Why are medicines getting more expensive?
The rise in drug prices depends on the cost of clinical trials
The rise in global drug prices is caused by the high cost of clinical trials. Such findings were published in a 2014 report by the Tufts Center for the Study of Drug Development. Over the past 10 years, the cost of clinical trials of one drug has increased by 2 times. If in the early 2000s it did not exceed an average of $ 1.2 billion, then in 2014 it already reached $2.6 billion. According to experts, the cost of clinical trials can account for up to 50% of all investments in the development of a new drug.
The cost of imported drugs in Russia was high before, and after the sharp fall of the ruble in just 1.5 months, prices increased by another record 20%. Domestic healthcare continues to depend heavily on Western pharmaceutical companies. According to the DSM group, about 76% of medicines in 2014 were supplied from abroad.
The only way to reduce prices is to ensure the production of vital drugs in Russia on the principle of a full cycle: from the substance to the finished dosage form without the involvement of imported components. In recent years, such enterprises, the so-called "New Pharma", have appeared in our country. They successfully displace Western players from the domestic market by creating high-tech biosimilars and innovative medicines. In just 2 years, they managed to increase their share in the volume of purchases under the most expensive federal program "7 high-cost nosologies" by 3 times. If in 2012 Russian companies occupied only 9% of the market, then in 2014 – already 26%. At the same time, domestic enterprises achieved a dominant position in vital medicines in the amount of 64% of the market share.
However, despite the growing influence of Russian pharma in some segments, achieving 50% of the goals set by the Pharma 2020 program, in general, remains a difficult task for the market. It is possible to achieve such results only by creating biosimilars and innovative drugs in a shorter time. And here domestic companies face the same problem as their Western counterparts – huge costs for clinical research. The key question of the biopharmaceutical industry is how to increase the volume of clinical trials over a certain period of time without spending more resources on it and without losing quality.
According to GBI Research, automation software solutions can achieve significant cost reductions. For example, the use of Electronic Data Capture (EDC) or electronic individual registration cards (eIRC) in a clinical trial involving 40 medical centers and 1,000 patients can provide pharmaceutical companies with savings of up to $ 1.12 million.
According to Flex Databases, first of all, logistics costs are reduced, their reduction can reach 70%. The transition from paper IRCs to electronic ones allows monitors to monitor the quality of filling in EIRCS by doctors online and give prompt consultations. There is no need to make numerous long business trips to research centers located throughout the country, it becomes possible to conduct control centrally. Reducing logistics costs is important because, according to the U.S. Department of Health and Human Services, monitoring medical centers is one of the largest items of expenditure in conducting clinical trials, which accounts for 14% of total costs.
The use of electronic IRCs, according to IBM Institutefor Business Values, also reduces data processing costs by almost 80%. The volume of errors and missing data is drastically reduced compared to the paper method. Costs for other operational tasks are also reduced by 32%.
"The EDC software application has proven its effectiveness in thousands of clinical trials. A few years ago, this system was very expensive. Only large pharmaceutical companies could afford software of this level to conduct time-consuming international research. But the rapid development of web applications, combined with growing competition among firms specializing in EDC, has led to a significant reduction in the cost of the software application and simplification of the user interface. As a result, today the EDC software application has become available to small companies conducting clinical trials. For the Russian pharmaceutical industry, it is an effective tool for creating a market of new competitive drugs in a short time and getting rid of import dependence," says Olga Loginovskaya, Director of Quality and Corporate Development at Flex Databases.
The final price of medicines is influenced by many factors. This includes how quickly Russian pharmaceutical companies will be able to master new information technologies and direct them to the implementation of the import substitution strategy and the creation of their own database of innovative drugs. High-tech medicines of domestic production will be much more affordable for Russians than foreign drugs.
Portal "Eternal youth" http://vechnayamolodost.ru01.04.2015