Human Fertilisation and Embryology Bill [Lords]
Mark Simmonds: I beg to move amendment No. 144, in clause 19, page 15, line 12, leave out subsection (7).
No. 145, in clause 19, page 15, line 14, at end insert
(8) Notification to the applicant of a decision whether to grant or refuse a licence must be given within a specified time period to be determined by regulation..
Mark Simmonds: Again, I shall be brief; these are probing amendments. Perhaps the Minister could clarify why on page 15 there seems to be some duplication. In clause 19A there are four distinct categories:
In the case of a decision to grant a licence, the Authority shall give notice of the decision to
(a) the applicant, and
(b) the person who is to be the person responsible.
and those seem to be exactly the same for the four categories: granting, revocation and the two types of variation. I understand that in clause 19A(7) a distinction is drawn with subsections (2) and (4), but I cannot see why it is broken down into four distinct categories under 19A and not two or three. The people who must be notified after decisions are taken are exactly the same. That is the purpose of amendment No. 144.
Amendment No. 145 has been tabled because there are clearly delays that can be damaging both to business and researchparticularly the latter as research grants elapse after a certain period of time. Under the current provisions, the authority can take as long as it chooses to decide whether to grant or refuse a licence. The amendment would ensure that the authority understands that it would be helpful if a specific time periodspecified in the regulations after consultationcould be set out to help provide clarity. Perhaps the Minister and her officials could give that some thought.
Most public bodies have specific time scales within which they must respond. For example, the Department of Health is supposed to respond to correspondence from MPs within 20 days. I am sure that the Minister will be the first to acknowledge that that is not always the case, but attempts are always made to ensure that the time scale is met. There is concern within the industryif I can call it thatthat there may have been unacceptable and unreasonable delays in specific circumstances. I would not seek to specify the time period in the Bill; that will have to come through discussions and be put through regulations after consultation. However, it is a key point and requires addressing.
Dawn Primarolo: I understand the hon. Gentlemans point perfectly and the reasons why he seeks to set a time limit, or at least to get an indication of one. This issue is often raised. I accept that the HFEA should respond in reasonable time, and recognise that regulations would allow a suitable period to be determined in consultation with interested parties.
Howeverthe hon. Gentleman touched on this, so I think that what I am about to say might helpsetting out such a time limit in statute would restrict the HFEA in having the added flexibility that might be needed in certain situations in the more complex licence applications. I can reassure him and the Committee, however, that the HFEA is committed to notifying the applicant of its decision either to grant or refuse a licence within set time scales. It has a self-imposed target of three months for licence applications, and four for any new treatment and storage licences. It is right that we allow it that flexibility.
Over the past 12 monthsI accept that this would not necessarily apply to the more complex applicationsthe HFEA has received three applications for research licences, all of which were processed and decided upon within the required three months. That indicates that currently it is processing applications in a timely fashion, although
Proposed new section 19 provides that reasons must be given for certain licensing decisions and provides an opportunity for representations to be made before a decision is taken. It sets out the person to whom notice is to be given when the decision is made. The new provisions set it out that if the HFEA agrees to an application from a licence holder or person responsible to vary or revoke, it does not need to give reasons for its decisions when giving notice to the specified persons. That makes sense, because the HFEA is granting what was requested. That measure is aimed at reducing the unnecessary bureaucratic measures that have also been mentioned. When a decision goes against a request, proposed new section 19A(5) will require the applicant to be given reasons for the refusal. I think that that provision satisfies the concerns raised in relation to the amendment.
The hon. Gentleman then asked about the reason for the different categories. It is to cover the different areasgranting, revocation, application or any other variationso that they are all covered by slightly different notification requirements based on the relevant application. I accept that that might appear more complicated in the Bill, but in practice it will speed up and make clear what applies in the case of different decisions. I hope that that deals with his questions.
Mark Simmonds: Again, I thank the Minister for her response. Amendment No. 144 is really a probing amendment on which she has clearly satisfied me. I hear what the she says about amendment No. 145, but I urge her and the relevant officials in the Department to monitor the situation carefully, because there is concern among those applying for licences.
I am intrigued that the Minister says that there has been no delay in applications in the past 12 monthsthat is not what people have been telling me. What was the point of Tuesdays debate on delegated powers to speed up the process, if it does not need speeding up? From what she has said today, the process seems to be working well. I suspect, however, that because of the additional potential licence areas with which the HFEA will have to cope when the Bill is enacted, it will receive more licence applications than it has to date. The situation therefore needs to be monitored carefully.
Dawn Primarolo: I hope that I did not convey any complacency in explaining what has happened in the 2007-08 period. I accept that comments have been made, and the hon. Gentleman is right about needing to be vigilant and ensuring that the process continues to be accurate and timelywithout unwarranted delayunless there is complexity.
Mark Simmonds: I confirm that the Minister certainly did not give the impression of complacency on this particular occasion. On that note, I am happy to beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 19 ordered to stand part of the Bill.
Power to suspend licence
(2A) No more than four consecutive suspensions under subsection (1) can be granted, totalling a maximum period of twelve months..
The amendment relates to the number of consecutive suspensions that the HFEA may allow. Of course it is right that the HFEA should have the power to suspend a licence quickly and efficiently if it has reasonable grounds to believe that the terms of the licence might be broken. It also has the power to renew such a suspension indefinitely.
The amendment will either place an upper restriction on the number of times that a suspension may be renewed to a period of up to one year or establish why that is not acceptable to the Government. Clearly, a suspension for even a short period could be damaging to a business or research project that had a licence up to that point. In my view, it is correct that a decision should be made within a year. By then, the appeal process should have been gone through, if appropriate, and the authority should have had sufficient time in which to investigate, clarify its concerns and rectify any problems.
I would like to make an additional point if I may, Mr. Gale, about the timing of the appeal procedure. How quick will it be? Will it be dealt with within the three-month period, or is that one of the main reasons why there is no limit on the number of times that a suspension may be renewed? Clearly, if appeals can be heard and clarified expeditiously, that will benefit the authority and those who previously had a fully operational, licensed business or research facility.
Dawn Primarolo: Proposed new section 19C retains the right of the authority to suspend a licence, where it considers there are grounds to do so, for a period of three months and for further periods of three months after that, if it sees fit. In my view and in the experience of the authority, given the work that it has undertaken, that is the correct way to proceed and there should be no specification of the number of times that a suspension period has been repeated.
The hon. Member for Boston and Skegness touched on a case from June 2007 in which the HFEA used its powers to suspend a licence for three months, and then suspended it for another three months while it considered an updated report. He will be aware that there was interaction with the High Court in that case and a judicial review of the decision. I am sure he accepts that it is quite difficult to have a maximum period in such circumstances, because the suspension is needed until a decision is taken and there might be external factors to consider, such as judicial appeal or a High Court judgment.
Where we are is right. The period should be three months, with an option to suspend again. Clearly, we expect things to be speeded uppart of the flexibility given in the appeals procedure and the structure of the licensing committee is to ensure that matters are dealt with in that period. That will further reduce the time involved. However, to pick an exceptional case and then argue for a limit given those exceptional circumstances is incorrect. I hope the hon. Gentleman accepts that.
The hon. Gentleman then asked about the period for the appeal. The new provisions permit an appeal to be made within 14 days. Within the new framework for appeals, that will be set out in regulations. Safeguards remain in place to ensure that the suspension continues pending resolution of the appeal in order to protect public safety. It is right that we do not have a maximum period because of other interactions. It is right that we give the HFEA, as we have elsewhere in the Bill, the opportunity to speed up those considerations wherever possible. However, it would be unwise of us, with sometimes complex cases, to set a maximum period when the right resolution could not be achieved. We are talking about patient safety and quality of care. I hope that the hon. Gentleman accepts my comments.
Mark Simmonds: I thank the Minister for that response. I accept her arguments, particularly on judicial review and the time that those often complex cases take. I also take her reassurance on a focus on speeding up the decisions and considerations wherever possible. It is right that safety and quality of provision have to be fundamental to everything that happens under the Bill.
Following that explanation from the Minister, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
(6) During a period of suspension all necessary, suitable and appropriate steps must be taken by the Authority to ensure there is no damage to the cells, embryos and gametes that were the responsibility of the licence holder or person responsible when the licence was suspended..
The amendment relates to the authority having the power to suspend a licence quickly and efficiently in cases where there are reasonable grounds for the terms of a licence perhaps having been broken. Obviously, for the authority to have that right is correct. However, is it right that during the suspension the people undergoing treatment at that centre could suffer or, worse, lose their embryos or gametes?
I am not sure from either the 1990 Act or the Bill whether there is a duty on the authority to ensure that clients are unaffected during a licence suspension and can continue treatment at other licensed premises. Therefore, there is a crossover in how that impacts on the confidentiality of information going between the two.
Also, what happens to the gametes and embryos stored in a facility that is ultimately closed or has its licence removed? Are they transferred automatically to another facility under the auspices and guidance of the HFEA, or are they just allowed to wither, so to speak?
Dawn Primarolo: I assure the hon. Gentleman that the HFEA, within its requirements when it suspends a licence, has to issue special directions. Those special directions allow for the continued storage of gametes and embryos at the clinic. The HFEA would also expect the clinic to make appropriate arrangements for the continued treatment of its patients if a licence were revoked. Furthermore, it would expect gametes and embryos to be moved to another licensed clinic.
As with suspension, the HFEA would also expect the clinic to make appropriate arrangements for the continued treatment of its patients. The HFEA already has the
The hon. Gentleman has raised a series of important questions, but I hope that in each of those circumstances continued treatment of patients, safe storage and/or transfer of gametes and embryos will all be dealt with under the special directions, which are part of the licensing requirements.
Mark Simmonds: I am grateful to the Minister for clarifying the safety and continuing existence of those gametes and embryos that have been put in storage in these particular licence facilities, were one to have a licence revoked or suspended. On that basis, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Clause 20 ordered to stand part of the Bill.
Reconsideration and appeals
Mark Simmonds: I beg to move amendment No. 148, in clause 21, page 17, line 2, leave out from wholly to and in line 3 and insert
of persons who were not members of the initial grant, revocation or variation committee..
I hope the Minister will confirm that the amendment is not necessary, and that what it proposes already happens in practice. Clearly, however, it is important that those who were involved in an original decision are not also involved in the appeals process. It is certainly important that the appeals process is not only seen to be fair and independent, but is fair and independent, and that there are therefore no prejudices that might have been instilled through the original process.
We have discussed this before. There are, however, concerns surrounding conflict of interest on the licensing committee, and having an entirely new appeals committee mandated in the Bill would prevent such an incidence occurring, and in particular prevent it from occurring again.
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