- Latest gene therapy news
- Clinical trial databases
- Legislation and regulations
- Recent research articles
- Societies and more...

Home Patients Breaking news Clinical trials Conferences Articles Site map Contact
 
Menu
What is gene therapy
Gene Therapy news
Societies
Companies
Research institutes
Regulatory affairs
Clinical trial databases
Literature
 
 
Site Info

Time:




Best viewed at minimal screen resolution 1024x768
This website is hosted by Budget Webhosting Holland.

eXTReMe Tracker

Copyright © 2007, 2008 by Gene Therapy Net

 
 
Gene Therapy Legislation in Europe

The implementation of the European Union (EU) directives and guidelines for clinical gene therapy trials in the different EU member states and other European countries is gathered for the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

EU Clinical Gene Therapy Trials legislation
The EU has several directives and guidelines for conducting clinical gene therapy trials. EU Directive 2001/83/EC provides a consolidated Community code relating to medicinal products for human use. The directive describes in great detail the considerations for conducting clinical trials without reference to specific requirements for trials involving genetically modified organisms (GMOs) as is often the case in gene therapy trials.

The EU Clinical Trials Directive 2001/20/EC establishes specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products in particular relating to the implementation of good clinical practice. Its main purpose is to protect clinical trial subjects by establishing quality, safety and ethical criteria to be observed. In this evaluation the Ethics Committees at national level have a key role in evaluating the different aspects and providing an opinion before the trial can start. Although the Directive 2001/20/EC has led to harmonized procedures for authorizations of clinical
trials in the EU member states, the detailed procedures at national level are still somewhat different.

The legislative framework for the application of genetically modified organisms (GMOs) in clinical gene therapy research is provided by several European directives and regulations. Some EU member states consider clinical trials with gene medicines as deliberate release according to Directive 2001/18/EC, while others consider them as contained use according to Directive 98/81/EC.

Contained use is defined as any activity with GMOs for which specific containment measures are used to limit their contact with the environment. The focus of Directive 98/81/EC is on the assessment of the biosafety level classification of the GMO and the implementation of physical, chemical and biological barriers. The risk classification has consequences for the procedure and review period of the application.

Deliberate release is defined as any activity with GMOs that is not contained use. Directive 2001/18/EC is based on a case-by-case environmental risk assessment (ERA) covering effects on human health or the environment. The ERA should be carried out in accordance with the principles set out in Annex II of this Directive. In short, the five steps involved in the ERA are i) identification of potential adverse effects, ii) estimation of the likelihood, iii) risk estimation, iv) risk management and v) assessment of the overall environmental impact. Although the approach of Directive 98/81/EC is different from Directive 2001/18/EC, both directives aim at protecting the environment and human health and therefore require a risk assessment preceding the activity.

EU Market authorization procedure
The final stage in the development of a gene therapy product after conducting clinical trials is the market application. The legislative framework for market authorization of human gene therapy products and other medicinal products containing or consisting of GMOs is based on Directive 2001/83/EC, Regulation (EC) No 726/2004 and Directive 2001/18/EC. If the application concerns a product that contains a GMO, the market authorisation dossier submitted directly to the EMEA should also contain the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC. Regulation (EC) 726/2004 also describes that the competent authorities of 2001/18/EC must be consulted. In addition, the regulation indicates that an application must be accompanied by a written consent to the deliberate release into the environment of GMOs for research and development purposes provided for in part B of Directive 2001/18/EC.
Thus, there is a clear connection between market authorisation of a gene therapy product and the environmental risk assessment based on Directive 2001/18/EC for clinical trials. More information regarding the placing on the market of human medicinal products can be found on the EMEA website or check directly the Gene Therapy Working Party (GTWP).

Please keep the information up to date and accurate by posting your comments and suggestions to the webmaster.

 
 
EU Directives and Regulations

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p.67–128).

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121, 1/5/2001 p.34–44).

Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/1998 p. 13 - 31).

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (Official Journal L 106, 17/4/2001 p. 1 - 39).

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Official Journal L 136, 30/4/2004 p. 1–33).

EUR-Lex - The portal to European Union law

 
 
Literature and guidance documents

Gene therapy bio-safety: scientific and regulatory issues. Gene Ther 2005; 12: S146–152. This paper discusses the topics during the round table of the 2nd European Conference & Practical Course: Towards Clinical Gene Therapy: Preclinical Gene Transfer Assessment, held in Bellaterra (Spain), 1–14 February, 2004.

Opinion paper on the current status of the regulation of gene therapy in Europe. Hum. Gene Ther. 2002; 13:2085-110. A summary description of the current regulatory status of gene therapy in each European country is provided in order to emphasize the requirement for standardization and therefore foster the development of gene therapy. This description is followed by consensus comments and recommendations of the Euregenethy Network.

Analysis of the applicability of the contained use legislation for clinical trials (2006). Perseus BVBA. This report is the result of an initiative of the European Commission to perform an analysis of the applicability of the contained use legislation for clinical trials. The objectives of the project were to collect and prepare background information and data concerning clinical trials and the suitability of the legislation under which they are governed, and to undertake a detailed appraisal of the current legislation in terms of the suitability and adequacy of their provisions to address the potential risks from clinical trials.

European Association of Hospital Pharmacists (EAHP) Guidance on the Pharmacy Handling of Gene Medicines. EJHP 2007; 5: 29 -39. This guidance for the handling of gene medicines specifies the requirements for each step in the process from storage, dispensing and administration to the disposal of all materials involved in handling such therapeutic agents.
 
 
Related websites
European Agency for Safety and Health at Work
European Commission - Biotechnology
European Department for the Quality of Medicines
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Society of Regulatory Affairs
International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use
 
 
Navigation
  • United States of America
  • Europe
  •  
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovak Republic
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom
  • Azia / Pacific
  •  
  • Australia
  • China

  •