Monthly Round-Up: What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from premarket development times for biologics versus small-molecule drugs, to the characteristics of trials and regulatory pathways leading to U.S. approval of innovative vs. non-innovative drugs, to generic and brand-name thyroid hormone drug use among commercially insured and Medicaid beneficiaries. A full posting of abstracts/summaries of these articles may be found on our website.

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The NHS in England Launches a New Patient Safety Strategy

On July 2, 2019 a new National Health Service (NHS) patient safety strategy was launched in England. The strategy promises many things and lays out the future trajectory of NHS patient safety policy making.

Aidan Fowler, the NHS National Director of Patient Safety highlights the scale of the NHS patient safety problem in the foreword to the strategy:

 Too often in healthcare we have sought to blame individuals, and individuals have not felt safe to admit errors and learn from them or act to prevent recurrence…The opportunity is huge. Hogan et al’s research from 2015 suggests we may fail to save around 11,000 lives a year due to safety concerns, with older patients the most affected. The extra treatment needed following incidents may cost at least £1 billion (p3).

 

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Is Data Sharing Caring Enough About Patient Privacy? Part II: Potential Impact on US Data Sharing Regulations

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

Earlier, we discussed the new suit filed against Google, the University of Chicago (UC), and UChicago Medicine, focusing on the disclosure of patient data from UC to Google. This piece goes beyond the background to consider the potential impact of this lawsuit, in the U.S., as well as placing the lawsuit in the context of other trends in data privacy and security.

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Image of binary and dna

Is Data Sharing Caring Enough About Patient Privacy? Part I: The Background

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and regulation of data sharing in the health and life sciences. Cutting-edge biomedical research strongly demands high-quality data to ensure safe and effective health products. It is often argued that greater access to individual patient data collections stored in hospitals’ medical records systems may considerably advance medical science and improve patient care. However, as public and private actors attempt to gain access to such high-quality data to train their advanced algorithms, a number of sensitive ethical and legal aspects also need to be carefully considered. Besides giving rise to safety, antitrust, trade secrets, and intellectual property issues, such practices have resulted in serious concerns with regard to patient privacy, confidentiality, and the commitments made to patients via appropriate informed consent processes.

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A Professional In Vitro Fertilisation Laboratory Microscope Closeup - Image

Professor: The Law Has No Straight Answer for Our High-Tech Baby Boom

This is an excerpt of an article by Alaina Lancaster that originally appeared on Law.com. Read the full interview here. 

After thousands of dollars of in vitro fertilization treatments and nine months of pregnancy, a New York couple was forced to give up the twins they birthed. It turns out CHA Fertility Center, the Los Angeles clinic where the couple sought IVF treatment, mixed up the embryos of three patients, resulting in two of the couples having to give up children to their genetic parents. Now, those parents are suing.

Dov Fox, professor of law at the University of San Diego and the director of the school’s Center for Health Law Policy & Bioethics, said the law has not caught up with reproductive technology and victims of this type of medical malpractice aren’t left with many legal options. Yet, legal frameworks are out there, Fox said. Judges and lawmakers just might need to look outside the U.S.

Read the full interview here.

Border patrol facility

ICE Raids Hold Health Implications Beyond Borders

By Lilo Blank

A health care environment already rife with navigational challenges for immigrant communities likely just became much more complicated and more dangerous even after planned US Immigrant and Customs Enforcement (ICE) court-ordered arrests and deportations this past Sunday, July 14, in 10 major U.S. cities never really materialized.

News articles from New Jersey to California detail immigrant communities on high alert, with many members of those communities fearing to go out in public. As the LA Times reports, whether this self-induced quarantining is a “one-day shift” or whether it will continue remains to be seen, but it is likely one will further harm immigrant populations, particularly Latinx and Hispanic communities. The planned (though largely uneventful ICE raids) are authorized by the Immigration and Nationality Act, which was amended in 1996 to include the  Illegal Immigration Reform and Immigrant Responsibility Act, including section 287(g). Read More

Medical devices in a doctor's office

What the Trade War with China Means to the Medical Industry

If you rely on a pacemaker, an implanted defibrillator, a prosthetic hip, wear contacts or need an MRI, then you should be concerned about the constant threat and imposition of tariffs on Chinese imports by the Trump Administration. Using Section 301 of the Trade Act of 1974, President Donald Trump imposed new tariffs on an array of Chinese imports based on the assertion that they were stealing United States intellectual properties. The first volley occurred in July 2018 when the administration applied tariffs of 25% to over $34 billion in Chinese imports, and then again in August 2018 when it added another $16 billion in products to the list.

In an ongoing tit-for-tat, on May 10, 2019, the United States raised tariffs from 10% to 25% on an additional $200 billion worth of Chinese goods, including many health care products, from surgical gloves to chemical reagents. While medical supplies are only a small, biopsy-sized sample of the goods that will face these tariffs, they are sure to have some impact on an already financially burdened health care delivery system here in the United States. This will result in higher prices for health care products, devices, and components that are all passed off to the consumer.

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Magnifying glass examining a computer screen displaying medication

Online Content Moderation as Public Health Regulation

Recent events, such as the New Zealand mosque shooting in Christchurch and foreign meddling in the 2016 U.S. election, have made internet content moderation a subject of international concern. To shield users from harmful and misleading content, internet platforms scramble to review billions of uploads each day. A large portion of that content is health-related, and platforms are increasingly choosing to police it.

Facebook recently updated its policies on health-related content. On July 2, the platform announced new tools to reduce the appearance of sensational health claims on the site. According to Facebook, “in order to help people get accurate health information and the support they need, it’s imperative that we minimize health content that is sensational or misleading.”

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Man and woman on holding hands on a couch, pictured from the neck down

What Happens When Reproductive Tech Like IVF Goes Awry?

It sounds like the setup to a bad joke: Three couples walk into a fertility clinic. But the punch line—what happened to those families at one Los Angeles medical facility in August 2018—is no laughing matter. The embryos from two couples hoping to conceive were mistakenly implanted into a third patient. That third woman and her husband, both of Korean descent, suspected that something was amiss when their two newborns didn’t look anything like them.

DNA testing confirmed that Baby A and Baby B (as court documents called them) weren’t genetically related to either of the birth parents, or to each other—they were related to two other couples who had been seeking fertility treatments at the same clinic. The birth parents were forced to give up their “twins” to their respective genetic parents.

The other two couples, while granted the surprise of children they thought they’d never have, missed out on the experience of pregnancy and early bonding. One of the women explained her sense of loss: “I wasn’t there for his birth, I did not carry him, I did not feel him kick inside of me, I didn’t do the skin to skin, I didn’t breastfeed him.” The mix-up at CHA Fertility Clinic leaves all three couples bereft. They’re left to wonder what happened to their other embryos, and to worry whether their biological children might be born to someone else without them ever knowing.

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