The term «off-label» means that the medicine is appointed not as it is specified in the description: not in case of that disease, in other dosage, with other frequency, to the child, but not to the adult or with any other deviation from the instruction.
Referring to the legislation of our country, we can say that the use of drugs off-label is possible. Paragraph 5 of article 37 of the Federal law № 323 «On the basis of public health protection in the Russian Federation» provides for «the appointment and use of drugs outside the appropriate standard of medical care in case of medical indications (individual intolerance, for health reasons) by the decision of the medical Commission».Besides, Orders of delivery of health care, that are obligatory for executionand were approved by the Russian Ministry of Health, also do not include a ban on the off-label use of drugs in cases that are not covered by the manufacturer's instructions for use.
The use of off-label medicines can often be met at children and pregnant women. Often, the clinical trials on these groups of patients aren't experienced because of legislative restrictions (item 1, 2 of the p. 6 of Art. 43 of the Federal Law No. 61 «About drug circulation») and as on these groups of patients producers didn't research medicine, it is writtenin instructions that for them application of medicine is forbidden. According to 2015 in the Russian Federation 75% of drugs in pediatrics are applied not according to the instruction, in a neonatology – to 90%. 90 – 95% of the drugs which are used in treatment of pregnant women – are also off-label. At the same time the possibility of approach of side effects is rather high. The restriction on informing the doctors about the possibilities of off-label use creates in such situations additional risks, since the doctors do not have sufficient information about all the risks associated with such use.
Another problem is that Russian law explicitly doesn’t provide for liability of pharmaceutical workers for giving any recommendation to use the drug off-label. In addition, the pharmaceutical workers give advice orally and it is almost impossible to prove the fact that people were affected by the recommendations. Civil or criminal liability of pharmaceutical workers in case of prescribing a drug off-label can occur only in case of bodily injury because of improper use of this drug based on the recommendation of the worker. Thus it is necessary to prove the fact of giving such a recommendation and prove the direct link between the recommendation and the causing of harm to health of the citizen.
Use of off-label medicines in the USA
The use of off-label medicines in the USA legislation isn't forbidden now. The possible responsibility for such appointment lies on the practicing doctor. In some complex cases off-label use in principle can be the unique possible treatment for the patient. The important thing is that in the USA, pharmaceutical companies don't have the right to advertise the drug for off-labeluse, however, they can publish peer-reviewed articles about it in medical journals. Now the FDA considers permission option to the companies on advertising of use of the drugs off-label, trying at the same time to think through possible pluses and minuses.
The consequence of this change could be the release of pharmaceutical companies from legal disputes concerning the promotion of the use of drugs off-label. Over the past 10 years in the United States were at least five judgments on more than a billion dollars associated with off-label advertising.
In the poll conducted in the USA, a half of respondents considered that it is possible to appoint medicine only on the basic approved by FDA. In turn, a half also considers that prescription of medicine off-label shall be forbidden to the doctors.
Separately, it is necessary to tell about a case of the Amarincompany which in a dispute with FDA protected the right to inform doctors about researches of off-label use of medicines, provided that such information will be truthful and won't mislead doctors. In this case, it is curious that the constitutional right to freedom of speech was the basis of justification the attitude of the company.
Use of off-label medicines in the EU
As for the EU, currently, not all the countries have separate provisions that regulate the off-label use of drugs. For example, this minority include: France, Spain, Italy, and UK. In Germany, the Civil code stipulates that, in order to depart from the recognized medical practice of using one or another medication, you must have a good reason to choose the less secure method as well as apply additional security measures to minimize possible harm. In the federal law of Switzerland it is determined that the medicine which isn't intended for treatment of a specific disease can be used only when the disease threatens the patient's life and there is no needful medicine for treatment.
From this year the pharmaceutical companies working in the EU willbe required to collect and report information on the use of its drugs off-label. This information includes: reporting, by the presence of adverse reactions after using the drug off-label by the patients; periodic reporting on the clinically significant risks associated with such use; the planning of risk management based on a quantitative assessment of the use of medicines off-label.
The problem of use of the medicines off-label is global, and yet there is no consensus about whether it is really so necessary to use medicines off-label at the same time risking the health of patients.
The article was prepared by 24/11/2016
Maria Nikitina, junior associate of the BRACE Law Firm