Max Access Solutions is The Max Foundation’s operational program through which humanitarian donations of approved oncology products are channeled to patients in need. Max Access Solutions is meant to be a bridge for access to treatment specifically within low- and middle-income countries (LMICs) where the burden of disease is high and local government access programs may not be currently feasible.
Within Max Access Solutions, companies donate product to The Max Foundation and the organization channels product at its discretion to patients in need through their treating physician and within the scope of its collaboration agreements. Vetted health care providers (HCP) in LMICs initiate the product request and manage treatment of patients receiving product from The Max Foundation. The Max Foundation works through a third-party logistics provider (3PL) who, as its agent, receives product from manufacturers and ships it to end users on the organization’s behalf.
Treatment Access at a Glance
At the center of our model is a patient who has been diagnosed with a certain cancer and prescribed a treatment for which no local access exists by one of our partner physicians. Working in collaboration with a robust network of leading cancer treating institutions and physicians, drug manufacturers, an international distributor, and local patient support organizations, we provide humanitarian access to the treatment with the aim that each required daily dose reaches the intended patient at the right time, while strengthening the local healthcare system.
The Max Foundation has extensive experience in managing patient access programs for oncology products. The Max Access Solutions model guidelines are the result of the best practices and expertise developed through this extensive experience. These guidelines are reviewed and updated periodically and shared externally with Donor Companies, Health Authorities, and other relevant stakeholders. They are meant to provide a foundation for the development of internal procedures for product requests under MAS. The guidelines further aim to align with World Health Organization (WHO) international guidelines for product donation as well as Partnership for Quality Medical Donations’ (PQMD) standards for international product donations.
Download the Max Product Donation Guidelines
SECTION 1: BACKGROUND.. 3
SECTION 2: GOVERNANCE. 4
Governance. 4
Finance. 4
Gifts-in-Kind Policies. 4
Organizational Evaluation. 5
Information Systems. 5
Local Partners Assessment 5
Country and Regional Assessment 5
Clinic or Institution Assessment 5
Physician Assessment 6
Patient Assessment 6
Patient Verification. 6
Medical Eligibility. 6
Financial Eligibility. 7
Privacy & Consent 7
Adverse Event Reporting, Special Scenarios, &/or Product Complaints. 7
Case Closure. 8
SECTION 3: DEFINITIONS. 9
The Max Foundation is an international non-governmental organization (INGO) that believes everyone deserves access to cancer treatment – no matter who they are or where they live. Our mission is to increase global access to treatment, care, and support for people living with cancer.
Max Access Solutions is our innovative, patient-centered model for delivering cancer treatment to those in need. Through Max Access Solutions, we receive donations of lifesaving cancer medicines from pharmaceutical companies and channel them to people facing cancer in countries where those medicines are not locally available. This work is made possible through partnership with our network of vetted health care providers (HCPs), who initiate treatment requests and manage the treatment of patients receiving medication through our programs. We work through a third party logistics provider (3PL) who, as our agent, receives product on our behalf directly from manufacturers and delivers it to partner HCPs and clinics. Max Access Solutions is meant to bridge access to treatment in underserved countries, with a focus on low- and middle-income countries (LMICs), until local access channels can be put in place.
The Max Foundation has extensive experience managing patient access programs for oncology products. The Max Access Solutions: Product Donation Guidelines are the result of the best practices and expertise we have developed over time. These guidelines are reviewed and updated periodically and shared externally with donor companies, local health authorities, and other relevant stakeholders. They are meant to provide a foundation for the development of internal procedures for product requests under Max Access Solutions. The guidelines further aim to align with World Health Organization (WHO) international guidelines for product donation[i], as well as Partnership for Quality Medical Donations (PQMD) standards for international product donations[ii].
Adverse event – Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product
Clinic or Institution – Refers to a hospital, brokerage, pharmacy, other dispenser, or warehouse in which product is received once it clears customs and is dispensed to an intermediary or end user
Donor company – The pharmaceutical company or manufacturer that donates product to The Max Foundation for distribution to end users
Gift-in-kind – Also referred to as in-kind product donations
Max Access Solutions – The Max Foundation’s innovative, patient-centered model for delivering cancer treatment to those in need with a focus on low- and middle-income countries.
PATS — The Max Foundation’s proprietary, web-based, customer relationship management system used to tracks the treatment life cycle of each individual patient and integrate physician-driven treatment decisions with business processes and supply chain operations.
Product – Refers to pharmaceuticals, such as targeted oral chemotherapy, and/or biotechnical devices that are used to treat patients or enable health care providers to make treatment decisions
Product complaint – Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a medicinal product (including packaging and labeling) after it is released for distribution
Special scenario – Includes exposure during pregnancy, exposure during breastfeeding, lack of efficacy, disease progression, interactions, medication errors, overdose, abuse or misuse, off-label use, and occupational exposure
Third party logistics provider (3PL) – a partnering organization that manages product throughout the supply chain until product reaches its ship-to recipient
[i] World Health Organization, “Guidelines for Medicine Donations, Revised 2010”. http://www.who.int/medicines/publications/med_donationsguide2011/en/
[ii] Partnership for Quality Medical Donations, “PQMD Guidelines for Quality Medical Product Donations”. http://www.pqmd.org/programs/donation-guidelines/
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