Scaling patented, secretive technologies in healthcare is a risky business.
We witnessed an example of the problem recently in the Theranos debacle with Walgreens. A new blood-testing device called Edison was hidden from scientific scrutiny behind pile of patents and eventually led to the invalidation of two years of blood test results. Lawsuits are now piling up against Walgreens and Theranos.
Unfortunately, the same Silicon Valley mentality of high capitalization coupled with black-box technology that victimized Walgreens has the potential to be similarly catastrophic for international development. In particular, this mentality is infecting the world of social entrepreneurship, which seeks to help the world’s poor through market-based approaches.
The risks of rolling out patent-protected healthcare products is more acute for the people of the developing world. Those nations often have much less rigorous regulatory agencies without adequate facility inspection capabilities. So the inspections that brought the fraud to light, and which ultimately brought down Theranos, may not have ever taken place at all if this had occurred in a developing country. Further, when secretive, unproven technologies go south, customers often don’t have the opportunity to seek legal recourse to claim their justified compensation or hold the company that farmed out the technology accountable. So the people suffer and the failed companies move on to their next venture.
Even purely philanthropic efforts such as the donation of outdated medical equipment to hospitals in developing nations can hurt the recipients. While these donations have surely saved lives in many places, all too often these devices go unused or misused because of the often patent-protected, complicated nature of their function and their use of custom parts to discourage reverse engineering, resulting in a lack of spare parts available to fix them when they break.
The World Health Organization (WHO) estimates that 80 percent of medical equipment in some countries is donated or funded through foreign sources, but only 10 percent to 30 percent of the donations are ever put into operation. According to Robert Malkin, a professor of the practice of biomedical engineering at Duke University, “there is a great risk for every medical device donation that it’s going to hurt the recipient”.
How then, you might ask, can we mitigate this risk to the world’s poor? Both to their health and to the small disposable income they may have to buy products that hold the potential to drastically improve their quality of life. In a word, Openness. In the product-development context, this is referred to as open-source technology.
Choosing to be open source with health-related technology is not about being generous with our knowledge. It’s about protecting the public health by allowing for appropriate levels of public scrutiny of the products we introduce. This has the effect of flagging poor technologies early, before they scale, and thereby reducing the risk of harm to vulnerable people.
Open source also implies the use of easy to find, off-the-shelf components instead of patented or custom fabricated components. This access to spare parts makes products locally repairable so they don’t end up with broken medical equipment cluttering closets. Open source also tends to be intuitive to the user. Donated technologies in developing countries often go unused due to a lack of specialized training in operation.
Mission-driven social entrepreneurs are not primarily in the international development business to make a ton of money. If they are, they might be in the wrong business. Rather, their focus is first on making long-lasting, positive impacts on the lives of the world’s poor. These entrepreneurs need not rely on secret technology and a team of lawyers to guard it with lawsuits and cease & desist orders to have the “unfair” advantage that is so sought after by potential investors in startups.
Social impact investors must be willing to let go of their default closed-source, intellectual property (IP) protection requirements for technology startups before they would even consider investing in them. While IP protection may make sense when it comes to gadgets and games, when it comes to products that can potentially bring positive health impacts or cause great harm, especially in the developing world, it is just too risky.
The right kind of social investor will understand that to have sustainable, positive impact, being open and transparent with your technology is the way to be accountable to those you are most obligated to serve: your customers. The unfair advantage can be that you are the first to market, have more experience than anyone else doing what you do, and if you are serious, you should be better than anyone else at doing it.
In April 2016, health experts welcomed the announcement by pharmaceutical giant GlaxoSmithKline that it will stop seeking patent protections in developing and low-income nations, which will allow cheaper generic versions of name-brand drugs to be sold to the public. These new patent policies make it easier for people in the poorest countries to access medicine, particularly much-needed cancer drugs.
The Institute for Global Health Innovation notes that “frugal technologies that are specifically designed to meet the needs of low-income countries” are the preferred approach to spreading health technology. One example of this is the Jaipur prosthetic foot, which is now used in 22 countries. This rubber prosthesis does not have a patent and can be made locally for just $40.
In February 2016, UNICEF launched its Innovation Fund, which invests in open-source technologies for children. The Fund has raised $9 million so far and offers innovators in developing countries a pooled funding mechanism to help them take their tested projects to the next stage. The Fund brings together models of financing and methodologies used by venture capital funds and the principles of UNICEF’S award-winning Innovation Unit.
These are all moves in the right direction for the international development – but sadly, these open-source approaches are the exception, not the rule. Broadly, there needs to be a commitment to openness with our technology and our products, in particular when it comes to potentially life-saving technologies. This is the best way to avoid future Theranos fiascos in the developing world.
If you need a cautionary tale, just think of the last few decades of pesticide poisonings that have happened in the developing world. These patent-protected pesticide products were deemed safe by manufacturers and understaffed regulatory agencies, then they were introduced without public scrutiny due to their legal protections. It often takes years, like it did for Agent Orange and DDT, to see their health consequences. In 1990, the World Health Organization estimated three million severe pesticide poisonings every year.
This figure is likely an underestimate, since most rural poor have no access to healthcare workers, and therefore often fail to recognize and report poisoning cases.
A particularly worrisome development is the looming exportation of gene-edited organisms, using a new technology called CRISPR. This technology enables scientists to quickly alter the genetic make-up of the entire population of a species. While the intent is to create solutions like genetically modified mosquitoes, that could eradicate the scourge of malaria in the developing world, and thereby save the lives of countless millions every year. It seems like everyone can get behind the roll-out of that kind of technology ASAP.
Not so fast. Kevin Esvelt, a CRISPR innovator, told WNYC’s On the Media “under science’s current culture of secrecy, ensuring that scientists are taking necessary precautions with gene-drive research is next to impossible”. He also urged the scientific community to “open all experiments to public scrutiny, beginning with revolutionary and potentially world-changing gene-editing research” that he helped advance.
Open source is not about intellectual altruism – it’s about having an approach that is smart, effective, sustainable and ethical.