Original drug or generic?
Sergey Martsevich: "Copies of medicines, as well as copies in art, are different""Arguments and facts", 24.06.2010
We are talking about the original drugs and their copies – generics – with Sergey Martsevich, Head of the Department of Preventive Pharmacology of the Department of Preventive Medicine of Roszdrav, Professor of the Department of Evidence-Based Medicine of the M.I. Sechenov MMA.
Let 's define in terms of"AiF": – Sergey Yurievich, let's clarify what is the original drug and what is a generic?
SM: – The original is the one that was first synthesized by some company, studied, patented and released using the original technology. Ideally, the original drug should undergo serious clinical trials. But, unfortunately, this does not always happen.
"AiF": – Even in the USA and in Europe?
SM: – Of course! Do not assume that any original drug is obviously good. First of all, you need to look at which molecule underlies it (an international nonproprietary name), and secondly, what evidence of the effectiveness of this molecule exists. And the third question is what this molecule is represented by: an original drug or a copy of it, a generic.
And one more important point. A generic drug can be registered and produced only after the expiration of the patent of the original drug, and this is usually 15-20 years. If we take, for example, oncology, where new drugs appear very quickly, there to treat with generics means to treat with old drugs, realizing that there are more modern and probably more effective. And in cardiology, the picture is different. Over the past five to ten years, we have received few fundamentally new drugs and continue to successfully use the old (very good!): statins, beta blockers, ACE inhibitors, aspirin, which were created 15-20 years ago, or even more.
"AiF": – That is, a generic is an officially recognized exact copy of someone's invention?
SM: – If that were the case, we would not be discussing this problem now. Yes, the copied drug is based on the same active substance as in the original, but the method of production, the composition of impurities, fillers may be different. That is, the degree of compliance with the original may vary. Generics are copies and, like any copies, including in art, are different.
The curse of domestic pharmaceutical manufacturers"AiF": – And how can an inexperienced person figure it out?
SM: – First: it is necessary to clearly know how and where the generic is produced, whether GMP standards (international requirements for the production of pharmaceuticals) are observed. – Ed.). According to official statistics, only 10% of Russian medicines are manufactured according to the GMP standard. That is, we ourselves admit that 90% of our medicines do not correspond to it! And at the same time we promote the same generics.
"AiF": – What are the requirements in addition to GMP compliance for high-quality generics?
SM: – Determination of their pharmaceutical equivalence (compliance. – Ed.). Tablets are examined without the participation of the patient. This is the second stage. And the third, which is most criticized and discussed, is the study of the behavior of a substance in the body of a healthy volunteer.
"AiF": – Can an exact copy of the medicine behave differently than the original?
SM: – There can be many moments here. How are these studies conducted? Healthy people are selected. In Russia, this requires 18 people. Each of them receives a generic pill, and after a week or two – a tablet of the original drug. Take blood samples and see if the drug is distributed equally in the body. It is considered that if the generic hits the target by 100% plus or minus 5%, then it corresponds to the original. As a result, it turns out that the compliance of the generic with the original drug is guaranteed, but ... not 100%.
The copies are accurate and not very"AiF": – What would you recommend to people – generics or original drugs, even if they are obviously more expensive?
SM: – Personally, I try to buy original drugs for my relatives and myself. Not because I don't trust generics in principle, but because I very often don't have complete information about them.
But treatment with only original drugs is purely economically impossible in any country, and especially in our country. So the quality of generics and their huge range need to be investigated in each case. The first, of course, is to pay attention to the manufacturer. Large Western companies, as a rule, produce high-quality drugs. Although there are exceptions. The advice is very simple: go to the website of the US Food and Drug Administration – FDA and see if this generic is registered there. For me, this is proof that he has passed a rigorous test.
Unfortunately, this method of verification does not work for Russian drugs. Perhaps only a doctor can figure out these drugs, and even then, if specific information is provided: where the active molecule is taken, what raw materials are used, whether GMP standards are met, whether a medical representative of the company who came to the doctor with beautiful brochures describing the properties of an inexpensive new generic, tell about the tests and certifications that he passed.
So, our dear citizens, it's time to master the evidence base. Be critical of any advertising. You check the shelf life of the product, even if you shop in a very decent store… And in the pharmaceutical market, the price of reckless trust may be too high.
"AiF": – And when the choice is limited to the list of preferential medicines?
SM: – To be honest, I think it's better to receive monetary compensation. At least for these 500-600 rubles, you can choose the right medicine for yourself, and not depend on what you brought to a "preferential" pharmacy or to a polyclinic. The trouble is that primary care doctors, who, in fact, treat the majority of patients, have completely abandoned the attempt to assess the quality of medicines that are offered to them. And the choice of drugs in the list of preferential medicines is conditional: today one generic was brought, and tomorrow another, and the doctor prescribes what is there.
And about money
"AiF": – The main, if not the only advantage of a generic is the price. Why is generic always cheaper than the original drug?
SM: – The official point of view is this: since an innovative drug requires a lot of money to create and study. It really is. But, on the other hand, if this is the reason, all copies would be 10 times cheaper than their originals. And we see that there are generics that approach the price of the original drug, and there are penny generics. Let's take the most prescribed drug in Russian cardiology, enalapril. There are more than a hundred generics for it.
"AiF": – Russian production?
SM: – Including. And these hundred generics are very different, and their cost is ten times different.
"AiF": – How to explain it?
SM: – The degree of compliance of the generic with the original drug is directly proportional to the rigidity of the registration standards. In the USA, for example, these norms are strict. Skipping a low-quality generic is unlikely there. And then periodically there are some scandals. There are cases when a generic is registered and used in the Russian Federation, and we open the FDA website and see that in the USA this generic was denied registration.
But we also have companies that produce very decent and decent generics, although they are not the leaders in the market, because they do not have their own promotion system, a network of medical representatives… So they are trudging along with their high-quality generics in the tail.