Posted 27 апреля 2022, 07:10
Published 27 апреля 2022, 07:10
Modified 24 декабря 2022, 22:36
Updated 24 декабря 2022, 22:36
While the sanctioning states have made it clear that the restrictions will not affect the medical industry, and the supply of drugs and equipment will continue, in reality, many clinics are already experiencing serious difficulties.
Yulia Suntsova, Natalya Seybil
Donation is considered important all over the world. Collected blood, materials and organs for transplantation save thousands of lives every day.
International registries, for example, help patients with leukemia - they look for a suitable donor who could not be found within the country where the patient lives.
The closed payment systems and the restriction of air traffic make it impossible to quickly transport transplants - and their suitability for transplantation is counted by minutes. Transport restrictions also affect those who want to travel outside of Russia for this purpose. There are growing problems with graft storage solutions - and without them, donor materials generally lose their meaning.
Equipment for the conservation of blood and the production of medicines from its components is also taken abroad. There are only a few laboratories in the country where it is available. In the event that the supply of this high-tech equipment is stopped, the existence of blood quarantine and storage in Russia in general is called into question.
There are many blood-based medicines, and all of them are vital and indispensable for patients. Important components, for example: blood clotting factors (a group of substances), proteins that patients with hemophilia take, and immunoglobulins. With many pathologies, in particular immunodeficiencies and various autoimmune diseases, there is nothing to replace immunoglobulins.
In Russia, the immunoglobulin crisis has been observed since the end of 2021. Now supply disruptions are becoming chronic. As many as 2,000 patients could be cut off from life-saving therapy that needs to be done every month.
The country's needs for blood and donor materials are not covered. The state fence system works with slippage, and the technologies and equipment do not meet modern requirements. Only the simplest products are produced from blood plasma in the country, and bone marrow is often ordered from abroad.
"In order to modernize the blood collection system, more open data is needed - about the functioning of the blood service itself (data on patients are depersonalized by default). NGOs and other participating organizations could significantly help the development of donorship in the country. Now the processes are slowed down by the lack of an overall picture before our eyes. Today's blood service in Russia is a very closed and self-contained system. And in order to quickly search for and find donors for recipients, it is important to understand what is happening in each region, city, what is the number of donations per month (including for all their types), what percentage of marriage and its reasons, what percentage of rejections and for what reason they happened. Other countries create public system APIs, in our country public data is shown only occasionally and only for individual centers", - says Ruslan Shekurov, the head of the social network of donors of the NGO "DonorSearch.org".
On April 14, a bill was submitted to the State Duma for consideration, allowing the transfer of Russian blood plasma not only to medical institutions (as it has always been), but also to pharmaceutical companies. The initiative assumes a public-private partnership, however, the state monopoly on the procurement, storage and transportation of blood and its components remains in force. Thus, at the expense of resources, equipment and infrastructure, investments of private companies, they are trying to increase the volume of domestic production of drugs from blood plasma in order to eliminate dependence on imported raw materials, follows from the explanatory note to the bill.
In addition to the ban on the export of donated blood and its components from the Russian Federation, a ban on the export of pharmaceutical substances from blood plasma "as a valuable biological resource" is also added.
"It seems to me that they are expanding access to work with donated blood in order to scale up the production of drugs. The adoption of the law is an attempt to achieve self-sufficiency in vital areas. We bought some of the pharmaceuticals abroad, now we can probably be cut off from this opportunity. There is not enough state capacity to ensure the required volume of drug production, so private production facilities are connected. This had to be done, of course, not in the months when something happened, but years and decades in advance. These things don't happen quickly. It's not about money and equipment. Medicine is a science-intensive industry. We need personnel, we need people who know how to do this and are ready to pick up technology. That's the trouble with this", - says Nikolay Prokhorenko, First Vice-Rector of the Higher School of Health Management Organization.
By the way, they will not pay the Russians for the blood that will go to the production of medicines. Parliamentarians fear that otherwise the poor will rush into donation and make it the main source of income, and besides, they will all donate blood only to pharmaceutical companies, and patients in medical institutions who need blood transfusion will not have enough of it.
"As far as I know, in general, the domestic healthcare covers the need for donor blood, but only the basic one. If you need a rapid increase in volumes, for example, for the wounded, then there will be a shortage. Other countries solve this problem with money. But then another problem arises: everyone goes to donate blood. And those who, on the eve of the surrender, want to drink / inject (and their blood is different). It is found in this blood and HIV, tuberculosis, viral hepatitis. Such blood must go through a quarantine period (quarantines last up to six months), such blood can only be used after a secondary check of the donor's tests", - says Nikolay Prokhorenko.
Equipment for blood storage and quarantine is very expensive and in Russia the subjects who own it can be counted on the fingers of their hands. If something happens to these precious pieces of imported equipment (for example, wear and tear), and there are no new deliveries, the existence of such a thing as blood quarantine can be forgotten.
In Germany, of course, they found a way out. Blood that has not been "quarantined" can be used for transfusion if the patient signs an agreement about the risk of being infected with viral hepatitis (1 case in 50 thousand) or HIV (1 case in 2 million). In Russia, there is no such option yet, the question itself, of course, is debatable and has a pronounced socio-political aspect, the expert adds.
While the state is trying to solve the issue of self-sufficiency in medicines made from blood, other problems arise due to sanctions with patients dependent on donor materials.
The countries promised that they would not impose bans on the supply of medicines and medical equipment. For the most part, the promise was kept. But there are overlays with logistics, packaging, and the so-called. components, preparations for preservation, dual-use equipment, etc. All these failures directly affect the availability of medical care for patients in Russia.
The imposed sanctions are not directly directed against the donation of, for example, bone marrow, but actually prevent the receipt of a transplant both from abroad for Russian patients, and in the opposite direction.
The process of obtaining bone marrow from a foreign non-domestic donor is not very simple: a special analysis of HLA typing, a request from a Russian clinic to a foreign organization with access to the donor database, a medical commission, the elimination of errors in the compatibility of donor material, donor activation, biomaterial sampling by a courier from Russia.
"The average cost of the entire process is 20 thousand euros, takes about 3 months and is not covered by the state. As a rule, charitable organizations help patients. Unfortunately, not every patient can wait that long. Accordingly, due to the limitation of transnational transactions, NPOs may have problems with paying for donor search and activation services to a foreign partner. The lack of direct air communication with European countries (and most donors for Russian citizens are usually located in Germany and Poland) disrupts the logistics of delivering biomaterial for confirmatory typing, as well as the cells themselves. The search for new logistics leads to an increase in the cost of finding and activating a donor and an increase in waiting times. Although the share of foreign donor material is now small, it still ensures the availability of transplantation from an unrelated donor, and often this is necessary precisely for medical reasons (when relatives are not suitable)", - says Alexander Sinitsyn, General Director of the Tinkoff Family Foundation.
Andrey Abrosimov, a hematologist and pediatrician at the admission department of the Dmitry Rogachev National Research Center for Pediatric Hematology, Oncology and Immunology, explains why Russian clinics today prefer to search for bone marrow donors abroad:
"There is no unified national registry of bone marrow and hematopoietic stem cell donors in the Russian Federation, but there are 18 isolated ones, two of which are private. Clinics have to apply to each of them separately, which lengthens and complicates the search for donor material, and they need high-tech treatment urgently, in the horizon of a month - a month and a half. But even after making these scattered requests, we know that the chances of finding a donor are not great. The total number of donors in all Russian registries is about 170 thousand people, which is obviously not enough. About 10,000 hematopoietic cell (or bone marrow) transplantations are required annually in Russia, while today only no more than 2,000 are performed annually".
At the moment, the search and activation of bone marrow donors have not disappeared in Russia. The last meeting point of two couriers - from Germany and Russia was Istanbul airport. However, the situation is really complicated due to payment restrictions and difficulties with air traffic - and the courier has only 72 hours to deliver the special container, Andrey Abrosimov adds.