Country Focus


Country Focus/Poland | Posted 28/11/2013

First posted: 14 November 2013 

Poland is already a mature (well-established) market* in the use of generic medicines.

Policies and Legislation

Country Focus/Poland | Posted 26/11/2013

First posted: 26 November 2013 

Poland does not have a coherent generic medicines policy however there is generic medicines competition within the existing regulatory frameworks [1].

Market Analysis

Country Focus/Poland | Posted 22/11/2013

First posted: 22 November 2013 

Poland has a mature generic medicines market. Irrespective of whether the shares are expressed by value or by volume, market shares of generic medicines fell in the 1990s, but stabilised in the early 2000s [1].

Licensing Guidelines and Regulations

Country Focus/Poland | Posted 18/11/2013

First posted: 18 November 2013 

In 1999, a mandatory social health insurance scheme was established in Poland. In each of the 16 provinces, self-administering, regional sickness funds were set up; furthermore, sickness funds for certain professions were installed. This system proved to be inefficient and therefore the national health fund (Narodowy Fundusz Zdrowia, NFZ) under the control of the Ministry of Health(Ministerstwo Zdrowi)was established in 2003 [1]. The national health fund is a third-party payer in public health care. The basic source of financing for health care is income from healthcare contributions from personal income [2].


Country Focus/Germany | Posted 14/10/2013

First posted: 14 October 2013 

Concerning biosimilars approved and marketed in Germany, view the following related articles:

Biosimilars approved and marketed in Germany

Germany wants to increase biosimilars penetration

Germany is already a mature (well-established) market* in the use of generic medicines.

Policies and Legislation

Country Focus/Germany | Posted 10/10/2013

First posted: 10 October 2013 

In Germany, pricing of medicines is officially unregulated even though the authorities influence medicine prices through the reference pricing system (RPS).

Market Analysis

Country Focus/Germany | Posted 08/10/2013

First posted: 8 October 2013 

The market share of generic medicines by value has only risen slightly in Germany since 1994. Public expenditure on generic medicines rose from 32.2% of the market share by value in 1994 to 36.8% of the market share by value in 2008 [1].

Licensing Guidelines and Regulations

Country Focus/Germany | Posted 30/09/2013

First posted: 30 September 2013 

The German healthcare system is characterised by a predominance of mandatory Social Health Insurance (SHI) with multiple competing sickness funds and a private/public mix of providers (Bismarck model). In 2005, about 85.4% of the population were covered by comprehensive SHI. This is complemented by three co-existing schemes: private health insurance and two specific governmental schemes for civil servants [1].

Market Analysis

Country Focus/China | Posted 14/11/2012

First posted: 14 November 2012 

Concerning the 2013 status of generics market in China, view the following related article:

The generics market in China

  • The enormous population growth and the outbreak of chronic disorders and communicable diseases have driven the Chinese Government to resort to cost-effective healthcare solutions [1].
  • Market shares of generic medicines in terms of value have increased from 54% in 2000 to 63% in 2010 [1], while the volume of consumption of generic medicines was 95.1% in 2011 [2].

Licensing Guidelines and Regulations

Country Focus/China | Posted 09/11/2012

First posted: 9 November 2012 

Concerning biosimilars in China, view the articles: 

Chinese guidelines for biosimilars

China releases draft biosimilars guidance

Strategy for biosimilars in China

According to the Chinese Ministry of Health, by the end of October 2010, the three public health insurance schemes covered 1,233 million Chinese citizens, accounting for more than 90% of the total population [1].