What makes up the price of medicines
How many rubles are in a tablet?
The final price for a package of medicine in a pharmacy consists of many components. In theory, they should all be clear and logical, but in fact it turns out that even experts cannot always explain why medicines with the same active ingredient may differ in price by thousands of times.
On the one hand, medicines, like any other product, obey the laws of the market and depend on supply and demand. On the other hand, it is a product of strategic importance – the health of its residents depends on its price and availability in a particular country. How and who forms the price of the medicine, and whether they will ever get cheaper, said Alexander Hadzhidis, Chief clinical pharmacologist of St. Petersburg.
How much does a pill costThe cost of a drug consists, first of all, of its cost price – the actual costs of the manufacturer for the development, research and production of a specific drug.
According to Alexander Hadjidis, it is believed that the cost is 30-35% of the final cost of the drug, but no one knows for sure.
– In the total price of the drug, the cost of the active substance is no more than 5%, 20% is the trade margin, which is laid down by the manufacturer himself, 25% is the cost of research and development (so–called R& D, research and development) and half of the cost of one package of the drug is marketing costs: promotion of the drug on the market and advertising, because the introduction of a new drug to the market is a very risky process," explains Alexander Hadzhidis.
The cost of producing a newly invented drug is estimated in billions of dollars. Therefore, the price of original drugs will always be fairly higher than the prices of reproduced drugs.
– Every year, only about 15 new molecules appear in the world, respectively, the number of new original drugs on the market per year is calculated in units, – explains Alexander Hadzhidis. – In 1995, the cost of bringing one original drug to the market (including conducting preclinical, clinical and post-marketing studies) averaged about $ 100 million, in 2000-2005, the costs of one manufacturer increased to almost one and a half billion dollars, now they reach $ 10 billion. And this, consider, the budget of the whole of St. Petersburg.
At the same time, it can take up to 10-12 years for the manufacturer to develop only one drug. And at every stage of development – from the chemical laboratory to human testing, there is always a risk of complete failure. Even after all the research, it may turn out that the drug has side effects that did not manifest on three thousand people, then it will have to be withdrawn from the market, and therefore lose the money invested in it from scratch.
Why Aspirins cost differentlyIf a drug that has just appeared on the market is invented and synthesized for the first time by one company, it is called original.
It has been protected by a patent for 20 years – other manufacturers cannot produce and sell medicines with the same active substance.
After this time, the chemical formula of the drug can be copied by other manufacturers. They register a drug with the same active substance, but under a different trade name. For example, "Viagra" is an original Pfizer drug with the active ingredient sildenafil, its analogues with the same substance are "Ternetis", "Dynamico", "Taxi", "Revazio", "Vizarsin" and others.
In Russia, manufacturers of reproduced drugs (generics) are not required to check their medicine for the identity of the original drug, and therefore bear the same financial losses that the drug developer had.
According to Russian legislation, generics and original drugs must have pharmaceutical equivalence (that is, contain the same active substance in the same dosage), biological equivalence (equally absorbed into the blood and excreted from the body). At the same time, it is not prescribed anywhere that such drugs should act equally, be as effective and safe, that is, they also have therapeutic equivalence.
– In fact, companies producing generics produce a completely new medicine: other dyes that are used in them, other fillers (auxiliary, inactive substances), even another substance of the active substance create a new medicine. However, in Russia it should not be investigated as thoroughly as its original version. — explains Alexander Hadzhidis.
According to the chief clinical pharmacologist of St. Petersburg, in addition to the fact that there are no studies of the therapeutic equivalence of original and reproduced drugs in Russia, biological identity is also being investigated doubtfully.
– According to Russian laws, 20% differences with the original drug are allowed. That is, it is considered normal that out of 100 mg of the active substance, only 80 mg will actually "work", – the expert explains. – In addition, these studies themselves are conducted very formally: 18-20 volunteers participating in such a study are paid one and a half thousand rubles, three months of waiting – and there is a paper from the Ministry of Health on the bioequivalence of drugs. The manufacturer receives a formal admission to the market, behind which there is nothing.
Since generics are cheaper to produce (there are no costs for drug development, for safety research), they should cost significantly cheaper than the original drugs. However, what exactly their price should be, is also not specified in Russian legislation. In the USA, for example, their price is fixed at around 20% below the price of the original drug, in Europe the difference can be 20-50%. In Russia, some reproduced medicines may, by a strange coincidence, be more expensive than the original.
– And we also have medicines 1000 times cheaper than the original ones. It would seem that we should be happy about this, but this is very frightening data. They only say that no one checks what our patients really buy," explains Alexander Hadzhidis.
From the manufacturer to the buyer – 40%What the final price of the medicine will be, the Federal Tariff Service decides together with the Ministry of Health.
After the medicine has passed the state registration procedure, experts determine its price.
The cost of imported medicines is determined based on the analysis of weighted average prices for this drug in 21 countries. That is, the Ministry of Health and the Federal Tax Service compare how much this medicine costs on average in other countries, and on the basis of these data they decide on the maximum allowable price for the drug in Russia.
It is impossible to say exactly how the price of Russian medicines is formed, because there is nothing to compare them with – they are not used in other countries. As the chief clinical pharmacologist of St. Petersburg suggests, it is taken, as they say, from the ceiling, by agreement with the manufacturer.
A distributor company will add another 15% to this final price, a pharmacy can "wind up" 25%. In total, the difference between what the manufacturer released and what the buyer received can be up to 40%.
Who regulates the price of medicine – the state or the market?Every state strives to participate in the pricing of medicines, since their accessibility to the population is an integral part of social policy and healthcare.
However, depending on how actively it does this, pricing schemes may be different.
- Market pricing. It is based on the classical scheme of supply and demand. If the buyer is satisfied with the final price of the medicine, they vote for it in rubles. If they are not satisfied with such a price, they refuse to buy it, the manufacturer notes a decrease in demand and reduces the price of the drug.
- State pricing. The State determines the prices of medicines by setting the maximum allowable prices for medicines. In countries with active government pricing, there are drug or health insurance and reimbursement programs.
- Mixed pricing. The state is only partially involved in regulating the price of certain groups of drugs (as a rule, prescription drugs). The pricing of over-the-counter drugs that can be freely purchased at a pharmacy is not reimbursed by the social insurance system and is not subject to state control.
In fact, a mixed type of pricing has developed in Russia, but, as it often happens, with a bias. The state tried to stabilize and regulate the prices of certain drugs and created the so-called list of vital and essential medicines (VED). The prices of medicines from this list are regulated by the state: it determines the maximum allowable pharmacy allowance for these medicines (36% of which are produced only abroad), that is, in fact, interferes with the work in the commercial sector, which is not and cannot be anywhere else in the world.
– The list of VED in Russia exists only on paper, in practice it turns out to be useless, because there is no budget for its implementation. The medicines included in this list make up almost a third of all the funds circulating on the market. However, among them there are ineffective and useless medicines that cannot be called vital in any way. The buyer does not get anything at all from the fact that the medicine is included in this list," explains the chief clinical pharmacologist.
Ideally, according to Alexander Hadzhidis, the state should make a list of medicines, the cost of which it is ready to reimburse customers as part of compensation for the cost of treatment.
– For example, 50 different "enalapril" are registered in Russia with a price range from 4 to 150 rubles. The state, together with experts, analyzes these drugs and says that it guarantees the quality and safety of "Enalapril" of such and such production for 50 rubles. If a patient buys such a medicine at a pharmacy, the state reimburses him for its cost. If he wants to buy a more expensive medicine, he will pay the difference out of his own pocket.
However, it is not that there is no institute of pharmacovigilance and expertise in Russia, there is no established dialogue between the state and business, which creates, among other things, difficulties in organizing the procurement of very expensive medicines.
– There are many schemes of interaction between the pharmaceutical business and the state practiced all over the world. In the UK, for example, risk sharing is used to treat high-cost diseases: the state buys medicine from the manufacturing company, but if there is no effect from the treatment, the company returns the money back, and if there is an effect, the state continues purchases. This, among other things, increases the social responsibility of the business. There are other schemes in which manufacturers and the state agree on the average price of course treatment of patients. However, all this becomes impossible in our country due to the existing system of public procurement," the expert explains.
When expensive medicines are for the goodAccording to Alexander Hadjidis, fluctuations in the dollar and euro will inevitably affect the cost of medicines.
Now pharmacies are selling those stocks of medicines that they bought at the same prices, and so far buyers do not feel a significant increase in prices. However, as soon as pharmacies have to restock, the Russians' wallet will quickly get better.
– Since medicines are only getting more expensive and almost never fall in price, we need to take this for granted and reassure ourselves that we don't need most of them – they are simply useless. Maybe there is a silver lining, and the rise in price will force our fellow citizens to stop eating all medicines in a row?
Portal "Eternal youth" http://vechnayamolodost.ru15.04.2014