Impact of COVID-19 on the Ukrainian Pharmaceutical Market
From the beginning of the COVID-19 pandemic, the global pharmaceutical industry has been under tremendous pressure to provide a solution for treating COVID-19 and, at the same time, to ensure the uninterrupted access of patients to treatment for other diseases. Obviously, this challenge has influenced the pharmaceutical market, including in Ukraine. Although COVID-19 has affected the Ukrainian pharmaceutical market in many ways, in this article, we will explore the impact of COVID-19 on the most critical areas, i.e., supply chain management, clinical trials and digitalization.
Supply Chain Management
During the COVID-19 pandemic, pharmaceutical and medical devices companies faced an unprecedented demand for the supply of personal protective equipment and pharmaceuticals used for treating COVID-19 symptoms. At the same time, export bans introduced by China and India on the supply of certain active pharmaceutical ingredients and travel restrictions resulted in product supply delays and product shortages. Therefore, companies had to quickly find alternative suppliers, reorganize supply chains and change their approaches to managing stock and warehousing. In certain instances, these changes triggered the need to update the registration dossiers of finished products and obtain approval of such variations from the Ministry of Health of Ukraine. These changes may also trigger the need to amend companies’ commercial policies or distribution agreements.
The pandemic has shown that access to treatment and protective equipment is a matter of national importance. This may create opportunities for local manufacturers. In particular, to decrease the dependency on imported pharmaceuticals, in June 2020, the Ministry of Health of Ukraine proposed for public discussion the draft concept of the state target program to develop the local manufacturing of pharmaceuticals for treating especially dangerous diseases for 2020-2025. Under this draft concept, the government would incentivize local manufacturers, including through guaranteeing the state procurement of certain pharmaceuticals.
Due to the risk of infection and travel restrictions, many patients were not able or willing to attend clinical trial sites to collect their treatments and/or undergo screening/tests. Furthermore, sponsors had to limit the enrolment of new patients, halt the ongoing trials and refrain from launching new trials (other than for products to treat COVID-19 symptoms) because of the risks to patients and site personnel. These risks have had a significant impact on the quantity and procedures of clinical trials conducted in Ukraine.
To ensure the continuation of trials with minimum risks to patients and site personnel, sponsors found new solutions and implemented changes in the standard clinical trial procedures. Such solutions include the direct-to-patient delivery of trial products, collecting used products from patients’ homes for disposal, engaging additional personnel to help clinical trial sites process documentation, handling records within short time frames, etc. The implementation of such changes to clinical trials in Ukraine requires careful consideration to take into account various restrictions set out in Ukrainian laws.
In light of the spread of COVID-19, pharmaceutical and medical devices companies limited or abandoned face-to-face visits by their sales representatives. In order to continue promotional activities, such visits are now conducted online/by phone. Medical and scientific events have also been transformed into online events. The COVID-19 pandemic has triggered the need for increased online interaction between healthcare practitioners (HCPs) and patients.
The digitalization of promotional, educational, scientific and other activities has raised a number of questions and issues that need to be considered in advance. In particular, should the consents of HCPs for their personal data processing be adjusted to allow for the collection of personal data in the new format of communication? If so, how can such consents be collected remotely? In terms of the new approach to holding medical and scientific events, should companies seek the consents of those featured in the streaming/recording?
The increased demand for remote communications has opened new possibilities for healthcare facilities, HCPs and healthcare and technology companies to expand existing, and to explore new, instruments for digital communication in the healthcare area. These instruments include technology for remote diagnosis, treatment and monitoring, keeping track of symptoms and treatment progress, education platforms for patients, etc. We expect that the demand for digital solutions in healthcare will continue to grow, thus resulting in the development of new technologies and investments in this sector by strategic, financial and venture capital investors. To ensure regulatory and data protection compliance, providers and users of healthcare digital solutions should enhance the procedures for the collection, processing and use of personal data. They should also consider what cybersecurity measures are required to protect that data.
Olha Demianiuk, Partner, Head of the Healthcare Industry Group, Baker McKenzie – Kyiv
Olha Sviatenka, Associate, Baker McKenzie – Kyiv
Posted in Covid-19 Guidance