Joint committee on the Human Tissue and Embryos (Draft) Bill

Joint committee on the Human Tissue and Embryos (Draft) Bill First Report

Chapter 6: part 2 of the draft bill—amendments of human fertilisation and embryology act 1990

130. Part 2 of the draft Bill contains a series of key definitions intended to define the parameters of both the regulator's remit and acceptable practice in embryology research and fertility treatment. These functional definitions are fundamental to the Government's approach to the regulatory architecture in the draft Bill. Similarly, our approach to definitions is guided by our approach to regulatory design set out in Chapter 4. Getting the definitions right is therefore a key challenge, summed up by Roger Brownsword, Professor of Law at King's College London: "you want the best of all possible worlds and people who want flexibility also want calculability and certainty in knowing where they stand as well as accountability—it is not straightforward." (Q 16)

131. Definitions can be drafted more or less restrictively, depending on whether the aim is to provide flexibility or legal certainty. Some witnesses favoured a more restrictive approach with a high degree of parliamentary control and less leeway for the regulator in terms of its remit and its scope for interpretation. (Ev79, para 3.2) Others, however, have argued that this approach places unacceptable fetters on the development of scientific research. (Ev17, para 3.2)

132. We have already recommended that the draft Bill should embrace the principle of 'devolved regulation'. This would require definitions to be broad enough to allow the regulator appropriate flexibility in the exercise of its regulatory functions, yet certain enough that both the regulator and the scientific community can be reasonably confident about the legal boundaries of their actions. We think this approach will be particularly useful where the future direction of research or treatment is unclear, so that the regulator has greater scope for granting or refusing licences for activities which had not been foreseen at the time the legislation was passed. We also favour a strong ethical framework, to be provided by Parliament, within which the regulator can operate.[75]

133. The draft Bill (clause 14) sets out a series of very broad definitions of embryos and gametes, which effectively set the scope of the regulator's authority. These concepts are then refined in a tiered approach for different purposes: there are "permitted embryos" and "permitted eggs and sperm", which are the only sort which may be placed in a woman; and "inter-species embryos" which are marked out for more stringent regulation. Professor Brownsword had twofold concerns about the general approach in the draft Bill: first, they did not map to scientific understandings of the defined concepts (he considered it important that definitions were understood by researchers and clinicians); and, second, the tiered approach was overly complex and apt to confuse. (Q 29) However, Hugh Whittall, Director of the Nuffield Council on Bioethics, thought the tiered approach was helpful in defining what did and did not fall within the definitions. He acknowledged, however, that this approach introduced complexity which could be problematic for practitioners unless the regulator could find a way to clearly present their effects. (Q 32) The HFEA and the HTA favoured the pragmatic, functional definitions in the draft Bill. (QQ 195, 198)

DEFINITIONS IN CLAUSES 14 AND 15

134. Clause 14 amends the definitions of "embryo", "eggs", "sperm" and "gametes", the practical effect of which would be to amend the existing definition of "embryo" so that the 1990 Act would apply to all live, human embryos, regardless of their manner of creation.[76] Therefore, "embryo" will mean a live human embryo, including an egg that is in the process of fertilisation or which is undergoing any other process capable of resulting in an embryo.

135. Some witnesses objected that the definition of "embryo" made no scientific sense or that it should be clarified. For example, Dr Dave Morroll, Chair of the Association of Clinical Embryologists, stated a preference for a distinction to be made between "eggs in the process of fertilisation and embryos that have undergone cleavage". (Q 391)[77] However, many witnesses supported the revised definition of "embryo".[78] Dr Mark Hamilton, Chair of the British Fertility Society, acknowledged that the end use of the entity was the most important aspect for regulatory purposes. (QQ 391, 393)

136. Clause 14 includes in the definition of "eggs", "sperm" and "gametes", not only mature eggs and sperm, but also "immature gametogenic cells, such as primary oocytes, and spermatocytes".[79] "Eggs" will include "cells of the female germ line at any stage of maturity", and "sperm" will include "cells of the male germ line at any stage of maturity" (clause 14(4)). Some concern was raised about the breadth of these definitions[80] and several witnesses argued that this would bring within the scope of regulation under the 1990 Act basic science projects on the development of germ cells which are not at present regulated by the HFEA and which, subject to consent, do not currently require an HTA licence.[81]

137. Clause 15 defines "nucleus" and clarifies that the definition includes the pronucleus. As with the other definitions, some witnesses welcomed this clarification while others objected that it made no scientific sense and the intention underlying the definition needed to be clarified.[82]

138. While we note the calls for clarification of some of these definitions, we agree with the HFEA that "It is essential that the definitions in the Act enable the regulator to regulate tissues with reproductive capacities whichever way they are created or derived … It is almost impossible to arrive at a scientifically acceptable definition of an embryo, for example, that avoids creating unintended exceptions or anomalies."(Ev12(a), para 22) We support the definitions in clauses 14 and 15 of the draft Bill and recommend that the detail in relation to how these definitions will be applied be left to the regulator.

SECRETARY OF STATE'S POWER TO EXTEND DEFINITIONS

139. Clause 14(5) provides that the Secretary of State may make regulations to extend in prescribed circumstances the definitions of "embryo", "eggs", "sperm" and "gametes", although he may not extend the definition to include anything containing non-human DNA. There is also a limited power in clause 16(5) for regulations to provide that eggs and embryos which have been treated to prevent the transmission of serious mitochondrial disease may be "permitted" (we comment on the provisions in clause 16 in more detail in paragraphs 179 to 189).

140. Some witnesses objected that developments in this particularly sensitive field of science should be a matter for Parliament alone and a regulation-making power should not be given to the Secretary of State.[83] Conversely, one witness argued that all such decisions should be left to the regulator. (Ev64, para 4.2) A significant number of witnesses, however, supported the approach in the draft Bill.[84] The House of Lords Delegated Powers and Regulatory Reform Committee advised us that:

"… the use of an affirmative procedure order to bring additional matters within the scope of an Act is well established. Since the power in this case may be used only in the light of developments in science or medicine, and cannot be used to apply the Act to items which could not reasonably be described as embryos, eggs, sperm or gametes, we do not consider the approach inappropriate."[85]

141. We note this advice and we support the provisions in clause 14(5) which provide a degree of flexibility for the regulatory regime.

Inter-species embryos

142. Clause 17 proposes a new section 4A to be inserted into the 1990 Act to introduce prohibitions in connection with genetic material not of human origin.[86] Clause 17(2) defines "inter-species embryo". This has been one of the most contentious issues in our inquiry and one in which many witnesses had opposing, deeply-held views. The net effect of new section 4A is that an inter-species embryo may only be created, kept and used under licence, subject to the 14-day rule (see below) and may not be placed either in a woman or in an animal. There is no question of an inter-species embryo being allowed to develop past the 14-day stage. We have set out the main provisions below:

(1) Section 4A(1) provides that only a human embryo and human gametes may be placed in a woman. Any other types of embryo or gametes, including inter-species embryos, are specifically prohibited from being placed in a woman.

(2) Section 4A(2) prohibits the mixing of human and animal gametes and the creation, keeping or use of inter-species embryos except in pursuance of a licence.

(3) Section 4A(3) provides that an inter-species embryo, created under licence, may not be kept or used after the earliest of:

(a) the appearance of the primitive streak;

(b) 14 days from the beginning of the process of creation; or

(This provision is sometimes referred to as the '14-day rule', 14 days being the longest possible period that such an entity may be kept and used.)

(4) Section 4A(4) provides that an inter-species embryo may not be placed in an animal.

(5) Section 4A(5) defines an inter-species embryo as follows:

(a) an embryo created by using human gametes and the gametes of an animal, ('true' hybrid)

(b) an embryo created by replacing the nucleus of an animal egg or a cell derived from an animal embryo with a human cell or the nucleus of a human cell (cytoplasmic hybrid or cybrid)

(c) a human embryo that has been altered by the introduction of any sequence of nuclear or mitochondrial DNA of an animal (human transgenic embryo)

(d) a human embryo that has been altered by the introduction of one or more animal cells (human-animal chimera) or

(e) any other embryo that contains both—

(i) any haploid set of human chromosomes, and

(ii) any haploid set of animal chromosomes or any other sequence of nuclear or mitochondrial DNA of an animal (the 'catch-all' provision).

143. In line with the definitions in clause 14, section 4A(7) states that "embryo" means a live embryo, including an egg in the process of fertilisation, and section 4A(8) defines eggs, sperm and gametes as live eggs or sperm, including cells of the female or male germ line at any stage of maturity.

144. The approach to the definition of inter-species embryos is different from the approach to definitions in clauses 14 and 15. Rather than a single, wide definition the Government has chosen to list the known methods of creating the entity in question (subsections (a) to (d)) and to add the 'catch-all' in subsection (e).

GENERAL POINTS ON INTER-SPECIES EMBRYOS

145. We have received a significant quantity of evidence on inter-species embryos and we recognise the strongly-held views. It is largely the case that those in favour of the inter-species embryo provisions support the scientific potential of such research, and those against see them as ethically ambiguous or wrong. We have sought in our deliberations to respect these views and find a balanced approach.

146. We heard from many witnesses who were opposed entirely to the provisions in clause 17. Some noted that inter-species entities were banned in other countries.[87] Most witnesses who opposed inter-species embryos did so on one (or more) of the following grounds: the moral status of the embryo; crossing the species barrier; and the lack of scientific merit of such research.

147. Most of those who attended the evening forum were opposed to inter-species embryos on the basis of the moral status of the embryo. For example, Paul Tully, General Secretary of the Society for the Protection of Unborn Children (SPUC), argued that it was precisely because the moral status of the resulting entity was not known that his organisation objected to the creation of 'true' hybrids. The Rt Revd Dr Lee Rayfield, Bishop of Swindon, and representative of the Church of England Mission and Public Affairs Council, thought that the Church of England would probably view them as genetically disabled human beings. Dr Donald Bruce, Director of the Church of Scotland Science, Religion and Technology Project, thought that the fact of its non-viability may itself be morally objectionable.[88]

148. Søren Holm, Professorial Fellow on Bioethics at Cardiff Law School, and Professor of Medical Ethics at the University of Oslo, told us that, in his view, all inter-species embryos were equally problematic for the reason that they cross the species boundary. This view was supported by many others.[89] For example, Donald Fleming told us "This is unethical research: the more the species barrier is crossed, the less clear cut will become the definition of being human. The mixing of human and animal would challenge the very concept of being entirely human. The unnatural entities created will be less human than fully human embryos and natural boundaries will be violated." (Ev1, para 4b)

149. Reservations were also expressed that the scientific rationale for the creation and use of interspecies embryos was flawed. Several witnesses thought that an inter-species embryo could never form a suitable model for human disease and treatment because of its mixed genes and that its creation and use should be prohibited on the basis that it could perform no scientifically useful function.[90]

150. However, we also heard from a large number of witnesses who supported the licensing of inter-species embryos.[91] Some witnesses argued that the creation and use of inter-species embryos are essential, both to compensate for the shortage of human eggs and embryos donated for research and to avoid the potential harm caused to the women and families who donate them.[92] This claim goes hand in hand with the argument that genuinely useful scientific developments are likely to arise out of research using inter-species embryos. (Q 782)

151. Furthermore, Professor Colin Blakemore, Chief Executive Officer of the Medical Research Council, argued that there was no evidence of the public revulsion asserted by some. He highlighted a recent survey in which 70% of the public were found to be supportive of inter-species embryos and noted that there has been no real outcry in the press against the practice. (Q 39) This view was echoed by Mr Fergus Walsh, Medical Correspondent for the BBC, who was "not sure the public is really staying up late worrying about it". (Q 331)

GOVERNMENT POLICY

152. The Government's changes in policy in this area have not been helpful in trying to find the right balance. In its December 2006 White Paper, the Government stated that the creation of inter-species embryos in vitro would be prohibited, but that a regulation-making power would allow Parliament to agree exceptions to that prohibition for research purposes.[93] This is the policy reflected in the text of the draft Bill.

153. Following the White Paper, the Commons Science and Technology Select Committee published a report recommending that legislation should be permissive and provide that "in general, the creation of all types of human-animal chimera or hybrid embryos should be allowed for research purposes" under licence by the regulator. The intention was that 'pure hybrids' should be included in the licensing regime.[94]

154. On publication of the draft Bill in May 2007, the Government announced its intention to accept, in part, the Science and Technology Committee's recommendation and allow in legislation, under licence, the categories of inter-species embryo described in section 4A(5)(b) to (d).[95] 'True' hybrids and entities falling within the 'catch-all' provision would remain proscribed unless permitted by regulations made by the Secretary of State.[96] The Government confirmed this policy to us in a letter dated 12 June (see Appendix 9). Given the time available for our inquiry, the level of uncertainty about the Government's position has been extremely unhelpful.

155. From the evidence received, we have identified three particular issues which we cover in turn below. The first issue relates to the rationale for treating 'true' hybrids differently from those entities falling within categories (b) to (d). The second issue arises from the 'catch-all' provision. Related to this is a third issue of the regulatory 'gap' between clause 17(2) of the draft Bill and the Animals (Scientific Procedures) Act 1986.

SECTION 4A(5)(A): 'TRUE' HYBRIDS

156. A significant number of witnesses told us they did not understand in principle why a distinction is being made between 'true' hybrids and other categories of inter-species embryos.[97] For example, Dr Vivienne Nathanson, Director of Professional Activities at the British Medical Association (BMA) stated that she could "see no sense" in the exclusion of true hybrids. (Q 95) On a different basis, Professor Holm argued that there is no qualitative difference to be found between 'true' hybrids and other inter-species embryos, because the creation of all types of inter-species embryo is equally objectionable on ethical grounds. (Q 854)

157. We asked the Chief Medical Officer, Sir Liam Donaldson, to clarify the distinction between a cytoplasmic hybrid and a 'true' hybrid. He told us "The process involved and the resulting entity is very different in character to the first. I am surprised that you cannot see that. I think the outside world would see a big distinction." (Q 249) He also sought to explain the rationale for treating 'true' hybrids separately from other types of inter-species embryos. He argued that there was no clear scientific benefit to be derived from 'true' hybrids and that this would constitute a "step too far as far as the public are concerned". (Q 244) He further argued that scientific development should not forge ahead of public opinion to this extent in the absence of strong, scientific imperatives. (Q 244) Surprisingly, Sir Liam Donaldson gave no evidence of how he had ascertained the state of public opinion.

158. We put to the Minister the argument presented to us, that once researchers have "crossed the species barrier" there is no valid distinction to be made between an entity that is 99% human and an entity that is only 50% human and that it would be nonsensical to accord greater protection to the latter via a ban on research use. The Minister rejected this argument. (Q 555) She told us that the decision to ban 'true' hybrids for the time being was pragmatic, on the basis that there was currently no call for research using 'true' hybrids. She thought that Parliament should be given the opportunity to discuss the issue at a later date, rather than now permitting on the face of the draft Bill research in an area which was, as yet, largely unknown. (QQ 556, 566) She also argued that public opinion was a concern and that, although policy-making should not be a hostage to public opinion, it was nevertheless important to give reassurance that there was a purpose to the research which was being allowed. (Q 567) We are not persuaded by this evidence.

159. In addition, several witnesses noted the so-called 'hamster test', in which human sperm are mixed with hamster eggs to test the health and motility of the human sperm. This is well established and explicitly endorsed in paragraph 6 of Schedule 2 to the draft Bill.[98] They argued that, if the hamster test is allowed, there should be no problem allowing other types of inter-species entity to be created (subject to the 14-day rule and prohibition on implantation). Although it was noted that there is currently no research demand for the creation and use of 'true' hybrids (other than for the hamster test), they did not rule out their usefulness in future.[99]

160. The Government sought to explain the difference in principle between a hamster-human 'true' hybrid, which is destroyed at the two cell stage, and any other sort of 'true' hybrid, which would, in any event, be destroyed by the 14-day stage at the latest. Mr Ted Webb, Director of Scientific Development and Bioethics at the Department of Health, described the hamster test as an exemption from the general rule that 'true' hybrids would be banned (Q 252) and on another occasion he stated simply that the draft Bill makes the distinction and that the hamster test is used for a very specific purpose. (QQ 559-561)

161. We consider that the Government's approach on this issue is misguided and rests on no sound point of principle. We can see no clear reason why certain categories of inter-species embryo should be permitted under licence and 'true' hybrids proscribed. We recommend that the HFEA should be left to judge which entities may be created, kept and used for research purposes under licence.

SECTION 4A(5)(E): THE 'CATCH-ALL' PROVISION AND THE REGULATORY GAP

162. The Government's approach to defining inter-species embryos has caused us much difficulty, in particular the 'catch-all' provision in subsection (e) and this is reflected in the number of submissions we have received. The Government's intention is that the 'catch-all' will bring within the regulatory regime new types of inter-species embryo which may emerge in the future and it has been explicit that this is only intended to catch entities which are at least 50% human, but which have been created using a process other than fertilisation.[100] This has given rise to two issues. The first is the meaning of subsection (e) itself. We have received an overwhelming body of evidence that its meaning and effect are unacceptably unclear.[101] For example, Professor Blakemore said that the Medical Research Council had pored over this provision and "decided that we are all incompetent" because none of them could understand what subsection (e) meant. (Q 25) We see this as a fundamental flaw in the Government's approach to the definition of inter-species embryos.

163. The second issue centres on the human-animal boundary and which entities should be regulated as human embryos and which should be regulated under the Animals (Scientific Procedures) Act 1986. We have received a lot of evidence suggesting that there is no principle, as such, which underpins the Government's choice of 50% as a cut-off point for whether an entity is sufficiently human to merit regulation by the HFEA, or whether it is more appropriately regulated as an animal by the Home Office. The 50% rule intended to be embodied in subsection (e) is essentially an arbitrary attempt to draw a line between what qualifies as human and what as animal.

164. We heard evidence arguing that the issue as to what proportion of the entity is human and what proportion is animal is not clear-cut. For example, Professor Martin Bobrow, Chair of the Academy of Medical Sciences working party on interspecies embryos, told us that what makes an entity human rather than animal is not easily measured in DNA terms, although, if a line in the sand had to be drawn, he saw no reason why it should not be drawn at 50%. (Q 936) Professor Sir Richard Gardner, Edward Penley Abraham Research Professor of the Royal Society in the University of Oxford, raised the more technical issue of what the 50% actually refers to—for example, when calculating the relative quantities of mitochondrial DNA (which may come from a cow egg) against quantities of nuclear DNA (which may come from a human skin cell), different answers would result according to whether you measured the mass or the number of genes. (Q 791) Dr Robin Lovell-Badge, Head of the Division of Stem Cell Biology and Developmental Genetics at the Medical Research Council National Institute for Medical Research, explained to us that:

"… it is very hard to come up with any strict definition saying this is 50 per cent human and 50 per cent animal, therefore it falls into this category rather than this one, because things change ... You may start off with an embryo which is 20 per cent human and end up with something which is 60 per cent human or vice versa." (Q 621)

165. This raised the third issue of the interface between the regulatory regime for human embryos and that for animals. The issue arises out of the boundaries between the 1990 Act, as amended by clause 17(2) of the draft Bill, and the Animals (Scientific Procedures) Act 1986. The 1986 Act regulates "protected animals" which are defined in section 1 as any living vertebrate other than man from the time when half the gestation or incubation period for the relevant species has elapsed. However, subsection 4A(3)(c) of the 1990 Act, as amended by the draft Bill, would only allow development of inter-species entities to the earlier of the 14-day stage; the appearance of the primitive streak; or the time when half the gestation or incubation period for any species whose DNA is contained in the embryo has elapsed. The intention behind section 4A(3)(c) is to avoid conflict with the Animals (Scientific Procedures) Act 1986 in cases where half the gestation period for the relevant species is less than 14 days.

166. We note the potential problems this could cause for researchers who may wish to take a mouse-human cytoplasmic hybrid, for example, to the 14 day stage, since the half-way point for the gestation of a mouse is around nine days. (Ev84, para 3) Professor Bobrow explained the effect of subsection 4A(3)(c):

"If you have a human embryo with some mouse DNA, it cannot be carried beyond in that case nine and a half days, half of the mouse's gestational age. There is a tighter restriction on that than on a fully human embryo. It is my understanding that the only rationale for blocking this group of experiments between nine and a half and 14 days is the administrative inconvenience of having to coordinate two regulatory regimes which is not to me a very persuasive argument." (Q 940)

167. We are concerned that section 4A(3)(c) as it stands would have the potential to prevent useful, and possibly established, research from being carried out, as Professor Bobrow explains. This problem contributes to the reasoning behind our recommendation on an alternative approach to defining inter-species embryos in paragraphs 174 to 176.

168. We recognise that the 'catch-all' in subsection 4A(5)(e) is at least partly motivated by the practical desire not to include in the regulatory regime for tissue and embryos entities which should more properly be considered as animals and, therefore, subject to regulation by the Home Office under the 1986 Act. Mr Ted Webb told us that the Department was working with the Home Office to ensure that the relevant legislation was consistent. (Q 530) As currently drafted, anything that did not fall into categories (a) to (d) and was less than 50% human would remain outside the remit of the regulator and if the entity was not placed in an animal, it would not fall within the regulatory remit of the Home Office until it reached the time at which half its gestation period has elapsed.

169. We acknowledge that, even outside the regulatory framework, researchers would need to gain approval for any work of this type from the Local Research Ethics Committees. (Ev62, para 8(b)(i)) However, we remain concerned that there is a category of entities which would not be regulated under either the draft Bill or the 1986 Act. We note evidence from the Academy of Medical Sciences that "regulatory questions will increasingly arise from research involving non-human embryos and animals incorporating human material … we consider that the interface between the regulatory regimes governing human embryos, human embryonic stem cells and animal research will become increasingly important. (Ev84, para 3) It is therefore important that a solution to this problem is found before the Bill is presented to Parliament.

A WAY FORWARD WITH DEFINITIONS

170. There is a large degree of agreement that subsections 4A(5)(a) to (d) are clear definitions. However, we note the significant issues raised in relation to the 'catch-all' definition proposed in the draft Bill and we have sought to find an alternative approach.

171. Some witnesses supported discretion for the regulator to interpret definitions in particular circumstances. For example, the HFEA told us they would prefer that the regulator should be left to take decisions about what constitutes an 'inter-species embryo' rather than introducing confusion into the Act in the form of an unclear 'catch-all' definition. (Ev12(a), on clause 17(2))

172. Many more witnesses, including the BMA, the Royal College of Obstetricians and Gynaecologists and the Wellcome Trust and MRC, favoured an approach where section 4A(a) to (d) remained but the 'catch-all' would be replaced by a regulation-making power for the Secretary of State to extend this definition if, in the future, clear proposals for research falling outside the existing definition were presented.[102] This approach would also seem to satisfy Professor Sir Ian Kennedy's three tests:

"For the purposes of the regulator what there has to be is first of all clarity; secondly, some degree of collective agreement around whatever is clearly being expressed; and, thirdly, some capacity to have a process of negotiation if some challenge to that definition which previously was deemed to be clear appears, warranting some further form of words ..."(Q 775)

173. We consider the Government's approach to the definitions of inter-species embryos to be wholly unsatisfactory, particularly in respect of the 'catch-all' definition in subsection (e)—a definition that none of our witnesses was able to explain to us. We also reject the approach proposed by the BMA and others that the 'catch-all' in subsection (e) should be replaced by a regulation-making power for the Secretary of State to extend definitions of inter-species embryos if, in the future, proposals for research falling outside the existing definition were presented. It is entirely unsatisfactory to have an area of regulation as important as this defined by Ministerial Order.

174. While taking evidence, we sought views on an alternative approach in which section 4A as a whole would be replaced with a single, overarching definition of an inter-species embryo. We sought evidence from several witnesses on this approach and there was little opposition to the concept of a single, broad definition per se.[103] Mr Ted Webb agreed that this approach had the merit of simplicity, but objected that it would encroach on "Home Office territory". (QQ 532-533)

175. In the time available, we have clearly not been able to provide a final definition, but what we propose below is a starting point to illustrate our thinking. We have sought advice from several witnesses, including Professor Bobrow, on the proposed definition, and their feedback has been very useful.[104] We recognise that further work would be required to amend this draft to deal with certain problems that it entails, for example, the definition would catch some entities that are not appropriate for regulation by the HFEA. There may also be the potential for regulatory overlap with the Home Office. However, we believe these problems are not insurmountable. Above all, it is important to have a definition that is clear and understandable to everyone.

176. With the caveats above, we set out our thinking in Box 1 so the Government is clear about our intention.

BOX 1
Inter-species embryo: working definition

"An inter-species embryo is an embryo which—

(a) contains genetic material of human and animal origin, and

(b) in which the genetic material of human origin consists of at least a complete haploid set of human chromosomes in one or more cells."

In this definition genetic material means DNA in a form capable of being expressed, mutated and replicated heritably (i.e. genes).

OVERALL CONCLUSION ON INTER-SPECIES EMBRYOS

177. As set out above, we have had evidence of strongly held views in favour of and against inter-species embryos. We recognise that this is a very sensitive area. Indeed, this sensitivity was reflected in our own discussions. Some members of the Committee hold strong reservations about the creation of inter-species embryos while others are supportive of this area of research; and we have been unable to reach a consensus on this point. We note that, when what is now the 1990 Act was before Parliament, the issue of embryo research was put to a free vote. We consider that the creation and use of inter-species embryos for research purposes is a comparable issue, and we recommend that the issue is put to a free vote in both Houses.

178. If Parliament supports the provisions regulating inter-species embryo research, we would make the following further recommendation. In line with our recommendation supporting an architecture of 'permitted regulation', we recommend that the Government should revisit its approach to the definition of inter-species embryos in the draft Bill with a view to providing a general definition along the lines of the approach set out in paragraph 176, with authority given to the regulator to interpret and apply that definition to individual research applications, based on the principles set out in legislation; statutory authority to exempt areas of research from the licensing provisions where appropriate; and with a statutory power for the Secretary of State to make regulations, only on the application of the regulator, to make provisions in respect of a particular research application.

Prohibitions in respect of embryos and mitochondrial DNA from two women (artificial gametes)

179. Clause 16(2) introduces the new concept of "permitted" eggs, sperm and embryos, which are the only entities which may be placed in a woman. This is the mechanism used in the draft Bill to distinguish those practices in relation to gametes and embryos which are licensable for research purposes and those practices which are licensable for treatment purposes. The definitions of "permitted egg", "permitted sperm" and "permitted embryo" are given in clause 16(5), new section 3ZA(2) to (4). These definitions prohibit in each case the alteration of nuclear or mitochondrial DNA. The combined effect of these provisions is a prohibition on placing in a woman artificial gametes, genetically modified gametes, genetically modified embryos and embryos created by cloning.

180. Clause 16(5) also introduces a new section 3ZA(5) which confers on the Secretary of State a power to make regulations (subject to affirmative resolution) to extend the definition of "permitted embryos" and "permitted eggs" to include an embryo or egg which "has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease". As a result of the other provisions in clause 16, subsection (6) repeals the Human Reproductive Cloning Act 2001.

181. Because other provisions in the 1990 Act, as amended by the draft Bill, assume that only one woman's egg would be used to produce a child, clause 34 is necessary in order to make regulations (by affirmative procedure) to effect certain consequential amendments. Examples of provisions requiring amendment include the registration of donor information (section 31); the ability of donor-conceived individuals to request information about their genetic parentage (clause 32, new section 31ZA); and the provision of information about donor-conceived genetic siblings (clause 32, new section 31ZD).[105]

182. The evidence we have received on the combined effect of clauses 16 and 34 has been divided. On the one hand, the Royal College of Pathologists argued that there was no reason why regulations should not ultimately permit the practice of mitochondrial donation, subject to verification of its safety.[106] Another witness went further and argued for a range of artificial gametes to be allowed in order that research should not be inhibited. (Ev67, para 2)

183. However, other witnesses objected to the provisions, not least because of a lack of clarity in the explanation about the underlying intention and anticipated effect. Concern principally centred on two issues. First, some witnesses' concern stemmed from their interpretation of the provisions as providing for the possibility that, subject to regulations, an embryo could be created from the genetic material of two women, without the need for fertilisation by a male sperm. They argued that a child having two biological mothers and no biological father was likely to become confused about its identity.[107] One witness considered this technology to be an "abuse" and considered the ethical concerns to be strong enough that further debate would be needed in Parliament when the need arises. (Ev26, paras 17, 19)

184. While we understand these concerns—and we too have found the provisions of the draft Bill extremely difficult to understand—we do not believe that the draft Bill would have this effect. There remains a continuing requirement in subsection (5) (new section 3ZA(4)(a)) for a "permitted embryo" (one which may be placed in a woman) to be fertilised by "permitted sperm". "Permitted sperm" must be "produced by or extracted from the testes of a man" and the Secretary of State has no power to extend the definition of "permitted sperm" to include any alteration of its nuclear or mitochondrial DNA. Our understanding is that, even if scientific development were such that the ability existed to create an embryo from the genetic material of two women, the draft Bill would not allow an embryo so created to be placed in a woman.

185. In our deliberations, we considered the case of a child created using the mitochondrial donation procedure under new section 3ZA(5) and whether it might be said to have three parents: two female and one male. We suspect that the Government's intention in this respect is that the child should have only two registered parents—those whose nuclear DNA was used to create the embryo—but that the child should be able to discover the identity of the female donor of mitochondrial DNA from the Register of information in the same way as other donor-conceived individuals. This is not entirely clear from the draft Bill and Explanatory Notes, although the Department of Health did provide further information on this point in a memorandum to the House of Lords Delegated Powers and Regulatory Reform Committee. This memorandum suggests that the power in clause 34 might, for example, be used to clarify that the woman who donated the egg with healthy mitochondria could not apply for a parental order on the basis that she only contributed mitochondrial, not nuclear, DNA to the embryo.[108]

186. We therefore recommend that the Explanatory Notes to the draft Bill be revised to make clear and explicit that a "permitted embryo" cannot be created from the genetic material of two women alone and that, in the case of mitochondrial donation, the child will essentially have only two parents, one male and one female. We also recommend that the Government gives an ongoing commitment that, if the technology became available to create an embryo only from the genetic material of two women without the need for fertilisation by a sperm, any question of whether such an embryo should be allowed to be inserted into a woman should be a matter for Parliament to decide.

187. The second concern raised by witnesses was that substituting the Human Reproductive Cloning Act 2001 with clause 16 would create a loophole that would legalise human reproductive cloning.[109]Again, we do not consider this to be the case because the definitions of "permitted" egg, sperm and embryo, which are the only entities allowed to be placed in a woman, preclude this possibility. Simply put, a cloned embryo would not qualify as a "permitted embryo" for the purposes of clause 16 and, therefore, could not legally be placed in a woman.

188. We therefore recommend that the Explanatory Notes to the draft Bill be revised to make clear and explicit that a cloned embryo cannot be a "permitted embryo" and we also recommend that the Government gives an ongoing commitment that any question of amending these provisions should be a matter for Parliament to decide.

189. Returning to the actual effect of the provisions, given that any regulations under clauses 16 and 34 must be passed subject to the affirmative procedure, we are satisfied that this will provide sufficient opportunity for parliamentary scrutiny should genetic modification to prevent serious mitochondrial disease be considered safe in the future.

Clause 18 and Schedule 2: Licensable activities

190. Clause 18 provides that the activities which may be licensed under the 1990 Act, as amended, are listed in Schedule 2. The Schedule starts with some amendments to the existing provisions for treatment licences (paragraph 2). Paragraph 3 inserts new provisions for embryo testing and sex-selection, including a power to amend these provisions by regulations. Some amendments are made in paragraph 4 to existing provisions on licences for non-medical fertility services introduced as a result of the EU Directive on tissue and cells. Paragraph 5 inserts a new provision allowing for regulations to be passed to permit storage of inter-species embryos, although this draft provision will likely be amended in the light of the Government's change of policy on inter-species embryos. Finally, new provisions on research licences are set out in paragraph 6.

191. We have not had sufficient time in this inquiry to consider in detail all of these provisions. Nevertheless, we have concentrated on a few, important issues, namely embryo testing under paragraph 3 and research licences under paragraph 6. Our findings on these issues are set out below.

EMBRYO TESTING

192. The HFEA currently has a wide discretion to make licensing decisions in relation to embryo testing of various sorts. The draft Bill introduces specific provisions which set out the framework for licensing embryo testing, including the selection of 'saviour siblings' and the cases in which sex-selection may be permitted.

193. Paragraph 3 of Schedule 2 of the draft Bill inserts new paragraph 1ZA which makes provision in relation to embryo testing. Under paragraph 1ZA(1), a licence may not authorise embryo testing except for one or more of five listed purposes. These purposes include testing for gene, chromosome (including X or Y chromosome) or mitochondrion abnormality which may affect capacity to result in a live birth or result in a serious medical condition; testing to select a 'saviour sibling' where the existing sibling suffers from a life-threatening medical condition which could be treated by umbilical cord blood stem cells; and testing whether a given embryo was created from the gametes of a particular person. New paragraph 1ZA(3) sets out the tests for considering whether the issue of a treatment licence is necessary or desirable under paragraph 1(3) of Schedule 2 of the 1990 Act. New paragraph 1ZA(4) sets out further considerations for which the regulator must have regard when taking a decision to issue a licence to test for a 'saviour sibling'.

194. We have received evidence on the subject of embryo testing generally, and in particular regarding the use of the technique of pre-implantation genetic diagnosis (PGD). Opinions on both sides of this debate are strong and we recognise the profound objection expressed by some witnesses to the idea of any type of embryo testing. However, whilst embryo testing techniques, although perhaps not widespread, are reasonably well established, we will not discuss further in this report whether or not the Government should retreat from the status quo and move to proscribe such practices.

195. We recognise that embryo testing is an issue of considerable sensitivity for some. However, on balance, we support the provisions set out in the draft Bill. We will, however, consider in more detail the evidence we have received in relation to 'saviour siblings' and sex selection.

TISSUE TYPING AND 'SAVIOUR SIBLINGS'

196. Where an existing child suffers from a life-threatening medical condition which could be treated by umbilical cord blood stem cells, new paragraph 1ZA(1)(d) permits as a licensable activity testing to select a sibling with a suitable tissue type to enable treatment of the existing child. For this reason, the child selected is often known as a 'saviour sibling'. The additional safeguards in section 1ZA(4) require the regulator, before granting the licence, to have regard to any alternative sources of tissue which may be or become available for treating the child; and the likely long-term effect of awareness of the testing on any child who results from the embryo testing. We are not convinced that the likely long-term effects on the resulting child are easily ascertained, as the draft Bill requires.

197. As with other types of embryo testing, the evidence on this issue, although not particularly plentiful, has been split. Some people regard the selection of saviour siblings in the same light as all embryo testing and are fundamentally opposed to the practice. (Ev72, para 3) It has been argued that the practice of tissue typing raises serious ethical problems, because a child is viewed not as a gift, but as a source of biological material. (Ev97)

198. Others have argued that the new provisions are actually too restrictive. The HFEA has expressed concern that the requirement that the existing child suffers from a life-threatening condition capable of treatment by umbilical cord blood stem cells is more restrictive than the current regime and would prevent the selection of a sibling who would be able to provide bone marrow, for example. The HFEA considers that this requirement would be difficult to enforce and would restrict its capacity to respond appropriately to individual cases. (Ev12(a) Appendix A) Professor Sally Sheldon, from the Kent Law School at the University of Kent, and Professor Stephen Wilkinson, from the Centre for Professional Ethics at Keele University School of Law, have agreed with the HFEA's view. They did not understand the restriction to "life-threatening medical conditions" and suggested that the provision should be expanded to include "serious" medical conditions. They and others noted further that the requirement that the condition be capable of treatment by umbilical cord blood stem cells would not necessarily prevent the resulting child from being used as a tissue or organ donor at a later stage in life.[110] However, we also note that the issue of donation subsequent to birth is not within the remit of the HFEA and is covered by common law. Although the regulator must take into account the likely long-term effect of awareness of testing for tissue type on the resulting child, it has been suggested that the safeguards for that child's welfare should be strengthened further.[111]

199. We recognise that this is a delicate area. However, given the Government's apparent acceptance of the principle of selecting for 'saviour siblings' we do not understand why the practice is limited to "life-threatening" conditions capable of treatment using umbilical cord blood stem cells. We recommend that the draft Bill be amended to substitute "serious" for "life-threatening".

SEX SELECTION

200. The HFEA currently permits sex selection of embryos only for medical reasons. Schedule 2, paragraph 3, of the draft Bill would permit under licence sex selection of embryos, by embryo testing or other practices, but only to avoid a significant risk that the resulting child will have or develop a serious medical condition. New paragraph 1ZC introduces a power for the Secretary of State to make regulations to amend the provisions on embryo testing, but the provisions on sex selection may only be amended on grounds relating to the health of the child.

201. In evidence, we explored the possibility of widening the scope for sex selection for non-medical reasons beyond that permitted by the draft Bill, in particular for family balancing. Some witnesses were entirely opposed to sex selection, even for medical reasons, on ethical grounds.[112] At the other extreme, witnesses have argued that there is no evidence that demonstrable harm would result from a policy allowing sex selection for non-medical reasons, for example, family balancing. Professor Brownsword thought that it was essentially a matter of human rights and reproductive autonomy. (Q 45) The British Fertility Society told us "We have seen no convincing evidence of harm from sex selection in the UK, and do not believe that there is likely to be enormous uptake of this kind of service." (Ev23, para G) The organisation Antenatal Results and Choices argued that "fears about women or couples en masse seeking [Pre-implantation Genetic Diagnosis[113]] to try to secure a 'designer baby' are unwarranted" and favoured allowing sex selection for non-medical reasons, subject to regulation, to benefit a relatively small number of parents, who could make an informed choice together with clinicians.

202. The majority of witnesses, including the BMA and the Royal College of Obstetricians and Gynaecologists, were in favour of sex selection as long as it was only for medical reasons.[114] Some thought that to go further than this would amount to the UK setting a bad example on the international stage.[115] For example, the Royal College of Obstetricians and Gynaecologists, who have members and fellows throughout the world, told us "If we came out in support of sex selection this would send a very clear message saying, 'Whatever means you wish to select for boys or girls is okay', so that is a very difficult message to send out." (Q 126) It was also argued that it would place a value on gender which some considered undesirable. (Q 43; Ev8, para 4)

203. The HFEA told us that their public consultation carried out in 1993 showed that participants were overwhelmingly against sex selection for social reasons. A further review exercise, starting in 2002, considered sex selection from social, ethical, scientific, technical, legal and regulatory perspectives. (Ev12(a), Appendix B, paras 1 and 3) They told us that the results of the 2002 review once again demonstrated that, in general, participants were tolerant of sex selection for medical reasons, but were generally opposed if it were to be used for social reasons. In coming to a policy decision based on the review, the HFEA noted that widespread public hostility to a policy allowing sex selection for non-medical reasons would not necessarily show that that policy was wrong. However, the HFEA concluded that the likely benefits of permitting sex selection for non-medical reasons were not substantial enough to merit a policy going against public opinion in this case. The HFEA therefore recommended that sex selection for non-medical reasons should not be permitted. (Ev12(a), Appendix B, para 32)

204. The HFEA contrasted its current policy, that sex selection is not permitted for non-medical reasons, with the approach in the draft Bill, under which sex selection is only permitted for reasons connected with the health of the child. The HFEA argued that the wording of the draft Bill effects a more restrictive approach than the HFEA's current policy, and that this may lead to future problems. It gave as an example conditions which correlate with sex but are not X-linked, such as autism—the draft Bill would bind the regulator's hands if tests for non X-linked conditions became possible in the future. (Ev12(a) Appendix A)

205. We recognise that there are finely balanced arguments on either side. Although we have heard some arguments in favour of sex selection for non-medical reasons and in some circumstances we recognise that it may not do harm, on balance we recommend that the draft Bill be amended in line with the HFEA's current policy.

RESEARCH LICENCES

206. Paragraph 6 of Schedule 2 extends the list of purposes for which a research licence may be granted. These provisions make significant changes to the current arrangements. First, new paragraphs 3A(1)(a) and (b), inserted by the draft Bill into Schedule 2 of the 1990 Act, extend the existing arrangements to cover "serious medical conditions" as well as "serious disease" so that, for example, research into neural trauma, which is not a disease as such, would be permitted. Second, new paragraph 3A(1)(b) allows for the licensing of research "which may be capable of being applied" to increase knowledge or develop treatments for serious medical conditions. This is intended to allow fundamental research which, while not specific to any disease or condition, nevertheless could lead to better understanding of fundamental phenomena on which more specific future research into serious disease or conditions may be based.[116]

207. We received limited evidence about this extension of licensable research purposes. The HFEA welcomed the widening of the research purposes, and told us the current system had worked well by providing a strong framework for case-by-case decision making, thus enhancing public confidence. (Ev12(a), paras 27-28) The MRC welcomed the strong guidance and saw this as a valuable mechanism for Parliament to make clear its intentions. (Ev9, para 8) Others have welcomed the clarification that fundamental, as well as applied, research is licensable.[117] We consider the clarity of the conditions on research licenses might be focussed by expanding on the two tests that the MRC uses for assessing applications for financial assistance, namely how important the questions, or gaps in knowledge, are that are being addressed, and what the prospects are for good scientific progress.

208. In the light of this evidence, we consider the extensions to the existing research purposes to be sensible and we therefore support these provisions.

209. Another issue arose from the provisions on research licences. Paragraph 3(4) of the 1990 Act currently prohibits the altering of the genetic structure of a cell of an embryo unless this is specifically permitted in regulations. No such regulations have ever been made. The draft Bill omits this prohibition from the section on research licences, so that genetic modification of embryos may now be permitted for research purposes under licence.[118]

210. Some witnesses saw this as a move to open the door to genetic engineering. For example, we were told that the "Government may not have fully appreciated the far-reaching consequences of such a decision" and that it raised concerns about eugenics. (Ev56, section 2) The Church of England Mission and Public Affairs Council saw this as "a dangerous and unwarranted change". They noted that scientists were not calling for such research to be permitted and said they are "at a loss to know why the Government would countenance such an action". (Ev68, para 19(i))

211. In its White Paper, the Government made clear its continuing opposition to genetic modification for treatment purposes, but stated that the need to proscribe genetic modification for research purposes was less clear.[119] Such research would, in any event, be required to meet the statutory research purposes and any additional licence conditions which may be imposed by the regulator.

212. There is clearly some confusion surrounding the Government's decision to omit from the draft Bill the current provision which prohibits the genetic modification of embryos for research purposes. We make no determination on this point but we recommend that the Government clarifies its policy decision to allay the concerns which have been expressed.

Consent to storage and use of gametes and embryos

213. Schedule 3 to the draft Bill adds a requirement to the 1990 Act that written consent must be signed by the consenting person in relation to the storage or use of gametes and embryos. Provision is made for those unable to give consent in writing through physical incapacity, such as quadriplegia, to direct another to sign on their behalf in the presence of a witness. Paragraph 5 introduces a "cooling off period" in cases where consent to storage and use of gametes and embryos is being withdrawn. Paragraph 8 of Schedule 3 also provides for storage of gametes in cases where a person is unable to give written consent or unable to consent at all, either through incapacity or, in the case of a child, a lack of competence. We have had evidence in relation to two aspects of these provisions

214. We have received evidence, first, about the 'cooling off' period which applies when consent has been withdrawn; and, second, in relation to cases in which storage of gametes can occur without consent. The draft Bill provides that notice of withdrawal of consent to storage and/or use of gametes or embryos must also be made in writing and signed by the person withdrawing consent. Notice served on the establishment storing or keeping gametes will result in those gametes being allowed to perish. In the case of embryos, paragraph 5 is intended to provide a 12 month "cooling off period" during which the parties can attempt to resolve any differences between them, either privately or through the courts.

215. The BMA welcomed this provision. (Ev07, para 13) The HFEA also supported a cooling off period, but were concerned that the provision as currently drafted would not distinguish between, on the one hand, cases where the embryo is created with the gametes of two partners and, on the other hand, cases where the embryo is created with one or more donor gametes. For example, where an embryo has been created using a woman's (W) egg and donor sperm, the current provision would suggest that, if W gave notice to the clinic that she no longer consented to the storage of that embryo, the clinic would be required to notify the donor and keep the embryo for a year, unless the donor gave his consent to its destruction before that time. The HFEA did not think that this was the intention behind the clause.[120] We recommend that the Government should consider the concern raised by the HFEA in relation to donor gametes and the withdrawal of consent to the storage of an embryo. Subject to this, we support the provisions in Schedule 3 to the draft Bill.

216. The second issue raised in evidence related to storage without consent. Some witnesses welcomed these provisions.[121] However, the British Fertility Society expressed concern that these provisions may expose clinicians to allegations of assault. (Ev23, para H) The British Infertility Counselling Association was uncomfortable with the removal and storage of gametes without consent, but accepted that it may be necessary in cases of severe illness or for legal minors. In such cases, they argued that proxy consent should be obtained. (Ev43, para 8)

217. On a more detailed point, the Royal College of Pathologists argued that one of the conditions in paragraph 9 stipulates that the "gametes are lawfully taken from or provided by" the child donor or patient. Their concern was that gametes could only be lawfully obtained by consent and, if consent was given for that purpose, it is highly unlikely that consent to storage would not be given at the same time, since storage would generally be the purpose of taking the gametes in the first place. They told us that "To provide for gametes to be stored without consent is likely to give rise to the situation where lack of clarity leads to storage where gametes have not been legally obtained". (Ev06, Part 2, para 10)

218. We agree with the Government that there should be some mechanism for allowing the storage of gametes in cases where an individual lacks the capacity to give consent, either through temporary mental incapacity or because of legal minority. We recommend that the Government consider more carefully the technical point raised by the Royal College of Pathologists; and consider making express provision for the circumstances in which it would be lawful to take gametes without explicit consent. This aside, however, we support the provisions on storage without consent.

Conditions of licence for treatment: 'Welfare of the child' and 'need for a father' provisions

INTRODUCTION

219. Clause 21 of the draft Bill proposes changes to section 13 of the 1990 Act covering the conditions of licences for IVF treatment, including:

(i) Removing the words "(including the need of that child for a father)" from section 13(5) of the 1990 Act. The effect of this change would be to remove from the existing conditions of treatment licences the requirement for clinics to take account of the need for a father of any child which may result from fertility treatment before providing treatment services. The duty on treatment licence holders to consider the welfare of the child who may be born as a result of treatment, or the welfare of any other child who may be affected by the birth, remains.

(ii) Applying the requirement to take account of the welfare of the child to all basic treatment services covered by the 1990 Act, including those brought within the HFEA's remit by the transposition of the EU Tissue Directive into UK law.

(iii) Extending the existing requirements to provide counselling.

220. We received relatively little evidence on proposed changes (ii) and (iii) above, and what we did receive was largely supportive of the provisions in the draft Bill. Lady Julia Tugendhat, Vice President of the British Association for Counselling and Psychotherapy, told us that counselling was "very important throughout, through every stage, and sometimes not enough emphasis is given to the early stages, where people are trying to make decisions". (Q 415) The South East Post Adoption Network argued that legislation should make it mandatory "for prospective parents to attend counselling, preparation and information sessions prior to receiving donated gametes". (Ev54, para 3.5) We do not support mandatory counselling. By contrast, we received a large amount of evidence on the duty to consider the 'welfare of the child' generally, which will remain in the 1990 Act as amended by the draft Bill, and on the proposal to remove the 'need for a father' provision. We discuss these issues in more detail below.

WELFARE OF THE CHILD

221. In this area, as in others covered by the draft Bill, there has been a debate about whether the welfare of the child should be paramount. The Minister told us that "Welfare of this child is paramount here". (Q 580) This stance was supported by many who gave us evidence. For example, Professor Andrew Fergusson, Head of Communications at the Christian Medical Fellowship, felt that the right of the child should be paramount because of the child's vulnerability. (Evening Forum Report, Appendix 5)[122] The Rt Revd Dr Lee Rayfield, Bishop of Swindon, noted that the Adoption and Children Act 2002 stated that the welfare of the child should be paramount (Evening Forum Report, Appendix 5). However, Professor Raanan Gillon, Emeritus Professor of Medical Ethics at Imperial College London, told us that "It seems to me that one needs to be very careful about the welfare of the child being paramount, it does not seem to me that this is the normal reason for having a child". (Q 865) Whilst we understand and share the view that the welfare of the child is extremely important, the word 'paramount' indicates 'above all else' and this may present legal difficulties. We therefore support retaining the current position of 'taking into account' the welfare of the child.

222. Others told us that the 'welfare of the child' provision should be removed from the statute book. Professor Peter Braude, Head of the Department for Women's Health at King's College London, and Chairman of the Scientific Advisory Committee (SCAG) of the Royal College of Obstetricians and Gynaecologists, argued that neither provision should be in statute but should be left to the judgement of the doctor providing that treatment in accordance with good medical practice: "It is the one [provision] that caused the most havoc" in terms of getting the right paperwork to the HFEA. (QQ 132-133) Dr Gillian Lockwood, Medical Director of Midland Fertility Services, argued that there should be more equality of treatment with those conceiving naturally: "I do not think we should put IVF treatment in some little hallowed glass box and make everyone better than the rest of society". (Q 471) The British Medical Association acknowledged that there was a clear difference from those who conceived naturally because of the involvement of a third party with assisted reproduction. (Ev07, para 15) CARE similarly argued that when prospective parents go to a fertility clinic for assistance in creating a child, "it becomes a public not a private issue". (Ev66, para 1.5)

223. Professor Margaret Brazier of the Centre for Social Ethics and Policy, School of Law, University of Manchester, argued that the clinic providing treatment and the professionals who deliver that treatment "share in the responsibility for the birth of the child". (Ev109, para 8) We consider that the special status of the embryo distinguishes this case of third party involvement from others where the creation of an embryo is not part of a procedure.

THE 'NEED FOR A FATHER'

Reasons for proposed change

224. In its White Paper in December 2006, the Government said it was "not convinced that the retention of this provision could be justified in terms of evidence of harm, particularly when weighed against the potential harms arising from the consequences of encouraging some women who wish to conceive to make private arrangements for insemination rather than use licensed treatment services".[123] Since then, the Government has given us a number of further reasons why they propose to remove this provision.

225. Mr Ted Webb told us that the current legislation "does not actually seem to achieve anything. So we have looked at it from a legalistic point of view more than anything else. It does not prevent treatment being provided to single women or same-sex couples, and also does not seem to fit too comfortably with the Government's wider civil partnerships policy. So I think that is really our starting point for recommending that the need for a father reference is taken out of the legislation". (Q 256) When asked whether this was a decision made on a legalistic argument rather than any other area of consideration, he replied "That is right" (Q 257), but later clarified that this was "in the context of the assessment of the welfare of the child". (Q 260)

226. In oral evidence, the Minister told us that the current 1990 Act provision "does not prevent someone having access to fertility treatment as a single woman, whether she is heterosexual or gay" and in this context, having to take into account the need for a father presented all sorts of issues and was "illogical". (Q 578) Furthermore, she commented that the current provision was "very difficult to implement in any rational way" and that "To be honest, we have a piece of legislation which says one thing in terms of legal entitlement and then has a caveat which is difficult to enforce in any coherent way. I am not sure if that is good law." (QQ 582, 585)

227. The evidence we received on the proposal to remove the 'need for a father' provision was highly divided. The HFEA took the view that "considerations relating to the welfare of the child should not make reference to particular family structures". (Ev12(a), para 34) Hugh Whittall thought that there were many families who do not have a father present and that it was "timely to recognise this by concentrating on the welfare of the child". (Q 53) Dr Vivienne Nathanson, Director of Professional Activities at the British Medical Association (BMA) said "we think that the evidence is that what children need is security, unconditional love, all of those things, and that does not necessarily mean a father". (Q 131) Dr Tony Calland, Chairman of the Medical Ethics Committee at the BMA, added that "the words about need for a father are perhaps slightly emotive" and that the welfare of the child can be provided for by a loving relationship with two parents who "may be two male parents who have had a child by a surrogacy". (Q 134)

228. Professor Simon Fishel, Managing Director of the CARE Fertility Group was "not sure [the provision] should exist" and acknowledged that while the assessment process was adhered to in order to satisfy the 1990 Act, the need for a father provision did not prevent single women from accessing treatment at his clinic: "Generally, they tend to find a father figure—uncle, brother, somebody". (QQ 473, 474) Dr Gillian Lockwood told us "I do not believe it does stop anybody getting treatment and I do not think it should … We may prefer the 'Janet and John' world in which there is a mother and father, a boy and a girl and a dog named Spot but the real world is one of single parents, women deciding to have a baby on their own, or being left pregnant or whatever". (Q 471) Many other witnesses supported the removal of the 'need for a father' provision[124].

229. On the other hand, there were as many witnesses who told us they opposed the removal of the provision. The Rt Revd Dr Lee Rayfield, Bishop of Swindon, accepted that the Government was motivated by a desire not to discriminate in proposing to remove the provision but said that this was misguided, created confusion and came across as an attempt at social engineering (Evening Forum Report, Appendix 5). Several witnesses argued that the proposal was inconsistent with other Government policies towards fathers. For example, Professor Andrew Fergusson from the Christian Medical Fellowship said that the proposal flew in the face of recent proposals regarding the Child Support Agency. (Evening Forum Report, Appendix 5)[125] We also note the inconsistency with the removal of sperm donor anonymity to allow donor-conceived persons to trace and identify their donor fathers.

230. Dr Daniel Boucher, Director of Parliamentary Affairs at CARE, argued that rather than removing the provision, it should be made to work better (Evening Forum Report, Appendix 5), an approach supported by others.[126] The Lawyers' Christian Fellowship supported retaining the provision on the grounds that "legislation should continue to make clear that fathers are important to children to ensure that this aspect of their welfare is not overlooked" and they stated that other areas of law recognise the importance of two parents in the life of a child. (Ev52, para 12) The Centre for Social Justice argued that the provision operated on two levels: providing a statement of principle in law and in some cases providing useful guidance for clinicians and patients. (Ev53) The Church and Society Council of the Church of Scotland said that to deny the need of a child for a father "would be repugnant, as well as contrary to plain common sense". (Ev97, para 12) Again, many others opposed the removal of the provision, including several donor-conceived people.[127]

RESEARCH EVIDENCE ON ROLE OF FATHERS

231. We heard from several witnesses involved in research on the influence of the role of fathers on children. Professor Ann Buchanan, Director of the Oxford Centre for Research into Parenting and Children, told us that that from her research, "the evidence for the role of fathers is important" and "is strongly related to children's later educational attainment. Children with involved fathers are less likely to be in trouble with the police. Father involvement is associated with good parent-child relationships in adolescence. Father involvement protects against adult experiences of welfare and later mental health problems and it applies in different ways to both girls and boys". (Q 878) Several other witnesses supported this view, for example, Professor Andrew Fergusson, who stated that everything in social policy research showed that children with fathers do better. (Evening Forum Report, Appendix 5)[128]

232. However, Professor Buchanan also acknowledged from a wider perspective that "if there was one intervention which would increase the wellbeing of children, it should be that children should be wanted and planned for" and "in civil partnerships it may be possible to compensate for the need to have some male presence in the children's lives". (Q 880)

233. Professor Susan Golombok, Professor of Family Research and Director of the Centre for Family Research in the Faculty of Social & Political Sciences at the University of Cambridge, told us that "there is really no evidence that having a father is necessary for girls to develop typically or boys to develop typically in terms of gender identity and sexual behaviour". (Q 883) She highlighted studies which showed that children growing up in single-parent families do less well at school and are more likely to show problems in terms of psychological adjustment than children in two-parent families. However, she went on to say that "these greater difficulties … are very much associated with the circumstances of being in a one parent family rather than just whether or not there is a father present. For example, a drop in income, to do with lack of social support for the family, a disrupted relationship with the father … and moving into step families … It is not simply a matter of there being no father per se". (Q 883)

234. Professor Golombok's studies of families with same-sex parents, particularly families headed by two lesbian women, "tend to show that children … are no less disadvantaged in terms of their emotional wellbeing or other aspects of development than children in comparable heterosexual families, which leads to the conclusion that, it is really the second parent that is most important … more important than the gender of that parent". (Q 884) She later clarified that "It is the relationship rather than the gender" that was important. (Q 893) This was supported by Professor Buchanan who also said "I think what is absolutely critical here is that there are two parents". (QQ 890, 894) Similarly, the British Fertility Society in written evidence argued that research showed that children do better when there is "a supportive social network". (Ev23, para I) Professor Sir Ian Kennedy said that "raising a child by two parents rather than one should be encouraged in all circumstances. Whether the parents are of the same or different sex is less important than there should be two of them". (Ev108) Professor Søren Holm told us that "to single out the father as the thing that we need to take account of in the welfare calculation, it is very difficult to justify. Why not single out stable income or the presence of a caring mother or something else". (Q 866)

235. However, Professor Almond, Emeritus Professor of Moral and Social Philosophy at the University of Hull, argued that despite the research evidence "the idea that a mother and a father are both a good thing on the whole for children and also some basic assumption about the structure of family life is undeniable". (Q 891) In written evidence she urged caution "when tampering with something as fundamental as having a parent of each sex". (Ev21, para 2) Professor John Haldane, Professor of Philosophy and Director of the Centre for Ethics, Philosophy and Public Affairs at the University of St. Andrews, felt that "To engineer a situation in which one of those [mother or father] is to be absent is to wrong a child". (Q 867) The Centre for Social Justice argued that a wealth of social research findings challenge the notion that deliberately planning to have fatherless children can be in the long term best interests of those children. (Ev53) Despite her research findings, Professor Golombok said that in her view "fathers have been under-valued in many ways and I think, especially over the last 30 years, there has been a change in fathers' relationships with their children". (Q 895)

HFEA GUIDANCE ON THE WELFARE OF THE CHILD AND THE NEED FOR A FATHER

236. The Minister told us the Government did not want to micromanage from the centre, and acknowledged that it was for the HFEA to issue guidance and for clinicians to make a judgement. (Q 580) Under the 1990 Act, the HFEA is required to provide guidance on the duty to take account of the welfare of any child. The current HFEA Code of Practice, arrived at through experience and a consultation on the welfare of the child provisions with professionals, patients and the public, says a treatment centre should "carry out an assessment of risk of harm to the welfare of the child before providing any licensed treatment".[129] (para G.3.1.1) The guidance then sets out the factors the treatment centre should consider, factors "likely to cause serious physical, psychological or medical harm, either to the child to be born or to any existing child of the family". (para G.3.3.2)

237. In respect of the need for a father provisions, the guidance says that "Where the child will have no legal father, the centre should assess … the prospective mother's ability to meet the child's/children's needs and the ability of other persons within the family or social circle willing to share responsibility for those needs." (para G.3.3.3) In addition, the current guidance says that "In particular, patients should not be unfairly discriminated against on grounds of gender, race, disability, sexual orientation, religious belief or age." (para G.3.2.2)

238. Once the assessment has been undertaken, the guidance states that "treatment should be refused if the centre concludes that either the child to be born or any existing child of the family is likely to experience serious physical, psychological or medical harm or where the treatment centre is unable to obtain sufficient further information to conclude that there is no significant risk." (para G.3.4.5)

ALTERNATIVE PROPOSALS

239. Several witnesses proposed that the 'welfare of the child' provision should be revised in line with the HFEA guidance. Indeed, the HFEA supported the "vague" wording on the welfare of the child being replaced with wording reflecting their current guidance, cast in terms of the duty to consider whether a child born might be at risk. (Ev12(a), para 36) Professor Brazier felt strongly that "some form of principle should be retained" in legislation but supported an obligation drawn up on the same lines as the Children Act 1989 to "ensure that any child or children born as a result of treatment 'is not at risk of significant harm'". (Ev109, para 8) The BMA supported a re-writing of the provision to specifically refer to cases where there is 'foreseeable risk of serious harm'. (Ev07, para 15) The British Association of Social Workers Project Group on Assisted Reproduction (PROGAR) and UK DonorLink both supported a new provision of likelihood to experience 'significant harm'. (Ev29, para 3.1)(Ev30, para 4.5) The South East Post Adoption Network (SEPAN) agreed that the requirement to ensure the child would not experience significant harm should be put in primary legislation. (Ev54, para 3.3)

240. However, the Lawyers' Christian Fellowship expressed concern that HFEA guidance since 1990 had eroded the force of the welfare of the child provisions. In particular, they opposed what they view as a shift in the burden of proof to a presumption of treatment unless there is evidence of serious harm, which they considered to be too high a threshold. (Ev52, para 13)

241. The welfare of a child is a key area where consistent, understandable and enforceable legislation is needed. We support the approach taken in the 1990 Act towards the welfare of the child and the positive shift in HFEA guidance towards a risk-based approach with the presumption of treatment unless information suggests serious harm will be caused.

242. The proposal to remove the 'need for a father' provision involves complex ethical and social issues. We have had a weight of evidence on both sides which has been logical and well argued. We note the Government's intention to ensure that the treatment conditions are not discriminatory and are in line with other legislation such as civil partnerships but have had reassurance from the Minister that the existing provisions do not prevent access to treatment services either to same sex couples or single women. We also note other areas of government policy that take a different approach towards the role of fathers in bringing up children and we have had little evidence that the existing provisions have caused harm. We have found persuasive the evidence presented to us that a loving, supportive family network is more important for a child's development than the gender of the second parent and we note the provisions on parenthood in the draft Bill, in particular clause 59 in which a reference to a 'father' would no longer simply refer to a child's male parent, but would also refer to a woman who is a child's parent by virtue of clauses 48 and 49. In an area such as this, the law has symbolic value. Ultimately, however, the issue is one of what is in the best interests of the child.

243. We recommend that the proposal to remove the 'need for a father' provision from section 13(5) of the 1990 Act should be put to a free vote of both Houses of Parliament. To inform that vote, the balance of view of this Committee is that it would be detrimental to remove entirely the requirement to take into account the 'need for a father'. Instead, we recommend that the current provision in section 13(5) on "(including the need of that child for a father)" should be retained but in an amended form in a way that makes clear it is capable of being interpreted as the 'need for a second parent' in line with the parenthood provisions currently in Part 3 of the draft Bill. In making this recommendation, we do not seek to discriminate against single women seeking treatment and we recommend that in such circumstances and the requirement to consider the need of a child for a second parent should, as now, not be a barrier to treatment.

Storage limits

244. Clause 22 of the draft Bill would amend section 14 of the 1990 Act so that the statutory storage period for gametes and embryos would be raised to ten years, consistent with the existing storage period for gametes. If the gametes or embryos are still in storage at the end of that period, they shall be allowed to perish. As is currently the case, couples would have the opportunity at any point during the ten year period to donate gametes or embryos for the treatment of others or for research.[130]

245. Some witnesses have called for flexible storage periods for gametes or embryos created or donated destined for treatment to benefit individuals and couples in exceptional circumstances.[131] Sheila Pike from Sheffield Teaching Hospitals NHS Trust, and Kate Grieve from University Hospitals Coventry and Warwickshire NHS Trust, gave the example of embryos created for a surrogacy arrangement prior to a young patient undergoing a hysterectomy or cancer therapy. In such cases, the individual concerned might wish to use the embryos over a period of time greater than ten years and in more than one surrogacy arrangement to create a family. (Ev34, para 10)

246. There were also calls for the current limits on storage for research purposes to be extended or removed entirely. (Ev51, para 14) The British Fertility Society have advocated greater flexibility to deal with the situation where embryos created for treatment purposes, which are suitable for donation for research, become available only a short time before the statutory time limit for storage is reached. (Ev23, para J) Others also felt strongly that embryos created for treatment should be permitted to be used in research after the ten year time limit.[132] The MRC and the Wellcome Trust said "We believe a longer storage period for research purposes should be permitted so that if a patient wishes and gives consent, the potential value of this precious and valuable resource can be maximised for future research. We … would advocate a storage period of at least 50 years (as this would be within the normal lifespan of the average donor)." (Ev09, answer to Q14)

247. Similarly, the Royal College of Pathologists argued that banks of material built up for research use should be available indefinitely, with donor consent, since this reflected good practice in research methods and would become a valuable resource. This applied not only to embryos, but also to sperm and oocytes initially banked for research purposes, including as yet undefined future research. Under the current legislation, these would have to be disposed of after 10 years which they considered nonsensical and not an efficient use of "precious funds and resources". The ethics of disposing of material which patients have donated to research without maximising its potential in this regard were, they thought, questionable. (Ev06, Part 2, para 13) Alison Murdoch, Professor of Reproductive Medicine at Newcastle Fertility Centre, told us that thousands of human embryos are discarded annually because they are no longer needed or wanted for fertility treatment. Her experience was that over 70% of couples were happy for these embryos to be used for research. (Ev17, para 3.3)

248. The HFEA, however, supported the provisions in the draft Bill and agreed that there should continue to be a statutory storage period for gametes and embryos and that a limit of 10 years was reasonable.[133] They argued that without a statutory maximum, the storage periods for gametes and embryos would likely be variable, leading to the undesirable outcomes of variable treatment for different individuals and couples as well as the risk that clinics may be required to store gametes and embryos indefinitely in the absence of agreement to their destruction. (Ev12(a), para 24) The Royal College of Pathologists were also content with the statutory time limit in relation to gametes and embryos destined for treatment. (Ev06, Part 2, para 13)

249. We acknowledge that a storage limit for embryos destined for treatment is useful in practice and we are persuaded by the reasons for increasing the storage limit to ten years. In relation to gametes or embryos created for or donated for research, we are less persuaded by the argument that these, too, should be subject to a ten year time limit on storage. We therefore recommend that, in relation to gametes or embryos created or donated for research, the ten year limit should either be extended or removed.

250. We also recommend that there should be a system of consent such that, at the commencement of fertility treatment, couples are asked for their consent that any gametes or embryos left unused for treatment at the expiry of the ten years become the property of the HFEA and may then be used for research purposes. At any point up to the 10 year limit, there should be the ability to withdraw consent so that gametes or embryos would be destroyed in accordance with patients' wishes.

Register of Information

251. Clause 32 of the draft Bill proposes a series of new provisions to replace existing section 31 of the 1990 Act requiring the HFEA to keep a register of information. Clause 33 allows the Secretary of State to make regulations requiring or regulating the disclosure of otherwise confidential information for medical research purposes. We have dealt below with those provisions on which we received substantive evidence.

NEW SECTION 31ZA: ACCESS TO THE REGISTER FOR CIVIL PARTNERS

252. Proposed new section 31ZA(2)(b) and (5) of the 1990 Act (in clause 32) extends the current provisions, enabling an applicant to find out whether they are related to a person with whom they propose to marry, to those intending to enter a civil partnership.

253. The Government's motivation is to update the 1990 Act in line with civil partnership legislation. The current provisions are principally designed to avoid consanguinity, but we recognise that for those entering a civil partnership the issue is more likely to be avoiding incest. Professor Almond found the provisions "puzzling" since the decision to introduce civil partnerships was made by Parliament on the basis that they were not the same as marriage. (Ev21, para 2.4.5)

254. Almost all of those who raised this provision supported it as far as it went, but most argued that access should be extended more generally beyond those planning to enter civil partnerships. For example, the HFEA noted that approximately 40% of children are now born to unmarried couples. They said there was "something rather old fashioned and inappropriate about limiting access to couples entering into formal legal arrangements" and argued that the provision should extend to all cohabiting couples or even to all donor-conceived people embarking on an intimate relationship. (Ev12(a), para 40) This position received much support.[134] The Donor Conception Network noted that other parts of the draft Bill recognised unmarried partners in the context of legal parenthood. (Ev31, para 12 and 14)

255. Although this was not raised by witnesses, we were concerned that wider access might put an administrative burden on the regulator. The HFEA noted that the Human Tissue Act 2004 contained a statutory definition of 'partner' which could be adopted to define increased access. (Ev12(a), para 40) Professor Brownsword argued that the registrar should have the discretion to resist vexatious or frivolous claims. (Q 56) Several witnesses were concerned that these provisions were silent on the consent requirements. The HFEA noted that there was no requirement for a joint application or for consent from the other person and argued that this appeared to create a right to access genetic information about a third party without their consent. Donor Conception Network also noted this "odd omission" and argued that consent should be required. (Ev31, para 13, 14)

256. We understand the Government's logic in extending access provisions to those entering civil partnerships, but we are concerned that limiting access only to those entering civil partnerships misses many people who are entering (or planning to enter) intimate relationships and those who may be planning children outside marriage or civil partnership. We recommend that the draft Bill be amended to extend to cohabiting couples and those planning intimate relationships the right of access to the register to find out whether they are related to the other person. We also recommend that the Government amends the draft Bill to require consent from the other person before access is provided.

SECTION 31ZA (ACCESS TO IDENTIFYING INFORMATION ABOUT GENETIC HALF-SIBLINGS)

257. Proposed new section 31ZA(2)(c) of the 1990 Act makes a new provision that a donor-conceived person aged 18 or over is entitled to request information about the number, sex and year of birth of their donor-conceived half siblings. New section 31ZD enables donor-conceived people to request and obtain identifying information about their genetic half-siblings.

258. Most witnesses welcomed these provisions.[135] However, the PGH Foundation were concerned that the provisions might vary or extend the duty of care owed by clinical geneticists to their clients and that the legal basis for disclosure was not clear cut. (Ev51, para 15(2) and (3)) Several witnesses argued that the provision should be extended: to people conceived as the result of surrogacy; and to the descendants of donor-conceived people. (Ev54, para 3.5 and Ev31, para 7) We support the provisions in the draft Bill subject to the relevance, if any, of the Data Protection Act being taken into account.

SECTION 31ZE (VOLUNTARY CONTACT REGISTER)

259. Proposed new section 31ZE provides the regulator with the power to set up or keep a voluntary contact register. This has been trialled by UK DonorLink and has been supported by several witnesses. (Ev54, para 2.6, Ev37, para 2.6) We also support this provision and we recommend that the draft Bill be amended to allow the HFEA to set up a voluntary contact register.

USE OF INFORMATION FOR RESEARCH PURPOSES

260. Clause 33 allows the Secretary of State to make regulations requiring or regulating the disclosure of otherwise confidential information for medical research purposes. Most witnesses supported these provisions, but raised concerns about safeguarding data and consent.[136] For example, the PHG Foundation supported "medical research using identifiable information from those registers … subject to proportionate safeguards being taken and provided that disclosure is in the interests of improving patient care or is in the public interest". (Ev51, para 15(1)) The HFEA welcome disclosure "with appropriate consent". (Ev12(a), para 40) The BMA argued that much research could be undertaken using anonymous data and that the draft Bill should make it clear that section 33C should only be used where it was not possible to seek patient consent. (Ev07, paras 21 and 23) However, the Society for the Protection of Unborn Children (SPUC) argued that permission to disclose information for research purposes breaches the most basic of ethical principles. (Ev65) We support the provisions in the draft Bill subject to consent provisions being satisfactorily resolved.

AGE OF ACCESS

261. Access provisions in the draft Bill are limited to those aged 18 or over. We heard from many witnesses who argued that the age limit should be lowered. Most witnesses argued that the limit should be set at 16 rather than 18.[137] However, some witnesses argued that there should be no age limit in accessing information. For example, Tom Ellis, a donor-conceived person, argued that "Age 18 is too late. Developing human beings need access to their (genetic, biological) parents during the adolescent years when they are forming their own independent, individual identity." (Ev16, para 15)[138] Andrew Bainham, Reader in Family Law and Policy at the University of Cambridge, noted that not all jurisdictions regard 18 as the appropriate age to access information. He suggested that in England 'Gillick competence' guidelines[139] could be used as a test, although he acknowledged that this could be problematic. (Ev14, para 15)

262. We recommend that the age of access to the Register should be reduced to 16.

75 This approach was supported by witnesses: QQ169, 619-620, 622, 640, Ev12(a), paras 3, 4, 10 and 43 Back

76 Explanatory Notes, para 45, White Paper, para 2.11 Back

78 See Ev12, para 13, Ev12(a), para 21, Ev28, comments on clauses 14 and 15, Ev41, question 7(a) and (b), QQ395, 770-771 Back

79 Explanatory Notes, para 49 Back

80 Ev23, para D, Ev28, comments on clauses 14 and 15, Ev08, para 1.13, Ev41, answer to Q7(a) & (b), Q396 Back

81 Ev08, para 1.13, Ev09(a), answer to Q2, Ev06, para 6, Ev23, para D Back

82 See Ev12(a), para 21, Ev28, comments on clauses 14 and 15 and Ev06, para 6 Back

83 Ev25, para 7(b), Ev28, comments on clauses 14, Ev40, para 3.3, Ev52, para 7(b), Ev55, para 7(b), Ev62, paras 7(b)(ii) and (iii), Ev92, heading: Definitions Back

84 Ev38, para 5, Ev12, para 13, Ev12(a), para 23, Ev39, para 11, Ev41, answer to Q7(a) and (b), Ev59, para 7(a), Ev84, para 2, QQ16, 32, 197, 392, 946-948 Back

85 Memorandum dated 13 June 2007, see Appendix 7 Back

86 In this Report we refer to these new provisions by reference to their new section number (as inserted in the 1990 Act). Back