By Rachel Marder/JNS.org
JERUSALEM – While Israel is fast
becoming a leader in the biomedical and
biotechnology fields, industry experts say the Israeli Health
Ministry may be unduly hindering its growth.
Click photo to download. Caption: Israeli Prime Minister Benjamin Netanyahu and U.S. President Barack Obama seen during an exhibition of technological innovations, “Israel Technology for a Better World,” at the Israel Museum in Jerusalem on March 21, 2013. While Israel is fast becoming a leader in the biomedical and biotechnology fields, industry experts say the Israeli Health Ministry may be unduly hindering its growth. Credit: Kobi Gideon/GPO/FLASH90.
Famously called a “start-up nation,” a
nickname coined by Dan Senor and Saul Singer in their 2009 book about the
Jewish state’s economic miracle, today Israel proudly parades that title, proving
to be a fertile ground for thousands of tech start-ups. But Steve Rhodes, CEO
and chairman of the Trendlines Group, a company that helps young Israeli
companies developing medical devices, biotech and pharmaceutical products get
off the ground, says the book overlooked certain industries. In the last 15-20
years, thousands of biotech and
meditech companies have opened in Israel, and the country ranks fourth in the
world for patents filed on medical devices, he says.
But all too often, says Rhodes, the
Israeli Health Ministry takes an inordinate amount of time to approve companies
for clinical trials. As a result, many companies travel to Eastern Europe or
elsewhere to conduct this testing, losing Israel untold dollars.
“The system here is overly cautious,”
Rhodes says in an interview with JNS.org.
“I’m in favor of being careful, but when the FDA and the Europeans give
approval faster than we do here, it really means there’s something not right in
the process here. It’s a lost opportunity for Israel in many respects.”
While the Health Ministry says it takes
an average of six months to approve a medical device for clinical trials,
Rhodes and others say it takes much longer.
“I’ve seen devices where it took almost
a year to get approval, where the only real risk to the patient would have been
if it had fallen off the table and hit them in the foot,” he says.
According to Dr. Mitko Shoshev, the head
of Bulgarian Operations for Global Clinical Trials, it can take 60-90 days to
get approval on drug treatment clinical trials in Eastern Europe, depending on
the country. In 2009, he says, Russia approved 577 trials, Ukraine 340, and
Poland 498. Israel still receives a high volume of requests; institutional
review boards considered more than 2,099 applications for clinical trialsin 2004. In Israel, both the medical
institute’s Helsinki Committee (the Israeli name for an institutional review
board) and the Health Ministry must give approval for a trial.
In 2007, just over 300 FDA-regulated
clinical trials were conducted in the U.S., and fewer than 100 were held in the
Middle East, according to a 2010 study by the Tufts University Center for the
Study of Drug Development.
Rhodes attributes Israel’s approval pace
to a fear of risk-taking, one which he says also costs Israeli hospitals
business from companies abroad who would come to Israel for their trials if it
were more feasible.