The letter below is an updated version of the one mailed on September 13th.
September 13th, 2010
Mr. John O. Jeffery
General Counsel
Internet Corporation for Assigned Names and Numbers
4676 Admiralty Way, Suite 330
Marina del Rey, CA 90292-6601
RE: White House meeting to discuss online pharmacies
Dear John –
We are the president and vice president of PharmacyChecker.com, the leading online verification company for U.S. and international online pharmacies. We learned recently of the White House meeting scheduled for September 29th intended to focus on “voluntary protocols to address the illegal online sale of counterfeit non-controlled prescription medication” (the “Meeting”).
The broader legal and policy issues affecting whether and when ICANN and its members should accede to government requests to deny or cancel domain name registrations is a very serious one for the future of the internet, and is generally beyond our purview. Our purpose is to set out for you and your members some considerations that should affect your evaluation of whatever may be presented at the Meeting. We request that you make this letter available to all members invited to or attending the Meeting. The letter is necessarily in summary form, and we would be pleased to provide upon request additional information that may assist you.
In accordance with its public position that it “does not control content” or “deal with access to the internet,” any ICANN protocols that prevent or remove internet access to people and companies should be undertaken only in the most egregious cases involving criminality, and then only after weighing the effects on the international user and business communities and the affected public, but not as a substitute for appropriate governmental action against alleged wrongdoers by the nation seeking the protocols.
“Illegal online sale of counterfeit non-controlled prescription medication”, the phrase used in calling the Meeting, is a hodge-podge of undefined terms, which should not be misapplied to sweep into its ambit an entire commerce in safe medications dispensed by online pharmacies pursuant to physician-written prescriptions, within and outside the U.S.
PharmacyChecker.com does not sell or offer to sell any products, prescription medications or otherwise, and has no ownership in or from any firm that does. It verifies the licensure and safe operation of online pharmacies that fill valid prescriptions with safe and genuine medications. Companies that meet our requirements are able to publish the PharmacyChecker.com seal on their websites and publish their pharmacy profiles and drug prices on our site, which is free for consumers to access.
As some of these pharmacies are based outside the U.S., they are able to sell genuine brand name medications at prices that are much lower than in the U.S., which unlike most other countries, does not set or negotiate drug prices. This commerce results in lower profit margins for pharmaceutical companies and reduced business for U.S. pharmacies, though both groups earn enormous profits notwithstanding. Not surprisingly, these major industries are allied in the effort to end this channel of prescription drug fulfillment. Sweeping protocols that would deny a place on the web for such pharmacies would be a misuse of ICANN and would have the effect of denying Americans access to safe, inexpensive medicine, adversely affecting public health.
Public statements by high-ranking U.S. officials, including Vice President Joseph Biden, affirm that concern for public health is the central reason for government attention to online pharmacies. By that standard, denial to uninsured and underinsured Americans of access to safe and affordable medications would be harmful and counterproductive.
Laws in the U.S. relating to personal importation of prescription medication are, within our understanding, rarely, if ever, enforced. Individuals who import medicine for personal use are not, to our knowledge, prosecuted. The FDA’s internal guidance policy authorizes its personnel to use their discretion in permitting personal drug imports. The practice, to the extent it may contravene law, is effectively decriminalized.
Moreover, with respect to the inclusion of the term “counterfeit” in the Meeting notice, we note that pursuant to the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights, “counterfeit” refers only to violations of trademark law [TRIPS 1994: Art. 51 n.14]. Peddlers and dealers of unregulated and counterfeit drugs should not be confused with reputable online pharmacies, wherever based, operating domestically and internationally, that sell genuine and regulated medications.
As to so-called “rogue pharmacies”, meaning those who provide substandard or unsafe medication, dispense without valid prescriptions, or who engage in identity theft, PharmacyChecker.com agrees that they should be shut down by any legal and proper means. Whether ICANN voluntary protocols, rather than government (or inter-government), including executive or judicial actions, are the appropriate means is open to question, but we have no interest in excusing or defending such “rogue activity” and would cooperate in any effort to deny them access to the public.
Finally, to support our basic position, we refer you to a very recent (August 13, 2010) study, called “Assessing Website Pharmacy Drug Quality: Safer Than You Think?”, published in a peer-reviewed journal, Public Library of Science One, without government, industry or online-seller sponsorship or funding. In the study, medications were purchased from 152 pharmacy websites. All those that had been reviewed and approved by either PharmacyChecker.com or the National Association of Boards of Pharmacy required prescriptions and sent genuine medications. Some which had not been so reviewed and approved did not.
We are advised that only ICANN and its members are invited to the Meeting but please let us know if we can be of assistance in any way.
Yours very truly,
Tod Cooperman, M.D., President
Gabriel Levitt, Vice-President
cc:
Rod Beckstrom, President and CEO, ICANN
Brad White, Director of Media Affairs, ICANN
Victoria Espinel, U.S. Intellectual Property Rights Enforcement Coordinator, White House
Andrew Kline, Senior Advisor, Office of U.S. Intellectual Property Rights Enforcement Coordinator, White House
Senator Herb Kohl, Chairman of the Senate Special Committee on Aging
Senator Patrick Leahy, Chairman, Senate Committee on the Judiciary
Congressman John Conyers, Chairman, House Committee on the Judiciary
John Rother, Executive Vice President, Policy and Strategy, AARP
Jerry Flanagan, Healthcare Advocate, ConsumerWatchDog.com
Douglas Heller, Executive Director, ConsumerWatchDog.com
Congresswoman Nita Lowey
Congressman Henry Waxman
