Medicines and the State

Weekly “APTEKA” tells its readers repeatedly about case law of the Ukrainian and foreign courts regarding settlement of disputes on medicines. As a rule, dispute concerns name of a medicine and more rarely – its formula, but now I would like to tell the readers about a completely innovative decision which, in fact, is an alternative to the state registration of a medicine.

Between creation of a medicine and its registration and bringing to the market many questions arise related to the competing rights of different nature and legality of certain actions. “Information relations” occupy a special place here, which I would like to illustrate by a unique example.

It refers to the judgment by default approved on December 24, 2013 by the Podilsky District Court of Kyiv upon the claim of the citizen N. to the Kyiv regional public organization “25th Hour” on the protection of honor, dignity and business reputation.

The essence of dispute was as follows. The plaintiff sued the defendant on the protection of honor, dignity and business reputation stating that on October 14, 2011, the Kyiv regional public organization “25th Hour” organized and held near the Austrian Embassy in Ukraine a protest movement against use in Ukraine of anticancer medicinal product Ukrain.

The plaintiff noted that during the event the representatives of the organization handed to the embassy staff a press release entitled “In Ukraine fraudsters poison people by false medicine called Ukrain”. Furthermore, the said document was placed in the Internet information network.

Judging by the contents of the press release, the plaintiff believed that the public organization raised the questions of using anticancer medicine Ukrain in the territory of Ukraine. The above information was negative with respect to the plaintiff, and to some extent it contained offensive description of his business, moral and human qualities as a citizen of Austria, the inventor of the medicine, Doctor of Chemical Sciences.

Therefore, the plaintiff concluded that his right to respect of honor was violated, because taking into account that information, in the absence of alternative source of information about him reduced his public assessment in the eyes of others not only in Ukraine, but also abroad. The said information also offended his dignity, which adversely affected his self-assessment as an individual, humiliated the qualities defining his reputation in the society.

The plaintiff’s theses were enhanced by reference to the contacts of an Austrian citizen N (scientists, pharmacy technicians, occupational therapists, diplomats, etc. – It can be found in detail in the decision).
Accordingly, the plaintiff asked the court to disprove the negative information, some quotes from which I would like to provide (in the original):

“… The medicine “Ukrain” does not meet registration standards of medicines, all therapists who tested the medicine refused further tests in connection with its complete inefficiency. After trials between the inventor of “Ukrain” and the European Medicines Agency, the Court upheld the ban on the dissemination and use of the medicine in Austria. The decision can be found under the archive number T-74/08 on the web-site of MOH of Austria… Besides the official ban on the synthesized medicine “Ukraine” is already effective… The effectiveness of the medicinal product “Ukrain” cannot be verified due to refusal of experimental cancer patients to take the medicine of unknown origin…” (paragraphs five, six of the press release);
“The product was imported into the territory of Ukraine illegally…” (paragraph two of the statement);
“Use of poison “Ukrain”…” (second sentence of paragraph three of the statement);
“Poison “Ukrain” continues to flow into the country illegally through representatives, including through the diplomatic pouch..” (second sentence of paragraph seven of the statement).
The court granted the claim recognizing information unreliable and specifying in the decision that dissemination of such information about the plaintiff and his activities resulted in non-pecuniary damage meaning humiliation of his honor, dignity and business reputation and ordered the Kyiv regional public organization “25th Hour” to refute false information published in the press release dated October 14, 2011 and the statement to the Extraordinary and Plenipotentiary Ambassador of the Republic of Austria in Ukraine dated July 26, 2012 by sending to the Embassy of the Republic of Austria in Ukraine of a relevant letter.
When granting the claim, the court refers to the general provisions of the Constitution of Ukraine on the individual’s right to life, health care, safe for life and health environment, freedom and personal inviolability, inviolability of private and family life, respect for dignity.

The decision was also motivated by reference to Ar. 277(1, 3) of the Civil Code of Ukraine stating that an individual, which personal non-property rights were violated due to dissemination of misleading information about him and/or his family members has the right to respond and disprove such information.
“Negative information disseminated about a person is considered to be unreliable, if the person, who spread it, does not prove the opposite” is the so-called legal presumption of unreliability of any negative information.

Since the cases on protection of honor, dignity and business reputation are the most difficult in terms of proving, judging by my practice I dare say that considering the above presumption it is the negative nature of information disseminated about a person that is always so difficult to prove in court: without empirical evidence the defendants usually assume “what’s wrong with that exactly? We wanted to make a kind of compliment”.

If we analyze the practice of such cases consideration by courts, it can be concluded that the majority of claims for the protection of personal non-pecuniary rights resulted in dismissal motivated by the conclusion of the court that the disseminated information was a kind of “value judgments”.

About 8 years ago I wrote in the article on the protection of business reputation that nowadays the line between insult and compliment is very thin and conventional. In recent years my assumption was confirmed by numerous court decisions. I would like to provide a few examples.

On April 24, 2008, the Sviatoshinskiy District Court of Kyiv approved unfavorable decision in a civil case, where an individual sued his neighbor for calling him a rat in the presence of their mutual acquaintances several times. The plaintiff asked the court to order the defendant to disprove the disseminated information that was untrue and discredited his honor, dignity and business reputation by oral apology within one month since the decision becomes effective. His claim was motivated by the fact that the information that was untrue and defamed his honor, dignity and business reputation, caused his negative assessment as a citizen and humiliated assessment of honor and dignity in the view of acquaintances and friends in terms of generally accepted rules and principles of common life and human morality.

The defendant asked the court to dismiss the claim arguing that “rat” is a literary widespread “word expression”, it does not discredit honor, dignity and business reputation of the plaintiff, the expression was associated with the Year of the Rat.

Refusing the plaintiff’s claim, the court explained that “the word “rat” is a non-ofensive word and does not bear any information about a person” (http://reyestr.court.gov.ua/Review/5111312).

Apparently (although our procedural law does not have the concept of “precedent”), the above served as a precedent for a much more interesting case.

On November 17, 2009, the Golosiivsky District Court of Kyiv dismissed the claim of the State Tax Inspection of Golosiivsky district of Kyiv to the head of the Creative Union “Tvorchist” on the protection of honor, dignity and business reputation and preventing abuse of free access to public information.

The cause of the dispute was that on October 5, 2007, October 8, 2007, October 9, 2007, October 10, 2007 and October 11, 2007, the defendant in the territory near the administrative buildings of the tax police in the Golosiivsky District of Kyiv from 10:00 a.m. to 01:00 p.m. and the State Tax Inspection in the Golosiivsky District of Kyiv from 02:00 p.m. to 05:00 p.m. at the following addresses: 19/20 Narodna St., and 23 Zhylyanskaya St. disseminated untrustworthy information about the employees of police and tax inspection.

In particular, the defendant stated: “The Tax Inspection of Golosiivsky district is robbing residents shamelessly. The Tax Police mocks citizens…”.

The respondent did not provide any evidence, in particular confirmation of any relation of tax service employees to foreign cars standing near the building of the tax service.

However, the court dismissed the claim explaining that the plaintiff’s written evidence, namely postcards, flyers do not confirm their distribution by the respondents. “The arguments of the plaintiff’s representative were not confirmed at the hearing and are based only on assumptions of facts and events specified in the statement of claim that in the plaintiff’s opinion humiliated his honor, dignity and business reputation”.

Therefore, the questions of proof, expert examination and evidence are the cornerstones in the cases on information relations.

When representing plaintiffs in such cases, lawyers of Ilyashev & Partners Law Firm, despite the legal presumption of unreliability of negative information and the defendant’s obligation to prove his arguments, prove firstly that the disseminated information contains specific facts, which are inconsistent with reality and a negative character of such information.

If to put yourself in the defendant’s legal representative place (whose “traces” in this case I did not find) in the case with medicine Ukrain I would substantiate my legal position by the absence of state registration of the medicine in Ukraine, which permitted the Kyiv regional public organization “25th Hour” to cast doubt on the quality, efficiency and safety of the medicine and, thus, the legitimacy of its distribution channels.

According to the statement of reasons in the decision of the Podilsky District Court of Kyiv dated December 24, 2013, the defendant did not prove reliability of the disseminated information contrary to the requirements of Art. 277(3) of the Civil Code of Ukraine. Thus, the court resolved on its recognition as misleading and granted the claim of an Austrian citizen N.

Pursuant to Art. 124 of the Constitution of Ukraine, the jurisdiction of the courts extends to all legal relations that arise in the state. Therefore, the decision did not only disprove that “In Ukraine fraudsters poison people by false medicine called Ukrain” (the title of the press release), but actually the medicine was found consistent with “registration standards of medicines” (without the effective registration certificate).