Medicines and Medical Devices Bill

Debate between Baroness Jolly and Baroness Garden of Frognal

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

My understanding is that the noble Lord, Lord Lansley, has withdrawn, so I call the noble Baroness, Lady Jolly.

[Baroness Jolly (LD) [V]]

My Lords, since March 2011, the European Medicines Agency made available information on clinical trials in children via a public interface, the European Union Clinical Trials Register. The register is based on the information stored in EudraCT, a European database that contains information on all clinical trials with at least a site in the EEA. Can the Minister clarify whether this information will be available to researchers and paediatricians in the UK? Can he confirm whether this point has been part of EU negotiations? Can he further clarify whether there is any difference with data from joint research projects operating across the island of Ireland? Are all data equally accessible? We support the amendment.

--- Later in debate ---

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

The noble Lord, Lord Blunkett, has withdrawn, so I call the noble Baroness, Lady Jolly.

[Baroness Jolly (LD) [V]]

My Lords, we support these amendments, which relate to the disapplication of regulatory provisions in an emergency. As the Bill stands, the Secretary of State may make regulations about these provisions. This can be subject either to

“conditions set out in the regulations”

or in

“a protocol published by the appropriate authority.”

As the protocol is not subject to parliamentary scrutiny, the amendment in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel, would remove this provision from the Bill so that, as the noble Baroness, Lady Wheeler, said, conditions would have to be set by regulations alone.

Medical Innovation Bill [HL]

Debate between Baroness Jolly and Baroness Garden of Frognal

Friday 12th December 2014 Lords Chamber

[Baroness Garden of Frognal]

My Lords, I thank my noble and learned friend for his suggestion. I think that the noble Lord, Lord Winston, suggested moving Amendment 13 into the group which begins with Amendment 5 but leaving Amendments 11 and 12 in this group. If we proceed on that basis, then, as my noble and learned friend said, when Amendments 11 and 12 are called, he will have the opportunity to speak.

[Baroness Jolly (LD)]

My Lords, this group of amendments relates to the scope of the Bill. As noble Lords are aware, the Bill relates to a decision by a doctor to depart from the existing range of accepted medical treatments for a condition. I make it clear that the Bill applies not to research but only to decisions relating to individual patient treatment. My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee that the conditions of the Bill might add to the requirements under which researchers operate. Amendment 8 in the name of my noble friend Lord Saatchi responds to these concerns, clarifying that the Bill does not apply to treatment carried out for the purpose of research. As such, Amendment 9 removes the existing provision on research, which is no longer necessary.

My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee and at the round-table event hosted by my noble friend on 11 November that cosmetic treatment may be subject to less scrutiny than other treatments. Peers were therefore reluctant that the Bill should apply to this area of practice. Amendment 10 ensures that the Bill does not apply to treatment which is carried out solely for cosmetic purposes. Beyond this, the Government do not consider it necessary to exclude certain treatments or conditions from the Bill.

Amendment 1 from the noble Lord, Lord Winston, seeks to clarify that a doctor would not have to rely on the Bill where time or place did not allow the required consultation. The Government do not view this as a necessary amendment as the Bill already makes it clear that there is no requirement to innovate. If a doctor chooses to innovate, it is for that innovating doctor to decide whether to rely on the protection of the Bill and therefore to take the steps set out under the Bill. Clause 2, as amended in Committee, ensures that the common law test of clinical negligence is not affected by the Bill.

My noble and learned friend Lord Mackay of Clashfern suggested that Amendment 1 would be a helpful clarification to the Bill. Amendment 14 in the name of my noble friend Lord Saatchi will clarify that the Bill does not limit the circumstances in which the common law may be relied upon, and it expressly gives emergency treatment as an example. Amendment 1 is not necessary and could create confusion for doctors in determining exactly when the Bill applies. The amendment might also suggest that it is only in these limited circumstances that the Bill would not apply, whereas it is intended that doctors can choose whether to rely on the Bill, and it provides an option for them to demonstrate that they have acted responsibly. Amendment 14 proposed by my noble friend Lord Saatchi clarifies the point, confirming that the Bill does not limit the circumstances in which the common law may be relied upon, giving emergency treatment as one such example.

I want to pick up a point raised by my noble friend Lord Colwyn concerning placing GPs in a position where they are asked to innovate but are not able to do so. The Bill requires a doctor, in making a decision to innovate, to consider any opinions or requests expressed by, or in relation to, the patient in order to ensure that the decision to do so is taken responsibly. The clause in question does not confer any additional rights on patients to demand innovative treatment. However, it is crucial that, when making a decision to innovate, a doctor considers the view of that patient. As such, I hope that noble Lords will throw their support behind Amendment 14 put forward by my noble friend Lord Saatchi.

A further clarification is provided by my noble friend’s Amendment 15. In Committee, the noble and learned Lord, Lord Woolf, argued that the Bill does not offer an alternative defence to that under common law; rather, it is supplementary. The Government agree with that interpretation and also that the Bill’s current wording is not sufficiently clear on this point. Amendment 15 clarifies that a decision to innovate in accordance with the Bill does not prevent a doctor also relying on the existing common law defence under Bolam, and it would be a valuable addition to the Bill.

Amendments 11 and 12 seek to extend the application of the Bill to dentists as well as doctors. The Bill applies only to doctors, as it responds to concerns that doctors have raised concerning the fear of litigation. The Bill is aimed at reassuring doctors who feel unable to innovate due to concerns about litigation. The Department of Health’s consultation on the Medical Innovation Bill revealed that some doctors find the threat of litigation to be a block to innovation, although this view was not universally held. The consultation did not reveal the same demand for the Bill from dentists. If the Bill passes, we will consider its impact and will continue to listen to the concerns of all healthcare professionals.

Amendment 12 also seeks to limit the application of the Bill to practitioners or health workers who are registered by the GMC or to dentists who are registered by the General Dental Council. The Government consider this amendment to be unnecessary as the Bill’s scope is already limited to doctors, who are defined under the Bill as registered medical practitioners. All registered medical practitioners are registered with the GMC.

Amendment 6 in the name of the noble Lord, Lord Winston, seeks to define the meaning of innovation under the Bill. Over the course of the debates on this Bill, a number of suggestions have been brought forward on how to approach this issue. Drafting a positive definition of innovation is a difficult task. This is revealed by the addition in this amendment of paragraph (e) relating to the application of a monitoring device or biosensor, which has been absent from prior definitions. It is crucial that the definition of innovation under the Bill is future-proof and clear for both doctors and patients.

The Bill defines innovation as a situation where a doctor decides to depart from the existing range of accepted medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether they are following accepted treatments. Here I pick up three points, one being from the noble Lord, Lord Colwyn. I was asked about upholding the advice given by NICE and whether the Bill would allow doctors to go against NICE guidelines. The Bill does not impact on the existing legal obligation for NHS commissioners to provide funding for drugs that have been recommended in NICE technology appraisals. However, it will remain for doctors to decide on the most clinically appropriate treatment for their patients, whether or not they are innovating under the Bill.