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Licensing Guidelines and Regulations 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].

The Federal Ministry of Health, Family and Youth (Bundesministerium für Gesundheit, Familie und Jugend, BMGFJ) is the main policymaker in health care at a federal level [1].

The main Association of Austrian Social Security Institutions (Hauptverband der österreichischen Sozialversicherunsträger, HVB) and its 19 sickness funds ensure the implementation of the social insurance system, which covered approximately 99% of the population of 8.3 million Austrians in 2008 [1, 2].

Generally, healthcare contributions are based on the income of the insured, although exemptions are made for low income households and patients with communicable diseases such as HIV and tuberculosis [1].

Health insurance contributions account for about 50% of health care in Austria. The rest is funded through private expenditure such as out-of-pocket payment and private health insurance (30%), and general taxation (20%) [1].

The average time for generics to obtain marketing authorisation in Austria is more than nine months, which is above the EU average of around seven months [3]. The average time interval between marketing authorisation and patient access to medicines is one of the shorter periods among the EU countries with 82% of medicines being available within 126 days after receiving marketing approval [4].

Since 2006, and according to the new Law on Food and Health (Gesundheits-und Ernährungssicherungsgesetz,GESG2) [5], the Austrian Federal Agency for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) has been responsible for granting the marketing authorisation and classifying medicines according to prescription status [1]. A limited liability company owned by the Republic of Austria was founded by the same law: the Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, AGES). A subdivision of this agency, the AGES PharmMed, supports the BASG in its work [5].

The BMGFJ has overall responsibility for the reimbursement and pricing of medicines in Austria. The BMGFJ is assisted by the Pricing Committee (Preiskommission, PK) on taking pricing decisions and by the HBV on reimbursement decisions .The HBV in turn relies on the recommendation of the Pharmaceutical Evaluation Board (Heilmittel-Evaluierungskommission, HEK) [1].

An independent drug commission (Unabhängige Heilmittel-Kommission, UHK) within the BMGFJ is charged with monitoring the HBV and the HEK. The UHK acts as an appeal board for manufacturers and has the power to veto (but not overrule) any decisions taken in relation to reimbursement applications [1].

An application for a generic drug may be submitted in Austria eight years after the first-time authorisation in the EU. After expiry of another two years, i.e. after 10 years in total, the generic medicinal product may be placed on the market for the first time (8+2 rule). When the marketing authorisation holder of an original product successfully applies for new fields of application within the first eight years after the first authorisation was awarded, data exclusivity is extended from 10 to 11 years (8+2+1 rule) [2].

Medicinal products may only be put into circulation by the marketing authorisation holder after they have been officially ‘approved’ by the authorities. The legal basis for this approval in Austria is the frequently amended law of 1984 relating to the manufacture and distribution of medicines (Medicinal Products Act, MPA) [2].

The authorisation is granted if the applicant can demonstrate that the expected benefits of a medicine exceed the expected side effects. The proof is provided by submitting pharmaceutical, preclinical data as well as clinical data [2].

There are three different procedures to obtain a marketing authorisation:

National procedure
The (purely) national authorisation procedure is set forth by the MPA and is only applicable for medicinal products which are to be authorised for Austria. AGES PharmMed, an agency within the AGES, evaluates the application while the BASG awards the marketing authorisation [2].

Mutual recognition/Decentralised procedure
The authorisation procedure is applicable when the medication is to be approved in more than one EU country. This procedure is based on the principle of mutual recognition of marketing authorisations from the Member States. The mutual recognition procedure should be applied for an authorisation already existing in one of the Member States [2].

The decentralised procedure is only applicable when there is no other corresponding authorisation in one of the Member States. The applicant is free to choose in which Member State the medicinal product is to be approved. A basic prerequisite is the positive approval of the authorisation application by all Member States involved in the process. Every Member State issues a national marketing authorisation once the procedure has been completed [2].

Centralised procedure
Authorisation through this procedure is mandatory for biotechnical medicinal products, medicinal products for novel therapies, certain veterinary drugs, orphan drugs as well as new substances for certain indications [2].

In this procedure, the evaluation is conducted not by the national authority but by the EMA, headquartered in London, UK. Based on the EMA evaluation, the European Commission awards an EU authorisation for all Member States [2].

References

1.  International Society for Pharmacoeconomics and Outcomes Research (ISPOR). ISPOR global health care systems roadmap: Austria – Pharmaceuticals. October 2009.

2.  Association of the Austrian Pharmaceutical Industry (Pharmig). Medicinal products and health care in Austria: Facts 2008/Edition 2010.

3.  Glowicka E, Lorincz S, Pesaresi E, Sauri Romero L, Verouden V. Generic entry in prescription medicines in the EU: Main characteristics, determinants and effects. 8 July 2009. Available from: www.ec.europa.eu/dgs/competition/economist/prescription_medicines.pdf

4.  European Federation of Pharmaceutical Industries and Associations (EFPIA). The Pharmaceutical Industry in Figures. 2010.

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

Useful information sources
EMA, Committee for Proprietary Medicinal Products (CPMP), Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) 24 July 2008 [monograph on the Internet] London, UK, EMA [cited 2012 Apr 13]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003011.pdf

EMA, Committee for Medicinal Products for Human Use (CHMP), EMEA Procedural Advice for Users of the Centralised Procedure for Generic/Hybrid Applications (EMEA/CHMP/ 225411/2006) 2 July 2008 [monograph on the Internet] London, UK, EMA [cited 2012 Apr 13]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP), Note for guidance on modified release oral and trans-dermal dosage forms: Section II (pharmacokinetic and clinical evaluation) (CPMP/EWP/280/96) 1999 [monograph on the Internet] London, UK, EMA [cited 2012 Apr 13] Available from: www.ema.europa.eu/pdfs/human/ewp/028096en.pdf

EMA, Committee for Proprietary Medicinal Products (CPMP), Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) 1995 [monograph on the Internet] London, UK, EMA [cited 2012 Apr 13] Available from: www.ema.europa.eu/pdfs/human/ewp/023995en.pdf

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