Svitlana Didenko, Director General of the Ukrainian pharmaceutical market leader* and the national giant PrJSC “Pharmaceutical Firm “Darnitsa” (“Darnitsa”), told “Apteka” Weekly Paper about the trends in the pharmaceutical market, the potential of the Ukrainian Pharmacy and plans for the development.
Human right to health is a fundamental notion in the pursuit of a decent standard of living. By its content, it is much wider than human access to the healthcare system, and includes the possibility of access to quality, effective and safe medicines. It is difficult to overestimate the role of domestic enterprises in the process of providing such medicinal products, since they produce effective and affordable medicines in line with international standards.
Strive not to be a success, but rather to be of value. (Albert Einstein)
— Svitlana Vasylivna, the pharmaceutical industry, just like everything around us, is constantly changing. New technologies, trends, opportunities and challenges emerge every day. What are the main trends and prospects of the pharmaceutical market in Ukraine for the near future?
— Of course, the main trends of the market are dictated, first of all, by the purchasing power of our citizens. And since in Ukraine almost all expenses in the structure of the pharmaceutical market fall on the retail segment, the increase of nominal and actual income of the population will determine the development of the pharmaceutical market as a whole for a long time*.
Due to the stabilization of the economic situation in the country, today we can observe a redistribution of consumption towards more expensive medicinal products (more than UAH 100 per pack) and medicinal products of foreign manufacture. Thus, the balance of imported and domestic medicines in Ukraine is 62:38% in monetary terms and 28:72% in volume terms, respectively**.
Also, under the influence of various factors over the past 10 years, the share of consumption of prescription medicinal products has increased by almost 7% in both monetary and volume terms.
The vast majority of medicines in Ukraine are generics. Due to affordable prices, such medicinal products significantly save money in the health system and help to ensure access of the population to medicines. The mandatory requirement for generics is their full compliance with the same quality, safety and efficacy requirements as for reference (original) products. To prove this and to confirm the interchangeability of medicinal products, bioequivalence studies are conducted.
The regulatory framework on bioequivalence in Ukraine is almost harmonized with that in the EU, but there are still significant discrepancies not only between the rules of Ukraine, the EU, the WHO and the Food and Drug Administration (FDA), but also regulatory documents of Ukraine.
Therefore, market participants expect the prompt introduction of changes to the regulatory system of Ukraine to improve regulatory acts on the bioequivalence of generic medicines to improve access of the population to effective, safe and high-quality medicinal products.
A characteristic feature of the market of generics is the urgency of the issue of patent protection. Ukraine is continuing the process of bringing intellectual property legislation in line with the European one. At present, it is necessary to resolve issues related to the protection of property rights, speeding up of the procedure for obtaining a patent and termination of the activity of possessors not in good faith.
The issue of the prohibition on the research and registration of generic drugs until the patent on the original drug expires remains unresolved. However, in the world, this practice is widely used by generic companies. This speeds up bringing of the generic to the market, which means that patients will receive high-quality and affordable medicines sooner. In anticipation of these changes, domestic producers are not able to compete with European generic companies on equal footing, and thus Ukrainian patients are limited in access to affordable and effective medicines.
There is much concern about protecting medicines from counterfeiting. According to the WHO, in 2017, every tenth pack in a number of countries, including Ukraine, was falsified. In order to combat this phenomenon, mandatory two-dimensional coding of pharmaceutical products is introduced in the EU and other countries. This is a global trend, since it makes it possible to control the supply of medicines, to stop the turnover of a particular batch or pack quickly, to keep record. This method is convenient for use for patients who can verify the purchased products. In the EU, the mandatory coding of medicines is introduced from February 2019; in the USA, 2D coding is gradually being implemented from 2015 to 2023, while in China there is a system of identification, authentication and tracking medicinal products using a linear bar code. The practice of many countries shows that the implementation of the program takes 7-10 years, whereas in Ukraine, the Ministry of Health plans to be through in 3 years.
It is important for us as manufacturers to clearly understand how this process will take place, since modernization of only one line with special equipment, according to preliminary estimates, costs from EUR 500 thousand to 1 million. This figure includes not only the cost of equipment, but also software for managing processes at the company level.
Therefore, apart from understanding how the implementation process will take place, it is also absolutely necessary to formulate technical requirements and standards that, in combination with the implementation stages and classes of products, will give a final understanding of the cost and time limits of the project implementation. Another aspect of reforming the health care system in Ukraine is accelerating the implementation of healthcare technology assessment tools.
An additional factor that, in my opinion, influences the market, may be the state reimbursement program “Affordable Medicines”, provided that it is substantially expanded. In 2017, the share of this program in the overall market structure was about 1%. In the 2019 budget, the amount provided for the reimbursement program is the same as in the current one. Therefore, in the near future it will not have a significant influence on the market. However, subject to a significant increase in funding for this program, there may be changes in the market structure towards an increase in the share of medicinal products reimbursed by the state.
— The dynamic development of the pharmaceutical market poses new challenges, and consumers have additional expectations of manufacturers. It is a prompt response to them that is a key to the company’s success. How to identify and meet these needs in a timely manner? How Darnitsa reacts to these challenges?
— In my opinion, renewal of the product portfolio in line with current and future medical needs is a guarantee of the success of any pharmaceutical company. According to the market trends, the company made a strategic decision to expand the Rh-group of the product portfolio. Thus, in 2018 three solutions for infusions – antimicrobial ORNIDAZOL-DARNITSA, a remedy for the treatment of liver diseases ARHITEK and a psychostimulant and nootropic CITIMAX-DARNITSA® – were launched to the market.
Furthermore, in 2018 three medicinal products for the treatment of arterial hypertension and other cardiovascular diseases in the form of tablets appeared - PERINDOPRES®, NEBIVOLOL-DARNITSA and TORASEMID-DARNITSA. The OTC segment of the Darnitsa portfolio was supplemented with nasal spray RINAZAL®; in the category of throat soothers the company introduced throat sprays and solutions CELISTA® and SANGIVA®. For the treatment of neuropathic pain, the company offers a new remedy PREGABALIN-DARNITSA. In general, in 2018, Darnitsa presented 12 new products to the Ukrainian consumer, and there are another 91 brands at different stages of development and introduction of new medicinal products.
— In 2018, pharmaceutical markets in many countries of the world encountered the situation with the prohibition by specialized regulators of valsartan products because of the suspected presence of N-nitrosodiethylamine (NDEA) impurities. The State Service of Ukraine on Medicines and Drugs Control (Derzhliksluzhba) also reacted to this situation. Has this ban on the medicinal products affected your company?
— Indeed, Derzhliksluzhba in 2018 twice issued orders on the prohibition of the valsartan substance: in July - the one manufactured by Zhejiang Huahai Pharmaceuticals Co. Ltd. (China), and in December - by Mylan Laboratories Limited (India). In the latter case, the regulator was prompted to take such step by the notification of the European Directorate for the Quality of Medicines & Healthcare (EDQM) on the suspension of the certificate of conformity R1-CER 2009-396-Rev 03 for said substance.
Therewith, this manufacturer of valsartan substance provided EDQM with explanations and documentary evidence of the quality of the substance required to renew the Certificate of European Pharmacopeia. However, the duration of the renewal of the certificate is at least 9 months.
For this reason, Darnitsa, as a responsible manufacturer, that strictly observes European quality control standards at all stages of the life cycle of medicinal products, recalled the banned batches of TIARA TRIO® and TIARA DUO.
At the same time, we take all necessary measures to return these effective and safe medicines to the market. TIARA TRIO® and TIARA DUO follow the latest trends in the treatment of cardiovascular diseases. TIARA DUO offers patients a combination therapy with two components presented in one tablet. If it does not help - the next step is a triple combination, also presented in one pill of TIARA TRIO®.
Our achievements were highly appreciated by scientists from many countries of the world during the European meeting on arterial hypertension and cardiovascular prophylaxis held in Barcelona (Spain). Within the program of the event, employees of the Department of Arterial Hypertension of the National Scientific Center “M.D. Strazhesko Institute of Cardiology”, namely, L.A. Mishchenko, Doctor of Medical Sciences, presented a poster presentation and universal solutions for the treatment of cardiovascular diseases offered by the Pharmaceutical Firm “Darnitsa”. Therefore, despite the regrettable situation with the prohibition of valsartan, we do our best to return TIARA TRIO® and TIARA DUO to patients to continue their treatment.
— Thus, we can observe that “Darnitsa” actively cooperates with national scientists. What other projects are aimed at interaction with healthcare professionals?
— Of course, there are plenty of such projects. After all, Darnitsa is a reliable partner for physicians and, within the framework of the social function, has assumed the responsibility to promote the training of physicians and their professional development, using the latest communication tools. In 2018, with the support of our company, more than 100 research and practice events were held. The largest of them were the National Congress of Cardiologists, the International Conference of ENT Specialists in Odesa, the International Medical Forum “Innovations in Healthcare - the Health of the Nation”, etc. More than 15 thousand medical practitioners became the guests of these and a number of other events.
Cooperation with professionals in healthcare is carried out within the framework of the educational platform EduMedicalHub created by us. For its functioning, the company engages leading scientists, who together with the specialists of Darnitsa combine the theory and practical familiarization with how modern pharmaceutical production operates. Thus, in 2018 about 40 thousand physicians were involved in the events that took place within its framework. The platform includes interactive trainings, research and practice events, excursions, Green Book Digital platform, virtual presentations, online seminars and lectures, webinars.
The core of the EduMedicalHub platform is the GreenBook mobile app. Within the 9 months of functioning of the mobile application, nearly 4,500 physicians joined it. GreenBook focuses primarily on specialists in cardiology, neurology and therapists, as well as pharmacists and pharmaceutical chemists. The application contains treatment guidelines, algorithms of medical care delivery, information about events in the industry.
The additional value of Green Book is ensured by the availability of educational content and new opportunities for upgrading the qualifications of physicians. We offer specialists an opportunity to take interactive training in the form of webinars and online lectures with the further opportunity of obtaining a certificate. This format is popular today because of its ease of use and guaranteed result. Thus, Darnitsa seeks to provide always busy doctors with the opportunity to get the necessary information in the most convenient way and time using customized service tools.
— Svitlana Vasylivna, what is success in your opinion and what are the plans for the future of the leader of the domestic pharmaceutical market?
— Being one of the leaders of the domestic pharmaceutical industry means not to shy away from the challenges, to be proactive and not to be afraid to change. I believe that the effectiveness of management of a company, first of all, is measured by its financial status and the loyalty of consumers to its products. Companies do not spare resources and time, scrupulously establishing open and honest relationships with all the stakeholders. That is what reputation is - an invaluable asset of any business. And here we have something to be proud of.
Thus, Ukrainians expressed their trust in us, giving Darnitsa the preference in the Choice of the Year Awards in Ukraine. According to the All-Ukrainian market research of consumer preferences, representative of the adult population aged 18+, Darnitsa won in the “Pharmaceutical Company of the Year” nomination, having gained the support of more than one-third part of consumers and surpassing the nearest competitor by 25.2%. It is worth noting that we win this award for the third year in a row. In addition, in the nomination “Medicine for Headache”, 24.8% of consumers chose CITRAMON-DARNITSA among medicines of domestic and foreign manufacture. CORVALOL-DARNITSA® received 14% of the consumer's votes in the nomination “Domestic Sedating and Sleeping Medicine of the Year”.
It is the sincerity in relations multiplied by the product of uncompromising quality that ensures the high rating of the company. Therefore, continuous improvement of both Darnitsa itself and the portfolio of the company to meet the highest expectations of our customers has always been our main task and so it will remain. After all, by improving "Darnitsa", we create new values and traditions.
Iryna Bondarchuk, “Apteka” Weekly Paper
photos were provided by the Pharmaceutical Firm “Darnitsa”
* According to the analytical system of market research “PharmXplorer”/“Pharmstandard” of Proxima Research, based on the results of the retail sale of medicinal products in terms of volume, YTD - 11 months of the year 2018.
** According to the analytical system of market research “PharmXplorer”/“Pharmstandard” of Proxima Research, based on the results of the retail sale of medicinal products at the place of manufacture for 11 months of the year 2018.