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Generic and innovative drugs market in Poland 2012 Development forecasts for 2012-2014

May 2012
Pages: 131
Delivery: PDF


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The report is a comprehensive analysis of the pharmaceutical market in Poland following the introduction of the reimbursement act. It presents the details of the key provisions of the act, as well as the possible actions that companies can take in order to minimise its negative impact.
 

The publication also contains development forecasts for 2012-2014, for both the entire market and the market of prescription medicines – broken down into innovative and generic segments.

In addition to insightful analysis, the report presents the profiles of top generic and innovative producers in Poland, and an assessment of the impact on each company of the reimbursement act and the changes to the refunded drug lists.

Key topics covered:

Did you know... 
In recent years there has been an increasing number of projects in Poland focusing on innovative research.
The reimbursement act has introduced a ban on advertising pharmacies in Poland.
Changes in legislation will boost parallel export of medicines from Poland.
In 2007-2011 the Agency for Health Technology Assessment issued a total of 651 recommendations.
Generic products have dominated the Polish pharmaceutical market.
Currently, wholesale and retail profit margins on medicines in Poland are fixed.
  • The share of generic and innovative drugs in the pharmaceutical market and the Rx market  - in terms of value and volume
  • Development forecasts for generic medicines in Poland in 2012-2014
  • Development forecasts for innovative medicines in Poland in 2012-2014
  • Average prices of innovative and generic drugs in Poland
  • Prices of innovative and generic drugs in Poland in comparison to other countries
  • Generic substitution procedures
  • The outlays of the National Health Fund for the reimbursement of chemotherapy and on therapy programmes
  • A comparison of the operating principles of therapy programmes and medication programmes
  • The reimbursement decision-making process in Poland
  • Drug payment structure in Poland from the point of view of the patient and the state
  • Medicines generating the highest reimbursement costs for the National Health Fund
  • New active substances added to the lists of drugs refunded in Poland
  • An analysis of the recent changes on the lists of refunded drugs
  • The expected changes concerning drug reimbursement
  • A summary of the key changes introduced by the reimbursement act
  • Fixed reimbursement outlays of the National Health Fund and the payback mechanism
  • Limit groups
  • An assessment of the effects of the reimbursement act on market players
  • Ways to minimise the negative impact ofthe reimbursement act on producers in Poland
  • Top manufacturers of innovative and generic medicines in Poland
  • Changes in the prices of selected products of the top generic and innovative drug manufacturers on the subsequent lists of refunded drugs
  • An assessment of the impact of the reimbursement act on the top manufacturers of generic and innovative drugs.

Questions answered by the report:

  • Which segment is going to grow faster in the coming years: generic or original medicines?
  • Has the share of original drugs in the Polish pharmaceutical market expanded or contracted in the last few years?
  • Are the prices of generic drugs lower in Poland than in other countries?
  • What are the main implications of the reimbursement act for pharmaceutical companies?
  • Which companies had to lower their prices the most after the negotiations with the Minister of Health?
  • How long is the reimbursement decision-making process in Poland?
  • What is the role of the Transparency Commission and the Head of the Agency for Health Technology Assessment (AOTM) when making a reimbursement decision?
  • What are the risk-sharing instruments?
  • How are reimbursement limits for limit groups determined?
  • What medication/substances may become refunded in Poland in the near future?

Unique features include

  • Development forecasts for generic and innovative drugs in 2012-2014 in light of the new reimbursement act
  • Ways to minimise the negative impact of the act on producers.

Companies mentioned in this report:

Adamed, AstraZeneca, Bayer, Bioton, Boehringer Ingelheim, Bristol-Myers Squibb, Egis, Eli Lilly, Gedeon Richter, GlaxoSmithKline, Janssen-Cilag, Jelfa, Krka, Merck & Co., Merck Sharp & Dohme (MSD), Novartis, Novo Nordisk, Nycomed, Pfizer, Pliva, Roche, Sandoz, Sanofi, Servier, Teva, Zentiva.

Business and Industry events

  • Introduction of the new reimbursement act (1 January 2012), which: introduces risk-sharing instruments, introduces fixed prices and price margins for refunded drugs, and sets limit groups under a common funding limit
  • Price negotiations between pharmaceutical companies and the Ministry of Health at the end of 2011 resulted in substantially reduced prices of refunded drugs
  • Changes in the lists of refunded drugs from November 2011, December 2011 and February 2012.

This report is especially useful when...

  • Beginning operations in the generic drug segment in Poland
  • Beginning operations in the innovative drug segment in Poland
  • Developing a product portfolio of generic and/or innovative medicines
  • Analyzing Polish regulatory policy with regard to generic and/or innovative medicines
  • Monitoring latest changes to the reimbursement lists in Poland
  • Estimating the growth potential of generic and/or innovative medicines in Poland
  • Preparing forecasts about the generic drug segment in Poland
  • Preparing forecasts about the innovative drug segment in Poland.

We recommend this report for: 

  • Manufacturers and distributors of generic and/or innovative medicines
  • Companies planning to enter the Polish pharmaceutical market
  • Companies with a business focus on generic and/or innovative medicines
  • Consulting, research and analysis firms
  • Government institutions, embassies, universities and research institutes
  • Chambers of commerce, trade and industry organisations
  • Financial institutions (banks, brokerage houses, investment funds, private equity funds).

Extract from this report

  • According to our forecasts, in the coming years the generic medicines market in Poland will develop faster than the innovative drugs market, mainly due to the reimbursement act and changes on the lists of reimbursed medicines. This will bring cuts to the outlays of the National Health Fund on reimbursement, itself impacting heavily on the segment of innovative medicines.
  • Limit groups covered by common funding limit. The basis of the limit is the highest value among the lowest wholesale prices per daily dose of a medicine that completes 15% of the monthly volume sales achieved in a given limit group.

Market commentary by expert

Expert commentary:

The reimbursement act that entered into force in January 2012 will revolutionise the Polish pharmaceutical market and greatly impact the production of both generic and innovative drugs.
The key changes are concerned with fixing the reimbursement expense ceiling at 17% of the whole budget of the National Health Fund, introducing risk-sharing instruments, introducing fixed prices and price margins for refunded drugs, and determining limit groups under a common funding limit.


Agnieszka Skonieczna, Senior pharmaceutical market Analyst

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Generic and innovative drugs market in Poland 2012
Development forecasts for 2012-2014

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