Thursday, March 23, 2017

An Open Letter to President Trump: How personal importation of brand-name medicines can help lower health costs

Dear President Trump:

Recently, you have once again called for measures to lower the costs of prescription medicines for millions of Americans who continue to be denied the health benefits of access to a regime of vital medicines for one reason—they are unaffordable.

Estimates are that as many as 46 million Americans have been forced to make a decision to ‘skip ‘ their medicines because of the predatory pricing practices of Pharma.

All of this is unnecessary. 

If you act in support of a workable legislative bill to allow the personal importation of brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries—including but not limited to Canada—whose standards of safety and efficacy meet or exceed those of the U.S., there could be almost immediate relief from what are the highest drug prices in the industrial world.

However, recently, a great deal of attention has been directed towards a proposal from Senator Bernie Sanders (I-VT), Senator Corey Booker (D-NJ),  Rep. Elijah Cummings (D MD 24)and others  to pass what was a failed model when it was first introduced in 2003, and then brought forth again a few years later.

The irony of Senator Booker’s sponsorship of the bill should be a red flag.  He represents New Jersey, which is nicknamed the United State of Pharma due to the presence of 46 Pharma companies, leading to Pharma’s long-standing influence upon New Jersey politics. 

Senator Booker, who before the 2016 elections had received $239,000 from Pharma-related contibutions voted against an amendment to allow personal importation offered by Senator Sanders during the recent budget reconciliation process, one of 13 Democrats to do so,  a vote which drew a great deal of criticism from media, the public and Democrat Party members.

He said he would support personal importation IF the proper safety standards were included.  Instead, he and others have come together in support  of the fatally flawed 2003 legislation.  (To review the built-in failings of the bill S. 469  click here, published in RxforAmericanHealth.)

Simply put, this is not legislation based upon the right and ability of American citizens to make independent, informed healthcare decisions.    It is not a personal importation bill.   Rather,  it is an awkwardly written set of procedures that could actually lead to higher prices as it calls for wholesaling of medicines from Canada to wholesalers in the U.S., with no guarantee that they would pass along savings to American patients.

It would also impose  U.S. oversight and approval of the safety, efficacy and validity of medicines approved by the Canadian system, which is widely recognized as being on par with the U.S. and other Tier One Countries. 

The solution is not that difficult.  There are bills offered by Senators John McCain (R-AZ) and Amy Klobuchar (D-MN), and Rep. Keith Ellision (D MN 7) that would allow American patients to personally import medicines from Canada (and/or) other countries whose standards of safety and efficacy are recognized as being equal to those of the U.S.

Recently, the FDA has announced the launch of a series of reciprocal agreements with a number of Tier One Countries so the structure for guaranteeing the safety of medicines from those countries is already in place.

So, Mr. President when supporters of S. 469 come to you, we recommend you ask some straight questions that demand straight answers:

1. Does anyone truly believe that Canadian provincial licensing authorities will cede any of that authority to allow the FDA to come into Canada to provide what is basically an oversight of the authority/ability of licensing procedures? As Senator Sanders has often said, “Show me the Dead Canadians” a reference to those who have died from non-existent  failures of the Canadian system.
2. How will personal importation into the U.S., which has been identified with Canada for more than 17 years be defensible within Canada if wholesaling is allowed, reviving an old argument about Canadian objections to the Country becoming 'America's Drugstore'? 
3.  In a related issue, there is a continuing push for Pharmacare in Canada.  Will S. 469 become the cause of what could be viewed in Canada as a threat to its ability to address its own challenges and problems of pharma costs and availability?
4.  S. 469 is not personal importation, but is instead a push for a different, unworkable, doomed-to-failure importation strategy.
5.  You have suggested that you want to renegotiate the North American Free Trade Agreement (NAFTA).  Perhaps you should consider  the recommendation from more than 14 yearsa go that personal importation should be a ‘trade issue,’  a recommendation from no less an authority than  then-Pfizer CEO Kimball.   
5.  A fatal flaw of S. 469 is that it is a mistaken claim that without FDA approval (US Approval), the regulatory agencies in Tier One countries are not capable of determining the safety and efficacy of medicines, despite their  record that proves that  the medicines from Tier One Countries are  safe,  and their regulatory agencies are capable of guaranteeing the safety, efficacy and authenticity of medicines on a par with U.S. authorities.  
6.  Some proponents of  S.  469 say or hope it is a shift of the determination of safety, efficacy and authenticity of medicines and sources from countries of origin to the dispensing entity, such as pharmacies who dispense the medicines.
7.  Perhaps you should ask the supporters of S. 469 if they will guarantee that any savings they claim from wholesale operations will be shared with American patients.
So, Mr. President, we urge you: Be alert as to what policy or combination of policies you might choose to end the predatory pricing of Pharma. 
With that, we respectfully  suggest that you consider the provisions in the AmericanRxBillof Rights.  And, as a first ‘baby’ step,  that you consider issuing an executive order for HHS Secretary Price to implement reciprocity (the framework is now in place for Memorandums of Understanding ) with Tier One countries. By allowing true personal importation for individuals, you will plant the seeds for lowering other health care costs thanks to the improved health of American patients who will thereby avoid worsening medical conditions that can be avoided by access to the benefits made possible by access to a regimen of  authentic, safe and affordable prescribed medicines.
Respectfully submitted,

Daniel Hines
Publisher
TodaysSeniorsNetwork
RxforAmericanHealth
AmericanRxBillof Rights


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