Human Fertilisation and Embryology Bill [Lords]
Dr. Harris: I am grateful to have the opportunity to respond to the Minister. I was listening carefully to what she said. In my opening remarks, I did not answer my own question or put the Governments case. I raised two points that I thought that the Minister might use in her response and raised further points on them to save time. I thought that that would be easier than seeking to intervene on the Minister, which might not be her preference, during her response.
In respect of her second point about the need to have this information for follow-up, even for unsuccessful treatment cycles, that follow-up is done by the doctor and the clinic. That is the same with any medical treatment. There are often follow-up treatments in medicine. It is not usual to be required to record all the details, including identifying information, on the central database in order for there to be an appropriate follow-up. Because of the stringent confidentiality requirements, which we are about to discuss, it might be difficult for one doctor to pass on to another doctor information about previous treatments. I am not sure whether the matter will be helped by this form of national database. I do not believe that future doctors would use the resource to check what existing treatments someone has had; they would normally ask the patient. I do not understand why the issue of follow-up is a good reason to hold this information about unsuccessful treatment cycles.
The Minister also argued in respect of long-term research. I said that I did not see how that was different from any other form of medical treatment in which there is a research interest. I said that research can be done through the usual consent arrangements prospectively or even retrospectively, again with the appropriate consents
Dawn Primarolo: The hon. Gentleman will concede, I hope, that I also made the point that follow-up was much wider than on the individual patients cycles. There is also follow-up about the impact of drugs and incidents of cancer 20 years on. It is about access to information from longer term studies and to understand why one cycle was not unsuccessful and another one was. That may be something that needs to be studied over time. The information was necessary for that type of follow-up as well.
Dr. Harris: I understand that justification. As I said earlier, I would argue that it is not necessary to have a national database to do that. We do not have a national database in any other form of medicine, but prospective, case-controlled, and retrospective epidemiological trials are done. Also, no useful data have been gathered from this database in the nearly 20 years that it has been going. I accept, however, that the Bill changes provisions to allow more research. I guess we will know in the future whether that is possible, not only prospectively for new patients, but for all the patients that have been treated.
I understand what the Minister is saying about motives. I am not arguing that this is some form of malevolent intervention. I happen to be of the viewI accept what she says about the consultation and that this is not a majority viewthat the benefits of this type of central database for the treatment of donor cells from pregnancy are not worth the regulatory burden. However, I was pleased to hear what she said about the fact that the data collection and entry may be made easier due to technological advances. I think that we all have our fingers crossed on that, given the possibility of these things going wrong. I think that I have made my case, and the Minister has put the Governments case, and on that basis, I shall finish.
Question put and agreed to.
Clause 24, as amended, ordered to stand part of the Bill.
Restrictions on disclosure of information
(za) the disclosure is made
(i) on clinical grounds, as part of the patients medical care, to a practitioner who is bound by the ordinary duty of patient confidentiality, or
(ii) in order to ensure the safety of medical treatment which the patient is to receive outside of licensed premises..
The Chairman: With this it will be convenient to discuss the following: Government amendments Nos. 45 and 46.
Amendment No. 150, in clause 25, page 27, line 27, at end insert
(v) the disclosure is made in order to ensure the safety of medical treatment which the patient is to receive outside of licensed premises..
Amendment No. 151, in clause 25, page 27, line 27, at end insert
(v) the disclosure is made, on clinical grounds, as part of the patients medical care, to a practitioner who is bound by the ordinary duty of patient confidentiality..
Government amendments Nos. 47 to 54.
Amendment No. 37, in clause 25, page 28, leave out line 46 to line 8 on page 29.
Mark Simmonds: Clause 25 relates to the sharing of informationbetween and with whomthe restrictions on disclosure, and the exceptions to those restrictions. I shall speak specifically to amendment No. 38.
In proposed new section 33C to the 1990 Act, the Bill provides for consultation and regulations to be made to allow the disclosure of identifying information without consent for the purposes of medical or other research that is
necessary or expedient in the public interest or in the interests of improving patient care.
However, as the Minister and many members of the Committee will be aware, this was debated at some length in the House of Lords. Members of the Lords believed that the confidentiality provisions of the Bill were too tight, thus preventing sufficient research on children born by IVF. In situations in which women conceive through IVF, there is no procedure for the womans obstetrician to be told about the method of conception. Clearly, this must be looked at in the context of patient confidentiality. Obviously, if a woman does not want that information to be passed on, her privacy should be protected.
However, there are cases in which sharing such information would be beneficial, and there seems to be a presumption against that information flow, although perhaps the presumption should be in favour of it, even though I do not think that it is relevant that obstetricians need to know who the donor was, or whether it was the partners sperm or a donor sperm that fertilised the egg. Clearly, with IVF, women undergo treatment and complex procedures that change the body. Such a thing would, in some circumstances, enhance patient care in the context of strict confidentiality, which does not apply to other sensitive or personal conditions, such as considerations of mental health. The amendment would allow for the sharing of information between medical practitioners, which could improve patient care, in the context of confidentiality. The womans privacy would be respected, and consent for that information to be passed on could be withdrawn, if she wished.
Amendment No. 37 would remove the regulation-making power in proposed new section 33B of the 1990 Act. My understanding is that the power enables future additional exceptions to be made on who can request information,
My final point about the clause concerns proposed new section 33A(3)(a), which details the interrelationship between the Bill and the Congenital Disabilities (Civil Liability) Act 1976? Will the Minister explain how the measures work together?
It would be helpful if the Minister could clarify whether the Government amendments are all tidying-up provisions, or whether they would actually change the meaning of the clause. They seem to remove certain provisions, but that could just be tidying-up drafting.
Dr. Harris: I tabled a couple of the amendments in the group, but it might be best to hear the Ministers description of the effects of the Government amendments. They are better drafted than those in my name and, if I may say so, those tabled by the hon. Member for Boston and Skegness. The right hon. Ladys amendments are comprehensive and complex, and if she is willing to accept questions after she has explained them, that might speed things along.
Amendment No. 151 states that an exception would be made for disclosure on clinical grounds
as part of the patients medical care, to a practitioner who is bound by the ordinary duty of patient confidentiality.
Those of us who want the rules on confidentiality to be loosened are not talking about a free-for-all. We just want to bring the provisions more, albeit not totally, in line with standard medical care rules under which medical notes are confidential. There are significant professional and, indeed, possibly criminal consequences from a breach of medical confidentiality, which is something that I feel strongly about. I have argued that the same procedure should apply to politicians and their children in respect of vaccinations, given that many in the media think that that should be a free-for-all, although I disagree.
Nevertheless, several clinicians have raised a problem with me. I shall not repeat what Lord Patel and Lord Winston said in the other place because that can be read, but scientists from Newcastle have explained that when a treatment is provided in a separate tertiary clinic, there is a clear distinction between the initial investigation of the problem and the subsequent provision of treatment. In a tertiary NHS referral centre, it is likely that the initial investigations and counselling will be carried out in a general infertility clinic. That might also occur a long time from the possible treatment. For instance, an unmarried 18-year-old with a severe pelvic infection will be counselled about the potential impact on fertility and the need to consider IVF. Such recordsI
There are two ways in which to tackle the problem. We could argue that only limited information should be included in the provisions and that they should be loosened to enable communication between doctors in the best interests of the patients in good faith. Doctors should always be answerable in respect of complaints to medical regulators and the professional regulator, the General Medical Council.
The Government have heard such concerns in the House of Lords on several occasions and I note that their amendments represent a response to that. I look forward to hearing the right hon. Lady explain their effect in detail. I hope that the clinicians who have contacted me will be satisfied by what she says, as well as the potential of the regulation-making power. I share the view of any Opposition parliamentarian that wide-ranging, regulation-making powers are questionable, but I feel more comfortable with the inclusion of the provision, given that I do not think that this debate has ended.
IVF still has a cachet, which makes it sensitive, but as its special status becomes less special, and as it becomes more routine, for many patientsit will always be their decisionit might well become appropriate to change the provisions to ensure that we keep up to date with what is practical and appropriate, rather than stick to what was felt to be appropriate in 1990.
Dr. Ian Gibson (Norwich, North) (Lab): I wonder, Mr. Hood, whether I could have your view on an issue about the running of this Committee that is beginning to bother me. Several documents are being floated by people who have tabled amendments. During my time in Parliament, I have sat on several such Committees, and when documents are received from experts, it is important that every Committee member sees them so that we can come to a balanced judgment. Could you rule, Mr. Hood, that if people read from documents from eminent professionals, they be made available to the whole Committee? I say that because, advisably, I challenged a document before, and within an hour, I was being challenged by those who put the document in. My answer to them was, Why didnt you send it to all of us? How do I know whether what you are saying is true? Give us the evidence so that we can see. I think that we are getting restrictive readings from different documents and that the Committee is hearing only half the story. We all feel passionately about this issue and want to get seriously involved.
The Chairman: I thank the hon. Gentleman for his point, but that is not a matter for the Chair. If Members receive information from other sources, it is for them to deal with that as they see fit. If evidence was given to the Committee per se, all members of the Committee would have that information, so that would not be a matter for the Chair.
Dr. Gibson: Perhaps the organisations or individuals that send in such information are not aware of Committee procedure. By floating it to one Committee member,
The Chairman: Again, the hon. Gentleman makes his point, but I reiterate that that a matter for not the Chair, but those supplying the information to Members and, indeed, the Members themselves.
Dawn Primarolo: The HFEA is required to collect details of licensed treatments for its register of information, which contains identifying information about everyone who has received treatment, including IVF or donor insemination. The 1990 Act prohibits the disclosure of such information by either the HFEA or a licensed practitioner, and that is subject to a criminal offence, as the hon. Member for Oxford, West and Abingdon reminded the Committee. The Bill provides for exceptions to be made to that provision, so we have moved from the requirements of the 1990 Act to the exceptions, some of which we have dealt with this morning. Such exceptions are when a person identified in the information to be released has consented to its release, with the exception, of course, of donor informationwe covered this in the previous clausewhich is protected to a particular age; when the information would not identify any individual; or in an emergency, when a woman who has received treatment or services is in imminent danger that makes it necessary for information to be released. The list of exceptions consolidates those already permitted under the 1990 Act, as well as introducing some new ones. Furthermore, as the hon. Member for Boston and Skegness mentioned, the Bill contains a regulatory power that enables additional exceptions to be made.
When the hon. Member for Boston and Skegness referred to amendment No. 37, he asked me specifically why we need the regulatory measure. He referred to paragraphs (a) to (u) of proposed new section 33A(2). To be frank, the answer is that every exception that we can think of is already there, although we cannot think into the future in terms of future-proofing. The regulation-making power was in the 1990 Act. Measures would be subject to the affirmative procedure and the power would be a method of future-proofing the Bill, just in case. The hon. Gentleman is right to say that we made every attempt to put everything in the Bill, but we still believe that this measure is necessary in caseas has happened in the pastwe need further exemptions. The regulations would not change the principles within which the exemptions work. He asked whether I could name any; I am afraid that I cannot because we think that we have been quite thorough.
I shall deal with amendments Nos. 38, 150 and 151 and respond to the questions asked by both hon. Gentlemen before moving on to the Government amendments. The amendments would provide additional exceptions for the disclosure of information. Specifically, they relate to the situation if the disclosure is made on clinical grounds as part of the patients medical care to a practitioner who is bound by the ordinary duty of patient confidentiality, or if it is necessary to ensure the safety of medical treatment that the patient is to receive outside licensed premises. Again, the hon. Member for Oxford, West and Abingdon drew comparisons with what happens elsewhere in medicine with regard to the exchange of information.
The Governments view is that consent on disclosure should always be obtained when possible, and that doing so need not necessarily be burdensome. We appreciate that there are occasions when, during the course of treatment, it would be necessary for clinicians to share information with other health professionals. However, because of the consent arrangements in the BillI will go on to make further pointswe feel that it is more appropriate to provide for the obtaining of general consent from the patient for that purpose at the beginning of treatment. That would enable clinicians to be confident that they were not acting outside the patients wishes, while also allowing them to share appropriate information regarding the treatment of the patient.
There are circumstances in which patients would perhaps want to limit the people who could be told about their treatmentperhaps they would not want such information to go to a GP who is a relative or a friend. By consenting at the beginning of treatment, the extent of information sharing could be limited accordingly. Again, that echoes back to a theme that we have discussed in previous clauses about the importance of clear explanation to the patient and clear adherence to consent.
Even after amendment, the provision would not provide scope for clinicians to disclose confidential patient information without the patients consent. I am not referring to drafting; I will reference other requirements. I should say something to the hon. Member for Oxford, West and Abingdon as a caveat because I have been a Member of the House for 21 yearsquite a long time in opposition, although not recently, thank goodness. It is hard to draft amendments because parliamentary counsel are highly skilled. His amendments are about making progress on the principle, and I understand entirely what he wants to do.
The amendments would not provide for that because before information was disclosed to the health care professionals involved in a persons treatment, the doctor would still need to consider whether disclosure was compatible with the Data Protection Act 1998, common law and any other relevant law where consent is generally required. Therefore, requiring the consent right at the beginning, and allowing that general disclosure, is in our view much more secure for the clinicians as well. They would have to satisfy themselves in all those other areas that they were disclosing information in the correct way. It is the Governments view that the Bill strikes the right balance in respect of requiring consent to be obtained before identifying information is disclosed, even when that is to other health care professionals, with the exception of emergency situations. Consent to such disclosure in the course of treatment can be obtained, as I said, prior to the initiation of treatment, when the patient is consenting to that treatment.
The amendments that would introduce an exception to the disclosure are, in the Governments view, inappropriate. The disclosure of identifying information without consent should be permitted only where there is good justification. There was a lot of discussion about that between the Government and stakeholders. The British Medical Association supported the Bills position. Obtaining consent for disclosure to health care professionals is possible. Therefore, the exception proposed by the amendments is not justified.
The hon. Member for Oxford, West and Abingdon made a point about the problems of disparity between different medical professions and that we are setting a higher level. I hope that I have dealt with that point, because a general consent at the beginning gives greater certainty and clarity to clinicians than having to satisfy themselves subsequently about data protection, common law and other law relating to confidential information, which is what the amendments would require.
The hon. Member for Boston and Skegness asked about the Congenital Disabilities (Civil Liability) Act 1976. That did not trip off my tongueI was prompted on the exact date, I hasten to add. The 1990 Act extended the reach of that legislation to cover infertility treatments. Basically, the Bill does not alter that position. The 1976 legislation was carried over to the 1990 Act, which made the cross-reference and put infertility in, but the Bill, as it amends the 1990 Act, is silent on that, because it does not alter the positions. I hope that that deals with his point.
On the Government amendments, I suppose the quick response, although I might have to give a little more detail, is yes, they mostly tidy up the consent exceptions, following discussion in another place. The changes are tidying-up measures. However, there is one instance in which we need to be absolutely clear with regard to the interaction of the exceptions. We have to ensure that we do not inadvertently open up the consent to disclosure of non-identifying information or cause some difficulties in that regard. We are managing two types of informationthe identifying and non-identifyingand under what basis it can be disclosed.
We recognise that it is very important that the 1990 Act and the Bill strike the right balance between safeguarding the confidential information of patients, their partner, donors and children held by the HFEA and clinics while, at the same time, allowing information to be disclosed by the HFEA and clinics in circumstances that warrant it. However, the 1990 Act is not always as conducive as it could be in that regard. For example, it prohibits the HFEA from disclosing identifying information about patients, even in cases in which the patient consents to such disclosure. That is one issue that needs to be addressed.
I will go through the Government amendments very quickly and return to them if Members have further questions. Amendment No. 45 amends and simplifies the wording in new section 33A(2)(g) to (j) and clarifies it to strike the important balance on consent, including identifying information as long as individuals have given their consent.
Amendment No. 46 is consequential to the new wording in proposed new section 33A about the disclosure of information, and replaces wording removed by amendment No. 50. It clarifies that the HFEA can disclose identifying information from its register to avoid imminent danger to a persons health.
Amendment No. 47 removes wording from proposed new section 33A about consent to disclosure when treatment services are provided to two people together and both are identifiable. It recognises the provisions in proposed new section 33AB whereby the consent of each individual identified must be obtained.
Amendment No. 48 removes wording that is consequential and replaces it with wording that will be introduced by amendment No. 54. Amendment No. 49
Amendment No. 50 removes wording from new section 33A consequential to the replacement wording that is introduced by amendment No. 46. Amendment No. 51 reflects the fact that the Bill introduces provisions for fatherhood agreements for unmarried couples in which donor sperm is used. Amendment No. 52 is consequential on amendment No. 45. Amendment No. 53 defines what the term identifying donor information means with regard to new section 33A(2), which is a consequence of amendment No. 45. Amendment No. 54 applies in conjunction with amendment No. 45.
Therefore, without going into any detail, I am trying to indicate to the hon. Member for Boston and Skegness that we are cross-referencing and making it absolutely clear that the exemptions fit together and do not breach any of the principles. Overall, the Government amendments provide clarification rather than a change of policy by continuing to strike the balance between disclosure of identifying information, particularly that which might be helpful for follow-up research into the health of patients and their children, and ensuring that consent is properly and rightly obtained.
If I have not covered any of the points, Mr. Hood, I would be happy to catch your eye and return to them.
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