§ John CryerTo ask the Secretary of State for Health if he will amend the draft Medicines for Human Use (Clinical Trials) Regulations 2003 to ensure that non-commercial publicly or charitably-funded drug development work will not come under the same regulatory framework as commercially-funded trials. [135584]
§ Ms Rosie WintertonThe European Directive on the conduct of clinical trials was adopted in February 2001. The main aim of the Directive is to simplify and harmonise procedures across the Community while ensuring the protection of trial subjects and providing a684W safe environment for the development of new medicines. member states are required to fully implement the Directive by 1 May 2004.
The scope of the Directive is wide and the United Kingdom Regulations will apply to all clinical trials on medicinal products for human use conducted in the UK, including academic and healthy volunteer studies, with the exception of non-interventional trials.
Because the Directive makes no distinction between commercial and non-commercial publicly or charitably funded clinical trials, they cannot be treated differently in the UK implementing regulations. However those drafting the Directive recognised the special position of non-commercial trials conducted by researchers without the participation of the pharmaceutical industry. The Government has 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 regulatory requirements and costs.
In responding to concerns, and to provide an environment in which patients are protected but high quality research is not inhibited, my noble Friend Lord Hunt of Kings Heath, the then Parliamentary Under-Secretary for Health, invited the Medical Research Council (MRC) and the Academy of Medical Sciences to co-ordinate a report on the impact of the Directive on academic studies. The impact assessment, prepared by the MRC with the active support of others including Cancer Research UK, the National Co-ordinating Centre for Health Technology Assessment and a number of academic experts formed the basis for a response to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the draft regulations to implement the Directive into UK law earlier this year.
The MHRA is giving careful consideration to legislation and guidance linked to these issues. For example, they are considering the acceptability of different approaches to monitoring the validity of trial data that are less labour intensive and expensive than those usually used in commercial trials. The aim is the use of appropriate quality systems proportionate to risk (thereby minimising increases in costs). A list of responses to frequently asked questions are published on the MHRA website at www.mhra.gov in the Clinical Trials Directive pages, which will be kept updated.
In another initiative, the Department and the MRC 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.
With our careful exploration of the impact on publicly-funded research and organisations that support it and delays in the Commission finalising the GCP Directive and other guidance, the United Kingdom's implementing regulations are not expected to be made until early in 2004.