Israeli pharmaceutical companies are scrambling to comply with a law forcing them to label all prescription medication boxes in four languages: Hebrew, English, Arabic and Russian. With a deadline of May 1 that was missed, Israeli media report there are shelves of prescription drugs boxes in warehouses that still don’t meet the requirement and thus cannot legally be sold.
Racing against the clock, the Knesset held an eleventh hour damage-control hearing late last month to extend the deadline and try to avert a prescription drug shortage. Part of the remedy: steep fines imposed by the Health Ministry for each drug that doesn’t have a multilingual label, specifically $8,100 for each drug not properly labeled, and about $16,200 for what are considered to be high-volume marketed medications. If manufacturers and importers are not ready again in three months with the new multilingual labels, the plan is to fine them once again.
Critics are calling it “overregulation” and say burdening the pharmaceutical companies will ultimately hurt consumers, since monies that might otherwise be spent on life-saving medication research is going instead to printing multi-language labels.
They point out that most Israeli Arabs, who comprise a fifth of Israel’s population, speak and read Hebrew as do most Russians who make up an estimated one-eight of the population. It’s also a slippery slope. In a country where an estimated “33 languages are in daily use,” there’s no end to the number of languages that could in theory be mandated to be printed on a box.
The labeling bill was passed in 2010 with the aim of protecting the safety of Israel’s Arabs and native Russian speakers who immigrated from the former Soviet Union. While prescription drugs in the past were labeled in both Hebrew and English, the new law says those boxes must now be printed in two additional languages, Arabic and Russian.
The Knesset aimed to protect Russian and Arabic-speaking consumers, but the safety leaflets inside the boxes which list ingredients and drug interaction warnings are mandated to be only Hebrew, English and Arabic, not Russian, raising the question how much safer non-Hebrew speaking Russian immigrants will actually be.
The Israeli website Mako checked with pharmacies and found a “serious shortage” of some medications. Israel’s Army Radio reports that among the drugs missing from pharmacy shelves are anti-depressants and painkillers. Its reporter found that in some cases, patients were visiting multiple pharmacies to locate missing remedies.
An Israeli pharmaceutical industry source who asked not to be named due to ongoing tension with the Health Ministry tells TheBlaze that the pharmaceutical companies are facing “a heavy logistical load” and that the new labeling is “a huge burden for the companies.”
Army Radio reports that in the case of certain drugs it’s not economical for the companies to pay the high fines, so those won’t be marketed for the next few months.
A senior Health Ministry official tells TheBlaze that pharmaceutical companies already got three extensions to comply with the law that passed in 2010.
Health Minister Yael German told the Knesset last month, “They had plenty of time to prepare for the change.”
“They are showing contempt for the public,” she added, according to the Jerusalem Post.
Dr. Eyal Schwartzberg who heads the pharmaceutical division at Israel’s Ministry of Health tells TheBlaze that the government plans to use the late fees collected from the pharma companies “for an internet campaign and a hotline so people can call and ask the name of their medicine” when they are not printed on the box in Arabic or Russian.
He contests media reports that there are shortages, saying “If there are going to be shortages, they will be momentary, they won’t be ten month shortages.”
“We have people working on it 24/7 so if we get a member of public telling us we can’t find the drug, we will look into it and find out why,” Schwartzberg says.
Complicating matters, he explains that some packages can’t be labeled in four languages because the boxes are too small. Others can be compromised if taken out of refrigeration for too long during the relabeling process.
Schwartzberg emphasizes, “It’s not a crisis, but it has to be looked at as a crisis in order to prevent a crisis.”
Despite the protest of the drug makers, Schwartzberg explains how important it is “to educate the public, give them all the information they need to give informed consent and read their medicine and comply with it. And part of that is reading it in their own language.”
Suggesting that pharmaceutical companies have in the past balked at new regulations, he says, “I never saw them coming happily, because at the end of the day somebody has to pay money for it.”
One critic of the new regulation is Director of the Ayn Rand Center in Israel Boaz Arad who tells TheBlaze, “This is just the tip of the iceberg of regulatory decisions that harm consumers instead of helping them. It demonstrates that regulations whose rationale is to help the citizens and the pharmaceutical company’s customers harm both the customers and the drug companies, because every bureaucratic fine like this one is at the end of the day passed onto the consumers and patients.”
“It increases the cost of the drug, this after they [patients] already suffered from the get-go from the many delays in the arrival to market of drugs that can ease their pain,” he added.
Arad directed us to this 2007 Ayn Rand Institute critique of the FDA’s “onerous, years-long” drug approval process in the U.S., which described terminally ill patients as having to pay the ultimate price for bureaucratic delays in the availability life-saving drugs.
TheBlaze reached out to the Ayn Rand Institute in the U.S. which e-mailed us this statement from Executive Director Yaron Brook: "In a free country, companies would be able to choose what language they use on their product labels, and more fundamentally, they'd be able to determine what sort of information to offer with their products."