Why foreign drugs are needed
According to DSM Group, in 2017, sold on Russian commercial
Parents of patients were the first to sound the alarmcystic fibrosis due to cessation of sales of antibiotics Colistin, Fortum and Tienam in the Russian Federation. "Colistin" is used by patients with cystic fibrosis daily, the other two - with exacerbations. "Colistin" is a unique drug, there are no analogues in the Russian Federation at all. Discontinuation for a sick child means a quick and painful death.
Leila Morozova, mother of two children with cystic fibrosis,says that due to the massive replacement of the original drugs with generics, mortality among sick children has increased sharply and that interruptions in the supply of necessary medicines are noted not only in the regions, but also in Moscow and St. Petersburg. According to her, before drugs could even be bought, albeit for a lot of money, now the required antibiotics cannot be obtained or purchased at all. Leila writes on Instagram: prescribing ineffective antibiotics to sick children, they are simply doomed to a long and painful death for the sake of "import substitution."
Pulmonologist Vasily Stabnitskyconsiders this a real disaster fordomestic medicine, since these medications are constantly needed not only for patients with cystic fibrosis, but also for any patients in serious condition, for example, in intensive care.
Roman Alekhine, founder of the Alekhine and Partners marketing group and the Ortho-Doctor medical rehabilitation center,says that the Russian pharmaceutical market is veryIt is of interest to foreign companies primarily due to its lack of regulation and the ability to actively sell using marketing tools: “This has not been the case in the West for a long time, and even though some drugs there are quietly sold in supermarkets, in Russia drugs are more accessible due to the huge number of pharmacies. In addition, in Europe prescription sales are controlled much more strictly, but in our country attempts to begin control constantly fail. We all remember how last year, after deaths from antibiotics that patients bought on their own, checks began, and pharmacies sold all prescriptions only. But the control lasted for several months, and now you can again buy any medicine without presenting a prescription. And, of course, foreign companies are disingenuous when they say that it is precisely because of their priorities in the needs of the patient that they have more than 70% of the market. Their medical representatives actively work with doctors, thanking them for their referrals with various bonuses - from stationery to trips to conferences or vacations abroad, and at the same time, advertising, which they can afford, finalizes the patient’s behavior even when he is at home. There are cases when doctors do not even delve into the instructions, indications and contraindications and prescribe drugs only from the words of medical representatives. There are complaints that the drug, which is prescribed for a child from 12 years of age, is prescribed to two-year-old children. There is also an opinion that foreign drugs sold in Russia and abroad are of different quality, and many Russians bring children's Panadol from abroad along with jamon and cheese. To begin to limit something and give an opportunity to develop the Russian market, it is necessary to restore order in it, and not just introduce bans on something. We must not forget that medicines are not just a matter of economics and finances, they are a matter of life and health of Russians, and therefore, taking into account the life expectancy goals announced by the President of the Russian Federation, they should be a priority. “We still have a mess in this market and the interests of ordinary patients are placed much lower than the interests of pharmaceutical companies.”
Import substitution in pharmaceuticals
As Chinese practice shows, not so muchusing market mechanisms, it is difficult to create such economic conditions in a country that domestic drugs are no less competitive in the eyes of consumers than foreign drugs. To do this, instead of “forbidding and not letting go” it’s enough to create conditions in which there will be own laboratories, state-of-the-art equipment, long-term research, high-tech production, investments, staff, logistics and, most importantly, the most modern medicines at low prices.
For example, the Chinese government went the exact opposite way. Finding that from 2006 to 2016, none of the 426 new medicines began to be sold in China, it:
- zeroed import duties on medicines;
- reduced to 3% VAT on the production of medicines;
- reduced the period for registration of drugs to 3 months;
- increased the term of patent protection by 5 years;
- toughened penalties for unlicensed copies of drugs;
- established a rule that all quality checks are carried out after the registration of the drug;
- set priority for the procurement of foreign medicines;
- allowed the release of generics only with the consent of the copyright holder and the opportunity for the copyright holder to suspend the release of a generic drug already manufactured for 2 years;
- allowed the conclusion of long-term contracts for the supply of drugs.
China’s loyalty to foreign pharmacists isthat even the documents submitted for registration of the drug can remain in the language of the country of origin, without being translated into Chinese. The result of the measures taken was a sharp (and without any pressure from the Chinese regulators) price reduction, an unprecedented increase in investment and production of pharmaceutical products in China and the saturation of the market with high-quality medicines. According to available information, today in China more than 4,500 drugs are produced in any dosage forms demanded by the market, and Chinese pharmaceutical enterprises produce 90% of pharmaceutical substances for the world industry. In 2018, investments in Chinese pharmacology exceeded $ 103 billion, which is twice as much as the Russian Federation spent on health care in general.
This is not to say that the drug issuesecurity of the Russian state arose after the introduction of sanctions against our country, adopted by the Western powers and their allies in response to the actions of the Russian Federation in Ukraine. The corresponding state program “Pharma-2020” for import substitution of medicines was approved back in 2011 and its validity in 2019 was extended to 2024.
The success of the program, despite the huge overallthe outflow of foreign investment and the economic downturn in Russia are truly impressive. As of the end of 2019, the share of drugs produced in the Russian Federation reached 29.5% in value terms and 60.6% in kind, and more than 81% of drugs are already produced in the segment of vital and essential drugs (Vital and Essential Drugs) in Russia. Russian investors invested in 30 new industries, foreign companies opened 7 new factories for the production of pharmaceutical products, about 80 of the world's largest pharmaceutical companies localized production at the facilities of Russian enterprises. In total, 364 drugs were localized during the program’s operation in the Russian Federation.
Moreover, Russia began to exportown pharmacological products - for example, in 2017, nearly $ 700 million of drugs were shipped to foreign consumers, which is 16.6% more than a year earlier. “Pharma 2020” can safely be called one of the few state programs whose market mechanisms, even despite their clear protectionist orientation, worked as intended.
Why storms Russian pharmaceuticals
Professor Alexei Maschan, director of the Institute of Hematology, Immunology and Cell Technology of the National Research and Practical Center for Pediatric Hematology, Oncology and Immunology, saysabout the disappearance of highly efficient marketsforeign-made medicines needed daily for the treatment of patients with cancer. Russian pharmaceutical companies either do not produce such drugs, or produce too few of them, in inconvenient forms and with very low quality. And this is the situation not only with drugs for chemotherapy, but also with the simplest drugs, such as three percent NaCl, used in the treatment of cancer patients.
Sodium Chloride Supports Appropriateosmotic pressure of blood plasma and extracellular fluid. With a decrease in the concentration of sodium chloride in blood plasma, water passes from the vascular bed to the interstitial fluid, with a significant deficit, spasms of smooth muscles and convulsive contractions of skeletal muscles occur, and the functions of the nervous and cardiovascular systems are disrupted.
0.9% sodium chloride solution isotonic to plasmahuman blood and therefore quickly removed from the vascular bed, only temporarily increasing the volume of circulating fluid. Hypertonic solutions (3-5–10%) are used intravenously and externally. With external application, they contribute to the release of pus, exhibit antimicrobial activity, and when administered intravenously, they increase diuresis and make up for the deficiency of sodium and chlorine ions.
Unfortunately, in recent years, our legislators andofficials are guided not by economic, but by political logic. The requirements of the RF Ministry of Health and the Federal Antimonopoly Service to establish the maximum initial contract price, that is, its reduction from tender to tender, significantly worsened the situation on the market. As a result, an absurd situation began to arise more often when on INN the price for the supply of drugs was set below their prime cost, and manufacturers simply stopped participating in tenders.
In accordance with the rules of justification of the initialthe maximum contract price (NMCC) the customer is invited to first determine the cost of the drug planned for purchase, equal to the price of such a drug in a previous purchase. Then, the previous price is compared with the reference price contained in the information-analytical “monitoring and control system in the field of procurement of medicines for state and municipal needs”. If the previous price is lower than the reference price, then the initial maximum price of the contract is determined as the previous price multiplied by the number of units of the purchased drug.
At the cost of the FAV and Ministry of Healtha significant decrease in the cost of drugs was that Russian pharmaceutical companies simply did not have the funds that they could invest in the development of new drugs or in the modernization of production. Original drugs began to disappear from the market, and their place was replaced by lower-quality generic drugs or even fakes.
In October 2018, a group of leading Russianpsychiatrists sent an appeal then to the head of the Ministry of Health of the Russian Federation Veronika Skvortsova with a request to resume deliveries of the injection form of the Akineton corrector of the German company Desma GmbH. The drug is used to treat Parkinson's disease and is not available in the Russian Federation to reduce the side effects of taking antipsychotics in the treatment of psychiatric diseases and in injectable form. After the cancellation of the FAS (despite the fact that the medicine is included in Vital and Essential Drugs) registration of this drug, due to the overestimation of the price, which, in its opinion, the medicine disappeared from sale in August 2017. Without the use of Akineton, the administration of antipsychotics causes painful extrapyramidal disorders in patients. The drug has generic drugs made in Russia in the form of tablets, the price of which was determined by the FAS as a reference drug, but they cannot be used to treat emergency cases.
In addition, protectionism against Russiancompanies and the priority of the purchase of domestic drugs led to the fact that foreign investment in the localization of production in the Russian Federation turned out to be meaningless: even if there is localized production of the original drug at the auction for state needs (and this is the main sales channel for pharmaceutical companies in the Russian Federation), a generic drug will be purchased, released by a little-known but Russian company.
The situation presented by the Federal Antimonopoly Service of the Russian Federation seriously complicated the situation.in 2019, the draft amendments to the Civil Code of the Russian Federation, allowing “compulsory licensing”, and in fact - the release of drugs by Russian companies without the permission and control of a foreign drug developer in cases where the copyright holder refuses to produce them in our country. Such a legitimate theft of someone else's intellectual property deprives any sense of localization in the Russian Federation of the release of drugs, and even more so - the construction of new pharmaceutical enterprises by foreign companies.
Generics and original drugs
Professor Alexei Maschan saysthat they demand from Russian doctors insteadOriginal foreign drugs use less quality domestic ones. He gives an example that the activity of the “import-substituting” version of the main drug for the fight against acute lymphoblastic leukemia, depending on the batch, can fluctuate several times. As a result, the recurrence rate of this most common malignant tumor in children and, as a result, deaths after replacing the original drug with a Russian generic drug went up sharply.
In the pharmaceutical market, there are twovarieties of medicines - branded (original) drugs and their analogues. The first developed drug with the original formula of the active substance is called branded or original. Development companies invest material and human resources in the synthesis, preclinical and clinical studies of substances and preparations, go through the stages of naming, registration, and launch of the original product on the market. The leaders in 2018 among such companies, according to the DSM Group, are Sanofi, Novartis and Bayer. Original drugs produced by these companies are effective to the extent indicated in the instructions for use, have investigated side effects and contraindications.
Validity of patent protection of the originalthe drug is legally limited: for example, in the USA it is 12 years old, in Russia - 20–25. After patent protection expires, a generic drug based on the formula of the original active ingredient can be released by any pharmaceutical company without the permission of the copyright holder.
Manufacturing Companiesgeneric drugs, take as a basis the formula of the active substance developed previously by the brand company. The composition of excipients, doses and methods of packaging may vary. The generics manual copies the instructions of the original drug, sometimes with some changes. The proof of the effectiveness of the newly obtained drug is bioequivalence - the ability of a similar drug to be absorbed, act and excreted like the original one.
When registering generics in the Russian Federationa simplified procedure for checking their biological equivalence, which often does not establish the degree of complete identity of the presented drug to the original. However, in the current Russian legislation the concept of “original drug” is generally absent, and instead the definition “reference drug” is used, which does not have to be original. As a result, generic drugs equivalent to ... other generics easily get into hospitals and pharmacies.
Naturally, this approach brings to marketinstead of really effective medicines, strange substances, not only not having a therapeutic effect, but also causing a lot of side effects in patients. The patient, in order to prove to Roszdravnadzor a causal relationship between the use of a domestic drug and a negative reaction to it, must wait several times for the symptoms to recur and then go through all the circles of bureaucratic hell to justify the need to purchase an original medicine for him. Naturally, patients or parents of sick children are not eager to experiment with health to satisfy bureaucratic whims and are forced to purchase a branded drug on their own.
Irina Myasnikova, chairman of the board of the interregional public organization "Assistance to patients with cystic fibrosis"says instead of four drugs forFor the treatment of cystic fibrosis, only one was included in the High-Cost Nosology program. "Forgotten" to include in the "High-cost nosology" and high-quality antibiotics used to treat severe exacerbations. Due to the actions of the Ministry of Health, two highly effective original drugs left the Russian market, as they stopped buying them at the expense of the budget. Instead, cheap generics are purchased under 44-FZ, after which remission is reduced from six months to two to three weeks. As a result, the chances of a child with cystic fibrosis surviving into adulthood are only 23%, while in developed countries - more than 60%.
Drugs not registered in the Russian Federation
“Patients face bureaucraticindifference, doctors’ fear of losing their jobs due to the prescription of sanctioned drugs, the inadequacy of the legislation regulating the circulation of drugs, and self-medicate: they themselves try to smuggle pharmaceutical products across the border, ask intermediaries for help, or order drugs, which are then supplied to Russian pharmacies. But the pharmacist who dispensed such a product is also breaking the law. The media has already stirred up the stories of ordinary people against whom legal proceedings have been opened,”believes lawyer Alim Bishenov.
A separate category is patients, drugs.for which they are not officially sold on the territory of the Russian Federation due to lack of registration. Many drugs are innovative and have no analogues in our country or are not suitable for those suffering from a particular disease. And this means that patients with rheumatoid arthritis, epilepsy, oncology, hepatitis cannot be treated normally. The inability to legally buy life-saving drugs makes people look for alternative ways, such as buying online. Such cases are qualified by the Federal Customs Service as smuggling.
The case with Elena was widely publicized.Bogolyubova, who ordered through the global Frizium network a drug to prevent seizures. As part of the drug - clobazam, a substance whose turnover is regulated by a regulation of the Government of the Russian Federation. Thanks to the intervention of Lydia Moniava, director of the House with a Lighthouse hospice and Nyuta Federmesser, head of the Moscow Palliative Care Center, the incident was resolved without a criminal case, but this is far from the only one. To solve the problem, the Ministry of Health of the Russian Federation proposed an algorithm for the legal import of unregistered drugs.
Ekaterina Chistyakova, Development Director at the Give Life Fund,speaks:“Patients with drug allergies will suffer. For example, a drug has Russian and Israeli analogues, but you are allergic to them, and you need a German medicine (and it is under sanctions). This is a hypothetical situation. Patients with severe chronic diseases who need drugs for life and in large doses may be affected. For example, an antibiotic for the treatment of pneumonia can be of any quality, since the course of treatment does not last long and the doses are small. But exactly the same antibiotic for a patient with cystic fibrosis should be of the highest quality (in terms of toxicity in particular), since it is taken daily, for life, and in large doses. Competition in the drug market may be affected. In order for all manufacturers to work on the quality and availability of their drugs, the market must be large. But if the access of drugs to the Russian market is limited, then competition may shrink.
The United States will definitely not suffer. The Russian drug market is not a very tasty pie. There are a lot of people in Russia, but not enough money. And what interests any farm, and even American? That's right, the money that can be obtained from the sale of drugs. Only the poor can suffer from the adoption of the law, and the rich will certainly not suffer. The draft law does not limit the ability of citizens to import any medicine for personal use. And who can go to Germany for pills for themselves? Certainly not those who are poor. But the rich can, and therefore, after the adoption of the law, they will only feel some inconvenience. ”
The official alternative to the illegal online drug trade
Suffering sluggish schizophrenia Daria Belyaevafrom Yekaterinburg in April 2019, they were detained at the post office for receiving 30 tablets of the antidepressant bupropion. According to Daria, domestic selective serotonin reuptake inhibitors did not help her cope with the manifestations of the disease and had a large number of unpleasant side effects, so she decided to try a drug that has a different mechanism of action - affecting the production of dopamine and norepinephrine.
GlaxoSmithKline registered in the Russian FederationWellbutrin (bupropion) in 2010, but the Ministry of Health canceled the registration of the drug in 2016. This medicine is often used in world medical practice, in the USA alone in 2016 it was prescribed more than 23 million times. Having proved its effectiveness and safety for 30 years of its release, this drug does not cause addiction and side effects. Although bupropion is not on the list of drugs prohibited for import into the Russian Federation, the FCS expert considered that the active substance of the drug is similar in molecular composition to the prohibited ephedron.
To get the necessary drug, registration for which is not available in the Russian Federation, you can go in three ways:
- personally bring a small amount of the drug;
- contact your regional healthcare institution;
- contact a charity foundation.
In the first case, the patient bears the costs forflying / traveling to another country may have difficulty acquiring the drug locally. When imported into the Russian Federation, the Customs Service will require a prescription or a doctor’s opinion on the need to take this medicine. It will also be necessary to prove that the drug is imported for personal rather than commercial purposes.
The algorithms of the next two paragraphs are similar, sohow the charity fund will carry out the order of the necessary drug through public health institutions. In this case, on behalf of the patient, a package of documents will be presented:
- Birth certificate (for the child) or a copy of the passport, certified by the signature and seal of the person in charge.
- The conclusion of the consultation or medical commission on the need to use a particular drug.
- Application for import authorization.
- Covering letter.
Ministry of Health clarifiedfilling out an application. After making a decision and issuing a permit, an agreement is made with the courier delivery service, and the drug is imported into the country at the appointed time. The Chairman of the Moscow City Scientific Society of Therapists (MGNOT), Professor Pavel Vorobyov, confirms that such an algorithm works, but significant delays occur at the stage of obtaining the opinion of the medical commission.
Evgeniy Kan, Deputy General Director of the federal medical concierge service Etnamed, believes:“Many Russians accepted the news of the cancellationcertification of medicines is wary of two reasons: firstly, they considered that now they would uncontrolledly import vaccine for vaccinations into Russia. However, this is not so - immunobiological preparations, that is, a specially created commission of representatives of the Ministry of Health, Roszdravnadzor, the Ministry of Industry and Trade and pharmaceutical associations will deal with the vaccine. Before sending to pharmacies, each batch of vaccines will be checked - see how it meets the requirements established during the registration of the drug. Secondly, people felt that since they had abolished mandatory certification, drug manufacturers and suppliers would submit information about them voluntarily. This is also not true. In fact, one type of documentation replaces another, and this is mandatory for everyone. Now the quality of medicines will be confirmed not by certification centers, but by federal structures. This is the Scientific Center for Expertise of Medical Devices for Medical Use of the Ministry of Health of the Russian Federation and the Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Devices for Medical Use of Roszdravnadzor. Previously, a certificate was received for each batch and batch of drugs. Due to the lengthy and cumbersome procedures, some certification authorities resorted to a simplified quality control procedure - they looked, roughly speaking, only at the packaging, because of which low-quality medicines entered the market. The system showed that it can not protect the market from counterfeit medicines, because certification authorities often approached their task formally. In fact, the system for confirming the quality of drugs is not canceled, it will just now be confirmed by federal authorities, not certification authorities. You can call it a global reform. And they conduct it in order to, on the contrary, ensure safety and quality. In addition, remember that another anti-counterfeiting system will soon begin to work - mandatory drug labeling. All drugs will have their own barcode.
Who exactly is on hand with this initiative istesting laboratories and quality commissions. They obviously have more work to do. Business and manufacturers will be forced to adapt. Like any innovation, before it works effectively, it must go through a break-in stage, during which all participants in the process, as a rule, experience inconvenience. "
Matvey Chepushtanov from the city of Rubtsovsk AltaiKrai became one of the few patients with spinal muscular atrophy (SMA) who received the drug "Spinrase" at the expense of the state budget. “We acted according to the scheme approved by the Ministry of Health - Matvey hospitalization, medical commission. Probably, we were more fortunate than others, ”says Papa Matvey Roman. - The drug must be injected into the spinal cord, in Russia there are no specialists and medical institutions ready to do this. For this, we flew to Israel - only there they agreed to give us injections as foreigners. Six injections were paid, four have already been done. ”
Spinal muscular atrophy- a heterogeneous group of genetic hereditarydiseases occurring with damage or loss of motor neurons of the spinal cord. The disease manifests itself in infancy; children with this diagnosis, as a rule, do not live to see the age of five. The list of the SMA Families Foundation includes about 400 patients; in total, in the Russian Federation, according to various estimates, there are from 7 to 24 thousand people.
There is only one drug in the worldstopping the development of the disease. This is Spinrase from Biogen, one injection of which costs about 10 million rubles. The Ministry of Health has been considering the issue of registration of Spinraza since February 2019 in an “accelerated mode”, but it was entered into the state registry of medicines only on August 19, 2019.
Cancellation of mandatory certification of drugs imported from abroad
It may seem that under pressurepublic, the state has withdrawn from the problem of certification of medicines. In fact, this is not so, and the procedure for admitting foreign-made drugs remains permissive.
In fact, the state has replaced the requirementproviding a certificate received by the manufacturer at independent certification centers for the requirement to submit a declaration of conformity, verified by federal government agencies. Theoretically, such an order will reduce the time it takes to go through bureaucratic barriers to a few days, but no one knows how the new rules will work in reality.
Also for vaccines and otherimmunobiological preparations the previous procedure is in place, with the exception that permission to admit the drug will now be issued by a special commission of representatives from the Ministry of Health, Roszdravnadzor, the Ministry of Industry and Trade and pharmaceutical associations.
Medicinal anti-sanctions, who suffered?
June 4, 2018, Vladimir Putin was signedLaw No. 127-FZ on the introduction of counter-sanctions in the form of a ban on the import of products, including drugs, from the United States and other countries that support US sanctions against the Russian Federation. The list of these drugs should have been approved by the Government of Russia.
This bill caused a great resonance insociety. A petition was created calling for a review of retaliatory measures and a ban on the import of foreign medicines. The author of the petition, Alexander Saversky, president of the League of Patient Advocates League, urged the Government of the Russian Federation to rethink the provisions of the document and not allow counter-sanctions to harm citizens of their own country. Naturally, this petition, like the vast majority of others, was ignored by the Russian authorities.
First of all, narrowing the rangemedicines affected those who used branded drugs that have no analogues in the Russian Federation. The doctor, of course, can verbally recommend a specific medicine to the patient that has a similar effect to a medication not available for sale, but in any case, the patient must understand that this drug will not be as effective or safe.
Resident of the Belgorod region Yuri Mozalev fortreatment of myeloma (blood cancer) due to the fact that conventional methods of treatment have been ineffective, and the disease is progressing, the Federal Medical Research Center named after V. A. Almazov issued a recommendation on the use of the drug "Pomalidomide". Despite the recommendation, the Department of Health of the Belgorod Region refused to purchase imported medicine for the patient, and therefore the patient was forced to go to court.
The Regional Court also refused the plaintiff, substantiating itsthe decision is that the conclusion of the medical commission contained a number of inaccuracies. The decision of the Supreme Court found that the task of correctly and timely processing of documents for obtaining the required drug rests with the officials themselves, therefore inaccuracies in the documents cannot serve as a basis for refusing to purchase the drug, thereby obliging the regional health department to purchase the required drug.
Patients with drug allergies suffered. If, for example, the drug has Russian and Israeli analogues, but the patient is allergic to them and they need German medicine (which is sanctioned), then they will most likely have to be imported in a roundabout way.
Charity Fund Helps Misha's ParentsRabotkina, suffering from acute lymphoblastic leukemia, to raise 495,000 rubles for the purchase of three bottles of Onkaspar in Germany, because after several courses of chemotherapy he had a severe allergic reaction to the Russian analogue Asparaginase. Registration of Onkaspar in the Russian Federation was terminated in 2018 by the Ministry of Health due to the fact that the manufacturer changed the dosage form of the drug - from injection for lyophilisate (the powder from which the solution is prepared immediately before injection). The last batch of Onkaspar was officially imported into the Russian Federation in the spring of 2018, since then the drug can only be purchased abroad. As of January 2020, registration with Onkaspar is still missing.
Severely affected patientsdiseases. If, for example, an antibiotic for treating pneumonia in an ordinary person can be of any manufacturer, since the course of treatment does not last long and the doses are small, then the antibiotic for a patient with cystic fibrosis should be of the highest quality and least toxic, as it is taken daily, for life and in large doses . Drugs of this class in Russia are not available at all.
According to the doctor Alexei Romanov, even the presence ofGenerics registered in the Russian Federation is not a guarantee that the state will fulfill the task of providing medicines to citizens. For example, despite the fact that generics of the drug “Baraclude”, used to treat viral hepatitis B and C, are present in the Register of Medicinal Products, in fact they are not marketed. Nevertheless, the original drug "Baraclude" was on the list of drugs that fell under anti-sanctions, as it is produced in the United States.
Naturally, competition in the Russian market suffered. There is no longer any incentive for domestic manufacturers to chase product quality - the government will buy their drug at the auction anyway.
Who definitely didn’t suffer from the introduction of anti-sanctions,so these are foreign manufacturers. Foreign pharmaceutical companies are primarily focused on the release of new drugs with high added value. Old low-margin drugs, and even more so drugs with expiring patent protection, are of much less interest to them. The rich Russians, who can always afford to travel abroad simply to purchase drugs that are forbidden in the Russian Federation, will not suffer in any way.
Ministry of Health requested listingschildren who need unregistered drugs for the centralized importation of drugs in an amount sufficient for a year of therapy for each child. Lists are being compiled by the Children's House with a Lighthouse.
According to former Minister of Health of the Russian Federation Veronika Skvortsova, at the moment no more than 7 children across the country need unregistered drugs.
However, in reality, such a scheme, parents say,it doesn’t work yet, and even these children are far from 7. According to Lydia Moniava, director of the House with a Lighthouse hospice, more than a year ago a list of young patients from more than 2,000 people who needed drugs not registered in the Russian Federation was transferred to the Ministry of Health .
In August 2019, to the Minister who promisedto assist with deliveries, an updated registry was sent, but the situation still remains unresolved. The promised separate purchase for the hospice of the required drugs was never made. After a wave of protests, then the head of the Ministry of Health Veronika Skvortsova instructed Roszdravnadzor only to conduct a comprehensive check on the provision of medicines for patients with cystic fibrosis and prepare a detailed report with proposals to improve the situation.