Patients 'organizations, medical staff and pharmacists warn of changes planned by the Ministry of Finance under the Arrangements Law, which will lead to harm to patients' health, and may even cost human lives.
If the changes are approved, the supervision and control of drug administration in Israel will be greatly reduced.
These include the abolition of the Ministry of Health's drug registration system and the reliance on approvals from foreign regulatory authorities such as the FDA, and the approval of the HMO to replace existing drug treatments with biological and cheaper treatments, without the discretion of a attending physician.
In addition, the sale of drugs in vending machines and pharmacies, without the involvement of a pharmacist, will be allowed.
Collapses all defense mechanisms. "Automatic drug vending machine, Photo: GettyImages
The health system warns that this is a "slippery slope" and the abolition of the work of all gatekeepers in the field of drug treatment.
On the other hand, the explanatory memorandum in the draft Arrangements Law states that the move is intended to facilitate regulation and save on health expenses.
Fines for doctors
The length of time for registering drugs in the Ministry of Health currently stands at 500 days instead of 70, which delays the entry of new drugs into the Israeli market and harms patients' health.
The State Comptroller's latest report states that the cost of the delay to the Israeli economy is about NIS 12 million a year.
The doctor is the one who decides.
Prof. Eidelman, Photo: Yehoshua Yosef
The Treasury's explanatory statement states that "the delay in prescribing drugs prevents patients from receiving preparations on time, and prevents them from switching to generic drugs (alternative drugs that are identical to the patent drug; MI) or to biosimilar drugs (biologically similar, but not completely to the source drugs; MI) that cost "It is hundreds of percent lower than the source drugs, so it is proposed to rely on the registration standards of some advanced countries."
Also, another clause is likely to undermine the attending physician's discretion, and allow HMOs to order physicians to transfer patients to the cheap drugs (biosimilar drugs; MI), even in the case of veteran patients. Only in exceptional cases will physicians be able to appeal.
In the past, Ran Reznik revealed in "Israel Today" an outrageous procedure that she referred to her doctors in general, not to provide a source drug for patients with intestinal diseases and rheumatological diseases, and to replace everyone with treatment with cheap substitute drugs.
It was also reported that Clalit gave fines and financial incentives to doctors to transfer patients to cheaper biosimilar drugs.
"delusion".
Prof. Schwarzberg, Photo: None
Following the publication, a forum of experts from the Medical Association determined that transferring patients from one drug to another that is biologically similar is prohibited without medical consideration, and will only be possible after a professional discussion by the medical associations and the decision of the Medical Association.
"We will reach the High Court"
Shmulik Ben Yaakov, chairman of the Association for the Rights of the Patient, warns: "We will go to war to cancel all the sections, and if the catastrophe continues we will reach the High Court. There are sections here that harm the health of patients one by one."
As for the cancellation of the drug registration, he says that "it is a shame for the health system that has reached such a situation. We are in favor of changing the registration process because the waiting time for drugs hurts patients, but the shortening they offer is catastrophic. "Otherwise, all the gatekeepers will be removed and the citizens of Israel will be left without supervision and control over quality and side effects."
In addition, Ben Yaakov says about the replacement of the drugs that "biologically similar drugs are not identical to the original drugs, and there is agreement in the medical community. The doctor is allowed to change the treatment only if he is certified that the treatment is the same. "Only then will it be possible to appeal and return it to the previous treatment. An official in the Ministry of Finance decides to cancel the discretion of all committees and doctors, and this may harm patients."
According to him, the offer to buy medicines in machines and not by a pharmacist stems from economic considerations and a shortage of pharmacists.
"I agree that there is a shortage of pharmacists in Israel, but if the section is passed, a situation will be created where people do not notice drugs and have no one to consult. They will take drugs in a way that will impair their effectiveness and even harm. Pharmacist training is mandatory."
"slippery slope"
Prof. Eyal Schwarzberg, chairman of the Pharmacy Association, added that "this circular is a hallucination.
There are several steps here that endanger the patient public.
It is a slippery slope where one is offered to remove all the protections required during drug treatment.
Break down and collapse all the defense mechanisms that kept patients healthy.
Instead of being given resources to solve the problems in the system, they seek to undo and change world orders.
There is no country that has abolished the supervision of drugs in legislation, the essence of which is economic. "
Perform medication monitoring.
Ben Yaakov, Photo: None
He said, "We have risen to the reality of a world without pharmacists, that the machines will replace us. There will be no medical advice, patient accompaniment and help in preventing mistakes, and all in the name of logistics. This is not a sale of off-the-shelf milk. ".
Prof. Leonid Eidelman, Chairman of the Institute of Quality in Medicine at the Medical Association, emphasizes: “We strongly oppose this section.
Such a decision will not pass quietly by the medical community.
Our professional position says that a patient who receives treatment will not automatically be replaced by treatment with a biosimilar drug.
The effect of such drugs on the patient can be different.
"The doctor is the one who has to decide on the replacement of a drug, according to professional medical judgment only, and not receive instructions from his superiors that may be on an economic or other basis. .
The Ministry of Finance's response: "This is a draft, and until a final wording is formulated, it is not possible to comment on things."
The Ministry of Health stated that it is working to "position Israel as a country with advanced regulatory processes for the registration of preparations, so that the products that arrive in Israel are safe, effective and high quality, and conform to the standards accepted in the Western world." "The proposals raised in the Arrangements Law are not acceptable in their wording, and will be discussed with the Treasury."
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