Closed consultation

Disclosure of industry payments to the healthcare sector

Updated 5 October 2023

Ministerial foreword

This consultation comes at an important time for the UK life sciences industry. Advances in technologies such as software and artificial intelligence (AI) have the potential to transform patient care, while COVID-19 has spurred innovation in antivirals and diagnostics. At the same time, there is work to be done to ensure that the medicines and medical devices we use remain safe and effective for everyone.

Last year, the Department of Health and Social Care (DHSC) launched the Equity in medical devices: independent review, chaired by Professor Dame Margaret Whitehead, to explore what can be done to ensure that medical devices are free from bias. We are committed to this work and know that there is more that we can do.

The First do no harm report of the Independent Medicines and Medical Devices Safety (IMMDS) Review led by Baroness Cumberlege showed us that industry and the healthcare system must adapt to listen to patient needs and prevent the failings of the past. To address these issues, transparency is key.

To build trust and protect the health system from real and perceived conflicts of interest, we must understand and support the important ways in which industry interacts with the healthcare profession. We now wish to understand whether information about these interactions should be accessible to the public to ensure that these do not compromise patient care.

Patients across the UK place great trust in our health system. To preserve that trust, we must continue to strive for the highest standards of practice from industry, healthcare professionals and organisations. Through this consultation, we have an excellent opportunity to further these efforts, and ensure that decisions over healthcare products are always centred on the needs and best interests of patients.

Will Quince MP
Minister of State (Minister for Health and Secondary Care)

Executive summary

We want to seek views on the possible introduction of new secondary legislation to place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations. This consultation aims to address the second part of recommendation 8 contained in the IMMDS report, regarding real and perceived conflicts of interest in the health system. Gathering views through the consultation is an important step in the development of policies in this area.

The scope of this consultation has been developed following engagement with patient groups, industry and regulators to design a potential approach that delivers transparency for patients and the public while minimising the burden on our vital life sciences industry. The aim of these questions is to explore increasing the transparency of the relationships between industry and the healthcare sector to enable patient trust in the health system and protect the impartiality of clinical decision-making.

We will continue to engage with the devolved governments to support in achieving our aims across the whole of the UK.

Introduction

The life sciences industry is crucial to the nation’s health, developing innovations in medicines and medical devices that improve citizens’ quality of life across the UK. To achieve this, industry works closely with leading hospitals, clinicians and researchers to develop products and ensure these are used safely and effectively.

These relationships sometimes involve the provision of payments and benefits by industry such as research grants, training events and reimbursement for work such as testing and consultancy. A lack of transparency around the reporting of these transactions, however, could lead to real or perceived conflicts of interest between healthcare providers and industry.

The IMMDS Review, led by Baroness Cumberlege, investigated 3 medical interventions resulting in adverse consequences:

• Primodos
• sodium valproate
• pelvic mesh

The IMMDS report raised concerns about the real and perceived conflicts of interests between clinicians and manufacturers, and how this may influence patient care and, ultimately, patient safety.

Page 34 of the IMMDS report stated:

We have heard particular [patient] concerns that clinicians have been paid or otherwise incentivised by manufacturers. This may influence their practice, and the course of action they recommend to patients, such as preferentially using particular procedures or drugs.

The IMMDS report acknowledged the Association of the British Pharmaceutical Industry’s (ABPI) Disclosure UK system, which publishes information about payments made by certain pharmaceutical businesses to the healthcare sector. In 2022, 145 manufacturers declared payments through Disclosure UK. The IMMDS report highlighted that there is no similar system in place for the medical device sector.

Page 34 of the IMMDS report stated:

Medicines and medical device manufacturers should… ensure that they publish details of payments and payments in kind that they make to teaching hospitals, research institutions and individuals.

Since the government’s response to the IMMDS report, we have engaged with patients, professional regulators and trade associations about ways to strengthen industry reporting requirements. We know that medicines and medical device trade associations have codes of conduct in place that set standards for how businesses should engage with researchers and healthcare providers. These supplement professional codes of conduct that healthcare professionals are required to follow.

The government is also undertaking separate work to address the concerns raised by the IMMDS report in relation to conflict of interest declarations from healthcare professionals. Once both tranches of work are complete, consideration will be given to how to utilise both industry and professional declarations to support patients across the whole of the UK in having a clear view of any potential conflicts of interest across the health and care system.

The present public consultation deals exclusively with the industry aspect and is not designed to identify or consider clinical professional declarations of conflicts of interest.

Policy objectives

The government agrees with the IMMDS report that increased transparency would help to protect the integrity of the healthcare system from perceived and actual conflicts of interest. The potential mandating of sponsorship reporting may achieve 2 key objectives that address the report’s findings:

• improving patient trust in healthcare professionals and organisations
• helping to ensure that healthcare professionals continue to make impartial, evidenced-based decisions about patient care

As identified in the IMMDS report, there are limitations to, and gaps in, existing systems for disclosing this information and, to achieve our objectives, comprehensive and consistent transparency could be required.

We have considered several options to enhance transparency, including:

• expanding voluntary schemes such as ABPI’s Disclosure UK
• working with trade associations to improve codes of conduct
• a statutory approach to require disclosure

We want to understand public views on whether a legislative requirement to ensure the information is made public is the way to provide transparency. This is in line with systems in place internationally, including the Netherlands, US and France.

The Health and Care Act 2022 (the 2022 Act) gives the Secretary of State the power to make regulations to impose a requirement for businesses to make public details of the payments or other benefits they provide to persons providing healthcare or carrying on activities connected with healthcare in the UK. Regulations would define the scope and operation of the reporting requirements.

This public consultation seeks views on our proposals for a duty that is comprehensive, clear and easy to implement. The questions in the consultation are therefore framed as proposals for if the decision is taken to proceed with regulations. The proposals outlined below will enable businesses to share views on whether they would be captured by any duty and what payments (if any) should be in scope. The proposals will also provide clarity on whether and how information should be made public. The consultation also seeks views on alternatives to regulation.

Businesses that may need to publish information

The 2022 Act allows regulations to place an obligation on manufacturers and commercial suppliers of healthcare products and connected persons. We are seeking views on proposals to define further who should be required to publish information.

We believe the most straightforward way to identify businesses in scope is by reference to the products they place on the UK market. We propose to bring into scope every manufacturer and commercial supplier of medicines, medical devices and borderline substances, as well as their subsidiaries and parent businesses. Where possible, we would use existing legal definitions. This would make it easier for businesses to know whether they would need to comply with this new duty. For example, medicinal products and medical devices are defined in the Human Medicines Regulations 2012 and Medical Device Regulations 2002 (as amended), respectively.

In practice, this would mean that, if a business manufactures or commercially supplies medicinal products or medical devices, they would need to publish information. This approach would provide clarity to businesses and ensure an easy way for them to self-identify whether they are subject to the reporting duty.

Alongside medicines and medical devices, clinicians can prescribe certain food and dermatological products, collectively known as borderline substances, some of which are listed in the Drug Tariff. These are prescribed to manage the medical conditions of thousands of patients a year. Therefore, we propose that businesses manufacturing or supplying these products (and connected persons) should also be within the scope of the requirement.

We propose defining borderline substances within scope of the regulations by reference to the inclusion of the product in the relevant parts of the Drug Tariff. This approach to defining borderline substances has been used in other legislation, for example the Health Service Products (Provision and Disclosure of Information) Regulations 2018 (see definition in Annex A).

Manufacturers and commercial suppliers of these products would therefore be required to publish information.

The 2022 Act includes the reference to connected persons to ensure businesses cannot avoid reporting obligations by using other business entities to make payments. The intention is to define ‘connected persons’ as subsidiaries, parent businesses or businesses otherwise within the same group of businesses as manufacturers and commercial suppliers of relevant products. We also propose the capture of payments or benefits provided through a third party acting on behalf of a relevant business.

The government is committed to proportionality of business burden relative to the benefits. Note that we ask about the size of the businesses that could need to report in the ‘Impacts and monitoring’ section.

Question

The government proposes to make the following businesses subject to this reporting duty - the manufacturers and commercial suppliers of:

• medicines
• medical devices
• borderline substances

Do you agree or disagree with this proposal?

• Agree
• Disagree
• Don’t know
• I have an alternative suggestion

Please explain your alternative suggestion (maximum 100 words).

Recipients in scope

The 2022 Act refers to ‘payments or other benefits’ made to ‘relevant persons’. This is defined in section 92(11)(b) as including both persons and organisations who provide healthcare in the UK, and a person or organisation who carries out activities connected with healthcare in the UK. We propose to clarify recipients in scope by defining those terms further in the regulations.

If we proceed with regulating, we propose to require businesses to publish information about in-scope payments to any registered healthcare professional or any hospital, trust, clinic, health board, pharmacy or surgery, whether in the public or independent sector.

Payments to public and private healthcare providers alike would be in scope. This is because the lines between public and private cannot be drawn clearly in practice. Some healthcare providers deliver health services for both NHS and self-funded patients within the same facilities, using the same equipment and other infrastructure.

Regarding persons who carry out activities connected with healthcare, we believe that medical research and training organisations (for example, royal colleges), as well as entities linked to healthcare provider organisations such as charity arms of a hospital, should be in scope. The government recognises the valuable and integrated role these types of organisations play in the health and care ecosystem. It’s for the same reason that they may influence the healthcare pathways and products used by frontline professionals and the care they provide. Information about payments or other benefits provided to them should therefore be published.

Question

The government proposes to require information about payments or other benefits provided to registered healthcare professionals, healthcare provider organisations and organisations connected to the provision of healthcare to be published, with regulations making no distinction between public or private sectors.

Do you agree or disagree with this proposal?

• Agree
• Disagree
• Don’t know
• Other - please specify

Question

Do you or your business currently make payments or provide other benefits to registered healthcare professionals and healthcare provider organisations?

• Yes
• No
• Don’t know

Question

Do you or your organisation currently receive payments or receive other benefits from manufacturers or suppliers of healthcare products?

• Yes
• No
• Don’t know

Question

The government proposes to require information about payments or other benefits provided to any organisation involved in medical research or training to be published. Payments to charity arms of hospitals or similar organisations linked to healthcare providers should also be in scope.

Which of the following organisations do you think should be included in the scope of these regulations? (Select all that apply)

• Charity arms of hospitals
• Medical or clinical research organisations (including medical research charities)
• Professional bodies responsible for the core training of healthcare professionals (for example royal colleges, Membership of the Royal Colleges of Physicians (MRCP))
• Other medical education or training providers
• Patient advocacy organisations
• Don’t know
• Other - please specify

Operation of the duty

The 2022 Act allows regulations to specify when and how information should be published. We can also exempt businesses from the requirement to publish information where they are taking part in equivalent third-party reporting schemes, enabling existing best practice to continue.

Reporting frequency

The government proposes that businesses would be required to publish data annually, containing the payment information for the previous calendar year. The annual frequency aligns with most other obligatory business reporting, including the modern slavery statement and gender pay gap reporting. If proceeded with, there would be 6 months between the regulations being laid and coming into force, in order to provide businesses with time to put processes for compliance into place. Businesses would be given 6 months each year to internally collate, review and then publish the information pertaining to the previous calendar year. This is sometimes referred to as a publication grace period.

The government recognises the importance of accessibility so that patients and members of the public can find and interpret the declarations. We propose a regulatory requirement for businesses to publish the relevant information on their websites with a link to the information in a prominent place on the website’s homepage, in line with current requirements under the Modern Slavery Act 2015.

Question

The government proposes to require businesses to publish payment information on their websites with a link in a prominent place on the website’s UK homepage.

Do you agree or disagree with this proposal?

• Agree
• Disagree
• Don’t know
• I have an alternative suggestion

Please explain your alternative suggestion (maximum 100 words).

Question

The government proposes to require businesses to publish details of relevant payments and benefits annually on their websites with a link in a prominent place on the website’s UK homepage.

What should the reporting frequency requirement be?

• Every 12 months
• Every 6 months
• Every 3 months
• Don’t know
• Other, please specify

Businesses in scope for only part of the year

We are considering the implications for businesses who might only be subject to the reporting requirement for part of the reporting cycle. For example, some products included in the Drug Tariff are added or removed throughout the year. This may mean uncertainty about whether or not to report payments and other benefits if a business does not supply other products putting them in scope. We anticipate this being a rare situation, but would welcome views from businesses on whether they think this applies to them or could cause issues.

Question

The government proposes to require businesses to report all relevant payments and benefits provided over the full year, if they supplied a product in scope at the beginning of the reporting cycle.

Do you agree or disagree with this proposal?

• Agree
• Disagree
• Don’t know

Submission to other portals or systems

We recognise the existing voluntary Disclosure UK portal run by ABPI used by medicines manufacturers to declare their payments. Supporting self-regulation would make industry a joint stakeholder in upholding this duty, giving them an opportunity to maintain their high reputation and positive outcomes. Such schemes may also provide the public with resources to aid understanding of the purpose and significance of these payments. We therefore want to continue encouraging industry-led initiatives that meet the minimum statutory requirements.

The powers in the 2022 Act allow the Secretary of State for Health and Social Care to allow businesses to comply with the reporting requirement by publishing information under a designated ‘relevant’ third-party reporting scheme. The Secretary of State can designate a scheme where the Secretary of State considers that the provision of information under the scheme renders compliance with the requirements imposed by the regulations unnecessary.

We would propose to allow businesses to comply by exception with the reporting requirements through a designated third-party scheme and signpost to the scheme on their website. The Secretary of State would assess any schemes that come forward for designation as a relevant alternative scheme. The government proposes to designate schemes that render participants fully compliant with the requirement to publish information set out in the proposed regulations to avoid gaps or dual reporting.

Question

The government proposes to allow businesses to comply by exception with the reporting requirements through reporting through a third-party scheme. Only schemes meeting regulatory standards would be designated by the Secretary of Health and Social Care.

Do you agree or disagree with this proposal?

• Agree
• Disagree
• Don’t know

Question

Do you currently report any payments to Disclosure UK, a voluntary scheme run by the Association of the British Pharmaceutical Industry (ABPI)?

• Yes
• No
• Don’t know

Question

Would you consider participating in or launching a similar scheme if this meant you or your members could be exempt from the legislative duty to report payments on your own website?

• Yes
• No
• Don’t know

Information to be published

We propose that the regulations would specify what information businesses would be required to publish about relevant payments or other benefits provided. The government believes it is paramount to consider intended user needs alongside ensuring businesses can comply in a simple and straightforward manner.

We propose to require the publication of a register of payments with the entries set out below. Further considerations on individual recipients are given in the section below.

Proposed register of payments entries to be published:

• name of recipient
• individual or organisation
• professional registration number (if applicable)
• work address
• aggregated annual sum value of payments or benefits (in GBP)
• reasons for payment or benefit

This means the primary way declarations would be organised would be by the recipient, which is advantageous for members of the public wishing to understand who provides payments or other benefits to researchers, hospitals and clinicians. To support businesses with this and encourage consistency in reporting, we would publish a compliant template to collect and upload this information in guidance.

Publications should be accompanied by an explanatory note setting out how the business has determined which payments are in and out of scope, how complex payments are represented, and other relevant considerations such as exchange rate conversion on non-sterling payments. We would provide further guidance to assist businesses to meet this requirement.

Data protection

A patient should be able to identify and track payments made to known healthcare professionals involved in their care. This means that personal data would be made public relating to individual healthcare professionals. Businesses should proactively inform the data subject of the need to publish information on a payment at the time that payment is made. Businesses should also manage expectations with healthcare providers when any payment or benefit is granted.

Regulations may stipulate how long information about payments should remain publicly accessible. The intention is that businesses would be required to keep this data in the public domain for 3 years. We selected this period based on the purpose for collecting this data, domestic and international examples, principles under the UK data protection laws, and the anticipated user needs. We consider that patients interested in understanding more about their clinicians’ relationships with industry should have the means to do so and to have a conversation about any concerns impacting their care.

The Disclosure UK system and, internationally, the Dutch register and the disclosure scheme in place for Spanish pharmaceutical businesses have set a 3-year time limit on retention (see table 1). The US and French systems have not set a limit. For those seeking to access the information, records need to go far enough back to provide a sense of the relationship between industry and healthcare providers. This, however, needs to be proportionate to and balanced with the rights and interests of the data subjects whose data must not be kept for longer than needed.

Alongside the period for retaining the information in public, we have considered what data should be published. Table 1 shows data fields required by disclosure systems in other countries as well as Disclosure UK.

On balance, we do not consider it appropriate to require the publication of work or home addresses of individual recipients. Professional registration numbers, on the other hand, may be helpful to identify clinicians that have recently changed their employer or name (for example, due to marriage). For individual recipients, we would therefore require businesses to publish the relevant organisations they work for and their professional registration number (if applicable and only if the relevant professional body already publishes these).

Industry-led schemes may choose to capture more information than that specified in the regulations. Individual businesses and third-party schemes must always consider their obligations under relevant data protection legislation.

Table 1: payment reporting requirements and retention periods in the US, France, Netherlands and ABPI’s Disclosure UK

Requirement	Netherlands	US	France	Disclosure UK
Personal ID	No	No	No	No
Professional regulation ID	Yes	No	Sometimes	No
Place of work	Yes	Yes	Yes	Yes
Work address	Yes	Yes	Yes	Yes
Aggregated per company	Yes	No	No	Sometimes (see note)
Time limit on retention	3 years	None	None	3 years

Note: non research and development values are published against individual healthcare professionals (where UK data protection laws allows) and healthcare organisations.

Question

The government proposes to require publication of a register of payments with entries containing the name of the recipient, the annual sum value of payments and benefits made, and a complete list of reasons for each payment and benefit. If the recipient is an individual, we would require businesses to publish their employer and professional registration number (if applicable and published by the professional body).

What information do you think should be published?

• Name of the recipient
• The annual sum value of payments and benefits
• Complete list of reasons for each payment and benefit
• If the recipient is an individual, their workplace and professional registration number (if applicable and published by the professional body)
• None of the above
• Don’t know

Question

The government proposes to require declarations to remain in the public domain for at least 3 years. Please choose your preferred timescale from the following options.

• At least 1 year
• At least 3 years
• At least 5 years
• Don’t know
• Other - please specify

Enforcement

If the government were to proceed with legislation, we would lay out an enforcement approach for this duty in our official response to this consultation. We are committed to fair and balanced enforcement that encourages companies to comply with the duty. This would include notifying businesses if we have reason to believe they have fallen short of their responsibilities. It would also include the potential to impose financial penalties if a company continues to fail to comply with the regulations or provides false or misleading information. There would also be a clear and transparent appeals route for businesses.

The enforcement mechanism would be outlined in the regulations. This would include serving a notice of intent of a proposed financial penalty if compliance is not thought to be met, assessing culpability and allowing the person to make representations. This would be followed by serving the final notice imposing the penalty, which would include the ability to appeal against it. The standards of evidence required to demonstrate compliance, including the provision of data, would be outlined in the regulations.

Questions

Should compliance with the requirements be monitored?

• Yes
• No
• Don’t know

How often should compliance with the requirements be monitored?

• Every 3 months
• Every 6 months
• Every 12 months
• Every 24 months
• Don’t know
• Other - please specify

Who should monitor compliance?

• Trade body
• Government
• Don’t know
• Other - please specify

Questions

How should suspected non-compliance be reported?

• Contactable phone line
• Email
• Online platform
• Through official checks only
• Don’t know
• Other - please specify

Where non-compliance is reported directly or flagged through the monitoring process, an investigation of compliance with the requirements could be triggered. Should all cases identified as potentially non-compliant be reviewed in full?

• Yes
• No
• Don’t know
• Other - please specify

Question

What triggers should be used to determine whether a case is fully investigated?

• Financial value of the case
• Prior instances of non-compliance
• Don’t know
• Other

If you answered other, please provide more information (maximum 100 words).

Question

Do you consider that financial penalties would be an effective and fair deterrent for non-compliance?

• Yes
• No
• Don’t know
• Other - please specify

Question

Please share further comments or feedback relating to enforcement if you have any (maximum 500 words).

Payments out of scope

The primary legislation enables all ‘payments or other benefits’ to be within the scope of the regulations but allows exceptions to be provided for.

The intention would be that every payment or other benefit that can be expressed as a monetary value should be reported. This would include those payments and benefits made anywhere geographically, directly or indirectly.

The government believes in introducing comprehensive transparency that sheds light on industry-provider relationships.

An example of a direct payment would be a cash payment to an NHS trust to sponsor an event.

An example of a direct benefit would be a service provided, such as training on products and procedures relevant to the provision of healthcare, outside of contractual agreements.

An example of an indirect payment would be a payment that goes through a legal person connected with a recipient, for example a charitable foundation.

Where a healthcare professional may use, for example, a company to receive payments on their behalf, the regulations would still require the manufacturer to declare such payments. We recognise that many of these benefits provide value to patients and the health and care system by ensuring the safe and effective use of healthcare products.

Minimum threshold

Having considered similar international schemes and engaged with trade associations, the government also identified specific circumstances under which there could be an exemption to reporting of some payments or benefits.

To manage the business burden and considering that low-value payments or benefits are unlikely to create a conflict, we consider it appropriate to place a minimum value on the payments that should be declared. Thresholds for reporting payments are presented in table 2.

Table 2: payment reporting thresholds in the US, France and Netherlands

System	Individual payment reporting threshold	Annual aggregated reporting threshold
US Sunshine Act	$10	$100
France Loi Bertrand	€10	Unknown
Netherlands Transparency Register	€50	Currently none but was €500 in 2017

The US Physician Payment Sunshine Act excludes transfers of value under US$10, where the total value of all payments or transfers of value made to a single covered recipient does not exceed US$100 during the reporting year.

We propose to take a similar approach with additional flexibility, and set a minimum threshold of £50 for individual payments if the annual aggregated value does not exceed £500 for that recipient. Businesses would, however, still have to report payments if any recipient received payments and benefits valued at £500 and above in any given reporting year. The government believes it is necessary to include an aggregated annual threshold to avoid the reporting duty being undermined by dividing payments.

Question

The government proposes to exempt businesses from reporting payments below £50 where the total annual value of payments does not exceed £500 for that recipient.

What minimum value of payment do you think should be exempt from these regulations?

• Below £10 where the total annual value of payments does not exceed £100
• Below £50 where the total annual value of payments does not exceed £500
• Below £100 where the total annual value of payments does not exceed £1,000
• Don’t know
• Other - please specify

Research and development

The life sciences sector is critical to the country’s health, wealth and resilience. Advances in the life sciences have improved the length and quality of life in the UK and globally. As set out in the Life Sciences Vision, one of the strengths of the UK is the opportunity for the sector to work collaboratively with the UK’s best academics, many of which are active clinicians, and the National Health Service (NHS).

This can lead to commercially sensitive interactions between businesses and healthcare professionals. Therefore, information about payments or benefits provided may disclose commercially sensitive information. If we proceed with regulating, the government proposes to exempt businesses from disclosing commercially sensitive information. We propose to define ‘commercially sensitive information’ as information whose disclosure the business thinks will significantly harm the legitimate business interests of the undertaking to which it relates. This is similar to definitions provided in the Medicines and Medical Devices Act 2021.

For example, a healthcare company seeks to expand its portfolio in a new therapeutic area and establishes new relationships with key experts in the field. Other market players already established in this area could use information about these new relationships to attempt to prevent new entrants from competing with them effectively. Healthy competition and incentives for innovation are essential to ensure the healthcare industry delivers value to patients and providers, so an exemption should apply for reporting commercially sensitive information.

It is important to note that the payment would still need to be disclosed and the exemption would only apply to the disclosure of sensitive information. The bar for meeting this definition is high, given that not every combination of payee and recipient would constitute commercially sensitive information (see data proposed to be published in table 1 above). Additionally, annually aggregating payments, and allowing businesses to provide a complete list of reasons for payments and benefits already limits the risk of disclosing commercially sensitive information.

If businesses apply this exemption, they would be required to publish their rationale for using the exemption and declare that they have applied it visibly on their website, without disclosing any commercially sensitive information. This should demonstrate that businesses have explored ways of ‘desensitising’ the information before applying the exemption.

Question

The government proposes to exempt businesses from reporting payments which may disclose commercially sensitive information under the condition that they publish their rationale for using the exemption and declare that they have applied the exemption.

Which, if any, of the following options do you agree with?

• I agree with the government proposal - that exemptions are permitted, the rationale for using the exemption should be given for every use and there should be a public declaration that the exemption has been applied
• I agree in part with the government proposal - exemptions should be permitted, and there should be a standard disclaimer published that the exemption has been applied to some payments
• I disagree with the government proposal - there should be no exemption, all payments should be reported
• A redacted version of the payments should be reported
• Don’t know

It should be noted that some medicines and medical device manufacturers provide educational grants to a wide variety of recipients, including medical societies, hospitals and professional associations. In circumstances where the business does not know which healthcare professional received funding from the grant, such payments should be reported by the business with the first recipient named.

We consider that businesses should not be required to publish information about services or products they provide to a healthcare provider or person carrying out an activity connected with healthcare, where the recipient is paying for those services or products at fair market value. In England, NHS trusts make procurement activity transparent by publishing all tender opportunities with contract value over £25,000 and details of total spend by supplier each month on their websites. We therefore believe that appropriate reporting mechanisms exist for contracted expenditure.

To deliver the best value for money, healthcare providers require confidentiality to negotiate with industry to award contracts. These negotiations can lead to discounts on the publicly declared price for medicines or medical devices. We propose that businesses should not be required to publish information about discounts given on the prices of products or services that are provided as part of a contractual agreement. The pricing of medicines is complex and the net price paid by the NHS for a medicine may be significantly lower than its public list price due to a range of commercial agreements.

This exception would not apply to contracts with healthcare professionals, as we believe transparency of consulting services provided by clinicians to businesses, for example, will be vital to achieving the policy objectives. Disclosure UK already provides information on contracted services fees and we anticipate that similar provisions would form part of the regulations.

Question

The government proposes to exempt businesses from reporting payments and benefits made under contractual obligations where the healthcare provider organisation pays the business at fair market value, including discounts on prices that meet these criteria.

Do you agree or disagree with this proposal?

• Agree
• Disagree
• Don’t know

Impacts and monitoring

Impact of mandatory reporting on industry

We consider that the proposals outlined would balance consistent reporting of payments made by pharmaceutical and medical device businesses to the healthcare sector against the administrative burden on businesses. We would welcome views from industry to better understand the impact the proposed new regulations would have on businesses.

Question

Do you think small and micro businesses should be exempt from the duty?

• Yes, exclude small businesses (up to 50 employees)
• Yes, exclude micro businesses (up to 10 employees) only
• No, don’t exclude businesses based on size
• Don’t know

If you answered yes, please explain why you believe small and/or micro businesses should be exempt (maximum 250 words).

If you answered no, please explain why you believe small and/or micro businesses should not be exempt (maximum 250 words).

Question

How much time and cost do you expect to incur in joining or setting up an alternative third-party reporting scheme?

Please provide an estimate by types of cost you expect, for example IT set-up (maximum 500 words).

Question

How much (additional) time and cost do you expect to incur each year to declare payments, including to collect, review and publish the information?

Please provide an estimate.

Question

If available, how many in-scope payments do you expect to make each year?

Please provide an estimate.

Question

Are there any other issues or comments you would like to provide feedback on? (maximum 500 words)

Realising the benefits of proposals

The government believes that mandatory reporting of information about payments and other benefits provided by businesses to healthcare providers could help reduce the risks of conflicts of interest, while preserving the positive effects of industry or healthcare provider relationships.

We would welcome views on how effectively mandatory reporting would achieve the intended objectives: enabling greater patient trust in healthcare professionals and organisations and helping to ensure that healthcare professionals continue to make impartial, evidenced-based decisions about patient care. The government is committed to exploring all options to deliver on this policy.

Question

Thinking about the proposals outlined in this consultation, are there any other options for payment reporting which would achieve similar aims which the government should explore? You may choose as many of the options below as you wish.

• Voluntary compliance with government-issued guidance
• Voluntary publication of information currently required to be held by any trade association you are a member of
• Other

If you answered other, please provide more information (maximum 500 words).

Question

Please provide details of any current reporting systems in the UK which may result in duplication if this new duty is introduced.

This could be either voluntary or mandatory, industry or official reporting, excluding overseas requirements (maximum 500 words).

Question

Do you think the proposals will change patient relationships with their healthcare professionals?

• Yes
• No
• Don’t know

If yes, how do you think these proposals would change patient relationships with healthcare providers?

• I think it would improve the relationship
• I think it would be detrimental to the relationship

Question

Do you think these proposals would increase impartial decision-making from healthcare professionals and organisations?

• Yes
• No
• Don’t know

Question

Would you access and use the published information to make decisions on your healthcare?

• Yes
• No
• Don’t know

Question

If this published information had been available to you in the past, would you have used it?

• Yes
• No
• Don’t know

Question

Reflecting on the answers given to our proposals, please share any thoughts and further information to help us understand your views, especially where you disagree with proposals (maximum 250 words).

How to respond

The consultation is open for 6 weeks, and will close at 11:59pm on 16 October 2023. We welcome responses from any interested person, business or organisation.

The easiest way to respond is by completing the online survey.

If you are unable to use the online form, email industry-reporting-consultation@dhsc.gov.uk. Do not send any personal information to this email address.

Annex A: legal definitions

Medicines (medicinal products)

Medicines (medicinal products) are defined in regulation 3(12) of the Human Medicines Regulations 2012 as follows.

In these regulations ‘medicinal product’ means either:

• any substance or combination of substances presented as having properties of preventing or treating disease in human beings
• any substance or combination of substances that may be used by or administered to human beings with a view to either:
  • restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action
  • making a medical diagnosis

These regulations do not apply to:

• whole human blood
• any human blood component, other than plasma prepared by a method involving an industrial process

Medical devices

Medical devices are defined in regulation 2(1) of the UK Medical Device Regulations 2002 (as amended), as follows.

‘Medical device’ means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which:

• is intended by the manufacturer to be used for human beings for the purpose of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process
  • control of conception
• does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means, and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device

Borderline substances

Borderline substances are defined in part 16 of the Drug Tariff and section 22(4) of the Health Service Products (Provision and Disclosure of Information) Regulations 2018 as follows.

A food or dermatological product is listed in a Drug Tariff if the food or product is listed:

• in part XV of the Drug Tariff (England and Wales) for the given month
• in part X of the Drug Tariff (Northern Ireland) for the given month

The Scottish Drug Tariff does not define borderline substances but the products that can be prescribed of this nature can be found in parts XII and XVI.

Annex B: privacy notice

Over the course of April and May 2023, DHSC will seek the views of individuals and organisations through a public consultation, to inform new regulations for medicines and medical devices manufacturers to report payments made to healthcare providers. This notice sets out how data collected through this consultation will be used and respondents’ rights under Articles 13 or 14 the UK General Data Protection Regulation (GDPR).

Data controller

DHSC is the data controller.

What personal data we collect

You can respond to the consultation through our public survey, which can be completed online and submitted by email.

We will collect data on:

• whether you are responding as an individual or on behalf of an organisation.
• your occupation
• your name and name of your organisation
• the country and region you live in, or where your organisation provides services in the UK
• (if responding online) your internet protocol (IP) address (this is for security purposes and will not be attached to your survey response)

If volunteered by you, we will also collect data on:

• your email address (if completing a paper survey and submitting it by email, or if responding on behalf of an organisation and confirming DHSC can contact you about your response)
• any other personal data you volunteer by way of evidence or example in your response to open-ended questions in the survey

How we use your data (purposes)

Your data will be treated in the strictest of confidence.

We collect your personal data as part of the consultation process:

• for statistical purposes, for example, to understand how representative the results are and whether views and experiences vary across demographics
• so that DHSC can contact you for further information about your response (if you are responding on behalf of an organisation and have given your consent)

Legal basis for processing personal data

The legal basis for processing your personal data is to perform a task carried out in the public interest, or in the exercise of official authority vested in the controller.

Data processors and other recipients of personal data

All responses to the consultation will be seen by:

• professional analysts and policy leads working on the new regulations for medicines and medical devices manufacturers to report payments to healthcare providers (or overlapping areas) in DHSC
• DHSC’s third-party supplier (SurveyOptic), who is responsible for running and hosting the online survey

No personally identifiable data will be shared.

DHSC may also share your responses, when anonymised, with:

• individuals supporting this project within DHSC’s executive agencies or executive non-departmental public bodies, such as NHS England
• other government departments
• external researchers if additional support is required to analyse the responses received

International data transfers and storage locations

Storage of data by DHSC is provided via secure computing infrastructure on servers located in the European Economic Area (EEA). Our platforms are subject to extensive security protections and encryption measures.

Storage of data by SurveyOptic is provided via secure servers located in the UK.

Retention and disposal policy

Personal data will be held by DHSC for a minimum of 1 year and a maximum of 3 years.

SurveyOptic will securely erase the data held on their system 5 years after the consultation online survey closes, or when instructed to do so by DHSC if the data has served its intended purpose (whichever happens earlier).

Data retention will be reviewed on an annual basis. Anonymised data may be kept indefinitely.

How we keep your data secure

DHSC uses appropriate technical, organisational and administrative security measures to protect any information we hold in our records from loss, misuse, unauthorised access, disclosure, alteration and destruction. We have written procedures and policies which are regularly audited and reviewed at a senior level.

SurveyOptic is Cyber Essentials certified.

Your rights as a data subject

By law, you have rights as a data subject. Your rights under the UK General Data Protection Regulation and the Data Protection Act 2018 apply.

These rights are:

• the right to get copies of information - individuals have the right to ask for a copy of any information about them that is used
• the right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected
• the right to limit how the information is used - individuals have the right to ask for any of the information held about them to be restricted, for example, if they think inaccurate information is being used
• the right to object to the information being used - individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case
• the right to get information deleted - this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme in the first instance should contact data_protection@dhsc.gov.uk or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can make a complaint to the Information Commissioner’s Office or write to:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision-making or profiling

No decision will be made about individuals solely based on automated decision-making (where a decision is taken about them using an electronic system without human involvement) that has a significant impact on them.

Changes to this policy

This privacy notice is kept under regular review, and new versions will be available on our privacy notice page on our website. This privacy notice was last updated on 4 September 2023.