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Lord Warner: My Lords, that is outside the scope of the Bill. Perhaps it would help the House if I simply said that, as I thought that I had made clear, the changes will not take place until there is a review of the HFE Act. There will almost certainly be a response to the Health Committee, which has reported on the subject, and there will be an opportunity for Parliament to debate those issues. The merger itself will require primary legislation, which will give Parliament an opportunity to scrutinise the area. I hope that that helps the noble Lord.

On Question, amendment agreed to.

Clause 15 [General functions]:

[Amendment No. 31 not moved.]

Clause 16 [Licence requirement]:

Earl Howe moved Amendment No. 32:


"(c) "relevant material", in relation to use for the scheduled purpose of research, does not include material obtained during the conduct of clinical trials on medicinal products for human use."

The noble Earl said: My Lords, we come to an issue debated in general terms in Committee, but not by way of this amendment, which is new. Clause 16 sets out the activities relating to human tissue for which a licence will be required. It also makes provision for exceptions from the licensing requirement and, in subsection (7) specifies two particular exclusions.

My amendment is prompted by a concern about the bureaucratic burden which the clause places on researchers, and in particular on those who undertake clinical research on medical products. Clinical trials are already regulated under the clinical trials directive—implemented under Statutory Instrument No. 1031 of this year—which includes requirements for there to be informed consent and ethics committee approval in place. It also provides for inspection of documents, facilities and records, and sets out quality assurance arrangements and penalties.

Given those existing regulations, it seems difficult to justify imposing additional licensing provisions for blood and other tissue obtained during clinical research on medical products. If we look at Clause 16(7)(b), we see that there is an exclusion from the licensing provisions in respect of blood and blood
 
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products for transplantation. The reason for that is that those are covered by other regulations. Exactly the same principle should apply to blood and other tissue obtained during the conduct of clinical research on medical products.

This is an instance of unnecessary overregulation in the Bill. I hope that the Minister will agree to consider the amendment in a constructive way. I beg to move.

Baroness Neuberger: My Lords, we support the noble Earl on the amendment.

Lord Warner: My Lords, I have some sympathy with the case of the pharmaceutical industry, which in this country has a very good record regarding obtaining the proper consent to use tissue in its research. The industry has long been subject to regulation of one sort or another relating to clinical trials of medicines, and is expert at risk management. However, the activities regulated by the recent clinical trials regulations are not identical to those regulated under the Bill. The clinical trials regulations monitor the safe and proper conduct of clinical trials for medicinal products, while the Bill regulates the storage and use of tissue for scheduled purposes, among them research. That includes blood stored and used for research. As the noble Earl said, it is blood for transplantation that is excluded from the Bill on the grounds that it will be separately regulated under the blood directive.

That said, the Government certainly have no desire to burden industry with unnecessary regulation. Research itself is not licensable under the Bill, and the Secretary of State has the scope at Clause 16(3) to exclude from licensing storage for research in circumstances to be specified in regulations. The circumstances of clinical trials undertaken by pharmaceutical companies can be examined in the context of those regulations, which will be made in time to coincide with the effective date of the Bill's implementation.

As I have said before, there is no intention to license—if I can put it this way—every pot on a laboratory bench. I draw your Lordships' attention to Clause 43(2), which requires the HTA to have regard to the principles of best regulatory practice, which includes targeting regulatory activities only at cases in which action is needed. It is intended that the Human Tissue Authority will take a pragmatic approach, using a light touch where appropriate.

We have met representatives of the industry since Grand Committee, and my understanding is that they were reassured by what we said. I hope that, with the assurance that we have every intention of avoiding unnecessary bureaucracy, the noble Earl will be able to withdraw his amendment.

Earl Howe: My Lords, that was a very helpful reply. I noted that the Minister was careful not to make any specific pledges. Nevertheless, the spirit and drift of his remarks were encouraging. I hope very much that
 
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these matters will be borne in mind when the regulations come to be drawn up. I am much reassured and I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 25 [Breach of licence requirement]:

[Amendments Nos. 33 and 34 not moved.]

Clause 30 [Possession of anatomical specimens away from licensed premises]:

[Amendments Nos. 35 and 36 not moved.]

Clause 31 [Possession of former anatomical specimens away from licensed premises]:

[Amendments Nos. 37 and 38 not moved.]

Clause 32 [Prohibition of commercial dealings in human material for transplantation]:

[Amendments Nos. 39 and 40 not moved.]

Viscount Chandos moved Amendment No. 41:


"Promotion of transplants and the giving and recording of appropriate consents
(1) The Secretary of State may make regulations for the purposes of promoting or securing—
(a) an increase in the number of transplants that are carried out using transplantable material removed from a human body or of such transplants of a particular description,
(b) an increase in the number of appropriate consents given for such transplants or for such transplants of a particular description, or
(c) the recording of such consents in a manner that enables it to be determined whether consent for such transplants or for such transplants of a particular description has been given by a particular person within a period which enables any transplant for which he has given consent to be carried out with a reasonable prospect of success.
(2) Regulations under this section may make such modifications of this Act or any other enactment or any provision made under any enactment as the Secretary of State thinks appropriate for the purposes of the regulations.
(3) In this section "transplantable material" has the same meaning as in section 33."

The noble Viscount said: My Lords, I should like to speak to Amendment No. 41, standing in the name of my noble friend Lord Hughes of Woodside. With the permission of the House, I shall also speak to Amendment No. 42.

The amendments relate specifically to organ donation for the purpose of transplantation. They have been tabled in response to concern about the current system of consent for donation and to raise awareness of the opportunity this Bill presents to improve the rate of organ donation in this country. I declare an interest in this area as president of the National Kidney Research Fund, the UK's leading charity funding research into kidney disease and helping to improve patient care. The fund is committed to helping to improve the organ donation rate and to increasing the number of patients who can be treated with viable transplant.
 
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Transplantation provides patients who have end-stage renal failure with their best chance of rehabilitation. Without a transplant, patients with end-stage renal failure require either haemodialysis or peritoneal dialysis if they are not to die.

My interest in renal treatment is based on my father's 15 years on haemodialysis, starting as one of the first recipients in this country of such treatment in 1965. While he and other dialysis patients, including, in this House, the noble Lord, Lord Biffen, have demonstrated what a full life can still be led with such treatment, that should not obscure the extent to which a considerably higher quality of life is generally attributable to a patient in receipt of a transplant. Nor should it obscure the heavy, continuing cost to the NHS of long-term dialysis treatment, compared with a transplant.

The purpose of these amendments is to allow the Secretary of State to move from the current system of informed consent for organ donation to a system of presumed consent with opt-out. We have opted for an enabling clause, with the attendant difficulties, I admit, in the belief that this may represent the best way to allow the Secretary of State to move forward in this direction at a time when the appropriate measures can best be implemented and public support can best be mobilised. This system would be based on the presumption that an individual's organs would be available for donation unless he or she registers their desire to opt out. It would still ensure that relatives were approached and informed before any organs were made available, so that any objection to donation on their part could be made.

We believe that a system of presumed consent with opt-out, alongside other measures to tackle the shortage of organs, would increase significantly the level of organ donation in this country. Other European countries that have adopted and continue to practise a system of presumed consent have organ donation rates that are almost twice as high as that in the UK. For example, figures for 2003 showed that the UK had around 12 cadaveric donors per million of the population compared with, say, 23 in Austria and 24 in Belgium.

Presumed consent would work best as part of a package of measures to increase organ availability. Under the current system, if a person has failed to register their consent to donate in the appropriate way, their relatives are put under very great pressure, having to second-guess their wishes after their death. At times of great stress, if relatives are unsure of their loved one's wishes, they tend to resort to the default position and refuse donation. Research has shown that this uncertainty is the principal reason behind the 40 per cent refusal rate by relatives in this country.

Moving to a system of consent, where it was accepted that organs would be made available unless relatives objected, would help to alleviate some of the pressure on relatives to make this difficult decision.

I am acutely conscious that the primary purpose of the Bill is to help restore public confidence after the tragedies at Bristol and Alder Hey in the overall
 
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practice of organ removal. Against this particular background, I recognise the difficulty and sensitivity of incorporating a measure which may, rightly or wrongly, raise fears of the sort that the Bill has been designed precisely to allay. However, I believe confidently that, particularly with the huge improvement in information technology and the progressive implementation of electronic patient records, a system of presumed consent can now offer the very security and confidence that the public desire. Even 10 years ago, I recognise that that might have been much more difficult to assert.

It is never easy to approach relatives about organ donation at a time of great sadness, particularly if the law states that organs are not available for donation unless appropriate consent has been given. It is right that the wishes of the deceased are paramount in this situation and that relatives are fully consulted ahead of any decision. However, the current system does little to encourage health professionals to make the approach in the first place, and organs are lost as a result of a failure to request donation. Many bereaved people have in fact expressed regret at not being asked at the time whether they would consent to donating their loved one's organs.

A system of presumed consent with opt-out would place a positive emphasis on the importance that organ donation can make to the lives of those waiting for a transplant. It would also reassure healthcare professionals that it was acceptable to request donation, and would therefore encourage them to approach relatives more routinely.

It is for these reasons that I hope the Minister will seriously consider these amendments and recognise the opportunity that the Bill presents to make a real commitment to improve the rate of organ donation in this country.


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