Of course, some of the wind pharmacy, and the other will take the company – distributor of drugs, many manufacturer will spend on marketing – promotion and advertising of the drug. Another count the real costs of the manufacturer on the development and production of the drug.
To the question what causes the increase in the cost of drugs is responsible
Svetlana Zavidova, Executive Director of the Association of clinical research.
But the most significant item of expenditure on which to save the patient harm. This is the clinical trials which must prove the drug is safe and effective.
The patent without the right to defense. Whether compulsory licensing of medicines
From the life cycle of drugs a long and difficult journey – from the moment of the first scientists on the selection of the desired molecules of the substance before the withdrawal of the drug on the market. 10 thousand molecules-candidates participate in screening. And, finally, to the finish ribbon comes one single substance, which will become a drug.
In the first step the manufacturers of the drug are conducting preclinical studies on laboratory animals and specific biological models. The main thing here is to get the correct information on the safety of substance and to assess its ability to provide the desired effect. If it is not, the drug for clinical trials will not fall. But how effective a drug can be demonstrated only in the next phase clinical trials with the direct participation of the people. And avoid such a long chain of tests does not, as shown by the sad story that happened in Europe.
Almost 60 years ago, German pharmaceutical company Chemie Grunenthal developed a drug thalidomide.
First, it wanted to use as a medicine against convulsions. But doctors impressed another action of the drug is a sedative. The doctors decided that the invention thalidomide a major breakthrough in the treatment of insomnia.
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Experiments were conducted on rodents. The overdose did not kill laboratory animals, allowed to consider the drug safe. However, the sedative effects of the medication did not render the mice, therefore, representatives of pharmaceutical companies had to make special cell that is used to measure the slightest movements of animals. Despite the fact that rodents after taking the pills were awake, their movements slowed to a greater extent than those animals that were administered other sedatives. The Commission was convinced of the efficacy and safety of the offered pills and gave the production license.
2 years after this drug was officially released in Europe and some other countries. A total of thalidomide was sold in 46 countries under 37 different names. Any additional independent studies of the drug in any country was conducted.
In 1958 the producers, without conducting any research, without proof, stated that thalidomide is the best tool for pregnant women who are prone to sleep disorders. And that was a fatal mistake. After 9 months in Europe began to be born babies with various deformities – absence of the auricles, upper or lower extremities, defects of the eyes and facial muscles. In addition, thalidomide affects the formation of internal organs, destructive way of acting on the heart, liver, kidneys, digestive and urogenital systems of a baby, and could also lead to the birth of children with epilepsy, autism.
According to various estimates, the victims were between 8,000 and 12,000 children whose mothers took the drugs thalidomide during pregnancy. 7 thousand babies died in the first minutes of life. Perhaps it was one of the most scandalous stories associated with side effects from any drug. Later it turned out that the germ of the apes thalidomide causes the same deformities that humans. This example again proves the necessity of testing each new drug, even if the research is a very lengthy and expensive process.
How to test the effectiveness and safety of medicines. Infographics
How are clinical studies
During registration of the drug professionals have to evaluate all the evidence which was produced in the previous stages of the study. Clinical trials must first confirm the safety of the drug in humans, then the efficiency of how the drug affects specific patient.
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In the first phase of clinical trials involves 20-100 healthy volunteers. They tested the tolerability, pharmacokinetics (the chemical conversion of drugs in the body), pharmacodynamics (mechanism of drug action on the body).
In the second phase the drug is tested already on 100-500 patients that allows you to choose the dosage to consider regimens of drugs, to evaluate the effectiveness of a new drug, to test the first hypothesis.
Usually at this stage already carried out an international study, because the task of the pharmaceutical company as soon as possible to bring the drug to market and gain the necessary pool of patients for whom the drug is being developed. The quickest way to do this if attract a different country. For the manufacturer it is the necessary groundwork to then not hesitating to enter the international market.
Up to 3,000 patients and more than can be held the third, most massive research phase, when confirmed the effectiveness of the drug for specific indications in specific populations.
After registration is the fourth phase of the research. The range of patients expands, the pharmaceutical companies can gather additional information on the safety of the drug, trace its interaction with other drugs. Reputable company, such as national “NGOs Petrovax farm”, will continue to conduct post-marketing clinical trials and observational studies, despite the accumulated experience of application of preparations on the market, to assess the efficacy and safety in different groups of patients compared with existing analogues, to examine the possibility of expanding the indications for use.
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20 years for everything
If the drug soon appeared on the market, invented and synthesized for the first time, it is called original. For 20 years it is protected by patent, other manufacturers can’t produce and sell drugs with the same active ingredient. After this time the chemical formula of the drug can be copied by other manufacturers. They register the drug with the same active substance, but under a different trade name. So there are generic drugs.
The task of the manufacturer of the original drug as soon as possible to enter the market, because he is only 20 years old for everything. But the first stage – research and registration – takes up to 10 or more years. In the remaining before the end of the patent time the manufacturer of the original drug needs to recoup the costs of the development phase (from the search of the current molecule to the completion of clinical trials). And they, according to the Association of American pharmaceutical manufacturers, can reach astronomical sums – 1,8–2,4 billion dollars. That is why the development of new drugs involved only the largest companies – small is simply not affordable.
As for the generics, of course, easier to bring to market. Although clinical studies are conducted, but they are simplified: no longer checks the entire process of effectiveness, the task is to see how fast the substance enters the systemic circulation, with the same speed as the original drug, or slower, how is it then displayed. The mechanism is more simple output of a generic to the market is justified because the state is interested in getting cheap drugs and improving their availability on the market. And subject to appropriate conditions of quality control generic becomes absolutely normal medication, sometimes several times cheaper than the original.
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The myth of the “Guinea pigs”
We have a common misconception that Russia is used as a testing ground for new drugs. If you look at the numbers, it is not so. The share of participation of our country in international clinical trials is only 1%. Here are leading other countries – Belgium, Switzerland, Israel, Sweden, USA. Most often, Russia is taking part in the study of drugs for treatment of oncological, neurological, rheumatologic, infectious and pulmonary diseases.
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As already explained, our country’s participation in clinical trials is a chance for her to obtain the necessary innovative products one of the first. Potential opportunities to conduct clinical trials on the territory of our country is huge. But foreign companies face bureaucratic obstacles in obtaining permits. And if pharmaceutical companies need to recruit 1,000 patients for the second phase of research, often to the point where finally in Russia issued a long-awaited resolution, it turns out that the needed number of patients in other countries.
How to solve the problem of the high cost of drugs
But how to do to the man was available good innovative drugs? Here care of its citizens should be the government. It is obliged to participate in the pricing of medicines, as their availability for the population is an integral part of social policy and health.
The government is trying to stabilize and regulate the price of certain drugs, created the so-called List of vital and essential drugs (EDL). But sometimes the list in Russia exists only on paper, in practice they find themselves useless, because the budget for its implementation were not included. Medications included in this list make up almost a third of all marketable assets. However, there are inefficient and useless, which is not really vital.
Ideally, the state should make the list of medicines, which cost it is willing to compensate the buyers in the payment of the cost of treatment. And while a trip to the pharmacy becomes a ruin to the pockets of the majority of Russians.