Focus Part Three: The debate - 'The lack of regulation really shocked me'

Shelley Jofre says existing rules deny patients the protection they deserve

Dipping into the world of fertility treatment for Panorama over the past few months has been something of an eye-opener. I had always assumed it was a world that was very tightly regulated.

But our investigation found that the Human Fertilisation and Embryology Authority (HFEA) is struggling to keep up with what is happening inside Britain's fertility clinics.

In Hampshire, embryologist Paul Fielding was jailed earlier this year for deceiving dozens of his patients. He had told them he was freezing their embryos, when he was not. Some even had what they thought were thawed embryos placed back inside them. In fact, it was salt water.

But when the case hit the headlines, the public did not hear about the gross failure of the HFEA to stop Fielding's deception at a much earlier stage. We have discovered that the regulator knew he had no success with frozen embryo transfers for three years, yet did nothing.

And, incredibly, on one HFEA inspection, the team did not even bother to visit one of the clinics where Fielding worked before signing it off.

We have also discovered that some senior fertility experts believe the HFEA is not doing enough to protect patients. There are 24,000 women a year going through fertility treatment, most in the private sector. One in four attempts fails, so it's hardly surprising that some women will take desperate measures to try to get pregnant.

Many women, who need treatment but can't afford the £2,000-£3,000 that each attempt costs, are attracted to egg-sharing schemes that are being run in clinics around the country. If they have healthy eggs they can share some with another woman who needs eggs for her treatment. That woman then pays for some of the donor's treatment.

It sounds like a win-win situation. But donating eggs is a risky and often painful procedure. And what happens if the recipient gets pregnant and the donor does not? Or vice-versa? The HFEA has outlawed the sale of donor eggs, so why does it allow them to be traded for treatment?

One Harley Street doctor has taken egg-sharing a step further. A donor on Professor Ian Craft's egg-giving scheme gives a whole harvest to the woman paying for her treatment, then has a second harvest collected to use for her own treatment. Professor Craft says it gives both women a higher chance of getting pregnant, which must sound attractive to both sides. But when it does not work according to plan it can leave the donor feeling like little more than a battery hen. Women who agree to donate their eggs purely as an act of charity have been left feeling equally cheated. One altruistic donor we spoke to agreed to give her eggs to a childless couple, only to discover straight after the operation that they had pulled out. She had not produced enough eggs and they did not want to waste their money using them in a course of IVF if there was little chance of success. Another woman became ill after taking drugs to stimulate her ovaries, but the clinic went ahead with the operation to remove her eggs anyway. Afterwards she had to spend five days in hospital, and the consultant said she could have died.

The regulator has a tough job. Commercial pressures for private clinics to get results have never been greater and policing them must be tricky. But it is clear from our investigation some patients feel badly let down by the HFEA.

Shelley Jofre reports on tonight's 'Panorama'

UK law is envy of the world

says Suzi Leather

The reality of the European fertility industry's annual gathering, this year in Madrid, is far less bizarre than recent media reports would suggest. It tackles benign subjects such as lessening the risks associated with reproductive technology by replacing only one or two embryos or eggs to bring down the numbers of twins and triplets. This reflects exactly the proposed code of practice of the Human Fertilisation and Embryology Authority (HFEA).

In Madrid, there was also discussion of how to advance stem cell research while outlawing reproductive cloning. Again, in Britain, Parliament has already legislated to allow the research and ban the cloning.

The UK is regarded as a world leader in this kind of regulation. The Human Fertilisation and Embryology Act 1990, which set up the Human Fertilisation and Embryology Authority, is widely admired. But in such a fast-moving field as this we cannot afford to stand still. Nor has our regulation proved perfect.

Now we have instituted wide-ranging reforms. Gone is the system of authority members themselves chairing inspections; we have recruited and trained new inspectors and expect existing inspectors to undergo updated training. There is double witnessing for all stages of gamete and embryo transfer. We require clinics to carry out an annual 100 per cent audit of embryos in store. We have random unannounced inspections and have started to involve patients in inspections to ensure that their voices are heard.

This year, we have also introduced an alert system whereby when clinics report adverse incidents the HFEA alerts all other clinics in the country with the details so they can ensure they learn from actual and potential mistakes. This is truly ground-breaking: no such system operates either in Europe or the United States.

Our job is certainly not made easier by the increasing gap between what the science could do in 1990 and what is possible now. And there are methods of assisted reproduction that cannot be regulated by the HFEA; gamete intrafallopian transfer (Gift), for instance, was not deemed in need of regulation by Parliament in 1990 because it did not involve the creation of embryos outside the body. Yet Gift contributes to the multiple birth problem and it is difficult to see why patients having this kind of assisted reproduction treatment should not have the same protection as others having IVF. Some reform would be helpful.

None the less, many other countries look with envy to the system of regulation and control of IVF and embryo research we have achieved. And, above all, the advances in treatment have benefited the people who have become parents.

Suzi Leather is chairwoman of the Human Fertilisation and Embryology Authority

Lifelines: 25 years of pushing back the embryology frontiers

25 July 1978 Louise Joy Brown, the world's first successful test-tube baby, born in Britain. Technology is heralded triumph for medical science, but causes many to raise ethical doubts over misuse.

1980 Two Australian teams succeed in IVF deliveries after drug-induced superovulation in the mother, a step forward making IVF programmes viable.

1983 Freezing of human embryos by Linda Mohr and Alan Trounson, left, Infertility Medical Centre (IMC) in Australia, results in world's first frozen embryo baby.

1984 IMC team achieves the world's first birth in a woman without ovaries, using donor eggs, an artificial menstrual cycle, and a special hormone schedule.

1988-89 Gamete intrafallopian transfer (Gift) used as alternative to IVF. First successful pregnancies.

1990 Human Fertility and Embryology Act and Human Fertility and Embryology Authority created.

1992 Rosanna della Corte, above, gives birth at 62 after IVF treatment by Severino Antinori.

2000 The culture of embryonic stem cells opens way for made-to-order tissue for transplant surgery.

2001 US and Italian teams working on first human clone.

2002 Antinori claims three human-cloned pregnancies taking place, two in Russia, one in an Islamic country.