ASHG, AMP, and Partner Groups Oppose New Bill Allowing Gene Patenting

Posted by: Jil Staszewski, ASHG Policy & Advocacy Manager

Recently, there has been a re-emergence of gene patenting, an old issue that could impact the future of genetic research and medicine. On Wednesday, May 22, Senators Thom Tillis (R-NC) and Chris Coons (D-DE), along with Representatives Doug Collins (R-GA-9), Hank Johnson (D-GA-4), and Steve Stivers (R-OH-5) released text for a draft bill that seeks to reform Section 101 of the Patent Act. If passed, this legislation would effectively overturn the 2013 Association for Molecular Pathology (AMP) vs. Myriad Supreme Court decision, which ruled that our genomes are not eligible to be patented, as they occur in nature. Essentially, the bill would allow for the patenting of genes.

Background

To provide a bit of history on the issue, back in 2009, AMP, along with the American Civil Liberties Union (ACLU), filed a lawsuit against Myriad Genetics, challenging the validity of Myriad’s patents on the isolated BRCA1 and BRCA2 genes. AMP argued that these patents created extraordinary burdens for researchers, as they skyrocketed the cost of related testing and prevented further innovation. ASHG and several other medical associations submitted an amicus brief in support of AMP’s claims. In March 2010, the case was heard before the United States District Court of New York, where the judge ruled that products of nature could not be patented.

Upon successful appeal by Myriad, the case was eventually heard by the Supreme Court. In 2013, the Supreme Court ruled that isolated genes were still considered products of nature, and were not eligible to be patented.

ASHG’s Position

This AMP vs. Myriad ruling has played a large part in fostering an environment where researchers and clinicians are unencumbered by patent barriers.

Reacting to the news of the pending legislation, ASHG President-Elect, Anthony Wynshaw-Boris, MD, PhD, stated, “ASHG remains firm with our support of the 2013 Supreme Court ruling of AMP vs. Myriad that established that naturally occurring DNA is not patentable because it is a product of nature. It allows researchers to investigate the entire genome without fear of legal barriers and repercussions, helping to advance genetic discoveries and the development of new diagnostics and treatments for patients.”

ASHG has signed onto a joint, multi-society letter to the proposed bill’s sponsors, in opposition to the bill.

Next Steps

This week, a two-part hearing titled “The State of Patent Eligibility in America” was held by the Senate Judiciary Committee’s Subcommittee on Intellectual Property, where Senators Tillis and Coons serve as Chairman and Ranking Member, respectively. In his opening remarks, Senator Coons stated that the bill does not intend to overrule the 2013 Supreme Court ruling, but instead hopes to draw the line for how much human intervention is needed to determine patent eligibility.

Senator Tillis, Chairman, and Senator Coons, Ranking Member, welcome the participants of the “State of Patent Eligibility in America” hearing.”
Senator Tillis, Chairman, and Senator Coons, Ranking Member, welcome the participants of the “State of Patent Eligibility in America” hearing.

In his testimony, Charles Duan, Director of Technology and Innovation Policy at the R Street Institute, disagreed with Senator Coons’ claims, citing that the draft bill “provides that patent eligibility inheres in any ‘invention or discovery’ that arises ‘through human intervention.'”

Also amongst the panelists was Kate Ruane, Senior Legislative Counsel at the ACLU, who stated that the draft bill’s proposed revival of patent claims on genes would essentially violate the First Amendment, as it would deny scientists the ability to freely study and research genes. A third group of panelists will testify for a final hearing early next week.

ASHG will be following this impending legislation closely in the next coming weeks, and will alert ASHG members on any significant updates or grassroots advocacy efforts that may require your action and support. To stay up-to-date on the issue, be sure to subscribe to our monthly policy and advocacy email updates.

Why is a 2011 Budget Relevant to Science Funding Today?

Guest Post By: Mary Woolley, President and CEO, Research!America

Each year, Congress develops a federal budget, which establishes funding for each federal department and agency for the following fiscal year. This determines how much funding agencies like the NIH have to support scientific research through grants, as well as in their own labs.

Budget Caps Threaten Research Funding

A federal law, the 2011 Budget Control Act (BCA), placed stifling caps on spending that have threatened funding for the NIH and other agencies. These caps are blunt tools that batter crucial national priorities, compromising security, prosperity, and progress.

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Research!America and partner organizations, including ASHG, are running ads urging Congress to #RaisetheCaps. (courtesy Research!America)

Why It’s Time to #RaisetheCaps

Because the caps established by the BCA are so low, Congress has raised them repeatedly to allow sufficient funding for federal agencies. Unfortunately, those “caps deals” were temporary. Unless Congress acts again, we’re looking at a cut of approximately $55 billion to non-defense discretionary spending in the next fiscal year, which guarantees trouble. If the cuts are distributed evenly or no budget deal is reached, then NIH and every other public health and science agency faces a cut of about 10%. In the case of NIH, that would mean a cut of as much as $4 billion.

Achieving another agreement to raise the budget caps is crucial, time-sensitive, and not by any means a sure thing.

You don’t need a laundry list of the negative consequences on science that these cuts would engender. Suffice it to say that promising research will be choked off, fewer new grants will be funded, and medical and other scientific progress will slow dramatically. All this during a time of unprecedented scientific opportunity, when other nations are already nipping at our heels and would surely attract more and more young scientists if the U.S. signaled lack of support. Starving research is not the solution to what ails us — literally or economically.

Your voices, your story, and your expertise are needed now. Tell your friends, colleagues, and Congressional representatives why medical progress, public health progress, and science itself are crucial, and why federal funding for these priorities is so important.

Research!America, supported by partner organizations including ASHG, has created resources for you to advocate for federal research funding. Additional resources and tools to urge your representatives to #RaisetheCaps are available on ASHG’s Advocacy Center.

 

Pivoting Your Career Toward Science Policy and Advocacy

By: Staff

ASHG and the National Human Genome Research Institute (NHGRI) co-sponsor the Genetics & Public Policy Fellowship to give genetics professionals an opportunity to contribute to the policymaking process. If you’re interested in the development and implementation of genetics-related health and research policies at a national level, then this Fellowship may be right for you. Applications are open now through April 19, 2019.

Questions about what the position is like? Read on for real-world details from past Fellows about their experiences.

How is the position structured?

The Fellowship lasts for 16 months, during which time the Fellow rotates through three positions within the Policy and Program Analysis Branch of NHGRI, a congressional office of a member of Congress or a committee, and the Policy & Advocacy Department at ASHG. This allows Fellows to gain experience in different roles of national policymaking and decide which aspects of policy and work settings they are interested in pursuing as a career.

2016-17 Fellow Christa Wagner said, “The ASHG/NHGRI Fellowship has provided me with a diverse array of experiences, both in terms of topics covered and settings in which I worked on policy. The Fellowship provides an exceptional experience for those with a background in genetics to play a role in effective policymaking.”

Cari Young, 2015-16 Genetics & Public Policy Fellow, walks us through her experiences.

What kind of work will I do? 

While it depends on the needs of each organization at the time of arrival, 2017-18 Fellow Nikki Meadows gave us a look into her work during two of her rotations through several blog posts.

Nikki Meadows 2017-18 Policy Fellow
2017-18 Fellow Nikki Meadows discusses advocacy with members.

During her rotation with the Senate HELP Committee, Nikki organized a panel of genetics experts to answer questions from congressional staff working on health issues. This allowed her the opportunity to network with seasoned geneticists and help enhance the scientific knowledge of congressional staff. At ASHG, Nikki also provided updates to members on important policy issues such as the federal biomedical research budget  and genetic privacy. She additionally promoted the ASHG Advocacy Center and encouraged scientists to make use of these vital tools, both at the 2018 Annual Meeting and through online forums.

While these certainly weren’t all of Nikki’s duties, she explored several areas of work with a variety of audiences. Nikki said, “I had some amazing opportunities during the course of this Fellowship. I’ve gained so much from this program, both personally and professionally, that I am forever changed by it.”

Will this position help further my career? 

The rotational aspect of the position is a huge bonus to many applicants. 2015-16 Fellow Cari Young said, “This Fellowship provided a unique opportunity to take on varied roles within the science and health policy landscape, allowing me to experience the pros and cons of working in each setting and helping me to crystallize my thinking on where I might want to go next. It also made me a more marketable applicant for policy positions beyond the Fellowship.” As Fellows gain experience in different areas of public policy in just 16 months, it is a vital starting point that lays a solid base.

Being a Fellow additionally opens a new professional network to benefit from. 2012-13 Fellow Laura Koontz said, “Not only has the experience been invaluable, the network of Fellows I’ve joined as an alumna are among the best policy professionals in D.C. The Fellowship has also allowed me to fully realize my commitment to bettering the lives and treatment of people with cancer – the reason I got into scientific research in the first place!”

What kind of jobs might I get afterwards?

Check out our policy fellowship page to see where all our past Fellows are working now! Our Fellows have gone on to positions at the National Institutes of Health, the U.S. Food and Drug Administration, the White House, and a number of other organizations focused on science and health.

Applications are open now through April 19, 2019. Apply today!

Voice Your Concerns about the U.S. Government Shutdown’s Impact on Science

Posted By: Staff

The American Society of Human Genetics (ASHG) deeply believes that ongoing federal government support is essential for the scientific enterprise in the United States. We affirm the important role of normal operations to keep scientific progress moving forward.

20190124_capitolAlthough – fortunately – the National Institutes of Health (NIH) is operational during the partial U.S. government shutdown, other science-based agencies that support and facilitate ASHG members’ work and that of their colleagues are not. Notably, the National Science Foundation (NSF) is affected.

ASHG is proud to stand with the Federation of American Societies for Experimental Biology (FASEB) in letting Congress know how the shutdown is affecting science. Please use FASEB’s Legislative Action Center to contact your members of Congress about how the shutdown is impeding progress and reaffirm the importance of science agencies in advancing research.

 

H.R. 7083: Improving Access to Genetic Counseling

Posted By: David L. Nelson, 2018 President

Genetic counseling is an integral part of advancing human genetics in medical care and vital to our collective research agenda. Recognizing this, ASHG took action last week in strong support of H.R. 7083, the Access to Genetic Counselor Services Act of 2018, which would expand access to genetic counseling services for Medicare beneficiaries. We took this action under the leadership of the National Society of Genetic Counselors (NSGC), and are proud to add our largest voice in the human genetics community to urge this policy change. NSGC is our valued partner on this legislation and other new programming to serve genetic counselors in research.

Specifically, I wrote to bill sponsors Representatives Erik Paulsen (R-MN) and David Loebsack (D-IA) expressing the Society’s gratitude for introducing this legislation and for seeking to resolve a problem that has existed for many years (see image). Currently, while genetic counseling is covered under Medicare, genetic counselors themselves are not currently recognized as providers by the Centers for Medicare and Medicaid Services, the federal agency that runs the program. This means that genetic counselors are unable to bill directly for any services rendered to Medicare beneficiaries.

The letter written by David Nelson, PhD, ASHG President, to U.S. Representatives Erik Paulsen (R-MN) and David Loebsack (D-IA).
The letter written by David Nelson, PhD, ASHG President, to U.S. Representatives Erik Paulsen (R-MN) and David Loebsack (D-IA).

H.R. 7083 is designed to resolve this coverage gap. If it were to become law, this bill would recognize licensed genetic counselors as Medicare healthcare providers, and further establish a path for Medicare reimbursement for other genetic counselors.  In this way, it will reduce the access issues to genetic counseling services currently faced by Medicare beneficiaries.

For this bill to become law, it will need to be passed by Congress in the next few days.  Given the many steps in the legislative process, this is highly unlikely.  However, we hope that the legislation is re-introduced when the Congress reconvenes next year and that Congress advances it swiftly through the legislative process.

To receive updates regarding progress of this bill and on other issues, I urge you to sign up as an ASHG Advocate if you have not already done so.

David L. Nelson, PhD, is the 2018 President of ASHG. He is a Cullen Foundation Professor of Molecular and Human Genetics at the Baylor College of Medicine, Associate Director of the BCM Intellectual and Developmental Disabilities Research Center, and Director of the BCM Integrative Molecular and Biomedical Sciences Graduate Program.

Legislation Funding NIH Also Protects Genetic Privacy of Vulnerable Families

Posted By: Nikki Meadows, PhD, 2017-18 ASHG/NHGRI Genetics & Public Policy Fellow 

Buried within the legislation establishing funding for the National Institutes of Health for Fiscal Year (FY) 2019 (H.R. 6157) is a little-reported provision to protect the genetic privacy of immigrant family members. Congress often uses the annual appropriations bills to direct federal agencies on how to proceed on a particular activity or to commission a report about a particular topic. This provision, proposed by Representatives Marcy Kaptur (D, OH-09) and Katherine Clark (D, MA-05), is one such directive.

The U.S. Capitol Building
The U.S. Congress gave some attention to genetic privacy through the annual budget. (courtesy the Architect of the Capitol)

In April, the Department of Homeland Security (DHS) began enforcing an existing family separation policy with the stated goal of stemming what DHS and other related agencies perceived to be a rise in illegal immigration at the U.S.—Mexico border. As was widely reported in the media, children were separated from their parents or legal guardians at the border and placed in the custody of the Department of Health and Human Services’ (HHS’s) Office of Refugee Resettlement (ORR), while the parents and legal guardians were held in criminal detention. In response, many members of Congress and the general public demanded reunification of these families, and in June a federal judge ordered that the more than 2,500 children in ORR custody be reunited with their families.

Family Reunification Involved Genetic Testing 

To help reunite young children with their families by the July 5 deadline, HHS began using DNA testing to verify parentage. However, HHS provided few details regarding the testing, such as who was being tested, which labs were involved in performing the tests, and what testing was being performed. Importantly, there was also a lack of clarity regarding whether individuals were consenting to such testing, how HHS was protecting individuals’ genetic privacy, and how the test results could be used.

The provision added by Reps. Kaptur and Clark was designed to address some of these concerns. It directs ORR to “ensure the protection of privacy and genetic material, data, or information of children, parents, and of all individuals being tested and their relatives.” It also requires consent prior to collection and sample destruction once testing has concluded.

ASHG Applauds Kaptur and Clark for their Attention to Genetic Privacy 

ASHG was very supportive of this provision, and President David L. Nelson sent letters to Reps. Kaptur and Clark thanking them for their “leadership in advancing measures to ensure individuals’ genetic privacy as immigrant families seek to be reunified.” He wrote that “…an individual’s genome includes information on his or her risk for disease, their ancestry, and their relatedness to others, [so] it is important that we protect the genetic privacy of people tested.” He went on to further say that “genetic analysis should be restricted to the explicit purpose for which a person is being tested.”

ASHG’s support for this provision is the latest way in which the Society is championing measures to protect individuals’ genetic privacy. ASHG is a strong supporter of the Genetic Information Nondiscrimination Act (GINA), which among its provisions protects genetic privacy related to employment and health insurance, as well as a similar law in Canada. It also supports provisions in the 21st Century Cures Act strengthening participant privacy in research. The Kaptur/Clark amendment extends some privacy protections to those seeking reunification and ensures that federal agencies cannot use their genetic information for any purpose beyond reunification.

Nikki Meadows, PhD, is the 2017-18 ASHG/NHGRI Genetics & Public Policy Fellow. For more information on ASHG’s policy and advocacy programs, please visit the Policy & Advocacy webpage. 

U.S. Congress Approves $2 Billion Increase for NIH Funding

Posted by: Nikki Meadows, PhD, ASHG/NHGRI Genetics & Public Policy Fellow

Last month, the U.S. Congress approved legislation establishing a $2 billion (or 5.1%) funding increase for the National Institutes of Health (NIH) in Fiscal Year (FY) 2019. NIH’s total funding for FY 2019 is $39.1 billion. This includes increased funding for several priority research initiatives, such as the Cancer Moonshot and the All of Us research Initiative.

Increase Will Support New Priorities in Genetics and Genomics

The legislation (H.R. 6157) was signed into law by President Trump on September 28, after passing both the Senate (93-7) and the House (361-61). The $2 billion boost is the fourth consecutive increase in the NIH budget in recent years, demonstrating strong bipartisan support for biomedical research in Congress. Significantly, it is the first time in over 20 years that Congress has finalized the NIH budget on time.

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The $2 billion increase is consistent with the increase recommended and advocated for by ASHG and other FASEB organizations. (Credit: NIH Research Funding Trends, FASEB)

In addition to Congress being able to allocate funding for specific research initiatives, the annual appropriations bill also gives Congress an opportunity to issue directives to federal agencies, such as establishing how an agency should proceed on a particular activity or commissioning a report about a particular topic. One such directive you may be familiar with is the so-called “Dickey-Wicker Amendment,” which forbids the use of federal research dollars on any research that harms human embryos. In the FY 2019 appropriations, there are three directives related to genetics and genomics:

  • Representatives Marcy Kaptur (D-OH) and Katherine Clark (D-MA) advanced an amendment protecting the genetic privacy of individuals seeking family reunification. The amendment directs the Office of Refugee Resettlement to ensure the protection and privacy of genetic material, data, or information of children, parents, and all of the individuals being tested and their relatives.
  • A Government Accountability Office report was commissioned to analyze the medical genetics workforce nationwide. The report is asked to determine whether there are a sufficient number of qualified professionals to serve this growing health need and whether there are any geographic areas that lack access to genetic counseling professionals.
  • An amendment from Senator Marco Rubio (R-FL) requires the HHS Secretary to submit a report on the circumstances in which the Centers for Medicare and Medicaid Services may be providing payments to, or otherwise funding, entities that process genome or exome data in the People’s Republic of China or the Russian Federation.

Funding Bill’s Timely Passage Will Help with Long-Term Planning

The fiscal year runs from October 1 through September 30 of the following year, and each year, Congress is required to establish funding for upcoming fiscal year. For the past 21 years, Congress has missed the deadline, and in order to avoid a government shutdown, had to pass a Continuing Resolution (CR) that agreed to continue to fund the government until a new spending bill was completed. Indeed, such a scenario caused brief shutdowns last winter.

This year, the Department of Health and Human Services, which includes NIH, was funded through all of FY 2019, so there is no possibility of a shutdown for NIH. The budget’s timely passage means that institutes and centers can plan for the year ahead knowing what funds are available. However, other agencies, including the National Science Foundation, are currently funded by a CR until December 7, 2018, and funding for these agencies in FY 2019 remains uncertain.