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European Biopharmaceutical Review
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Timur Bondaryev and Svitlana Ivasenko at Arzinger provide an overview of the biotech sector in Ukraine’s pharma industry
In Ukraine the pharmaceutical industry is one of the most profitable
and dynamic, and plays a significant role in the Ukrainian economy.
However, the biotechnological sector of the industry lags significantly
behind that of more developed countries. Despite its scientific and
industrial potential – which are considered to be valuable assets of
Ukraine – outdated equipment and lack of funding do not allow
commercial development of biotechnologies and hinder the transfer of
its results into practical areas.
The Ukrainian pharmaceutical market today is represented by more than
300 manufacturers from a range of countries and approximately 160
domestic manufacturers, including 22 enterprises that were engaged in
the manufacture of drugs in the former Soviet Union.
Today, hospital purchases account for about 16 per cent of the
pharmaceutical market of Ukraine; another 12 per cent of the market is
covered by direct state procurement and the remaining portion is retail
drugstore pharmacy. According to research, 55 per cent of sold
medicines are Rx drugs, and the other 45 per cent are OTC. Currently,
only about a quarter of drugs consumed in Ukraine are produced by
domestic manufacturers, while the rest are imported (1).
The pharmaceutical market of Ukraine, which declined last year to
approximately $2.1 billion, began to recover to pre-crisis levels in
2010, and experts predict that the volume of the market in 2011 will
expand to about $2.6 to $2.9 billion.
The value of biotech products in the pharmaceutical market of Ukraine
is approximately $5.5 million, but Ukraine’s share is only about $1.6
million (20 to 30 per cent). It should be noted, however, that these
are rough estimates as the Ukrainian biotech market is poorly
structured and official statistics do not exist. The largest segments
of the pharmaceutical biotechnology market in Ukraine are probiotic
drugs, vaccines and serums, closely followed by blood proteins,
antibiotics, enzymes and genetically engineered drugs.
NEW DIRECTIONS
Ukraine has had success in the creation of multi-probiotics –
multi-component probiotics with a broad spectrum of biotherapeutic
activity. Currently one of the promising directions for the development
of new biological drugs in Ukraine is the development of probiotics
based on micro-organisms with desired properties, which are obtained by
genetic engineering methods (2).
Today in the pharmaceutical sector of Ukraine there is a harmonisation
of national laws and regulations with the relevant EU directives
concerning the coordination of the drug development procedure,
registration procedures and manufacturing, as well as IP protection.
The Pharmaceutical Sector Development Concept of the Healthcare of
Ukraine, which was developed according to the recommendations of the
World Health Organization and adopted at the end of 2007, defines the
future directions and challenges of the pharmaceutical industry. It
aims to create an appropriate legal framework that regulates
pharmaceutical activities, the development of national policy in the
pharmaceutical field in determining social priorities in providing the
population with drugs, and the introduction of international standards,
such as manufacturing (GMP), clinical (GCP), laboratory (GLP),
distribution (GDP), pharmacy (GPP) and other good practices in
divisions of the pharmaceutical sector (3).
At present, Ukraine is trying to become a member of the Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Cooperation Scheme
(jointly referred to as PIC/S), of which there are 37 member countries,
including Canada, Denmark, France, Germany, Lithuania, Malaysia and
Spain. In this regard, on the 22nd to 26th March the PIC/S inspectors
carried out the audit of the State Inspection on Medical Drugs Quality
Control by the Ministry of Health of Ukraine. Its results will
determine whether Ukraine will join this respected international
organisation. Ukraine’s accession to the PIC/S will undoubtedly help to
strengthen its prestige on the international pharmaceutical scene and
will provide Ukrainian pharmaceutical manufacturers with many more
opportunities to enter the world market (4).
ACADEMY ACHIEVEMENTS
The top scientific medical institution in Ukraine is the Academy of
Medical Sciences. The State Budget of Ukraine for 2010 expects to
provide approximately 1 billion UAH ($125 million) to finance the
activities of the Academy, including 66.6 million UAH ($8.3 million)
for basic research in the field of theoretical and clinical medicine,
and 114.8 million UAH ($14.5 million) for applied scientific and
technological developments and work performance on state programmes
targeting the prevention and treatment of human diseases and the
training of scientific personnel (5).
Within these budget programmes the execution of nearly 500 research
projects is scheduled, including research designed to improve the
population’s health by using new medical technologies, as well as the
development of new tools for diagnostics and treatment using genetic
engineering techniques, nanotechnologies and embryonic tissues.
CENTER OF INNOVATION
The State Center of Innovation Biotechnologies was established in
Ukraine in 2010 for the development of the biotechnological sector in
the pharmaceutical industry. The Center is a state scientific
institution reporting to the Cabinet of Ministers of Ukraine. The main
activities of the Center in accordance with its statutory documents are:
- Research in the introduction of innovative biotechnology
- Research in the manufacture of immunological drugs
- Veterinary drugs and blood products, their testing and inspection
- The transfer of innovations to meet the needs of healthcare in
the relevant vaccines, including medical antiserums, immunodiagnostics,
antidotes, modern blood products
- Participation in drafting of State programs, concerning the implementation of innovative biotechnology and so on (6).
The decision of the Ukrainian government on the development of the
State Target Program of the Creation of National Immunobiological
Products (Ukrainian vaccine 2011 to 2015), to be approved by the end of
this year, highlights the importance of the development of
biotechnologies in Ukraine. The aim of the program is to create
favourable conditions for the production of medical immunobiological
products, to attract domestic and foreign investors, and to ensure the
needs of the state in such strategic areas as:
- Production of modern bacterial and viral vaccines, including
multicomponent ones (from more than 10 vaccines which are stipulated by
the immunisation calendar of Ukraine, only four are produced locally)
- Production of recombinant drugs based on recombinant proteins and monoclonal antibodies
- Production of the range of blood and plasma (during the last few
years blood and plasma, which are cured, amounted to 53 per cent of the
minimum standards required by WHO for countries with a population of
about 45 million people and the provision level for blood products
amounted to 23 per cent of the recommended WHO standards)
- Production of cell therapy products
- Production of diagnostic products (to date the part of registered diagnostic products of Ukrainian origin is only 27 per cent)
In order to achieve this aim, Ukraine is establishing the provision of
state support through the creation of scientific and technological
centres in specialised institutes under the National Academy of
Sciences, which will be entrusted with the functions of scientific
research, support of the introduction of technology in production,
technical supervision, and so on. Ukraine’s government is planning to
invest 1.5 billion UAH ($190 million) in this program (7).
On 1st January 2010, the Law of Ukraine ‘On scientific parks’ came into
force. It specifies the peculiarities of the state support and the
introduction of special treatment of the activities of scientific
parks, as well as the peculiarities of imposing import duties for
scientific, laboratory and research equipment, components and materials
to be used for the implementation of the activities (8).
INFORMATION EXCHANGE
The lack of demand in Ukraine for hightech developments is caused by
the failure of domestic manufacturers to finance and implement relevant
research. Due to the lack of commercialisation of innovative products,
there is no mutually beneficial cooperation between the education,
science and business sectors. In order to solve this problem, in early
2010 the Ministry of Education and Science of Ukraine and the Academy
of Technological Sciences of Ukraine signed the Memorandum of Creation
and Development of the National Technology Transfer Network, which aims
to meet the challenge of increasing the exchange of information between
participants of technology transfer (including scientists, experts and
managers). The main tasks of the network are evaluation of new
technologies, and the development and implementation of the mechanisms
of their commercialisation (9).
International technological and scientific exchange, as well as the
transfer of intellectual capital, are the distinctive features of the
present time. National Information Centre for Ukraine-EU S&T
Cooperation (NIP) aims to create conditions to maintain and develop
Ukrainian scientific, technical and intellectual potential, by means of
industrial and economic implementation of innovations in Ukraine and
abroad. The NIP was established in 2003 (Order of the Ministry of
Education and Science of Ukraine No 514, dated 1st August 2003) and
assists Ukrainian scientific organisations and enterprises to promote
their technologies both to Ukrainian and world markets. The principal
activities of the NIP include attracting investment and searching for
sources of financial support for implementation of new technologies in
accordance with the priority fields of science and technology
development in Ukraine, as well as organisational and information
support to the application of science intensive technologies for the
manufacture of competitive domestic products (10).
CONCLUSION
The pharmaceutical market in Ukraine may have suffered a decline in
2009, but experts are already pointing to a bounceback. In light of all
the factors mentioned above, there is reason to believe that in the
coming years the development of drugs based on biotechnologies will
become a leading trend in the pharmaceutical industry of Ukraine.
References
- Pharmaceutical industry, http://www.mfa.gov.ua/data/upload/p ublication/12752/3217.htm
- Strelnikov L, Strilets O, Shcherbak E, Chicitkina V, Dolgova T,
Perspectives and ways of the development of manufacturing of biotech
medicines in Ukraine, Annals of Mechnicov Institute 4, 2006, http://www.nbuv.gov.ua/ejournals/ ami/2006/06slspnu.pdf
- Pharmaceutical Sector Development Concept of the Healthcare of
Ukraine, approved by Order of the Ministry of Health of Ukraine 838,
18th December 2007, www.moz.gov.ua/ ua/main/docs/?docID=9068
- Ukraine has passed the final stage to join the PIC, www.diklz.gov.ua
- Law of Ukraine, On State Budget of Ukraine for 2010, 2154-VI,
27th April 2010, http://zakon.rada.gov.ua/
cgi-bin/laws/main.cgi?nreg=2154-17
- Decision of the Cabinet of Ministry of Ukraine, On Aspects of the
Establishment of State Center of Innovation Biotechnologies, 27, 6th
January 2010, http://zakon1.rada.gov.ua/cgi-bin/
laws/main.cgi?nreg=27-2010-%EF
- Draft of the State Target Program of the Creation of National
Immunobiological Products, Ukrainian vaccine 2011-2015,
www.moz.gov.ua/ua/main/docs/
- Law of Ukraine, On scientific parks, 1563-VI, 25th June 2009 http://zakon1.rada.gov.ua/cgibin/ laws/main.cgi?nreg=1563-17
- Memorandum of creation and development of the National Technology
Transfer Network, www.nttn.org.ua/images/sait/Docume
nts/memorandum3.pdf
- About NIP, http://www.fp6- nip.kiev.ua/index.php?p=about
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