Report of the.pharmacy Executive Board Meeting

Transcription

1 Report of the.pharmacy Executive Board Meeting April 16, 2015 Members Participating: Louisiana Board of Pharmacy representative Malcolm Broussard, chair NABP Chairperson Karen M. Ryle, At-large member.pharmacy Supporter Advisory Committee representative Virginia Herold National Association of Pharmacy Regulatory Authorities representative Ronald F. Guse International Pharmaceutical Federation representative Luc Besançon NABP President Joseph L. Adams, Executive Committee liaison Others Participating: Carmen Catizone, Melissa Madigan, Larissa Doucette, Marty Allain, Gertrude Gg Levine, and Deborah Zak, NABP staff. Introduction: The.Pharmacy Executive Board was established by the NABP Executive Committee in accordance with NABP s contractual agreement with the International Corporation for Assigned Names and Numbers (ICANN). Informed, in part, by the expertise and strategic input provided by the.pharmacy advisory committees, the Board makes recommendations for review and approval by the NABP Executive Committee, concerning strategy, national and international standards that are consistent with the mission and purpose of the.pharmacy Top-Level Domain (TLD) and the interests of the global public health. The Board met at NABP Headquarters on April 16, Recommendation No. 1 Executive Board Recommendations The.Pharmacy Executive Board recommends that, as NABP continues to build upon and refine its US public outreach and consumer education campaign and looks to expand the outreach outside the US as appropriate and partnering with appropriate regulatory agencies and pharmacy organizations, the Association work to further engage the boards of pharmacy in the promotion of the.pharmacy initiative.

2 At the meeting, NABP staff presented the numbers and types of.pharmacy domain name registrations that have been completed so far, which include a total of 296 tokens issued and 60.pharmacy domain name registrations. With regard to specific registration periods: Board Members 24 domain names registered Trademark Clearinghouse (TMCH) Sunrise o NABP Approved Programs (VIPPS, vet-vipps, e-advertiser) 21 applicants 60 domain name requests 15 domain names registered to 10 registrants o Non-approved organizations 5 applicants 6 domain name requests NABP Approved Programs o 34 applicants o 274 domain name requests o 20 domain name registrations for 14 registrants Board members noted that this information may be useful in structuring messaging about.pharmacy to the boards and their licensees. It was reported that members of the boards of pharmacy are not as engaged in the.pharmacy initiative as they could be, and that more involvement from the boards is imperative to the success of the program, as they will likely have the most influence in promoting the program to licensees and others. To further promote awareness of and engagement in the.pharmacy program, Board members suggested creating a competition among the boards of pharmacy and/or appropriate regulatory bodies outside the US, or among student pharmacists to encourage creative use of the.pharmacy domain name. In addition, it was suggested that NABP consider doing the following: Present a session at NABP/AACP District Meetings on.pharmacy Exhibit at the National Community Pharmacists Association meeting, FIP meeting, and the Canadian Pharmacists Association Meeting To assist boards of pharmacy that may have limited website design resources, participants encouraged NABP to create a template, model text, or criteria for optimal use of a.pharmacy domain name by the boards. Recommendation No. 2 The Board recommends that NABP and its partners further explore whether.pharmacy domain names for generic drug terms, particularly controlled substances, should be available to potential registrants.

3 The Executive Board advised NABP to use caution and rely on evidence when balancing safety with accessibility of the.pharmacy domain in many aspects of the program s operations, but most notably in this area. Board members agreed that issuing domain names for brand name drugs to brand holders would be appropriate but raised concerns about granting generic drug terms to pharmacies or other organizations. Others noted that, if the name is used by a legitimate entity for informational purposes, it may be in line with the public health mission of.pharmacy. Members also commented that NABP may need to revisit its Registry Agreement with ICANN pertaining to the level of restrictions NABP, as a registry operator, can impose. Additionally, the Board noted that, while it is important to ensure the safety of the.pharmacy domain, it would be counterproductive to make obtaining a.pharmacy name so restrictive and arduous that legitimate entities are discouraged from applying. To counteract such concerns, it was recommended that NABP seek to obtain testimonials from.pharmacy registrants who found the application process to be easy or fair. Recommendation No. 3 The Board advises that, as NABP continues to expand and refine its collaborations with international regulators in relation to.pharmacy, NABP should clarify how national standards fit within the structure of the program. To facilitate collaborations with international regulators, Board members recommended that NABP develop an infographic to visually represent the decision-making process to evaluate applications for.pharmacy domain names. In addition, members advised that NABP continue its efforts to further investigate if the new European Union (EU) Common Logo requirement(s) could/should serve as a (or the) requirement for granting a.pharmacy domain for pharmacies established in one of the 27 countries of the European Union. The Board discussed the evaluation of non-us.pharmacy applicants and how that process might take place with the assistance of individual national regulators. It was thought that a visual representation of this process would make the process easier to comprehend and more directly illustrate contributions from, and value added for, international regulatory groups increase. It was reported by NABP that efforts to obtain the assistance of national regulators has moved forward, but the establishment of formal National Standard Setting Committees has not taken place due to the need for committed resources from each individual nation. Instead, NABP has moved forward with establishing informal partnerships that will allow non-us.pharmacy applicant evaluations to be performed by NABP with the support of and with information provided by national regulators. Ideally, NABP would prefer to enter into formal relationships that would involve national regulators assisting with the evaluation of.pharmacy application and will continue to pursue such. In support of this effort, FIP reported that it may be able to assist NABP in establishing additional contacts with regulators in Europe and elsewhere, noting that there may be more than one regulator in each country that need to participate.

4 Continued discussions revealed that there was some confusion regarding national standards that will be used to evaluate applications, specifically whether such standards supplement the program standards for.pharmacy registrants in specific jurisdictions or whether they are incorporated into such standards. Staff explained that the incorporation of national standards into the program standards is intended, as the wording of the standards defers to individual national laws and/or standards. NABP agreed to provide additional information that will alleviate this confusion. Regarding the common logo in the EU, the Board discussed how the.pharmacy program can support and complement the EU Common Logo requirement. One question that arose: should the.pharmacy program standards in the EU be set to those of the common logo? This option was presented as the simplest route to follow, and the route that would most likely appeal to international regulators. Complicating this route, however, is the fact that each EU member state is free to implement its own requirements for use of the common logo in that jurisdiction; thus, requirements may vary significantly from region to region. Additionally, it was pointed out that the regional requirements may not address shipping outside the region, or outside of the EU, which is an important component of the.pharmacy program standards as currently written. Some board members pointed out that the two programs,.pharmacy and the common logo, are not equivalent. They recognized that, currently,.pharmacy program standards are the bar that.pharmacy registrants in every jurisdiction must meet. Concerns were raised, however, that the.pharmacy program standards, as compared to common logo standards, could be a hard sell for international regulators. The hope was expressed that, years hence,.pharmacy might become the standard for the common logo. Recommendation No. 4 The Board reviewed the status of recommendations of the.pharmacy Supporter Advisory Committee and recommends that the Report of the.pharmacy TLD Supporter Advisory Committee Teleconference: January 29, 2015, be presented to the NABP Executive Committee for approval in May It was determined that Joseph Adams would review the report of the advisory committee at the next Executive Committee meeting. Recommendation No. 5 NABP, when listing.pharmacy domain names on the safe.pharmacy website, should list the domain names by state and by nation. This recommendation arose as part of the review of the January 2015 advisory committee teleconference report. Providing lists of.pharmacy domain name registrants according to

5 geographic regions was considered to be a useful resource for consumers and a value-added perk for registrants. Recommendation No. 6 NABP should develop a policy addressing country name and country abbreviation duplication. This recommendation arose as part of the review of the January 2015 advisory committee teleconference report. Examples of duplications that may arise and cause confusion are georgia.pharmacy, which could represent either the country or the state of Georgia; and ca.pharmacy, which could represent either Canada or California. Recommendation No. 7 The Executive Board recommends approval of Amendments to the NABP.Pharmacy Governance Document suggested by staff, with revisions. The recommended revisions by staff are denoted by underlines and strikethroughs. The recommended revisions by the Executive Board are denoted by double underlines and double strikethroughs. See NABP.Pharmacy Governance Document. Board members discussed the potential utility of dividing the.pharmacy Supporter Advisory Committee into two separate committees: the.pharmacy Registrant/Supporter Advisory Committee, and the.pharmacy Regulators Committee. Also discussed, but not decided, was whether the Registrant/Supporter Committee would report to the Regulators Committee, and the Regulators Committee report to the Executive Board, or whether both committees would report directly to the Executive Board. It was recommended that this structure, once established, should be represented visually to help clarify the relationship. It was also mentioned for consideration that some countries may have more than one regulatory body, such as one for pharmacists and one for pharmacies, and that some professional associations have some regulatory authority. For these reasons, board members discussed the need to define regulator in relation to this committee. The Board also discussed appointing a patient advocacy group to the Registrant/Supporter Advisory Committee to broaden the committee s representation. The Board recommended narrowing the focus of the governance document to the structure of leadership and the process for establishing or amending standards and policies, rather than including the specific standards and policies. Accordingly, the Program Standards, Eligibility Standards, Authorized Usage Policy, and Terms and Conditions should be removed from the governance document to become stand-alone documents. This way, any proposed changes could be considered and implemented in a narrower context, without revising the entire governance document or any of the processes defined therein.

6 Recommendation No. 8 The Executive Board recommends consideration by the NABP Executive Committee of the following policy issues: Amend.pharmacy requirements (Program Standards, Registrant Eligibility Standards, Authorized Usage Policy, and Terms and Conditions) to reflect all recommendations of this Board that are approved by the NABP Executive Committee. Ensure that unethical behavior is able to be addressed though.pharmacy program standards or policies. Consider restructuring application fees to address the increased cost of evaluating applicants practicing in more than one country. Consider incorporating cost recovery fees for reviewing complaints. Regarding the T&C: o Consider editing Section 10 as follows: 10. RIGHT OF PUBLICITY. Customer grants NABP a non-exclusive, transferable, royalty-free license to publish Customer s name, address, website address, and its date of approval of the.pharmacy domain application, along with other information required by ICANN. o Considering deleting the last sentence of section 15.1: Customer will notify NABP in writing if Customer, its pharmacy, owners, or affiliates become the subject of an investigation, indictment, prosecution, conviction, or disciplinary order within thirty (30) days of learning of such investigation, indictment, prosecution, conviction, or disciplinary order. Customer is not required to report any investigations that do not constitute public information under local, state, or federal securities laws, rules, or regulations. As members discussed proposed edits to the Governance Document, these additional policy issues arose and the Committee urged consideration by NABP. Specifically, regarding the T&C, members were: 1) interested in informing applicants that specific registrant data will be made public upon registration of their domain name; and 2) interested in non-public securities investigation information being reported. Recommendation No. 9 The Executive Board approved two of the three dates proposed for upcoming.pharmacy Executive Board meetings in 2015 and asked that the third be rescheduled. Members agreed to reconvene via teleconference on July 29, and to meet again in person at NABP Headquarters on December The Board directed NABP to survey the group to find an alternate date for the proposed October 8 teleconference.

7 It was suggested that a future topic of discussion be pricing for.pharmacy application evaluations. Input from members suggested that an additional evaluation fee be required from an applicant providing services in more than one country, noting that additional work must be performed to ensure compliance with each nation s laws and regulations.