Understanding Clinical Trial Costs in Eastern EuropeThursday September 14
Sharon Safranyos, CanReg In May 2004, the European Community (EC) was expanded to include 10 new member states, for a total of 25 members. This has not only opened up the market for finished pharmaceuticals but has increased the awareness of some of the eastern member states as possible areas for conducting clinical trials. Indeed some of the newer member states such as Slovakia, the Czech Republic and Hungary are eager to present themselves as attractive sites for the conduct of clinical trials in Europe. Clinical Research organizations (CROs), ever mindful of opportunities, are eager to present their services to assist manufacturers in not only gaining approval for their clinical trials, but also in running the trials. One of the drawbacks of conducting trials in Europe is the cost of application and approval, especially compared to Canada. Health Canada does not charge for the review and approval of a clinical trial application. In order to have access to a large demographic in the EC, it may be necessary to conduct clinical trials in a number of member states. Although there are centralized and decentralized procedures for the approval of new drugs in the EC, clinical trial applications are still managed on a national level.
The established member states such as Germany, the United Kingdom and the Netherlands have an established infrastructure designed to manage the applications both at the ethics review level and at the federal level. Applications in Germany are managed by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The infrastructure in the UK for the ethics review and coordination is also extensive and is managed by the Central Office for Research Ethics Committees (COREC)1. This established infrastructure provides a level of efficiency and reliability that sponsors have come to rely upon, but it comes at a price. The fees in Germany for applications to the Agency and to the Ethics Committees relating to a Phase III clinical trail are €3,800 and €2000-4000 respectively 2. In the UK the fees for application to the agency are currently €4,374, although there is no fee for application to the Ethics Committee3. In addition there may be fees for a Manufacturers License if the product is imported from a third Country.
The Netherlands has a slightly different process for the review and approval of clinical trials. The Central Committee for Medical Research (CCMO) and the Medical Ethics Review Committee (METC) may both be required to review the application, the CCMO does not charge a fee, the METC charges in the region of €4004. The Netherlands also has very specific requirements for insurance subjects as well as insurance for the sponsor and the Principle Investigator.
Cost in some of the new member states may be lower, for example the State Institute of Drug Control in Slovakia (SIDC) charges 10,000 SKK, which is approximately €266 for the assessment and issue of a clinical trial approval. There is currently no fee for the Ethics review5. The fees within the Czech Republic are at a little higher, at approximately €1,515, and the fees for the Ethics review vary5. Other expenses need to be taken into consideration when considering clinical trials in these areas. For example, in Slovakia the law requires that the applicant or the legal representative must be domiciled in Slovakia. This is over and above the requirement of the Directive, which required the applicant to be established in the community, this can incur extra costs.
The review times are generally favorable across the EU due to the implementation of Directive 2001/20/EC. The requirements of the directive are such that review is mandated to a maximum of 60 days; however some agencies are currently reviewing applications in a shorter time frame. Although the applications to the Agency and the Ethics committee may be made at the same time, the trial cannot start until both have given their approval.
It is certainly true that Europe has a lot to offer for the conduct of clinical trials. There is a varied demographic and excellent access to experts in a wide variety of clinical fields. Central Eastern Europe has certainly seen an increase in clinical trials over the last few years and it is anticipated that this trend will continue.
About the Author
Sharon Safranyos heads up CanReg’s International Regulatory Affairs Team (). Based in Dundas, Ontario, CanReg is dedicated exclusively to global regulatory affairs for life science companies. More than 100 in-house consultants and staff support our clients around the world.
References
1. COREC Website. http://www.corec.org.uk/index.htm
2. Clinical Trials BfArM http://www.bfarm.de/cln_043/nn_424304/DE/Arzneimittel/klinPr/klinpr-node.html__nnn=true
3. MHRA Regulatory Fees – Proposals For 1 April 2006 http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dID=17919&noSaveAs=0&Rendition=WEB
4. Central Committee for Medical Research Netherlands. http://www.ccmo-online.nl/main.asp?pid=10
5. IDRAC
6. Directive 2001/20/EC
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