International Developments

EU Adopts New Privacy Shield for Data Transfers to U.S.

Back in April, we reported on some new developments in European Union law that have implications for the life sciences industry. One of these developments was in the privacy area—the final approval of the EU’s new General Data Protection Regulation (GDPR). The GDPR will have enormous significance for medical research and practice, since it will govern the collection and use of health data related to EU citizens. This month has brought a complementary and equally significant development, this time dealing with the transfer of personal data—including health data—from the EU to the U.S.

On July 12, 2016, the European Union announced that it had formally adopted the long-awaited EU-U.S. Privacy Shield to permit the transfer of personal data from EU countries to the United States.
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Filed under International Developments, Privacy, Privacy, Privacy

Recent Developments in European Law with Implications for the U.S. Life Sciences Industry

Safe HarborThe last several months have seen several developments in European privacy and intellectual property that have significant implications for life sciences interests—both commercial and academic—in this country. Here is a brief review:

1. Final Approval of Pending EU General Data Protection Regulation

On April 14, 2016, the Parliament of the European Union gave final approval to the long-discussed GDPR. It will replace the current regime of country-by-country laws under the 1995 Data Protection Directive. Whereas an EU Directive requires implementation by individual EU member states, the GDPR is a Regulation (much like a federal law in this country) that will take immediate effect in all EU countries in the spring of 2018.
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Filed under General Interest, International Developments, Legal & Regulatory, Pending Regulation, Privacy, Privacy, Privacy

How Privacy Law Affects Medical and Scientific Research

eyeball_nOver the last five or so years my law practice has focused increasingly on privacy law, both domestic and international. In hindsight, this was a predictable outcome: as an intellectual property lawyer, many of my clients do business on the Internet or are engaged in scientific research and development, with many of the latter in the health care area. These are the very kinds of people who need to worry about privacy—of their customers, users, patients, and subjects. As they started on focusing on privacy concerns, these clients turned to their IP lawyers for help, and my Robinson Bradshaw colleagues and I have tried to stay ahead of their needs.

As a consequence of my growing privacy practice, I am regularly called on to give overviews to other lawyers as well as non-lawyers in the scientific and business communities. I thought it might be useful to devote a GLR post to a privacy law summary targeted at readers who conduct medical and other scientific research. Privacy law is a transnational mess, so this will be a bit longer than I’d like—my apologies, and please don’t shoot the messenger—but I’ll try to cut through the legal jargon.
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Australian appeals court upholds patents on isolated BRCA1 DNA

Robert Cook-Deegan, MD

Bob Cook-Deegan 0546.05 © Duke University Photography Jim WallaceOn September 5, the Federal Court of Australia (the appeals court) upheld a claim on isolated DNA from the BRCA1 gene. It dismissed Yvonne D’Arcy’s appeal of a case that has attracted international attention. Australian patent 686,004 has never been enforced, so the court decision has little real-world concrete impact. As Richard Gold and Julia Carbone explained in their classic case study, “Myriad Genetics: In the Eye of the Policy Storm,” the patent rights on BRCA1 and BRCA2 were exclusively licensed for use in Australia and New Zealand to Genetic Technologies, Ltd. (GTG), which in turn made them a “gift to the people of Australia.” When the CEO of GTG proposed taking back that gift in the summer of 2008, he provoked a firestorm and the company backed down in October, restating that it would not enforce its patent rights against laboratories offering BRCA testing. The Australian Senate held a series of hearings, and a bill proscribing DNA sequence patents was proposed, but the new government opposed it, and it lapsed. Instead, Australia enacted patent reforms in 2012 that raised the bar for utility and clarified the Australian law’s exemption from infringement liability for research and regulatory approval. Most of the provisions of that law took effect on April 15, 2013, the very day Association for Molecular Pathology v Myriad Genetics (AMP v Myriad) was argued before the U.S. Supreme Court.


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Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP

Revisions to the Ethical Standards for Research

HelsinkiThe World Medical Association published revisions to the Declaration of Helsinki (DoH) in JAMA on October 19, 2013. As noted previously on the Genomics Law Report, the DoH was adopted in 1964 and is considered a foundational guiding document for ethical medical research. The DoH has been revised six times previously, and these are the first revisions since 2008. The revised DoH was announced following the Working Group’s public consultation from April to June 2013 on the text of proposed changes, though the Working Group has apparently spent at least two years contemplating revisions and consulting with experts. In the United States, the DoH has been an important foundational document promoting the creation of institutional review boards (IRBs) but has had relatively little practical influence since it was effectively abandoned by the administration of former President George W. Bush. Nonetheless, the DoH continues to exert significant influence over international ethical standards.
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Filed under Genomic Policymaking, Genomics & Medicine, Genomics & Society, Informed Consent, International Developments, International News

Genomic Research Ethics: Special Rules for HeLa Cells

In her 2010 book The Immortal Life of Henrietta Lacks, Rebecca Skloot told the story of Henrietta Lacks and the cell lines derived from her cervical tumor biospecimen (cell lines known to scientists simply as “HeLa cells”). To make a long story short, in 1951 physicians at Johns Hopkins Hospital took a biopsy from a patient, Henrietta Lacks, and from that biospecimen developed the first human cancer cell line. The biospecimen was taken without Lacks’ knowledge or informed consent. No laws were broken in the creation of the HeLa cell lines that are now recognized (pdf) as “the most widely used human cell line in the world.” She died in 1951, and it was reportedly not until 1973 that her family learned about the HeLa cells (two years after Henrietta Lacks’ name was published as the source of HeLa cells in a scientific journal). As the table below shows, this incident occurred long before the adoption of regulations and ethical guidelines for biomedical research that, today, generally require researchers to obtain voluntary, informed consent from individuals before performing biomedical experiments.
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Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision

Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”

The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:


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Filed under Biobanking, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Big Changes Coming in EU Privacy Law

The European Union is about to make major changes in its privacy law that will have a significant impact on U.S. companies that do even modest amounts of business in Europe. On January 25, 2011, the European Commission (the EU’s executive branch) released a long-awaited Draft Regulation on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data (pdf).

While it will likely be a year or more before a final regulation takes effect, and there will almost certainly be amendments along the way, American companies – including those involved in the field of personalized medicine, where personal data is paramount by definition – should start paying attention now, since they may have to change the way that they do business in Europe.


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News Roundup: Patent Reform Passes House, Human Provenance Project Pulled by UK

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

Patent Reform Legislation Passes House. Several months after the U.S. Senate passed patent reform legislation that would make sweeping changes to America’ patent system, including a switch from a first-to-invent to a first-to-file system for awarding patents, the U.S. House of Representatives finally followed suit yesterday, passing a similar piece of legislation by a vote of 304-117. The version passed by the House, while similar to that passed by the Senate, contained a number of last-minute amendments (pdf).

One change of particular relevance to the personalized medicine community was the removal of a proposed safe harbor for second opinion genetic diagnostic testing, which was replaced by a requirement that the U.S. Patent and Trademark Office (USPTO) investigate the relationship between genetic diagnostic tests, gene patents and exclusive licenses. The USPTO would be given nine months to complete its investigation and to return to Congress recommendations for ensuring the availability of second opinion genetic diagnostic testing. (The USPTO study on genetic diagnostic testing was not included in the bill passed by the Senate in March.)


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, International Developments, International News, Legal & Regulatory, Patents & IP, Pending Litigation, Privacy

Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

UK Insurers Continue Moratorium on Predictive Genetic Tests. In 2008 the United States passed the Genetic Information Nondiscrimination Act (GINA). Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II of GINA addresses the use and misuse of genetic information by employers. In the United Kingdom, which provides universal health coverage through the government-funded National Health Service (NHS), discussion of genetic nondiscrimination has largely focused on the employment context (see, e.g., the 2009 report on Genomic Medicine from the House of Lords). To date, however, the United Kingdom has not enacted a formal prohibition on the use of genetic information by either employers or insurers.


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, GINA, Industry News, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP