NEW YORK, May 27 Reportlinker.com announces that a new market research report is available in its catalogue:
The Outlook for Pharmaceuticals in Central & Eastern Europe
The countries of Central and Eastern Europe represent a total market of 285 million people and a combined GDP of US$3.0 trillion in 2008
The impact of EU accession on the pharmaceutical market
In May 2004, five of the CEE markets in question joined the European Union. Much of the pharmaceutical legislation within the region has therefore been harmonised with that of the EU, although countries such as Poland are still in the process of transposing EU directives into national law.
Romania and Bulgaria have also amended the relevant legislation and became full EU members in January 2007. The implementation of GMP is also taking place across most of the region and this will inevitably improve the quality of overall production and lead to a rise in market values.
Variations in the quality of IP protection
The level of IP protection offered by the CEE nations varies across the region, but the issue generally remains an international concern. Problems that are commonly raised include a lack of transparency in IP procedures and the lack of effective enforcement. Some countries, such as Bulgaria, have made a lot of progress in improving the legal climate by strengthening patent laws and extending the standard patent term to 20 years.
The dominance of the generics market
The demand for affordable drugs is the principal factor in the dominance of the generics in the region. Despite recent improvements in patent protection, legislation and effective enforcement are still needed in many countries where counterfeiting of Western drugs continues. Generics production has managed to remain strong in countries that are also home to the producers of branded drugs. In the former Czechoslovakia for example, the merger of Leciva with Slovakofarma enhanced generics production in 2003. However, as economies develop the trend to importing higher value branded products can be seen.
These reports analyse the issues which matter
That is why Espicom Business Intelligence has published these new management reports The Outlook for Pharmaceuticals in Central & Eastern Europe to 2013. Each report provides individual and highly-detailed analysis of each market, looking at the key regulatory, political, economic and corporate developments in the wider context of market structure, service and access. The reports are available individually, or as a discounted collection, and prices include 4 completely updated reports sent quarterly, plus a comprehensive report sent annually. There are over 60 markets covered in the worldwide series.
Different IP protection levels
Much of the pharmaceutical legislation within the region has been harmonised with that of the EU. The level of IP protection, however, varies across the region therefore the issue generally remains an international concern. Problems that are commonly raised include a lack of transparency in IP procedures and the lack of effective enforcement.
Dominance of generic medicines
The demand for affordable drugs is the principal factor in the dominance of generic medicines in the region. Generic production has managed to remain strong in countries that are also home to the producers of branded drugs. However, as economies have developed, the trend to import higher value branded products has continued.
Russia, a potentially vast market
Russia has the largest pharmaceutical market in the region, followed by Poland and the Czech Republic. Russia has a sizeable domestic generic industry, but local production of innovative drugs is negligible. The market environment remains challenging; major weaknesses include corruption, bureaucracy, counterfeiting and poor data confidentiality. Opportunities, however, exist.
Highlights from the report
Issues still exist with regards to patent protection and data exclusivity, due to the often premature registration of generic pharmaceutical products. The United States Trade Representative has listed Poland on its Special 301 Report Watch List in 2009. Around 66% of the pharmaceutical market is supplied by imports. France and Germany are the leading suppliers, accounting for over 30% of imports. Domestic production tends to concentrate on the generics market. Many of the state-owned 'Polfas' have been bought out by foreign companies. The Polish Pharmaceutical Holding is looking to sell Polfa Pabianice, Polfa Warsaw and Polfa Tarchomin by the end of 2009.
The Czech pharmaceutical market is the third largest in the region. Local production of generics is strong. There is little branded manufacturing but the market is increasingly dominated by imported products. The country has a history of high drug consumption, a legacy of many years of reliance on cheap generics. One major concern of EU entry was that branded drugs priced cheaply on the Czech market would be parallel exported to high-price EU markets. The accession treaties for the new entrant countries specifically prevented this, however, as long as the drug in question has a patent in the target market.
Around two thirds of the pharmaceutical market is supplied by imports. France, Germany and Switzerland are the leading suppliers, accounting for over half of imports. Manufacturers have reported loss of profits since the enforcement of the Pharma Economic Act. Tax implications and changes to the reimbursement system have discouraged investment in the country and have forced companies to look for opportunities elsewhere; Gedeon Richter is expanding its business in Poland and Russia, for instance.
Around 89% of the pharmaceutical market is supplied by imports. Germany, France and Hungary are the leading suppliers, accounting for over 40% of the total. The quality of drug production has risen since the enforcement of GMP standards. However, the number of local drug producers has fallen as a result. Large foreign companies such as Zentiva, Actavis and Ranbaxy have acquired large domestic companies. This has increased the range of products on the market, provided access to new export markets and improved sales performances. The enforcement of IP law remains weak; Romania was listed on the United States Trade Representative's Special 301 Watch List in 2009.
Along with Romania, Bulgaria represents one of the least developed European countries of the former Soviet bloc. An estimated 78% of the pharmaceutical market is supplied by imports. Germany and Hungary are the leading suppliers, accounting for over 30% of imports. Pharmaceutical legislation has been harmonised with that of the EU. Manufacturers are also required to comply with GMP standards and many have invested heavily to modernise production facilities. Generic drugs continue to have a sizeable market presence in Bulgaria, due to their low cost. They represent around 80% of the market by volume and 50% by value.
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Pharmaceutical Industry: The Outlook for Pharmaceuticals in Central & Eastern Europe
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