Ukrinform studied how national pharmacists got involved in the fight against coronavirus and how long it will take pharmacies to run out
Last week, several companies in the national pharmaceutical market announced the expansion of production due to the outbreak of the COVID-19 epidemic in Ukraine and the use of investigational drugs in the fight against the virus. And the Verkhovna Rada Commission on National Health, Medical Assistance and Medical Insurance, in turn, is preparing a bill on the compulsory license of medicines (authorization to use patents without the consent of the holders of the rights d ‘author) to fight the epidemic. According to the head of the Committee, Mikhail Radutsky, COVID-19 is reason enough to introduce a mechanism for granting temporary compulsory licenses. “In addition, the pharmaceutical companies that now hold patents are physically unable to supply drugs to our market due to the export ban on drugs introduced by other countries,” said Radutsky. It is logical that the national pharmaceutical industry today has great hopes of supplying doctors and the public with all the necessary medicines. The urgent task of pharmaceutical companies is, at a minimum, to eliminate the rush of demand for drugs for the symptomatic treatment of coronavirus infection. For example, the replenishment of pharmacies with the same paracetamol “penny”, which some thrifty Ukrainians have completely crushed from the shelves of the pharmacy as a result of the hype – so that the rest was nothing. Or antivirals or disinfectants. Ukrinform has “scoured” the market to understand what operational measures pharmacists are taking, meeting the needs of the state and people, and what problems they are encountering.
In case of emergency, you can forget about copyright
The other day, the Verkhovna Rada commission on national health, medical care and medical insurance Mikhail Radutsky announced the drafting of a bill on compulsory license of medicines. A compulsory license is offered for three months. In other words, Ukrainian manufacturers will be able to produce the necessary drugs for three months without obtaining the consent of the patent holders. However, patent holders will receive compensation from Ukrainian manufacturers according to the methodology developed by the Cabinet.
Radutsky noted that Ukraine is negotiating the supply of medicines with India and certain other countries. “Governments in other countries are increasingly deciding to completely ban the export of pharmaceutical products that can be used to fight coronavirus infection,” wrote Radutsky.
But, according to the deputy, Ukraine has no choice but to independently establish production. “We have five manufacturers who are ready to launch a list of nine important drugs in one week. The only barrier is the consent of patent holders. According to global practice, in emergencies the state has the right to ‘temporarily authorize the use of a patented invention because people’s health takes precedence over patent protection. ” This concept is called compulsory license. The practice of compulsory licensing of medicines already exists around the world, but in Ukraine it has never been applied. “- said Radutsky.
He did not name specific manufacturers, but judging by the statements of the companies, these are at least the following companies.
Everything to fight against coronavirus!
DARNITSA HAS ANNOUNCED THAT IT WILL BE ABLE TO START PRODUCTION OF HYDROXYCHLOROCHIN-CONTAINING PRODUCT FOR A MONTH after receiving registration of the substance. The most famous drug based on this ingredient, “Plaquenil”, which is used to treat a number of diseases (rheumatoid arthritis, lupus erythematosus) in the coronavirus pandemic, has been used experimentally to treat COVID-19. What caused a real agitation around this drug in Ukraine.
“We are already transporting the active substance to the country. We have managed to reserve hydroxychloroquine before other countries stop exporting this substance. We are eagerly awaiting legislative changes to register this active substance in Ukraine and begin the process of development of the drug, “The chairman of the Darnitsa group, Dmitry Shimkiv, said.
The company has also launched the ADDITIONAL PRODUCTION OF 100 BILLION IMUSTAT ANTI-VIRUS DRUGS. He also promises to deliver an additional batch of Paracetamol-Darnitsa drugs to pharmacies within a month. Indeed, today, people who take paracetamol literally withdraw from pharmacies on the recommendation of doctors to take it to lower the temperature – one of the main symptoms of coronavirus infection.
“We are monitoring the development of the COVID-19 epidemic in Ukraine and are studying the experience of colleagues from other countries in order to rapidly respond to the growing demand for drugs to treat symptoms of coronavirus. Consequently, in March, we delivered 1 million packages of Paracetamol-Darnitsa to pharmacies and in April, we continue to market this product. In a month, Darnitsa will ship an additional 1.6 million packages, ”said Dmitry Shimkiv.
But according to the general manager of Yuri-Farm, Dmitry Derkach, the scientific center of the company, since the beginning of the announcement by the WHO of the coronavirus pandemic, began to study and to evaluate the protocols of treatment of the sickness. In addition, pharmacists have noticed that there are no drugs in the form of intravenous injections in the protocols. “In our opinion, DOMESTIC MEDICINES CAN HELP SERIOUS PATIENTS and those who are already on mechanical ventilation (artificial ventilation of the lungs – Auth.), Because then a pill can no longer be used,” said the CEO of Yuri-Farm . Therefore, the pharmaceutical sector develops appropriate proposals for the Ministry of Health.
The Ukrainian unit of the international group of companies Kusum, specializing in the development and production of drugs for the treatment of cardiovascular, gastroenterological and endocrine diseases (especially diabetes mellitus), also plans to start the production of preparations of hydroxychlorlorine in its city facilities in the near future. Sumy. The company’s press service said that in development centers (R&D centers) IN UKRAINE AND IN INDIA, HYDROXYCHLOROCHIN HAS BEEN DEVELOPED AND WILL BE READY TO START PRODUCTION IN UKRAINE THIS MONTH.
The press service of the company Mimkrohim, specialized in the production of cardiological preparations, indicated that the scientific divisions of the company had started the development of a generic copy of the antiviral drug “Avigan”, also known by trade names such as 70-type. “The original drug was developed in Japan in 2014, in 2015 it passed the third phase of clinical trials in the United States. At the same time, it was tested during an epidemic in Wuhan and approved for experimental use in Italy against COVID-19, “said the report. Mikrokhim plans to reach the finish line – the release and first deliveries of the finished drug within six months, but the company team is ready to switch to an improved mode of operation, said Mikrokhim.
Filya Zhebrovskaya, Chairman of the Supervisory Board of Farmak JSC, said the company is exploring the possibility of producing antiseptics and disinfectants, test systems for detecting coronaviruses and other medical devices, but a final decision is not has not yet been taken. According to Ms. Zhebrovskaya, the COVID-19 pandemic had a major impact on the Chinese economy, which increased the cost of raw materials for the production of drugs. According to her, Farmak imports from China about 20% of the active pharmaceutical ingredients of APIs, which increased by 40% in relation to the epidemic. “We have reservations and so far the situation is not critical. But it is already clear that we will have to review the company’s budget. European pharmaceutical manufacturers are in the same situation, “noted Filya Zhebrovskaya.
Pharmacists also need help
In fact, the COVID-19 acute respiratory disease epidemic has shown that the globalization of the global economy is a fragile phenomenon. The coronavirus has closed borders not only for people, but also for goods. In particular, it has been found that MANY BATCHES OF MEDICINES CANNOT BE DELIVERED TO UKRAINE WITHOUT PERSONAL INTERVENTION FROM THE HIGHEST HEADS IN THE STATE. For example, the restriction of air traffic has created barriers for domestic pharmaceuticals in the supply of medicines from India and China.
Another challenge was the significant reduction in the production of pharmaceutical raw materials of active pharmaceutical ingredients (API) in China. This has resulted in a shortage and higher prices for substances in Ukraine.
And therefore, given the current problems in domestic and foreign markets, pharmacists have proposed the creation of a coordination group under the chairmanship of Ukraine with the participation of central executive authorities, industry associations and manufacturers of medication to quickly resolve medication supply issues during the spread of coronavirus infection.
According to the president of the Association of Ukrainian Drug Manufacturers (AVLU) Petr Bagrii, the task force, in particular, could quickly resolve problems related to the increased demand for certain groups of drugs, the shortage of a number of active pharmaceutical ingredients (APIs) and drug logistics downtime, as well as patent law issues.
“Today, the companies involved in API production have stopped, there are problems with the supply of substances, packaging materials, problems with the logistics of medicines, so today it would be very good to create a seat and plan our work in government and the presidential office in order to help domestic manufacturers face these challenges and provide medicines to the Ukrainian people, “he said at a conference. press at Interfax.
Among the problems expressed which can be solved today, for example, the problem of individual quotas for excised alcohol (the Ministry of Health analyzes the use of ethyl alcohol by companies every year, is used for the production of drugs and submits to the Cabinet of Ministers appropriate proposals to determine 1 liter of purchase quota for each company 100% alcohol at zero excise rate – Aut).
The manufacturers insist that today all those who have the appropriate licenses for the production of drugs receive sufficient alcohol. In their view, IT IS NECESSARY TO ALSO DELETE THE REGISTRATION OF SUBSTANCES FOR THE PRODUCTION OF MEDICINAL PRODUCTS AND TO ACCESS THE EUROPEAN PROCEDURE WHEN THE MEDICINAL PRODUCT IS REGISTERED TOGETHER WITH THE SUBSTANCE. According to pharmacists, this will help to address the shortage of certain popular products at a time when the main international manufacturers of these substances prohibit their export.
Therefore, the speed with which domestic pharmaceuticals can adapt to the needs of the medical industry and offer their own drug developments or analogues will depend on the timely actions of the authorities. The builders, as we can see, are already starting off badly …
Oksana Polishchuk, Kiev
According to the materials: ukrinform.ru