Bioethical Inquiry DOI 10.1007/s11673-015-9637-5
RECENT DEVELOPMENTS
Supporting Innovation in the UK: Care Act 2014 Developments in Social Care Legislation in England and the Medical Innovation Bill Bernadette Richards & Laura Williamson
Received: 17 February 2015 / Accepted: 9 March 2015 # Journal of Bioethical Inquiry Pty Ltd. 2015
Care Act 2014: Developments in Social Care Legislation in England The Care Act 2014 becomes law in England in April 2015. The statutory reform of social care for adults in England that led to the Act was announced by the Law Commission in its Tenth Programme of Law Reform (2008). The Commission explains: The legislative framework for adult residential care, community care and support for carers is in adequate, often incomprehensible and outdated. It remains a confusing patchwork of conflicting statues enacted over a period of 50 years (Law Commission 2008, 10). Prior to reform, more than 30 Acts of Parliament were relevant to adult social care (Law Commission 2010, viii). The Commission highlights that the outdated nature of legislation risks Bstifling innovation^ and efforts to promote Bflexibility and new policy
B. Richards (*) Law School, University of Adelaide, North Tce, Adelaide 5005, Australia e-mail: [email protected] L. Williamson Institute for Applied Health Research, Glasgow Caledonian University, Glasgow, UK e-mail: [email protected]
approaches in practice^ (Law Commission 2010, 2). Hence its intention to produce a Bsingle, modern statute to which service providers and service users can look to understand whether services can or should be provided^ (Law Commission 2008, 10f). A large amount of primary and secondary legislation will be repealed when the new Act comes into force (Department of Health 2014b, 74f). This, for example, includes the National Assistance Act 1948 and the protection it archaically affords to Bdumb and crippled persons^ (pt III, s 29). However, as the new statute only relates to adults, some legislation will be partially repealed, leaving laws relating to minors in place— e.g., the Chronically Sick and Disabled Persons Act 1970. Thus, there are some limitations on the Law Commission’s efforts to streamline legislation. Beyond simplifying current legislation, a central aim of the new statute is to ensure that legal provision in the area of adult social care fits and is able to inform contemporary health culture in a pertinent manner. In this respect, moves towards Bpersonalisation^ and service user choice have an important place in the legislation (Law Commission 2010, 3f). This emphasis is arguably most apparent in measures like those covering Bdirect payments^—the allocation of a personal budget to those who receive local authority support to allow them to choose how to spend the funds on care (Care Act 2014, pts1, ss 31–33). But the client-centred emphasis of the Act is also evident in the broad statutory principles that underpin it.
Bioethical Inquiry
A cornerstone of the statute is the duty it places on local authorities to promote the well-being of adults in their jurisdiction. The guidance on the Act seeks to add specificity to the broad concept of Bwell-being^ by drawing on the importance of dignity, mental and physical health, and protection from abuse in local authority decision-making (Department of Health 2014a, 1ff; Care Act 2014, pt 1, s 1). The Law Commission acknowledges in its consultation document that principles such as Bdignity^ can also be subjective and hard to define, but the commission suggests that they can help to set limits (2010, 23f). In addition, the Commission utilises other principles to guide the duties and actions of local authorities in respect of well-being. These principles include acknowledging: that individuals are bestplaced to assess their own well-being; the need to ensure decisions are based on individual circumstances, rather than flawed, generalised assumptions; the importance of individuals participating fully in decisions; and the need to ensure any restrictions on individual rights are justified (Care Act 2014, pt 1, s 1.3). Particularly important in supporting the well-being of individuals are the duties the Act places on local authorities to meet the needs and desired outcomes of adults. The duty enshrined in the Care Act for local authorities to assess need Bwhere it appears^ to an authority that it may exist (pt 1, s9) does not, in itself, depart significantly from previous legislation (e.g., National Health Service Community Care Act 1990). However, because the Law Commission is keen to avoid care that is Bservice-led,^ rather than client-led, the Care Act 2014 is enhanced by additional provisions (Law Commission 2010). In this respect, the guidance on the Act explains Bpromoting well-being does not mean simply looking at a need that corresponds to a particular service^ but requires Ba genuine conversation about people’s needs for care and support^ (Department of Health 2014a, 5). To deliver on this commitment the Act makes it necessary for the assessments local authorities conduct to focus on Bthe outcomes that the adult wishes to achieve in day-to-day life^ (Care Act 2014, pt 1, s 9). On this point, in its response to the Law Commission consultation, the Joseph Rowntree Foundation (2010) highlights the value of an outcome-based approach, including its ability to support people in attaining “the ordinary things in life” that they most value but which are often overlooked by a service-focussed approach (Law Commission 2010, 15). Although this commitment to supporting the perspective of clients is commendable,
for a number of reasons it is questionable whether it can be realised in the thoroughgoing manner identified in the statute and its accompanying regulations and guidance. Firstly, there is a tension between the duty to support the well-being, needs, and outcomes specified by adults and their carers and a duty to enforce the principles that the new legislation will use to determine whether people are eligible for care. That is, a key part of the legislative process of allocating care is the determination of eligibility as outlined in the Care and Support (Eligibility Criteria) Regulations 2015. This document sets a “minimum threshold” for eligibility and simplifies the requirements of existing legislation that allow local authorities to determine their own local threshold (Law Commission 2010, 6; Department of Health 2010). Preventing local authorities from arbitrarily altering the eligibility threshold will help to prevent unjust, differential support being offered between locations and amongst individuals with similar conditions and circumstances. This is a considerable advance. However, the new legislation may still encounter significant challenges in guiding and, importantly, being seen to guide the delivery of care in a fair, person-centred way. Within the legislation a new Bminimum threshold^ for eligibility is determined by assessing how an individual’s needs impact on the outcomes he or she wishes to achieve and, in turn, the ramifications this has for the person’s well-being. More specifically, to be Beligible^ for care all three of the following Bneed^ criteria must be met: Bphysical or mental impairment or illness^; the inability to achieve at least two of the outcomes specified in the regulations; and how the former points impact on a person’s well-being (Care and Support (Eligibility Criteria) Regulations 2015, s 2.1). The sections of the Act that deal with well-being and needs suggest that it is the outcomes identified by adults and their carers that direct service provision. But the eligible outcomes are specified in a broad manner within the legislation. They include: maintaining nutrition, hygiene, toilet needs, and clothing and engaging in work (Care and Support (Eligibility Criteria) Regulations 2015, s 2.2). While these outcomes may tally with many of those that particular adults and their carers would specify themselves, it is also possible that they represent a rather traditional perspective on the care people want. Indeed, their specification may, unintentionally, function as an obstacle to local authorities hearing from adults what their preferred outcomes really are.
Bioethical Inquiry
Secondly, at a number of points the new statute increases the duties of local authorities in a manner that is likely to require more resources. For example, the new statute gives local authorities a duty to assess and address the eligible needs of carers (Care Act 2014, pt 1, s 10). In his foreword to the consultation document, Norman Lamb, Minister of State for Care and Support, notes that the Act is Ba landmark moment for carers. For the first time, they will be put on the same legal footing as the people they care for^ (Department of Health 2014b, 6). In fact extant legislation does afford carers the right to request an assessment (e.g., Carers (Recognition and Services) Act 1995, Carers and Disabled Children Act 2000), but the Bfragmented, multi-layered and internally inconsistent^ nature of this legislation makes its interpretation and application difficult (Law Commission 2010, 39ff). The Care Act simplifies this and removes the need for carers to provide a Bsubstantial^ amount of care before they can request an assessment and receive (Care Act 2014, pt 1, s 10). Thus, this provision lowers the threshold at which carers might expect support and so increases the burden on local authorities. Another area in which the duties of local authorities increase under the Act is in the context of prevention. The statute gives local authorities a duty to take steps that will: prevent or delay adults developing care needs (Care Act 2004, pt 1, s 2); prevent or delay carers requiring support (Care Act 2014, pt 1, s 2.1b); reduce care needs of adults and carers more generally within its jurisdiction (Care Act 2014, pt 1, ss 2.1c–1d). The guidance states that the aims of the legislation must be to promote Bindependence^ and not Bwait to respond when people reach a crisis point^ (Department of Health 2014a, s 2.1). In focusing on early intervention the legislation endeavours to move social care in England away from a “traditional model” of care and its focus on adults with the most acute needs (Law Commission 2010, s 1.16). The aspiration to ensure social care meets fundamental care needs throughout the life course, like the extension of support to carers, requires significant resources. But these have not been provided to support the implementation of the Act. As Clements states in relation to the provisions surrounding prevention: Given the very serious financial problems of most local authorities and the lack of any significant
Bnew money^ to accompany this legislation—it is difficult to see how (in the short term) this duty can be made more than cosmetic (2014, 4). Once it becomes law, it will take time for the ethical and legal implications of the Care Act 2014 to become apparent. But the “indecent haste” with which the statute is being introduced means much early questioning of it is likely to be prompted by requests for clarification (Clements 2014, 2). Given the person-centred drive of the legislation, it is ironic that adults with care needs and their carers must rush to understand their duties, entitlements, and responsibilities under it. It seems essential for new funding, not recycled money, to be given to help deliver the ambitions of the revised social care legislation. Furthermore, the tensions that are already apparent between the prominent person-centred focus of the Act and the (necessary) assessments of eligibility for care will become more acute when the supporting financial regulations come into force in April 2016. Despite the positive contributions of the new statute to help promote the continuing improvement of social care services in England, further work and resources are required. Unfortunately, ethical interest in social care has lagged significantly behind concern for technology-driven science dilemmas. For ethicists to help identify and analyse the issues that will impact on maximal social care provision—from the just allocation of services to satisfactory understandings of its foundational drivers (well-being, dignity, etc.)—requires greater interest in the provision of social care services. —Laura Williamson
Medical Innovation Bill The Medical Innovation Bill, popularly referred to as the BSaatchi Bill,^ is progressing through Parliament. The Bill had its final reading in the House of Lords on January 23, 2015, and then moved to the House of Commons where it was debated in late February. The summary describes it as a BBill to [m]ake provision about innovation in medical treatment,^ but the aim of the Bill takes this one step further and claims to encourage responsible innovation. This aim therefore opens two key questions: what constitutes innovation and how is “responsible” defined? The first question is given only cursory attention in the Bill, whilst the response to
Bioethical Inquiry
the second forms the substance of the provisions in the Bill. With regards to the concept of innovation, there is little in the Bill that explains this term. The Bill simply refers to a “departure from the existing range of accepted medical treatment for a condition” (2(1)(a)). Thus there are no parameters drawn around the extent or type of innovation, and it is a fair assumption that it potentially covers everything from a minor change in the approach to treatment through to a radical change involving a new form of treatment altogether. The key focus on the Bill is on the term Bresponsible^; if a departure from the existing range of accepted treatment can be defined as responsible under the Bill, then the doctor will not be negligent. The bulk of the Bill focusses on the concept of Bresponsible^ and setting out what will constitute a responsible treatment decision. To summarise the requirements of Bresponsible^ behaviour, a doctor must: & & & &
obtain the views of one or more appropriately qualified doctors … take full account of [those] views … obtain consents as required by law … consider— – – –
procedures and the second is that the best interests of the patient must provide the impetus for the innovation. A final point to make is that there is a specific provision that nothing in this BAct^ is to impact on the common law test of support by a responsible body of medical opinion (2(1)(a)). The Bill has not received universal support, with the mildest detractors merely questioning what it adds to the law and the most extreme lamenting that it will Bput patients at the mercy of quacks^ (Hills 2014, article headline). The Bill has triggered significant debate and currently sits poised to continue its passage through Parliament. There remains one significant question to consider: what does the Medical Innovation Bill bring to the law? In practical terms it seems reasonable to borrow words from the Bill itself to provide one possible response to that question: nothing in the Bill Baffects any rule of the common law … [or] is to be read as limiting the circumstances in which any such rule of common law may be relied on^ (2(1)(a)–(b)). (Since writing this summary the Bill stalled in the House of Commons, where it was not debated. It seems that, for now, the Medical Innovation Bill has run its course.) —Bernadette Richards
any opinions or requests expressed by or in relation to the patient, the risks and benefits … associated with the proposed treatment [alongside those of existing treatment], and any other [relevant] matter (1(3)(a)–(d)).
The final amendment to the Bill as it passed out of the House of Lords was to include the additional formality of compulsory registration of innovation. The twin requirements of accountability and transparency were highlighted. Some further clarification of terms employed in the Bill is also provided. BAppropriately qualified^ is defined as a doctor having the Bappropriate expertise and experience in dealing with patients with^ the specific medical condition (1(4)). And to meet the expectation of Baccountability and transparency^ a doctor must record the views of other doctors, the reason for departing from existing treatment, and the nature of the proposed treatment in the patient’s notes (1(5)(a)–(c)). There are two cautionary notes sounded in the Bill: the first is that the Bill does not apply to medical research or cosmetic
References Clements, L. 2014. The Care Act 2014 overview. http://www. lukeclements.co.uk/wp-content/uploads/2014/12/Care-Act2014-updated-overview-09.pdf. Accessed 13 Jan 2015. Department of Health. 2010. Putting people first: A whole system approach to eligibility for social care. London: Department of Health. Department of Health. 2014a. Care and support statutory guidance: Issued under the Care Act 2014. London: Department of Health. https://www.gov.uk/government/uploads/system/ uploads/attachment_data/file/315993/Care-Act-Guidance. pdf. Department of Health. 2014b. The Care Act 2014: Consultation on draft regulations and guidance for implementation of Part 1 of the Act in 2015/16. London: Department of Health, Care and Support Consultation. https://www.gov.uk/government/ uploads/system/uploads/attachment_data/file/317820/ CareAct_cons_040614.pdf. Hills, D. 2014. The Saatchi medical innovation bill will put patients at the mercy of quacks. The Guardian, May 22. http://www.theguardian.com/science/brain-flapping/2014/ may/21/saatchi-medical-innovation-bill-patients-quackstreatments.
Bioethical Inquiry Joseph Rowntree Foundation. 2010. Response to the Law Commission Consultation on Adult Social Care. York: Joseph Rowntree Foundation. http://www.jrf.org.uk/system/ files/consultation-law-commission-adult-care.pdf. Law Commission. 2008. Tenth programme of law reform. London: Law Commission (Law Com No 311). http://
lawcom mission.justice.gov.uk/docs/lc311_10th_ Programme.pdf. Law Commission. 2010. Adult social care: A consultation paper. London: Law Commission (Consultation Paper No 192). http://lawcommission.justice.gov.uk/docs/cp192_Adult_ Social_Care_consultation.pdf.
RECENT DEVELOPMENTS
Supporting Innovation in the UK: Care Act 2014 Developments in Social Care Legislation in England and the Medical Innovation Bill Bernadette Richards & Laura Williamson
Received: 17 February 2015 / Accepted: 9 March 2015 # Journal of Bioethical Inquiry Pty Ltd. 2015
Care Act 2014: Developments in Social Care Legislation in England The Care Act 2014 becomes law in England in April 2015. The statutory reform of social care for adults in England that led to the Act was announced by the Law Commission in its Tenth Programme of Law Reform (2008). The Commission explains: The legislative framework for adult residential care, community care and support for carers is in adequate, often incomprehensible and outdated. It remains a confusing patchwork of conflicting statues enacted over a period of 50 years (Law Commission 2008, 10). Prior to reform, more than 30 Acts of Parliament were relevant to adult social care (Law Commission 2010, viii). The Commission highlights that the outdated nature of legislation risks Bstifling innovation^ and efforts to promote Bflexibility and new policy
B. Richards (*) Law School, University of Adelaide, North Tce, Adelaide 5005, Australia e-mail: [email protected] L. Williamson Institute for Applied Health Research, Glasgow Caledonian University, Glasgow, UK e-mail: [email protected]
approaches in practice^ (Law Commission 2010, 2). Hence its intention to produce a Bsingle, modern statute to which service providers and service users can look to understand whether services can or should be provided^ (Law Commission 2008, 10f). A large amount of primary and secondary legislation will be repealed when the new Act comes into force (Department of Health 2014b, 74f). This, for example, includes the National Assistance Act 1948 and the protection it archaically affords to Bdumb and crippled persons^ (pt III, s 29). However, as the new statute only relates to adults, some legislation will be partially repealed, leaving laws relating to minors in place— e.g., the Chronically Sick and Disabled Persons Act 1970. Thus, there are some limitations on the Law Commission’s efforts to streamline legislation. Beyond simplifying current legislation, a central aim of the new statute is to ensure that legal provision in the area of adult social care fits and is able to inform contemporary health culture in a pertinent manner. In this respect, moves towards Bpersonalisation^ and service user choice have an important place in the legislation (Law Commission 2010, 3f). This emphasis is arguably most apparent in measures like those covering Bdirect payments^—the allocation of a personal budget to those who receive local authority support to allow them to choose how to spend the funds on care (Care Act 2014, pts1, ss 31–33). But the client-centred emphasis of the Act is also evident in the broad statutory principles that underpin it.
Bioethical Inquiry
A cornerstone of the statute is the duty it places on local authorities to promote the well-being of adults in their jurisdiction. The guidance on the Act seeks to add specificity to the broad concept of Bwell-being^ by drawing on the importance of dignity, mental and physical health, and protection from abuse in local authority decision-making (Department of Health 2014a, 1ff; Care Act 2014, pt 1, s 1). The Law Commission acknowledges in its consultation document that principles such as Bdignity^ can also be subjective and hard to define, but the commission suggests that they can help to set limits (2010, 23f). In addition, the Commission utilises other principles to guide the duties and actions of local authorities in respect of well-being. These principles include acknowledging: that individuals are bestplaced to assess their own well-being; the need to ensure decisions are based on individual circumstances, rather than flawed, generalised assumptions; the importance of individuals participating fully in decisions; and the need to ensure any restrictions on individual rights are justified (Care Act 2014, pt 1, s 1.3). Particularly important in supporting the well-being of individuals are the duties the Act places on local authorities to meet the needs and desired outcomes of adults. The duty enshrined in the Care Act for local authorities to assess need Bwhere it appears^ to an authority that it may exist (pt 1, s9) does not, in itself, depart significantly from previous legislation (e.g., National Health Service Community Care Act 1990). However, because the Law Commission is keen to avoid care that is Bservice-led,^ rather than client-led, the Care Act 2014 is enhanced by additional provisions (Law Commission 2010). In this respect, the guidance on the Act explains Bpromoting well-being does not mean simply looking at a need that corresponds to a particular service^ but requires Ba genuine conversation about people’s needs for care and support^ (Department of Health 2014a, 5). To deliver on this commitment the Act makes it necessary for the assessments local authorities conduct to focus on Bthe outcomes that the adult wishes to achieve in day-to-day life^ (Care Act 2014, pt 1, s 9). On this point, in its response to the Law Commission consultation, the Joseph Rowntree Foundation (2010) highlights the value of an outcome-based approach, including its ability to support people in attaining “the ordinary things in life” that they most value but which are often overlooked by a service-focussed approach (Law Commission 2010, 15). Although this commitment to supporting the perspective of clients is commendable,
for a number of reasons it is questionable whether it can be realised in the thoroughgoing manner identified in the statute and its accompanying regulations and guidance. Firstly, there is a tension between the duty to support the well-being, needs, and outcomes specified by adults and their carers and a duty to enforce the principles that the new legislation will use to determine whether people are eligible for care. That is, a key part of the legislative process of allocating care is the determination of eligibility as outlined in the Care and Support (Eligibility Criteria) Regulations 2015. This document sets a “minimum threshold” for eligibility and simplifies the requirements of existing legislation that allow local authorities to determine their own local threshold (Law Commission 2010, 6; Department of Health 2010). Preventing local authorities from arbitrarily altering the eligibility threshold will help to prevent unjust, differential support being offered between locations and amongst individuals with similar conditions and circumstances. This is a considerable advance. However, the new legislation may still encounter significant challenges in guiding and, importantly, being seen to guide the delivery of care in a fair, person-centred way. Within the legislation a new Bminimum threshold^ for eligibility is determined by assessing how an individual’s needs impact on the outcomes he or she wishes to achieve and, in turn, the ramifications this has for the person’s well-being. More specifically, to be Beligible^ for care all three of the following Bneed^ criteria must be met: Bphysical or mental impairment or illness^; the inability to achieve at least two of the outcomes specified in the regulations; and how the former points impact on a person’s well-being (Care and Support (Eligibility Criteria) Regulations 2015, s 2.1). The sections of the Act that deal with well-being and needs suggest that it is the outcomes identified by adults and their carers that direct service provision. But the eligible outcomes are specified in a broad manner within the legislation. They include: maintaining nutrition, hygiene, toilet needs, and clothing and engaging in work (Care and Support (Eligibility Criteria) Regulations 2015, s 2.2). While these outcomes may tally with many of those that particular adults and their carers would specify themselves, it is also possible that they represent a rather traditional perspective on the care people want. Indeed, their specification may, unintentionally, function as an obstacle to local authorities hearing from adults what their preferred outcomes really are.
Bioethical Inquiry
Secondly, at a number of points the new statute increases the duties of local authorities in a manner that is likely to require more resources. For example, the new statute gives local authorities a duty to assess and address the eligible needs of carers (Care Act 2014, pt 1, s 10). In his foreword to the consultation document, Norman Lamb, Minister of State for Care and Support, notes that the Act is Ba landmark moment for carers. For the first time, they will be put on the same legal footing as the people they care for^ (Department of Health 2014b, 6). In fact extant legislation does afford carers the right to request an assessment (e.g., Carers (Recognition and Services) Act 1995, Carers and Disabled Children Act 2000), but the Bfragmented, multi-layered and internally inconsistent^ nature of this legislation makes its interpretation and application difficult (Law Commission 2010, 39ff). The Care Act simplifies this and removes the need for carers to provide a Bsubstantial^ amount of care before they can request an assessment and receive (Care Act 2014, pt 1, s 10). Thus, this provision lowers the threshold at which carers might expect support and so increases the burden on local authorities. Another area in which the duties of local authorities increase under the Act is in the context of prevention. The statute gives local authorities a duty to take steps that will: prevent or delay adults developing care needs (Care Act 2004, pt 1, s 2); prevent or delay carers requiring support (Care Act 2014, pt 1, s 2.1b); reduce care needs of adults and carers more generally within its jurisdiction (Care Act 2014, pt 1, ss 2.1c–1d). The guidance states that the aims of the legislation must be to promote Bindependence^ and not Bwait to respond when people reach a crisis point^ (Department of Health 2014a, s 2.1). In focusing on early intervention the legislation endeavours to move social care in England away from a “traditional model” of care and its focus on adults with the most acute needs (Law Commission 2010, s 1.16). The aspiration to ensure social care meets fundamental care needs throughout the life course, like the extension of support to carers, requires significant resources. But these have not been provided to support the implementation of the Act. As Clements states in relation to the provisions surrounding prevention: Given the very serious financial problems of most local authorities and the lack of any significant
Bnew money^ to accompany this legislation—it is difficult to see how (in the short term) this duty can be made more than cosmetic (2014, 4). Once it becomes law, it will take time for the ethical and legal implications of the Care Act 2014 to become apparent. But the “indecent haste” with which the statute is being introduced means much early questioning of it is likely to be prompted by requests for clarification (Clements 2014, 2). Given the person-centred drive of the legislation, it is ironic that adults with care needs and their carers must rush to understand their duties, entitlements, and responsibilities under it. It seems essential for new funding, not recycled money, to be given to help deliver the ambitions of the revised social care legislation. Furthermore, the tensions that are already apparent between the prominent person-centred focus of the Act and the (necessary) assessments of eligibility for care will become more acute when the supporting financial regulations come into force in April 2016. Despite the positive contributions of the new statute to help promote the continuing improvement of social care services in England, further work and resources are required. Unfortunately, ethical interest in social care has lagged significantly behind concern for technology-driven science dilemmas. For ethicists to help identify and analyse the issues that will impact on maximal social care provision—from the just allocation of services to satisfactory understandings of its foundational drivers (well-being, dignity, etc.)—requires greater interest in the provision of social care services. —Laura Williamson
Medical Innovation Bill The Medical Innovation Bill, popularly referred to as the BSaatchi Bill,^ is progressing through Parliament. The Bill had its final reading in the House of Lords on January 23, 2015, and then moved to the House of Commons where it was debated in late February. The summary describes it as a BBill to [m]ake provision about innovation in medical treatment,^ but the aim of the Bill takes this one step further and claims to encourage responsible innovation. This aim therefore opens two key questions: what constitutes innovation and how is “responsible” defined? The first question is given only cursory attention in the Bill, whilst the response to
Bioethical Inquiry
the second forms the substance of the provisions in the Bill. With regards to the concept of innovation, there is little in the Bill that explains this term. The Bill simply refers to a “departure from the existing range of accepted medical treatment for a condition” (2(1)(a)). Thus there are no parameters drawn around the extent or type of innovation, and it is a fair assumption that it potentially covers everything from a minor change in the approach to treatment through to a radical change involving a new form of treatment altogether. The key focus on the Bill is on the term Bresponsible^; if a departure from the existing range of accepted treatment can be defined as responsible under the Bill, then the doctor will not be negligent. The bulk of the Bill focusses on the concept of Bresponsible^ and setting out what will constitute a responsible treatment decision. To summarise the requirements of Bresponsible^ behaviour, a doctor must: & & & &
obtain the views of one or more appropriately qualified doctors … take full account of [those] views … obtain consents as required by law … consider— – – –
procedures and the second is that the best interests of the patient must provide the impetus for the innovation. A final point to make is that there is a specific provision that nothing in this BAct^ is to impact on the common law test of support by a responsible body of medical opinion (2(1)(a)). The Bill has not received universal support, with the mildest detractors merely questioning what it adds to the law and the most extreme lamenting that it will Bput patients at the mercy of quacks^ (Hills 2014, article headline). The Bill has triggered significant debate and currently sits poised to continue its passage through Parliament. There remains one significant question to consider: what does the Medical Innovation Bill bring to the law? In practical terms it seems reasonable to borrow words from the Bill itself to provide one possible response to that question: nothing in the Bill Baffects any rule of the common law … [or] is to be read as limiting the circumstances in which any such rule of common law may be relied on^ (2(1)(a)–(b)). (Since writing this summary the Bill stalled in the House of Commons, where it was not debated. It seems that, for now, the Medical Innovation Bill has run its course.) —Bernadette Richards
any opinions or requests expressed by or in relation to the patient, the risks and benefits … associated with the proposed treatment [alongside those of existing treatment], and any other [relevant] matter (1(3)(a)–(d)).
The final amendment to the Bill as it passed out of the House of Lords was to include the additional formality of compulsory registration of innovation. The twin requirements of accountability and transparency were highlighted. Some further clarification of terms employed in the Bill is also provided. BAppropriately qualified^ is defined as a doctor having the Bappropriate expertise and experience in dealing with patients with^ the specific medical condition (1(4)). And to meet the expectation of Baccountability and transparency^ a doctor must record the views of other doctors, the reason for departing from existing treatment, and the nature of the proposed treatment in the patient’s notes (1(5)(a)–(c)). There are two cautionary notes sounded in the Bill: the first is that the Bill does not apply to medical research or cosmetic
References Clements, L. 2014. The Care Act 2014 overview. http://www. lukeclements.co.uk/wp-content/uploads/2014/12/Care-Act2014-updated-overview-09.pdf. Accessed 13 Jan 2015. Department of Health. 2010. Putting people first: A whole system approach to eligibility for social care. London: Department of Health. Department of Health. 2014a. Care and support statutory guidance: Issued under the Care Act 2014. London: Department of Health. https://www.gov.uk/government/uploads/system/ uploads/attachment_data/file/315993/Care-Act-Guidance. pdf. Department of Health. 2014b. The Care Act 2014: Consultation on draft regulations and guidance for implementation of Part 1 of the Act in 2015/16. London: Department of Health, Care and Support Consultation. https://www.gov.uk/government/ uploads/system/uploads/attachment_data/file/317820/ CareAct_cons_040614.pdf. Hills, D. 2014. The Saatchi medical innovation bill will put patients at the mercy of quacks. The Guardian, May 22. http://www.theguardian.com/science/brain-flapping/2014/ may/21/saatchi-medical-innovation-bill-patients-quackstreatments.
Bioethical Inquiry Joseph Rowntree Foundation. 2010. Response to the Law Commission Consultation on Adult Social Care. York: Joseph Rowntree Foundation. http://www.jrf.org.uk/system/ files/consultation-law-commission-adult-care.pdf. Law Commission. 2008. Tenth programme of law reform. London: Law Commission (Law Com No 311). http://
lawcom mission.justice.gov.uk/docs/lc311_10th_ Programme.pdf. Law Commission. 2010. Adult social care: A consultation paper. London: Law Commission (Consultation Paper No 192). http://lawcommission.justice.gov.uk/docs/cp192_Adult_ Social_Care_consultation.pdf.
