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HFEA complaints policy

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1. About this document

1.1 This document sets out the procedure that we will use, and the principles we will take into account, when considering complaints from members of the public and other external stakeholders.

1.2 In establishing our Complaints Policy, we have had regard to paragraphs 9.5 to 9.7 of the Statutory Code of Practice for Regulators issued on 17 December 2007.

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2. What is a complaint?

2.1 A complaint is an expression of dissatisfaction with the way we acted, or failed to act, in the exercise of our statutory duties, which actively seeks a remedy.

2.2 Under the Human Fertilisation and Embryology Act 1990 (as amended) (the Act), we have a number of statutory duties. These are to:

  • (a) license and monitor clinics carrying out in vitro fertilisation and donor insemination;
  • (b) license and monitor centres undertaking human embryo research;
  • (c) regulate the storage of eggs, sperm and embryos;
  • (d) produce a code of practice;
  • (e) maintain a register of information about donors, treatments and children born as a result of those treatments;
  • (f) publicise our role, and provide relevant advice and information to patients, donors and clinics;
  • (g) review information about human embryos, and any subsequent development of embryos, and the provision of treatment services and activities governed by the Act; and
  • (h) give advice to the Secretary of State for Health if requested to do so.
  • (i) Maintain a statement of general principles that the HFEA considers should be followed in the carrying on of activities governed by the Act and its functions in relation to such activities;
  • (j) Promote compliance with the Act and the Code of Practice.

The Authority must also carry out its functions effectively, efficiently and economically. So far as relevant, it must have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).

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3. What does this procedure cover?

3.1 This procedure covers any complaints about the work of the HFEA in carrying out its functions. This includes complaints about the services we provide, the work of our staff, and the information we publish.

3.2 In order to make a complaint, you must have been directly affected by the matters that you wish to complain about.

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4. What doesn't it cover?

4.1 This procedure does not cover appeals against decisions about licences, or complaints about matters that are not our responsibility.

4.2 We are not able to investigate general complaints about the statutory framework governing fertility treatment and research, general dissatisfaction with our  policies, or matters which are the responsibility of other bodies, such as Primary Care Trusts.

4.3 If we think that your complaint should be dealt with by  another body, such as the General Medical Council, we will provide you with their contact details.

4.4 Complaints about the services you may have received at a particular clinic are handled under a separate procedure, which is dealt with by the Regulation Directorate of the HFEA.

4.5 Those affected by a decision made by an HFEA Licensing Committee or Executive Licensing Panel, and who wish to appeal that decision, must follow the statutory procedures laid down in the Act, and the Human Fertilisation and Embryology (Appeals) Regulations 2009.

4.6 Complaints about how we have handled requests for information under the Freedom of Information Act 2000 or Data Protection Act 1998 are dealt with separately and complainants should follow the procedure laid down in our Freedom of Information and Data Protection Policies.

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5. How can you make a complaint?

5.1 All complaints should be made in writing, addressed to the Head of Business Planning and sent to us at one of the addresses below:

By post: HFEA, Finsbury Tower, 103-105 Bunhill Row, London, EC1Y 8HF.

By email: enquiries@hfea.gov.uk  

5.2 When making a complaint, you should provide your full name and postal address. We are not able to investigate anonymous complaints.

5.3 To assist you in making a complaint, we have provided a complaints form which is annexed to this document, and which can be downloaded from our website. You can also obtain a copy by ringing the Head of Business Planning on 0207 291 8220.

5.4 We would prefer you to use this form when making your complaint. It will help us, and you, if you do. This is because the form sets out the information that we need in order to investigate your complaint properly. It is important that you set out clearly what the grounds of your complaint are, what outcome you would like to achieve, who was involved in the subject matter of  your complaint(if known), and that you provide any relevant supporting evidence. Use of the HFEA?s form will enable your complaint to be dealt with more quickly and will reduce the need to seek further information.

5.5 If you would like assistance in completing the complaints form, please contact the Head of Business Planning on 0207 291 8220.

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6. Time limit for making a complaint

6.1 If you wish to make a complaint, please do so as soon as possible after the matter that you wish to complain about has occurred.

6.2 Please note that we will not normally consider complaints if they are made more than 12 months after you became aware of the matters that gave rise to the complaint.

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7. What principles will we apply when dealing with a complaint?

7.1 The HFEA will ensure that:

  • (a) complaints are handled speedily and complainants are kept informed about the progress of their complaint especially if expected timescales are likely to be exceeded;
  • (b) complaints are handled fairly, effectively and objectively;
  • (c) persons who are the subject of a complaint will be given an opportunity to respond;
  • (d) complainants are informed of the outcome of any investigation and provided with reasons for the decision to uphold or dismiss the complaint;
  • (e) clear information is given on the options available to a person dissatisfied with our response, including an opportunity for a review; and
  • (f) actions are identified where necessary to secure improvements.

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8. Acknowledgement of your complaint

8.1 We aim to acknowledge all complaints within five working days of receipt.

8.2 The acknowledgment will give you the name and contact details of the person who will be responsible for responding to you.

8.3 All complaints received by the HFEA are logged and the Chief Executive will be notified of the existence of the complaint.

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9. How will we respond to complaints?

9.1 Some complaints are caused by misunderstandings which can be resolved informally once the matter has been explained.  A member of staff will discuss the complaint informally with you, and will confirm whether the complaint can be properly considered under this procedure.

9.2 If you do wish the complaint to be dealt with formally, the person investigating  the complaint will write to you, setting out the likely timescale of the  investigation, and setting out any matters on which further information or clarification will be needed from you.

9.3 A copy of your complaint, and any additional information or material that you provide may be shown to any person who is the subject of your complaint, for comment.

9.4 We aim to complete all investigations within 6 weeks of our receiving the complaint. Some complaints may raise complex matters which require more time to investigate. If it is not possible to complete our investigation within the 6 week timescale, we will write and let you know.

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10. Who will investigate my complaint?

10.1 The Head of Business Planning will ensure that the complaint is investigated by a more senior person not directly involved in the matter.

10.2 If a complaint involves the Chief Executive, the Chair will decide the most appropriate method of investigating the matter.

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11. What if I am not satisfied with the response?

11.1 If you are not satisfied with the outcome of the initial investigation, you can ask for a review to be conducted. If you wish a review to be conducted, you should write to the Head of Business Planning asking for the review within 10 working days of receipt of our letter informing you of the outcome of the investigation.  If you do not follow this time limit, we may decide not to conduct the review.

11.2 You should set out in your letter the specific reason(s) for your dissatisfaction with the outcome of the original investigation, stating what aspects of the original complaint and response you believe require further investigation and the reasons for this.

11.3 A review will only take place if you produce new or additional evidence which  was not, for a valid reason, available at the time of the original investigation and which might have influenced the outcome, or if you can demonstrate that the complaints procedure has not been followed correctly.

11.4 The Chair or the Chief Executive will ensure that the review is carried out by a senior member of staff, or an Authority member, who is not directly involved in the matter and who did not conduct the original investigation.

11.5 If your complaint involved the Chief Executive, the Chair will decide the most appropriate method of conducting the review.

11.6 We will write to you within five working days of receipt of your request, to inform you whether or not a review is to be held. If a review is to be held, the person conducting that review will inform you of the likely timescales for completion of the review. If a review is not to be held, you will be informed of the reason for this decision.

11.7 We aim to complete any review within 4 weeks. When the review is complete, the person conducting the review will confirm the outcome in writing to you.

11.8 The decision of the person conducting the review will be final. Once the decision has been communicated to you, we will not usually enter into any further correspondence with you about your complaint.

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12. Complaints about the Chair and members of the HFEA

12.1 Members of the HFEA are appointed by the Secretary of State for Health and are required to abide by the Code of Conduct for Authority Members (pdf) and the seven principles of public life.

12.2 If your complaint involves a member of the HFEA, the Chair of the Authority will  determine the most appropriate means of investigating the matter.

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13. Outcome of Review/Investigation

13.1 If we uphold your complaint, we may:

  • (a) apologise by letter, telephone or in person as considered appropriate;
  • (b) give a full explanation of what happened and why;
  • (c) make changes to our processes and procedures; and
  • (d) take any other action we consider appropriate to put the matter right.

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14. The Parliamentary and Health Service Ombudsman

14.1 If you remain dissatisfied with the outcome of the initial investigation and any subsequent review, then you are entitled to refer the matter to the Parliamentary and Health Service Ombudsman (?the Parliamentary Ombudsman?). To do so, you must refer your complaint and supporting documents through a Member of Parliament.

14.2 Further information about this process can be found at http://www.ombudsman.org.uk/.

14.3 The Parliamentary Ombudsman will normally expect you to have gone through our complaints procedure first.

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15. Vexatious and Persistent Complaints

15.1 Whilst we recognise that most complainants will exercise their rights to complain sensibly and responsibly, some individuals or organisations may attempt to abuse their rights with requests which are vexatious, persistent or are an abuse of process.

15.2 A complaint will be considered to be vexatious and/or persistent and/or an abuse of process if:

  • (a) it makes demands for action or information that would impact substantially and unreasonably on our work;
  • (b) it is persistently pursued when our complaints procedure has been fully and properly exhausted;
  • (c) the substance of the complaint is continually changed with new issues and concerns being raised whilst the complaint is being addressed or following conclusion of the review/investigation under our complaints procedure;
  • (d) the complainant refuses to identify precisely the issues that they wish to be investigated despite reasonable efforts by staff to help them identify their concerns;
  • (e) it is designed to cause disruption, annoyance or expense or has the effect of harassing the HFEA including where the complaint is identical or substantially similar to a previous complaint made by or on behalf of the complainant;
  • (f) it can be fairly characterised as obsessive or manifestly unreasonable; and
  • (g) The subject matter of the complaint is, or has been the subject of legal proceedings.

15.3 We reserve the right to deal with vexatious or persistent complaints or complaints that are considered to be an abuse of process by:

  • (a) limiting communication with the complainant to just one form and to one point of contact;
  • (b) confirming to the complainant in writing that the investigation/review is complete and that continued correspondence will serve no purpose;
  • (c) informing persistent complainants in writing that if they continue to complain unnecessarily, we reserve the right to take no further action in response to their complaints; or
  • (d) suspending any investigation/review pending the conclusion of any legal proceedings in an appropriate case

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16. Monitoring and recording

16.1 All complaints will be recorded on a central complaints database and monitored regularly by us. This knowledge will be used to improve the way in which we continue to operate.


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17. Data Protection and Freedom of Information

17.1 By using our complaints procedures, you consent to us processing your personal data for purposes related to your complaint.

17.2 We may disclose your data to other individuals or bodies if we are legally required or permitted to do so under the Data Protection Act 1998 or the Freedom of Information Act 2000

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Page last updated: 08 June 2012