Dorgan-Snowe needs changes (Chapter 2)

Summary: Earlier, Daniel Hines, publisher of www.TodaysSeniorsNetwork.com and a long-time and continuing supporter of personal importation of safe, affordable prescription medicines from pharmacies in Tier One countries, expresses concerns about current limitations on personal importation in U.S. Senate Bill 525, popularly referred to as Dorgan-Snowe, and urged supporters and sponsors to consider ramifications of the proposed legislation upon access to prescription medicines via the Internet or mail-order—access, which ironically might actually be decreased because of changes in the operations of those pharmacies created by the legislation, sources of supply, and a need to adapt the legislation to the challenges and opportunities that personal importation can provide.In this post, he deals with specific issues:

(1) Importation of medicines is an established fact. The right of individuals to make purchases via importation is established by the fact that a medicine that is unaffordable is unavailable, and Americans therefore have the right to make such purchases. The support on behalf of such access was the result of a classic populist movement by Americans, primarily the elderly, against the predatory pricing practices of pharmaceutical companies.

(2) The bill as presented fails to address the important role of access to prescription medicines as a part of the tremendous opportunity to be a part of comprehensive healthcare reform, and is instead a ‘stand-alone’ bill. This is evidenced by the fact that while drafts of healthcare reform bills such as that of Senator Ted Kennedy (D-MA) have a brief mention of access to prescription medicines as a part of vital healthcare for all Americans, no mention is made of the potential contribution and benefit that could be made by expanded access to safe, affordable prescription medicines from licensed, registered pharmacies in Tier One countries. The supporters of importation on The Hill have missed a tremendous opportunity to establish a presence for importation of medicines to be integrated into the discussion over opportunities for importation of prescription medicines as a part of comprehensive healthcare reform.

(3) One of the biggest challenges facing elderly Americans is the tremendous price increases of prescription medicines in Part D and the larger ‘Doughnut Hole’ in which seniors in the plan are forced to pay out-of-pocket for their prescriptions, while still paying a premium for coverage they are not receiving until their out-of-pocket expenditures reach the catastrophic level. Many never do. That is why we supported the bill introduced in the last Congress by Representative Dennis Kucinich (D-OH) to include imported medicines into the choices for Part D recipients, and why many advocates of importation believe that, properly constructed, there is an opportunity for importation to not only serve the health needs of Americans, but to contribute to budget savings. Yet, there is no provision at this stage of the healthcare reform debate that is just evolving about such a role for importation as an element of Part D, another opportunity lost.

(4) The legislation does not address issues of sourcing of medicines from Canadian pharmacies that reflect changes over the years in Canadian pharmacy operating models. Instead, there is a trapdoor that will stop Dorgan-Snowe from reaching its hoped-for goals because in its first year it limits personal importation of medicines to those from Canadian pharmacies with the medicines coming from Canada only. This in spite of the fact that there are estimates that as much as 80 percent of the prescriptions being fulfilled by Canadian pharmacies comes from Tier One countries whose standards meet or exceed those of the U.S.. But these will not be allowed to be imported into the U.S. by Canadian pharmacies, even though large numbers of Americans are currently doing so, enjoying the health benefits of access to vital medicines that are safe and affordable.

(5) The safety of medicines from pharmacies in Tier One countries such as Australia, New Zealand, the European Community and Japan is an established fact. Ironically, they will be designated for purchase by U.S. consumers after the first year of the limitation in (2), but only from U.S. pharmacies or wholesalers. Why is there a year-wait for such access, particularly in light of the probable shortage of medicines available from Canadian pharmacies because they will be unable to fulfill orders by utilizing sourcing from those same countries?

(6) How eager are Canadian pharmacies to be the engine that drives Dorgan-Snowe? Projections of anticipated revenues by policy-makers fail to account for the possible loss of sales by Canadian pharmacies that will lose access to medicines from Tier One countries as noted above. More significantly, the tremendous drop in the number of mail-order or Internet pharmacies in Canada will have an impact on the funding of importation. The Canadian International Pharmacy Association reportedly has 21 members, a far cry from the 140 pharmacies cited by Senator Charles Grassley (R-IA) that he counts on to generate the sales and the revenues that will contribute to the implementation and administration of Dorgan-Snowe. Over the years, there has been a concern expressed by Canadian pharmacies and Canadian policy-makers over ‘bulk shipments’ to the U.S. Many Canadian authorities fear a scenario in which Canada becomes ‘America’s Drug Store.’ Although when wholesale shipments are authorized in a year there will be the opportunity for shipments to pharmacies and wholesalers in this country from sources other than Canada, what might be the impact if Canadian officials fear a loss of access to medicines for their own citizens? Perception molds reality. Also, how may Canadian pharmacies will choose to participate in Dorgan-Snowe, with its registration fees, posting a $1 million bond, and seeing their margins reduced by other fees based on sales? If they choose not to participate, but continue sales to U.S. citizens, how will the provisions of the bill be enforced? Will they be declared ‘bogus’ pharmacies even though they are operating under the jurisdiction of their particular Provinces? The risk is that untold numbers of Americans might be denied vital medicines, with possible severe health consequences.

(7) How will Americans replace the medicines from other Tier One countries such as Australia, New Zealand, Great Britain, Japan and the European Community that they are now receiving through individual purchases from legitimate, authorized pharmacies that are already complying with standards in their countries that meet or exceed those of the U.S.? These are medicines that are now available but which might be denied for twelve months. Why should there be a year-long wait to establish the arrangements for wholesalers and pharmacies that might want to establish U.S.-based operations to import medicines or to administer plans to provide huge numbers of U.S. citizens the health benefit of access to safe, affordable medicines, access which would otherwise might be denied. Why, when the safety and efficacy of these medicines is already proven, and will be accepted in a year by the U.S., should Americans be denied the ability to make such purchases individually at this or any other time?

(8) The safety of imported medicines from legitimate pharmacies is a fact of life. There are, as far as I have been able to ascertain, no recorded deaths from medicines imported by individuals from legitimate, authorized pharmacies outside the U.S. Sadly, the same cannot be said of medicines from U.S. pharmacies. As a writer for The American Enterprise Institute, hardly a friend of importation, noted: “Only the stupid, lazy or woefully uninformed," would purchase medicine from a bogus pharmacy,” citing the many reliable sources to utilize to verify the safety of pharmacies. As noted, it is a fact that legitimate, authorized pharmacies in a Tier One country of origin must meet standards that meet or exceed those of the U.S. And, all anyone has to do to verify a Canadian pharmacy is to visit the web site of The Canadian International Pharmacy Association. The tragedy of persons buying from counterfeit pharmacies is undeniable. But, no legitimate pharmacy will make a shipment without a physician’s prescription, nor will it ship a controlled substance. Ironically, Google alerts for prescription medicine prices, which once were reliable sources of news about pharmaceutical industry and medicines events and trends, now include numerous mention to ‘pharmacies’ selling a number of drugs—usually Viagra and related medicines—with no prescription required, a sure tip-off to an illicit pharmacy and proof that no amount of regulation can completely stop someone from purchasing from such operations. Common sense and individual responsibility have a role to play. Rather than limiting access to legitimate pharmacies, Dorgan-Snowe should expand it.

(9) The bill lacks the transparency that more citizen involvement could provide. The claim is made on the one hand that the reason for not having hearings on the bill’s proposed language is that it is virtually the same bill that has been offered in the past so there is no need for Congressional hearings. Even granting the validity of this, the fact remains that the circumstances surrounding the bill have changed. Dorgan-Snowe is a bill that, when the importation issue first arose, had defining purposes—safety, efficacy of drugs, improved public health and lower costs for medicines It was a recognition by the supporters of importation that there were benefits to be obtained from allowing Americans access to safe, affordable prescription medicines from other countries, but that there was also a need to reassure patients and families that the proper oversight would be provided to help them identify pharmacies offering those medicines. What have changed are the forces of importation, forces that will shape and determine the success of providing safe, affordable medicines to Americans , not merely measured by passage of the bill.

These forces are described above. But, for importation of medicines to achieve its hoped-for benefits of improved health and well-being of Americans through access to a regimen of vital medicines, some ‘old ground’ will have to be gone over again. We encourage the policy-makers inside the Beltway to welcome the opportunity for additional input and fine-tuning of Dorgan-Snowe that will ensure the success of the legislation for which they have worked so hard for so long. Without such consideration, the consequences might be that the legislation might actually have an impact completely opposite of what is hoped for and cause a reduction in the ability of Americans to benefit from access to safe, affordable imported medicines.