Access to Yellow Card data

The primary purpose of the Review was to consider whether, and if so under what conditions and for what purposes, the Yellow Card Scheme data should be made more widely available. It was stimulated in part by increasing numbers of requests for access to the data for research and audit purposes, and in part by the potential for new uses, for example in researching the use of genetics to reduce the burden of ADRs.

A 12-week public consultation exercise  (MLX 308) ended on 9 January 2004. The report of the Review was published on 4 May 2004. On 17 January 2005, Lord Warner announced that the main recommendations from the Review had been accepted. The following documents were issued:

• Response to public consultation on the Independent Review of Access to the Yellow Card Scheme (16Kb) 
• Question and answer document (17Kb) 
• Department of Health press release  (external link)

Terms of reference

The terms of reference for the review are, taking into account the role the Yellow Card Scheme has played in protecting public health since it was set up in 1964 and with potential for strengthening this role in future, to:

• identify and describe the range of issues which should be considered when considering access to data generated by the Yellow Card Scheme including: 
• • public health
  • ethical
  • operational;
    
    
• financial and statutory (including Freedom of Information);
• identify relevant stakeholders to the Scheme and to define how such interests arise;
• consider in what circumstances access to the data generated by the scheme could be said to be in the public interest and the extent to which this falls within existing legal provisions;
• make proposals for guiding principles for handling such requests; and
• make recommendations for action.
   

Membership of the Steering Committee

Names of those invited to serve as member of the Steering Committee

Professor Gordon W Duff
Chairman of the Committee on Safety of Medicines

Dr Simon Thomas
Northern & Yorkshire MREC

Mr Philip Webb
Trustee of Genetic Interest Group

Dr Sandy Thomas
The Nuffield Council on Bioethics

Dr Jane Richards

Mr Simon Williams
Director of Policy, the Patients Association

Professor Christine Bond
Professor of Primary Care – University of Aberdeen

Ms Kristin McCarthy
Developing Patient Partnership

Minutes of the Steering Committee meetings

• 29 September 2003 (101Kb) 
• 1 December 2003 (127Kb) 
• 12 January 2004 (105Kb) 
• 16 February 2004 (128Kb) 
• 26 March 2004 (93Kb)