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Some experts doubt shift to generic drugs is best prescription for health care system

by

Staff Writer

In a desperate bid to stem the rise in health care costs, the government is reining in one of its biggest medical outlays: prescription drugs.

Japan spent a record ¥39.2 trillion on health care in fiscal 2011, out of which prescription drugs accounted for ¥8.4 trillion. The drug costs are expected to rise further, with 1 in 3 people reaching age 65 or older in 2035.

The Council on Economic and Fiscal Policy, headed by Prime Minister Shinzo Abe, is weighing an overhaul of the social security system as part of measures to restore the nation’s ailing fiscal health.

Reform proposals being tossed around and likely to be adopted by the council later this month include an all-out push for generic drugs, crackdowns on over-prescriptions and making more drugs available over the counter to promote “self-medication.”

But some experts question whether such measures are effective in curbing costs. They also worry that the quality of care will deteriorate and the nation’s long-standing universal health care system could be eroded.

Health, Labor and Welfare Minister Yasuhisa Shiozaki told a meeting of the council on May 26 that his ministry will move up the deadline for raising the market share of generic drugs to 60 percent from the current 46.9 percent by one year — to March 2017. The ministry will also set a new target to raise the ratio to 80 percent by March 2021, he said, noting these measures would save ¥1.3 trillion in medical costs.

Generic drugs, which use the same ingredients as branded drugs and hit the market after the 20-year patents on the new drugs expire, are around 40 percent cheaper than branded drugs. Japan lags behind the West in the use of generics, whose market share is 90 percent in the U.S., 82.5 percent in Germany and 75.2 percent in Britain, according to the Finance Ministry.

In fact, the Finance Ministry — bound by Japan’s international pledge to achieve a surplus in its primary balance, or government net income and spending, by fiscal 2020 — wants a more aggressive switch to generics. It is calling for upping their ratio to 80 percent by March 2017.

To achieve this, the government should raise the fee incentives for doctors switching to generic drugs, as well as requiring that doctors who prescribe patented drugs explain to their patients why they must use those drugs when generic equivalents are available, Finance Minister Taro Aso said at the May 26 meeting.

“We should set the goal for generic drugs at 80 percent (by March 2017) this summer,” Aso said. “If we decide on it this summer, pharmaceutical companies can make necessary investments in equipment in time. Banks will lend them money if they know that the orders for generics are rolling in. We need to urgently prepare for production and investment in this field.”

Some members of the council have gone even further, saying generics should account for 90 percent of drugs used, and that, in the long run, insurance coverage should be reduced for patented drugs.

The plan, if realized, will be a mixed blessing to consumers. It means patients going with generics will pay less at hospitals and pharmacies. It also means patients who prefer patented drugs might be forced to pay for the gap in prices between generic and nongeneric drugs.

But Tomohiro Tada, a gastroenterologist and proctologist at Musashi-Urawa Medical Center in Saitama Prefecture, warns the quality of some generic drugs is much lower than their patented counterparts.

“The government should stop saying generics are the equivalent of branded drugs,” Tada said. “It’s like saying Matsuzaka beef is the same as ordinary beef sold for ¥100 per 100 grams.”

Tada said some of his patients who switched to generic drugs have seen their conditions deteriorate. The doctor cites the example of Asacol (mesalamine), an anti-inflammatory drug the prime minister himself has been using to treat ulcerative colitis, an incurable disease.

Abe recalled his 40-year battle with the illness in an interview with his doctor, Toshifumi Hibi, in the fall 2012 issue of the Japanese Society of Gastroenterology magazine, noting that Asacol tablets, which became available in Japan in 2009, have dramatically improved his condition.

“A generic version of Asacol is a powder drug and does not work for patients because it dissolves before it reaches the bowels,” Tada said. “Generics are approved only if they use the same ingredients as branded drugs. No tests on how they actually work in the human body are conducted for their approval.”

Tada also doubts that the switch to generics will save much money, because generics in Japan are not cheap. “In the U.S., generics cost only 10 or 20 percent of (the price of) patented drugs. In Japan they cost 60 percent. So we will see more overpriced, substandard drugs,” he said.

Health minister Shiozaki also stressed in the meeting his ministry will work harder on the zanyaku (leftover drugs) problem. A 2008 study by the Japan Pharmaceutical Association found that prescription drugs worth an estimated ¥47.5 billion go to waste every year among people aged 75 or older receiving outpatient care, because they don’t use up the drugs they get.

The government wants to step up surveillance of such patients and reduce over-prescription by having pharmacies point out redundancies in drug dispensing, Shiozaki said. As it is, patients can take their prescriptions to any pharmacy in the nation, with no centralized system for pharmacists to monitor the total volume of drugs each patient gets from different doctors, thus excessive prescriptions go unnoticed, according to the ministry.

But Norihiro Kimura, an associate professor of health care policy at Takasaki University of Health and Welfare in Gunma Prefecture, says drugs are unused not so much because they are overprescribed but because patients don’t follow doctors’ instructions, stop taking drugs halfway through their treatment or reduce the dosage based on their own judgment.

“The biggest problem, I think, is patients’ lack of understanding about drugs,” he said. “You should not stop taking antibiotics, for example, just because symptoms subside. To cure the illness you should finish all doses prescribed.”

If patients cut doses on their own without telling their doctors, they might prescribe more in subsequent visits, judging that the original dosage wasn’t effective enough, he said.

Meanwhile, Kimura expressed concern about a recent proposal by some council members to exclude prescription drugs that are similar to over-the-counter (OTC) drugs from coverage in the public insurance scheme.

If the switch to OTCs, intended to promote “self-medication,” escalates, areas of insured health care could shrink to the point that patients might feel that their access to doctors has become severely restricted, he said.