Health and Social Care Bill

Lord Clement-Jones Excerpts

Tuesday 13th March 2012 Lords Chamber

Moved by

[Lord Clement-Jones]

297: After Clause 294, insert the following new Clause—
“Contravention of section 64 of the Medicines Act 1968: due diligence defence
In section 67 of the Medicines Act 1968 (offences under Part 3), after subsection (2) insert—“(2A) But it is a defence for a person charged with an offence under subsection (2) in respect of a contravention of section 64 to show that the person exercised all due diligence to avoid committing the offence.””

[Lord Clement-Jones]

My Lords, in moving Amendment 297, I shall speak also to Amendment 301. First, I declare an interest as chairman of the council of the School of Pharmacy, University of London. For the avoidance of doubt from the outset, I will not press these amendments.

In Committee, I moved an amendment to provide a due diligence defence to the currently strict liability criminal offence committed under Section 64 of the Medicines Act 1968. This has the potential to operate very harshly on those making single errors dispensing medicines, whether in retail or hospital pharmacies. The intent of the original amendment was to remove the injustice that pharmacists and some others among healthcare professionals face criminalisation through single dispensing errors.

It was also very importantly designed to increase patient safety by removing barriers to a learning culture within the pharmacy profession and to ensure that pharmacists who wish to declare a dispensing error in the interests of patient safety are not penalised. The formulation of a defence, which gains universal acceptance among the pharmacy profession, has however proved more difficult than originally anticipated. Although the regulator, the General Pharmaceutical Council, has been supportive of the proposed amendment, there is as yet no consensus with the pharmacy professional bodies as to the best way legally of formulating a defence that meets these objectives.

There is, however, a unanimous view among professional pharmacy bodies that it would be better not to amend the Act at this juncture in this way but to wait for the full review of offences under the Medicines Act due to be carried out by the Medicines and Healthcare products Regulatory Agency, the MHRA. There have of course been helpful discussions to this effect with the chief pharmacist and his colleagues at the department, and agreement, as I understand it, that we should go forward on this basis.

In this context, it would extremely helpful for all concerned if the Minister could confirm the timetable for the scoping of the sanctions and penalties in medicines legislation review to be carried out by the MHRA and any other details of the review that he can give at the present time, such as the procedure, the timetable, and the involvement of the regulator—the GPhC—and professional bodies.

Although this is not directly within the gift of the Minister, it would be extremely helpful if he could also indicate that the department will engage with the DPP and the Crown Prosecution Service to encourage them in the mean time to engage with the profession and the regulator in reviewing the prosecution guidelines for offences under the Medicines Act. That would be extremely welcome to all those concerned in the profession. I beg to move.

[Lord Hunt of Kings Heath]

I must say that I am surprised that the noble Lord moved this amendment. He told me yesterday that he was not going to and did not have the courtesy to tell me that today he is. The amendment raises a very interesting question. No doubt we will be very interested to hear the response of the noble Earl, Lord Howe. He might perhaps add the membership of the review team to the details of the review.

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In conclusion, I reiterate my thanks to my noble friend for enabling this afternoon’s debate on the issue. I hope he will be reassured by the undertakings I have given that, despite the current lack of consensus, we will continue to work with interested parties on a way forward.

[Lord Clement-Jones]

My Lords, I thank the Minister for that reply. First, let me say to the noble Lord, Lord Hunt, that no discourtesy at all was intended. We may have misunderstood each other. I never intended to press the amendment, but of course wished to raise the issue in order to get a response from the Minister about the way forward in the absence of this amendment being incorporated in the Bill. I apologise if I inadvertently misled the noble Lord.

We all have the same purpose, which is, as the Minister said, to encourage a learning culture within the profession so that it no longer has hanging over it a lack of a defence to the absolute liability in Section 64 of the Medicines Act; and, it may well be, other aspects of the Act as well, which no doubt will be uncovered as the MHRA carries on its work. I, too, share the Minister’s disappointment that we were not able to agree a suitable solution between the department, the regulator and the pharmacy profession.

I thank the Minister for showing us the way forward with the MHRA review of the scoping that will be done by September 2012. I very much hope that, as he said, the DPP will consider this debate very carefully, and that he will respond favourably and engage in a review of the guidelines. I also reiterate the Minister’s wish and hope that the profession will engage very closely with the MHRA in this review and in any review of the guidelines by the Crown Prosecution Service. In the mean time, I beg leave to withdraw the amendment.

Amendment 297 withdrawn.

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[Lord Owen]

My Lords, the case has been made extremely well for accepting that one of the most vehement elements of criticism could be somewhat defused if this amendment was accepted by the Government. After all, some people have argued that the whole of Part 3 should be abolished. By accepting that the Government are going to go ahead but just asking that the relevant measures should be phased in seems to me a very rational and reasonable way of acknowledging that there is very deep-seated and justifiable criticism of this legislation.

Reference has been made to the primacy of the need to make the efficiency savings and the need to carry the people in the health service with regard to the provisions in the Bill. I do not want to weary the House by listing the royal colleges that are now opposed to this legislation but it is a staggering development. Nobody can deny the phenomenon that we are seeing; it is unprecedented. I would never have conceived it possible that there would be this degree of professional criticism of the Bill when I first started to look at it and realised that it was in my judgment a very bad Bill. Indeed, it remains so in my judgment. However, I am not here to argue all these cases. This seems to me an important amendment which is geared to accepting that the Government will certainly resist the dropping of Part 3, but may be amenable to phasing it in. Indeed, the Minister might propose a different phasing-in period. It would seem to be a very wise course to deal with the essential elements—the efficiency savings—then bed in some of the other aspects that are new in the Bill and may well be accepted within a short period of time, and leave the element which causes the most deep-seated opposition until later. I hope that the Minister will listen to the argument, reflect it in his speech and be ready to make this important concession to his critics.

[Lord Clement-Jones]

My Lords, I am afraid that I cannot agree with the noble Lord, Lord Owen, as regards supporting the amendment. However, I appreciate that the noble Baroness, Lady Thornton, has adopted a much more emollient line on Amendment 300A, is not making a full frontal attack on the whole Bill and is looking simply at Part 3. There is certainly an argument to be explored in what she had to say but I cannot understand the logic of why, of all the parts of the Bill that she has talked about today, she is focusing on Part 3. I find it extraordinary that throughout the debates that have taken place on the Bill the Opposition have refused to accept that the National Health Service Act 2006 introduced price competition into the NHS. If Part 3 did nothing else but plug some of the competition problems in the 2006 Act, I would support it.

[Baroness Thornton]

Would the noble Lord care to tell me to which part of the 2006 Act he is referring because, according to my recollection of the Act, it does not mention the word “competition” anywhere?

[Lord Clement-Jones]

My Lords, that is precisely the point and that is precisely why the Labour Government were avoiding any argument because that is where the big loophole lies. Any competition lawyer will tell you that that was the point where EU competition law started to bite in the NHS. That is a fact which you cannot deny. The establishment of independent treatment centres constituted a major introduction of the private sector into the health service by the Labour Government. That process was far more unregulated than it will be in the future under this Bill. There were major flaws in the 2006 Act which have never been fully acknowledged by the Labour Party throughout these debates. The noble Baroness’s speech could have been written three or four weeks ago. The Opposition refuse to accept the value and benefit of the amendments that have been made to Part 3 just in the past two weeks. I will not adumbrate them all. I refer the Opposition to the House of Commons paper that has just been written which sets out in great detail something like 2,000 amendments that have been made to the Bill since it started its passage through the House of Commons. We have had Future Forum, we have had 1,000 amendments tabled in this House alone and we have had changes to the Competition Commission’s involvement.

[Baroness Thornton]

What is the noble Lord’s answer to the question which I put? I was not attacking him and his party. I realise that he has to attack; that is his method of dealing with issues. That is a shame as I have from time to time tempted him not to do so. However, does he accept what the noble Lord, Lord Owen, said about the hundreds of thousands of people and professionals who are fearful of this Bill? Attacking me as much as he likes will not alter that fact.

[Lord Clement-Jones]

My Lords, I really enjoyed the noble Baroness’s intervention. Today’s news about the change in attitude of the Royal College of General Practitioners shows that we have reached a genuine watershed. It may not have changed its mind absolutely, although it appears that membership pressure is being applied to the leadership of the royal college, but this is a real watershed whereby the acceptance of the fact that the Bill is going through is changing hearts and minds—not just minds but hearts as well. I am far more optimistic than the noble Lord, Lord Owen, because I believe that the other royal colleges will follow suit. They are actually looking at the substance of the Bill, not at some of the alarmist propaganda being put out. They are considering how mergers between foundation trusts will be regulated, how Monitor will do its duty and the additional powers that Monitor will have following consideration by Future Forum and Members of this House. They are also considering the impact of EU competition law following the Pepper v Hart statement that was made the other day. They are looking at the substance, which is exactly the way to look at the Bill. I believe that Part 3 is one of the most valuable parts of the Bill. I did not believe that it was acceptable to start with. That is precisely why I put down amendments in Committee and on Report. I am very pleased to say that it is much improved. The Bill should not be held up because of Part 3. In fact, it should be celebrated because of Part 3.

[Lord Newton of Braintree]

My Lords, those who have been here will have realised by now that this is one of my “good boy” days. At the risk of seeming sycophantic, even beyond being a good boy, I support every word that my noble friend Lord Clement-Jones has just said. I will refer back in a moment to something the noble Baroness, Lady Thornton, said about former Ministers. This chunk of the Bill—Part 3—is largely about Monitor and includes a lot that the House has been pressing for in terms of increasing Monitor’s power to intervene and do sensible things in a sensible way. It also includes all the stuff about pricing and tariffs, which in my view need to be addressed now, not in four years’ time.

My main point concerns what the noble Baroness, Lady Thornton, said about former Ministers knowing about the problems caused by upheaval. We do. I became very much aware that the publication of a White Paper was the start of a process, not the end. Too often Ministers think that all they have to do is publish an edict and everybody on the ground will carry it out. These things take time, trouble and involve culture change. However—this is the point here—what is equally or even more damaging is year upon year of uncertainty, which is what this amendment seeks to bring about.

I have referred on a number of occasions to the merger/takeover proceedings in which I was involved last year with the health trust that I then chaired. That occurred partly against the background of Monitor and the competition matters that are being changed in this Bill for the better. The worst thing was the uncertainty for everybody involved—the way it was dragging on and nobody knew what the future was. Good people started to leave or think about whether they had a future with the organisation. It would be insane to go down this path and I strongly recommend that the House should not do so.

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[Baroness Thornton]

I thank the noble Earl for his, as usual, extremely expert and very technical response, and I think that he completely missed the point. He did not address the risks that I mentioned all the way through the Bill, the risks that are contingent on implementing so much change so quickly and simultaneously. We will be back here very soon, I suspect, when we will be trying somehow to manage and mend.

I want to make just one or two remarks and will not keep the House very long on this matter. I would like to read to the House a Motion that Liberal Democrat MPs have tabled in the debate that is going on in the Commons right now. Both ends of this building are, as we speak, engaged with their concerns about the Bill. In seeking to amend the Labour amendment in the other place, colleagues of the noble Baroness, Lady Williams, and the noble Lord, Lord Clement-Jones, have said that they decline,

“to support the Bill in its current form”,

and they call for,

“an urgent summit of the royal colleges, professional bodies, patients’ organisations and the government to plan health reforms based on the coalition agreement”.

[Lord Clement-Jones]

Would the noble Baroness like to say how many Liberal Democrat MPs have put their name to that particular Motion?

[Baroness Thornton]

It does not really matter. Five of his colleagues have put their names to it. The point I am making to the noble Lord is that I agree with them about the way forward. It echoes very much what the noble Baroness, Lady Williams, was saying about recognising the disquiet, hostility and fear that exists towards this Bill, particularly this part.

At the end of the day, the Royal College of General Practitioners and the other royal colleges, trade unions, nurses and doctors are the people who will save our NHS, whatever the Government have decided to do to it. They are the people who will actually deliver the healthcare. That is what the royal college of GPs is saying now. It did not say that it resiled from its position about this Bill; not at all. It is acknowledging that, along with the nurses and everybody else, it will deliver this Bill. It will put patients at the heart of the health system. I think that we should all pay tribute to that and be reassured by it.

The noble Lord, Lord Newton, said that mergers will still proceed. They will still proceed regardless of whether this amendment is agreed. However, he also said that good people leave when there is disruption in the health service. That is very true. They are leaving in their droves. We are losing hundreds if not thousands of good people from the National Health Service because of the past two years, the White Paper and the Bill.

I thank the noble Lord, Lord Crisp, for his remarks—I think he was very wise—and the noble Baroness, Lady Williams, for hers. She is quite right. I am flattered that she took my remarks seriously, because this is not about wrecking the Bill. I did not tackle any of the policy issues that the noble Earl chose to stand up as Aunt Sallies and then knock down. When I introduced the amendment, I said that this was about doing things in an orderly fashion, in a way that would help to save our NHS. That is the point. The noble Earl did not tackle any of the risks that I raised about how to deliver the Nicholson challenge simultaneously with all the other changes in the Bill. In fact, he went close to saying that we have gone too far anyway to stop that. I was not convinced by his remarks about the risks and how they might be mitigated. We need time to work on this. We need time to get support for it, if it goes through. The amendment allows us to do that. I wish to test the opinion of the House.