Can One-Shot Syringes Save The World?

Marc Koska has had a shot at saving the world; a single shot that has taken him 31 years.
Back in 1984 the Englishman, then a 23-year-old who spent much of his time yachting in the Caribbean, was horrified like many others by the dire prediction that the newly-identified HIV virus could claim as many as 60 million lives. Unlike many others, he decided to do something about it.
Koska spent three years researching the issue, reading everything he could find about the transmission of the virus, finding out how drug addicts used syringes and travelling to immunisation camps in Africa and to Geneva to learn about public health policy.
He concluded that the pressing need was an inexpensive, non-reusable syringe, immersed himself in the intricacies of syringe design and patents, toured syringe manufacturing plants and studied plastic injection moulding techniques.

Thirty one years later he found himself in Geneva again in February when he watched as the World Health Organisation executed only the third Global Health Initiative in its 67-year history. Its edict that only curative health programmes using auto-disable syringes and safety needles will receive WHO funding after 2020 should radically reduce infections caused by dirty syringes.
Dr Selma Khamassi, head of the WHO team for injection  safe, told BBC News that the new policy will hopefully help eliminate the 1.7million new hepatitis B cases, 300,000 cases of hepatitis C and 35,000 new cases of HIV  each year, as well as other infections.
“It was one of the proudest days in my life,” says Koska. “To hear the head of the WHO giving this the push that she did was phenomenal. I had a tear in my eye at one point.”
Koska’s invention in 1996 of the K1 auto-disable syringe has led the way. The syringes of his Star company are made of the same materials as conventional syringes, manufactured on tooling and assembly equipment that already existed and used in exactly the same way as traditional syringes.

Smarter and safer: a single-use syringe

“It looks and behaves exactly like a normal syringe,” he says. “It uses 95 per cent of the same manufacturing equipment that makes a traditional syringe and when using it you do everything you would do with a normal syringe. But if you try to re-use it after that, it locks and then snaps and breaks in half. We have sold nearly five billion of these and we have never heard of an instance of them being re-used.”
Koska’s innovation was to insert a mechanical valve in the plunger. That sounds simple enough but what he had not anticipated was the difficulty he would have trying to change the business model of syringe manufacture.
“Fifty billion traditional syringes are made around the world every year, of which about 20 billion are relevant in the developing world where the problem is most extant,” says Koska.
“Syringes are made at very, very low cost, as a commodity product and are used by healthcare firms as a brand carrier, a market-getter, a loss leader. They have been a way of a manufacturer building a market share for the rest of their catalogue.

Indeed, the price differential between conventional and auto-disable syringes has been a major barrier to getting the world to convert to safe syringes without the big stick of a global regulator. Standard syringes cost between two and four cents each, while “smart syringes” typically come in at between four and six cents. Applied to 16 billion injections that are made annually in developing and transitional WHO member states, the differential becomes a major deterrent.

That’s why the WHO has got involved, urged on by Koska, who was heavily involved in drawing up its new syringe policy. “The world needed guidance,” he says. “It just needed to unite under something sensible.” Koska is trusted by the US Senate to advise on syringe policy and had a personal audience in Davos this year with most of the leaders in the developing world to get them to commit to adopting his syringe practice. Britain’s Queen Elizabeth has also awarded him the Order of the British Empire for service to global health.
“I have been able to pull the manufacturers together,” he says. “The WHO has given the manufacturing and purchasing community five years to change.”
The real fight is just beginning. The WHO’s edict states that the organisation wants to convert every syringe in the world to auto-disable by 2020. The battleground is in the curative market – the use of syringes to treat existing health conditions, which accounts for 95 per cent of the world’s syringes. The remaining 5 per cent – the use of syringes to vaccinate against potential disease – converted en-masse to auto-disable syringes in 1999.
Koska is realistic, expecting the quickest conversions to come in nations that are supported by international donors.  ”It would be ridiculous to give a country $50m to help them with health if they were re-using syringes because it would not be helping.” he says.
Conversion costs manufacturers “only a couple of million dollars,” according to Koska – an expense that is set to become the effective cost of staying in the syringe manufacturing business.
To prove the point, he invited 45 syringe manufacturers to Geneva to see the edict become official. “Now they have got it from the horse’s mouth,” says Koska. “They will have to convert within the coming years.”
Koska is evangelising from a position of strength. While a handful of other producers have invented their own auto-disable syringe,  Star’s K1  syringes are manufactured under licence by 13 companies around the world, giving them a substantial lead.

“There’s no other product in this space that I know of that is in more than one factory,” says Koska. “We have completely dominated in the preventative market because of our easy conversion process.”

It’s not been cheap for Koska and his mates, however. Star, he says, has swallowed investment of £4m-£5m from “family, friends and connections,” though royalties from K! and Star have brought in more than $20m over the last years.

Indeed, getting to this point has taken so long that the entrepreneur now has only two years left on his 20-year patent for K1 and Star.
Star has responded by offering to supply the syringes free of charge to manufacturers who also licence its needle-stick device, which ensures that syringe needles are always covered when not in use – another requirement of the new WHO edict.
“Ours is the cheapest one for covered needles,” says Koska. “It’s in prototype form and we’re pretty certain that nobody will be able to make it more cheaply.
“What we hope, with the offer of the free syringe royalty and our innovative needle stick, is that Britain, which has already had a major effect because we are the leading company, will grasp that position firmly and have a lasting impact and make an over the next 20 years. We’re a little British company with British funding and we hope we can fly the flag.”


forbes.