Country Focus

Policies and Legislation

Country Focus/Austria | Posted 24/04/2012

First posted: 24 April 2012

Austria does not have a coherent generic medicines policy and there is no generic medicines competition within the existing regulatory frameworks [1].

Policies and Legislation

Country Focus/Italy | Posted 23/05/2012

First posted: 23 May 2012

Concerning biosimilars policies in Italy, view the following related articles:

Biosimilars policies in Italy

The term ‘generic medicine’ was first defined in Italian legislation in 1996. A generic medicine has to be marketed under the international non-proprietary name (INN) followed by the name of the company. The definition of ‘generic medicine’ was extended in 2003 to cover all off-patent medicines, including copies (drugs of the same active substance marketed, with their own brand name, often by the originator itself) [1].

Policies and Legislation

Country Focus/France | Posted 16/08/2012

First posted: 16 August 2012

France has a coherent generic medicines policy, however there is no generic medicines competition within the existing regulatory frameworks [1]. Instead, there is competition by discounts to wholesalers and to pharmacists in France [2]. Although discounts of 10.74% are legally allowed in France, actual discounts vary from 20% to 70% of the wholesaler selling price [3].

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).

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].

Policies and Legislation

Country Focus/The Netherlands | Posted 30/11/2010

In The Netherlands generic pricing is regulated in the same way as originator medicines and has been subject to many policy and legislative changes over the past years, including the Drug Price Act (WGP), the Health Care Market Regulation Act (WMG), Claw-back (De Geus measure), Covenant Years 2004–2007 and Pharmaceutical Care Transaction Agreements.