Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.

I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.

I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.

In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role

“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.

Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?

To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.

[Lord O'Shaughnessy (Con)]

My Lords, I join other noble Lords in expressing my sincere thanks to my noble friend the Minister for the progress that we have made. In all fairness to him, he said that since Second Reading he was listening, but we all know that it is sometimes possible to listen and not hear, let alone act. On this occasion, he heard and acted. I join other noble Lords in expressing my sincere gratitude for that.

I also pay tribute to my noble friend Lady Cumberlege. No one doubted her tenacity but it has been on display in bucketloads, and she has made the progress that her superb report deserves. More than anyone, I pay thanks to the army of campaigners; many of us have met them, and they could not help but move us with their stories. This legislation is ultimately for them and a tribute to them.

I had a close look at my noble friend the Minister’s amendment and compared it to that of my noble friend Lady Cumberlege. Clearly, there is a specific issue about where the organisation, the commissioner, should sit, but there is a precedent for doing that in the way in which the Minister suggested. I take confidence from his determination to give proper independence to the role. A lot will depend on the kind of person recruited, how they are recruited and to whom they are accountable. I should like him to say a little more about how he envisages that happening.

We also need to hear more detail on the timetable. The Minister will know that when one makes big commitments of this kind, they are staging posts—never the destination. There is still some way to go in making sure that we get there quickly. That is important, as my noble friend pointed out. However, the powers in the amendment are important to recognise. On the ability to demand information from relevant persons, as other noble Lords have said, we need to hear a little more about who they are and the consequences of non-compliance. However, they are powerful ways in which the commissioner can act and create change in the system. I have no doubt that they will be effective.

In conclusion, I make a couple of comments provided by the ABPI’s briefing. They relate to further questions around the nature of the relationship between the commissioner and the MHRA and other bodies, how the four nations of the UK will act together on patient safety, given that we are a single market, and ensuring diversity of patient voice.

I would also add one more thing to that. Patient safety is not just about finding out when medicines and devices go wrong; it is also about access to them. Will the patient commissioner have a remit to investigate these kinds of issues?

However, these questions are for tomorrow. Today, we want to recognise the progress that has been made and the amendments put down in the name of my noble friend. I thank him sincerely for them and I thank my noble friend Lady Cumberlege for her dedication to this particular cause.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I, too, add my congratulations to my noble friend the Minister and pay particular tribute to the tireless work of my noble friend Lady Cumberlege in bringing us this far. I welcome government Amendments 1 and 54.

I want to take this opportunity to mention two specific issues that we focused on in Committee and seek confirmation on where we are in this regard. I want in particular to look at the right of patients to report directly on their own experience, rather than waiting for the patient safety commissioner to investigate. I would welcome hearing that my noble friend the Minister imagines that the commissioner should have this power. If not, would he consider introducing such a measure at the first available opportunity? It is so important that the voice of patients is heard. I remember the accounts that my noble friend Lady Cumberlege gave in Committee of her work and that of her team in producing the report, First Do No Harm; that will be a lasting legacy. Allowing patients the right to report directly, without necessarily waiting to be asked, would cut through many of the difficulties with medicines and medical devices, and would enable the patient safety commissioner to report directly to the Government in this regard.

The only other point that I wish to make at this stage is that of the regulations that my noble friend envisages in the government amendments in this group. Can he confirm that these will be discussed and agreed with the devolved Administrations at the earliest possible stage? Can my noble friend assure us that if the devolved Administrations raise any significant issues or highlight any problems that they have with the draft regulations, these will be acted on before the regulations are adopted and sent to each House of Parliament?

We are in a very good place. I congratulate my noble friend Lady Cumberlege and her team on bringing us here, and I pay special tribute to my noble friend the Minister for listening to the concerns of so many people, over so many years, to bring us to where we are today. I wish the amendments godspeed.

--- Later in debate ---

[Lord Sharkey (LD) [V]]

My Lords, I welcome the amendments in this group. They add clarity to the obligations laid on the Secretary of State in making regulations under Clause 1(1) and its counterparts.

I particularly welcome Amendment 12 in the names of the noble Baroness, Lady Thornton, and my noble friend Lady Jolly, as it seems particularly important. It requires the Secretary of State to publish the criteria used in determining the benefits and risks caused by regulation and to set out how they have been weighed against each other. This amendment touches on the whole issue of transparency in devising regulations. The level of transparency that Amendment 12 requires should certainly apply to the factors listed in the Minister’s Amendment 9. These factors, which the Secretary of State must have regard to, are the safety of human medicines, the availability of human medicines and the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to carry out research related to human medicines, conduct clinical trials, or manufacture or supply human medicines. These are all clearly important, and I am glad that the Minister has added manufacturing to this list, as I suggested in Committee.

The list contains three rather vague notions: “likelihood”, “favourable” and “being seen as”. For all these terms, we need to know what definitions will be used and what evidence will be required in support. For “being seen as”, the question arises: being seen as by whom? What weight will be given to different views from different sectors? If, for example, it turns out that academic researchers and pharma companies have different views about the favourability of the UK, how are they to be weighted? On “likelihood”, could the Minister say whether he considered the word “desirability” instead, which seems closer to what we want here?

I hope the Minister is able to give reassurance on the points I have raised and that he accepts the merits of Amendment 12 and its counterparts.

[Lord O'Shaughnessy (Con)]

My Lords, I will make three quick points about the government amendments in this group, which I broadly welcome. The first relates to Amendments 4 and 42, where the Minister has clearly listened carefully to the forceful arguments made by my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, the noble Baroness, Lady Jolly, and others in Committee. I am delighted that he has.

For those of us who have not been involved in the discussions, and following on from the points that the noble Baroness, Lady Thornton, made about why language from the European regulation has been adopted—“safeguarding public health”—it would be helpful if my noble friend could explain, on the record, why that language has been chosen. That is particularly the case given that he expressed some reluctance in Committee, bearing in mind that the regulations being referred to also had some relevance to operating the internal market, not simply medicines safety. It would be good to hear from him on that.

Secondly, on Amendments 8 and 44, unlike other noble Lords I did not believe that there was a suspect motivation behind the use of the word “attractive” by my noble friend and the Bill team, or any desire to reduce stringency to attract investment. But I would be grateful if my noble friend could confirm that the Government remain as determined as ever, if not more so, to grow the UK’s life sciences sector, and that it was never their intention to lower regulatory standards to achieve this.

Thirdly, on Amendments 9 and 45, I commend my noble friend on the subtle but important changes already referred to by the noble Lord, Lord Sharkey, in Clauses 1(3)(c) and 14(3)(c), especially the inclusion of manufacturing and broader medical research. The salience of these two parts of our overall supply chain has come to the fore during the pandemic, which has demonstrated our strengths in basic science but, unfortunately, exposed our weaknesses in manufacturing resilience. It seems right that this should be explicitly recognised in the Bill and I commend my noble friend for making those important changes and for demonstrating, once again, his ample appetite for listening and acting.