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3D printing of body parts is coming fast – but regulations are not ready
Today, a quickly emerging set of technologies known as bioprinting is poised to push the boundaries further.
In the last few years, the use of 3D printing has exploded in medicine. Engineers and medical professionals now routinely 3D print prosthetic hands and surgical tools. But 3D printing has only just begun to transform the field.
Today, a quickly emerging set of technologies known as bioprinting is poised to push the boundaries further. Bioprinting uses 3D printers and techniques to fabricate the three-dimensional structures of biological materials, from cells to biochemicals, through precise layer-by-layer positioning. The ultimate goal is to replicate functioning tissue and material, such as organs, which can then be transplanted into human beings.
We have been mapping the adoption of 3D printing technologies in the field of health care, and particularly bioprinting, in a collaboration between the law schools of Bournemouth University in the United Kingdom and Saint Louis University in the United States. While the future looks promising from a technical and scientific perspective, it's far from clear how bioprinting and its products will be regulated. Such uncertainty can be problematic for manufacturers and patients alike, and could prevent bioprinting from living up to its promise.
From 3D printing to bioprinting
Bioprinting has its origins in 3D printing. Generally, 3D printing refers to all technologies that use a process of joining materials, usually layer upon layer, to make objects from data described in a digital 3D model. Though the technology initially had limited applications, it is now a widely recognized manufacturing system that is used across a broad range of industrial sectors. Companies are now 3D printing car parts, education tools like frog dissection kits and even 3D-printed houses. Both the United States Air Force and British Airways are developing ways of 3D printing airplane parts.
The NIH in the U.S. has a program to develop bioprinted tissue that's similar to human tissue to speed up drug screening. (Paige Derr and Kristy Derr, National Center for Advancing Translational Sciences)
In medicine, doctors and researchers use 3D printing for several purposes. It can be used to generate accurate replicas of a patient's body part. In reconstructive and plastic surgeries, implants can be specifically customized for patients using "biomodels" made possible by special software tools. Human heart valves, for instance, are now being 3D printed through several different processes although none have been transplanted into people yet. And there have been significant advances in 3D print methods in areas like dentistry over the past few years.
Bioprinting's rapid emergence is built on recent advances in 3D printing techniques to engineer different types of products involving biological components, including human tissue and, more recently, vaccines.
While bioprinting is not entirely a new field because it is derived from general 3D printing principles, it is a novel concept for legal and regulatory purposes. And that is where the field could get tripped up if regulators cannot decide how to approach it.
State of the art in bioprinting
Scientists are still far from accomplishing 3D-printed organs because it's incredibly difficult to connect printed structures to the vascular systems that carry life-sustaining blood and lymph throughout our bodies. But they have been successful in printing nonvascularized tissue like certain types of cartilage. They have also been able to produce ceramic and metal scaffolds that support bone tissue by using different types of bioprintable materials, such as gels and certain nanomaterials. A number of promising animal studies, some involving cardiac tissue, blood vessels and skin, suggest that the field is getting closer to its ultimate goal of transplantable organs.
Researchers explain ongoing work to make 3d-printed tissue that could one day be transplanted into a human body.
We expect that advancements in bioprinting will increase at a steady pace, even with current technological limitations, potentially improving the lives of many patients. In 2019 alone, several research teams reported a number of breakthroughs. Bioengineers at Rice and Washington Universities, for example, used hydrogels to successfully print the first series of complex vascular networks. Scientists at Tel Aviv University managed to produce the first 3D-printed heart. It included “cells, blood vessels, ventricles and chambers" and used cells and biological materials from a human patient. In the United Kingdom, a team from Swansea University developed a bioprinting process to create an artificial bone matrix, using durable, regenerative biomaterial.
Though the future looks promising from a technical and scientific perspective, current regulations around bioprinting pose some hurdles. From a conceptual point of view, it is hard to determine what bioprinting effectively is.
Consider the case of a 3D-printed heart: Is it best described as an organ or a product? Or should regulators look at it more like a medical device?
Regulators have a number of questions to answer. To begin with, they need to decide whether bioprinting should be regulated under new or existing frameworks, and if the latter, which ones. For instance, should they apply regulations for biologics, a class of complex pharmaceuticals that includes treatments for cancer and rheumatoid arthritis, because biologic materials are involved, as is the case with 3D-printed vaccines? Or should there be a regulatory framework for medical devices better suited to the task of customizing 3D-printed products like splints for newborns suffering from life-threatening medical conditions?
In Europe and the U.S., scholars and commentators have questioned whether bioprinted materials should enjoy patent protection because of the moral issues they raise. An analogy can be drawn from the famed Dolly the sheep over 20 years ago. In this case, it was held by the U.S. Court of Appeals for the Federal Circuit that cloned sheep cannot be patented because they were identical copies of naturally occurring sheep. This is a clear example of the parallels that exist between cloning and bioprinting. Some people speculate in the future there will be 'cloneprinting,' which has the potential for reviving extinct species or solving the organ transplant shortage.
Dolly the sheep's example illustrates the court's reluctance to traverse this path. Therefore, if, at some point in the future, bioprinters or indeed cloneprinters can be used to replicate not simply organs but also human beings using cloning technologies, a patent application of this nature could potentially fail, based on the current law. A study funded by the European Commission, led by Bournemouth University and due for completion in early 2020 aims to provide legal guidance on the various intellectual property and regulatory issues surrounding such issues, among others.
On the other hand, if European regulators classify the product of bioprinting as a medical device, there will be at least some degree of legal clarity, as a regulatory regime for medical devices has long been in place. In the United States, the FDA has issued guidance on 3D-printed medical devices, but not on the specifics of bioprinting. More important, such guidance is not binding and only represents the thinking of a particular agency at a point in time.
Cloudy regulatory outlook
Those are not the only uncertainties that are racking the field. Consider the recent progress surrounding 3D-printed organs, particularly the example of a 3D-printed heart. If a functioning 3D-printed heart becomes available, which body of law should apply beyond the realm of FDA regulations? In the United States, should the National Organ Transplant Act, which was written with human organs in mind, apply? Or do we need to amend the law, or even create a separate set of rules for 3D-printed organs?
We have no doubt that 3D printing in general, and bioprinting specifically, will advance rapidly in the coming years. Policymakers should be paying closer attention to the field to ensure that its progress does not outstrip their capacity to safely and effectively regulate it. If they succeed, it could usher in a new era in medicine that could improve the lives of countless patients.
Dinusha Mendis, Professor of Intellectual Property and Innovation Law and Co-Director of the Jean Monet Centre of Excellence for European Intellectual Property and Information Rights, Bournemouth University and Ana Santos Rutschman, Assistant Professor of Law, Saint Louis University.
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How would the ability to genetically customize children change society? Sci-fi author Eugene Clark explores the future on our horizon in Volume I of the "Genetic Pressure" series.
- A new sci-fi book series called "Genetic Pressure" explores the scientific and moral implications of a world with a burgeoning designer baby industry.
- It's currently illegal to implant genetically edited human embryos in most nations, but designer babies may someday become widespread.
- While gene-editing technology could help humans eliminate genetic diseases, some in the scientific community fear it may also usher in a new era of eugenics.
Tribalism and discrimination<p>One question the "Genetic Pressure" series explores: What would tribalism and discrimination look like in a world with designer babies? As designer babies grow up, they could be noticeably different from other people, potentially being smarter, more attractive and healthier. This could breed resentment between the groups—as it does in the series.</p><p>"[Designer babies] slowly find that 'everyone else,' and even their own parents, becomes less and less tolerable," author Eugene Clark told Big Think. "Meanwhile, everyone else slowly feels threatened by the designer babies."</p><p>For example, one character in the series who was born a designer baby faces discrimination and harassment from "normal people"—they call her "soulless" and say she was "made in a factory," a "consumer product." </p><p>Would such divisions emerge in the real world? The answer may depend on who's able to afford designer baby services. If it's only the ultra-wealthy, then it's easy to imagine how being a designer baby could be seen by society as a kind of hyper-privilege, which designer babies would have to reckon with. </p><p>Even if people from all socioeconomic backgrounds can someday afford designer babies, people born designer babies may struggle with tough existential questions: Can they ever take full credit for things they achieve, or were they born with an unfair advantage? To what extent should they spend their lives helping the less fortunate? </p>
Sexuality dilemmas<p>Sexuality presents another set of thorny questions. If a designer baby industry someday allows people to optimize humans for attractiveness, designer babies could grow up to find themselves surrounded by ultra-attractive people. That may not sound like a big problem.</p><p>But consider that, if designer babies someday become the standard way to have children, there'd necessarily be a years-long gap in which only some people are having designer babies. Meanwhile, the rest of society would be having children the old-fashioned way. So, in terms of attractiveness, society could see increasingly apparent disparities in physical appearances between the two groups. "Normal people" could begin to seem increasingly ugly.</p><p>But ultra-attractive people who were born designer babies could face problems, too. One could be the loss of body image. </p><p>When designer babies grow up in the "Genetic Pressure" series, men look like all the other men, and women look like all the other women. This homogeneity of physical appearance occurs because parents of designer babies start following trends, all choosing similar traits for their children: tall, athletic build, olive skin, etc. </p><p>Sure, facial traits remain relatively unique, but everyone's more or less equally attractive. And this causes strange changes to sexual preferences.</p><p>"In a society of sexual equals, they start looking for other differentiators," he said, noting that violet-colored eyes become a rare trait that genetically engineered humans find especially attractive in the series.</p><p>But what about sexual relationships between genetically engineered humans and "normal" people? In the "Genetic Pressure" series, many "normal" people want to have kids with (or at least have sex with) genetically engineered humans. But a minority of engineered humans oppose breeding with "normal" people, and this leads to an ideology that considers engineered humans to be racially supreme. </p>
Regulating designer babies<p>On a policy level, there are many open questions about how governments might legislate a world with designer babies. But it's not totally new territory, considering the West's dark history of eugenics experiments.</p><p>In the 20th century, the U.S. conducted multiple eugenics programs, including immigration restrictions based on genetic inferiority and forced sterilizations. In 1927, for example, the Supreme Court ruled that forcibly sterilizing the mentally handicapped didn't violate the Constitution. Supreme Court Justice Oliver Wendall Holmes wrote, "… three generations of imbeciles are enough." </p><p>After the Holocaust, eugenics programs became increasingly taboo and regulated in the U.S. (though some states continued forced sterilizations <a href="https://www.uvm.edu/~lkaelber/eugenics/" target="_blank">into the 1970s</a>). In recent years, some policymakers and scientists have expressed concerns about how gene-editing technologies could reanimate the eugenics nightmares of the 20th century. </p><p>Currently, the U.S. doesn't explicitly ban human germline genetic editing on the federal level, but a combination of laws effectively render it <a href="https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsaa006/5841599#204481018" target="_blank" rel="noopener noreferrer">illegal to implant a genetically modified embryo</a>. Part of the reason is that scientists still aren't sure of the unintended consequences of new gene-editing technologies. </p><p>But there are also concerns that these technologies could usher in a new era of eugenics. After all, the function of a designer baby industry, like the one in the "Genetic Pressure" series, wouldn't necessarily be limited to eliminating genetic diseases; it could also work to increase the occurrence of "desirable" traits. </p><p>If the industry did that, it'd effectively signal that the <em>opposites of those traits are undesirable. </em>As the International Bioethics Committee <a href="https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsaa006/5841599#204481018" target="_blank" rel="noopener noreferrer">wrote</a>, this would "jeopardize the inherent and therefore equal dignity of all human beings and renew eugenics, disguised as the fulfillment of the wish for a better, improved life."</p><p><em>"Genetic Pressure Volume I: Baby Steps"</em><em> by Eugene Clark is <a href="http://bigth.ink/38VhJn3" target="_blank">available now.</a></em></p>
A leading British space scientist thinks there is life under the ice sheets of Europa.
- A British scientist named Professor Monica Grady recently came out in support of extraterrestrial life on Europa.
- Europa, the sixth largest moon in the solar system, may have favorable conditions for life under its miles of ice.
- The moon is one of Jupiter's 79.
Neil deGrasse Tyson wants to go ice fishing on Europa<div class="rm-shortcode" data-media_id="GLGsRX7e" data-player_id="FvQKszTI" data-rm-shortcode-id="f4790eb8f0515e036b24c4195299df28"> <div id="botr_GLGsRX7e_FvQKszTI_div" class="jwplayer-media" data-jwplayer-video-src="https://content.jwplatform.com/players/GLGsRX7e-FvQKszTI.js"> <img src="https://cdn.jwplayer.com/thumbs/GLGsRX7e-1920.jpg" class="jwplayer-media-preview" /> </div> <script src="https://content.jwplatform.com/players/GLGsRX7e-FvQKszTI.js"></script> </div>
Water Vapor Above Europa’s Surface Deteced for First Time<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="9c4abc8473e1b89170cc8941beeb1f2d"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/WQ-E1lnSOzc?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span>
Scientists discover burrows of giant predator worms that lived on the seafloor 20 million years ago.
- Scientists in Taiwan find the lair of giant predator worms that inhabited the seafloor 20 million years ago.
- The worm is possibly related to the modern bobbit worm (Eunice aphroditois).
- The creatures can reach several meters in length and famously ambush their pray.
A three-dimensional model of the feeding behavior of Bobbit worms and the proposed formation of Pennichnus formosae.
Credit: Scientific Reports
Beware the Bobbit Worm!<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="1f9918e77851242c91382369581d3aac"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/_As1pHhyDHY?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span>
The idea behind the law was simple: make it more difficult for online sex traffickers to find victims.
- SESTA (Stop Enabling Sex Traffickers Act) and FOSTA (Allow States and Victims to Fight Online Sex Trafficking Act) started as two separate bills that were both created with a singular goal: curb online sex trafficking. They were signed into law by former President Trump in 2018.
- The implementation of this law in America has left an international impact, as websites attempt to protect themselves from liability by closing down the sections of their sites that sex workers use to arrange safe meetings with clientele.
- While supporters of this bill have framed FOSTA-SESTA as a vital tool that could prevent sex trafficking and allow sex trafficking survivors to sue those websites for facilitating their victimization, many other people are strictly against the bill and hope it will be reversed.
What is FOSTA-SESTA?<span style="display:block;position:relative;padding-top:56.25%;" class="rm-shortcode" data-rm-shortcode-id="723125b44601d565a7c671c7523b6452"><iframe type="lazy-iframe" data-runner-src="https://www.youtube.com/embed/WBaqDjPCH8k?rel=0" width="100%" height="auto" frameborder="0" scrolling="no" style="position:absolute;top:0;left:0;width:100%;height:100%;"></iframe></span><p>SESTA (Stop Enabling Sex Traffickers Act) and FOSTA (Allow States and Victims to Fight Online Sex Trafficking Act) were signed into law by former President Trump in 2018. There was some argument that this law may be unconstitutional as it could potentially violate the <a href="https://constitution.congress.gov/constitution/amendment-1/" target="_blank">first amendment</a>. A criminal defense lawyer explains this law in-depth in <a href="https://www.youtube.com/watch?v=RoWx2hYg5uo&t=38s" target="_blank" rel="nofollow">this video</a>. </p><p><strong>What did FOSTA-SESTA aim to accomplish?</strong></p><p>The idea behind the law was simple: make it more difficult for online sex traffickers to find victims. FOSTA-SESTA started as two separate bills that were both created with a singular goal: curb online sex trafficking. Targeting websites like Backpage and Craigslist, where sex workers would often arrange meetings with their clientele, FOSTA-SESTA aimed to stop the illegal sex-trafficking activity being conducted online. While the aim of FOSTA-SESTA was to keep people safer, these laws have garnered international speculation and have become quite controversial. </p><p><a href="https://www.businesswire.com/news/home/20180321006214/en/National-Anti-Trafficking-Coalition-Celebrates-Survivors-Senate-Passes" target="_blank" rel="noopener noreferrer">According to BusinessWire</a>, many people are in support of this bill, including the National Center for Missing and Exploited Children and World Without Exploitation (WorldWE). </p><p>"With the growth of the Internet, human trafficking that once happened mainly on street corners has largely shifted online. According to the National Center for Missing & Exploited Children, 73 percent of the 10,000 child sex trafficking reports it receives from the public each year involve ads on the website Backpage.com."</p><p>As soon as this bill was <a href="https://www.pivotlegal.org/sesta_fosta_censoring_sex_workers_from_websites_sets_a_dangerous_precedent" target="_blank" rel="noopener noreferrer">signed into law</a>, websites where sex workers often vetted and arranged meetings with their clients could now be held liable for the actions of the millions of people that used their sites. This meant websites could be prosecuted if they engaged in "the promotion or facilitation of prostitution" or "facilitate traffickers in advertising the sale of unlawful sex acts with sex trafficking victims." </p><p><strong>The bill's effects were felt around the world — from Canadians being unhappy with the impact of this American bill to U.K. politicians considering the implementation of similar laws in the future.</strong> </p><p>Heather Jarvis, the program coordinator of the Safe Harbour Outreach Project (SHOP), which supports sex workers in the St. John's area, <a href="https://www.cbc.ca/news/canada/newfoundland-labrador/heather-jarvis-website-shutdown-1.4667018" target="_blank" rel="noopener noreferrer">explained to CBC in an interview</a> that the American bill is impacting everyone, everywhere: "When laws impact the internet — the internet is often borderless — it often expands across different countries. So although these are laws in the United States, what we've seen is they've been shutting down websites in Canada and other countries as well."</p><p>Jarvis suggests in her interview that instead of doing what they aimed to do with the bill and improving the safety of victims of sex trafficking or sexual exploitation, the website shutdowns are actually making sex workers less safe. </p><p>While <a href="https://gizmodo.com/the-uk-wants-its-own-version-of-fosta-sesta-that-could-1827420794" target="_blank" rel="noopener noreferrer">one U.K. publication</a> refers to FOSTA-SESTA as "well-intentioned but ultimately deeply-flawed laws," it also mentions that politicians in the United Kingdom are hoping to pursue similar laws in the near future. </p>
Has FOSTA-SESTA done more harm than good?<img type="lazy-image" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNTUxMzY5Ny9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2ODUyNDc4OX0.dSEEzcflJJUTnUCFmuwmPAIA0f754eW7rN8x6L7fcCc/img.jpg?width=1245&coordinates=-68%2C595%2C-68%2C595&height=700" id="69d99" class="rm-shortcode" data-rm-shortcode-id="734759fa254b5a33777536e0b4d7b511" data-rm-shortcode-name="rebelmouse-image" alt="sex worker looking online for a job" data-width="1245" data-height="700" />
Is this really going to help, or is this bill simply pushing sex work and sex-related content further into the dark?
Credit: Евгений Вершинин on Adobe Stock<p>While <a href="https://www.businesswire.com/news/home/20180321006214/en/National-Anti-Trafficking-Coalition-Celebrates-Survivors-Senate-Passes" target="_blank">supporters of this bill</a> have framed FOSTA-SESTA as a vital tool that could prevent sex trafficking and allow sex trafficking survivors to sue those websites for facilitating their victimization, many other people are strictly against the bill and hope it will be reversed.</p><p><strong>One of the biggest problems many people have with this bill is that it forces sex workers into an even more dangerous situation, which is quite the opposite of what the bill had intended to do.</strong> </p><p>According to <a href="https://www.theglobeandmail.com/canada/article-anti-trafficking-activists-cheer-but-sex-workers-bemoan-shutdown-of/" target="_blank" rel="noopener noreferrer">Globe and Mail</a>, there has been an upswing in pimps sending sex workers messages that promise work - which puts sex workers on the losing end of a skewed power-dynamic, when before they could attempt to safely arrange their own meetings online. </p><p><strong>How dangerous was online sex work before FOSTA-SESTA? </strong></p><p><a href="https://www.beyond-the-gaze.com/wp-content/uploads/2018/01/BtGbriefingsummaryoverview.pdf" target="_blank" rel="noopener noreferrer">The University of Leicester Department of Criminology</a> conducted an online survey that focused on the relative safety of internet-based sex work compared with outdoor sex work. According to the results, 91.6 percent of participants had not experienced a burglary in the past 5 years, 84.4 percent had not experienced physical assault in the same period, and only 5 percent had experienced physical assault in the last 12 months. </p><p><a href="https://www.pivotlegal.org/sesta_fosta_censoring_sex_workers_from_websites_sets_a_dangerous_precedent" target="_blank" rel="noopener noreferrer">PivotLegal</a> expresses concerns about this: "It is resoundingly clear, both from personal testimony and data, that attacking online sex work is an assault on the health and safety of people in the real world. In a darkly ironic twist, SESTA/FOSTA, legislation aimed at protecting victims of and preventing human trafficking for the purposes of sexual exploitation, will do the exact opposite."</p><p><strong>Websites are also being hypervigilant (and censoring more content than needed) because they can't possibly police every single user's activity on their platform.</strong> </p><p>Passing this bill meant any website (not just the ones that are commonly used by sex traffickers) could be held liable for their user's posts. Naturally, this saw a general "tightening of the belt" when it came to what was allowed on various platforms. In late 2018, shortly after the FOSTA-SESTA bill was passed, companies like Facebook slowly began to alter their terms and conditions to protect themselves. </p><p>Facebook notably added sections that express prohibited certain sexual content and messages:</p><p style="margin-left: 20px;"><em>"Content that includes an implicit invitation for sexual intercourse, which can be described as naming a sexual act and other suggestive elements including (but not limited to):</em></p><p style="margin-left: 20px;"><em>– vague suggestive statements such as: 'looking forward to an enjoyable evening'</em></p><p style="margin-left: 20px;"><em>– sexual use of language […]</em></p><p style="margin-left: 20px;"><em>– content (self-made, digital or existing) that possibly portrays explicit sexual acts or a suggestively positioned person/suggestively positioned persons."<br><br> </em></p><p>Additionally, sections like this were also added, prohibiting things that could allude to sexual activity: </p><p style="margin-left: 20px;"><em>"Content in which other acts committed by adults are requested or offered, such as:</em></p><p style="margin-left: 20px;"><em>– commercial pornography</em></p><p style="margin-left: 20px;"><em>– partners that share fetishes or sexual interests"</em></p><p>Facebook wasn't the only website to crack down on their policies — the Craigslist classifieds section being removed and Reddit banned quite a large number of sex-worker related subreddits. </p><p><strong>Is FOSTA-SESTA really helpful?</strong> </p><p>This is the question many people are facing with the FOSTA-SESTA acts being passed just a few years ago. Is this really going to help, or is this bill simply pushing sex work and sex-related content further into the dark? Opinions seem to be split down the middle on this — what do you think?</p>