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Generic drugs: are they a benefit or a problem?

March 18, 2014, 21:18 UTC+3 Alexandrova Lyudmila

MOSCOW, March 18. /ITAR-TASS/. Russia’s Constitutional Court ruled on Monday that the authorities were obliged to check information on the dangers of generic drugs (short: generics), which are prescribed to patients on preferential terms as replacements for expensive original drugs. In this connection, the problem of how to treat generics has re-appeared in the Russian media again.

Generics are intended for replacing original brand names with identical formula after patents for the latter’s use expire. While generics are sold at lower prices, they are assumed to be as effective and safe for use as original medications. Generics are produced in strict compliance with established rules and conform to all quality standards.

Differences between generic forms and original drugs have always caused confusion in consumers’ minds. However, no one can deny that generics make quality treatment available to broad masses of people.

The Constitutional Court’s decision had been preceded by litigation of Leisan Sharafutdinova, a resident of Kazan, the capital of Russia’s Republic of Tatarstan, who refused to take Iranian-made sinovex, offered to her free of charge, instead of the prescribed American-made annovex. Sharafutdinova based her arguments in court on findings made by foreign scientists and Russian researchers, who confirmed that replacing one protein-containing drug with another one, even if it has an identical molecular composition, might be useless and could have a negative impact on human health.

The courts admitted that the Russian government had not approved a list of drugs which could be purchased according to their international brand names. However, they ruled that the absence of legal regulations was not the reason for calling existing rules illegal. After that, the woman turned to the Constitutional Court claiming that the practice of drug purchases in Russia was depriving patients with serious diseases of an opportunity to get a free medication that has passed clinical tests in Russia.

The Constitutional Court considered Sharafutdinova’s complaint and ruled that the constitutional rights of citizens were not violated. However, the Court said the question about the use of generics raised by the woman was very important. Many people take generics which are often prescribed by doctors as free drugs. Because the situation is so widespread and the problem is so serious, the Constitutional Court considered it possible to elaborate on its own legal position on the matter.

The Constitutional Court did not oblige Russian courts to review their previous decisions but clarified that the authorities should be able to monitor the safety of drugs on the basis of reports received from specialists or patients. If the authorities have trustworthy information that the efficacy of a certain generic for a particular person differs radically from the impact of an original drug, it cannot be considered to be completely replaceable. That gives the right to the patient to demand another medication.

The Constitutional Court’s decision is particularly important for other patients who will now be able to refer to its ruling when they demand that regional authorities meet the necessary treatment conditions, the Kommersant daily says, citing David Melik-Guseinov, the director of the Social Economy Center.

According to the center, generics account for about 25% of the Russian market of biotechnological drugs valued at more than $2 billion.

Many experts assume that generics are worse than their original analogues. However, the various versions of one and the same drug are not supposed to differ radically from each other or the brand name in terms of health safety and clinical effect. They usually differ in price and appearance. Generics are much cheaper than their brand names because their producers do not make capital expenditures on R&D and advertising.

Last year, the Russian Health Ministry published amendments to the law “On Circulation of Drugs” which forbids the state to buy and doctors to prescribe drugs according to their international unpatented names. The amendments clarify conditions under which it would be possible to buy and prescribe generics instead of original drugs. Generics with the same properties as original drugs will not be automatically regarded as replacements before their therapeutic equivalency is proven and until they are formally included in the list of replaceable drugs.

The Health Ministry-proposed amendments are yet to be adopted. Meanwhile, experts warn that such measures will slow down the access of inexpensive drugs to the Russian market and, consequently, budget spending on public health.

Igor Artemyev, the head of the Federal Anti-Monopoly Service, has recently suggested that a government commission led by First Vice-Premier Igor Shuvalov should consider prices for medications in Russia at one of its meetings.

“We have the most expensive or one of the most expensive drugs in the world,” Artemyev said, adding he had based his conclusions on results of a three-year study carried out by the Russian Anti-Monopoly Service.


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