New innovation ecosystems for drug discovery and development are emerging.
Members of the ‘do-it-yourself biology’ community, sometimes called ‘biohackers,’ are contributing to this new frontier by experimenting with the development of medical treatments and devices.
An initiative known as the Open Insulin Project is working to develop a protocol for insulin production in order to sidestep intellectual property.
Follow-on work could contribute to a number of different insulin distribution structures, including ‘home-brewed’ insulin for personal use.
The current regulatory system is incongruous with emerging innovation ecosystems such as the Open Insulin Project.
New innovation ecosystems are emerging that challenge the complex intellectual property and regulatory landscape surrounding drug development in the United States (US). A prime example is an initiative known as the Open Insulin Project. The goal of the project is to sidestep patents and enable generic manufacturers to produce cheaper insulin. However, the US regulatory environment, not patent exclusivity, is the main barrier to insulin affordability. If the Open Insulin Project succeeds in releasing an open protocol for insulin manufacturing, follow-on work could enable a number of new insulin production ecosystems, including ‘home-brewed’ insulin. Regulators will need to consider how to proceed in a future where commercial pharmaceuticals remain unaffordable, but patients are empowered to produce drugs for their personal use.
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