Accepted 3 days (Oct 16-18, 2017) of expert facilitation by 3 professionals from Google Ventures including preparation and follow up, using Sprint methodology, to accelerate prototype development of digital platform for hypertension management.
Conflict of interest statement
PRINCIPLES FOR INTERACTION WITH AND ACCEPTANCE OF SUPPORT FROM FINANCIAL, TECHNICAL AND OPERATIONAL INDUSTRIES
INTRODUCTIONThis document serves as a guide to the staff of Resolve to Save Lives, an initiative of Vital Strategies, on whether and how to engage with industry-associated donors, either for financial support or in-kind donations. This policy is guided by principles of public health, ethical concern, avoidance of perceived or real conflict of interest, or impropriety. These include general principles and principles for case-by-case review. Every philanthropic award must go through case review.
RESOLVE TO SAVE LIVES PRINCIPLES AND RULES OF ENGAGEMENT
- Resolve to Save Lives will avoid both impropriety and the appearance of impropriety.
- Resolve to Save Lives will set its own priorities and these will not be influenced by external support, other than guidance from its philanthropic donors (as of 2018, Bloomberg Philanthropies, Chan Zuckerberg Initiative, and the Bill and Melinda Gates Foundation). Philanthropic donor priorities will be considered with the scope of their donation.
- If Resolve to Save Lives accepts any support from for-profit entities, all support, including the amount and commitments related to that support will be transparent and posted on the Resolve to Save Lives website.
- Resolve to Save Lives will not actively seek support from for-profit entities. Resolve to Save Lives recognizes that some not-for-profit entities are funded by for-profit entities and that this may create improprieties that need to be investigated before accepting support from not-for-profit enterprises, including but not limited to those explicitly connected to for-profit entities.
- If for-profit entities approach Resolve to Save Lives with offers of support, these will be considered on a case-by-case basis to determine whether the potential benefit of accepting support outweighs the potential risk.
- Resolve to Save Lives will not accept support that is branded in a way that might give the supporter a market advantage for its products.
- Resolve to Save Lives will not accept support that could influence any recommended course of action (e.g., medical regimens, blood pressure monitoring, or epidemic prevention technologies).
- The bar to accept support that emanates, directly or indirectly, from a for-profit entity is therefore high: the benefit to advancing public health must be clearly greater than the risk that an overall project will be tainted or, even worse, inappropriately influenced by the support.
- These principles do not apply to paid contractual arrangements with private sector entities for delivery of products or services.
- Resolve to Save Lives recognizes the value of obtaining information from private sector entities (e.g., regarding possible replacement products for artificial trans-fat or different options for blood pressure monitoring devices) and distinguishes information-gathering from technical assistance and financial or product support. Resolve to Save Lives recognizes that information provided by industry may not always be unbiased.
- Potential donors can be considered for monetary and non-monetary resource contribution (personnel, technical assistance, consultation, partnering with an existing organization that is funded by corporate interests, donation of products [medications, devices, proprietary software, etc.]) if the donation satisfies all of the following criteria:
- Is unrestricted.
- Is from a donor organization whose mission and values align with the Resolve to Save Lives initiative as determined by the CEO or designee.
- Will not create dependency on the specific resource when the resource is no longer provided at no (or reduced) cost.
EXAMPLES OF ACCEPTABLE AND UNACCEPTABLE SUPPORT
- Examples of support that will not be accepted:
- Free medications or medications sold substantially below fair market value. (Possible exception might be a specific drug already selected by a specific jurisdiction, in which case Resolve to Save Lives need not be directly involved in the donation.)
- Free blood pressure monitors that would influence program design or limit substitution of other potential devices
- Free laboratory equipment that would create dependency on limited options for future reagent procurement
- Offer to build an IT solution which would not be open source and free to all users.
- Examples of support that would be accepted:
- Provision of market data such as cost, specifications, and volume of sales on products (e.g., edible oils, medications).
- Specialist technical assistance not otherwise readily available to Resolve to Save Lives for a project Resolve to Save Lives has already determined to pursue (e.g., Google Ventures support for rapid prototyping of an information technology tool to improve hypertension control).
- Unrestricted support for operations, if approved on a case-by-case basis (e.g., logistics support from an office of Bloomberg LP in a country where Resolve to Save Lives is beginning to operate).
- Donations from for-profit entities which do not have a potential conflict of interest with health issues, if approved on a case-by-case basis (e.g., transport manufacturers donating vehicles, oil companies funding malaria control).
- Examples of support that will not be accepted:
PROCESS FOR REVIEWING ENGAGEMENTS ON A CASE BY CASE BASISThe decision to accept resource contributions will be determined by the CEO or designee. Each engagement will be evaluated by the terms outlined in sections B-C and the following questions:
- Benefit for patients: Is the donation life-saving? Is the product already accessible? Does the donated product meet international quality standards?
- Impact on Resolve to Save Lives: Are the benefits to the patients commensurate with any additional costs? Is Resolve to Save Lives’ involvement consistent with its mission? What do the beneficiaries of Resolve to Save Lives programs stand to gain by this engagement with an industry/partner? What does Resolve to Save Lives risk?
- Alternative sources of a proprietary (originator) medical product: Do affordable, quality alternate sources of the branded medical product exist? Can they legally be used in the target country?
- Sustainability: Is there a set time limit to the donation? Is the time limit related to any public health goals or indicators, or is it arbitrary? What happens to programs and patients when the donation ends?
- Scale: Does the volume of the donation meet the global/regional/national/local/project need?
- Indication restrictions: Does the donor restrict the indications for which patients the medical product, vaccine or test can be used? If yes, is this acceptable, or does it distort other public health goals?
- Consultation with recipient country for a country specific donation (if applicable): What level of consultation has occurred between the country and the donating corporation and have conditions (if any) or impact on the country’s health policy and system been considered?
- Time Delays: Is there a supply system in place to make sure that medical products are properly and safely delivered to the patients? Could the donation be integrated into or could it weaken the country’s existing medical product procurement and distribution system? Does the recipient country want the medical product? Is the product registered with the regulatory authority? Is there a pharmacovigilance system in place to monitor and report adverse events from use of the medical product?
- Cost-effectiveness: Could recipient countries be burdened with extra expenses when accepting a medical product donation?
- Strings attached: Are there any “strings” (asking the countries to reciprocate in some way e.g., guarantees for overly-strict patent protection) attached to this donation? If yes, what are the potential negative effects? Overly-strict patent protection can handicap a country’s ability to address accessibility of medicines in the long term. Donor requriements should be transparent, public, and carefully weighed.
- Solutions by default: Will the donation detract attention from finding a sustainable solution and push the problem out of the limelight? How much political leverage will the donation give the donor? Will responsible authorities (at the national or UN level) consider the problem solved, if, in fact, it is not?
- Public relations value: What kind of public relations boost will this donation give the donor corporation? Is this boost justified, considering the real impact and cost of the donation or other actions the corporation has taken?
DONOR REQUIREMENTSAll sections of this document are subject to modification and more stringent guidelines or rules may be applied to satisfy donor requirements.
ONGOING POLICY ALIGNMENTResolve to Save Lives is a new initiative and cannot anticipate all possible scenarios. This policy will be reviewed and updated as needed. The principles outlined in Section B will not change without review of the leadership of Resolve.
COMMITMENT TO TRANSPARENCYResolve to Save Lives is committed to full transparency in our efforts to save 100 million lives from cardiovascular disease and help prevent global epidemics. Resolve to Save Lives will thoroughly review opportunities to engage with for-profit entities and will only accept support if the public health need outweighs all potential risks. The process for review, and approval of engagements with industry, will be publicly documented. Resolve to Save Lives will always prioritize public health needs above any other concern, and is committed to conducting business in an open, honest and transparent manner.