NABP effort seeks worldwide protection for consumers and users of pharmacies online.
In June 2012, the National Association of Boards of Pharmacy (NABP) applied to the Internet Corporation for Assigned Names and Numbers (ICANN) in an effort to own and operate the .PHARMACY suffix, which is otherwise referred to as a generic top-level domain (gTLD). Other commonly used gTLD’s in the marketplace are .edu, .gov, .org, and .com. The purpose of such application relates to NABP’s desire to create a secure and trustworthy online space for pharmacies. Only “legitimate” pharmacy operators who are compliant with applicable pharmacy laws and regulations will be permitted to register domain names in .pharmacy, according to NABP.
The .pharmacy suffix had received initial approval from ICANN by May 2013, and NABP is poised to launch the gTLD in the next several months. It will begin to be operational while the ICANN places the .pharmacy application in the final approval stages. The remaining issues relate to the finalizing of a registry agreement with ICANN and to the vetting of the technical apparatus to ensure that NABP and its technical partners have the proper operational safeguards in place to manage the .pharmacy gTLD in a stable and secure manner.
The effort to engage ICANN involved NABP’s collaboration with other partners who share concerns about illegal online drug sellers distributing products that pose a risk to patient health and safety. Those partners included international regulatory bodies, pharmacy organizations, and law enforcement agencies. Examples of stakeholders who supported the NABP effort to engage ICANN included the Alliance for Safe Online Pharmacies, the European Alliance for Access to Safe Medicines, the International Pharmaceutical Federation, INTERPOL, the National Association of Pharmacy Regulatory Authorities, and numerous state pharmacy boards, among others.
The overriding concern is the proliferation of websites purporting to sell legitimate prescription drugs to unsuspecting consumers. Such patients are placed at risk, because they may be purchasing prescription drugs that are non-approved FDA medications or products of foreign markets. These prescription drugs may be counterfeit, substandard, and adulterated medications distributed by internet sellers who are out of compliance with pharmacy laws, regulations, and practice standards, all of which are intended to protect the public from harm.
By way of example, in January 2013, NABP reviewed 10,275 websites purporting to be legitimate pharmacy operators. Of those, 9,938 (97% of the websites reviewed) were determined to be noncompliant with pharmacy laws and regulations.
Although registration for the .pharmacy gTLD will be voluntary, it is intended to provide the public with a “trusted, hierarchical, and intuitive namespace for legitimiate Internet pharmacies and other prescription drug-related entities,” says NABP.
Responsibilities associated with the .pharmacy gTLD will be delegated in several ways.
First, NABP will form an executive board, which will establish other supportive committees.
National standard-setting committees will outline the requirements and processes to obtain content in the .pharmacy space and ensure that geographical identifiers are used in a prominent, accurate, fair, and clear way.
Another committee will be the supporter advisory committee, which will work with the executive board to draft the domain name registration agreement. This agreement will impose ICANN requirements and any others on an applicant.
There will also be a registrant advisory committee, which will represent the perspective of registrants in recommendations to the executive board.
Other elements connected with the new gTLD address:
· Back-end registry-services providers, who will be responsible for vetting applications, implementing active and passive safeguards, and adding policies or safeguards set forth by the executive board
· Suspension and/or cancellation of domain names, in the event of violation of any terms of the domain name registration agreement
· Post-registration monitoring and enforcement
· Public awareness efforts rolled out through NABP’s AWARxE Consumer Protection Program.
Ned Milenkovichis a partner and head of the drug and pharmacy legal practice at Roetzel and Andress LPA. He is also a member of the Illinois State Board of Pharmacy. Contact Ned at 312-582-1676 or email@example.com.