Country Focus

Licensing Guidelines and Regulations

Country Focus/United Kingdom | Posted 25/05/2011

The main characteristic of the British healthcare system is that nearly all healthcare services are offered by public authorities. The most important healthcare institution is the National Health Service (NHS), which was introduced in 1948 and covers all British residents. It is funded mainly through general taxation together with an element of national insurance contribution (an income based tax payable by employers and employees) and co-payments [1]

Licensing Guidelines and Regulations

Country Focus/Spain | Posted 14/10/2011

Under dictatorship there was a means-tested and centralised healthcare system, rooted in a social security scheme. The Spanish Constitution established the rights of all Spaniards to health care and set out a new regionally-based organisational framework. The National Health Institute was created in 1978 and the Ministry of Health in 1981 [1].

Licensing Guidelines and Regulations

Country Focus/Denmark | Posted 07/12/2011

Denmark has a state-run healthcare system, which has retained the same basic structure since the early 1970s. The administration of hospitals and personnel is dealt with by the Ministry of the Interior, while primary care facilities, health insurance, and community care are the responsibility of the Ministry of Social Affairs [1, 2].

Licensing Guidelines and Regulations

Country Focus/Japan | Posted 27/01/2012

The healthcare system in Japan provides healthcare services including screening examinations, prenatal care and infectious disease control, with the patient accepting responsibility for 30% of these costs while the government pays the remaining 70%.

Licensing Guidelines and Regulations

Country Focus/Portugal | Posted 24/02/2012

First posted: 24 February 2012 

The Portuguese healthcare system is organised as a national health service (Service National de Sáude, SNS), financed through general taxation, which provides health coverage to 75% of the population. The rest of the Portuguese are covered by one of the subsystems, funded mainly by contributions of employers and employees [1].

Licensing Guidelines and Regulations

Country Focus/Austria | Posted 18/04/2012

First posted: 18 April 2012 

The Austrian health insurance system is based on a social insurance system, which includes health, accident, pension as well as unemployment insurance. The underlying law is the Austrian Social Insurance Law (Allgemeines Sozialversicherungsgesetz, ASVG), which was brought into effect in 1955 [1].

Licensing Guidelines and Regulations

Country Focus/Italy | Posted 16/05/2012

First posted: 16 May 2012 

Concerning a concept paper on biosimilars published by the Italian Medicines Agency (AIFA), view the following related article:

Italian Medicines Agency publishes concept paper on biosimilars

Italy has a governmental medical service. In 1970, Italy still had approximately 100 different health insurances, which were abolished in 1978. At that time the National Health Service (Servicio Sanitario Nazionale, SSN) was introduced, which covers the entire population [1]. The system is based on the UK NHS model and provides uniform and comprehensive care and delivers the majority of care free of charge [2].

Licensing Guidelines and Regulations

Country Focus/France | Posted 03/08/2012

First posted: 3 August 2012 

The French public health insurance system was implemented in 1945. It is divided into three main schemes:

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].

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].