One of the most basic arguments that Americans have these days is “what the role of government should be” and how that applies to any topic in question. This is not a new argument, in fact it was at the very heart of the founding of our constitutional republic. “What role should the government play in our daily lives? How much power should that government have over the citizens? What is the balance a government must achieve in order to provide security and personal liberty?”, are all questions that the framers debated, wrestled over, and even in some cases dueled over. In that respect, not much has changed. In our modern America we debate issues like “gun control”, “gas company profits”, “funding of Planned Parenthood”, the “cost of healthcare” just to name a few, but at their base, all of these issues and many more that we face-off over still come down to what we believe the role of government should be.
For those people who hold that the Declaration of Independence and the Constitution of the United States of America are divinely inspired documents meant to guide a Godly people to unprecedented prosperity and liberty want a federal government bound by a strict and originalist interpretation of the U.S. Constitution. The role of that federal government is very limited and very specific. That federal government is: to provide defense from those who would look to take resources from us by force, do harm to us in order to claim new territory for themselves, or those who pose a threat to our safety and/or “way of life”; to pass and enforce laws so that disputes between citizens may be settled in accordance with our societal values (which should be rooted in a sense of morality and liberty); and most importantly to foster a climate of opportunity and personal liberty which can most often be achieved by staying out of the daily lives of citizens as much as possible.
For those people who hold that the U.S. Constitution is an out-dated document with little to no value in our modern world, many want a central government with broad and nearly unlimited powers. Those people believe that only a powerful central government can provide the “help” that it’s citizens need and that it is okay for that central government to use whatever means are necessary to “provide” for those citizens. Those people are very often used by others who see the Constitution as an obstacle and who wish to grow their own individual power by pretending to fight for the cause of the day while really only working to dismantle the constraints on that central government and set precedent for wielding power which that government did not previously have allotted to it. Many who claim the label “communist”, “socialist”, “progressive” or “liberal” often desire the powerful central government with little thought or concern about the damage done to personal liberty.
Now there are many Americans that fall in different places between the positions I described. This is why you will find some people who will side with the small, limited government philosophy on some issues but then come down on the powerful central government philosophy on other issues. It is in that fertile ground that those who wish to plant the seeds of discontent and division in America work their hardest to weaken the Constitution and the Rule of Law by confusing issues that are a matter of law with emotions, feelings, and “fairness”.
A new case in point is the effort to use the Bayh–Dole Act to “reduce to cost” of Xtandi, a prostate cancer drug. Presidential candidate Senator Bernie Sanders along with other members of Congress sent a letter to the National Institute of Health (NIH), asking the agency to employ what is commonly called “march-in rights”. The Bayh–Dole Act is a law dealing with intellectual property arising from federal government-funded research which was passed in 1980 and was intended to establish a single policy for all government agencies to follow when dealing with patent rights when government funding was involved. (Before that each agency had it’s own set of policies and procedures.) One of the most contentious provisions of Bayh-Dole is the government’s “march-in” right which plainly put allows the funding agency (whatever government agency paid the grant for the research), on its own or at the request of a third party, to ignore the exclusivity of a patent awarded under the act and grant additional licenses to other “reasonable applicants.” This “right” is strictly limited and can only be exercised if the funding agency determines, after an investigation, that one of four criteria is met. The most important of the criteria, and the one most relevant to the argument being used is “a failure by the contractor to take "effective steps to achieve practical application of the subject invention” or a failure to satisfy “health and safety needs” of consumers.“
Xtandi’s patent is held by a Japanese company which has subsidiaries and partners here in the United States. The complaint is that Xtandi costs four times more in the U.S. than in other developed countries. (Which is not an uncommon practice even for American drug companies.) Enter the calls of unfairness. Here Senator Sanders and others start chipping away again at Rule of Law in the name of "compassion”.
The Constitution does give Congress the power to grant patents under Article I, Section 8, Clause 8, so the congress was within it’s authority to pass Bayh-Dole. Xtandi was developed through research at the University of California, Los Angeles, with taxpayer-funded research grants so it would fall under the Bayh-Dole Act. But does a high price constitute “a failure to satisfy "health and safety needs” of consumers.“? Not according to the NIH in it’s previous decisions when asked to invoke the "march-in” right. (In the Case of NORVIR a prescription drug used to treat AIDS, Abbott Labs, who held the patent, raised the price of Norvir 400% for U.S. customers, but not for consumers in any other country. The NIH denied the petition finding no grounds to exercise its “march-in” rights citing 1.) The availability of Norvir to patients with AIDS 2.) That there was no evidence that health and safety needs were not adequately met by Abbott and 3.) That the NIH should not address the issue of drug pricing, only Congress. Then again in the Case of Xalatan, a glaucoma drug held by Pfizer, The NIH said that “the extraordinary remedy of “march-in” was not an appropriate means for controlling prices.) In fact, in the 35 years since the implementation of Bayh-Dole the NIH has never invoked the “march-in” right for ANY reason, despite multiple requests by third parties to do so.
Are you beginning to connect the dots yet? Why would Bernie Sanders or any other member of Congress ask the NIH to intervene over the price of a drug when the NIH has been so clear in the past on that point? The “communist”, “socialists” and “progressives” all play the long-game of incrementalism. They know that the people at the NIH change over time and that the new faces may not hold the same views as their predecessors. In the effort to once again increase the power of the central government they will take-up to cause of “helping the people” against (in this case) the evil drug company. In an effort to gain public support they will even lie as Sanders and company have done in a public statement where they claimed that “Under current law, NIH can take this step if federal funds supported a drug’s development and the company is selling it at an unreasonably high price.” A falsehood they know most Americans won’t know is a lie and even fewer will research to find-out. This group of politicians are counting on an uninformed, emotional response. One they are likely to get from those who normally support them.
Make no mistake here friends. No matter where Sanders and company say they are drawing the line, the drug company is not the enemy they are fighting. It is capitalism that is the target. Bernie is a well-known avowed socialist and many of those whom he allies himself with may not be “out of the closet” but they do share the same powerful central government ideology which can not abide capitalism or personal liberty. The patent is a powerful tool of capitalism. It is what guarantees that those who create or invent will receive the fruits of their labors. The patent is more than just a tool of capitalism though, it is a driving force for innovation and breakthroughs that propel a nation forward and improves the quality of life for all. I would not expect a socialist to understand this simple fact, if they did then they wouldn’t be a socialist anymore, but I do hope that most American’s will understand this as truth.
Bernie Sanders and his co-horts will tell you that this is for the good of the American’s in need of this medicine who cannot afford it (I guess Obamacare must not be working like they promised). He will tell you that the government already has this power and needs to use it for the “good of the people”. He will even tell you that this is only a one-time deal directed at the pharmaceutical industry. Knowing that what he is suggesting is a complete re-interpretation of the law, that the Bayh-Doyle Act was adopted to assist in the manufacturing of products to meet need during health or other public emergencies. And he will do all of this to play on the natural desire most Americans have to help one another while setting the precedent of “march-in”. And we all know that once that precedent is set it will be used again and it will be used in other industries as the central government (and those who run it) sees fit.
The cost of drug development is ridiculously high. The patent protection is often the only guarantee that those who invested in bringing a new treatment to market will see any reward. This is not a justification to unfairly price a drug in different markets and something should be done but not “march-in”. Should a company be charging one group of people so much more than another group is a completely different question than if patent protection should be stripped away. A different solution, one with far less ramification on capitalism and personal liberty, can be found and should be implemented. Sanders isn’t looking out for the “little guy” here, he’s looking to move us yet one more step away from our Republic.
For those people who hold that the Declaration of Independence and the Constitution of the United States of America are divinely inspired documents meant to guide a Godly people to unprecedented prosperity and liberty want a federal government bound by a strict and originalist interpretation of the U.S. Constitution. The role of that federal government is very limited and very specific. That federal government is: to provide defense from those who would look to take resources from us by force, do harm to us in order to claim new territory for themselves, or those who pose a threat to our safety and/or “way of life”; to pass and enforce laws so that disputes between citizens may be settled in accordance with our societal values (which should be rooted in a sense of morality and liberty); and most importantly to foster a climate of opportunity and personal liberty which can most often be achieved by staying out of the daily lives of citizens as much as possible.
For those people who hold that the U.S. Constitution is an out-dated document with little to no value in our modern world, many want a central government with broad and nearly unlimited powers. Those people believe that only a powerful central government can provide the “help” that it’s citizens need and that it is okay for that central government to use whatever means are necessary to “provide” for those citizens. Those people are very often used by others who see the Constitution as an obstacle and who wish to grow their own individual power by pretending to fight for the cause of the day while really only working to dismantle the constraints on that central government and set precedent for wielding power which that government did not previously have allotted to it. Many who claim the label “communist”, “socialist”, “progressive” or “liberal” often desire the powerful central government with little thought or concern about the damage done to personal liberty.
Now there are many Americans that fall in different places between the positions I described. This is why you will find some people who will side with the small, limited government philosophy on some issues but then come down on the powerful central government philosophy on other issues. It is in that fertile ground that those who wish to plant the seeds of discontent and division in America work their hardest to weaken the Constitution and the Rule of Law by confusing issues that are a matter of law with emotions, feelings, and “fairness”.
A new case in point is the effort to use the Bayh–Dole Act to “reduce to cost” of Xtandi, a prostate cancer drug. Presidential candidate Senator Bernie Sanders along with other members of Congress sent a letter to the National Institute of Health (NIH), asking the agency to employ what is commonly called “march-in rights”. The Bayh–Dole Act is a law dealing with intellectual property arising from federal government-funded research which was passed in 1980 and was intended to establish a single policy for all government agencies to follow when dealing with patent rights when government funding was involved. (Before that each agency had it’s own set of policies and procedures.) One of the most contentious provisions of Bayh-Dole is the government’s “march-in” right which plainly put allows the funding agency (whatever government agency paid the grant for the research), on its own or at the request of a third party, to ignore the exclusivity of a patent awarded under the act and grant additional licenses to other “reasonable applicants.” This “right” is strictly limited and can only be exercised if the funding agency determines, after an investigation, that one of four criteria is met. The most important of the criteria, and the one most relevant to the argument being used is “a failure by the contractor to take "effective steps to achieve practical application of the subject invention” or a failure to satisfy “health and safety needs” of consumers.“
Xtandi’s patent is held by a Japanese company which has subsidiaries and partners here in the United States. The complaint is that Xtandi costs four times more in the U.S. than in other developed countries. (Which is not an uncommon practice even for American drug companies.) Enter the calls of unfairness. Here Senator Sanders and others start chipping away again at Rule of Law in the name of "compassion”.
The Constitution does give Congress the power to grant patents under Article I, Section 8, Clause 8, so the congress was within it’s authority to pass Bayh-Dole. Xtandi was developed through research at the University of California, Los Angeles, with taxpayer-funded research grants so it would fall under the Bayh-Dole Act. But does a high price constitute “a failure to satisfy "health and safety needs” of consumers.“? Not according to the NIH in it’s previous decisions when asked to invoke the "march-in” right. (In the Case of NORVIR a prescription drug used to treat AIDS, Abbott Labs, who held the patent, raised the price of Norvir 400% for U.S. customers, but not for consumers in any other country. The NIH denied the petition finding no grounds to exercise its “march-in” rights citing 1.) The availability of Norvir to patients with AIDS 2.) That there was no evidence that health and safety needs were not adequately met by Abbott and 3.) That the NIH should not address the issue of drug pricing, only Congress. Then again in the Case of Xalatan, a glaucoma drug held by Pfizer, The NIH said that “the extraordinary remedy of “march-in” was not an appropriate means for controlling prices.) In fact, in the 35 years since the implementation of Bayh-Dole the NIH has never invoked the “march-in” right for ANY reason, despite multiple requests by third parties to do so.
Are you beginning to connect the dots yet? Why would Bernie Sanders or any other member of Congress ask the NIH to intervene over the price of a drug when the NIH has been so clear in the past on that point? The “communist”, “socialists” and “progressives” all play the long-game of incrementalism. They know that the people at the NIH change over time and that the new faces may not hold the same views as their predecessors. In the effort to once again increase the power of the central government they will take-up to cause of “helping the people” against (in this case) the evil drug company. In an effort to gain public support they will even lie as Sanders and company have done in a public statement where they claimed that “Under current law, NIH can take this step if federal funds supported a drug’s development and the company is selling it at an unreasonably high price.” A falsehood they know most Americans won’t know is a lie and even fewer will research to find-out. This group of politicians are counting on an uninformed, emotional response. One they are likely to get from those who normally support them.
Make no mistake here friends. No matter where Sanders and company say they are drawing the line, the drug company is not the enemy they are fighting. It is capitalism that is the target. Bernie is a well-known avowed socialist and many of those whom he allies himself with may not be “out of the closet” but they do share the same powerful central government ideology which can not abide capitalism or personal liberty. The patent is a powerful tool of capitalism. It is what guarantees that those who create or invent will receive the fruits of their labors. The patent is more than just a tool of capitalism though, it is a driving force for innovation and breakthroughs that propel a nation forward and improves the quality of life for all. I would not expect a socialist to understand this simple fact, if they did then they wouldn’t be a socialist anymore, but I do hope that most American’s will understand this as truth.
Bernie Sanders and his co-horts will tell you that this is for the good of the American’s in need of this medicine who cannot afford it (I guess Obamacare must not be working like they promised). He will tell you that the government already has this power and needs to use it for the “good of the people”. He will even tell you that this is only a one-time deal directed at the pharmaceutical industry. Knowing that what he is suggesting is a complete re-interpretation of the law, that the Bayh-Doyle Act was adopted to assist in the manufacturing of products to meet need during health or other public emergencies. And he will do all of this to play on the natural desire most Americans have to help one another while setting the precedent of “march-in”. And we all know that once that precedent is set it will be used again and it will be used in other industries as the central government (and those who run it) sees fit.
The cost of drug development is ridiculously high. The patent protection is often the only guarantee that those who invested in bringing a new treatment to market will see any reward. This is not a justification to unfairly price a drug in different markets and something should be done but not “march-in”. Should a company be charging one group of people so much more than another group is a completely different question than if patent protection should be stripped away. A different solution, one with far less ramification on capitalism and personal liberty, can be found and should be implemented. Sanders isn’t looking out for the “little guy” here, he’s looking to move us yet one more step away from our Republic.
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