§ Mrs. Iris RobinsonTo ask the Secretary of State for Health what estimate he has made of the impact of implementing EU Directive 2001/20/EC on non-commercial drug research in the United Kingdom. [138989]
§ Miss Melanie JohnsonAs part of the consultations on the UK regulations, a partial regulatory impact assessment (RIA) was provided revealing potential increased costs. Universities, national health service trusts and charities were invited to submit estimates on recurring and non-recurring compliance costs for non-commercial trials. The comments received revealed the difficulty of estimating costs with so much uncertainty surrounding the Commission Directives.
The Government have taken further steps to attempt to influence the Commission in its consideration of a Commission Directive on Good Clinical Practice and also in reviewing guidance that the Commission published earlier this year with a view to avoiding any unnecessary costs. This work is continuing.
In another initiative designed to reduce the cost impact, the Department and the Medical Research Council are working with experts to find practical solutions to the issues identified in the partial impact assessment. Details of the project can be found at www.ncchta.org/eudirective/index.asp.
Further information on the partial regulatory impact assessment and the proposed United Kingdom implementing regulations is available on the Medicines and Healthcare products Regulatory Agency (MHRA) website at www.mhra.gov.uk and in the MHRA Consultative Documents: MLXs issued in 2003, MLX 287.