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Read Rt. Hon. Frank Dobson’s Lecture on Lisa Jardine and the HFEA

Last November, the Rt. Hon. Frank Dobson delivered the annual Speaker’s Lecture at the Houses of Parliament dedicated to highly-esteemed former HFEA Chair Professor Lisa Jardine CBE.

The former Secretary of State for Health, able to speak first-hand about the origins of the HFE Act and the HFEA, says the UK regulatory regime has become “the envy of scientists and clinicians in many other countries”.

With the birth of Louise Brown in 1978 the debate fell on “fundamental issues about the future of human kind and the nature of our society“ featuring an “enormous range of views and concerns”.

This led to the Committee of Inquiry into Human Fertilisation and Embryology, commissioned by the then health minister Ken Clarke, and led by the “inspired choice” of Dame Mary Warnock, whose eponymous report would become a classic of its kind.

The former MP for Holborn and St Pancras offers a fascinating account of the twists and turns that led first to the passing of the HFE Act 1990, its sister Act in 2006, and up to the present day and the issuing of the first licence to use mitochondrial donation in treatment by Professor Doug Turnbull and team.

“The HFEA,” says Mr Dobson, “with its excellent and dedicated staff, has been remarkably effective. It has benefited from the leadership of strong characters such as Ruth Deech, Suzi Leather, Lisa Jardine and now Sally Cheshire, who have maintained its independence and integrity… It has stood the test of time and looks set to be in place to respond to foreseeable and far-reaching future developments in science and treatments.”

“The argument in favour [of such innovative law-making] is brilliantly summarised in the words of Lisa Jardine’s great hero Francis Bacon who said: “If we are to achieve things never before accomplished, we must employ methods never before attempted”. This has required the innovators to spell out what they are trying to do, how they are going about it and the benefits that could flow.”

The lecture was attended by current HFEA Chair Sally Cheshire CBE, Chief Executive Peter Thompson, and Director of Information and Compliance Nick Jones.

Read the full speech

Speaker’s Lecture Delivered by The Rt. Hon. Frank Dobson –

20 November 2017

I dedicate this Speaker’s Lecture to the memory of Professor Lisa Jardine who chaired the Human Fertilisation and Embryology Authority from 2008 to 2014. Lisa brought to this demanding task a matchless combination of talent. She had a well-founded knowledge of science and an acute awareness of how scientists go about their work. She had a deep concern for women and men denied the opportunity to become parents. She had a flair for explaining complex ideas in ways the rest of us could understand. She knew how to make best use of public opinion and political processes. She was thoughtful, practical, committed and hardworking. It was as if she had been purpose-built for the job.                                                      

Professor Jardine had come to academic and public prominence as an historian and biographer of scholars and scientists whose work in their time had helped bring about a new understanding of the world. They included Erasmus, Shakespeare, Kepler, Hooke, Wren and Newton. Her doctorate was on Frances Bacon and, I believe, her whole life reflected Bacon’s dictum: “It’s not what we profess but what we practice that gives us integrity”. Lisa didn’t confine herself to her scholarship, however distinguished. She believed that knowledge should be sought out, explained and spread as part of the promotion of a better-informed, fairer and more equal society. That required her to operate in the public realm. Just one example. She believed in comprehensive education – so she became a school governor.

In everything she did Lisa displayed great intellect, energy and commitment. But to me and many others it was her personality that singled her out. She was kindly and bubbling with human warmth and understanding. Her twinkling eyes revealed her sense of mischief and her glee when her efforts brought success.

So it’s right to dedicate this lecture to Lisa Jardine who helped make sure the HFEA remained a success.

The British arrangements for the regulation of infertility treatment and the research on which it is based have been a great success. They are public, open and accountable. They command public confidence. They facilitate continuing developments in scientific understanding and improvements in treatment. They have worked well and been updated as necessary. They are the envy of scientists and clinicians in many other countries.                                 

It could easily have been very different. It could have been an unworkable shambles. The statute book is littered with laws that have never achieved what Ministers and Parliament intended. Some laws have proved almost unworkable. Sometimes the shortcomings have arisen because a law was passed in too much of a hurry – a rush to misjudgement. More frequently, the failings result from inadequate, and often furtive, consultation – with Ministers and officials consulting ‘in confidence’ often only with individuals and organisations who favour what the Government is proposing in the first place leaving doubters in the cold. And all this happens in what might be called the familiar ‘bread and butter’ of day-to-day politics.

But there was nothing ‘bread and butter’ about the law-making required to match radical developments in infertility treatment and embryo research. That involved fundamental issues about the future of human kind and the nature of our society.

Could the needs of the infertile and the work of scientists and clinicians be reconciled with the concerns of society as a whole? Should limits be set? If so, what limits, where should they be set and who should set them? Could any laws keep up with the rate of technical and scientific developments? Different groups - scientists, clinicians, ethicists, infertile individuals and couples, people of all religions and none - had an enormous range of views and concerns. Ministers, MPs and Parliament had to decide how to try to reconcile all, or most, of these deeply-held concerns and develop laws acceptable to society as a whole. And over three decades they did.

It had all started off in July 1978 at Oldham General Hospital with the birth of Louise Brown, forever after referred to as the world’s first ‘test tube baby’.

This achievement came as a shock to most people, although her successful birth was the end product of years of painstaking research and clinical developments by Robert Edwards, Patrick Steptoe and Jean Purdy.  And I hope you will understand when I single out Jean Purdy in particular. Because, rather like Rosalind Franklin, she often gets left off the credits. Jean had trained as a nurse.  She ran the laboratory and personally developed processes now a standard part of IVF. Described as “the first embryologist”, she was credited as an author in more than 20 academic publications. Robert Edwards went on record that “there were three original pioneers in IVF and not just two” and that without Jean “none of our work would have been possible”.                                               

The response by the public and the news media to the remarkable tidings from Oldham ranged from enthusiasm by some for the excitement of the science and the help it could provide for the childless, through a spectrum of doubt and concern by many more to outright revulsion and rejection by others who saw it as interfering with nature or with the will of God. Through all the responses ran a common thread - a recognition that these revolutionary developments involving human reproduction raised fundamental moral issues. And that the human embryo had a special status. It was some time before any formal Government or Parliamentary response. Partly because most sensible Members of Parliament and Ministers are very chary of pronouncing on moral or ethical issues. And partly because no-one knew what to do for the best.

However, in July 1982 the Government Health Team, with Norman Fowler Secretary of State and Ken Clarke Minister of State, took the far-reaching decision to establish a Committee of Inquiry into Human Fertilisation and Embryology and made the inspired choice of Dame Mary Warnock to chair it.  This group of doctors, scientists, lawyers, theologians, social scientists and citizens had the daunting task of considering the ethical and legal implications of the new developments and then to formulate proposals for appropriate new laws and regulations in a sphere where no existing laws were relevant. Any such new laws would also need to be able to respond effectively to further developments. The Inquiry covered a wide-range of topics including surrogacy, embryo research, cloning, in-vitro fertilisation and other methods of helping childless couples. It invited open representations from interested organisations and individuals across the whole spectrum of views and expertise.                                            

While the Committee deliberated, things kept moving on. Later that year, the Medical Research Council issued guidance to researchers and in 1983 the BMA and the Royal College of Obstetricians and Gynaecologists issued guidance to clinicians and in 1985 set up an interim licensing authority.

At my age, I really should have given up having heroes, but sometimes I can’t help it. To be fair, I don’t have many but Mary Warnock is one. Under her guidance, the Committee did a remarkable job. The Warnock Report is a classic. It should be compulsory reading for every MP, civil servant, scientist, clinician, news media commentator, academic and interested citizen. Like the philosopher herself, it is clear, concise, persuasive and to the point. It tackled all the issues. It spelled out the pros and cons. And, despite dealing with fundamental timeless moral issues and complex scientific concepts, it was a jargon-free zone.                                    

The publication of the Report in July 1984 was greeted with a predictable torrent of abuse from self-proclaimed champions of morality.  Many referred to Dr. Frankenstein’s Monster. It is a commonplace assertion that debates in the House of Lords are better informed and of a higher calibre than debates in the House of Commons. Not many people reading Hansard would be likely to conclude that the Lords’ debate on Warnock in October 1984 was superior to the Commons’ debate in November that year. Most of the speeches in the Lords displayed both closed minds and a failure to open a copy of the Report. In the Commons, the debate opened with measured speeches by Norman Fowler, Secretary of State, and Michael Meacher, his shadow. As Shadow Health Minister, I replied to the debate. Like both Norman and Michael I was strongly in favour but recognised the doubts and reservations of others.            

I pointed out that some people who had given evidence to the Warnock Committee had been very open-minded and had revised their own views when they read the Report. Somewhat hypocritically, I urged this open-minded approach on others and quoted Oliver Cromwell’s wise words: “To be a Seeker is to be of the best sect after that of a Finder and so shall all humble Seekers be in the end”. To which the Reverend Ian Paisley responded with a ringing “Here, Here”. In the Members’ Lobby after the debate, he congratulated me for quoting ‘the Great Oliver’ adding that, he had been watching Scottish Roman Catholic Archbishop Thomas Winning in the gallery as I said it. He added, “I have to say, I don’t think you carried him with you”.  Ken Clarke closed the debate with a brilliant speech which managed to encompass both balance and personal commitment. But there was still a long way to go.                                                 

The next major development was a Private Member’s Bill to ban embryo research introduced by Enoch Powell. This got through its Second Reading. Its Committee Stage could not be guillotined so we had several day-long and all-night sittings in which those of us opposing the Bill got considerable help from Professor Robert Winston who stayed up all night with us. It wasn’t all tedious. During one breakfast break, Bob got a message from the Hammersmith Hospital on his pager. It read, ‘help, help the embryos have escaped’. Enoch Powell claimed he wasn’t against in-vitro fertilisation but that his concern was for the fate of embryos used in research. But when David Crouch – good old Tory MP for Canterbury – asked him what then should happen to surplus embryos produced in the course of in-vitro fertilisation, Enoch gave the game away by accepting they should be washed down the sink.

Enoch’s Bill had been helped along by the then Labour Chief Whip Michael Cocks but when it came back to the floor of the Commons, it was ‘talked out’ by a marathon speech from Labour’s Dennis Skinner – demonstrating both Dennis’ talent and staying power and that the subject wasn’t a matter of party political loyalties. 

1985 also saw the passage of the Surrogacy Arrangements Act which provided that the law should not interfere with privately-arranged surrogacy understandings but which made it a criminal offence to create or operate agencies to provide or facilitate surrogacy whether for profit or not.

The need for statistics on infertility services had been identified in the Warnock Report so in July 1986, as Shadow Health Minister, again with help from Robert Winston, I conducted a survey of the provision of infertility treatment in England, Wales and Scotland.   

No one had any idea how many people were infertile or how many were seeking treatment. But the survey did reveal that such infertility services as did exist were inadequate and patchy. London and the South East were better provided but even there almost half the districts had no special services.

Later in 1986, the Government published a consultation document based on the recommendations of the Warnock Report which received the expected widespread range of responses. In November the following year the Government issued a White Paper. This was based on the Warnock recommendations with some modifications which reflected the outcome of the protracted consultations.

Two years later the Human Fertilisation and Embryology Bill was published. Given a free vote in both Houses, it was debated first in the Lords in December 1989.

This time the issue was given a much more reasonable reception which reflected both the passage of time and the willingness of those in favour to muster both their arguments and their supporters. The Bill included Clause 11 which gave stark alternatives – either permit embryo research or outlaw embryo research. The Lords voted for embryo research. The Bill arrived in the Commons in April 1990 with the continued committed personal support of both front benches.  Ken Clarke led for the Government and the late Jo Richardson for Labour. Ken is quick to point out that the bulk of the heavy lifting on the Bill was undertaken by Virginia Bottomley for the Government and Harriet Harman for Labour. They arranged extensive briefings by experts drawn from various bodies including the Royal Society.  With most of the debate being on the floor of the House, their hard work and collaboration really paid off.

The measures in the Bill included most of the Warnock recommendations, with the modifications in the light of the extended consultations with both lay and expert opinion and also continuing developments in both research and clinical practice. Faced with their version of Clause 11, the Commons voted for embryo research.  So the Bill as passed provided for embryo research and infertility treatment to be carried out subject to strict regulation. It established the Human Fertilisation and Embryology Authority to regulate both research and clinical practice by means of licences backed up by inspections. The Bill prohibited non-human embryos or gametes being placed in a woman or human embryos being placed in any other animal. It also limited research on an embryo to the first 14 days of life. It made provisions for control of the storage of embryos and gametes.

The Bill made clear that the carrying mother of a child born as the result of treatment should be regarded in law as the mother and that donors of embryos or gametes had no rights nor duties in relation to the child. It clarified the recently enacted law on surrogacy. The HFEA was empowered to grant, refuse, vary or revoke licences within the limits set by the Bill.

Licences could only be issued by the HFEA for research purposes if the work

  • promoted infertility treatment;
  • increased knowledge on congenital diseases or miscarriages;
  • helped detect abnormalities in embryos;
  • or advanced more effective contraception.

The Authority was required to maintain and publish a code of practice giving guidance to licensees including the obligation to take into account the welfare of children born as a result of the licenced treatment including, at that time, the need for a father.

In August 1991 the Human Fertilisation and Embryology Authority was established, bringing together responsibility to consider and determine ethical issues within the limits of the new law, with the licensing and regulation of clinics providing IVF treatment and conducting embryo research and very importantly to secure the collection and confidential retention of personal information about treatments, donors and children born.

Over the next 15 years, further changes were made to the law. These included empowering the HFEA to issue licences for human embryos to be cloned but for laboratory research only – never to create a child. The authority to licence was also extended to permit research designed to

  • increase knowledge about development of embryos;
  • increase knowledge of serious diseases;
  • enable such knowledge to be applied in developing treatments for serious diseases;

and so paved the way for embryonic stem cell research.

This was very contentious but the necessary regulations got through with the help of a remarkably effective speech by the Minister Yvette Cooper which actually converted some doubters and even one or two opponents to support the measure.                                             

Parliament also changed the law to empower donor-conceived children on reaching 18 years of age to access the identity of the donors of sperm, eggs and embryos.

By December 2006, the Government concluded it was time to launch a review of the 1990 Act to update the law and regulations to match the pace of scientific developments and changing public attitudes. Partly drawing upon responses to the review, a draft Bill was published the following May. This included a proposal to amalgamate the HFEA with the Human Tissue Authority. This I think reflected the combined effects of a general inability in our system of government to let well alone and the timeless Treasury longing to reduce running expenses whatever the practical effects. The draft Bill was considered by a joint committee of both Commons and Lords chaired by Lib Dem MP Phil Willis.                                                    

Its members, reflecting the overwhelming majority of those consulted, banjoed the proposed amalgamation with the Human Tissue Authority. They also proposed a number of other improvements.

The Government revised the Bill, knocking out the proposed amalgamation. It was debated first in the Lords which accepted Government amendments broadly in line with the joint committee’s recommendations on hybrid embryos and replacing the need for a father with the need for supportive parenting. In the Commons, Labour gave a free vote on several contentious issues but not on the Bill as a whole. The other parties gave a full free vote. The Bill was introduced by Secretary of State Alan Johnson with Andrew Lansley his opposite number. As Alan acknowledges, the burden of the donkey work was carried by Dawn Primarolo for the Government and Mark Simmonds for the Opposition.     

This involved not only dealing with most of the Committee Stage of the Bill on the floor of the House but also organising seminars at which scientists and clinicians were open to questioning by MPs of all points of view.

The Bill provided for the licencing for laboratory purposes only of human and animal ‘admixed’ embryos and for stem cell research into degenerative diseases. It also provided for the extended creation of ‘saviour siblings’ to benefit an existing child suffering from an inherited condition. The requirement for a father was, as recommended, amended to provide for “supportive parenting”.  One unusual provision was to empower the HFEA in the future to licence mitochondrial replacement procedures if and when Parliament had considered their safety and effectiveness and had passed the necessary regulations.

The next major development was a proposal by the coalition Government as part of a ‘bonfire of the quangos’ to do away with the HFEA and separate out its functions between a number of bodies. This would have moved them back into the generality of the law governing medical research.

This proposal probably came from the same stable that had previously urged the amalgamation of the HFEA and the Human Tissue Authority.  There were divided opinions within some of the organisations involved about the merits of this proposal.  However, I and many others were convinced that this would be harmful because it would lead to the loss of the especial focus which a single-function body can provide. Lisa Jardine, as chair of the HFEA, shared this concern.  And in liaison with sympathetic MPs, she organised with outside bodies and individuals against abolition. She brought to this her understanding of the sciences, the practicalities and the political processes. Eventually the Government decided to let well alone.                                          

The wisdom of retaining the HFEA was demonstrated when the Government was confronted with having to take a position on mitochondrial replacement following remarkable developments by Doug Turnbull and his team at Newcastle University.

Faced with the complex scientific and ethical issues this raised, the Government recognised that the HFEA uniquely had the expertise and capacity to consider all aspects of the issue and come forward with authoritative advice.  This they did under the active leadership of Lisa Jardine and with considerable help from the Wellcome Trust.  The concept remained highly contentious but Jane Ellison as Minister and Luciana Berger as her shadow successfully piloted the necessary regulations.

The HFEA with its excellent and dedicated staff has been remarkably effective. It has benefited from the leadership of strong characters such as Ruth Deech, Suzi Leather, Lisa Jardine and now Sally Cheshire who have maintained its independence and integrity.

The HFEA cannot possibly secure the approval of those who are opposed on principle or of those who see no need for special regulation. However, the recent consultation about its future showed the overwhelming majority of respondents to be very satisfied. It has stood the test of time and looks set to be in place to respond to foreseeable and far-reaching future developments in science and treatments.

It is the envy of researchers, clinicians and legislators in many other parts of the world where some face total bans and others a sinister free-for-all. It has relieved both Ministers and Members of Parliament from having to take decisions on individual cases and the public from the ghastly spectacle that would have involved.

As I have said, Parliament and Ministers have been much criticised for the repeated introduction of ill-considered changes in the law which seldom produce all the outcomes intended and promised. The history of the legislators’ response to revolutionary developments in infertility treatment demonstrates the advantages of careful in-depth consideration, widespread involvement of both expert and lay opinion and measured debate.

What makes this success all the more remarkable is that the issues considered and dealt with so well arose at the frontiers of bioscience, involved unusually complex, sensitive and deeply-felt ethical considerations and the difficult relationship between individual morality and public policy.

It involved developing law to cover situations where no controls existed and for which there was no precedent in practice or in law and where the risks of getting things wrong were starkly apparent.

I believe the success of this law-making stems from the fact that the whole process has been conducted in the open. Starting with the Warnock Committee, everyone, of every opinion, at every stage has been able to question and to have their say. There have been innumerable Parliamentary debates, Select Committee inquiries and public consultations which have helped develop some common ground.     

It has also been important that almost everyone has had to acknowledge that in our country the human embryo is regarded as unique and needs to be accorded special status. The honestly-expressed objections of those opposed in principle have served as a constant reminder of that.

For this open process to work, it has been necessary for scientists and clinicians to work with Ministers and MPs and to attend seminars and consultations and respond to questions and views across the whole spectrum of opinion.

The argument in favour is brilliantly summarised in the words of Lisa Jardine’s great hero Francis Bacon who said: “If we are to achieve things never before accomplished, we must employ methods never before attempted”. This has required the innovators to spell out what they are trying to do, how they are going about it and the benefits that could flow.       

That raises problems because by the nature of scientific endeavour, such benefits are uncertain and may be a long way off. And some lay people find it difficult to accept, or even understand, such uncertainties and timescales. This has faced the scientists with dilemmas about how best to explain how existing regulation may affect future prospects. Ministers and sympathetic MPs have sometimes been able to give them useful advice on how best to present their case, for example, on the arguments for the application of research on embryos to deal with wider concerns than infertility.

However, no one can dispute the fact that scientific and clinical innovations have substantially improved the treatment of infertility. They have delivered, or perhaps I should say made possible the delivery of, thousands of healthy children. They have given joy and fulfilment to parents whose mental and physical health and relationships would otherwise have suffered from the sorrows and strains of childlessness.   

Sadly, the availability of treatment is still patchy. Poor general health, bad living, working or environmental conditions remain significant causes of infertility in both women and men. But these problems do not spring from any shortcomings in the legal framework which regulates research and treatment. They can only be addressed through public policy.

The novel issues raised by developments in human fertilisation and embryo research were dealt with by what amounted to a novel legislative process. The result has been a general success. This approach to the problems of formulating effective laws should be regarded not as an anomaly but a precedent. It should certainly be the approach to the new ethical and regulatory issues which are looming up both in this field and more widely.  We owe that not just to those ‘seeking to achieve things never before accomplished’.

We owe it to future generations to make sure they get the benefits without Dr. Frankenstein’s monster.

 

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Publication date: 5 December 2018

Review date: 5 December 2020