The Open Insulin Project: A Case Study for ‘Biohacked’ Medicines

Abstract

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.

A global perspective on the issue of access to insulin

“…Other insulin manufacturing companies have been identified, including producers in India and China [18], but their current impact on the global market is negligible. In parallel to industrial production, so-called 'biohackers' are attempting to provide an open-source method for the production of insulin to possibly lower the costs of production, as well as increase competition [19]. Gotham et al [20] estimated that the cost of production for human insulin for a 10 ml 100 U vial would be between US$2.28 and US$3.42, whilst the cost of manufacturing most formulations of analogue insulin was slightly higher (US$3.69-6.34), with the exception of insulin detemir, with costs of production of US$13.47-17.…”

Bioengineering horizon scan 2020

“…Barriers to distributed pharmaceutical manufacturing becoming broadly adopted include the scale of production required for individual or community use; meeting appropriate safety standards for manufacturing and administration; and interfacing with drug approval pathways. Efforts in non-traditional pharma, such as The Open Insulin Project (Gallegos et al, 2018), are rising in profile and will likely continue, whether individual projects are successful or not. This is supported by the Open Pharma movement which seeks to empower innovation through open-access research and development (Munos, 2010;Gassmann et al, 2018;Open Source Pharma, 2020).…”

On the Emerging Area of Biocybersecurity and Relevant Considerations

“…Examples can be seen among a few groups in the Community Bio movement which arose out of the Maker Movement, in which groups of people have been inspired to pursue these research areas and more through a mix of traditional and nontraditional cooperation with mixed success [17][18][19]. Plenty of these successes resulted in the creation of start-ups that deal in a great amount of biometric data or material which is tracked, for improving health outcomes or expanding functions [14][15][16][17][18][19]. Much of what is thought of as cyberpunk in science fiction has reached reality, and this implies that the time to think ahead regarding the protection of biometric data is now.…”