Joint Committee On Human Rights Fourth Report


4 Mental Capacity Bill

Date introduced to the House of Commons

Date introduced to the House of Lords

Current Bill Number

Previous Reports

24 November 2004

15 December 2004

HL Bill 13

15th Report of 2002-03 (on the draft bill)

23rd Report of 2003-04

Background

4.1 The Mental Capacity Bill is a Government Bill carried over from the previous session, during which it completed its Committee stage. We reported on our initial consideration of the Bill in November 2004, identifying the main human rights issues raised by the Bill and explaining why we had written to the Government on 18 November 2004 asking a number of questions.[154] The Bill was reintroduced into the House of Commons on 24 November 2004 and completed its Report stage and Third Reading in the Commons on 14 December 2004.

4.2 The Bill was introduced in the House of Lords on 15 December 2004. The Parliamentary Under-Secretary of State at the Department for Constitutional Affairs, Baroness Ashton of Upholland, has made a statement of compatibility with Convention rights under s. 19(1)(a) of the Human Rights Act 1998.

4.3 The Minister responded to our letter on 16 December 2004.[155] In this Report we set out our conclusions about the human rights compatibility of the Bill in light of the Minister's response and the proposed Government amendments to the Bill.

4.4 We have also received a number of letters from individuals expressing concern about the compatibility of the Bill with the ECHR.[156] Most of these asked us to consider the compatibility of the Bill in the light of the decisions of the High Court in Burke and of the European Court of Human Rights in Glass II v UK and HL v UK. Many of the letters also enclosed an extract from an Opinion by Richard Gordon Q.C. dated 1 October 2004 which considers the Convention compatibility of the Mental Capacity Bill in the light of the decisions in Burke and Glass II. We have considered the representations we have received and the legal opinion. We had already considered for the purposes of our initial Report all of the decisions in question, and we find that neither the representations nor the legal opinion add anything to the concerns we have already expressed about the human rights compatibility of the Bill.

4.5 After considering the Government's response and the various representations received, it remains our view that the Bill should be broadly welcomed from a human rights perspective, because it enhances the ability of people who lack capacity to make their own decisions where they can and makes it more likely that sound decisions will be made on their behalf where they cannot make those decisions for themselves. Some of the concerns we expressed on our initial consideration of the Bill about the adequacy of various safeguards in the Bill have been allayed by the Government's response, amendments already made to the Bill, and by the Government's undertaking to bring forward further amendments strengthening certain safeguards in a number of important respects. The non-availability of these promised amendments in time for the conclusion of proceedings in the Commons made it very difficult for Members of that House to give proper consideration to the Bill. We regret that these proposed amendments have still not been made available as amendments to the Bill, despite the time which has elapsed since we and others raised these concerns, but we welcome the Government's preparedness to respond positively to them. Certain other concerns about inadequate safeguards, however, still remain.

Involuntary placement

4.6 On our initial consideration of the Bill, we were concerned that clauses 5 and 6 of the Bill could lead to deprivations of liberty which are not compatible with Article 5(1) ECHR, and in particular could lead to the involuntary placement (or "informal admission") in hospital of a person lacking capacity and thereby deprive them of the procedural safeguards which apply when they are compulsorily admitted under Mental Health Act powers.

4.7 The principal reason for these concerns was that the provisions in the Bill concerning the use of "restraint" appeared to be sufficiently broadly defined as to authorise the use of force to deprive someone of their liberty, for example, if they were resisting being admitted voluntarily to hospital.

4.8 We welcome the Government's very helpful clarification of this issue in response to our questions. The Government states that the Bill's provisions about restraint "do not permit deprivations of liberty within the meaning of Article 5 ECHR. Restraint is defined as including restriction of liberty. The Government has never intended this to include actions which would amount to a deprivation of liberty for Article 5 purposes." This makes clear that the power to restrain is not intended to be interpreted as authorising deprivation of liberty and therefore engaging Article 5.

4.9 The Government's response meets our substantive concerns in relation to involuntary placement. This should be made clear on the face of the Bill, bearing in mind that what is at stake is the liberty of the person. We therefore invite the Government to consider amending the Bill to make clear, for the avoidance of doubt, that "restraint" in the Act does not include deprivations of liberty.

The Bournewood gap

4.10 Our second main concern on initial consideration of the Bill was that it fails to fill the so-called "Bournewood gap" identified by the European Court of Human Rights in the recent decision of HL v UK, whereby compliant incapacitated patients, who notwithstanding their informal admission to hospital are deprived of their liberty, do not have access to the procedural safeguards available to compulsorily admitted patients. Those safeguards include access to a court which can review the ongoing basis for their detention. In light of the Strasbourg judgment, we wrote to the Minister asking for more details about how this grave procedural deficiency might be remedied, and seeking the Government's assurance that the necessary remedial measures will be introduced into the current Bill to ensure Parliament's early attention to the problem.

4.11 We welcome the Government's acceptance that "the priority now is to put in place appropriate safeguards for incapacitated patients who are, in fact, deprived of their liberty other than by use of the compulsory powers in the Mental Health Act", and its commitment to bring forward proposals for appropriate new safeguards as soon as possible.[157] It has initiated a consultation on how to remedy the incompatibility identified in Strasbourg, and although it cannot make any commitment to bringing forward proposals in the form of amendments to the Mental Capacity Bill, it has not ruled out the possibility of doing so.

4.12 We recognise the need for proper consultation in relation to how best to remedy the deficiency identified. At the same time, we note that the Government has been on notice of this potential difficulty for several years (the Bournewood decision in the House of Lords which highlighted the Convention compatibility problem was delivered in 1999). We would therefore urge the Government, in recognition of the urgency of the issue to the many informal patients who are currently without procedural protections, to bring forward proposals for filling the Bournewood gap during the passage of the present Bill.

Withholding or withdrawing life-sustaining treatment

THE NATURE OF OUR CONCERNS

4.13 Our concern about the provisions in the Bill concerning the withholding or withdrawing of life-sustaining treatment is primarily a concern about whether the provisions are compatible with the State's positive obligation under Article 2 ECHR to take active steps to protect life, particularly the life of vulnerable people. As we said in our earlier Report, the inclusion in the Bill of provisions for advance decisions to refuse treatment is not per se a breach of Article 2 ECHR.[158] Our concern is that the safeguards surrounding such directives, and other decisions about the withholding or withdrawal of life-sustaining treatment, are not sufficiently strong to protect the rights and interests of vulnerable patients, by ensuring that they are not subjected to the withdrawal of life-sustaining treatment without their fully informed consent.

ADVANCE DECISIONS TO REFUSE TREATMENT

Adequacy of the safeguards

4.14 In our earlier Report we raised certain concerns about the adequacy of the safeguards provided to ensure that advance decisions to refuse treatment do not lead to wrong decisions being made about the existence, validity or applicability of an individual's advance decision to refuse treatment.

4.15 The Government has indicated that it proposes to meet these concerns in three ways:[159]

(1) by bringing forward amendments to the Bill in the House of Lords requiring advance decisions concerning life-sustaining treatment to be recorded in writing and to be witnessed;

(2) by exploring with professional bodies whether it can require those making advance decisions to have benefited from medical advice explaining the consequences of such a decision;

(3) by stressing the importance of making advance decisions as clear as possible in the Code of Practice and future guidance.

4.16 We welcome the Government's willingness to bolster the safeguards surrounding advance directives to refuse treatment. Requiring such advance directives to be in writing and to be witnessed will introduce a degree of formality and certainty which we consider to be essential safeguards against wrong decisions being made about advance directives.

4.17 We also welcome the Government's willingness to explore the possibility of a further safeguard in the form of a requirement on the face of the Bill that advance decisions have benefited from medical advice explaining the consequences of such a decision. At present there is no such requirement on the face of the Bill, it is merely proposed that the Code of Practice and further guidance will stress the importance of people discussing the situation with a health professional to assist with their awareness of their treatment options and all the possible consequences of any advance decisions they might make.[160] In our view, just as consent to treatment must be properly informed consent in order to be compatible with Articles 3 and 8, so an advance refusal of life-sustaining treatment should be properly informed in order to be compatible with Article 2. We recommend that such a safeguard be included on the face of the Bill for that reason.

4.18 We note that the Government says that it is exploring with professional bodies whether it "can" impose such a requirement. While we see the good sense of consulting with professional bodies as to how such a requirement would work in practice, we do not see any constraint on the Bill imposing such a requirement. It is for Parliament to decide on the conditions for the validity of an advance directive.

4.19 We also welcome the Government's proposal to ensure that the Code of Practice and future guidance will stress the importance of making advance decisions as clear as possible.

4.20 In light of the concerns expressed in the debates on the Bill and some of the views expressed in the representations made to us, we also now consider that certain other safeguards would help to make breaches of the right to life in Article 2 less likely in practice.

4.21 For example, although an advance decision to refuse treatment can be withdrawn or altered at any time, we note that this is only so long as the person concerned has the capacity to do so.[161] This gives rise to the appalling prospect that an advance directive refusing life-sustaining treatment will have to be complied with where the person has lost capacity but is sufficiently aware to want to change his earlier decision. In our view advance directives should be revocable regardless of the mental state of the person concerned.

4.22 We also consider that advance directives should be time limited, to guard against the danger of directives being overtaken by developments in treatment and medicine (a consideration adverted to by the Government itself in another context in its response[162]), or being forgotten about by a person who would have revoked it had they remembered its existence.

4.23 A number of other procedural safeguards may also be appropriate, for example a requirement that a witness to an advance directive not be a person who stands to gain from the person's death, or employed at the relevant health care establishment which is caring for the person.

4.24 We recommend that consideration be given by the Government to these additional safeguards in order to strengthen the Bill's protections against advance directives being used to exploit vulnerable people.

Need for specific refusal of ANH

4.25 In our earlier Report, we also expressed concern that laypeople may not be aware that artificial nutrition and hydration ("ANH") counts as "treatment", and that there is therefore a risk that an advance directive refusing consent to life-sustaining treatment in general might be construed as extending to a refusal of consent to ANH.[163] This might lead to individuals having food and water withdrawn from them when this was never their intention. In light of this concern we asked the Government whether it was its intention that a specific advance refusal of ANH would be required in order to be effective as an advance directive.

4.26 We have considered the Government's answer[164] to this important question very carefully, but ultimately we are not satisfied that the position under the Bill is sufficiently clear to satisfy the positive obligations under Article 2, 3 and 8 ECHR.

4.27 On the one hand, the Minister states that since an advance decision is not applicable to any treatment which a doctor considers necessary to sustain life unless the individual specified in the advance decision that it was to apply to such treatment,[165] and since ANH constitutes life-sustaining treatment, "if a person has not specified that the refusal is still to apply where ANH is necessary to sustain life then ANH (if in the person's best interests) will have to be given".[166] This suggests that the answer to our question is that specific advance refusal of ANH is required in order to be effective as an advance directive. On its own, this would have met our concern, although we might still have considered it desirable that, if this is the Government's intention, it be stated explicitly on the face of the Bill.

4.28 However, the Minister's letter goes on to state that the Bill does not require any particular mention of particular treatment options, and that "requiring people to specify particular treatments, such as ANH, would be difficult in practice".[167] This suggests the opposite answer to our question: that an advance directive refusing life-sustaining treatment does not have to specify that this advance refusal includes refusal of ANH.

4.29 In another passage of the Minister's response, the Minister states that in all cases the treatment that the person wishes to refuse must be clearly identifiable by the doctor. "If a doctor has determined that a particular treatment would be in his patient's best interests, and is not satisfied that the treatment in question is one 'specified' by an advance decision, then he will be able to provide it".[168] This suggests that the effect of the Bill is to leave the matter to the discretion of the treating doctor, who will be "able" to provide ANH if not satisfied that the advance decision refusing life-sustaining treatment includes a refusal of ANH.

4.30 We are not satisfied that such reliance on the treating doctor's discretion is a sufficiently strong safeguard against ANH being withheld or withdrawn from a patient who has made an advance directive but who would not have authorised their death from starvation or dehydration. Nor in our view, in light of the uncertainty described above, is it a sufficiently strong safeguard that the Code of Practice will make clear that ANH is regarded as "treatment".[169] In our view, if ANH is in a patient's best interests, in order to be compatible with Articles 2, 3 and 8 ECHR the legal framework must ensure that there is a duty to provide it, even to a patient who has made an advance directive refusing life-sustaining treatment, unless that advance directive specifically applies to the refusal of ANH.

4.31 We are concerned about the lack of clarity in the Minister's answer to this important question. The reason given by the Minister for not requiring on the face of the Bill that a specific advance refusal of ANH is required is that in practice it would be extremely difficult to produce an exhaustive list of all the treatments which are being refused in advance. For example a person who wished to refuse invasive treatment, even if death might result, would have to specify each and every treatment that could potentially be considered life-sustaining. The Minister says that this would be extremely difficult, especially given the continuing developments in treatment and medicine.[170]

4.32 We note however that in the written ministerial statement of 10 January 2005 providing an update on the Code of Practice Mr Lammy stated that, under the Code, people "will need to specify what treatment they are refusing and then specify, in addition, if they wish the refusal to apply even where that treatment is necessary to sustain life"[171]. It would appear to us that this is an encouraging recognition that it is feasible for advance directives to specify individual treatments, including ANH, which are being refused in advance. In any case, our concern is with ANH, not with other potential treatments. As we said in our earlier Report, we are particularly concerned that laypeople may not be aware that ANH is regarded as "treatment" and that an advance refusal of life-sustaining treatment may therefore be treated as authorising the withholding of food and water leading to death by starvation/dehydration. The Minister's response to our question has confirmed our concerns that there is insufficient clarity in the Bill in this respect. In our view, this concern can only be satisfactorily dealt with on the face of the Bill, by an amendment which makes clear that a specific advance refusal of ANH is required in order to be effective as an advance directive. This could, for example, be achieved, by the insertion of a new clause 25(6) providing—

(6) Without prejudice to the generality of subsection (5), an advance decision is not applicable to artificial nutrition and hydration unless P so specified in the decision.

4.33 The recent case of W HealthCare NHS Trust v KH demonstrates the importance of specificity in relation to advance directives concerning withholding of food and water.[172] The case concerned an MS sufferer in the advanced stages of the disease whose artificial feeding tube had fallen out. Her carers wanted to reinsert it but the patient's brother and daughter opposed it. The hospital applied to court for a declaration. One of the issues was whether or not there was a valid advance directive refusing her consent for such treatment. There was evidence that she had said "I don't want to be kept alive by machines" and that if she had to go to hospital and the time came when she could no longer recognise her daughters, she did not want to be kept alive. The court found that on the evidence there was not an advance directive which was sufficiently clear to amount to a direction that she preferred to be deprived of food and drink for a period of time which would lead to her death.[173]

Advance decisions requiring ANH

4.34 We also pointed out in our earlier Report that the common law, as interpreted by the High Court in Burke, now recognises that an advance directive requiring the provision of ANH in certain circumstances is determinative of whether such treatment should be provided, but the Bill only provides for advance decisions refusing treatment.[174] We wrote to the Minister asking whether the Bill would now be amended, in light of the Burke judgment, to enable advance directives to be made requiring ANH to be provided, and if not why not.

4.35 The Minister's response makes clear that the Government does not intend to amend the Bill to make provision for advance requests to require ANH.[175] The Government agrees that people should be able to request ANH in advance, and that there would be a duty on any treating clinician to consider this statement of wishes as part of the best interests determination that they are required to make under clause 4 of the Bill. It also accepts that such an advance statement would be likely to carry quite a lot of weight in that determination. However, the Government does not intend to amend the Bill to provide for such advance requests for ANH to be legally binding.

4.36 The Government gives two reasons for this position. First, it says it is concerned that the judgment in Burke could be read as giving the right to demand any life-prolonging treatment they wish, no matter how untested, inappropriate or expensive, and regardless of their doctors' views as to whether such treatment might benefit them or not. Second, it says that in giving undue weight to patient autonomy, the judgment could potentially allow a request for life-ending treatment. The Department of Health has therefore sought permission to join the GMC's appeal against the judgment.

4.37 We have considered carefully the Government's reasons for refusing to amend the Bill to enable advance directives to be made requiring ANH to be provided. In our view the Burke ruling is confined to the provision of ANH. It also explicitly recognises that even where an advance directive requiring the provision of ANH has been made, a doctor will not be obliged to provide it if it is not in the best interests of the patient in the sense that it would make their life intolerable. Nor do we consider that there is anything in the reasoning in the Burke judgment which would require an advance decision requesting life-ending treatment to be treated as legally binding.

4.38 In our view the decision in Burke correctly spells out of the right to dignity and autonomy in Articles 3 and 8 ECHR a right to make an advance directive requiring the provision of ANH in certain circumstances. We consider that this should be reflected in the provisions on advance directives in the Bill in order to make future breaches of Articles 3 and 8 less likely. We recognise that the Government is currently seeking to be joined in the GMC's appeal against the Burke judgment. We trust that in the event that the Burke judgment is upheld the Government will bring forward an amendment to the Bill or the Act, particularly in light of its view (which we endorse) that legal certainty is enhanced by providing a statutory framework for advance directives.

WITHDRAWAL OF LIFE-SUSTAINING TREATMENT WHERE NO ADVANCE DIRECTIVE

4.39 In our earlier Report, in addition to our concerns about advance directives, we also expressed the concern that, in relation to the withholding or withdrawal of ANH where there is no advance directive, the presumption in favour of life-sustaining treatment was not sufficiently strong in the Bill, and certain of the Bill's provisions may have the effect of permitting the withdrawal of ANH from people lacking capacity in circumstances which may breach that person's rights under Articles 2, 3 and 8 ECHR. We therefore asked the Minister whether the Government would now consider tightening the safeguards in the Bill in light of the Burke judgment, and whether it would amend the Bill to require that any authority to refuse consent to ANH in any instrument creating a power of attorney or any order appointing a deputy be expressly and specifically conferred.

Safeguards

4.40 The Government has responded to these concerns in two ways—

(1) by amending the Bill to include a requirement that a person making a determination of a person's best interests for the purposes of the Bill must, where the determination relates to life-sustaining treatment, begin by assuming that it will be in the person's best interests for his life to continue;[176] and

(2) by undertaking to bring forward a further amendment to the same provision in the Lords providing that, where the best interests determination relates to life-sustaining treatment, the decision-maker must not be motivated by a desire to bring about the person's death regardless of what would be in his best interests.[177]

4.41 We welcome the addition of a presumption in favour of life-sustaining treatment to the best interests provisions of the Bill. We consider this to be a valuable additional safeguard of real practical value which will make it less likely that decisions are made on behalf of an incapacitated person which are in breach of their Article 2, 3 or 8 rights.

4.42 We also welcome the Government's willingness to amend the Bill to attempt to meet the concern that there is insufficient protection against abusive decisions being taken in respect of vulnerable people lacking capacity, for example by unscrupulous relatives or others who stand to gain financially, or employees of a health establishment in need of additional beds. We are rather less persuaded, however, of the practical value of the proposed amendment as a safeguard for vulnerable people. The effect of the proposed amendment is said to be to make it absolutely clear that no person, whether doctor, attorney, deputy or court, can, when making a best interests determination, have the motive of causing death, regardless of what would be in his best interests.[178] Proving the motive of a person making a best interests determination will in practice be extremely difficult, however, and we therefore regard the proposed amendment more as a declaratory statement about the intention behind the Bill for the avoidance of doubt, similar to clause 58, than as an additional substantive safeguard.

4.43 A further safeguard which could be added to the Bill in light of the judgment in Burke would be an express provision that it is only in the best interests of a patient to withhold or withdraw life-sustaining treatment if it is intolerable for them to continue to receive treatment in order to sustain life.[179] This would add a very real practical safeguard, making it less likely that the withdrawal or withholding of ANH will be judged to be in the best interests of anyone who is not in the very narrow category of cases in which such withholding or withdrawal would not be in breach of Article 3 ECHR (identified in Burke as those cases where the patient is dying and has slipped into a final coma and lost all awareness of what is happening). We recommend that consideration be given to bringing forward an amendment to this effect in the Lords.

Specific authority in relation to refusal of ANH

4.44 The Government states that it does not consider it to be necessary to amend the Bill to require that any authority to refuse consent to ANH in any instrument creating a power of attorney or any order appointing a deputy be expressly and specifically conferred.[180]

4.45 The reason it gives for this view in relation to attorneys is that an attorney will only have the authority to give or refuse consent to the carrying out or continuation of life-sustaining treatment when the instrument contains express provision to that effect, and since there is no doubt that ANH constitutes life-sustaining treatment, "unless an LPA [Lasting Power of Attorney] gave express provision for such decisions to be made, an attorney would not be able to make decisions about life-sustaining treatment, which would include ANH."[181]

4.46 This reliance on the requirement that decisions regarding life-sustaining treatment must be expressly and specifically authorised and on ANH being life-sustaining treatment does not meet our concerns. It leaves unanswered the main uncertainty that concerns us, which is very similar to that which still concerns us above in relation to advance decisions to refuse life-sustaining treatment: will a lasting power of attorney which expressly extends to life-sustaining treatment authorise the refusal by the attorney of consent to ANH even in the absence of specific authorisation of such refusal? If so, we are concerned that the donor of a lasting power of attorney who expressly authorises their attorney to make decisions in relation to life-sustaining treatment, will not appreciate that ANH counts as treatment and that they are therefore conferring authority to refuse food and drink on their behalf.

4.47 Nor in our view, in light of this uncertainty, is it a sufficiently strong safeguard that the Code of Practice and guidance will make clear that ANH constitutes life-saving treatment.[182] In our view, if ANH is in a patient's best interests, in order to be compatible with Articles 2, 3 and 8 ECHR the legal framework must ensure that there is a duty to provide it, even to a patient who has appointed an attorney to make decisions concerning life-sustaining treatment, unless that lasting power of attorney specifically authorises the refusal of ANH.

4.48 In our view, as in the case of the advance refusal of ANH above, this concern can only be satisfactorily dealt with on the face of the Bill, by an amendment which makes clear that a specific authorisation to refuse ANH is required in order to be effective as a lasting power of attorney. This could, for example, be achieved, by the insertion of a new clause 11(8) providing—

(8) Without prejudice to the generality of subsection (7)(a), an instrument expressly providing for the giving or refusing of consent to the carrying out or continuation of life-sustaining treatment does not authorise decisions in relation to artificial nutrition and hydration unless the instrument so specifies.

4.49 The same concern also remains in relation to court appointed deputies. The Government relies on the existing safeguards in the Bill surrounding the exercise of powers by a court-appointed deputy, and on both the actual and proposed amendments to clause 4.[183] However, there is nothing in the Bill to require that a court appointed deputy who is expressly authorised to refuse consent to the carrying out or continuation of life-sustaining treatment must be specifically authorised to refuse to consent to ANH.

4.50 We recommend that consideration be given to amending the Bill to require that any authority to refuse consent to ANH in any instruments creating a power of attorney or any order appointing a deputy be expressly and specifically conferred.

Research (clauses 30-33)

BACKGROUND

4.51 On initial consideration of the Bill we raised a number of questions about the adequacy of the safeguards in the Bill designed to protect the rights of people lacking capacity against improper or unjustified interference by the conduct of research.[184] Our general concern was that the safeguards in the Bill were not sufficiently strict, and we had four specific concerns that those safeguards were weaker than the safeguards contained in the relevant international standards and would therefore lead to research being carried out on or in relation to people lacking capacity in circumstances which amount to an unjustified interference with their rights to dignity and privacy, to be free of inhuman and degrading treatment, and to physical and moral integrity.

4.52 In its response to our questions the Government explains both its aim in these provisions of the Bill and why, in some cases, it has departed from the language used in the European Convention on Human Rights and Biomedicine.[185] Although, as the Government points out, the UK is not a signatory to the Convention on Human Rights and Biomedicine, "the Government has been supportive of it and recognises its importance in setting out a common approach towards bioethical issues".[186] The Explanatory Notes to the Bill also explain that the provisions on research are "based on long-standing international consensus, for example, laid down by … the Council of Europe Convention on Human Rights and Biomedicine".[187] We have therefore proceeded on the basis that this Convention, although not signed by the UK, contains the relevant standards by which to measure the Bill's provisions, and that the onus is on the Government to explain and justify departures from those standards.

4.53 We welcome the Government's statement that its aim is to achieve a balance between allowing important research to proceed whilst not exposing an extremely vulnerable group of individuals to unacceptable interference with their rights and privacy.[188] Securing the benefits of research for people who lack capacity is a legitimate aim, but pursuit of it must be accompanied by strict safeguards in order to be compatible with the rights of people lacking capacity.

4.54 The Government accepts that in some cases the safeguards in the Bill depart from the language used in the European Convention on Human Rights and Biomedicine,[189] but offers two explanations for this.

4.55 First and foremost, the Government explains that the provisions in the Bill are intended to cover a broader range of research than direct medical interventions on the person, extending also to health and social care research projects which may include accessing medical records, or observation of the person in their care setting. The Government says that this broader range of research in relation to people lacking capacity which is intended to be covered by the Bill limits the relevance of the European Convention on Human Rights and Biomedicine because it does not extend across the breadth of research activities that the Bill is intended to cover.[190]

4.56 Second, other international instruments and domestic legislation have also been taken into account, including the Additional Protection to the Convention on Human Rights and Biomedicine concerning Biomedical Research[191] and the EU Clinical Trials Directive[192] and the UK implementing Regulations.[193]

4.57 Although the Government has referred in its response to the importance of these other instruments, it has not specified the precise ways in which they are said materially to differ from the Convention on Human Rights and Biomedicine in a way which justifies departing from the standards of the latter. In the absence of that information, we have treated the Government's main reason for departing from those standards as being the first reason summarised above, that the provisions in the Bill are intended to cover a broader range of research in relation to people lacking capacity.

4.58 As we noted in our earlier report,[194] that this is the intention of the provisions on research has only become clear during the passage of the Bill.[195] There is nothing on the face of the Bill to make clear that this is the intention or effect of the provisions, and the Explanatory Notes to the Bill do not make this clear, referring only to "intrusive research". Our concern is that designing a single set of provisions which is designed not only to cover intrusive medical research but also other less intrusive types of research has the effect of diluting the standards applicable to the former type of intrusive research. If the Bill provided separate safeguards for the two types of research this problem would not arise, but this is not the case. We recommend that the Bill should be amended to distinguish between the two types of research, so as not to dilute the standards applicable to research governed by the Convention on Human Rights and Biomedicine.

THE "NO ALTERNATIVE" CRITERION

4.59 The Government accepts that the requirement that there be "no alternative" to the involvement of adults who lack capacity is a "generally held concept", but believes that there is no significant departure from it in clause 31(3) of the Bill.[196] It believes that the wording of that clause makes the test that the researcher will have to satisfy clearer, and that "to establish absolute certainty would require the protocol for every research project to be referred to court".[197]

4.60 We disagree that the wording of the Bill does not represent a significant departure from the internationally recognised standard that there must be "no alternative" to such research. Stating the requirement in terms of "reasonable belief" about that fact is a departure from the standard, because it contemplates the possibility of research being authorised where in fact there is an alternative to such research being carried out. In such a case, there would be no means of challenging a decision to approve some research if there were reasonable grounds for believing there to be no alternative, even though such an alternative did in fact exist. This does not mean, however, that every research project proposal would have to be referred to court. It merely strengthens the precondition for authorising such research and allows for challenge if an alternative in fact exists. In our view, the Scottish version of this criterion,[198] which requires that research "of a similar nature cannot be carried out on an adult who is capable in relation to such a decision" (emphasis added) is faithful to the accepted international standard and the Bill should be amended to give effect to such a formulation.

THE NATURE OF THE BENEFIT

4.61 The Government accepts that the Bill departs from the precise language of the Convention on Human Rights and Biomedicine in relation to the benefit required in order for research to be permissible,[199] but disagrees that this departure is a lowering of the threshold of what research is permissible.[200] However, in its explanation for not following the wording of the Convention, it implicitly acknowledges that the provisions in the Bill are more enabling of research than the relevant international standards.

4.62 We have considered the Government's reasons for not following the language and structure of the Convention more closely. We accept that defining the legal framework for evaluating the benefit of research is a difficult question, but we remain of the view expressed in our earlier report, for the following reasons.

4.63 First, the Government's reason for not including the words "real and direct benefit" in clause 31(4) when defining the threshold is that "it may be hard to show that it will definitely benefit a person directly, even though it might generate valuable knowledge about their condition"[201] is based on a misapprehension of the relevant standard in the Convention on Human Rights and Biomedicine.[202] That provision does not require it to be shown that there will definitely be a direct benefit to the person concerned, as the Government supposes. Rather it provides that the results of the research must have the potential to produce real and direct benefit. The "real and direct" benefit test is therefore not as restrictive as the Government has assumed.[203]

4.64 Second, the Government invokes the higher level of safeguards provided in relation to research which does not produce a benefit to the individual.[204] As we pointed out in our earlier report, however, the Convention on Human Rights and Biomedicine provides a structure whereby research which has no potential for direct benefit is only permitted exceptionally, where certain additional conditions are met, including that the research has the aim of contributing through significant improvement in the scientific understanding of the individual's condition, to results capable of conferring benefit to the person concerned or others with the same condition. These are stricter safeguards than those relied on by the Government in its response.

4.65 We therefore remain of the view we held on initial consideration of the Bill, that the effect of the provisions in the Bill concerning the nature of the benefit to be achieved by the research is to relax the standards contained in the Convention on Human Rights and Biomedicine and the Helsinki Declaration and they therefore lower the threshold of when research will be permissible. The standard should be that the interests of science and society should never take precedence over considerations related to the well-being of the subject.

THE NATURE OF THE RISK OF HARM

4.66 On initial consideration of the Bill we were concerned that the additional conditions which have to be satisfied in the Bill for research without potential for direct benefit to the person lacking capacity were weaker than the condition in the Convention on Human Rights and Biomedicine that the research must entail "only minimal risk and minimal burden for the individual concerned".[205]

4.67 We welcome the Government's clarification of the intention behind the drafting of the relevant clause in the Bill.[206] It makes clear that it considers "negligible", in relation to risk, to be "synonymous with 'minimal'" which is the word used in the international standard. The intention is that the risk must always be at a very low level. The Government also makes clear that the term "significant" in clause 31(5)(b)(i) is used to mean "material" rather than "extensive", and that interference with a person's privacy or freedom of action "should be kept to a minimum."

4.68 Although we would prefer to see these clarifications made explicit by amendment of the language of the Bill (particularly the substitution of "material" for "significant" in clause 31(5)(b)(i)), and we remain concerned about the introduction of a reference to "reasonable grounds for believing" for the reasons explained fully above, these clarifications largely meet our concerns in our earlier report in relation to this particular clause.

THE COMPETENT BODY

4.69 In light of the requirement in the Convention on Human Rights and Biomedicine that a research project must have been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research and multidisciplinary review of its ethical responsibility, we asked the Government to provide more detail of how the appropriate body will conduct its work of deciding whether or not to approve a particular research project, in order for us to reach a view about the Bill's compatibility with this aspect of the procedural protections required by the Convention.[207]

4.70 We entirely accept the Government's point that, if regulations specify a body other than a Research Ethics Committee to be the appropriate body in relation to research in relation to people lacking capacity, "it does not automatically follow that it will not be consistent with the … Convention".[208] If the research concerned is outside the scope of that Convention, then we accept that its requirements are not relevant.

4.71 However, we are concerned to ensure that research which is covered by that Convention satisfies its requirements, including its prescription of the type of procedures to be followed by Research Ethics Committees. In this respect, the Government's response has not provided us with the information we sought in order to enable us to reach a view on this particular aspect of the Bill's compatibility with the relevant international standards. However, the Government states that a review of the functioning of the REC system has been announced, and that the recommendations of this review will be reflected in placing RECs on a statutory footing. We are not clear whether primary legislation is proposed and if so on what timescale. In the absence of the information we sought, however, we will look carefully at any legislation which is forthcoming to ascertain its compatibility with the relevant parts of the Human Rights and Biomedicine Convention.



154   Twenty-third Report of Session 2003-04, Scrutiny of Bills: Final Progress Report, HL Paper 210, HC 1282, Chapter 2 Back

155   Appendix 4a Back

156   Not published here Back

157   Appendix 4a, paras. 17-18 Back

158   Twenty-third Report of Session 2003-04, Scrutiny of Bills: Final Progress Report, para. 2.44.Contrary to the impression of some members, see for example, Dr. Iddon MP, HC Deb, 14 December 2004 col. 1557, our earlier report did not suggest that putting advance directives in the Bill raises serious human rights concerns. Back

159   Appendix 4a, paras. 24-26 Back

160   Appendix 4a, para. 31 Back

161   Clause 24(3) Back

162   Appendix 4a, para. 29 Back

163   Twenty-third Report of Session 2003-04, op cit., para. 2.46 Back

164   Appendix 4a, paras. 27-31 Back

165   Clause 25(5) of the Bill Back

166   Appendix 4a, para. 28 Back

167   ibid., para. 29 Back

168   ibid., para. 30 Back

169   Appendix 4a, para. 32, responding to Q9 in the Chair's letter to the Minister. Back

170   See below for the relevance of developments in treatment and medicine to the need for an additional safeguard limiting the duration of advance directives and requiring them to be renewed periodically. Back

171   HC Deb, 10 January 2005, cols. 3WS-4WS Back

172   [2004] EWCA Civ 1324 Back

173   ibid., para. 21 Back

174   Twenty-third Report of Session 2003-04, op cit., para. 2.47 Back

175   Appendix 4a, paras 34-36 Back

176   New clause 4(5) Back

177   Appendix 4a, para. 40 Back

178   ibid., para. 41 Back

179   That "intolerability" is the touchstone of best interests was upheld by the Court of Appeal in W HealthCare NHS Trust v KH (above) Back

180   Appendix 4a, para. 48 Back

181   ibid., paras. 49-50 Back

182   ibid., paras. 49-50 Back

183   ibid., paras. 51-52 Back

184   Twenty-third Report of Session 2003-04, op cit., paras. 2.52-2.66 Back

185   Appendix 4a, paras 53-70 Back

186   ibid., para. 56 Back

187   EN para. 93 Back

188   Appendix 4a, para. 53 Back

189   ibid., para. 60 Back

190   ibid., para. 59 Back

191   Adopted by the Committee of Ministers of the Council of Europe on 30 June 2004 Back

192   Directive 2001/20/EC Back

193   Clinical Trials Regulations 2004 Back

194   Twenty-third Report of Session 2003-04, op cit., para. 2.52 Back

195   See Rosie Winterton MP, Minister of State, Department of Health, HC Deb, 28 October 2004, col. 271 Back

196   Appendix 4a, para. 62 Back

197   ibid., para. 63 Back

198   In the Adults with Incapacity (Scotland) Act 2000 Back

199   Appendix 4a, para. 64 Back

200   ibid., para. 69 Back

201   ibid., para. 66 Back

202   Article 17(1)(ii) Back

203   Appendix 4a, paras. 66-67 Back

204   In clauses 31(5)(a) and (b) of the Bill Back

205   Twenty-third Report of Session 2003-04, op cit., paras. 2.61-2.62 Back

206   Appendix 4a, para. 67 Back

207   Twenty-third Report of Session 2003-04, op cit., paras. 2.63-2.66 Back

208   Appendix 4a, para. 74 Back


 
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