Corporate Responsibility
Sandoz’s Position Opposing the Misuse of Our Medicines in the Administration of Capital Punishment
Sandoz’s mission is to discover new ways to improve and extend people’s lives. Our purpose is to contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. While Sandoz takes no position on the death penalty itself, we object to the misuse of any of our products in the administration of capital punishment. Such misuse is fundamentally contrary to our mission and purpose.
Sandoz sells medicines that have important therapeutic uses, including medicines used in surgical procedures. Certain of these products have been identified by states for use in capital punishment, including some drugs which have never been used before in connection with lethal injections.
As a result, Sandoz has implemented distribution controls designed to prohibit the sale of such medicines to prisons and correctional facilities. Specifically, Sandoz has entered into contractual agreements with distributors stipulating that Sandoz medicines are to be sold exclusively to medical users such as hospitals for use consistent with approved product labeling. In addition, to prevent inappropriate diversion of our products, we have implemented similar contractual restrictions on any entity wishing to purchase such medicines for their own use, e.g., hospital or outpatient clinic.
Sandoz regularly monitors the distribution of our products to ensure compliance with our distribution controls and will take necessary legal action to ensure the proper use of our medicines.
Our corporate responsibility programs are an important part of how we help people around the world access high-quality medicine.
Despite the remarkable medical progress during the last century, there are still at least 400 million people worldwide who lack access to essential health services1 and more than two billion who cannot afford to buy the medicines they need2. A healthy life, unfortunately, is still far from a given for too many. Every year, eight million people die from cancer3 and 14 million new cases are diagnosed4. Nearly 10 million people develop tuberculosis (TB) annually, including one million children, and the disease claims 1.5 million victims per year5. Nearly half a million people still die of malaria every year6.
As a division of the Novartis Group, Sandoz is committed to playing a key role in achieving global healthcare goals, by pioneering new approaches to drive increased access worldwide. Increasing access to medicine is the basis of our day-to-day business model, but we also run a range of targeted corporate responsibility programs to ensure access for those most in need.
On the following pages, we explain more about the work we do on Corporate Responsibility and the programs we run. We focus on addressing specific health needs in underprivileged communities, including non-communicable and infectious diseases, as well as promoting access to medical information and capacity building through our maternal and child health and Breathe Africa programs. More details can be found by clicking on the links below.
Sandoz Inc. A Novartis Division, is committed to supporting educational grants for Independent Medical Education (IME), Fellowships, Medical Sponsorships, Corporate Memberships, and other worthwhile initiatives to support a specific educational or professional development activity directed to medical healthcare professionals and the scientific community in order to improve patient health. In addition, Sandoz will support activities that address the needs of nonprofit 501(c)(3), 501(c)(4), and 501(c)(6) organizations, healthcare or healthcare related organizations and foundations efforts in educating and supporting patients, their family members, caregivers and the public and are consistent with the mission of Sandoz. Such programs aim to improve patient health and are fully compliant with all legal and regulatory guidelines and the ethical standards under which Sandoz conducts business.
Sandoz Position for Independent Medical Education
Providers can help to advance healthcare equity, address disparities in healthcare delivery for underrepresented and diverse populations, and create culturally sensitive content. Providers should consider implementing systems which positively influence the way in which education is delivered to ensure diversity and inclusion with respect to faculty selection (ensuring diversity in faculty selection), intended learners or target audience (planning for diversity of the intended audience and content), and education plan (ensuring that the plan is inclusive, culturally sensitive, and that all diverse groups’ data are included).
The Sandoz Office of Grants and Education (SOGE) will review all requests received for Professional Independent Medical Education Grants, Patient Advocacy Organization Grants, Medical Sponsorships and Corporate Memberships that may cover the following therapeutic areas of interest:
• General Biosimilar Education
• Immunology
• Endocrinology
• Oncology
For more information and to submit a grant application, please access our new Grants, External studies and Managed access System (GEMS) platform at: Sandoz Office of Grants and Education
Guidance on using the Grants Submission portal is available here: Grants Submission Guide
Guidance on using the Sponsorships/Memberships portal is available here: Sponsorships/Memberships Submission Guide
Please take the time to consider how your educational program fits within the therapeutic areas of interest mentioned above and the established regulations, laws and guidelines and that your request is submitted at least 60 calendar days prior to the start of the event to allow adequate time for processing.
While many more requests are received than can be funded, we regret that we cannot accommodate every request. However, your request will receive a fair review once all documentation is submitted.
Contact Information
E-mail: [email protected]
Mail: Sandoz Office of Grants and Education, 100 College Rd West, Princeton NJ 08540
For additional questions, please refer to this 
FAQ
As part of our commitment to delivering innovative therapies to patients worldwide, Sandoz, a Novartis Division believes in the need to support ethical independent clinical research conducted by qualified third-party investigators.
The value of the scientific research produced by these investigators is key to complementing Sandoz-sponsored research by helping to ensure we better understand the benefit/risk profile of our therapies, as well as enabling us to explore new opportunities addressing unmet medical needs.
The proposed clinical research must offer meaningful scientific and/or clinical objectives supported by valid study designs in which the privacy rights, safety and welfare of patients is of paramount importance.
Sandoz defines IITs as “studies with scientific and medical merit developed and sponsored by an independent investigator or academic sponsor. An IIT may be a clinical or non-clinical study conducted without the participation of Sandoz, for which the IIT sponsor requests Sandoz to provide either funding, drug product or both.”
Supported IITs can include studies conducted in human subjects and/or studies that require a subject’s consent; as well as non-clinical studies, where Sandoz is supporting the conduct of the study with provision of funds and/or Sandoz drug supply in response to a request from a Third Party Sponsor. Studies may be either interventional (Phase I to Phase IV and where Sandoz provides drug), or non-interventional (the study does not focus on a Sandoz drug, or it may focus on a Sandoz drug but Sandoz does not provide that drug).
Sandoz accepts applications from either institutions (academic or governmental) and individual investigators or groups of investigators.
Novartis global investigator-initiated trial guidelines (PDF 0.3 MB)
IIT Investigator Awareness Brochure (PDF 3.4 MB)
We welcome unsolicited research proposals from qualified investigators in our strategic areas of interest which we list below. Well-thought through studies that enhance our delivery of innovative therapies to more patients worldwide, enhance patient care, and align with our strategic areas of interest will be considered.
Sandoz Therapeutic Areas:
- Immunology
- Endocrinology
- Neurology
- Oncology
When developing your study concept, please ensure you are considering guidance provided by the FDA, NIH and PhRMA regarding Diversity, Equity and Inclusion in clinical trial participation.
How do I submit an IIT request?
IIT requests are submitted via the Sandoz/Novartis Grants, External Studies and Managed Access System (GEMS) platform at: Sandoz Investigator Initiated Trial Portal
Guidance on using the GEMS portal is available here:
GEMS IIT External User Training Guide
The submission will be reviewed thoroughly and a disposition will be provided as quickly as possible.
While many more requests are received than can be funded, we regret that we cannot accommodate every request. However, your request will receive a fair review once all documentation is submitted.
Contact Information
E-mail: [email protected]
Mail: Sandoz Office of Grants and Education, 100 College Rd West, Princeton NJ 08540
For additional questions, please refer to this FAQ
What constitutes Managed Access at Sandoz?
There are instances where a patient has a serious or life-threatening disease or condition, for which all currently available treatment options have been exhausted and enrollment into a clinical trial is not possible. In these cases, the treating physician can request an investigational or pre-approval product prior to regulatory approval, provided it is allowed by the applicable local laws. Within Sandoz, A Novartis Division, we refer to such provision of investigational or pre-approval products as “Managed Access.”
The Sandoz “Managed Access” terminology covers all locally defined pre-approval access mechanisms and programs such as “Compassionate Use”, “Expanded Access”, “Named Patient Supply”, “Special Access Schemes/Programs”, “Authorizations temporaires d’utilisation (ATU)” and others.
Sandoz “Managed Access” addresses this need by making certain investigational or unapproved treatments available to eligible patients.
Who is eligible for Sandoz Managed Access programs?
Sandoz considers granting managed access to investigational or pre-approval products when all of the following criteria are met:
- The patient to be treated has a serious or life-threatening disease or condition, and no comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition;
- The patient is ineligible for enrolment into or unable to access ongoing clinical trials;
- The patient meets any other important medical criteria established by the medical experts working on the product development program;
- Sufficient data exists to believe the potential benefit of treatment outweighs the potential risk in the context of the disease or condition to be treated;
- Sandoz has an adequate supply of the investigational product and providing the investigational product will not interfere with ongoing clinical trial(s) or with the overall development program;
- Such access provision is allowed as per local laws and regulations.
- Outside these programs, individual patient requests can be submitted for other compounds provided the Managed Access criteria are fulfilled.
How do I submit a request for Managed Access?
- A request must be submitted by the treating physician on behalf of the patient.
All requests can be submitted via our GEMS (Grants, External Trials and Managed Access System portal by clicking: Submit a Managed Access request
Guidance on using the portal: Novartis GEMS Portal External User Guide (PDF 0.1 MB)
How are requests evaluated?
Please note that your request will be assessed in consideration of applicable local laws and regulations. Each request will be acknowledged immediately, and reviewed carefully and fairly by the appropriate Sandoz medical lead with every effort made to provide a response promptly once all the necessary information has been submitted.
In addition, since 2017 Novartis has collaborated with an external Independent Bioethics Advisory Committee (IBAC), which provides analysis and recommendations on Novartis guidelines and policies for the ethical conduct of clinical research, and on selected ethical challenges, which may arise in clinical trials, development programs and managed access programs. The IBAC is comprised of bioethicists, clinicians, healthcare practitioners, patient advocates and other domain knowledge experts appropriate to the problem at hand.
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Joint WHO/ World Bank news release; http://www.who.int/mediacentre/news/releases/2015/uhc-report/en/
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The 2016 Access to Medicine Index. Methodology 2015; http://apps.who.int/medicinedocs/en/m/abstract/Js22176en/
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World Health Organization; http://www.who.int/mediacentre/factsheets/fs297/en/
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World Cancer Report 2014; http://publications.iarc.fr/Non-Series-Publications/World-Cancer-Reports...
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World Health Organization; http://www.who.int/mediacentre/factsheets/fs104/en/
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World Health Organization; http://www.who.int/features/factfiles/malaria/en/