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PolandPosted 14/11/2013

First posted: 14 November 2013 

Poland is a mature (well-established) market* in the use of generic medicines. Generic medicines have been in use in Poland for more than 10 years [1].

Poland is the largest pharmaceuticals market in Central and Eastern Europe [2] and is the ninth-fastest growing market globally [3]. In 2009, the pharmaceutical industry in Poland stood at a healthy US$10 billion and current growth forecast for the next five years suggest a compound annual growth rate north of 9% reaching US$16 billion by 2014 [4].

The Polish market is dominated by domestic pharmaceuticals—accounting for over 60% of total turnover—as well as by generics. By volume (pharmaceutical packages), the local industry has a market share of over two-thirds [5, 6].

In 2009, Poland spent 7.4% of its gross domestic product on health care, of which approximately 70% was public expenditure [7-9].

In comparison with other European countries, Poland spends a disproportionately high percentage of total health expenditure on medicines [8]. In 2008, a total of 22.6% of the total healthcare budget was spent on medicines compared to only 9.8% in The Netherlands and 7.7% in the UK [10-11].

In 2009, 10.4 billion Złoty (Euros 2.67 billion) was spent on medicines by Poland [10].

The Polish generics market is large by international standards. The market share of generic medicines by volume of 76.6% in Poland in 2006 exceeded the market share of 68.8% in Denmark, 57.5% in the UK, and 56.4% in Germany [15]. In 2008, a total of 75% of prescriptions in Poland were dispensed as generics, accounting for 59% of the market value [12].

Poland has pricing regulation of generic medicines, included in the reimbursement system [13]. Setting the reference pricing (RP) at the price of the cheapest generic medicine in combination with the low level of medicine prices in Poland would be expected to keep down profitability of generic medicines. However, the economic viability of the Polish generic medicines market derives from the fact that it is a high-volume market as a result of the positive attitude of physicians towards generic medicines and the high level of patient co-payments [1].

According to the Polish Association of Pharma Industry Employers (Polski Związek Pracodowców Przemysłu Farmaceutycznego, PZPPF), the association that represents many of the leading generics producers in Poland, the use of ceiling prices for generic medicines is not conducive to price competition or market penetration of generic medicines. The PZPPF supports the principle of freedom of prices and competition [14].

In 2006, there were around 3,537 generic medicines with market authorisation in Poland [8].

The development of the Polish generic medicines market has benefited from the limited availability of originator medicines and a short data exclusivity period [1].

Physicians are allowed to prescribe by international nonproprietary name (INN), but are not obliged or encouraged to do so [1, 5]. Despite this, physicians in Poland have a favourable attitude towards generic medicines and patient co-payment seems to play a role in stimulating demand for generic medicines in Poland [1].

Generics substitution by pharmacists is allowed, but not obligatory [15]. However, only the same molecule can be substituted; changing the molecule, even for one of the same therapeutic group, is prohibited [8].

At the moment, parallel imports are not significant in Poland. Medicines from parallel trade are not currently reimbursed in Poland as these come in a pack without an approved Polish European Article Number and the reimbursement list identifies medicines by these numbers. However, it is planned to allow parallel importers to submit medicines for reimbursement as well, and this will probably come into effect in due course as parallel imported products are usually cheaper [8].

Generics companies are widely represented in Poland and the generics market is particularly ‘crowded’ [8]. The biggest local generics producer is Polpharma SA, with a market share of about 10% in volume and about 5% in value [5].

Key facts – contribution of generic medicines to Poland

  • The generics industry supplies 75% of dispensed medicines at 59% of the cost [12].
  • In 2005, the average cost of a brand-name medicine was Euros 32; the average cost of a generic drug was Euros 8.
  • Generic medicines are 20–80% cheaper than their branded equivalents [16].
  • In 2007, an average of Euros 210 per head of population per year was spent on medicines in Poland compared to an average of Euros 328 in the EU27 [17].
  • Increased substitution of generics for the top 10 originator medicines could reduce public expenditure on the originator medicines in Poland by 21% [1].
  • The Polish National Health Fund (Narodowy Fundus Zdrowia, NFZ) lost up to 70 million in one year due to delays in the introduction of a single generic drug [14].

* A mature generic market is one where generics have been on the market for more than 10 years and where the market share of generics exceeds 40% [18].

References

1.  Simoens S, De Coster S. Sustaining Generic Medicines Markets in Europe. April 2006. [monograph on the Internet]. Brussels, Belgium, European Generic Medicines Association (EGA); [cited 2013 Nov 14]. Available from: www.egagenerics.com/doc/simoens-report_2006-04.pdf

2.  Pharmaceutical pricing, reimbursement & distribution in Poland, 2010 and beyond. 2010 [cited 2013 Nov 14]. Available from: www.shetoldme.com/Business/Pharmaceutical-Pricing-Reimbursement-Distribution-in-Poland-2010-and-Beyond

3.  Business Monitor. Poland Pharmaceuticals and Healthcare Report Q4 2010. August 2010.

4.  Embassy of Poland trade and investment promotion section Johannesburg. Embassy of the Republic of Poland in Pretoria. Poland pharmaceutical report and forecast 2010. 2010. Available from: johannesburg.trade.gov.pl/en/download/file/f,8589

5.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. July 2006.

6.  Kuszewski K, Gericke C, Busse R. Health systems in transition: Poland. Copenhagen: World Health Organization, on behalf of the European Observatory on Health Systems and Policies; 2005. Available from: www.euro.who.int/__data/assets/pdf_file/0011/95159/E88670.pdf

7.  European Federation of Pharmaceutical Industries and Associations. The pharmaceutical industry in figures [homepage on the Internet]. 2010.

8.  Pharmaceutical pricing and reimbursement information Poland. October 2007.

9.  Centre for Pharmaceutical Pricing and Reimbursement Policies PHIS Database [page on the Internet]. [cited 2013 Nov 14] Available from: http://phis.goeg.at/index.aspx?_nav0031

10.  IHS Global Insight. Polish Pharma Association launches impassioned attack on Reimbursement Act [homepage on the Internet] 2010 Dec [cited 2013 Nov 14]. Available from: www.ihsglobalinsight.com/SDA/SDADetail19673.htm

11.  Nefarma. [Facts and figures]. Feiten en cijfers. [homepage on the Internet]. The Hague, The Netherlands, Nefarma [cited 2013 Nov 14]. Dutch. Available from: www.nefarma.nl/feiten-en-cijfers

12.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Access to essential medicines in Poland. August 2009.

13.  Bongers F, Carradinha H. European Generic medicines Association Health Economics Committee. How to Increase Patient Access to Generic Medicines in European Healthcare Systems. June 2009.

14.  Polski Związek Pracodowców Przemysłu Farmaceutycznego. [News: The delay means loss. Loss for the National Health Fund and patients due to delay in the introduction of generic drugs on the reimbursement list]. Aktualności: Opóźnienie znaczy strata. Straty NFZ i pacjentów z tytułu opóźnień wprowadzania leków generycznych na listy refundacyjne [page on the internet].2009 [cited 2013 Nov 14]. Polish. Available from: 212.85.101.126/news.php?id=47

15.  Simoens S. Developing competitive and sustainable Polish generic medicines market. Croat Med J. 2009;50(5):440-8.

16.  Polski Związek Pracodowców Przemysłu Farmaceutycznego. [About generic drugs]. O Leku Generycznym [page on the Internet]. [cited 2013 Nov 14]. Polish. Available from: http://212.85.101.126/o_leku.php

17.  Zimmerman N. Healthcare Forum 2009. Overview on current pricing and reimbursement schemes in the pharmaceutical sector in the EU. Bucharest, Romania. 30 September 2009.

18.  Simoens S. International comparison of generic medicine prices. Current Med Res Opinion. 2007;23(11):2647-54.

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