Biopharmaceutical company Biopharma (Kyiv) plans to invest from $20 million to $23 million in the development of a network of plasma centers by 2025, Biopharma President Kostiantyn Yefymenko said.
“We plan to invest about $15 million in the next three years (in 2021, 2022 and 2023) in the development of blood plasma processing facilities at our site in Bila Tserkva. And we plan to invest in plasma centers during this time about $20-23 million by 2025,” he said in an interview with Interfax-Ukraine.
Yefymenko said that the company already has seven plasma centers, including in Cherkasy, Kyiv, Kharkiv, Dnipro, Konotop, Shostka and Sumy.
In 2021, Biopharma plans to build four more plasma centers in Kamianske, Mykolaiv and Poltava.
“As for the fourth plasma center […] we are now thinking whether it will be Kryvy Rih or Kherson. We intend to build plasma centers and blood centers in every regional center of Ukraine in five years,” Yefymenko said.
By the end of 2020, domestic pharmaceutical manufacturers can maintain sales volumes of 2019 in monetary terms, said President of the Association of Manufacturers of Medications of Ukraine (AMMU) Petro Bahriy.
“The pharmaceutical industry doesn’t have deep minuses in its output, I think that in monetary terms we will reach the same volumes as in 2019, even with a slight plus,” he said in an interview with Interfax-Ukraine.
At the same time, Bahriy noted that significant changes have taken place within the portfolio of domestic pharmaceutical manufacturers, taking into account the fact that hospitals were closed for planned operations for a significant part of the year.”
“The assortment, which provides for planned operations, has decreased, but the anticovid group has grown and there is an increase,” he said.
At the same time, Bahriy called the great success of 2020 that domestic pharmaceutical companies have preserved and developed their exports.
He also stressed that if you take the American protocol for the prevention and treatment of COVID-19, then many of the products included in it are produced in Ukraine – and these drugs “work great.”
Foreign pharmaceutical companies are ready to provide Ukraine with instruments that will give access to innovative medicines without reducing the level of protection of intellectual property rights. “The companies that are members of the American Chamber of Commerce in Ukraine are ready to actively join this work and cooperate with all the interested parties to ensure effective solutions,” Vitaliy Gordienko, the co-chairman of the American Chamber of Commerce’s (AmCham) Healthcare Committee, said when presenting the issues of patients’ access to innovative medicines, which took place in Kyiv at the beginning of the week.
He stressed that non-compliance with patent law and a lack of intellectual property rights protection does not entail a reduction in prices for medicines.
At the same time, innovative pharmaceutical companies that are members of AmCham are ready to provide Ukraine with appropriate mechanisms to reduce prices and ensure equal access to medicines, in particular, confidential negotiation procedures, free goods, long-term contracts, direct contracts.
At the same time, Ukraine should create a regulatory framework for the application of a negotiation procedure, in particular, in the sphere of budget purchases.
Gordienko also drew attention to the importance of introducing the national list of essential medicines. However, according to the expert, the procedure of including drugs in the national list should not exclude the possibility of getting into it of innovative drugs that are used, in particular, at the secondary and tertiary levels of medical care.
Pharmaceutical companies at the global level will increase investment in innovation and support for a high level of quality of medicines, international expert in GMP Wolfgang Schumacher has said. “In the early 1990s there was rather a broad understanding of what quality is. Over the years, this understanding has become more formulated and detailed, supported by more stringent rules and regulatory government policies,” he told Interfax-Ukraine as part of a master class “Integrity of Data for Laboratories and Production” for employees of Farmak Pharmaceutical Company (Kyiv) involved in the pharmaceutical quality system.
According to the expert, now, due to the presence of an increasing number of regulatory requirements, the concept of “quality of medicines” is also becoming increasingly regulated. “Back in the 1990s, we could produce a quality product without having a large number of regulatory requirements, but in recent years the requirements have become more detailed. New regulatory documents are issued. New regulatory documents are about ten times larger than the previous ones,” he said.
At the same time, Schumacher stressed that increasing the number of regulatory requirements obliges pharmaceutical companies that comply with GMP standards to strengthen the training of new personnel in GMP, including those related to legislative requirements that are not specified in the documents. According to him, European pharmaceutical companies pay more attention to quality than, in particular, American companies, despite the fact that the U.S. market has more regulatory requirements.
“European pharmaceutical companies are most focused on quality products. The American market is more documented, with lower quality in its products. In the U.S. market the documentation and the process of documenting are better than in Europe, but in practice there is not everything as good as in Europe,” he said.
At the same time, the expert noted Farmak’s responsible approach to the issues of quality and innovation. “It is very noticeable that the Farmak team is dedicated to its work and very motivated, which is very good. The life of each company lies in its team,” the expert said. The expert also noted that small and medium-sized pharmaceutical companies are “more pragmatic in their approach to quality, while large companies very often follow the rules.”
According to the expert, priority investments in quality are “investments that help develop people, and “it is necessary to invest in the motivation of the team.” “I think that Ukraine will face the same problems that other countries faced as well. Attracting personnel will be more expensive than buying equipment,” he said. At the same time, the expert noted the high expenses for innovation that pharmaceutical companies have to bear.
