinxton Group Steering Committee member
Office: +44 (0)20 8816 2126; Mobile: +44 (0)7785 366987
robin.lovell-badge@crick.ac.uk

Or: The Francis Crick Institute media team:
Katie Matthews: +44 (0)20 7611 2197 or +44 (0)7734 955308
Peter Zarko-Flynn: +44 (0)7525 053795

East Asia Faces Unique Challenges, Stem Cell Innovation Opportunities

New Consensus Statement From The Hinxton Group Focuses On Japan, China

Tension is the theme running through the new consensus statement issued by the Hinxton Group, an international working group on stem cell research and regulation.  Specifically, tension between intellectual property policies and scientific norms of free exchange, but also between eastern and western cultures, national and international interests, and privatized vs. nationalized health care systems.

The consensus, titled Statement on Data and Materials Sharing and Intellectual Property in Pluripotent Stem Cell Science in Japan and China, was released on the Hinxton Group’s website Monday, November 19, 2012.

“China and Japan are among the world’s leading nations in stem cell research, but because of challenges distinct from western nations, they are dramatically underrepresented in terms of patents and licensing,” says Debra Mathews, PhD, MA, assistant director of Science Programs at the Johns Hopkins Berman Institute of Bioethics and a founding member of the Hinxton Group. Mathews was one of 22 co-signers of the consensus statement.

“We thought it was crucial, with the science advancing incredibly rapidly, and as intellectual property policies evolve in East Asia, to examine our 2010 global recommendations for proprietary issues in stem cell research in that regional context,” Mathews says.

Strengthening national stem cell innovation was the top goal articulated in Kobe, the statement says.  Whereas in the West there is a robust and mature infrastructure for encouraging and supporting the development of intellectual property rights such as patents, East Asian nations like China and Japan have comparatively less well-developed, younger systems, the group observes.  While this can make it more difficult to bring new inventions to international markets, the statement says, the opportunities created by the regional environment in Japan and China provide valuable lessons for the global development of this field.

“For example, as noted in the statement, Japan and China each have a large and highly qualified scientific workforce, paired with substantial national investment in stem cell research,” says Mathews. “This combination of factors means that both countries are well-situated to take the kinds of collective action that will be required to move the field forward efficiently and translate basic science discoveries into products and therapies.”

An area where Japan and China exercise strong state control to the possible benefit of stem cell-based invention is their national health care systems, the statement notes.  In the West, strong intellectual property rights have encouraged the “development of stand-alone blockbuster products,” the group says, whereas the national health systems in East Asia may allow patients access to more individualized, innovative treatments.  This, the group posits, could be a model for stem cell-based therapies.

“Innovation in China and Japan occurs in the context of national commitments to public health, and as a practical matter that should make access to cell-based therapies more equitable,” Mathews says.

The statement also notes the significant cultural differences that contribute to challenges — and opportunities — with intellectual property policy, practice and stem cell research in the region.  The group notes that Japan and China are “markedly less litigious” than western nations, and recognition for scientific work and publication priority are highly valued.  “Secrecy appears to be a relatively more common mode of protecting researchers’ raw [intellectual property rights], as opposed to more formalized legal systems of protection, such as patenting,” the statement says. In light of this, an appropriate incentive to sharing data and materials among scientists in the region would be the protection of their interests and rights, perhaps through a grace or priority period, the group says, during which the data is public but the original scientists have exclusive rights to publish.

The statement also discusses the challenges of sharing data and materials internationally, noting an “underlying tension between national and international interests.”  In China, for example, samples donated by citizens are considered intellectual property of the state and are governed by strict polices that create roadblocks to international sharing and access. Such policies, varying country by country, may present significant challenges to the Hinxton Group’s goal of creating an internationally coordinated stem cell bank, the statement says.

“There will always be tensions between national and international and between public and private,” as far as innovation and the protection of that innovation, the group says.  “Within the biomedical sciences, the key is to strike a balance that both promotes innovation and improves global health,” the statement concludes.

# # #

Consensus Statement: www.hinxtongroup.org/consensus_hg12_final.pdf

Japanese and Chinese translations will be posted at www.hinxtongroup.org as soon as they are available.

About the Johns Hopkins Berman Institute of Bioethics
One of the largest centers of its kind in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, nongovernmental organizations and private sector organizations to address and resolve ethical issues. Institute faculty members represent such disciplines as medicine, nursing, law, philosophy, public health and the social sciences. More information is available at www.bioethicsinstitute.org.