Life Sciences musings
Well, maybe not. But we can hope, at least, that the noise going forward will be somewhat reduced. On July 14, the U.S. House voted 306-117 to pass the “so-called” Roberts-Stabenow bill that cleared the Senate the week before by a 63-30 vote. It’s unlikely this will stop all the shouting, but against long odds, Democrats and Republicans forged a bipartisan compromise with bicameral support to quash a classic attempt at rent seeking by a special interest group, in this case strident activists advocating for organic food. The activists’ hope had been to tar and feather genetically improved foods with mandatory labels that would have signaled to consumers that any such foods are inherently suspect. But lawmakers sided instead with the overwhelming majority of scientists in the United States and around the world / who have examined the evidence and found no such thing. So this battle in the culture wars has been clearly lost by the insurgents.
The bill was designed to preempt an ill-considered Vermont law that entered into force on July 1, requiring labels on some foods (i.e., none of those important to local producers) containing
In November 2015, United Nations Secretary-General Ban Ki-moon convened a high-level panel tasked with studying the relationship between intellectual property rights (IPRs) and access to medicines. The panel was charged with “review[ing] and assess[ing] proposals and recommend solutions for remedying the policy incoherence between the justifiable [intellectual property] rights of inventors, international human rights law, trade rules, and public health in the context of health technologies.”
Were this a panel pursuing a comprehensive research program considering the complete range of factors impacting access to medicines and incorporating a diverse set of voices representing the patients using and the enterprises producing those medicines; the governments and their health-care systems (public and private) procuring, distributing, and disseminating those medicines; and engaging the viewpoints of a broad range of stakeholders, it could have represented a serious and constructive dialogue toward tackling a significant global health challenge.
But the panel has given the game away from the outset. First, by starting from a position of supposed “policy incoherence” between IP rights, innovation, and affordable access to medicines; and, second, by focusing exclusively on IP as the main determinant of access to medicines. The German
The global economy—across a range of industries from information and communication technologies (ICTs), to advanced manufacturing, to life sciences—has seen a substantial increase in countries’ use of forced localization policies, particularly since the beginning of the Great Recession in 2008. These so-called localization barriers to trade represent policies that seek to explicitly pressure foreign enterprises to localize economic activity in order to compete in a country’s markets.
The life sciences sector confronts a number of different types of localization policies, though they can be generally grouped into three categories: 1) local production as a condition of market participation (including in government procurement); 2) forced intellectual property or technology transfer as a condition of market access; and 3) the use (or threat of use) of compulsory licenses. Unfortunately, the roll call of countries employing these pernicious policies continues to grow.
For example, Indonesia’s Decree 1010 requires foreign pharmaceutical companies to manufacture locally or entrust manufacturing to a company already registered as a manufacturer in Indonesia (a company that could be a potential competitor) in order to obtain drug approvals. Further, Decree 1010 requires local manufacturing in Indonesia of all pharmaceutical products
Today, 107 Nobel Laureates have come together to call upon governments around the world to support and advance “genetic modification” technologies in agriculture and reject the fear-based campaigns opposing genetically modified organisms (GMOs) that are built upon falsehoods and denial.
The Laureates released a strongly worded statement addressed “To the Leaders of Greenpeace, the United Nations and Governments around the world.” In their words, “We urge Greenpeace and its supporters to re-examine the experience of farmers and consumers worldwide with crops and foods improved through biotechnology, recognize the findings of authoritative scientific bodies and regulatory agencies, and abandon their campaign against ‘GMOs’ in general and Golden Rice in particular.”
The Laureates note, “The World Health Organization estimates that 250 million people suffer from [Vitamin A deficiency (VAD)], including 40 percent of the children under five in the developing world. Based on UNICEF statistics, a total of one to two million preventable deaths occur annually as a result of VAD, because it compromises the immune system, putting babies and children at great risk. VAD itself is the leading cause of childhood blindness globally affecting 250,000 – 500,000 children each year. Half
U.S. National Academy of Science Reaffirms Safety of GMOs for 11th Time, But Confuses the Story on Yields
The U.S. National Academies of Sciences, Engineering, and Medicine recently revisited the topic of genetically engineered crops, commonly (if misleadingly) called “GMOs.” Their report, titled “Genetically Engineered Crops: Experiences and Prospects,” is the 11th examination of this issue by the Academies since its first look in 1987. The media has noticed, with coverage that has been abundant and global. And while the Academy’s presentation on yields is clumsy and confusing, they got it exactly right on the most important safety issues.
Media coverage, like the report itself, has also mostly gotten it right. The report reaffirms the safety of foods derived from transgenic crops strongly and unambiguously. It reaffirms that biotech crops have led to dramatic reductions in pesticide applications and that biotech has driven herbicide use away from older compounds to newer active ingredients with dramatically reduced and more favorable environmental impacts. And all this has recently been further corroborated with yet another major publication in the peer-reviewed literature. The National Academy of Sciences (NAS) report reaffirms the findings of all its previous reports and the findings of other authoritative bodies as well,
By most accounts, patients in the United States and across the globe are in the midst of a new era of medical discovery, one in which new treatments and cures for costly diseases will become increasingly commonplace.
As ITIF noted in a recent report, our nation has benefited from public policies that support innovation and discovery, including strong intellectual property (IP) protections, limits on price controls for innovative medicines, data protections for biologic drugs, and strong government research and development expenditures on health care.
Unfortunately, these core fundamentals are being set aside by proponents of expanding “march-in” rights to address concerns about the price of drugs.
“March-in” rights were included as a privilege for the government under the Bayh-Dole Act, which was enacted with bipartisan support in 1980 to address intellectual property created (at least in part) from government-funded research. The law has played a significant role in driving impactful medical discovery and life-sciences innovation by allowing academic and other research institutions to patent inventions created by federally funded research and exclusively license them to industry for further development and commercialization. As The Economist has written about Bayh-Dole, it
The headlines are breathless: “Gene-edited CRISPR mushroom escapes US regulation: A fungus engineered with the CRISPR–Cas9 technique can be cultivated and sold without further oversight.” So Nature magazine announced a recent decision by the biotechnology products regulatory division of the U.S. Department of Agriculture. The herd followed suit.
Let us pray that it does not frighten the horses.
The Twitterverse predictably erupted with lamentations and alarums, predictions of doom, and condemnations of the “outdated” regulatory system under which this miscarriage was promulgated. The Washington Post declaimed, “A new fungus shows just how murky our understanding of the technology – and our policy surrounding it – remains.” The reporter may be confused, but neither our understanding of the technology nor the relevant policy is at all “murky.” The idea that an innovation solving a problem might not present sufficient hazard to justify a requirement for pre-market approval seems unimaginable to some. It is clearly time to revisit the raison d’etre of government regulation.
The entire point of regulation is to mitigate hazard and manage risk. The definition of risk is exposure to a hazard. If there is no hazard,
Over the last two decades we’ve witnessed something unprecedented and remarkable in agriculture. Scientists have learned how to improve seeds by harnessing techniques cribbed directly from Mother Nature herself, whom we have discovered to be unexpectedly wanton, promiscuous, and generous in her sharing of genes between the far flung branches of the tree of life.
Using methods of the same sort nature used to make a viral DNA sequence the most common gene in the human genome, researchers have learned how to armor plants to fend off insect pests without the use of pesticide sprays; how to make plants that allow farmers to manage weeds more easily; and how to improve the productivity, nutritional value, flavor, and safety of foods derived from plants or animals in myriad ways, while at the same time dramatically reducing their environmental impacts, particularly greenhouse gas emissions.
The result of this explosion of innovation has been that seeds improved with these techniques have been adopted by farmers at stunningly rapid, in fact unprecedented rates wherever farmers have been allowed to buy them. Starting from zero only 20 years ago, the growth in adoption of
On March 17, the Boulder County Commission directed county staff to map a plan to begin to “phase out” the use of genetically modified (GM) crops on county open space land. This land has been acquired from farmers to preserve and sustain agriculture in the county and leased back to local family farmers. The criteria governing the management of these lands are public, and most reasonable people would find little in them with which to disagree. The guidance from the present commissioners to move towards eliminating GM crops was not part of the enticement previously used to encourage farmers to cooperate with the county in preserving Boulder’s diminishing open space.
The organic industry would like this to be seen as a trend, part of a burgeoning demand for organic food. But according to the Boulder Daily Camera, and in spite of increased organic sales, U.S. Department of Agriculture data show that “organic acreage declined nationally by 10.8 percent from 2008 (4.1 million acres) to 2014 (3.7 million acres). Colorado saw larger declines of 34 percent during that same time, from 153,981 acres in 2008 to 115,116 acres in 2014….
The Economic Research Service of the U.S. Department of Agriculture has just released a report titled “Economic Issues in the Coexistence of Organic, Genetically Engineered (GE), and Non-GE Crops.” It estimates the costs to producers of delivering harvests using organic methods versus “genetically engineered” (GE) seeds versus non-GE seeds, and it concludes that “In 2014, 1 percent of all U.S. certified organic farmers in 20 States reported that they experienced economic losses (amounting to $6.1 million, excluding expenses for preventative measures and testing) due to GE commingling during 2011-2014.”
To put these numbers in perspective, in 2012, organic crops were grown on 5.4 million acres, nearly 1.4 percent of the total U.S. crop area of 390 million acres. Despite “organic corn and soybean prices that are generally two to three times higher than conventional crop prices,” they accounted for less than half of 1 percent (366,000/390M) of total crop area. The total value of US agricultural production in 2012 was “nearly $395 billion.” In other words, though the injury to the farmers affected was no doubt significant, in the overall picture it falls several orders of magnitude below