Medicines and Medical Devices Bill

Debate between Baroness Garden of Frognal and Lord Patel

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

[Lord Patel (CB) [V]]

My Lords, I shall curtail my remarks, as time is limited and this is very much a probing amendment. It draws attention to the need to ensure that paediatric regulation-specific measures that preside over the licensing of medicines to better protect the health of children, are reflected in future legislation regarding clinical trials in the United Kingdom.

New medicines licensed in the EU are currently subject to an EU Parliament directive that requires research about new medicines to consider babies, children and young people. The directive means that standardised procedures are in place for sponsors to plan and conduct studies. To get new medicines intended for use by children licensed for marketing in the EU, sponsors must have in place a paediatric investigation plan that aims to ensure that the necessary data are obtained through studies in children. In short, new medicines applying to be licensed for use by children must be trialled by them. It is often the case that medicines trialled in adults are then given in lower doses to children.

New medicines trialled in the United Kingdom are currently subject to this regulation. Moving on, there are clear clinical reasons why it is important for babies, children and young people, as they may show differences from adults in their response to and tolerance of medicines. To ensure that new medicines are safe for their use, they must be involved in clinical trials. That is the important point of my modest amendment.

Furthermore, there is a commitment and a key pledge in the NHS long-term plan to raise to 50% by 2025 the involvement of children and young adults in clinical trials. If there is no regulation requiring that data be collected in clinical trials with children, we will not achieve this. So all I seek is an assurance from the Minister that the Government and the MHRA are well aware of this and that the paediatric regulation will be considered whenever the clinical trials regulations are drawn up by the MHRA. I beg to move.

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My understanding is that the noble Lord, Lord Lansley, has withdrawn, so I call the noble Baroness, Lady Jolly.

--- Later in debate ---

[Lord Patel (CB) [V]]

My Lords, I support these amendments. They touch on the issues and arguments returned to in respect of amendments to Clauses 15 and 42, which set out the procedures to be followed in exercising these powers, as was mentioned by the noble Lord, Lord Hunt of Kings Heath, its unjustified use of negative procedure and this case of protocols. Clauses 6 and 15 provide that the Secretary of State can disapply certain provisions of the medicines and medical devices regulations

“in circumstances which give rise to a need to protect the public from a risk of serious harm to health.”

Such provisions may be within the Human Medicines Regulations 2012, the Medicines for Human Use (Clinical Trials) Regulations 2004, and the Medical Devices Regulations 2002. However, they also may refer to those provisions that are still to be drafted at the current time and are thus unknown and not yet subject to scrutiny.

I recognise that it is necessary to be flexible in the face of an emergency situation as in the current pandemic. However, in its present form this is another example of broad-reaching powers falling outside of that which is reasonable and proportionate. While the disapplication of certain provisions using this power can be exercised to regulations under the affirmative procedure, they may also be passed in certain circumstances by the negative procedure, and, as in these amendments, by protocol. The use of a protocol, in particular, bypasses Parliament, and therefore is unnecessary. I support these amendments.

[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.

--- Later in debate ---

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

My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I say respectfully to my friend the Minister that he is putting up smokescreens. As he mentioned, he already has the power under the 2012 Act to do much of what he wants to do. Furthermore, the arguments used all relate to the Covid emergency. He alluded to this afternoon’s debate and the measures that are about to be taken, but he already has those powers, otherwise he would not be able to do it. We have emergency legislation related to Covid, which includes immunisation through vaccines. By the way, how many doses would be required? It is not necessary to have that in legislation: it is a clinical decision based on the effectiveness of a vaccine. I do not require legislation to tell me how many tablets I should prescribe to my patients for any disease, so I fear that these are smokescreens. He already has powers of disapplication in an emergency, and I continue to support the amendment.

Covid-19: Cancelled Medical Operations

Debate between Baroness Garden of Frognal and Lord Patel

Wednesday 10th June 2020 Lords Chamber

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

We do not seem to be able to hear the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I have unmuted my microphone and I hope that my voice is coming through. I am sorry for the delay.

As the Minister will know, several million patients are on waiting lists for surgery. Given the increased levels of hygiene safety that will be required, it is inevitable that productivity will be down. This means that there will be a need for the prioritisation of cases. Does he agree that the professional organisations should draw up advisory guidelines for clinicians, rather than leaving it to the individuals?

European Union (Withdrawal) Bill

Debate between Baroness Garden of Frognal and Lord Patel

Committee: 2nd sitting (Hansard): House of Lords
Monday 26th February 2018 Lords Chamber

[Baroness Garden of Frognal (LD)]

My Lords, I have added my name to Amendment 10, tabled by the noble Lord, Lord Hunt, and have Amendment 163 in this group in my name and those of my noble friend Lord Storey and the noble Earls, Lord Clancarty and Lord Dundee. The noble Lord, Lord Hunt, has set out clearly why we feel that assurances on Erasmus+ and Horizon 2020 are essential if our world-leading universities are to retain their reputation and our students are to be given the best opportunities to broaden horizons.

Does the Minister recognise the benefits of scientific research—including, as the noble Lord, Lord Hunt, has set out, for the economy? In particular, can he provide some clarity on how the UK Government intend either to remain in or replace the range of EU funds as we leave the European Union? Of course, it is not only the funding. Crucial to research is collaboration. Working with other European researchers and academics has resulted in work of benefit to the UK, the EU and, indeed, worldwide. As a recent CBI report set out:

“With science and innovation increasingly becoming globalised, the UK’s role as a leading global scientific power is at risk without an agreement”.


What a loss it would be if we were to walk away from these EU programmes.

Horizon 2020, as we have heard, is the biggest EU research and innovation programme, with nearly €80 billion of funding available over the seven years of 2014 to 2020. In addition to Horizon 2020, there is a range of other EU-based funding, which has included, for instance, valuable support for environmental science and the environment, whose future must also be carefully considered by the Government. Protecting the environment is best done in collaboration. We believe that these funds are key.

Horizon 2020 is a highly important source of funding for research in the UK. There are other funds such as Interreg and Life, which support applied research in the UK and are instrumental in turning academic research into public policy and maximising its benefits for society. As for the Erasmus exchange programme, it has been described as one of the greatest culture and character-building programmes that you can have in your whole life. The Liberal Democrats have long wholeheartedly supported Erasmus. It is heartening to hear that wholehearted support coming from the Labour Benches—it would be even better to hear it from the Government Benches, and not just for the niggardly couple of years that Ministers have mentioned so far but as an ongoing and enduring commitment.

Erasmus is aimed at cross-border co-operation between states to aid the growth of international studying, international understanding and fostering good international relations—and my goodness we will need all those in spades, if and when we leave the European Union. With over 4,000 students involved in the programme at any one time, it offers an excellent chance of experience abroad, which, we know, is highly valued by employers. Those from disadvantaged backgrounds can be helped by the Erasmus+ EU grant to help cover the travel and subsistence costs incurred in connection with their period of study abroad.

Erasmus has been of life-changing importance to so many young people from all walks of life. It would be an act of folly not to continue this scheme for our young people. I hope the Minister will respond favourably to these two amendments, in the interests of students, researchers and the greater good of the country.

[Lord Patel (CB)]

I support this amendment and will go a bit further. As we have heard, the UK is a major player in research and innovation in European countries and worldwide. A recently published document, Building a Strong Future for European Science: Brexit and Beyond, is Wellcome’s recommendation from the future partnership project, based on a survey of 200 institutions and top scientists in Europe. It might form the framework based on which the Government may wish to negotiate beyond Brexit.

If nothing were to change and we were to remain as we are, there would be no problem—the UK would remain a major player in science and innovation. But on the basis that we will have to negotiate post Brexit, I would say, as the document says:

“Brexit presents the UK and EU with choices about their future relationship on research and innovation”.


European nations, including the United Kingdom as a major player, have developed,

“a world-leading location for research and innovation”.

The EU and associated countries—there are countries which are not part of the EU but are currently associated with Erasmus and other EU research programmes—

“should accelerate and deepen development of the European Research Area (ERA), to help Europe and EU Framework Programmes capitalise on the strengths and talents of a wider group of nations”.

Each of these nations, including the UK, contributes heavily to these programmes. We have to find a way to continue, both for Europe and for us.

An EU-UK research and innovation agreement for Brexit could be possible:

“Evidence and views gathered through the Future Partnership Project showed the importance of finding a way for the EU and UK to maintain their important partnership”.


There was a strong view, both from scientists and research organisations in Europe, outside the UK, that they would like this partnership and strong relationship to continue.

As to funding, as has already been mentioned:

“The EU’s Framework Programmes are the most effective multilateral funding schemes in the world”.


The UK needs to be part of this, so:

“The UK should therefore secure Associated Country status in an excellence-focused Framework Programme 9”—


that will follow programme 8—

“as this would be the best way to participate in European research. To achieve this, the UK should be pragmatic about the cost of a good deal to access FP9, and the EU should be pragmatic about the terms of FP9 association for the UK”.

There are benefits for both sides, which the science community certainly recognises.

There will, of course, have to be some alliance with regulation and research policy. A later amendment in my name relates particularly to clinical trials, which are important for the life sciences industry in this country. It is important, therefore, for,

“the UK to participate in the EU’s harmonised clinical trials system”,

including the new system that will come. The report states:

“A research and innovation agreement should promote dialogue on areas of research policy where the EU and UK can provide global leadership, for example on open research … A research and innovation agreement should support full researcher mobility between the EEA and UK”.


Proposals of this kind, which have come from Wellcome and the Royal Society, could be the framework for future negotiations, particularly on research and innovation.