What is treated

• Import vital drugs disappear from Russian pharmacies; Patients left without drugs protest .
• Amendments to the Civil Code of the Russian Federation were adopted in the second reading : it is believed that they will save from the eviction of conscientious acquirers of housing in difficult situations.

What is it treated?

Government buildings in Moscow and other cities of Russia have pickets with a demand to stop the import substitution of vital drugs for people with a rare genetic disease - cystic fibrosis. They say that Russian counterparts are not suitable for them, and foreign pharmaceutical companies have been notifying doctors and patients since July that they are leaving the Russian market. However, people with diabetes, HIV, with oncological and other diseases collided with the problem of the forced replacement of original drugs with diabetes.

The situation is told by the Executive Director of the Union of Patients and Patient Organizations for rare diseases Denis Belyakov and the chairman of the board of public organization of assistance to patients with cystic fibrosis "in one breath" Irina Dmitrieva .

Video version of the program

Irina Dmitrieva: In our country there is no formulated system of effective care for patients with cystic fibrosis. The news of the departure of proven, well -known, effective and relatively safe antibiotics, which for many years worked for patients, was the last straw: it blew up people.

We are not familiar with the pharmaceutical market: neither Russian, nor Chinese, nor Indian. Everything that we are offered today have never been tested on a group of patients with cystic fibrosis. And this group is special: these are not just people who have been treated and cured, but patients taking antibacterial drugs in very large dosages and very long courses. We have a lot of our own observations: sometimes these drugs do not work as original. Sometimes doctors have to use dosages two to three times more than the original drugs that we are already used to. After all, when a patient with cystic fibrosis (with a liver that suffers from the main diagnosis) takes some incomprehensible antibiotic at times more dosage and long courses, any “side effect” that will be minimal for another person can become fatal: the load on the liver is very serious.

Maryana Torocheshnikova: You said: for many years everything worked - why did it end in 2019?

Irina Dmitrieva: Farm -worshipers have gone, they have taken away their drugs - now we have learned about it. In general, the state has changed the public procurement system since 2014. We stopped receiving drugs for trade names, as it was before, when the doctor could prescribe a drug that has already shown its effectiveness and safety. And since 2014, doctors can prescribe prescriptions only by an international unheard of name, by the current substance. And now the doctor does not know which drug will be purchased and proposed to the patient, that is, to some extent cannot be responsible for the consequences of this treatment.

The news of the departure of effective and relatively safe antibiotics was the last straw: it blew up people

Parents came out of this situation differently. Some, not wanting to endanger their child, bought medicines themselves (although this is a lot of money), contacted charitable foundations or at the expense of some other drugs that were already familiar with. And now there will be nowhere to buy them.

Denis Belyakov: The import substitution system that works in our country is absolutely justified. It is necessary for any country in the world. There are preferences for domestic manufacturers. The state is trying to develop the domestic pharmaceutical industry. But, in my opinion, in this case there was some kind of outrage.

We have a 44th federal law that regulates the purchase of drugs according to the international name. This law exists for everything: for the purchase of bricks, boards and drugs. In relation to domestic manufacturers, there is a preference for a price of 20%. The price may be higher if it is a domestic manufacturer or several CIS countries.

Maryana Torocheshnikova: That is, this drug will be bought more expensive from a Russian manufacturer?

Denis Belyakov: Yes. If a foreign drug is cheaper by 20%, then they will choose domestic. And there is a rule called "third extra": when two domestic drugs participate in the auction, the third, a foreign company deviates from trading.

Maryana Torocheshnikova: Regardless of which drug it offers and at what price?

Denis Belyakov: Yes. State purchases focused at the minimum price.

Maryana Torocheshnikova: But these purchases are made not just for something, but in order to treat people. And Russian patients are now shouting: "You are doing badly!"

Denis Belyakov: Yes, everything would be fine if high -quality analogues appeared on the market. But for some groups of preparations of high-quality analogues, for some reason, did not appear. For a group of patients with cystic fibrosis, part of the generics works, but some group of patients are simply immune to them. When the international name is identical, but the technological process is different and the ingredients are different, the clinical effect is different from the originator. And for such narrow groups of patients, this is critical and threatens even death.

Maryana Torocheshnikova: How many such narrow groups exists in Russia? Is it possible to say that this problem now concerns, for example, only those who have cystic fibrosis, or those who have HIV, or those who have diabetes?

Denis Belyakov: These are thousands or even tens of thousands of patients. But, again, for some part, these drugs work, but for some-no.

Maryana Torocheshnikova: And this is being clarified each time experimentally?

Denis Belyakov

Denis Belyakov: When registering a domestic generic drug, the company should take place for bioequivalence, for identity. And this test is really held. But there are different tricks, when during registration, during bioequivalenia one molecule is provided, and in fact, maybe over time, the drug is released with another history. Maybe these are Chinese or Indian analogues. There is no exact system for supervision and control against Russian manufacturers yet.

Maryana Torocheshnikova: But at the same time there are people who need these drugs, and not the day after tomorrow, not in a year, when all this begins to work, but right now. And they actually risk health.

Denis Belyakov: Of course. This story could continue, because these original, high -quality drugs did not fall into the public procurement system for a long time, but people with cystic fibrosis bought them for their own money, and these are tens or hundreds of thousands of rubles a year, or used the help of private funds.

Maryana Torocheshnikova: But now suppliers are simply leaving the Russian market?

Denis Belyakov: Foreign manufacturers of original drugs said that it is now unprofitable for them and they are leaving. It is not clear what to do to patients who will fall into a difficult situation with exacerbation (these are people who are waiting for light transplantation). Apparently, you will have to buy medicines abroad and bring here. But not everyone has such opportunities.

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Medicines that are not

Maryana Torocheshnikova: Irina, how do people get out of the situation now? And what do officials say?

Irina Dmitrieva: Officials say that they took control of the situation, that now they will be more carefully approaching the fixation of side effects. They say very little about the possible inefficiency of drugs, which also plays a rather large role, because it is not always possible to see a side effect, but sometimes after treatment, remission in patients can be very short. This is inefficiency. Or the titer of bacteria in the lungs did not decrease, remained the same, or maybe even grew - this is also a sign of the ineffectiveness of the drug. And no one talks about it.

And yesterday I read in the media that Murashko, the head of Roszdravnadzor, announced: he believes that all the original drugs that have left the market are absolutely replaced, and we have all the resources in order to replace them. It seems that they don’t hear us. We urge to consider this situation separately. Yes, we have little information about side effects, because doctors very rarely give this information. Now we hear an appeal to patient organizations that they collect all side effects in patients, but it is very difficult to do. And in general, it seems absurd to me. It turns out that patients are responsible for everything. And we want the system to have some other response, so that they formulate a clear position, say that they are ready to create some kind of working group, make changes to the existing legislation, and work out systematically, that is, with a special look at cystic fibrosis.

Denis Belyakov: The problem is not only with cystic fibrosis. Similar situations occur in oncology, and in hematology, and in rheumatology. For some reason, there are some of the low-quality domestic drugs on the market. There are Russian companies that produce excellent, high -tech drugs that are successfully included in public procurement. But there are some part of poor-quality. The system of fixing unwanted side effects is spelled out in the legislation, but doctors often either do not know about it or do not want to do this, given that they must fill out several documents.

Maryana Torocheshnikova: What do you want from doctors?! The local health department at the auction was bought by one drug, the doctor prescribes it, and he will write that there are some side effects? It turns out that he actually goes against the authorities.

Denis Belyakov: Of course, this is an administrative barrier. In the Russian outback, there were cases when three facts of filling out undesirable side effects for one drug and sending them to the appropriate body caused a fundamental audit of this medical institution. It turns out that we are trying to support “our own” by any means, and this is the use of hucksters from the pharmaceutical industry. There are good Russian developments, there are high-quality manufacturers, and there is some small part that simply makes money on this and uses the situation with import substitution.

Maryana Torocheshnikova: What to do to a person now, when the necessary imported drugs are already starting from pharmacies, and doctors prescribe some Russian analogues that cause doubts? Is it possible to ensure that the doctor prescribes exactly the medicine that a person has already used for many years?

It turns out that we are trying to support "our" by any means, and this is the use of hucksters from the pharmaceutical industry

Denis Belyakov: Indeed, you need to demand from the doctor to fill out the act on an undesirable side effect or contact the Roszdravnadzor website himself, where the same statements are accepted not only from doctors, but also from patients. And it is necessary to demand the conduct of the medical commission and the discharge of the drug by the trade name. On the basis of this document, the department of healthcare of the region is obliged to make an individual purchase of a drug. It is more difficult if the patient is in the hospital - then the procurement procedure will be quite long.

Maryana Torocheshnikova: And who will be liable if, after treatment, such drugs that are not suitable for a person, will be caused by serious harm to his health or, God forbid, will follow death?

Denis Belyakov: It's hard to say. This will require certain evidence, it will take some time. But I do not know about such precedents in Russia.

Maryana Torocheshnikova: What should officials do so that this year the situation does not become absolutely critical?

Denis Belyakov: First of all, you need to clearly interact with those manufacturers whose drugs we cannot replace in order to continue their supplies to Russia. In general, if the state can determine the list of drugs that are non-change for some groups of patients, then this must be done and done some targeted purchases, as recently by resolution of Medvedev, this was done for children in unregistered drugs.

Maryana Torocheshnikova: Do you mean Frisium?

Denis Belyakov: Yes. In addition, it is necessary to absolutely impartially carry out registration and inspection of production sites of domestic manufacturers.

Maryana Torocheshnikova: But difficulties can already arise with this.

Denis Belyakov: But I hope for the sound mind of our leadership, for the fact that import substitution is import substitution, but in the country's interests, preserving the life and health of our patients, including children.

House is not a fortress

This week, Russian deputies adopted in the second reading amendments to the Civil Code. It is stated that they will protect bona fide buyers of housing from eviction if officials want to take it away, citing the fraud of third parties. Is such eviction possible now? How!

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Conscientious homeless

Why is this problem still not resolved? Stories with the protection of conscientious acquirers for many, many years, and the first decisions were made almost in the late 90s or early 2000s and almost the same constitutional court, which explained that if a person bought an apartment in good faith, you can’t simply evict it to the street.

The head of the judicial practice of the Institute of Law and Public Policy Grigory Weipan (in the interests of the Ododvortsevs, he helped them draw up a complaint with the Constitutional Court of the Russian Federation), and Alexander Music , who, when he was his Commissioner for Human Rights in Moscow, tried to deal with the problem of evicting conscientious housing acquirers in the claims of officials.

Grigory Weipan

Grigory Vipan: The lawsuits of the state for conscientious acquirers will soon be 20 years old. Since the mid -zero years, at least in Moscow, such a practice has existed. Since 2011, the European Court of Human Rights has consistently adopts decisions in favor of conscientious acquirers. The first known resolution is Gladyshev against Russia. Since then, the ECHR has adopted more than 70 Russian citizens, and, which is characteristic, 100% of the applicants win these cases against Russia in the ECHR. And the decision of the Constitutional Court in the case of Dubovts in 2017 is a somewhat belated step to implement this legal position of the European Court in the Russian legal system.

Maryana Torocheshnikova: If this problem has so many years, if the ECHR has already intervened, it is not clear why people are still trying to evict from their own housing now.

Alexander Ilyich, when did you try to solve this problem, what did the officials say?

Alexander Music: July 23, 2015, a meeting of President Vladimir Putin with the Public Chamber was held. And I made a report there on this issue. The president listened to all this and said: "I am convinced that if we are talking about a really conscientious acquirer, and problems arose due to improper performance by the authorities of its functions, then the conscientious acquirer must be exempted from any problems associated with this. The state made a mistake, and it is obliged to solve it independently." Four years passed after that. In the development of this speech, the president ordered, including the State Duma: you can make a separate legislative decision and ask deputies to consider different options for protecting the interests of citizens. There was a corresponding resolution. The president asked for four and a half years ago, and finally at least something stirred-the second reading turned out.

In the first reading, this law was adopted in July 2019. But the first reading is not a law, it is just a profanity of legislative activity. In the first reading, deputy Krasheninnikov, presenting this law, said: "This law does not decide anything. It is necessary to do this and that. There is nothing of this there." Nevertheless, he said: "Do not reject this law, but accept it." And he was accepted in the first reading. That is, it is a profanity of legislative activity.

Now the law is adopted in the second reading, and it has nothing to do with the first reading. The first reading is half a page, and now the law makes changes not only in the 32nd article, but also in four more articles of the Civil Code, gives a new definition of a “bona fide acquirer” and other things. But it also has a lot of gaps and “white spots”. There you need to change a lot. But this is the second reading, and in the third reading you can correct only commas. I think the only way out is to return this law to the first reading, and what was customary three days ago is not considered the second reading, but the first. Then it will be possible to calmly discuss it, amendments and consider them in the second reading. And it is impossible to accept it in this form.

Maryana Torocheshnikova: Gregory, is it needed at all? Isn’t the explanation that the Constitutional Court of Russia, including the Dubovts case in 2017, is not enough?

Григорий Вайпан: Не достаточно, потому что Конституционный суд прямо в постановлении по делу Дубовца обязал законодателя внести изменения в статью 302 Гражданского кодекса и предусмотреть защиту добросовестного приобретателя от исков государства.

Марьяна Торочешникова: Что сейчас записано в статье 302?

Григорий Вайпан: Там записано, что у добросовестного приобретателя можно отобрать жилье, если оно выбыло из владения предыдущего собственника помимо его воли. И в ситуации, когда сталкиваются интересы двух частных лиц, это, в принципе, нормально. Если у вас украли квартиру, она ушла по цепочке сделок, и через пять лет вы ее обнаружили в чьих-то руках, то вы можете истребовать эту квартиру по суду. А тот приобретатель, у которого вы ее забираете, будет обращаться с иском об убытках к тому, у кого он эту квартиру купил. Это нормальная схема, она существует во всех странах. Но она перестает быть нормальной, когда в начале этой цепочки пострадавшим собственником является государство, потому что государству конкретная квартира не нужна. Для государства квартира – это некое абстрактное имущество. Государство должно идти с иском к мошенникам и разбираться с ними, получать эти деньги. Сейчас же сохраняется ситуация, в которой государство идет самым простым путем – решает свою проблему за счет того, у кого найдена квартира. Вместо того чтобы совершенствовать систему государственной регистрации прав на недвижимость, проще всего решить проблему за счет самого добросовестного и честного человека из этой цепочки, на самом деле не решая ее.

Марьяна Торочешникова: Его просто выселяют? Или дают какие-то компенсации, предоставляют альтернативное жилье?

Григорий Вайпан: Этот человек оказывается на улице, его выселяют.

Марьяна Торочешникова: То есть он честно приобрел квартиру, отдал свои собственные деньги, государство что-то прошляпило в позапрошлой сделке или несколько сделок назад, а сейчас спохватилось. И "крайний" все равно вот этот честный человек?

Добросовестный приобретатель полагался на данные Госреестра недвижимости, и государство должно отвечать за тот реестр, который оно ведет

Григорий Вайпан: Именно так. Ему говорят: "Идите с иском к продавцу и разбирайтесь с ним". Но, как правило, этого продавца уже днем с огнем не сыщешь: нет ни продавца, ни денег. Именно поэтому сейчас наше государство приняло закон о компенсациях – он вступает в силу с 1 января 2020 года. По этому закону, если у конечного добросовестного человека отобрали квартиру, если он не может взыскать деньги со своего продавца, то государство платит ему стоимость этой квартиры. И это правильная, хорошая мера. Конечно, она уже перезрела – ее обсуждают пять лет, если не больше. Проблема в том, что теперь эту схему хотят применить к тем ситуациям, когда собственник – государство, то есть получается совершенно бессмысленный размен, при котором государство будет продолжать выкидывать человека на улицу, забирать себе ненужную ему квартиру и потом этому же человеку платить деньги.

Марьяна Торочешникова: Вы сейчас идете в Конституционный суд с Однодворцевыми – на что вы рассчитываете?

Григорий Вайпан: Проблема семьи Однодворцевых – это проблема тех, кого успели потребовать выселить по суду до постановления по делу Дубовца, но они продолжают жить в этой квартире. Это вообще проблема исполнения постановления Конституционного суда, того, на кого оно распространяется. Дело в том, что московские суды и Верховный суд сказали, что постановление по делу Дубовца касается только Дубовца, а то, что есть другие семьи, такие как семья Однодворцевых, которые по-прежнему не выселены, после 2017 года это будет противоречить решению Конституционного суда. Тем не менее, московские чиновники, приставы по-прежнему добиваются выселения этой семьи. Вот об этом жалоба в Конституционный суд.

Марьяна Торочешникова: А их не выселили просто потому, что им так везет?

Григорий Вайпан: Это достаточно острая ситуация с гуманитарной точки зрения, и московские чиновники тоже осознают ее остроту. Проблема неоднократно обсуждалась и в Общественной палате, и в этом году – в Совете при президенте по правам человека. И неформально сейчас все эти исполнительные производства поставлены на паузу, но они могут в любой момент возобновиться. Но самое главное, что эти люди юридически не защищены. Их сейчас спасает исключительно добрая воля кого-то в московской мэрии. Но это не ситуация правового государства. This should not be.

Александр Музыкантский: Одновременно с Дубовцом в Конституционный суд обращалось еще несколько человек, находящихся в аналогичной ситуации. КС почему-то выбрал дело Дубовца, просмотрел его, принял решение, что пресловутая 302-я статья не может применяться, является антиконституционной, если при этом не учитывается, что публичное образование (в нашем случае – Департамент городского имущества) не приняло мер по оформлению этого имущества в собственность. Но наши суды общей юрисдикции говорят: "Это же дело Дубовца: на вас это не распространяется". А если эти люди обращаются в Конституционный суд и говорят: "Примите решение и по нашему случаю", – КС им отвечает: "Нет, мы уже приняли решение по делу Дубовца. Ваша ситуация уже рассмотрена. По предмету вашего обращения Конституционный суд принял решение, которое сохраняет свою силу".

Марьяна Торочешникова: И получается замкнутый круг. Но для того чтобы его разорвать, сейчас Однодворцевы обратились в Конституционный суд, чтобы тот уже наконец разъяснил, что делать в таких ситуациях.

Григорий, есть ли какие-то непременные требования к тем добросовестным приобретателям, для того чтобы они смогли получить от государства компенсацию в случае, если их сделка сорвалась, была оспорена?

Григорий Вайпан: По тому закону, который принят и вступает в силу в январе, путь для добросовестных приобретателей, конечно, все равно тернист. Их сначала выселят, они должны пойти с иском к своему продавцу, попытаться взыскать с него стоимость дома или квартиры, и только если им это не удастся, они получат исполнительный лист, а исполнительное производство никуда не сдвинется, то через шесть месяцев они могут подавать иск в суд к государству о получении компенсации в размере стоимости квартиры или дома. Это долгий и непростой путь, сложная конфликтная ситуация, но человек потому и называется добросовестным приобретателем, что он полагался на данные Государственного реестра недвижимости. И государство должно отвечать за тот реестр, который оно ведет.