International Developments
GLR Update: Australia Tackles Disclosure of Genetic Information without Consent
Last fall, the Genomics Law Report reviewed new medical confidentiality guidance from the U.K. General Medical Council (GMC) and wondered whether the “public interest” was a sufficient justification for the disclosure of patients’ genetic information without their consent.
Since that time, Australia’s National Health and Medical Research Council (NHMRC) has tackled the same issue, publishing new privacy guidelines for health practitioners on the disclosure of genetic information (pdf).
In each case, the basic thrust of the guidance for medical practitioners is the same – there are certain circumstances where a patient’s genetic information may be disclosed against his or her wishes. However, the guidance from the GMC and the NHMRC does differ in several important respects.
First, while the GMC’s guidance applies to all doctors in the United Kingdom, the NHMRC’s guidance is restricted to Australian doctors in private practice. The NHMRC’s guidance also restricts its applicability to the disclosure of genetic information to living genetic relatives for medical purposes. Disclosures relating to unborn children (e.g., information related to embryos or carrier status), to legal but non-genetic relatives (e.g., adopted children or spouses) or for genetic research are all outside of the scope of the NHMRC’s guidelines. The GMC’s guidelines, on the other hand, contain no such specific limitations, referring only to the practitioner’s responsibility to balance the patient’s interests against those of others, and to disclose genetic or other information when justified in the public interest.
Meet the New deCODE, Same as the Old deCODE?
When deCODE genetics declared bankruptcy last fall it made a big splash. Geneticists pondered the future of the Icelandic biotechnology company’s one-of-a-kind genetic database and research platform, while investors and creditors wondered if they were going to be left out in the cold.
The initial bankruptcy buzz gave way over the past several months to a steady but relatively unremarkable stream of filings in the United States Bankruptcy Court for the District of Delaware (the case is No. 09-14063). Last week, however, brought a noteworthy docket entry, with the bankruptcy court approving the sale of most of deCODE genetics Inc.’s assets to Saga Investments LLC (pdf) – an investment company whose owners include Polaris Venture Partners, ARCH Venture Partners and genomic sequencing giant (and DTC genomics dabbler) Illumina.
A Holiday Fire-Sale? The sale, as approved by the bankruptcy court, sends substantially all of deCODE genetics Inc.’s assets – including its valuable genetic research engine that is driven in part by its access to its large Icelandic population database – to Saga Investments. As we described back in November, the bankruptcy sale process required a Stalking Horse bidder (Saga Investments) and a sale and auction process that, at least in theory, allowed other interested parties a chance to step in and make a bid for deCODE’s assets. No other bidders came forward, and the sale to Saga Investments was approved in just under two months.
Follow-on Biologics: How Much Incentive Do We Need?
After almost a full year of debate, a pathway for approving “follow-on biologics” or “biosimilars” continues to be a hot topic in Congress. We are all familiar with generic versions of brand-name drugs, and the federal regulatory scheme sets out well-defined shortcut procedures for approval of generics. Congress is now grappling with designing procedures for approval of generic versions of biological drugs. Although follow-on biologics are in some ways similar to generic drugs, the differences are crucial, and in fact the regulatory scheme for generic drugs does not work at all for biologics. Congress has its work cut out for it.
Biologics 101. In short, here is the problem: typical pharmaceutical drugs (“small molecule drugs”) are chemically synthesized, and once the brand-name manufacturer’s exclusive patent rights expire, generic manufacturers are free to obtain approvals under abbreviated procedures, Generic manufacturers are generally not required to submit preclinical (animal) and clinical (human) data along with these Abbreviated New Drug Applications (ANDAs), thereby avoiding the huge expenses associated with developing new pharmaceuticals. But this route is only open to the generic manufacturer if it can prove that the generic version of the drug contains an identical replica of the drug’s active ingredient. Under the Hatch-Waxman Act of 1984, the Food and Drug Administration (FDA) may approve a generic version of a drug if the generic contains the same active ingredient as the original, shows bioequivalence to the original, and is demonstrated to be manufactured according to appropriate practices. Once these are shown, the generic is allowed to piggyback on the designation of the original drug as safe and effective.
Reproductive Genetic Screening: More Questions Than Answers
The Genomics Law Report has published a couple of guest commentaries recently dealing with genetic screening—a topic our own Adam Doerr also addressed in two posts this summer dealing with “wrongful life” claims brought against sperm banks by children with genetic diseases inherited from their donor fathers. Such claims are premised on the failure of the sperm bank to conduct genetic screening that could have detected the defective genes—thereby avoiding the conception of the child on whose behalf the wrongful life claim is brought.
In this post, I look at a recent gamete screening controversy—the revelation that a man fathered at least two dozen children, all but two through the donation of his sperm to a bank, despite having a potentially serious genetic defect—and examine numerous issues the story raises. Many relate to whose interests are valued the highest. Should the wellbeing of the children born of the process—the only people involved who have no say in the matter—come first, or does respect for the autonomy of the parents control? I do not attempt to answer the questions posed, but seek to encourage discussion with respect to the need for clearer policies and guidance in a number of these areas.
Disclosure of Patients’ Genetic Information Without Their Consent–Is the “Public Interest” Really a Sufficient Justification?
New guidance issued by the U.K. General Medical Council (GMC) regarding a physician’s ability to disclose to a patient’s relatives the diagnosis of such patient’s genetic illness1 has recently been a hot topic of discussion on several online forums.2 The guidance, which became effective on October 12, 2009 and addresses medical privacy issues in a variety of contexts (not just genetic information sharing), recognizes that the diagnosis of a patient’s genetic illness may indicate the likelihood of the same illness in the patient’s close blood relatives. The GMC suggests that a physician’s first obligation after diagnosing a genetic illness is to explain to the patient the likelihood that close relatives are also at risk and to encourage the patient to discuss his or her illness with relatives. However, should the patient refuse to voluntarily disclose the illness to at risk family members, the physician may disclose such information if disclosure would be “justified in the public interest.” Physicians are instructed to balance their duty to provide care to the patient against their duty to protect others from serious harm.3
U.K. Human Genetics Commission Proposes Principles for DTC Genetic Testing Services
Last month, the Human Genetics Commission, the U.K. government’s genetics advisory body, issued for public comment a “Common Framework of Principles” for direct-to-consumer (DTC) genetic testing services. The Principles are derived from earlier reports by the Commission (Genes Direct (2003) (pdf) and More Genes Direct (2007) (pdf)) and seek to:
…promote high standards and consistency in the provision of direct-to-consumer genetic tests among commercial providers at an international level in order to protect the interests of people seeking genetic tests and their families.
The Principles, which are ambitious in scope and detailed in their recommendations, represent an important next step in the ongoing debate over the appropriate level of oversight for the emerging DTC genetic testing industry.
Published in draft form, the Principles provide ample room for analysis, and companies and consumers are invited to provide responses and comments until December 6th, 2009.
In this post we take a close look at the draft Principles and summarize the core values and goals that appear to underlie these recommendations.
The Human Provenance Project Attempts to Unring the Bell
Last week I wrote about the U.K. Border Agency’s widely criticized Human Provenance pilot project (“Why the Errors of the Human Provenance Project Will Echo Beyond the U.K.’s Borders”) and suggested that “we should not be surprised to see the pilot project substantially revised, or even scrapped altogether.” I worried, though, that the damage may already have been done by contributing to a highly charged atmosphere that could add to pressure for premature regulation and public skepticism.
Today brings word, via ScienceInsider, that the Border Agency is pulling back on its plans to use DNA and isotope analysis to evaluate the nationality of asylum seekers attempting to enter the U.K. According to ScienceInsider:
In a statement released this afternoon by the Home Office, which oversees the Border Agency, the department’s Chief Scientific Advisor Paul Wiles now says such evidence will be collected for later analysis of its potential but will not currently be used for individual case decisions.
As Daniel MacArthur points out at Genetic Future, while some of the initial outrage over the Border Agency’s policy may have been overstated, “the initial policy was still grossly premature” and the “Border Agency’s decision to take a step back and consider the implications before wading into the morass of genetic ancestry testing” is a welcome development.
Why the Errors of the Human Provenance Project Will Echo Beyond the U.K.’s Borders
ScienceInsider has posted several pieces this morning describing and critiquing the U.K. Border Agency’s Human Provenance pilot project:
Scientists are greeting with surprise and dismay a project to use DNA and isotope analysis of tissue from asylum seekers to evaluate their nationality and help decide who can enter the United Kingdom. “Horrifying,” “naïve,” and “flawed” are among the adjectives geneticists and isotope specialists have used to describe the “Human Provenance pilot project,” launched quietly in mid-September by the U.K. Border Agency. Their consensus: The project is not scientifically valid—or even sensible.
In addition to the feature article, ScienceInsider has also published a FAQ describing what is now known about the program as well as links to the underlying documents and expanded reactions from leading geneticists and isotope specialists.
The project is, as the name indicates, a pilot project, and one spokesperson described it as being “in its baby stages.” Still, as reported by ScienceInsider, the scientific community’s reaction to the program appears to be swift, unanimous and extraordinarily critical. Daniel MacArthur of Genetic Future has a slightly more measured take, expressing skepticism about the ability of the government agency to identify precisely an individual’s geographic ancestry based on genomic data and rightly pointing out that the “crucial issue is that it must be shown that the data are used in appropriate ways, and not given undue weight in making serious decisions about a person’s future.” That’s an issue that cannot be resolved until the Border Agency provides additional details on both its scientific methods and its utilization of the collected DNA and isotope data.
The near-uniform scientific skepticism that has greeted the announcement of the Human Provenance project suggests that we should not be surprised to see the pilot project substantially revised, or even scrapped altogether. But has damage already been done?
Genetic Exceptionalism and Paternalism Themes in new German Legislation
In April, the German Parliament approved the Human Genetic Examination Act. An English translation of the Act (pdf), which appears likely to be enacted, was recently posted to EuroGentest. (Special thanks to the PHG Foundation for locating the translation.) The Act is a clear example of what is known as “genetic exceptionalism”—the belief that genetic information is qualitatively different from other forms of personal or medical information—staking out a position near the paternalistic end of genetic regulation. Despite aspiring “to protect human dignity and ensure the individual right to self-determination via sufficient information,” the substance of the Act severely restricts individual freedom of action.
Strict Regulation of Genetic Examinations
The Act employs the terms “genetic examination” and “genetic analysis” in most of its provisions and defines these terms so broadly (§ 3) as to admit some uncertainty as to what would or would not constitute a genetic examination or genetic analysis. The vagueness of the definitions is mitigated to a degree by other defined terms that clarify that the Act’s provisions on genetic examinations and genetic analyses apply, in fact, to such examinations and analyses for medical purposes or for determining descent. The Act requires that “diagnostic” or “predictive” genetic examinations be ordered and interpreted by medical doctors having appropriate training and conducted only by institutions having the appropriate accreditation (§ 7). Such genetic examinations and genetic analyses may be conducted only upon the express, written and informed consent of the patient (§ 8).
U.K. House of Lords Issues Report on Genomic Medicine
On July 7, the Science and Technology Committee of the United Kingdom’s House of Lords issued its report on genomic medicine (pdf). The Report is optimistic about the potential long-term benefits of translating advances in genetics into substantial improvements in medical care but determines that the National Health Service (NHS) is not currently equipped to take advantage of this scientific revolution. The Report identifies existing institutional deficiencies and makes a variety of recommendations for improving the U.K.’s current system.
The following first summarizes key features and recommendations of the Report and then considers how the Report may influence legislative and regulatory developments in the United States, as well as in the U.K.
Part I: Recommendations for Genomic Medicine
At a hefty but still manageable 126 pages, the full Report is recommended reading for those interested in the field of genomic medicine in any country with a developed healthcare system. But for the sake of convenience, some of the highlights of the Report are summarized below.
