Boris Mendelevich: “I understand perfectly well the indignation of people when one drug is changed for another”

“It is time to transfer drug provision for orphan patients to the federal level”

I'll start from afar. To date, there are 758 items in the list of VED — these are not commercial names, but so-called international non-proprietary names. The number of domestic drugs in this list has so far been small. The order of Prime Minister Mishustin two weeks ago increased this number four times.

What is the main point of the list? It is very simple — in the regulation of wholesale and retail extra charges on medicines from the list. Manufacturers and suppliers do not have the right to “inflate” the price of drugs from this list above a certain percentage. Moreover, when setting these percentages, the special service also studies the cost for which the corresponding drugs are sold in certain producing countries (these are the so-called reference prices). For example, now the list includes Spinraza — the drug for people with spinal muscular atrophy. In the countries where it is produced, it costs two or even three times cheaper than in Russia. This is a very expensive drug, like many others on the list of drugs for treating orphan diseases.

Certainly, we need to work in two directions: first, we need to negotiate with manufacturers so that they reduce prices. Second, it is time to transfer drug provision for orphan patients to the federal level. Because regional budgets cannot cope with such a load: innovative drugs that cost a lot of money (up to several tens of millions per injection) appear constantly. I remember that one of the healthcare officials bitterly joked that it is much more profitable for the region to buy an apartment for a patient in Moscow, register him or her there and transfer to the capital for support rather than to keep him or her in the region.

But this problem is gradually being resolved. Some drugs for the treatment of orphan diseases are already being provided at the federal level — this year, two more “orphan” drugs have been added to the federal list, and there are already 14 of them.

“The role of the VED list is seriously increasing”

I have already told you that the State Duma has recently passed the law on creating a federal register of beneficiaries. This is also relevant to the topic we are talking about today. The expansion of the list of VED and the list of drugs produced in Russia will primarily affect beneficiaries. The lists of medicines will now also be unified.

Until now, the federal register had its own list of medicines for beneficiaries (240 drugs), and for regional beneficiaries — its own lists, which differed from one subject to another. Now all beneficiaries will be linked to a single register and receive all drugs from the list of VED for free.

This list does not include medical devices — for example, consumables, hygiene supplies and equipment (necessary for certain diseases). I think we should also think about creating a single list of medical devices in addition to the list of VED.

So, the role of the VED list is seriously increasing. If previously it was not directly related to beneficiaries, today it is linked to all preferential provision of medicines. Besides, domestic health care is going to what is called drug insurance or drug compensation. I hope that in the coming years we will reach a point when we provide people with drugs not only on benefits and not only in hospitals but also in the outpatient network on prescription. And when this happens, people will be provided with free medicines just according to the list of VED.

Why is it important to increase the percentage of domestic medicines in this list?

Because the country's drug safety is a very important thing. In recent years, there has often been a shortage of a particular drug. It is absent at pharmacies, and benefit recipients can't get it.

First, this can happen when distributors impose their own price in the procurement. This is especially dangerous if the supplier in Russia is exclusive — a kind of monopoly can lead to adverse price changes.

Second, we must take into account the significant volatility of the ruble. Over the past 5 years, due to the fall in the exchange rate of the national currency, imported medicines have increased in price by more than two times. This is a serious burden on the budgets (federal and regional ones), as well as on the pocket of any patient (we still buy most drug for money, we do not get them for free). However, no matter how much we would like to increase the budget for healthcare, it is not infinite, so the funds allocated for it must be spent as efficiently as possible (and the effect in healthcare is the number of people whose condition has been improved). And this, by the way, is a problem not only for our country but for any other country. I have studied the healthcare system in Germany, France, and Israel — there citizens ask the same questions.

Therefore, the more domestic medicines in the list, the less the risk of their multiple rise in price after the dollar.

Third, the situation with coronavirus has shown the importance of some autonomy in the country's drug supply. For example, if the need for a certain drug increases within a country, it can significantly reduce supplies abroad to provide them to its citizens. This will inevitably lead to a deficit.

Accordingly, the list of VED — those drugs without which patients simply can not live, should be, as they say, feasible. To do this, the drug supply must be made as autonomous as possible (I mean to ensure the production of the maximum possible amount of VED within the Russian Federation).

“The topic of generics is a problem not only for our country but also for the whole world”

Certainly, it is necessary to move to the domestic supply of medicines very carefully, move smoothly and in no case act rashly. It shouldn't be an idea for the sake of an idea — to make 100% of the list Russian. The idea is different: the list should be balanced. In recent years, the pharmaceutical industry has been moving forward with leaps and bounds. Innovative medicines are emerging. Literally two years pass — and the disease, which was previously considered incurable, can now be cured with just one injection. That is why the increase in the number of Russian drugs in the list of VED shouldn't prevent the inclusion of innovative drugs produced abroad!

But non-innovative drugs remain on the list. There may be a problem with the lack of effectiveness of certain generics (medicines based on the original active substance). The topic of generics is a problem not only for our country but also for the whole world. Undoubtedly, there is a certain percentage of patients who, when given another drug (by trade name), either get a side effect, or the drug does not affect them at all. So, one shouldn't be afraid that they will be given another drug in any case. There is a scheme for how to continue to get the drug that helps you, and it was developed in detail long ago.

There is an algorithm of actions that doctors must perform in order to record either a side effect of a generic drug or its ineffectiveness for the treatment of a specific pathology in a patient. These are objectively formalised indicators. And if this is proved, then no one disputes this — doctors prescribe the necessary imported drug (foreign-made drugs are not excluded from the list of VED).

But the percentage of actually proven cases of inefficiency or side effects is not comparable to the total number of people who complain about generics. There's also placebo effect, psychological induction. The same chemical made in different laboratories cannot be so different as to affect the vast majority of people differently. Many years ago, our country signed an international agreement under which all pharmaceutical production passes through the GMP standard. This is an international standard that sets the production conditions. If the manufacturer does not have a certificate of compliance with this standard, no one will assign it this standard. Therefore, generics in Russia are produced in full compliance with international standards, and we do not have any sovereign standards.

By the way, the distrust of our own production of medicines is not just a Russian problem. Let's take, for example, Hungary, which is very seriously advanced in terms of pharmaceuticals and has supplied at least half of Europe with modern high-quality drugs for many years. But even there, when generics begin to be produced, people begin to be very indignant. So there is no prophet in own country.

“The main thing that we lack is clarification”

I understand that from the point of view of an average person, the new rules look quite grim: “The state does not have the money to buy a foreign drug, so it gives me a domestic one.” I understand perfectly well the indignation of people when one drug is changed for another.

But this is only because the main thing that we lack is clarification. Officials sometimes need to go down to people, explain, prove and explain. The pharmaceutical industry in our country is developing very actively. Our production and development are at international level. And people need to know and to be shown it.

To avoid loss in quality of treatment and the growing burden on the budget, we need, first, to establish the algorithm of establishing the objective state of health, if a person complains of the ineffectiveness of the drug. Second, it is necessary to inform people about production, how it is done, that it is done under the supervision of international inspectors according to international standards. And if there are violations in the system of drug supply — you need to immediately contact the Department of Roszdravnadzor.

To sum up, the country's drug safety is very important for us. We have seen from the example of the coronavirus that we must be prepared for everything, and every country in the world strives for sovereignty, including in the field of medicines. Therefore, the list of VED is changing in the direction of greater representation of Russian medicines in it.

But this does not mean that we refuse drugs that are produced abroad, and they are not thrown out of the list of VED! We are happy and welcome the development of innovative tools, and we also try to prevent the deterioration of the quality of life and improper treatment of patients with any diseases, even the most rare ones.