That MHRA Complaints Procedure in full

Please note that this procedure is followed in the event that the MHRA receives a complaint about its administrative activities. There is a separate review procedure, with respect to FOIA requests (which I don't have copy of).

Matt

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
AGENCY PROCEDURES Ref : GEN020/04
Title : Handling Complaints
Effective date
29/03/07
Review date
28/03/09

1. SCOPE

1.1. To define the MHRA procedures for the handling of complaints about administration or levels of service. It does not cover formal appeals against licensing, regulatory decisions on devices or enforcement decisions. It includes details of the "Independent Complaints Adviser" system, and referral to the Ombudsman.

2. INTRODUCTION

2.1. All organisations receive complaints from time to time and the MHRA is no exception. Information from complainants can be used positively, as a way of improving our services. The following procedure is intended to ensure that all complaints are handled consistently and effectively throughout the Agency, with the aim of treating all complainants fairly and, as far as possible, to their satisfaction.

2.2. The procedures described in this SOP apply to all MHRA staff.

3. GENERAL

3.1 What is a complaint?

3.1.1 There can be no hard and fast rules about what constitutes a complaint, and this part of the SOP is intended as guidance only. Broadly speaking, a complaint is an expression of dissatisfaction about the MHRA's service provision. These can be made both orally and in writing. If an oral complaint is made the complainant should be asked to submit the complaint in writing.

3.1.2 In short, for the purposes of these procedures, a complaint is a representation from someone who is:

- disagreeing with an administrative decision, concerning them, taken by the MHRA; or

- unhappy with the way an administrative matter has been handled by the MHRA.

3.1.3 In addition, the MHRA may receive complaints concerning Parliamentary Questions (PQs), Private Office cases (POs), Ministerial statements or articles published by MHRA staff. These should be dealt with in the following ways:

- Parliamentary Questions or Private Office cases or other Ministerial statements.

Complaints regarding Parliamentary Questions or Private Office cases or other Ministerial statements should not be addressed by MHRA staff and should be referred to Private Office. If the complaint covers PQs etc., together with other issues concerning the Agency, staff will be advised by the Agency’s Central Complaints Officer (CCO) as to which areas of the complaint they should address.

- Published Articles.
If the complaint relates to published articles where MHRA staff are authors or part authors the complaint should be referred to the CCO for advice.

4. SPECIFIC

4.1 What to do if you receive a complaint

4.1.1 When a complaint is received it should be acknowledged within 5 working days. The complaint should be logged, investigated and a response sent directly to the complainant from the relevant unit/division. For the majority of complaints, they will be resolved at a local level with the initial response, without the need for further action.

A full record of all correspondence in relation to the complaint should be kept.

If a complaint is received, in the first instance, by the Central Complaints Officer (CCO), the CCO will forward it to the relevant unit/division for resolution at a local level. A copy of the complaint should be held on file by the CCO. Again, the unit/division should acknowledge receipt of the complaint within 5 working days and proceed with its investigation and response.

4.1.2 The guiding principles at all stages of dealing with a complaint should be:

- speedy handling;

- answering all points of concern;

- being factually correct;

- fair investigation;

- effective response;

- confidentiality.

4.1.3 Replies should also:

- provide an apology (if appropriate);

- correct any misunderstandings;

- be signed by the officer dealing with the complaint;

- provide contact details (including fax and e-mail).

4.2 Specific action to be followed

Resolve the complaint locally

4.2.1 Attempts should be made to resolve the complaint as quickly as possible at a local level i.e. group/unit/divisional head level whichever is the most appropriate. The response should advise the complainant that “if they remain dissatisfied, they may make representations to the Central Complaints Officer”.

Complaint to the Central Complaints Officer (CCO)

4.2.2 As soon as a complaint to the CCO is received in writing, it should be sent to Central Complaints Co-ordinator (CCC) (see details below). Written complaints sent directly to the Chief Executive or Board Member should also be referred to the CCC immediately.

4.2.3 The CCC will send an acknowledgement letter to the complainant within 5 working days, register the complaint, inform the CCO and raise a file with an identifying number. The file will contain the letter of complaint and all subsequent correspondence.

4.2.4 The registered file will then be sent, by the CCC, to the relevant part of the Agency for a report. Relevant staff should maintain a simple record on the file of the action taken (by whom and when) as it may be necessary to refer to this later if the complaint cannot be resolved quickly or becomes more involved.

4.2.5 The report should be sent (by email) to the CCO within 6 working days of the date of receipt. The report should be placed on file. If this is not possible to provide a report within the stipulated time-frame, the CCO should be notified and given an indication of when the report will be provided.

4.2.6 All complaints will be considered thoroughly by the CCO. The circumstances leading up to the complaint should be fully and objectively reviewed before a reply is drafted. If it is necessary to consult with others for information or opinions, a record should be made and copies of any exchange of correspondence should be kept on the file.

4.2.7 The CCO will communicate the outcome of the review to both the
complainant and the relevant unit/division.

If the outcome of the review is in the complainant's favour, remedial action/an apology (or both) may be necessary.

- If the outcome is not in the complainant's favour, a full explanation must be included in the reply, even if one has been given previously.

- If the outcome raises questions of policy or is likely to have an impact elsewhere in the Agency, the necessary information should be passed by the CCO to the relevant person(s).

4.3 Referral to the Chief Executive

4.3.1 If, following an investigation and reply by the CCO, the complainant writes to say he/she is still dissatisfied with the outcome or the way the complaint has been handled, the CCO may decide, if appropriate (e.g. if referring the matter to the Chief Executive will add value to the complaints process), to refer the matter to the Chief Executive's Office.

4.3.2 Further action, including a further substantive reply, will be directed by the Chief Executive in discussion with the relevant part of the Agency. The Chief Executive’s office will respond within 20 working days. At this stage, the Chief Executive will advise the complainant of his/her right to contact the Independent Complaints Adviser, who has the power to investigate complaints fully and make representations to us on behalf of the complainant.

4.4 The Independent Complaints Adviser (ICA)

4.4.1 A matter may be referred to the ICA either after the CCO has unsuccessfully tried to resolve it, or one stage later after the Chief Executive has also unsuccessfully tried to resolve it.

4.4.2 The role of the Independent Complaints Adviser is: "To investigate complaints against the Medicines and Healthcare products Regulatory Agency leading to a dispute between it and the complainant, on matters relating to administrative actions. To make recommendations concerning resolution of the specific complaint, and, where appropriate, advise on a suitable form of redress. Also, where MHRA operating procedures appear at fault, to make recommendations for improvement."

4.4.3 The ICA will acknowledge the complaint within 5 working days.

4.4.4 Initially, the ICA may try to resolve the matter informally by discussion with the Board Member or line manager concerned. If a more formal course of action proves necessary, the ICA will investigate the circumstances fully and provide a report of any findings and any recommendations simultaneously to the complainant, the MHRA's Chief Executive and the relevant Board Member.

4.4.5 If the report cannot be sent within 20 working days, the ICA will write to the complainant explaining that the matter is being dealt with and giving reasons for any delay.

4.4.6 Following the submission of the ICA's report to the complainant, the Chief Executive and Board member, the report will be submitted to the next MHRA Board meeting for discussion and agreement on any policy or procedural changes recommended by the ICA.

4.5 The Ombudsman

4.5.1 If, following the ICA's report and the MHRA Board's consideration of any policy or procedure changes recommended by him, the complainant is still dissatisfied, he/she may refer the complaint to the Ombudsman through an MP. The letter from the ICA accompanying his report to the complainant should include a statement to this effect.

4.6 Monitoring

4.6.1 The Central Complaints Officer will be responsible for ensuring a record is maintained of complaints received and dealt with by him/her, of subsequent action and for supplying statistics to the MHRA Board.

A summary of the full process is at Appendix A.

For further information and advice on Risk Management contact the Central Complaints Officer, Deputy Central Complaints Officer or Central Complaints Co-ordinator whose details can be obtained on Policy’s site on Insite.

5. APPENDICES

Appendix A – Summary of the complaints process

6. CROSS-REFERENCES
GEN 037: Corrective Action
GEN 038: Preventive Action

7. REVISION HISTORY

Issue Effective Date Reason for revision Prepared by

01 01/01/2000 M Gosling
02 01/03/2005 Updating L O’Brien
03 19/06/2006 Reformatting and S Jones/

Updating S Fletcher
04 29/03/2007 Updating S Jones/S Fletcher

8. KEY WORDS
Complaint; parliamentary question; private office case; central complaints officer;
central complaints co-ordinator; independent complaints adviser; ombudsman

APPENDIX A


SUMMARY OF COMPLAINTS PROCEDURE


C O M P L A I N T
MHRA UNIT / DIVISION LOG AND ACKNOWLEDGE COMPLAINT WITHIN 5 WORKING DAYS
INVESTIGATE COMPLAINT AT GROUP / UNIT / DIVISIONAL
HEAD LEVEL
RESPONSE TO COMPLAINT
IF COMPLAINANT REMAINS DISSATISFIED WITH THE AGENCY’S REPLY, THEY MAY MAKE REPRESENTATIONS TO THE C.C.O.
CENTRAL COMPLAINTS OFFICER (C.C.O.) LOG AND ACKNOWLEDGE COMPLAINT WITHIN 5 WORKING DAYS
REPORT FROM RELEVANT DIVISION TO C.C.O. WITHIN 6 WORKING DAYS OF RECEIPT OF FILE
OUTCOME IN COMPLAINANT’S FAVOUR
REMEDIAL ACTION / APOLOGY
ACKNOWLEDGE COMPLAINT WITHIN 5 WORKING DAYS REPORT / UPDATE MATTER AND REASON FOR DELAY
WITHIN 20 WORKING DAYS
INDEPENDENT COMPLAINTS ADVISER
CHIEF EXECUTIVE: RESPONSE SENT WITHIN 20 WORKING DAYS
OUTCOME NOT IN COMPLAINANT’S FAVOUR
COMPLAINANT NOTIFIED OF OUTCOME.
IF COMPLAINANT REMAINS DISSATISFIED: