Hospital Heads Blast Gov't Plan on Imported Drugs Supervision

Health Ministry says no longer able to carry out checks on safety of imported drugs; Hospital directors say move could endanger public.

Directors at state hospitals are up in arms following the Health Ministry's decision to transfer supervision over thousands of imported medicines to the hospitals themselves. The directors are accusing the ministry of endangering the public, and in response, ministry officials say that they are only trying to overcome bureaucratic delays for medicines that are not yet approved in Israel.

The importation of medicines not yet approved for use in Israel, or used for different purposes than their original intention, is administered according to special pharmacist regulations. On the basis of these regulations, hundreds of medicines essential to thousands of patients are imported. Annually, about $80 million worth of medicines are imported to Israel.

To date, the Health Ministry's Pharmaceuticals Department was responsible for the supervision of imported drugs.

However, according to Batia Hern, the department head, notwithstanding the public interest in ministry supervision, the Health Ministry is no longer able to carry out the necessary checks to ensure the safety of imported medicines.

According to the new regulations, responsibility for ensuring that the imported medicines originate from an approved and reliable source will belong to the hospitals. The hospitals will also need to ensure that the medicines are stored under the necessary conditions, and supervise how these are used.

The hospital directors have described the new regulations as "seriously negligent."

"It is inconceivable that in an proper state, chemicals used for medicinal purposes are imported... without supervision and the proper quality inspection," said Dr. Meir Oren, director of Hillel Yaffeh Hospital in Hadera and former director general of the Health Ministry, in a letter to Hern. "It is unacceptable if every medical institution and pharmacy in Israel imports medicines independently and without the necessary supervision by the Health Ministry."

Oren also charges that "this constitutes an abandonment of the patients and an evasion by the Health Ministry of its responsibility. This borders on serious negligence and may harm the patients."

In response, Hern says that the arguments against the new regulations were taken into account when the decision was made by the Health Ministry. She insisted that the new procedures will "adequately ensure the quality of the imported medicines," adding that the doctor prescribing such medicines "is required to be aware of [the medicine's] effectiveness and also the possible side effects that may result from the treatment."

Hern also wrote that the current bureaucracy involved in acquiring an import license for not-yet-approved medicines, "is debilitating and unnecessary." The new regulations, she said, "increase the authority of medical institutions so that they can make decisions about how essential medicines not yet approved [for use in Israel] are distributed, and there is no attempt [by the Health Ministry] to evade responsibility."

The head of the pharmaceuticals department says that "the issue was studied for nearly a decade," and described the decision as beneficial to Israeli patients.

Opposition to the change had been voiced earlier by Dr. Gabi Barbash, director of Ichilov Hospital in Tel Aviv, and another former director at the Health Ministry.

He warned in 2005 that the ministry is trying "to evade its responsibility for the hundreds of medicines in everyday use today."

Barbash also contests the claim that a great deal of thought was put in this decision. "I do not understand the system in which such decisions are made at the Health Ministry," he says.

Dr. Shimon Sharf, director of Barzilai Hospital in Ashkelon, also complained about the changes when he wrote to the director general of the Health Ministry, Professor Avi Israeli, in November 2005.

The changes are a reflection of the trend in the pharmaceutical department, he wrote, "to completely evade responsibility and supervision, and laying all the responsibility at the feet of the hospital directors without [giving them] any real means... for inspecting the quality of the medicines."

For his part, Dr. Yitzhak Zeides, acting director of Sheba Medical Center at Tel Hashomer, wrote to Hern in April 2006, that the new procedures constitute "a general evasion by the pharmaceuticals department of any responsibility."

"The Pharmaceuticals Department should take responsibility for the quality of imported medicines, leaving to the hospitals the role of taking care of the patients," Zeides added.