Changes

The Commission specifically notes that this objection is not a part of the GAC Early Warning process, and goes on to note that "the Commission does not consider itself legally bound to [ICANN] processes," given that there is not legal agreement between the two bodies.<ref>[http://domainincite.com/docs/20121127093808906.pdf DomainIncite.com/Docs] Published 27 Nov 2012, Retrieved 11 Dec 2012</ref><ref>[http://domainincite.com/11130-europe-rejects-icanns-authority-as-it-warns-of-problems-with-58-new-gtlds Europe Rejects ICANNs Authority As it Warns of Problems with 58 New gTLDs, DomainIncite.com] Published 27 Nov 2012, Retrieved 11 Dec 2012</ref>

The Commission specifically notes that this objection is not a part of the GAC Early Warning process, and goes on to note that "the Commission does not consider itself legally bound to [ICANN] processes," given that there is not legal agreement between the two bodies.<ref>[http://domainincite.com/docs/20121127093808906.pdf DomainIncite.com/Docs] Published 27 Nov 2012, Retrieved 11 Dec 2012</ref><ref>[http://domainincite.com/11130-europe-rejects-icanns-authority-as-it-warns-of-problems-with-58-new-gtlds Europe Rejects ICANNs Authority As it Warns of Problems with 58 New gTLDs, DomainIncite.com] Published 27 Nov 2012, Retrieved 11 Dec 2012</ref>

==Application Details==

==Application Details==

The following is excerpted from the applicant's response to question #18:

The following is excerpted from the applicant's response to question #18:<blockquote>"The National Association of Boards of Pharmacy (“NABP”) is submitting this application on behalf of international pharmacy coalitions and national pharmacy associations to ensure that the .PHARMACY gTLD shall serve as a trusted, hierarchical, and intuitive namespace for legitimate Internet pharmacies. All registrants within this gTLD will be vetted prior to registration to ensure that they meet all applicable regulatory standards, including pharmacy licensure, drug authenticity, and valid prescription requirements. In addition, the registry will incorporate both active and passive safeguards into its operation to ensure that these registrants continue to abide by the terms and conditions set forth in their registration agreements.</blockquote><blockquote>NABP and the coalition are also filing this application for defensive purposes to ensure that a .PHARMACY gTLD is kept out of the hands of a third party that for commercial reasons, may turn a blind eye toward illegal and⁄or counterfeit activity within the gTLD. While NABP and the coalition have closely analyzed the objection mechanisms incorporated into the Applicant Guidebook, it was decided that filing this application was the most prudent course of action to protect the collective interests of the consumers who are currently subject to illegal and dangerous pharmaceuticals.</blockquote><blockquote>'''II. The Problem of Rogue Internet Drug Sellers'''</blockquote><blockquote>Online sales of unregulated and counterfeit medicines total an estimated $75 billion per year, and that total is growing. According to NABP research, over 95% of websites selling prescription drugs are out of compliance with applicable laws and regulations. LegitScript estimates that at any one time, there are over 40,000 Internet drug sites in operation. In September 2011, over 50,000 packages shipped from rogue Internet drug sites were seized and found to contain more than 2.4 million illicit and counterfeit pills worth $6.3 million.</blockquote><blockquote>In the U.S., prescription drug abuse is now the second-highest drug abuse problem ahead of cocaine, methamphetamine, and heroin use combined. This problem is perpetuated by the availability of dangerous and addictive drugs from illicit sellers online; one in six Americans has purchased medication via the Internet without a valid prescription. According to the World Health Organization (WHO) it is estimated that 8% of bulk drugs imported into the U.S. are counterfeit, unapproved, or substandard.</blockquote><blockquote>In addition to risking the health and safety of patients, illegal online drug sales present broader security and criminal risks to society as a whole. According to recent statistics, pharmacy spam constituted 31% of all spam in the fourth quarter of 2011. Also, many of the groups behind these illegal online drug sites have ties to international organized crime syndicates.</blockquote><blockquote>'''III. Partners in the .PHARMACY gTLD Initiative'''</blockquote><blockquote>Although NABP is the formal applicant submitting this application, the .PHARMACY initiative involves a much larger coalition of stakeholders. Below is a representative list of some of the founders behind this initiative. A full and current listing will be available on the NABP website at www.NABP.net.</blockquote><blockquote>NABP, founded in 1904, is an impartial professional organization that supports state boards of pharmacy in protecting public health. NABP’s member boards of pharmacy are grouped into eight districts that include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, Australia, eight Canadian provinces, and New Zealand.</blockquote><blockquote>The International Pharmaceutical Federation (FIP) is the global federation of national associations of pharmacists and pharmaceutical scientists and is in official relations with the WHO. Through its 126 member organizations, FIP represents more than two million practitioners and scientists around the world.</blockquote><blockquote>The Alliance for Safe Online Pharmacies is an informal international alliance of stakeholders led by a steering committee the purpose of which is to protect patient safety globally and ensure patient access to safe and legitimate online pharmacies in accordance with applicable laws.</blockquote><blockquote>The National Association of Chain Drug Stores (“NACDS”) is a membership organization consisting of over 39,000 community pharmacies with over $750 billion in sales. Its mission is to advance the interests and objectives of the chain community pharmacy industry by fostering its growth and promoting its role as a provider of health care services and consumer products.</blockquote><blockquote>Eli Lilly and Company is the tenth-largest pharmaceutical company in the world, and has developed productive alliances and partnerships around the world to develop innovative medicines at lower costs.</blockquote><blockquote>LegitScript is the leading Internet pharmacy verification and Internet monitoring service in the U.S. Its staff is made up of individuals with extensive background in law, law enforcement, government, health care, technology, and Internet compliance.</blockquote><blockquote>'''IV. Potential Business Models'''</blockquote><blockquote>NABP is still analyzing potential use case options regarding the type of domain names and registrants that will be permitted to be registered within .PHARMACY. While at the outset the coalition consisted primarily of North American entities, the coalition recognized the global scope of this undertaking and has been actively engaged in ongoing education and outreach throughout the global community. Following this initial outreach, the members of the coalition will discuss potential best practices within the .PHARMACY gTLD, which will be mandatory in all domain name registration agreements. However, initially, the following minimum business models and practices are currently anticipated to be incorporated into the gTLD at the time of its launch.</blockquote><blockquote>The current best thinking involves a business model in which generic terms (e.g., ʺcholesterol,ʺ ʺblood pressure,ʺ ʺHIV,ʺ etc.) and geographic names (city⁄state) would initially be reserved⁄allocated to develop information portals. The coalition is keenly aware that any new gTLD must be seeded with relevant content to drive traffic and build consumer recognition and trust. Based on an evaluation of the dotAsia Pioneering program, which was incorporated into the launch of the .ASIA gTLD, it is critical that this content be available as soon as possible, ideally before any general registration periods. At the time of filing this application there have been no decisions made regarding how the information portals for .PHARMACY will be developed or who will run them.</blockquote><blockquote>NABP is currently evaluating a validation process whereby only online pharmacies and related entities that meet all regulatory standards in the jurisdictions in which they are based and in which they do business, including pharmacy licensure, drug authenticity, and valid prescription requirements, as applicable, would be permitted to register in .PHARMACY. These qualified online pharmacies would only be permitted to register a domain name corresponding to their business or trade name. Specifically, generic domain names not initially reserved⁄allocated by the registry would not initially be permitted to be registered until a proper discussion could take place within the broader community.</blockquote><blockquote>All domain names within .PHARMACY would be subject to suspension and⁄or cancellation upon the violation of the terms and conditions set forth in the domain name registration agreement. In addition, the registry will incorporate active and passive safeguards into its operation to ensure that these registrants abide by the terms and conditions set forth in their registration agreements."<ref>[http://gtldresult.icann.org/application-result/applicationstatus/applicationdetails/1518 Application Download, gTLDresult.ICANN.org] Retrieved 17 Feb 2013</ref></blockquote>

 

"The National Association of Boards of Pharmacy (“NABP”) is submitting this application on behalf of international pharmacy coalitions and national pharmacy associations to ensure that the .PHARMACY gTLD shall serve as a trusted, hierarchical, and intuitive namespace for legitimate Internet pharmacies. All registrants within this gTLD will be vetted prior to registration to ensure that they meet all applicable regulatory standards, including pharmacy licensure, drug authenticity, and valid prescription requirements. In addition, the registry will incorporate both active and passive safeguards into its operation to ensure that these registrants continue to abide by the terms and conditions set forth in their registration agreements.

 

NABP and the coalition are also filing this application for defensive purposes to ensure that a .PHARMACY gTLD is kept out of the hands of a third party that for commercial reasons, may turn a blind eye toward illegal and⁄or counterfeit activity within the gTLD. While NABP and the coalition have closely analyzed the objection mechanisms incorporated into the Applicant Guidebook, it was decided that filing this application was the most prudent course of action to protect the collective interests of the consumers who are currently subject to illegal and dangerous pharmaceuticals.

 

II. The Problem of Rogue Internet Drug Sellers

 

Online sales of unregulated and counterfeit medicines total an estimated $75 billion per year, and that total is growing. According to NABP research, over 95% of websites selling prescription drugs are out of compliance with applicable laws and regulations. LegitScript estimates that at any one time, there are over 40,000 Internet drug sites in operation. In September 2011, over 50,000 packages shipped from rogue Internet drug sites were seized and found to contain more than 2.4 million illicit and counterfeit pills worth $6.3 million.

 

In the U.S., prescription drug abuse is now the second-highest drug abuse problem ahead of cocaine, methamphetamine, and heroin use combined. This problem is perpetuated by the availability of dangerous and addictive drugs from illicit sellers online; one in six Americans has purchased medication via the Internet without a valid prescription. According to the World Health Organization (WHO) it is estimated that 8% of bulk drugs imported into the U.S. are counterfeit, unapproved, or substandard.

 

In addition to risking the health and safety of patients, illegal online drug sales present broader security and criminal risks to society as a whole. According to recent statistics, pharmacy spam constituted 31% of all spam in the fourth quarter of 2011. Also, many of the groups behind these illegal online drug sites have ties to international organized crime syndicates.

 

III. Partners in the .PHARMACY gTLD Initiative

 

Although NABP is the formal applicant submitting this application, the .PHARMACY initiative involves a much larger coalition of stakeholders. Below is a representative list of some of the founders behind this initiative. A full and current listing will be available on the NABP website at www.NABP.net.

 

NABP, founded in 1904, is an impartial professional organization that supports state boards of pharmacy in protecting public health. NABP’s member boards of pharmacy are grouped into eight districts that include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, Australia, eight Canadian provinces, and New Zealand.

 

The International Pharmaceutical Federation (FIP) is the global federation of national associations of pharmacists and pharmaceutical scientists and is in official relations with the WHO. Through its 126 member organizations, FIP represents more than two million practitioners and scientists around the world.

 

The Alliance for Safe Online Pharmacies is an informal international alliance of stakeholders led by a steering committee the purpose of which is to protect patient safety globally and ensure patient access to safe and legitimate online pharmacies in accordance with applicable laws.

 

The National Association of Chain Drug Stores (“NACDS”) is a membership organization consisting of over 39,000 community pharmacies with over $750 billion in sales. Its mission is to advance the interests and objectives of the chain community pharmacy industry by fostering its growth and promoting its role as a provider of health care services and consumer products.

 

Eli Lilly and Company is the tenth-largest pharmaceutical company in the world, and has developed productive alliances and partnerships around the world to develop innovative medicines at lower costs.

 

LegitScript is the leading Internet pharmacy verification and Internet monitoring service in the U.S. Its staff is made up of individuals with extensive background in law, law enforcement, government, health care, technology, and Internet compliance.

 

IV. Potential Business Models

 

NABP is still analyzing potential use case options regarding the type of domain names and registrants that will be permitted to be registered within .PHARMACY. While at the outset the coalition consisted primarily of North American entities, the coalition recognized the global scope of this undertaking and has been actively engaged in ongoing education and outreach throughout the global community. Following this initial outreach, the members of the coalition will discuss potential best practices within the .PHARMACY gTLD, which will be mandatory in all domain name registration agreements. However, initially, the following minimum business models and practices are currently anticipated to be incorporated into the gTLD at the time of its launch.

 

The current best thinking involves a business model in which generic terms (e.g., ʺcholesterol,ʺ ʺblood pressure,ʺ ʺHIV,ʺ etc.) and geographic names (city⁄state) would initially be reserved⁄allocated to develop information portals. The coalition is keenly aware that any new gTLD must be seeded with relevant content to drive traffic and build consumer recognition and trust. Based on an evaluation of the dotAsia Pioneering program, which was incorporated into the launch of the .ASIA gTLD, it is critical that this content be available as soon as possible, ideally before any general registration periods. At the time of filing this application there have been no decisions made regarding how the information portals for .PHARMACY will be developed or who will run them.

 

NABP is currently evaluating a validation process whereby only online pharmacies and related entities that meet all regulatory standards in the jurisdictions in which they are based and in which they do business, including pharmacy licensure, drug authenticity, and valid prescription requirements, as applicable, would be permitted to register in .PHARMACY. These qualified online pharmacies would only be permitted to register a domain name corresponding to their business or trade name. Specifically, generic domain names not initially reserved⁄allocated by the registry would not initially be permitted to be registered until a proper discussion could take place within the broader community.

 

All domain names within .PHARMACY would be subject to suspension and⁄or cancellation upon the violation of the terms and conditions set forth in the domain name registration agreement. In addition, the registry will incorporate active and passive safeguards into its operation to ensure that these registrants abide by the terms and conditions set forth in their registration agreements."<ref>[http://gtldresult.icann.org/application-result/applicationstatus/applicationdetails/1518 Application Download, gTLDresult.ICANN.org] Retrieved 17 Feb 2013</ref>

==Contract signed==

==Contract signed==