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.
References
Abelson, R. and Thomas, K. (2018) Fed up with drug companies, hospitals decide to start their own. New York Times18 January 2018
Making individualized drugs a reality.
Nat. Biotechnol. 2017; 35: 507-513
Patient-centered drug manufacture.
Nat. Biotechnol. 2017; 35: 485
The place of crowdfunding in the discovery of scientific and social value of medical research.
Bioethics. 2017; 31: 384-392
Smith, P.A. (2016) A do-it-yourself revolution in diabetes care, New York Times 23 February 2016
Zhang, S. (2018) A biohacker regrets publicly injecting himself with CRISPR. The Atlantic 20 February 2018
Lussenhop, J. (2017) Why I injected myself with an untested gene therapy. BBC News 21 November 2017
Nuffield Council on Bioethics (2017) Genome editing an ethical review—a short guide. Nuffield Council on Bioethics
Expenditures and prices of antihyperglycemic medications in the United States: 2002–2013.
JAMA. 2016; 315: 1400
Why is there no generic insulin? Historical origins of a modern problem.
N. Engl. J. Med. 2015; 372: 1171-1175
Constraints and challenges in access to insulin: a global perspective.
Lancet Diabetes Endocrinol. 2016; 4: 275-285
Thomas, K. (2017) Drug makers accused of fixing prices on insulin, New York Times 30 January 30, 2017
Picchi, A. (2018) The rising cost of insulin: “horror stories every day.” CBS News 9 May 2018
Insulin access and affordability working group: conclusions and recommendations.
Diabetes Care. 2018; 41: 1299-1311
Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin.
Diabetes Care. 2013; 36: 1865-1869
Insulin analogs—is there a compelling case to use them?.
Diabetes Care. 2014; 37: 1771-1774
Socioeconomic inequalities in mortality, morbidity, and diabetes management for adults with type 1 diabetes: a systematic review.
PLoS One. 2017; 12e0177210
Inequalities in health care among patients with type 2 diabetes by individual socio-economic status (SES) and regional deprivation: a systematic literature review.
Int. J. Equity Health. 2014; 13: 43
Biosimilar insulins.
J. Diabetes Sci. Technol. 2014; 8: 6-13
The emergence of biosimilar insulin preparations—a cause for concern?.
Diabetes Technol. Ther. 2012; 14: 989-996
The state of the art in the development of biosimilars.
Clin. Pharmacol. Ther. 2012; 91: 405-417
Development and regulation of biosimilars: current status and future challenges.
BioDrugs. 2013; 27: 203-211
Worldwide experience with biosimilar development.
mAbs. 2011; 3: 209-217
Opportunities and challenges for biosimilars: What’s on the horizon in the global insulin market?.
Clin. Diabetes. 2012; 30: 138-150
Ramsey, L. (2016) A cheaper version of the lifesaving diabetes medication just launched in the US, Business Insider 15 December 2016
Decoding the research exemption.
Nat. Rev. Genet. 2006; 7: 148-154
The global intellectual property ecosystem for insulin and its public health implications: an observational study.
J. Pharm. Policy Pract. 2017; 10: 3
Understanding patent infringement under 35 U.S.C. 271(e): the collisions between patent, medical device and drug laws.
St. Clara High Technol. Law J. 2000; 17: 7-8
Monitoring quality of biotherapeutic products using multivariate data analysis.
AAPS J. 2016; 18: 793-800
Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe.
Health Policy (New York). 2014; 117: 328-333
Synthetic biology and microbioreactor platforms for programmable production of biologics at the point-of-care.
Nat. Commun. 2016; 712211
Health insurance coverage among people with and without diabetes in the U.S. adult population.
Diabetes Care. 2012; 35: 2243-2249
