A Guide to www.ShireSupport.com Updated: Spring 2012 Shire Pharmaceuticals-SP Our purpose We enable people with life-altering conditions to lead better lives. www.ShireSupport.com • The following slides provide an orientation on • • • • • • • Shire Pharmaceuticals-SP Registration eligibility and submission Therapeutic areas Funding types Definitions of funding types Funding availability Contact information To be as brave as the people we help. 2 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 To be as brave as the people we help. 3 Registration Eligibility • Eligible • Medical Schools • Hospitals/Medical Centers • Medical Associations/Medical Societies • Patient Advocacy Organizations • Medical Education Companies • Not for Profit organizations • • Ineligible • Individuals • Private or group medical practice(s) • An organization that has been debarred or is on the OIG exclusion list 501(c)(3)(4)(6) 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. To be as brave as the people we help. 4 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. To be as brave as the people we help. 5 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. To be as brave as the people we help. 6 Definitions of Funding Types Funding Request Type Definition Therapeutic Areas Independent Medical Education Grant 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. Shire Pharmaceuticals-SP Examples include: General meeting support for healthcare practitioner conference Annual conference at medical school or association meeting Session at annual meeting of local medical society Educational grants may be payable to organizations including hospitals, medical societies, medical schools, 501(c)(3)(4)(6) organizations, medical education companies, etc. Funds are to educate broad audiences; cannot be used to fund education for sole individual. • Gastroenterology – Mild to Moderate Ulcerative Colitis • Gastroenterology – Motility/Chronic Constipation • Hyperphosphatemia (Renal) • Pediatric Attention Deficit Hyperactivity Disorder • Adolescent and Adult Attention Deficit Hyperactivity Disorder www.ShireSupport.com Requesting organization has full control over selection of faculty, content, educational method, materials, venue etc. Shire has no role in the development or implementation of the activity. To be as brave as the people we help. 7 Definitions of Funding Types Funding Request Type Definition Therapeutic Areas Charitable Contributions 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 Shire Pharmaceuticals-SP Examples include: Fundraising events General support of patient advocacy organizations 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. • Gastroenterology specific to mild to moderate ulcerative colitis •Gastroenterology – Motility/Chronic Constipation •Hyperphosphatemia (Renal) • Pediatric attention deficit hyperactivity disorder • Adult attention deficit hyperactivity disorder www.ShireSupport.com 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 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. To be as brave as the people we help. 8 Definitions of Funding Types Funding Request Type Definition Therapeutic Areas Sponsorship Requests Support for healthcare-related events or activities where Shire may receive a material commercial benefit in exchange for its contribution Shire Pharmaceuticals-SP 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 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. • Gastroenterology specific to mild to moderate ulcerative colitis •Gastroenterology – Motility/Chronic Constipation •Hyperphosphatemia (Renal) • Pediatric attention deficit hyperactivity disorder • Adult attention deficit hyperactivity disorder www.ShireSupport.com To be as brave as the people we help. 9 Shire Pharmaceuticals-SP – 2012 Funding Availability Therapeutic Area Educational Grants Healthcare Related Charitable Contributions and/or Sponsorship Requests Limited Available Gastroenterology – Mild to Moderate Ulcerative Colitis Available Available Gastroenterology – Motility/Chronic Constipation Available Available Hyperphosphatemia (Renal) Limited Limited Pediatric Attention Deficit Hyperactivity Disorder Limited Available Adolescent and Adult Attention Deficit Hyperactivity Disorder To be as brave as the people we help. 10 Financial Reconciliation of Educational Grants • • • Educational grants must be reconciled within 90 days of the activity date Reconciliations are to be completed online at www.ShireSupport.com What’s needed • 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. To be as brave as the people we help. 11 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. To be as brave as the people we help. 12 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 • • • Funding requests must be in compliance with all applicable guidelines Timelines • • • • • • • Faxed, mailed, or e-mailed requests will not be reviewed All requests – educational, charitable contributions, or sponsorships – must be submitted 60 days in advance Decisions are communicated by e-mail within 30-60 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 Educational grant requests should not include sponsorship requests and vice versa Questions? • Shire Pharmaceuticals-SP: ShireSupport@shire.com To be as brave as the people we help. 13 Contact Information Shire Pharmaceuticals-SP Shire HGT E-mail: ShireSupport@shire.com E-mail: ShireHGTsupport@shire.com Phone: 484-595-8253 Phone: 617-613-4999 Funding Site: www.ShireSupport.com Funding Site: www.ShireHGTsupport.com Mail: Shire Pharmaceuticals-SP 725 Chesterbrook Blvd Wayne, PA 19087 Mail: Shire HGT 300 Shire Way Lexington, MA 02421 Therapeutic Areas of Interest Adolescent and Adult Attention Deficit Hyperactivity Disorder Gastroenterology – Mild to Moderate Ulcerative Colitis Gastroenterology – Motility/Chronic Constipation Hyperphosphatemia (Renal) Pediatric Attention Deficit Hyperactivity Disorder Therapeutic Areas Fabry Diseas Gaucher Disease Hereditary Angioedema (HAE) Hunter Syndrome Metachromatic Leukodystrophy (MLD) Sanfilippo Syndrome To be as brave as the people we help. 14