theproblem
1000s of off-patent therapies
What if a safe and affordable medical treatment or potential cure is ready to be tested in patients now but couldn’t get the private funding it needed for large Phase II/III clinical trials to prove efficacy because it was off-patent and you cannot charge a monopoly price? The pharmaceutical industry relies on patenting new drugs so it can charge a monopoly price to make its profits and recover its R&D costs.
Patented drugs cost $1-2+ billion dollars to develop and result in new medicines taking 10-15+ years to reach patients, instead of the quickest, safest and most effective treatments and cures. There are over 20k off-patent drugs and nutraceuticals that could be repurposed to treat and potentially cure new diseases for 1/100th of the cost and 5-10x faster than new patented drugs.This is the current broken system for incentivising medical innovation.
Off-patent or “generic” drugs are, in principle, available to be re-patented as reformulations or new uses to treat new diseases. But the pharmaceutical industry will never pay for clinical trials if an off-patent drug has similar efficacy and active ingredient to the patented drug, and can be prescribed off-label, which means they cannot receive a monopoly price. The same market failure applies to other “unmonopolisable therapies” such as nutraceuticals / supplements, diets and lifestyle interventions. Further, large clinical trials for these off-patent treatments rarely get funded by governments and charities due to the expense (US$1-20m+ per Phase II/III clinical trial) and high risk of failure (50% – 75%) .
OURMISSION
Crowd Funded Cures’ mission is to incentivise clinical trials for off-patent therapies that are otherwise ignored because a monopoly price cannot be enforced with patents.
Help us establish a Social Impact Bond for off-patent medicine. Because the best medical science that can help the most patients should get funding it needs, irrespective of patents.
FINANCIAL
INNOVATION
Social Impact Bonds designed to incentivise new uses for off-patent drugs and therapies
OPEN SOURCE
THERAPIES
Incentivising clinical trials for off-patent drugs allows everyone to benefit from affordable medicine
NO RISK FOR
BACKERS
Pay for success contracts mean that backers are guaranteed to only fund a medical breakthrough
HOW IT WORKSA PAY FOR
SUCCESS
CONTRACT
A pay for success (PFS) contract (e.g. Social Impact Bond/SIB) backed by Healthcare Payers (e.g. govts, health insurers, philanthropy and public via crowdfunding), correctly implemented, would incentivise Impact Investors to fund large Phase II/III randomised controlled trials (RCTs) to repurpose off-patent / generic drugs / unprofitable therapies in return for outcome payments from the SIB if successful.
The amount of outcome payments under a PFS contract / SIB would be based on Quality Adjusted Life Years (QALYs) gained or cost savings for Healthcare Payers due to the RCT showing that the off-patent treatments work (e.g. % reduction in hospitalisations or improved patient outcomes vs usual care).
The financially innovative idea is to transfer risk from Healthcare Payers (who are more risk-adverse and would only pay for successfully repurposed generic drugs) to the market (who are more willing to bear the risk of RCT failure) which would benefit from the spreading of risk and potentially large upside.
CFC is currently working to execute a feasibility study with the goal of raising a syndicate of payers to back a large ($20-100m+) fund to support a pilot generic drug repurposing Pay-For-Success contract and its administration in a specific disease class with high payer cost burden (e.g Covid-19, mental illness, cancer, autoimmune, age-related illness).
PAY FORSUCCESS
MODEL
Creating incentives to develop unpatentable medical therapies
OURPARTNERS
ALLABOUT US
Crowd Funded Cures (CFC) is an initiative of the Medical Prize Charitable Trust, a registered NZ charity incorporated under the Charitable Trusts Act 1957 (NZ) and having Charity No. CC49977. It was founded by Savva Kerdemelidis in 2013, who is an IP/Commercial/Crypto Legal Consultant and NZ/AU Patent and Trade Mark Attorney. Savva’s partner and family members at the time were being affected by chronic and deadly illnesses, and he was concerned by how otherwise viable medical therapies were not getting funding for clinical trials due to pharma industry’s reliance on the patent system for recovering their R&D expenditure.
The idea of using a flexible prize fund for specific disease classes (a type of “pay for success” contract) to “de-risk” large clinical trials for “unmonopolisable therapies” (including repurposing off-patent drugs and nutraceuticals) was first proposed in Savva’s Masters of Law thesis at the University of Canterbury (NZ) entitled “Deadly gaps in the patent system : an analysis of current and alternative mechanisms for incentivising development of medical therapies. (2014).” The use of Social Impact Bonds (another type of “pay for success” contract) had also been proposed by Bruce Bloom of Cures within Reach, and Findacure UK as a means for incentivising clinical trials for repurposing off-patent drugs to treat rare diseases.
Savva is currently working on a book “PATENT PANDEMIC”, based on his LLM thesis. The book proposes using extended regulatory exclusivity for unpatentable therapies and pay for success contracts / flexible prize incentives for unmonopolisable and unprofitable therapies. It will soon be available on Amazon with 100% of proceeds going to support CFC’s mission.
CFC is in the process of partnering with VitaDAO.com, Molecule.to, Open Source Pharma Foundation and various other stakeholders in order conduct a Feasibility Study by Guidehouse.com and launch CFC DAO. Our goal is build a platform that can leverage pay for success smart contracts and IP-NFTs to repurpose generic drugs and nutraceuticals to improve longevity and create a scalable financial model to develop low cost open source medicines. In order to participate, please join our community on Discord: https://discord.gg/6tFG8RDygW
