Note on the Decision of the Licence Committee Considering the Representations on the Proposals of Notice to Revoke the Licence at Centre 0157 and to Refuse a Licence at Centre 0206 on 13 July 2007 - Response by the ARGC.

This is a short summary of our response to some of the findings made by the Licence Committee. We have compiled this for our patients to give them a chance to see at least part of our side of the story.

Unlicensed Treatment

The RGI was established in early 2003 by the Reproductive Genetics Institute in Chicago, in collaboration with us, as a referral centre for all IVF clinics primarily for potential PGD and PGS treatment. This service was aimed at patients with advanced maternal age, repeated implantation failures and repeated miscarriages. The RGI was predominantly a laboratory only facility of the highest international standards.

At the beginning of 2006, the HFEA issued special directions allowing treatment at the RGI for certain patients for an initial period of three months. These special directions were further extended for another three months at the beginning of April 2006.

In the meantime, we were advised by the HFEA to consider reporting treatment undertaken at both the ARGC and the RGI under one licence. This was in the context of several conversations with Dr Debra Bloor, the member of the HFEA Executive responsible for the clinics. Indeed, based on this advice, we submitted an interim application form to the HFEA in February 2006, which listed the addresses of both clinics under the licence of the ARGC. This was put before a licence committee and no problems were raised at that time. It was only in late-2006 that the HFEA told us retrospectively that we could not treat patients in both centres under the same licence, notwithstanding their earlier advice. In March of this year, when a document showing this earlier advice was pointed out to the judge in our hearing in the High Court, he said he was "gobsmacked".

In mid-June 2006, the RGI was offered a new 3-year licence with a condition attached to it prohibiting the transfer of 3 embryos to patients more than 40 years old. We accepted this new licence and its condition in writing ticking the usual box on the usual form and expressed our wish to make representations in relation to the condition as soon as possible. Dr Bloor approved the whole process from the outset and never indicated that this would cause any problem. Later the HFEA claimed that our request to make representations constituted a refusal of this licence. This was despite the fact that, in the past 12 years, we and many other clinics had made representations in relation to various proposed licence conditions without this ever being taken as a refusal of that licence. We thought it necessary to take legal advice and this confirmed our position. As a possible solution, however, we offered to withdraw our request to make representations in relation to the condition but the HFEA informed us that this was no longer possible.

Obviously, everyone must draw their own conclusions but all of our actions were done in good faith on the advice of our regulator. We have never tried to conceal any treatment undertaken at the RGI. Indeed, the conclusions drawn by the Licence Committee in this regard do not match those of the High Court judge in our hearing in March of this year. As we understood it, the HFEA was fully aware of the situation from the beginning of 2006 onwards.

Registration with the Healthcare Commission

We have always had a very positive and constructive relationship with the Healthcare Commission and we look forward to this continuing.

The process of registration with the Healthcare Commission is a simple one. Our decision not to register the RGI with the Healthcare Commission was based on our understanding of the registration criteria, which preclude those premises with laboratory-only activities from registration.

In a fourteen-page form from the HFEA, one box in relation to registration with the Healthcare Commission was incorrectly ticked. This was a mistake by the person who completed the form and we accept that. If the HFEA had come back to us and asked for clarification, we would have realised the error and corrected it immediately. We are disappointed that the first time we were told of the mistake was when the HFEA appeared at the ARGC in January 2007 with search warrants.

Compliance with Special Directions

Special Directions are issued by the Licence Committee, clinics are expected to comply with them. We have always done our very best to meet the terms of these and will continue to do so.

We have been criticised for not meeting the deadlines imposed by these special directions. In 2006, we received numerous special directions asking for different sets of information within a very short period of time. For example, we received special directions on the afternoon of Friday 21 July 2006 requiring certain patient information (comprising hundreds of forms) to be submitted to the HFEA by noon on Monday 24 July 2006. In any circumstances, meeting this deadline would have been impossible but it was especially so when all our staff were dealing with a full clinic of patients on that Friday, over that weekend and on Monday. We wrote a letter to the HFEA explaining that unfortunately we would not be able to supply all the information by that time. On Friday 28 July 2006, we received further special directions from the HFEA requesting a different set of information by noon on Monday 31 July 2006. By that time, we were thoroughly confused as we were still trying to compile all the information from the previous set of special directions and did not know whether these new directions superseded the directions of the week before.

This is just one example of the general confusion that pervaded 2006 and the special directions that were issued and then changed within days rendering compliance within the limited time frame allocated extremely difficult. We did our very best at all times to gather the information while maintaining the best possible service for all of our patients but, if a timeframe was impossible to comply with, we always notified the HFEA in advance and in writing.

Shipper Incident

The incident to which the licence committee refers is the first incident to occur at our centre in over 12 years and involved the use of wet and dry shippers to transport sperm. Shippers are essentially canisters used to store and transport embryos and gametes.

Until late 2006, wet shippers were always used for such transportation. Just after the HFEA had advised that dry shippers should be used by clinics instead, one of our staff members mistakenly supplied a wet shipper (which was the standard vessel used for transport for many years) instead of a dry shipper (the newly recommended vessel) to another clinic in order to transport the sperm stored at that clinic to us. The other clinic, which received this shipper, informed the HFEA immediately and then told us on the same day that the incident had been reported. We did not therefore inform the HFEA as this had already been done. A dry shipper was eventually used for the actual transport.

We are obviously determined that this will be avoided in the future - we have introduced several new policies in this regard and our wet shipper has been retired from service. However, when compared to some of the incidents of which we are aware in other clinics, this was a relatively minor incident and we were surprised that it was referred to a licence committee (in excess of 600 incidents have been reported to the HFEA by clinics in the last 2 years, including in the last few months a mix-up of PGD embryos resulting in a pregnancy; none of these incidents have been referred to a Licence Committee).

Patient complaints

Although we receive very few patient complaints, we treat each one with the attention and care it deserves. As the HFEA did not tell us the details of the alleged two anonymous complaints, it was difficult for us to respond meaningfully. We were also rather surprised that this was again referred to a licence committee, as a quick review of inspection reports published on the HFEA website reveals that there are clinics with over 30 patient complaints annually which have neither been investigated nor sent to a licence committee. We were disappointed that the report commissioned by the Executive from an external clinician dealt very little with the two anonymous complaints.

There are obviously other points raised by the Licence Committee's note which we have not addressed, in an effort to keep this document to a readable length. Any points we have not addressed should not be taken as admissions. Similarly, we have not troubled you with the licence committee's more constructive findings.