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	<title>Comments on: White House Promises To Allow Imports, After All</title>
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	<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/</link>
	<description>News, Comment and Conversation</description>
	<pubDate>Fri, 10 Feb 2012 20:53:28 +0000</pubDate>
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		<title>By: Barb</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452987</link>
		<dc:creator>Barb</dc:creator>
		<pubDate>Tue, 22 Dec 2009 16:55:23 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452987</guid>
		<description>The drug industry was mandated by socialist medicine to give those prices!  Good grief, does no one see that the pharma industry is going down the tubes, and patients will ultimately suffer with no new products!   Do you really want your product coming from who knows where????   Why do you think that the gov't is seizing all sorts of medicine coming into our country? -- they are counterfeit, or don't have active ingredient in it?  You are willing to take a chance with your health and not know what in the world you are getting??</description>
		<content:encoded><![CDATA[<p>The drug industry was mandated by socialist medicine to give those prices!  Good grief, does no one see that the pharma industry is going down the tubes, and patients will ultimately suffer with no new products!   Do you really want your product coming from who knows where????   Why do you think that the gov&#8217;t is seizing all sorts of medicine coming into our country? &#8212; they are counterfeit, or don&#8217;t have active ingredient in it?  You are willing to take a chance with your health and not know what in the world you are getting??</p>
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		<title>By: Barb</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452986</link>
		<dc:creator>Barb</dc:creator>
		<pubDate>Tue, 22 Dec 2009 16:52:40 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452986</guid>
		<description>Well, you can't trust Obama, can you?  First he cuts a deal with big pharma, and then he goes back on his word with pharma. . he is making an enemy out of everyone. . . Like Joe Wilson said:  You Lie!!!</description>
		<content:encoded><![CDATA[<p>Well, you can&#8217;t trust Obama, can you?  First he cuts a deal with big pharma, and then he goes back on his word with pharma. . he is making an enemy out of everyone. . . Like Joe Wilson said:  You Lie!!!</p>
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		<title>By: Mike</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452958</link>
		<dc:creator>Mike</dc:creator>
		<pubDate>Tue, 22 Dec 2009 15:19:18 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452958</guid>
		<description>Here's the deal with patent infringement after importation:

35 USC 271(a) - "Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent."

TRIPS Article 27 (in part) - "Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced."

TRIPS doesn't speak to whether a country must adopt a national, regional, or global patent exhaustion doctrine (the doctrine saying that once a product is sold, patent rights on that product are exhausted - i.e. the patent owner can't sue for infringement when a re-seller sells a product without authorization).  The US (unlike Europe) follows a NATIONAL patent exhaustion doctrine.  A product sold in Canada hasn't exhausted patent rights in the US.  

So - if a bill would exclude drugs from national patent exhaustion, that bill would be in violation of TRIPS.  It would discriminate against pharmaceutical patents.  

Of course, this wouldn't be the first time the US violated TRIPS . . . but still.</description>
		<content:encoded><![CDATA[<p>Here&#8217;s the deal with patent infringement after importation:</p>
<p>35 USC 271(a) - &#8220;Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.&#8221;</p>
<p>TRIPS Article 27 (in part) - &#8220;Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.&#8221;</p>
<p>TRIPS doesn&#8217;t speak to whether a country must adopt a national, regional, or global patent exhaustion doctrine (the doctrine saying that once a product is sold, patent rights on that product are exhausted - i.e. the patent owner can&#8217;t sue for infringement when a re-seller sells a product without authorization).  The US (unlike Europe) follows a NATIONAL patent exhaustion doctrine.  A product sold in Canada hasn&#8217;t exhausted patent rights in the US.  </p>
<p>So - if a bill would exclude drugs from national patent exhaustion, that bill would be in violation of TRIPS.  It would discriminate against pharmaceutical patents.  </p>
<p>Of course, this wouldn&#8217;t be the first time the US violated TRIPS . . . but still.</p>
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		<title>By: vince</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452942</link>
		<dc:creator>vince</dc:creator>
		<pubDate>Tue, 22 Dec 2009 14:22:32 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452942</guid>
		<description>Predicted date of FDA being able to assure drug safety on imports or even non-imports. Shortly after the first snowball fight in hell.</description>
		<content:encoded><![CDATA[<p>Predicted date of FDA being able to assure drug safety on imports or even non-imports. Shortly after the first snowball fight in hell.</p>
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		<title>By: Anne PME</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452938</link>
		<dc:creator>Anne PME</dc:creator>
		<pubDate>Tue, 22 Dec 2009 14:02:37 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452938</guid>
		<description>Following up on what I think Adam Fein is trying to say, reimportation further convolutes the supply chain and will likely lead to even higher rates of drug diversion, adulteration and counterfeiting. 

Pharmaceutical companies likely outsource not only to cut costs, but b/c they have to have an increased presence in emerging markets and decreased exposure to the declining US market.
While I am not an attorney, Adam Fein's post and other information appears to indicate that reimported medicines like these may be viewed by oversight and enforcement officials as diverted drugs. Diverted drugs are not legal dispenses under any state or federal regulations that I am aware of. Note that prescription medicines obtained for personal use under FDA compassionate or personal use may be legally reimported into the US.

Drugs are PERISHABLE...they DO NOT IMPROVE with age, increased exposure to tampering, or increased exposure to adulterating elements like heat, freezing temperatures, humidity or other types of mishandling. Increasing exposure to these adulterating elements will likely result in greater numbers of life saving medicine to becoming ineffective or potentially toxic – for example tetracycline ABX may become nephrotoxic when adulterated. 

Increasing the time that a prescription drug spends in shipping channels increases not only risk of spoilage; it also increases things like liability costs, accounting costs and booking and reporting costs. 

I fail to see how the US can decrease the price of drugs and cost of health care by increasing the risk and cost of getting FDA approved prescription drugs to my pharmacy. 

We have very real problems in this country with drug pricing and access that congress and the white house need to admit to and take steps to successfully resolve. Instead, it appears as though we – all of us here in the US- are trying to pass them off by outsourcing them.</description>
		<content:encoded><![CDATA[<p>Following up on what I think Adam Fein is trying to say, reimportation further convolutes the supply chain and will likely lead to even higher rates of drug diversion, adulteration and counterfeiting. </p>
<p>Pharmaceutical companies likely outsource not only to cut costs, but b/c they have to have an increased presence in emerging markets and decreased exposure to the declining US market.<br />
While I am not an attorney, Adam Fein&#8217;s post and other information appears to indicate that reimported medicines like these may be viewed by oversight and enforcement officials as diverted drugs. Diverted drugs are not legal dispenses under any state or federal regulations that I am aware of. Note that prescription medicines obtained for personal use under FDA compassionate or personal use may be legally reimported into the US.</p>
<p>Drugs are PERISHABLE&#8230;they DO NOT IMPROVE with age, increased exposure to tampering, or increased exposure to adulterating elements like heat, freezing temperatures, humidity or other types of mishandling. Increasing exposure to these adulterating elements will likely result in greater numbers of life saving medicine to becoming ineffective or potentially toxic – for example tetracycline ABX may become nephrotoxic when adulterated. </p>
<p>Increasing the time that a prescription drug spends in shipping channels increases not only risk of spoilage; it also increases things like liability costs, accounting costs and booking and reporting costs. </p>
<p>I fail to see how the US can decrease the price of drugs and cost of health care by increasing the risk and cost of getting FDA approved prescription drugs to my pharmacy. </p>
<p>We have very real problems in this country with drug pricing and access that congress and the white house need to admit to and take steps to successfully resolve. Instead, it appears as though we – all of us here in the US- are trying to pass them off by outsourcing them.</p>
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		<title>By: Kurt</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452843</link>
		<dc:creator>Kurt</dc:creator>
		<pubDate>Tue, 22 Dec 2009 02:27:34 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452843</guid>
		<description>The drug industry screwed itself when it gave price concessions to foreign countries.  Now they are paying the price.</description>
		<content:encoded><![CDATA[<p>The drug industry screwed itself when it gave price concessions to foreign countries.  Now they are paying the price.</p>
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		<title>By: diane dalton</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452841</link>
		<dc:creator>diane dalton</dc:creator>
		<pubDate>Tue, 22 Dec 2009 02:12:07 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452841</guid>
		<description>And with this so goes more jobs down the drain.  The pharmaceutical
industry has trimmed over 100,000 jobs this year because of this.  It
costs more in the long run to pay everyones unemployment benefits,
its killing our economy and continues to decline real estate values when
so many middle class americans continue to loose jobs.  The savings
on these drugs reimported will not offset the deepening job cuts!!!</description>
		<content:encoded><![CDATA[<p>And with this so goes more jobs down the drain.  The pharmaceutical<br />
industry has trimmed over 100,000 jobs this year because of this.  It<br />
costs more in the long run to pay everyones unemployment benefits,<br />
its killing our economy and continues to decline real estate values when<br />
so many middle class americans continue to loose jobs.  The savings<br />
on these drugs reimported will not offset the deepening job cuts!!!</p>
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		<title>By: Adam J. Fein</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452830</link>
		<dc:creator>Adam J. Fein</dc:creator>
		<pubDate>Tue, 22 Dec 2009 00:48:37 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452830</guid>
		<description>The issue has nothing at all to do with the location of the manufacturing facility. The problems start because independent wholesalers and pharmacies can buy, repackage, and resell the products. 

This trading activity a.k.a. "parallel trade," creates openings for counterfeits/mishandled products to  enter the supply chain. It also can create shortages if your country happens to be "low cost" based on current exchange rates.

A recent news story: "Europe Awash in Counterfeit Drugs"
http://www.businessweek.com/globalbiz/content/dec2009/gb2009128_347306.htm

Adam</description>
		<content:encoded><![CDATA[<p>The issue has nothing at all to do with the location of the manufacturing facility. The problems start because independent wholesalers and pharmacies can buy, repackage, and resell the products. </p>
<p>This trading activity a.k.a. &#8220;parallel trade,&#8221; creates openings for counterfeits/mishandled products to  enter the supply chain. It also can create shortages if your country happens to be &#8220;low cost&#8221; based on current exchange rates.</p>
<p>A recent news story: &#8220;Europe Awash in Counterfeit Drugs&#8221;<br />
<a href="http://www.businessweek.com/globalbiz/content/dec2009/gb2009128_347306.htm" rel="nofollow">http://www.businessweek.com/globalbiz/content/dec2009/gb2009128_347306.htm</a></p>
<p>Adam</p>
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		<title>By: Doc</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452827</link>
		<dc:creator>Doc</dc:creator>
		<pubDate>Tue, 22 Dec 2009 00:19:51 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452827</guid>
		<description>We will see how smart phrma is, they gave alot of money to push through O's plan. Now he can argue that with 30 million more elidgible, phrma can afford to allow imports.

He is dedicated to imports, just a matter of time.</description>
		<content:encoded><![CDATA[<p>We will see how smart phrma is, they gave alot of money to push through O&#8217;s plan. Now he can argue that with 30 million more elidgible, phrma can afford to allow imports.</p>
<p>He is dedicated to imports, just a matter of time.</p>
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		<title>By: JaT</title>
		<link>http://www.pharmalot.com/2009/12/white-house-promises-to-allow-imports-after-all/#comment-452826</link>
		<dc:creator>JaT</dc:creator>
		<pubDate>Tue, 22 Dec 2009 00:08:57 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=20558#comment-452826</guid>
		<description>Fear not, pharma. This will likely go back to business-as-usual as soon as the votes are secured for the final health care reform draft. Some were very POed when the bipartisan Dorgan amendment went down. Something had to be done.

Ben Nelson got his medicaid bill paid by fed indefinitely.
Mary Landrieu got 300mil for LA.
Vermont's Sanders won 10-14billion???
Massachusetts got additional money.
Joe Lieberman got rid of government run insurance (do we even know what the benefit will be anymore?).
Florida got protection for medicare advantage,
as did Pennsylvania,
as did New York.
A few states got higher reimbursement rates for doctors.

I predict that the states that didn't get special consideration are going to have an itty bitty problem with it all. 
You know, the working people that get to foot the bill for working people in other states. It isn't exactly redistribution of wealth.

The whole thing is a sham. Of course, pharma, you contributed to the sham. You'll be safe.</description>
		<content:encoded><![CDATA[<p>Fear not, pharma. This will likely go back to business-as-usual as soon as the votes are secured for the final health care reform draft. Some were very POed when the bipartisan Dorgan amendment went down. Something had to be done.</p>
<p>Ben Nelson got his medicaid bill paid by fed indefinitely.<br />
Mary Landrieu got 300mil for LA.<br />
Vermont&#8217;s Sanders won 10-14billion???<br />
Massachusetts got additional money.<br />
Joe Lieberman got rid of government run insurance (do we even know what the benefit will be anymore?).<br />
Florida got protection for medicare advantage,<br />
as did Pennsylvania,<br />
as did New York.<br />
A few states got higher reimbursement rates for doctors.</p>
<p>I predict that the states that didn&#8217;t get special consideration are going to have an itty bitty problem with it all.<br />
You know, the working people that get to foot the bill for working people in other states. It isn&#8217;t exactly redistribution of wealth.</p>
<p>The whole thing is a sham. Of course, pharma, you contributed to the sham. You&#8217;ll be safe.</p>
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