Posted on 04/07/2016 7:00:57 AM PDT by Kaslin
Last week, presidential candidate Senator Bernie Sanders joined 11 other members of Congress in sending a letter to the National Institute of Health (NIH), urging the agency to cut costs for the prostate cancer drug, Xtandi, by employing its “march-in rights.” These rights, which have never before been utilized by the NIH, were established in 1980 under the Bayh-Dole Act, which gives federal agencies the authority to license a patent when action is deemed necessary, primarily as an emergency tactic. Using this provision as their justification, lawmakers are requesting that NIH override Xtandi’s patent protection, which guarantees its manufacturers exclusive sales, in an effort to reduce the costs of the drug.
This request represents an enormous overreach by the government into U.S business and a major threat to the drug development process as a whole. However, Senator Sanders’ proposal doesn’t just have the potential to undermine the drug development system, it also poses a serious danger to the patent system by allowing the government to intervene in the protection of intellectual property.
The Constitution gives Congress the power to grant patents under Article I, Section 8, Clause 8. The establishment of patents is a key constitutional right and critical to fostering American innovation and growth for well over two centuries. Like the property rights our founding fathers valued in the highest degree, the protection of intellectual property has been key to America’s success, responsible for establishing us as a global leader across many industries. Undermining the patent system, even for just one patent in one industry, would call into question our nation’s entire system for protecting intellectual property and undercut a core American value that sets us apart from other nations.
Encouraging NIH to utilize their “march-in rights” threatens all of this and although Senator Sanders’ letter focuses on the biopharmaceutical industry, it’s not just one industry that should be concerned. Having federal agencies intervene in patents, as Senator Sanders would like, sets a dangerous precedent of government overreach into the free market. Furthermore, what he is suggesting is a complete re-interpretation of legislation. The Bayh-Doyle Act was adopted to assist in the manufacturing of products to meet need during health or other public emergencies. In 35 years, these rights have yet to be deemed necessary by the NIH.
Patents are critical for any industry (or innovator) that takes risks to develop better products that move us forward and the biopharmaceutical industry is no exception. Biopharmaceutical companies operate under a complex business model-balancing the needs of patients, the demands of investors, and the hefty regulations imposed by the government. In order to encourage the development of innovative drugs (like Xtandi), the industry relies on patent protections to justify their investments. Allowing the government to step in and alter this system would most certainly have dire consequences-namely, new drugs might not be developed.
In their letter, lawmakers requested NIH hold a public hearing to override Xtandi’s patent, which they believe would lower the cost of the medication. What they fail to realize, however, is that in their attempt to improve access to life-saving medications like Xtandi they are actually threatening the future of innovative medicines. If investors know that patents are no longer protected and returns will be limited, the incentive to fund critical research and develop new treatments will plummet. If we want to continue to see progress in medicine, or in any industry for that matter, we can’t let the government interfere in patent protections.
Attacks like this on individual drugs and their manufacturers won’t fix the systematic problem of rising healthcare costs in our country, in which insurers, hospitals, and healthcare providers all play a role. Targeting Xtandi individually and asking for more government intervention is not only a clear political move by Senator Sanders that won’t actually improve access to medicines for Americans, but a play that will also dismantle the entire patent system that protects U.S. innovation and specifically the development of effective treatments. With innovators on the cusp of major advances in disease areas like cancer, diabetes, and Alzheimer’s we need to be looking towards reforms that encourage drug development and accessibility, not misguided proposals that propel unnecessary and unwarranted government overreach in the healthcare market and everywhere else.
I have a seven year old cat that stayed by my side though a five year recovery. He’s my best buddy.
I think your trying to help her in every way is great.
Gabapentin did have effects the first few nights but my body gets used to things so quickly.
She can be put on VERY high doses of it without any ill effects. It can not hurt her.
I am sorry and will pray for her. She is one of God’s creatures.
To which I must rhetorically retort, "What medicine?" If it costs 100's of millions in R&D to create a drug, but companies cannot recoup that cost plus make a profit, there will be no new drugs available for the consumer to buy. Someday your child or grandchild might develop a nasty MRSA infection, which few drugs are effective against. We desperately need new antibiotics to fight this and other resistant bacteria, but since there is little profit in this class of drug, we are seeing little research and precious few new drugs in this class come to market. With price controls, that situation will spread across all classes of drugs.
If the government is willing to steal the property of others then they should be willing to buy the rights to the drug from the owner if he is willing to sell. The price of T-Bones is too high would you force butchers to0 sell it for $1 a pound?
?Why would you drown yourself in a reservoir that is probably used for drinking water for others?
And why force someone else to haul your body in?
You can drown in 3” of water in your own home and not bother others .Don’t be a coward.
Number two; the argument 'I can do what I want with my property' is simply unreal as no legal system allows an owner to harm others with his property. I build a dam on my property that bursts and floods your land destroying your house, crops and animals, am I therefore free of any responsibility by interposing the idiot argument; 'it's my land and I can do what I please.'
Different principles apply to the sale of a product when lives hang in the balance.
Thanks...and I’ll pray for your continuing health improvement.
Please understand that I am both being direct with my thoughts on the matter as well as playing devil’s advocate.
The high price on the pill is set to what the seller believes the market will bear. In this case, the market is distorted because two of the three sources of buyer money are “socialized” - that is, they purchase on behalf of an individual using money from many individuals. The three sources are government plans, insurance plans, and individuals who foot the bill from their own pocket.
The market distortion is not caused by the seller (at least, not directly - lobbying complicates that judgment).
Further, if the market were not distorted, as with only being able to charge a fraction of the distorted market value, then the decision to create the product being sold may well have come out differently. The pharmaceutical company may well have chosen to not pursue approval of the drug, and therefore the drug may never have been marketed to begin with.
Finally, the drug companies cannot afford to only market successfully developed drugs for a price that only covers the development of that successful drug. Basic research and development is more than a crap shoot, but often not much more. One uses the accumulated knowledge of pharmaceuticals to decide on a course of investigation, but there are no guarantees of success. If the company has to absorb the cost of every failed attempt to develop a new drug, then the company quickly goes out of business for lack of revenue.
I can think of no clear examples where the government becoming involved directly in a marketplace has not distorted the market to inflate the prices. It worries me that more government intervention is so often floated as the solution or cure for government intervention caused issues.
“What they fail to realize, however, is that in their attempt to improve access to life-saving medications like Xtandi they are actually threatening the future of innovative medicine.”
They know exactly what they’re doing.
L
“While the drug companies may be entitled to $50.00 per pill they are NOT entitled to $750.00 per pill.”
How very fascist. What’s next? Want to tell me what wage I’m “entitled” to?
L
Wow. Bet you’re a lot of fun at a party.
I don’t go to parties, because I don’t have anything to celebrate.
You have an odd idea of property rights.
Just another example of how socialism does not work because it removes incentives to produce.
Where Bernie SCROOOOOOD up was that he chose a drug that only helps men to use as his test case.
He should have chosen something that is prescribed for female complaints. He would have gotten his wish faster than you can say War on Women.
“It worries me that more government intervention is so often floated as the solution or cure for government intervention caused issues.”
To the lovers of big government, the problem is always that there is not a big enough government yet.
Gun control laws don’t work because we need MORE gun control laws. Social programs like welfare have failed because we need MORE welfare, etc. etc.
Sorry to hear that B. In the last 5 years I’ve lost an aunt, two younger sisters, my mother and my grandfather. One of the sisters only a couple of weeks ago. I’ll be praying for you. Sadly, many, many people are suffering under Obama’s jackboot.
BTW, my post 31 was directed at RWGinger, not you.
You need to come up with a better argument than the breaking dam one.
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