LifeScan, Inc. is committed to Our Credo which guides us to provide high quality products and services to healthcare professionals and patients and to support the communities in which we work and live.
We recognize that medical science evolves rapidly with new information becoming available constantly. As part of the healthcare system, we also understand the need to support healthcare professionals in their pursuit of the most current education to provide the best patient care possible. There is further need to support patients, caregivers, and communities to ensure that they have the information and products required to live healthy, quality, and productive lives. As such, we are proud to have the opportunity to support educational programs and community programs through educational grants and charitable contributions, respectively.
We hold ourselves accountable to the highest standards to ensure that we are providing educational grants and charitable contributions in an appropriate manner. There are a number of policies and guidance documents from various external regulatory and policy-making organizations that form the basis for the development of our company's guiding principles used to evaluate grant and charitable request submissions.
Our primary focus is making life-changing, long-term differences in human health and disease management for those who may be helped by the products and services we provide. The purpose of our disclosure of supported educational grants and charitable contributions is to demonstrate our ongoing commitment to this endeavor. It is our hope that this disclosure will help the general public to better understand the nature and volume of programs that we support in the interest of advancing patient care and supporting local communities.
Educational Grants Process
LifeScan, Inc. understands the need to comprehend all aspects of disease management and treatment and that both healthcare professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques.
LifeScan, Inc. is proud to be able to provide grants to support educational activities and programs that help healthcare professionals enhance the care of their patients. We prioritize support in areas of scientific interest to the company that are intended to contribute to improvement in healthcare provider knowledge.
Our organization follows a defined and specific process to ensure that our procedures for making educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programs is based on recognized standards.
- Educational grants may be given to support bona fide educational activities directed toward healthcare professionals or patients and may include funding for accredited/certified continuing education, fellowships, and patient education.
- Independent, company-supported educational activities are intended to benefit healthcare professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.
- LifeScan, Inc. does not control or influence the content of programs or the selection of the speakers, authors, or faculty planners. This guideline applies equally to all educational activities involving any healthcare professional, or customer who is in a position to influence the purchase of LifeScan, Inc. products.
LifeScan, Inc. does not provide "unrestricted educational grants" and grant funds must be used for the purpose defined within the original request. Each grant request is evaluated for completeness based on four basic components:
1. An assessment documenting why the education is necessary
2. An agenda or brochure describing the schedule of events
3. A detailed budget identifying all sources of funding and how grant funds will be used
4. Evidence of accreditation to provide continuing education credit and/or tax exempt status
Educational grants must be provided in accordance with the policies and procedures of Guidance Documents and with the U.S. Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities.
They must also be consistent with the Accreditation Council for Continuing Medical Education Standards for Commercial Support (www.accme.org) ("ACCME Standards"), the American Medical Association Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org) ("AMA Guidelines"), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (www.phrma.org) ("PhRMA Code"), the AdvaMed Code of Ethics for Interactions with Healthcare Professionals (www.advamed.org) ("AdvaMed Code") and/or other relevant industry standards.
LifeScan, Inc.'s Medical Affairs, Scientific Affairs, or other relevant departments have responsibility for the monitoring and recordkeeping of independent educational programs supported by LifeScan, Inc., including budget, staff and interactions with educational providers. In addition, LifeScan, Inc. has:
- Written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers, so as to comply with applicable requirements of the guidelines mentioned above;
- An internal, multidisciplinary review process for evaluation of educational grant requests which includes our Medical Education, Medical Affairs/Clinical Research, Healthcare Compliance, Regulatory Affairs and Law departments, as necessary;
- Appropriate measures to ensure that support of educational programs are scientifically and clinically justified, and the program is not intended to be promotional in nature. LifeScan, Inc. may consider the following factors:
- The demonstrated scientific and clinical need for the program;
- Whether the proposed program is sponsored solely by LifeScan, Inc. or if our funding represents a significant proportion of the program budget;
- The grant requestor's history, and whether prior educational activities appeared to be conducted in an independent and unbiased manner and not influenced by support from industry sponsors.
Criteria for Grant Denials
Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may authorize educational grant support alone. In accordance with government guidance, it is inappropriate for individuals responsible for sales and marketing to be involved in educational grant-making decisions. Grant reviewers typically include personnel from Medical Affairs, Medical Education, Regulatory Affairs, Healthcare Compliance, and/or Legal departments, as necessary.
Numerous educational grant requests can be received by LifeScan, Inc. each year. Unfortunately, not all educational grants that are submitted for consideration can be funded.
LifeScan, Inc. abides by rules developed by several regulatory and policy-making organizations. These rules provide guidance on several parameters. For example:
- Grants should not take into account the volume or value of purchases made by, or anticipated from, a potential grant recipient;
- Accredited educational activities should be independent and without influence from commercial supporters;
- Educational grants may only be provided to recognized institutions, organizations, or societies; no funding may be provided by industry directly to an individual or medical practice;
- Presentations must give a balanced view of therapeutic options and not a specific proprietary business interest (product) of a commercial sponsor; and
- Any gift items provided to participating practitioners must provide educational value to the patient or healthcare professional.
LifeScan, Inc. uses established policies to evaluate each submission on its own merits. Funds are not provided as "unrestricted educational grants," which implies that recipients may use the financial support for a purpose other than what was originally intended.
Although LifeScan, Inc. only provides restricted educational grants, it is assumed that program content is developed in an independent manner by the requestor. It is expected that a provider should develop accredited medical education activities without interference, direct or nuanced, from a commercial supporter.
To ensure that the purpose of the educational activity is clearly understood, all grant requests include several key components to be provided within the grant application when submitting a grant request to our organization.
Each grant request submission is evaluated on four common components:
- The needs assessment documenting why the activity is necessary and how the proposed activity will address the educational need or gap
- A proposed or final agenda and/or brochure
- A detailed budget outlining how the funds will be utilized
- A statement of accreditation and/or tax exempt status
Unfortunately, educational grants may be denied for a variety of reasons. The primary criterion used by reviewers is that there must be a bona fide educational purpose that should result in improved patient care.
Examples of reasons for denial of educational grants may include:
- Vague or incomplete grant applications
- Requests that appear to promote a medical practice or office
- Support for educational activities that are outside the therapeutic scope of legitimate scientific or clinical interests of the manufacturer
- Funds to offset travel costs of attendees at an educational activity, other than a qualifying resident or fellow in training
- Grants to specifically promote an individual product
- Activities that include topics in a non-accredited environment that are designed to encourage unapproved uses of products
- Events that include a social activity or entertainment that overshadow the educational activity
- Requests that stipulate support is required in order to maintain access to health facilities, maintaining existing business relationships, or other quid pro quo
- All or parts of the proposed budget submitted by the requesting organization exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees)
- Limited funds available in LifeScan, Inc.'s educational budget
- Recent funding of similar educational activity
LifeScan, Inc. is proud to assist with the educational needs of health professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.
Charitable Contributions Process
"We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use protecting the environment and natural resources." --Our Credo
A charitable contribution includes cash or product donations. A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a non-profit organization to support a specific community-based (or regional/national) program, project, or event. A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic healthcare needs in under-served communities.
All requests are reviewed by a multidisciplinary committee, which may include Medical Affairs, Healthcare Compliance, Public Affairs, Human Resources, and Legal, as necessary. Recipients must be tax-exempt organizations with an appropriate federal tax-exempt status. Requests should include the organization's mission statement, IRS tax status, project/event description, description of how the funds will be used, project budget (if applicable) and annual operating budget (if applicable).
The following types of requests are generally not eligible for charitable contributions:
- Organizations that do not have a valid federal tax-exempt status
- Scholarships to individuals
- Direct contributions to individuals or physician practices
- Trips or tours
- Endowments of any kind
- Sectarian and religious organizations that do not serve the general public on a nondenominational basis
- Capital requests (building funds, endowments, multi-year commitments)
- Political, fraternal or athletic groups
Product contributions must be used in the manner defined below:
- Product contributions will only be placed with licensed medical and healthcare professionals;
- Product contributions cannot be transferred in exchange for money, other property or services;
- Product contributions cannot be used for research, experimental, or demonstration purposes;
- Product contributions cannot be billed to any third party payor (public or private); and
- For purposes of disclosure and reporting, product contributions are valued at the Company's list price.
See more about the LifeScan transparency policies here.
More information about reporting of grants and contributions can be found at www.jnj.com.