Moved by Baroness Cumberlege
284: After Clause 148, insert the following new Clause—“Industry reportingCompanies involved in the production, buying or selling of pharmaceutical products or medical devices must publish any payments made to—(a) teaching hospitals,(b) research institutions, or(c) individual clinicians.”Member’s explanatory statementThis amendment requires companies involved in the production, buying or selling of pharmaceutical products or medical devices to publish any payments made to teaching hospitals, research institutions, or individual clinicians.
My Lords, Amendment 284 would implement one of the major recommendations of the Independent Medicines and Medical Devices Safety Review. I will say from the start that I so welcome the government amendments. I thank the Minister and the civil servants for crafting them in such a thorough way.
There is one glitch, however, about which I have given the Minister forewarning. All the government amendments say that the Secretary of State “may”—and of course that is a very sneaky word. What we want to see is a more robust word: the Secretary of State “shall.”
However, I do not want to detract in any way from the burden of my amendment, which is that relationships between the pharmaceutical and the medical device industries on the one hand, and the hospitals, medical research institutes and individual clinicians on the other, can be a huge force for good. Industry collaborating with doctors, researchers and scientists working in the NHS, academia or elsewhere has led to great breakthroughs and great treatments that we have been able to introduce. No one should want to stop that happening—but we do have a right to see where the money goes. Despite all the undoubted good that collaboration between industry and the rest of healthcare brings, we know that there are long-standing concerns about undue influence.
We need transparency so that trust can be rebuilt where it has been undermined in the past. Voluntary arrangements are all well and good, but they have a drawback: they are voluntary; they are not a requirement; they carry no teeth. So I am encouraged to see that the ABPI, which represents many pharmaceutical companies in the UK, agrees. It is supportive of moving to mandatory disclosure.
Amendment 284 would make it a requirement for payment by the industry to teaching hospitals, research bodies and individual clinicians to be published by the companies themselves. Such legislation exists and works very effectively in the United States. It is called the Physician Payments Sunshine Act, and it has been in existence since 2010. All the information is held on a public website. Americans can see at a glance which pharmaceutical or device companies have made payments to physicians or others: when, why and how much. It is not just the US which benefits from this level of transparency; various European countries have similar legislation in place, and we should not be the poorer cousin.
I of course welcome the Government’s own amendments that are grouped with mine and very much look forward to what the Minister has to say about them. I hope we can all agree that transparency, trust and good, safe care go hand in hand. That is why the amendments are so important.
My Lords, this amendment is a companion piece to the previous amendment on declarations of interest that we believe should be made by doctors and other regulated healthcare staff, and ensures that any companies involved in the production, buying or selling of pharmaceutical products or medical devices must publish any payments made to teaching hospitals, research institutions or individual clinicians. Whether someone wants to know about a doctor working with a pharma company, or the other way around, we need a system that provides a golden thread of transparency and accountability.
Reporting payments or benefits in kind by the relevant organisations and individuals receiving them ensures that the links between donors, recipients and their respective interests are always visible. Although it is, we hope, rare, this is more than just transparency. As in any walk of life, occasionally there is malpractice and fraud, which needs to be prevented. A register such as this helps to remind all those concerned of the rules.
I echo the comments made by the noble Baroness, Lady Cumberlege, that “may” is not strong enough: “shall” is important here. The noble Baroness also referred to the USA Sunshine register; and, as I said on the last group of amendments, we definitely need the disinfection of sunlight. Can the Minister say whether any such regulations on industry reporting might be published and brought into force?
My Lords, I thank the noble Baroness, Lady Cumberlege, for tabling Amendment 284. If we are to avoid the risk of corruption and maintain full public confidence, it is vital that there should be full disclosure of payments by commercial interests to hospitals—I would have thought to all hospitals, not just teaching hospitals—research institutions and clinicians. It is a good maxim to follow the money and to be able to do so.
In regard to research, there has long been public concern about business interests suborning researchers whose judgments and pronouncements influence public understanding, sometimes with important implications for public health. Corrupt scientists certified that DDT and pesticides used in agriculture were not harmful to public health. Exposure of that by Rachel Carson in her book Silent Spring did not end the mischief. Bogus research evidence was paid for for decades by the tobacco industry in a rearguard action to persuade Governments and the public that tobacco was not harmful to human health.
Today, firms in the food industry deploy spurious evidence and arguments about the damage certain foods do to human health. They have lobbied Government with considerable success to the terrible detriment of human health—it is good that the Bill limits the advertising of unhealthy foods. Scientists, paid by energy firms, have abetted those who deny that climate change is manmade.
Disclosure payments in regard to research will help, but more is needed. The noble Baroness might have considered—and may yet consider—tabling another amendment needed to underpin research ethics. The data on which research conclusions are based should be held independently. The Engineering and Physical Sciences Research Council rightly now requires researchers to deposit data connected to the research they have funded.
There is huge pressure, in a competitive environment, on scientists to publish research, and there have been notorious instances of fake science—scientific discoveries announced that were made up and whose results could not be replicated by other researchers. A paper entitled Fake Science and the Knowledge Crisis published by the Royal Society said,
“it is especially important that the scientific world as a whole upholds the highest standards of ethical behaviour, honesty and transparency, aiming to sustain the gold standards of research integrity and validated information.”
However, the authors go on:
“Sadly, a range of forces are working counter to this aspiration.”
It is good that the pharmaceutical industry in the United Kingdom supports the transparency that the amendment calls for. We should certainly match the best standards and practice in the USA and Europe.
The NHS holds huge budgets for drugs, medical equipment and hospital building; big commercial interests are at stake. There is scope for corruption if the system is weakly regulated. The scandal of PPE contracts has led to widespread anxieties about the integrity of procurement. The public want to believe that the NHS is free of corruption, and I am sure it mainly is, but reassurance is needed. As the noble Baroness, Lady Brinton, reminded us. in the old saying, sunlight is the best disinfectant. We need the transparency that the amendment would secure.
The government amendments are, certainly at first blush, welcome. But, as the noble Baroness, Lady Cumberlege, noted there is a conspicuous difference in language between her amendment, which says that companies “must” publish payments, and the Minister’s amendments, which say that the Secretary of State “may” require or regulate. That slide of language is liable to weaken public confidence. I hope the Minister will explain why he has used the word “may” and not “shall” or “must”.
The government amendments are as elaborate as the noble Baroness’s is simple, and they prompt some questions. In the Government’s Amendment 312B, subsection (6)(b) states:
“The regulations may … create exceptions from requirements to publish or provide information.”
What would those exceptions be? Subsection (8) states that the Secretary of State may,
“grant an exception … in a particular case.”
What sort of case? Earlier in Amendment 312B, subsection (1)(a) refers to “payments or other benefits”. I ask the Minister whether the disclosure requirements he envisages cover benefits in kind, including donations to political parties. whether made by big pharma or small local donors.
I do not want to be cynical. How can the Minister reassure those who are?
My Lords, I shall try to be brief, otherwise we will be here until 3 am, and I am sure none of us want that. I join the noble Baroness, Lady Cumberlege, in the comments she has made, and I support her amendment and the government amendments. I also agree that the system should be mandatory— not “may” but “shall”— and aligned with the similar system in the United States which I was used to many years ago.
To try to explore this further with the industry, I have been in correspondence with the ABPI to test how committed it is to agreeing to this being mandatory and that they “shall report” in all aspects. I will read what it sent me:
“ABPI are supportive of the intention to move to a mandatory model of disclosure for payments made between industry and relevant individuals including Health Professionals, and” all healthcare organisations and research institutions. It continues:
“We believe proposals to introduce a legislative mandate are an opportunity to further strengthen the pharmaceutical sector’s existing transparency mechanism for branded medicines”— that was the point I made to it, that its system needs to be transparent, mandatory and easily accessible by patients and the public. It goes on:
“Our briefing outlines a number of considerations and learnings based on ABPI’s experience running Disclosure UK, which since 2016 has supported transparency around transfers of value made by the innovative pharmaceutical industry to relevant individuals including Health Professionals … and Healthcare Organisations”.
I asked for a similar comment from industries that market medical devices, and I understand that a similar commitment is made by those companies too.
I therefore support the noble Baroness, Lady Cumberlege, and support the Government’s amendment. However, I hope that the Minister can confirm that the loose word “may” is not intentional and they intend to make this mandatory.
My Lords, I rise very briefly, rather enjoying this reunion from our debates during the passage of the Medicines and Medical Devices Bill of a group of people who taught me a great deal about dealing with legislation. We also looked at an amendment that was very like this. There is a phrase I use often: “Campaigning works”. I should make that “Campaigning by the noble Baroness, Lady Cumberlege, works particularly well”. We are seeing real progress here, although, as many noble Lords have already said, we need to make sure that this is mandatory and not some kind of voluntary extra.
When I was working on the then Medicines and Medical Devices Bill, I spoke to a number of people from the industry. They were very much concerned about the fact that they wanted tight rules that apply to everybody, otherwise those who cut corners and push the envelope have a competitive advantage against people who doing the right thing, being absolutely open and not flinging money around. Many parts of the sector are keen on tight rules.
It is interesting that it has taken us so long to get to this point when the noble Baroness, Lady Cumberlege, presented ways of doing this back in the Medicines and Medical Devices Bill. We have not heard the Government using their favourite phrasing “world-leading” or “world-beating” very often in this area. As the noble Baroness, Lady Brinton, said, we are very much trailing behind other countries in our transparency here.
I will make one final comment. We have a huge problem with public trust—we see this on the street outside your Lordships’ House quite often. Absolute transparency and openness is crucial and, as we heard in Oral Questions earlier, the fact that some companies have been able to profiteer hugely from the pandemic causes more damage to public trust. We need to tackle that with as much of the sunlight of transparency and openness as possible.
Briefly, I also support these amendments, including the Government’s comprehensive amendment, but I was spurred into action by the noble Baroness, Lady Bennett. It is worth saying that when it comes to public trust, a survey of 28 countries conducted at the end of last year found that British doctors were more trusted by people in this country than doctors in any of the other 27, so we start from a well-founded position of high trust. However, trust in a profession is of course founded on the basis that people will act in a way that puts the interests of the person they are looking after first, and these amendments help to deliver that.
I want to use the opportunity to try to draw the Minister out slightly on a couple of questions supplementary to those which my noble friend Lord Patel raised. Sunlight may indeed be the best disinfectant. but we have two types of shade going on at the moment. The first is that, through the voluntary register which the ABPI established in 2017, we have just under a third of eligible doctors who are not reporting. Therefore, obviously to the extent that the Government commence these amendments on a mandatory basis, that will deal with that aspect of shade; the 68% will become 100%, which will be most welcome.
The second type of shade relates to the scope of the payments that have to be declared. Here, I think the Government’s amendment is potentially very suitably broad. However, it would be wonderful to hear the Minister confirm that it will cover payments to all NHS bodies, not just to trusts or indeed teaching hospitals; that primary care will be in scope; that it will cover the independent sector as well as the NHS; that it will cover payments made to patients’ organisations; and whether, in time, the Government will consider extending it to payments made to health professionals other than doctors. I conclude by simply reporting that when you ask people in this country which profession they most trust, the answer is actually not doctors; it is nurses.
My Lords, I have my name on this amendment. I will not repeat all the points made by other people so far, but I point out that using the words “shall” or “must” avoids any argument over threshold. The problem with having a word that is not definitive is that there would be arguments over what would and would not have to be declared.
To put a slightly positive note on the whole situation, I say from clinical experience that patients want to go into trials and to contribute to the level of knowledge. Very often, people who are seriously ill will say, “I know that I won’t benefit from it, but I hope that other people will by me going into this trial”. But they want to know that the trial is properly conducted, that everything is open, that nobody is profiteering from their generosity and that they are genuinely contributing to the body of knowledge across the country. When people who I know socially contact me because they have been given a potentially devastating diagnosis and have been referred to somebody, the question is always, “Are they the best in the field?”, which is often followed up with, “Are they doing research in the field?” and “Are they completely up to date?” So often, when people realise that they are deteriorating, they will ask whether there is a trial that they can be entered into.
This goes much further than just being sunlight. This amendment would support future endeavours and innovation in the country and would encourage people to enter into studies.
My Lords, very briefly, we welcome the Government’s proposals on mandatory disclosure of payments, a companion piece to the previous debate that we had, as has been pointed out.
As noble Lords have always stressed, greater transparency is highly desirable and a very good thing. I am grateful to the Minister for listening to the voices of stakeholders and parliamentarians on this. Indeed, nine out of 10 medical professional bodies think that patients have a right to know if their doctor has financial or other links with pharmaceutical or medical device companies and they support stronger reporting arrangements, as contained in the amendments. I am grateful for the briefing I have received from the ABPI, which, as we have heard, also supports mandatory disclosure.
“consent of the Scottish Ministers, the Welsh Ministers or the Department of Health in Northern Ireland … before making provision within devolved legislative competence in regulations relating to information about payments etc to persons in the health care sector.”
We would welcome the Minister reassuring us that full consultation is under way and setting out the timescales involved.
On Amendment 284, the non-government amendment leading this group, the intention of the amendment and the arguments put forward by noble Lords are extremely persuasive. The requirement for companies involved in the production, buying or selling of pharmaceutical products or medical devices to publish any payments made to teaching hospitals, research institutions or individual clinicians is a sensible measure that would complement the Government’s package, and I await the Minister’s thoughts on it, including on the one glitch underlined by the noble Baroness, Lady Cumberlege, on moving from “may” to “shall”.
My Lords, I thank all noble Lords who took part in this debate, especially my noble friend Lady Cumberlege for her work on the independent review of medicines and medical devices, and other noble Lords who were involved in that. I know that she worked tirelessly to make sure that patients and their families have been heard and I pay tribute to her and her team. I also thank her for her lobbying—or reminding—me of the pledge that I made when I first became a Minister on championing the patient.
I welcome my noble friend’s amendment to increase transparency and promote public confidence in the healthcare system. The Government fully support the intention behind the amendment. That is why I will be moving Amendments 312B, 312C, 312D, 313B, 313C and 314ZB in my name. Before I do so, let me answer some of the questions.
All these amendments relate to the transparency of payments made to the healthcare sector. The Independent Medicines and Medical Devices Safety Review led by my noble friend Lady Cumberlege listened to the brave testimony of over 700 people to understand where improvements needed to be made to make the healthcare system safer for all patients, especially women. The Government have given the review deep consideration and accepted the majority of its nine strategic recommendations and 50 actions for improvement.
To improve transparency, the review recommended that
“there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians”.
The amendments deliver on this recommendation by enabling the Secretary of State to make regulations requiring companies to publish or report information about their payments to the healthcare sector. The clause covers any person performing healthcare as part of their duties, benefiting patients and building on initiatives by regulators and industry. I hope that partly answers the questions raised by the noble Lord, Lord Stevens.
The amendment also allows for the Secretary of State to make regulations requiring that the information be made public and make further provision about when and how the information must be published. This could include requiring self-publication or publication in a central database. That ensures that we can adapt the system to improve reporting as necessary. To ensure that companies fulfil the obligation, requirements introduced by the regulations can be enforced using civil penalties.
There are benefits to this duty applying UK-wide, aligning with the approach taken by the pharmaceutical industry with its Disclosure UK system. As the noble Baroness, Lady Wheeler, referred to, the clause contains a statutory consent requirement, so we will work closely with the devolved Governments to develop regulations following the passage of the Bill. We will also work with patients, industry and healthcare providers to create a system that enhances patient confidence while maintaining a collaborative, world-leading UK life sciences sector.
A question was raised about the issue of “shall” versus “may”. The Government have not tabled these amendments in bad faith; we would not have tabled these amendments if we did not intend to work with them. It is the intention of my right honourable friend the Secretary of State to bring forward regulations under the clause to make sure that there is transparency. If that is not reassuring enough, perhaps between this stage and Report there can be some conversations to make sure that noble Lords are assured. It is for these reasons that I ask your Lordships’ Committee to support these amendments.
I have two points to make to the noble Lord. First, I have been advised that this is standard wording. Secondly, I have made the assurance at the Dispatch Box. It is here; it is on public record that the Government intend to bring forward regulations. On the timeframe, I will either write to noble Lords or arrange a follow-up meeting. I will make sure that there is some communication to bridge that gap.
My Lords, I thank everybody who has taken part in this debate, particularly my noble friend the Minister for the work he and his officials have done to bring this into the Government’s remit. That is so important, because I learned through the passage of the Medicines and Medical Devices Act that we could incorporate the patient safety commissioner and some of the other things we wanted to achieve only through government amendments. My heart leaped when I saw these amendments and I thank the Minister.
I still think these amendments could be improved and it is important that we get the word “shall” in, or “might” or whatever others have said, rather than “may”. I was looking at the Oxford English Dictionary. My father-in-law was the publisher to the Oxford University Press, so the dictionary is very close to my heart. The dictionary says that the verb “shall” relates to the right or sensible thing to do, whereas the verb “may” is defined as a possibility.
I have absolutely no doubt that the Minister will do all he can to ensure that the Secretary of State brings this into effect, but he will know, as all of us in this Chamber know, that Secretaries of State come and go. You are always starting from base again with a new Secretary of State, so there is an urgency about this.
Before I bring this to a close, I want to thank the noble Baroness, Lady Brinton. She is always so much on the ball and so concise and straight. The noble Lord, Lord Howarth, is so right that it is other, huge organisations that influence what is happening. There is the tobacco industry, which he mentioned, the food industry, and we saw the devices industry, which so influenced what is happening. I thank the other Members who took part, including the noble Lord, Lord Patel, with his second intervention, and the ABPI for its work.
I say to the noble Lord, Lord Stevens of Birmingham that of course he is right; we need to reach much more widely. But I have found throughout the Bill and previous Bills, where we have enacted them, that you have to start somewhere, and we felt that this was a credible way to start, and something to build on at least. But he is right; it should go wider.
I thank the noble Baroness, Lady Finlay, so much for supporting this amendment. She is absolutely right in what she has been saying. Research is so important, and that is all part of this. We are not trying to cut down research. We just want to see where the money is going, and we want patients to know how things are being influenced regarding the finances being poured into certain organisations. I mentioned the big hospitals, the teaching hospitals and so on. We have a right to know, us taxpayers and us patients, where the money is coming from. That is all I wish to say. I withdraw the amendment.
Amendment 284 withdrawn.
Amendments 285 not moved.
Amendment 286 had been withdrawn from the Marshalled List.