The UK BioIndustry Association has expressed serious concerns that the European Union's Clinical Trials Directive, due to be implemented by May 2004, could have a negative impact on the attractiveness of the UK as a location for clinical research.
In a submission to the UK's Medicines and Healthcare products Regulatory Agency consultation on the implementation of the Directive, the BIA said that the extra costs and bureaucracy could particularly affect early-stage bioscience companies.
One of the BIA's primary concerns is the requirement in the Directive that all investigational medicinal products should be produced to current Good Manufacturing Practice standards.
"Unlike the US situation, this appears to mandate full compliance with GMP as opposed to a level of manufacturing compliance commensurate with the stage of clinical development, i.e. manufacturing standards, which becomes progressively more controlled through the clinical development stages," said the BIA in its response document.
The effect of this will, it claims, be to add additional costs and time delays and potentially render a number of new projects uneconomic. A number of small sites used to manufacture Phase I and Phase II supplies will either need to be expensively upgraded or closed, it added. Meanwhile, the increase in approval times to commence clinical trials will lengthen development timescales and ultimately increase the overall cost of medicines coming to market.
"The BIA fully supports the Directive's aim of protecting public health, but we are calling for proportionate transposition into UK law. Additional costs and time delays as a result of the Directive could lead to a delay in medicines coming to market, which could affect millions of patients across the EU," said the Association.