§ John CryerTo ask the Secretary of State for Health (1) what estimate he has made of the additional cost to the Medical Research Council of implementing EU Directive 2001/20/EC;[135586]
(2) what assessment he has made of the impact of EU Directive 2001/20/EC on the non-profit-making sector. [135587]
§ Ms Rosie WintertonAs part of the consultation on the draft United Kingdom regulations, a partial regulatory impact assessment (RIA) was provided and universities, national health service trusts and charities were invited to submit estimates on recurring and nonrecurring compliance costs for non-commercial trials. The comments received will be taken into account in preparing the final legislation and the final RIA.
In another initiative designed to reduce the impact, the Department and the Medical Research Council have announced a joint project to work with experts to find practical solutions to the issues identified in the impact assessment. Details of the project can be found on www.ncchta.org/eudirective/index.asp. Furthermore, the Government have taken 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.
Further information on the partial RIA and the proposed UK implementing regulations is available at http://medicines.mhra.gov.uk/inforesources/ publications/mlxpub.htm.