Director of the SID & GP dispels myths about Russian medicines
In the perception of any Russian patient, there is an array of stereotypes and bias towards the domestic drugs. However, can these myths be justified and how to dispel them? Today in the Conference “What is going in the Russian pharmaceutical market?” discusses Director of the SID & GP Vladislav Shestakov.
Today in the Conference “What is going in the Russian pharmaceutical market?”, an express interview was held with the Director of the SID & GP Vladislav Shestakov, focusing on the subject of the myths, prevalent in the patient community in relation to domestic drugs. Amid the current informational agenda, whereby the key issues related to the accessibility of drugs, which are not registered in Russia, for a number of patients, the subject is rather pressing and topical.
Head of Bosnalijek’s business entity “Eurasia” Valentina Buchneva opened a series of questions on myths by stating thesis “the imported is better and, unlike the Russian drugs, do work”. As remarked by Vladislav Shestakov, such belief was formed under the influence of development of the modern pharmaceutical market and stems from the 1990s. The USSR was the supplier of substances, and the Socialist-bloc countries were supplying us drugs. Following the dissolution of the USSR, Russia encountered a severe deficit of drugs; black market emerged. In parallel, foreign pharmaceutical companies, which came to our market, were conducting an aggressive marketing campaign on popularization of the foreign-made drugs. As a result, there was a stereotype amongst the patient community regarding the high-quality foreign-branded generics. Russian pharmaceutical manufacturing sites at the time could only compete on price. During the 2000s, Russia’s Ministry of Industry and Trade and Russia’s Ministry of Health began to rebuild the Russian pharmaceutical sector, whose rapid developing continues in the current decade. And that includes programme “PHARMA – 2020”, decree “the third wheel”, the introduction of the GMP and transition to the doctor’s drug prescriptions not as per the trade name, but according to the International Non-proprietary Names. Russian pharmaceutical manufacturers themselves, according to the remark of Valentina Buchneva, had undergone a peculiar marketing transfer, embracing the experience of international colleagues in terms of brand promotion. Did the government policy have the influence on the citizens’ convictions? Partly, yes. According to several analytical agencies, following the August results of the current year, 61% of drugs, sold in the Russian market in physical terms, were manufactured in Russia.
Dispelling the myths “The imported is simply better”, and “Our medicines are of poor quality”, Deputy head of the Russian GMP Inspectorate reminded that following 1640 inspections of the foreign drug manufactures for the conformity with the GMP, more than 540 manufacturing sites were refused to be granted the GMP certificate. Meanwhile, the leaders – in terms of the refusals – were the Indian and Chinese manufacturers, where from today the whole world is procuring substances to produce generics. Speaking about Russia, on the phase of registration drugs undergo complex checks for the conformity with the national GMP standards, which are very similar to the ones of the European Union. Mr. Shestakov also pointed out towards the contribution of the Russian GMP inspectorate to strengthening the FDA inspectors’ attention to the Chinese and Indian manufacturers: “Since April 2016 the Russian inspectorate has been regularly capturing critical non-conformities on the manufacturing sites of India and China. We have been sharing this data with international regulators, who only in 2018-2019 have taken into account and began to conduct their own inspections with sampling, which lead to the recall and suspension of the circulation of products, containing Chinese and Indian substances, and also to the GMP certificates from the manufactures of the poor-quality substances”.
Talking about the quality of Russian medicines, Vladislav Shestakov noted about export increase of national pharma industry goods: only for the first quarter of 2019, the Russian vaccines were exported to 34 countries. Among the export leaders of Russian vaccines and other medicines are Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of Russian Academy of Sciences, Nizhpharm, Materia Medica, NPO Petrovax Pharm, Viferon.
The burning issue for every pharmaceutical manufacturer is the fair price, of which Valentina Buchneva and Vladislav Shestakov talked about, rather confirming, but not dispelling patients’ belief that “the cheapest does not mean the best”.
“Russian medicines are cheaper due to the fact that local generics are being part of VED list. Meaning that Russian medicines’ registration price deliberately differs from foreign one. In fact, Russian pharma industry deals with social business. However, the established pricing system influences the development of innovations, competencies and GMP standard maintenance on the international level, – Vladislav Shestakov stated the opinion of Russian medicines manufactures, while getting applauses from the audience. – Therefore, a balance needed between the health care system request and ability to pay for the medicines for patients, as well as between the manufacturer’s interest to have a fair price, enabling to develop and procure high-quality raw materials. After all, these manufacturers, in many ways make available to a larger number of patients much-needed medicines for therapy”.
Overall, it is worth noting that behind-the-scenes conversations on the conference about “What is going in the Russian pharmaceutical market?”, today were also centered around the myths that formed the basis of express-interview with Vladislav Shestakov. Manufacturers of medicines themselves, that were represented both by traditional Russian companies and those who have localized their manufacturing sites in our country, pay attention on how to determine that the medicine is Russian. More than 80 foreign companies are now localizing manufacturing of more than 360 of their medicines in our country. Meaning that these medicines are de-jure Russian ones. Consumers rarely notice that medicines of Stada, Berlin-Chemie, AstraZeneca and other well-known and trusted medicines have the manufacturing site address in the Kaluga region – they make a purchase under the influence of a strong stereotype that these are foreign medicines. Meaning that the stereotype regarding the quality of branded generics remains the same. A significant number of pharmaceutical companies’ manufacturing sites today is spread out all over the world: the head office is located in a country with a rigid regulatory system, and manufacturing is located in India or China, another country with a cheap labor force and an attractive tax system; according to the FDA, there may be several ways, aimed to manufacture products in specific countries, based on the requirements and the existing quality control system in the country where exports will be carried out. That is why the task of the pharmaceutical community: regulators, manufacturers, patient associations, professional associations, doctors – is to conduct a joint propaganda campaign that dispels the myth of the blind faith that “imported means simply better”.
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- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed