a guide to shiresupport updated: spring 2013

Our purposeWe enable people with life-altering conditions to lead better lives.

A Guide towww.ShireSupport.com Updated: Spring 2013

Shire Pharmaceuticals-SP

To be as brave as the people we help.

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www.ShireSupport.com

• These slides provide an orientation on• Registration, Eligibility and Submission Process• Therapeutic Areas of Interest• Funding Types

• Charitable Contributions• Sponsorship Requests• Independent Medical Education

• Continuing Medical Education• Fellowship Funding• Travel Grants for HCPs in Training

• Disclaimer: Massachusetts• Finances• Reminders• Contact Information


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Registration and Submission Process

• Step One• Become a registered user of www.ShireSupport.com• When registering please have the following materials available

• Legal name of the organization as registered with the IRS• A signed PDF copy of the organization’s W9 form

• Note: Electronic signatures are NOT acceptable• If applicable, a PDF copy of the organization’s non-profit

determination letter from the IRS• Step Two

• Select the request type• Medical Education Grants• Healthcare related Charitable Contributions and/or Sponsorship

Requests • Step Three

• Submit the request with attachments as applicable


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Registration Eligibility

• Eligible• Medical Schools• Hospitals/Medical Centers• Medical Associations/Medical Societies• Patient Advocacy Organizations• Medical Education Companies• Not for Profit organizations

• 501(c)(3)(4)(6)

• Ineligible• Individuals• Private or group medical practice(s)• An organization that has been debarred or is on the OIG exclusion list• An organization that is partially or wholly owned by practicing healthcare

professionals

If you represent an organization located in Massachusetts, please refer to slides 14-15.


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Therapeutic Areas of Interest

• ADHD• Adult

• ADHD is a chronic neurologically based disease. Therefore Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of adult patients with ADHD.

• Adolescents• ADHD is a chronic neurologically based disease. Therefore Shire’s

educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of adolescent patients with ADHD.

• Pediatric• ADHD is a chronic neurologically based disease. Therefore Shire’s

educational goal is to improve the screening, diagnosis, treatment, and management of pediatric patients with ADHD.


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Therapeutic Areas of Interest

• Gastroenterology • Mild to Moderate Ulcerative Colitis

• Mild to moderate ulcerative colitis is a disease characterized by inflammation and ulceration of the lining of the colon and rectum. Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of patients with mild to moderate ulcerative colitis.

• Motility/Chronic Constipation• Chronic constipation is characterized by infrequent and difficult passage of

stools over a prolonged period and a range of bothersome symptoms. Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of female patients with chronic constipation.

• Renal• Hyperphosphatemia

• Hyperphosphatemia is an abnormal concentration of phosphates in the blood. Shire’s educational goal is to fund education that provides specialists with the information and tools needed to improve the screening, diagnosis, treatment, and management of patients with hyperphosphatemia.


Charitable ContributionsSponsorship Requests


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Definitions of Funding Types

Funding Request Type Definition Therapeutic Areas

Charitable Contributions

Examples include:

Fundraising events

General support of patient advocacy organizations

Donations to support the general activities of a registered tax-exempt organization under sections 501(c)(3)(4)(6) of the Internal Revenue Code, which are engaged in healthcare-related charitable purposes

All charitable giving must serve a clearly defined legitimate charitable purpose, and Shire may only receive an incidental benefit from any such contributions

Charitable contributions may be payable to organizations including hospitals, medical societies, medical schools, 501(c)(3)(4)(6) organizations, etc.

Use of charitable contribution funds is unrestricted, which means Shire does not control the recipient’s use of the funds; use is at the sole discretion of the recipient

Shire Pharmaceuticals-SP• Gastroenterology specific to mild to moderate ulcerative colitis•Hyperphosphatemia (Renal)• Pediatric attention deficit hyperactivity disorder• Adult attention deficit hyperactivity disorder


Notice to all requestors located in Massachusetts: due to the Massachusetts Pharmaceutical and Device Manufacturer Conduct Law, Shire is unable to fund requests for the financial support for the costs of travel, lodging, or other personal expenses of non-faculty health care practitioners attending any CME event, third-party scientific or educational conference, or professional meetings, either directly to the individuals participating in the event or indirectly to the event’s sponsor. While Shire has information on the charitable section of this website relating to Fellows and Residents travel grants, any organizations located in Massachusetts are not eligible due to this law.


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Definitions of Funding Types

Funding Request Type Definition Therapeutic Areas

Sponsorship Requests

Examples include:Payments to become a tier (e.g., gold, platinum, etc.) sponsor at a medical society’s or patient advocacy group’s annual meeting

Payment for exhibit space at a medical conference or seminar

Patient Education

Support for healthcare-related events or activities where Shire may receive a material commercial benefit in exchange for its contribution

Sponsorships may be payable to organizations including hospitals, medical societies, medical schools, 501(c)(3)(4)(6) organizations, etc.

Shire does not fund sponsorships payable to individual healthcare providers or medical practices.

Shire Pharmaceuticals-SP• Gastroenterology specific to mild to moderate ulcerative colitis•Hyperphosphatemia (Renal)• Pediatric attention deficit hyperactivity disorder• Adult attention deficit hyperactivity disorder



Independent Medical Education

Continuing Medical EducationFellowship Funding RequestsTravel Grants for HCPs in Training


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Independent Medical EducationFunding Request Type Definition

Continuing Medical Education “CME consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public or the profession. The content of CME is the body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine and the provision of health care to the public.” Physician’s Recognition Award: Requirements for Accredited Providers http://www.ama-assn.org/resources/doc/cme/pra-booklet.pdf

Funding Request Type DefinitionFellowship Funding Shire may provide funding for post-graduate, medical training (fellowship

funding) for healthcare professionals (HCPs) participating in a medical training program that is aligned with Shire’s therapeutic areas of interests at an accredited organization

Funding Request Type Definition

Travel Grants for HCPs in Training Shire may provide modest travel grants to fellows, residents, medical students, and other HCPs in training for attendance at major scientific meetings aligned with Shire’s areas of interest

http://www.ama-assn.org/resources/doc/cme/pra-booklet.pdf


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Shire’s Expectations: Independent Medical Education

• Aligned with Shire’s areas of interest and are developed independently of Shire personnel involvement.

• Developed to address the educational gap identified through the needs assessment. The educational gap could be related to clinical practice, knowledge, or skills.

• Intent is to meet the identified educational gap, be appropriate for the educational audience, and lead to improved patient outcomes.

• Honoraria offered to healthcare professionals serving as faculty reflects fair market values.

• Live educational activities will be held at modest locations, which provide an environment conducive to learning.

• Modest meals or social events will not compete with or take precedence over the educational activity.

• Educational activities will be implemented in accordance with Shire’s Letter of Agreement.

• Organizations determined to be non-compliant will be precluded from requesting educational grant funding from Shire.


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Shire’s Expectations: Independent Medical Education

Educational interventions for healthcareprofessionals include, but are not limited to:

• Courses: Local, Regional, or National• Fellowship Funding

• Affiliated with an accredited organization• Internet CME: Live or Archived• Journal CME• Performance Improvement Initiatives• Teleconferences• Travel Grants for HCPs in Training

• Must be associated with a major scientific meetings

Examples of requests that Shire will notconsider:• Activities developed for professional or staff

development• Activities intended to develop clinical guidelines or

algorithms• Activities focused on promoting Shire products• Activities that include retroactive support• Activities developed by or in partnership with an

organization that is partially or wholly owned by practicing healthcare professionals


Disclaimer

Massachusetts Based Organizations


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Massachusetts Pharmaceutical and Device Manufacturer Conduct Law

• Shire is unable to fund requests for the financial support for the costs of travel, lodging, or other personal expenses of non-faculty health care practitioners attending any CME event, third-party scientific or educational conferences, or professional meetings, either directly to the individuals participating in the event or indirectly to the event’s sponsor.

• While Shire has information on the Continuing Medical Education section of this website relating to Fellowship Funding and Travel Grants for HCPs in Training, organizations located in Massachusetts are not eligible due to this law.


Finances

Funding AvailabilityIneligible Budget ItemsReconciliations


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Shire Pharmaceuticals-SP – 2013 Funding Availability

Therapeutic Area Independent Medical Education

(Continuing Medical Education, Fellowship Funding, and Travel Grants for HCPs in Training)

Healthcare Related Charitable Contributions and/or Sponsorship Requests

Adolescent and Adult Attention Deficit Hyperactivity Disorder

Available Available

Gastroenterology – Mild to Moderate Ulcerative Colitis

Available Available

Gastroenterology – Motility/Chronic Constipation

Available Available

Hyperphosphatemia (Renal) Limited Not Available

Pediatric Attention Deficit Hyperactivity Disorder

Available Available


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Shire’s Expectations: Ineligible Budget Items

• Independent medical education budget line items must not include: • Prizes• Gifts or service awards• Funding for guests• Travel and/or lodging reimbursement out of proportion with the activity

dates • Faculty dinners not aligned with content review• Operating expenses not specifically aligned with the educational activity• Expenses related to exhibits


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Financial Reconciliation of Sponsorships

• All sponsorships must be reconciled within 90 days of the activity date

• Reconciliations are to be completed online at www.ShireSupport.com

• What’s needed• Comparative budget to actual reconciliation

• Program expenses for the entire initiative must be included (not just funding provided by Shire)

• Documentation of the commercial support acknowledgement statement

• Note that failure to reconcile this request may prevent future Charitable and/or Sponsorship funding to your organization.


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Financial Reconciliation for Independent Medical Education

• Reconciliations are due within 90 days of the activity date• Reconciliations are to be completed online at

www.ShireSupport.com• Complete the online reconciliation form with

• Attendance information• Comparative budget to actual reconciliation (Program expenses for

the entire initiative; not just what Shire provided)• Total Funding received from all sources = registration income,

educational grants, and funding provided by the hosting organization• The evaluation summary• Documentation of the commercial support acknowledgement

statement, i.e. “This activity was supported by an independent medical educational grant from Shire.”

• Refunds are only due if the amount is greater than $250• Failure to reconcile educational grants may prevent future

funding to your organization.


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Some Reminders…

• Funding requests must be aligned to a Shire Pharmaceuticals-SP therapeutic area of interest to be considered

• Funding requests must be submitted online to www.ShireSupport.com by the requesting organization without assistance from Shire employees• Faxed, mailed, or e-mailed requests will not be reviewed

• Funding requests must be in compliance with all applicable guidelines• Timelines

• All requests – educational, charitable contributions, or sponsorships – must be submitted 60 days in advance

• Decisions are communicated by e-mail within 45-60 days of the request date• Requests will not be reviewed or approved after the activity has begun or taken place• Submission, or past approvals, does not guarantee support• Declined requests cannot be resubmitted

• If a request is inadvertently submitted in the wrong category ShireSupport personnel will provide appropriate direction

• Independent medical education requests may not include sponsorship requests and vice versa

• Questions?• [email protected] or [email protected]


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Contact Information

Shire Pharmaceuticals-SP

Charitable and Sponsorships E-mail: [email protected] Phone: 484-595-8253Independent Medical Education Email: [email protected]: 484-595-2632Funding site: www.ShireSupport.comAreas of Interest: ADHD, Mild to Moderate Ulcerative Colitis, and Motility/Chronic Constipation

Shire HGT E-mail: [email protected]: 617-613-4999Funding Site: www.ShireHGTsupport.comAreas of Interest: Fabry Disease, Gaucher DiseaseHereditary Angioedema (HAE), Hunter Syndrome, Metachromatic Leukodystrophy (MLD), and Sanfilippo Syndrome

Shire Regenerative Medicine

E-mail: [email protected]: 858-754-3886Areas of Interest: Diabetic foot ulcers, Complications associatedwith diabetes (e.g. renal impairment, peripheral neuropathy), Woundcare and Dermal repair

a guide to shiresupport updated: spring 2013

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