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I hope that, in the light of my explanation and the significant government amendments I have already tabled to address noble Lords’ concerns, my noble friend will agree to withdraw the amendments with the exception of Amendment No. 62A, which, as I have indicated, I am happy to accept.

On Question, amendment agreed to.

Lord Dubs moved Amendment No. 61:

The noble Lord said: My Lords, in the absence of the noble Baroness, Lady Stern, I have been asked to move the amendment in her name. I speak also to Amendments Nos. 61A to 61C. The Bill proposes that the Secretary of State has the power to make health protection regulations. This broad regulation-making power includes a power to enable others to impose restrictions and requirements on individuals through detention, isolation and quarantine. These amendments

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would conclusively remove any subjective element from these clauses and require any restriction or requirement to be proportionate, not only to the immediate aim of imposing the policy, but also to the risk to public health that it intends to meet.

Will the Minister clarify the grounds for a judicial review of a decision to impose special restrictions or requirements? Will he also confirm whether, on judicial review of a decision to impose a restriction or requirement engaging convention rights, the court will be able to substitute its own assessment of proportionality, quash the decision and remove the restriction or requirement? Finally, do the Government accept that a decision to impose a restriction or requirement which engages convention rights must be made on evidence of risk to public health and proportionate to that risk? I beg to move.

Earl Howe: My Lords, the noble Lord, Lord Dubs, has spoken extremely well to this group of amendments. Briefly, I support the thrust of all that he has said. I hope that the Minister can provide us with some reassurance. We left the important issue of proportionality in this part of the Bill somewhat in the air in our Grand Committee debates.

Lord Darzi of Denham: My Lords, subsections (1) and (2) of new Section 45D in Clause 114 of the Bill provide a safeguard in the domestic regulation-making power. That safeguard requires that where an appropriate Minister or decision-maker is imposing, or enabling the imposition of, a restriction or requirement, they must consider that the measure is proportionate to what is sought to be achieved by imposing it.

Amendments No. 61 and 61B remove from this proportionality test the specification of who must consider the measures to be proportionate, and the point in time when that consideration must be made. Amendments Nos. 61A and 61C then require that any measure taken must be proportionate not only to the aim of the particular measure but also that each measure in itself must be proportionate to the overall threat. I have given these amendments a lot of thought, both now and in Grand Committee, and I am still of the view that these amendments would render the provision at best ambiguous, and at worst unworkable. I hope that I can set out why in a way that will convince noble Lords that we are better off with the provision as currently drafted.

6.45 pm

My first concern with these amendments is that, instead of the provisions requiring the Minister or decision-maker to consider the measure proportionate, the provisions would read that the measure must be proportionate. I sympathise with the intention to ensure objectivity in the test. However, it may simply not be possible, at the time that the decision must be taken, to be absolutely sure that the measure is proportionate to the risk it seeks to address. Such a test does not allow for occasions where the scientific evidence may be weak or where the threat is unprecedented and of an unknown nature. The noble Baroness, Lady Finlay, put it very eloquently in Grand Committee when she

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explained that the measures taken during the SARS outbreak in Hong Kong were “taken in the dark” because the true pathogenic nature of that organism was not known at the time.

If the emergency nature of a situation requires that a decision be “taken in the dark”, someone has to make that decision. As I explained in Grand Committee, simply deleting the reference to the person making the judgment that a measure is “proportionate” does not change the fact that such a judgment must be made. Measures are not “proportionate” to threats all by themselves; someone must judge them to be so.

My second concern about these amendments is that they would mean that the measure taken must be judged to be proportionate not only at the point that the decision is taken but also at any given later time. They remove the idea that the proportionality test should be based on whether it was proportionate given the facts at the time of the decision. Instead, they would allow a court, in retrospect, and with further scientific evidence to hand, to look at whether the measures are still considered proportionate, and whether each measure, in and of itself, was proportionate to the overall risk. I have to say that the idea of such a retrospective second-guessing gives me grave concern, especially as the threat of such an examination with hindsight may discourage proper action from being taken at the time to protect public health. I hope that my noble friend Lord Dubs and the noble Earl, Lord Onslow, will understand my concerns and feel able to withdraw their amendments.

Lord Dubs: My Lords, I am grateful to my noble friend for the detailed way in which he dealt with the various points arising from the amendments. I accept what he said, and beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 61A to 61C not moved.]

Lord Darzi of Denham moved Amendment No. 62:

(a) the period specified by virtue of subsection (6A) and the intervals specified by virtue of that subsection must be 28 days or less, and(b) the regulations must require the continuation of the restriction or requirement to be reviewed without an application being made.”

The noble Lord said: My Lords, I beg to move.

Lord Dubs moved, as an amendment to Amendment No. 62, Amendment No. 62A:

On Question, amendment agreed to.

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[Amendments Nos. 62B to 62D, as amendments to Amendment No 62, not moved.]

On Question, Amendment No. 62, as amended, agreed to.

Baroness Thornton moved Amendments Nos. 63 to 68:

“(d) in the case of a dead body, that the body be buried or cremated;(e) in any other case, that the thing be destroyed or disposed of.”“( ) the first regulations to be made under section 45L(4),”

On Question, amendments agreed to.

Lord Dubs moved Amendment No. 68A:

The noble Lord said: My Lords, I wish to move Amendment No. 68A and speak to Amendment No. 68B.

The Bill provides for an emergency procedure for the passage of health protection regulations. This procedure is very broad and is triggered whenever the relevant Minister considers that it is urgent for the regulations to become law. These amendments would create two emergency procedures comprising an urgent procedure proposed by the Bill, which will apply to all regulations except those which enable administrative detention, quarantine or isolation, and a new emergency procedure, which applies to any regulations which enable the Secretary of State or other persons to order the detention, isolation or quarantine of persons. Therefore, a distinction is drawn according to the seriousness of the consequences for the individuals about whom we are talking.

This new formulation meets the Government’s concern expressed in Committee that the urgent procedure was intended for use in circumstances where technical or administrative arrangements might be urgently required by the World Health Organisation. The stricter procedures that I propose are now limited only to regulations which enable administrative orders for detention, isolation and quarantine. I question whether administrative powers to authorise restrictions on individuals, including measures which affect their right to liberty, such as detention, quarantine and isolation, are necessary or are accompanied by adequate safeguards in the Bill.

These provisions do not import the Civil Contingencies Act wholesale. In fact, that Act does not allow for the detention of individuals, as detention must be expressly

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authorised by Parliament in the relevant regulation-making power. Instead, these amendments provide that, where the Government seek to enable the use of emergency administrative detention for public health purposes, the parliamentary scrutiny is at least of the same degree as that envisaged in the Civil Contingencies Act.

The definition of a “public health emergency” is adapted from the Civil Contingencies Act 2004. The current emergency procedure provides no definition of “urgency”, which is left to the discretion of the relevant Minister. Could my noble friend explain why, in the circumstances which Ministers have previously highlighted, such as an outbreak of SARS, Ebola or a similarly life-threatening illness, the potentially draconian steps of enabling administrative detention, isolation or quarantine should not be subject to parliamentary oversight on at least the same terms as those provided in the Civil Contingencies Act 2004? I beg to move.

Baroness Finlay of Llandaff: My Lords, I hesitate to speak against the very erudite speech of the noble Lord, Lord Dubs, but I am concerned that this amendment would make the procedure somewhat clumsy. I have tried to think through different scenarios that might emerge. When you are making a decision, one of the difficulties is that situations constantly evolve; they do not necessarily comprise neat phases. If we take the worst case scenario of an extremely dangerous and infective episode occurring, where we do not want anyone to move around for a certain time, I am not sure that Parliament could be involved anyway. We would have to ask parliamentarians to travel unless we abandoned all parliamentary procedures and said that we would all vote over the internet, and I do not think that such an enormous change as that would occur.

I have tried to envisage different scenarios and how the legislation would work. Recently, I attended a seminar on climate change and potential new diseases. It is extremely scary to think of the way in which different viruses might mutate, resulting in a sudden incidence of high infectivity and mortality rates. Therefore, I am minded to stick with the Bill’s wording and not make decision-making any more difficult. If an emergency occurs, the decision-making will be extremely difficult and I hesitate to put further hurdles in the way.

Lord Darzi of Denham: My Lords, Amendments Nos. 68A and 68B would alter the effect of new Section 45R, which enables public health protection regulations to be made, in urgent circumstances, following a procedure set out in that section. The procedure allows regulations which contain the relevant declaration to take effect immediately and last for 28 days unless they are rejected by a vote in either House of Parliament and therefore cease to have effect. The regulations must be approved by a vote in each House before the 28th day in order to remain in effect.

Amendments Nos. 68A and 68B would reduce that 28-day period to seven days for regulations that enable the imposition of isolation, quarantine or detention. In addition, Amendment No. 68B would require Parliament to be recalled during any recess if such a debate was required, and would allow the regulations

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relating to these measures to be amended during debate in either House. Before I set out why I do not think these amendments are necessary, I emphasise that they do not reflect any recommendations put forward by the Delegated Powers and Regulatory Reform Committee. As noble Lords know, the Government accepted that committee’s recommendations in full and it has not raised any further issues since.

I understand the reasoning behind the desire to recall Parliament and allow only seven days before a debate on regulations relating to isolation, quarantine and detention. However, I believe that there are already sufficient safeguards in the Bill to ensure that individuals’ liberties are respected. All individuals who are placed under quarantine, detention or isolation through regulations will have a right to appeal at any time to a justice of the peace. In addition, they must have an automatic review of their case, whether or not they have used their right of appeal, within 28 days of the measure commencing. These provisions must be included in all regulations imposing quarantine, isolation or detention regardless of when Parliament approves them. I do not believe that it would be appropriate to recall Parliament in every situation where urgent regulations included isolation, quarantine and detention measures.

Reference was made to SARS. If there were another outbreak of an infection such as the outbreak of SARS in Hong Kong, and experts strongly believed that the UK was at imminent risk, we would want to make urgent regulations to ensure that we had immediate quarantine powers. However, although it would be necessary to ensure that powers were in place immediately, they might not be used immediately. In fact, they might not be used for weeks, months or at all. Their use would depend on whether the risk had materialised.

Such precautionary measures may be urgent but may not have such serious implications as to warrant the recall of Parliament, especially given that isolation, quarantine or detention can be imposed only where the serious and imminent threat is actually present at the relevant point in time. That said, our provisions would still allow the Government to recall Parliament where the threat warranted it.

The amendments would allow the regulations to be amended. If the Secretary of State were to decide that regulations were needed under the urgent procedure, the decision would be taken following important discussion with experts in the relevant fields. Advice might be sought from experts at the Health Protection Agency, senior doctors and scientists, and possibly even international health organisations such as the World Health Organisation. The regulations laid would seek to implement the measures recommended by these experts as necessary to deal with the public threat at hand. In such circumstances, I strongly believe that the decision that Parliament should be asked to take is to accept the measures in full or to reject them.

I hope I have addressed the issues raised by the noble Baroness and that my noble friend Lord Dubs will understand my concerns and feel able to withdraw these amendments.

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Lord Dubs: My Lords, my noble friend is the most persuasive of Ministers, and I say that in a complimentary and not a pejorative manner. I am most grateful to him for having explained so clearly his concerns about the amendments and how this part of the Bill would work. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 68B not moved.]

Clause 134 [Duty of Primary Care Trusts]:

7 pm

Earl Howe moved Amendment No. 69:

The noble Earl said: My Lords, I want to turn a spotlight on to an issue of considerable importance for NHS patients, and that is the issue of exceptional cases. What do I mean by an exceptional case? An exceptional case arises where a PCT receives a request from a member of the public or a clinician for a treatment which is not available through existing contracts or wider commissioning policies. There are several sets of circumstances where exceptional requests for treatment are likely to arise. One example is where new treatments being evaluated by NICE have not been explicitly funded in the operational plans of the PCT. Another is high-cost treatments for rare conditions. A third is where a treatment involves a drug where the requested use would be off licence. Recently a lot of the debate on exceptional cases has focused on drugs for the treatment of cancer but the situation also applies to a range of other conditions and it is clear that the issue will become much broader as more targeted therapies are developed which have smaller patient populations and which are at the same time more expensive. In 2005-06 Peterborough PCT received 156 applications for exceptional funding, of which 15 related to high-cost drugs, 13 to breast augmentation, 12 to pain management and 11 to orthopaedics.

It is the duty of PCTs, when an application of this sort is received, to assess the merits of the request. Exceptionality is demonstrated by evidence that the benefit from treatment for a particular patient is “significantly greater” than the benefit which would accrue to a patient with a similar clinical picture. The Faculty of Public Health in an article published three years ago offered three grounds on which a patient can be considered eligible for funding. The first is where a particular development in a patient’s condition for which treatment is required is “wholly unforeseen”. The second is where the treatment would “avert a crisis”. The third is where the use of the treatment in a particular patient has such a major health gain associated with it that it is “truly remarkable in its efficacy”.

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