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 lives. 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 educational 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.

Please click on the appropriate link for transparency reports on educational grants:

• Janssen Pharmaceuticals, Inc. (therapeutic areas of focus are cardiovascular, type II diabetes and mental health)
• Janssen Biotech, Inc. (therapeutic areas of focus are oncology, immunology and nephrology)
• Janssen Therapeutics, Inc. (therapeutic areas of focus are hepatitis C and HIV)

Please click on the link below for our transparency report on charitable contributions. Click here to learn more about our charitable giving program.

Janssen Pharmaceutical Companies of Johnson & Johnson (focus areas for giving are cardiovascular, immunology, infectious disease, metabolism, neuroscience, oncology, pulmonary hypertension, and local community giving)

• Educational Grants Process
• Educational Grants Frequently Asked Questions (PDF)
• Charitable Contributions Process Statement
• Transparency in Charitable Contributions Frequently Asked Questions
• Criteria for Evaluating Educational Grant Requests

We understand 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.

We are 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.
• Janssen 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 Janssen products.

Janssen does not provide "unrestricted educational grants.” Grant funds provided by Janssen are intended to 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 educational support is necessary;
2. An agenda or brochure describing the schedule of events (if applicable);
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 Janssen and with the United States 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.

Janssen’s Medical Affairs or Scientific Affairs departments have responsibility for the monitoring and recordkeeping of independent educational programs supported by Janssen, including budget, staff and interactions with educational providers. In addition, Janssen 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. Janssen considers the following factors:
  • The demonstrated scientific and clinical need for the program;
  • 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.

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 or basic healthcare needs in under-served communities. Requests for charitable contributions are evaluated through a formal review process which may include a multidisciplinary committee comprised of Medical Affairs, Healthcare Compliance, Finance 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). Some requests or categories may not meet our guidelines for giving. These exclusions include the following:

• Organizations that do not have a valid non-profit, tax-exempt status
• Loans
• Trips or tours
• Sectarian and religious organizations that do not serve the general public on a nondenominational basis
• Capital requests (building funds, endowments, multi-year commitments) are generally not supported
• Political groups
• Advocacy activities directed towards specific legislation
• Organizations whose missions/objectives do not meet our contributions guidelines
• Donations to individuals or to a charity on behalf of a customer
• Educational grants for healthcare professionals; see instead our education grants program for our funding priorities in this area.
• Research grants
• Commercial Co-Ventures (CCV)

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 payer (public or private)

Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may solely authorize educational grant support. In accordance with government guidance and Janssen policy, 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.

Several hundred to thousands of educational grant requests can be received by Janssen each year. Unfortunately, not all educational grants that are submitted for consideration can be funded.

Janssen 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 be tied to a specific product for commercial purposes.

Janssen 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 Janssen 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 (if applicable)
• 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 grantor
• 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 Janssen’s educational budget
• Recent funding of similar educational activity

Janssen is proud to assist with the educational needs of health care professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.

For more information about reporting of grants and contributions, please visit www.jnj.com.