The Agency communications strategy & Increasing the patient voice in regulation - Hansard

http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42we56.htm

Question 2






The Agency communications strategy





As requested, I am enclosing a copy of the MHRA Communications Review conducted by Stonehenge, the public relations firm appointed after a procurement exercise launched in late 2003.[118] The Report, entitled "A Case for Change" was presented to the Agency in April 2004. The Report also contains the Patient View Report at Annex C. I am also enclosing as requested the extracts from the minutes of the Agency and Executive Boards where this issue was discussed (Annex B). Should the Report be published with the evidence of the Committee, I would be grateful for the time to ensure that anyone named individually in the Report is happy for their name to appear. I have also removed Appendix E as this is a comparative study of the press functions of other Agencies not within the remit of this Inquiry.





Stonehenge's report was comprehensive and extremely detailed. It provided the basis for the development of short and long term plans for our communications policy. Given the detail the Report contained, and the relatively low base from which the Agency started its work, much progress has been made.





Recruitment of a Director of Communications started almost immediately. However, as with any senior appointment, the process and the notice period which followed the successful appointment, has meant that our new Director of Communications was only able to take up post at the end of January 2005. The new Communications Division, consisting of existing and newly recruited staff under Simon Gregor's direction will come into being on 1 April 2005. However, an internal working group set up before Mr Gregor's arrival has progressed a number of issues, including an audit of all internal and external publications, the preparation for the launch of a procurement exercise seeking advice on the "re-branding" of these documents using an agreed Agency format and livery, the recruitment of a media relations team and the development of the Agency website. The results of these activities will be visible within the next few months. For example, the Agency will be taking over responsibility for its own press and media relations in mid March (work previously carried out on our behalf by DH media centre). The new website, with considerable additional functionality, will be launched in the early Autumn of 2005. In the longer term, the Agency is planning to work with key stakeholders in raising a better awareness of risk literacy among patients and healthcare professionals.







Question 3





Increasing the patient voice in regulation





The MHRA seeks to involve patients as stakeholders in the regulatory environment in a number of ways, including formally, through the Committee on Safety of Medicines and its sub-committees and in less formal ways across the range of its work.





In 2004 you may be aware that the Agency consulted on the reform of the Medicines Act Advisory Bodies. The Agency's restructuring plans will include greater patient participation in the regulatory process. There will be two lay members on the on the Commission for Human Medicines and the Committees set up under section 4 of the Medicines Act. The Agency is also establishing Expert Advisory Groups to advise the Statutory Committees, and each of these will have two patient members. The lay and patient members will meet independently and regularly as a patient forum. The new committee structure will be in place for the Autumn of 2005.





As you also will be aware, in 2003 Ministers commissioned an independent review of access to the Yellow Card Scheme Scheme, which looked in particular at transparency issues. This publication is also available on the MHRAs website and gives examples of some important early warnings of new ADRs identified through the yellow card scheme. In May 2004, the Review concluded that there should be greater access to Yellow Card data to ensure the full potential of the data was realised, and proposed a system for facilitating this. Of particular note, is the fact that recommendation in the report on direct patient reporting to the Scheme was accepted immediately and, after piloting several different options, launched a direct patient reporting scheme in January this year.





The MHRA has been proactive in ensuring that leaflets, labels and packaging meet patients' needs for clear and authoritative information, especially in the recent Review of EU legislation. Labelling of medicines will have to include the name, strength and pharmaceutical form in Braille and changes to the order of the information in the PIL will be required. The Review importantly introduces a requirement for user testing which should help to ensure improvements to the PIL to make them more understandable for patients. Guidance on user testing is being developed by the MHRA, supported by advice from a CSM Working Group on Patient Information. The Group is also advising on possible revisions to the European Guideline on Readability. This will all involve patient consultation and be of direct benefit to patients.





In addition, the Agency is seeking to be more transparent in its working ways of working. The Agency now publishes details of all complaints received about medicines advertising and the outcome of its investigations as well as being more open about how such decisions are made. This transparency in decision making has also extended to drug safety issues where the Agency has released previously unpublished data. The MHRA has published summaries of clinical trial data to support key communications on drug safety when it has been in the public interest to do so. Summaries of clinical trial data have been released in respect of SSRIs used in children as well as for anti-psychotics (risperidone) used in the treatment of dementia. A full and open consultation process is also carried out before a decision to re-classify a medicine (from Prescription Only to a Pharmacy or General Sales List medicine). Patient groups and charities are included on this consultation list.