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ABPI champions use of ‘Legitimate Interests’ to boost transparency

The ABPI has today released new guidance to pharmaceutical companies using Disclosure UK to boost transparency in the relationships between healthcare professionals, other relevant decision-makers and the industry. 

I’m pleased the ABPI is launching this new guidance which will boost patient safety and public confidence in our healthcare professionals. An improvement in the transparency of payments made to clinicians was recommended by Baroness Cumberlege in her independent report, and I want to see as many pharmaceutical companies as possible adopt the guidance. Maria Caulfield MP, Minister for Patient Safety and Primary Care at the Department of Health and Social Care

All pharmaceutical companies abiding by the ABPI Code of Practice must disclose ‘transfers of value’ to healthcare professionals (HCPs), other relevant decision makers (ORDMs) and healthcare organisations in the UK on the database. Where possible, companies do this by naming the individuals and organisations.

The UK Data Protection Act and GDPR requires companies to choose a lawful basis to publish personal data about individuals – HCP/ORDMs. The act does not require a lawful basis to publish data about healthcare organisations.

Most pharmaceutical companies currently use “Consent” as their lawful basis and subsequently require explicit agreement from each individual before they can publish the value of collaboration against the name on Disclosure UK. Currently, the number of individuals who don’t consent is a challenge in further improving the transparency available through Disclosure UK.

An alternative lawful basis to “Consent” is ‘Legitimate Interests’. Under this framework, a company asserts their transparency commitments over the individual’s data rights. In practice, this means that the company does not ask for permission to publish the information with the value received on Disclosure UK, but still has a responsibility to be clear about their intentions and allow individuals the opportunity to raise objections.

The ABPI is now encouraging companies to use ‘Legitimate Interests’ as their lawful basis for processing individuals data. The ABPI is promoting this change in approach to help increase the number of named healthcare professionals and other individuals on Disclosure UK.

There are already a small number of companies using “Legitimate Interests” as their legal basis for publishing individual data on Disclosure UK and ABPI’s analysis of 2020 Disclosure UK data demonstrates that:

  • Of the 10 companies who we know used “Legitimate Interests” for their 2020 disclosures, all had 76% - 100% of their individuals named
  • Half of these companies had over 97% of individuals named
  • All 10 of these companies had above average percentages of individuals named – the average across all companies in 2020 was estimated at 68%

The Disclosure UK database is already one of the globally leading mechanisms for ensuring transparency in the relationship between healthcare professionals, other relevant decision makers and healthcare organisations and the pharmaceutical industry. These relationships are vital for the development of medicines and improving patient care.

President of the ABPI Ben Osborn said:

“We believe that championing an industry-wide change to the use of “Legitimate Interests” is the single most impactful step we can take to further increase the transparency available through Disclosure UK.

“My own company, Pfizer, is one of a small but growing group of companies already doing this. Like others, we are committed to transparency about the relationships we have with healthcare professionals and organisations. These relationships are critical to advance patient care.

“In Pfizer’s experience, our move to using “Legitimate Interests” has helped us share more detailed information about our relationships with named individuals. I would encourage other companies to consider how they can now adopt this approach”.”

Richard Torbett, Chief Executive of the ABPI said:

“Being transparent and open is something we’re passionate about, so I really want to encourage all companies to use “Legitimate Interests” when processing healthcare professionals’ data for Disclosure UK.

“This is not an ‘opt-out’ system. Whilst no longer asking for formal consent, the company has a responsibility to be clear about its intentions with healthcare professionals and must allow individuals to exercise their right to raise objections.

“Ultimately, we want to see 100% of healthcare professionals named on Disclosure UK for non-R&D work, and this move will help us get there.”

 

The move by ABPI has received support across the UK’s medical, government and regulatory bodies. 

Maria Caulfield MP, Minister for Patient Safety and Primary Care at the Department of Health and Social Care said:

“I’m pleased the ABPI is launching this new guidance which will boost patient safety and public confidence in our healthcare professionals.

“An improvement in the transparency of payments made to clinicians was recommended by Baroness Cumberlege in her independent report, and I want to see as many pharmaceutical companies as possible adopt the guidance.”

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Dr June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency said:

“Payments to healthcare professionals in association with the promotion of medicines are strictly regulated under UK law and the ABPI Code.

“We welcome measures such as this new guidance to increase the transparency of payments.”

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Nathalie Mol, Director General, European Federation of Pharmaceutical Industries and Associations said:

“EFPIA welcomes and supports the ABPI position. It is aligned with our priority to improve the disclosure of payments made to health professionals and increase the level of individual data disclosed across Europe.

“In 2019, EFPIA removed the reference to individual consent to disclose in the EFPIA Code. This allows EFPIA members to choose on which legal basis they base the disclosure.

“Reflecting the industry-wide commitment to transparency in our external relationships, other EFPIA member associations are taking a similar approach to the ABPI to continuously improve their disclosures. These developments further demonstrate our collective commitment to open, transparent relationships and ethical ways of working.”

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Daniel Mortimer, Chief Executive of NHS Employers and Deputy-Chief Executive of the NHS Confederation said:

“NHS organisations and their senior staff are committed to the highest standards of business conduct and ensuring public confidence in the commercial and clinical decisions they make. 

“Transparency is therefore a vital element in ensuring public confidence, and this latest step by the pharmaceutical industry is another positive step in our shared commitment to the highest ethical standards of conducting our business with each other.”

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Andrew Evans, Chief Pharmaceutical Officer for the Welsh Government: 

“We welcome the change in ABPI’s guidance, it is an important step forward in improving transparency for patients.

“Greater transparency of healthcare professionals’ interests will help people to make more informed decisions about their care and I urge every pharmaceutical company to adopt the guidance as soon as possible.”

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Charlotte Augst, Chief Executive of National Voices – a coalition of health and care charities in England:

“People who rely on advice and support from health professionals need to be sure that the needs of the patient are the one and only interest shaping the professional’s advice.

“That’s why this is a positive move - being transparent about any financial interests a health professional might have is important for maintaining that trust.”

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Irene Oldfather, Director of Strategy and Engagement, Health and Social Care Alliance Scotland (the ALLIANCE):

“The advancement of medicines is crucial for the needs of people in Scotland. Increasingly citizens want to see transparency in the process and relationships and at the ALLIANCE we support this call from ABPI.

“This way of working provides openness in relationships between health professionals and pharmaceutical companies. Maintaining trust in our NHS is vital.”

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Professor Helen Stokes-Lampard, Chair of the Academy of Medical Royal Colleges:

“The Academy has long argued that doctors’ relationships with pharmaceutical companies should be open and transparent.

“That’s why we support the ABPI’s ongoing work on disclosure and we congratulate those companies who are using Legitimate Interests to publish the nature of the relationship.

“This new ABPI guidance is another positive development which should further improve public confidence in those caring for them.”

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Dr Trevor Pickersgill, Treasurer and Chief Officer of the British Medical Association:

“Openness and transparency about arrangements between healthcare staff and pharmaceutical companies is an important way of identifying and managing potential conflicts of interest in health care, and is key in maintaining confidence and trust between the public and healthcare workers.

We support the existing high levels of disclosure of transfers of value, and we welcome this new guidance from the ABPI that we hope will boost transparency and public confidence further.”

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Professor Ramesh Arasaradnam, Academic Vice President of the Royal College of Physicians London:

“The RCP supports this move by the ABPI as we welcome any approach that increases transparency.

“Being open about our professional relationships not only increases public confidence, it is an opportunity to show the importance of the relationship between clinicians and the pharmaceutical industry in delivering healthcare.

“All physicians should declare any potential conflicts at their annual appraisal, and we support these being made public.”

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Professor Neil Mortensen, President of the Royal College of Surgeons of England:

“The Royal College of Surgeons of England, through our Good Surgical Practice guidance, encourages surgeons to have the care and wellbeing of their patient as their primary consideration and disclose all interests and financial benefits relevant to the circumstances of the patient’s care.

“This includes any personal affiliation or other financial or commercial interest relating to their practice, including research trials, healthcare companies, pharmaceutical companies or instrument manufacturers.

“We welcome the ABPI’s proposal to rely on legitimate interests for disclosure, which is in line with the College’s guidance and is designed to improve transparency and the rates of disclosure.”

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Rachel Hollis, Chair of the Royal College of Nursing’s Professional Nursing Committee:

“The RCN recognises the need for transparency and openness in all aspects of health care.

“This is a positive step forward. Patients and the public need to be able to trust that clinical decisions are always made in their best interests, and nurses need to be able to advocate from a position of confidence.”

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Dr Doug Brown, Chief Executive of the British Society for Immunology: 

“Collaborations between academia, the NHS and the pharmaceutical industry are vital for delivering new life changing treatments for patients, but at the same time it is equally vital to have transparency where these relationships exist to ensure we maintain public confidence.

“The British Society for Immunology therefore supports this new ABPI position to further increase transparency and ensure that the UK life sciences sector continues to innovate for patient benefit and goes from strength to strength.”

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Rachel Lambert-Forsyth, Chief Executive of the British Pharmacological Society: 

“Sharing knowledge to improve patient outcomes is at the core of the British Pharmacological Society’s work and so we welcome the ABPI’s efforts to improve the transparency of interactions between the pharmaceutical industry and healthcare professionals.

“It is encouraging that companies already using 'Legitimate Interests' as their lawful basis are reporting that the majority of their individuals are named.

“I hope that this change will be widely adopted to continue this shift to greater openness.”

Gareth Jones, Head of Corporate Affairs, National Pharmacy Association:

“Joint working between the pharmaceutical industry and pharmacists can add significant value to patient care.

“It is important, however, that we are open and transparent about joint work programmes and the NPA support’s this initiative from the ABPI to optimise this.”

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Natalie Beswetherick, Director of Practice & Development at the Chartered Society of Physiotherapy: 

“The Chartered Society of Physiotherapy is pleased to support ABPI’s announcement that will further increase the transparency available through Disclosure UK.

“This latest step will ensure the highest ethical standards and increased public confidence in the professional relationships between physiotherapists and the pharmaceutical industry in delivering healthcare.”

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Dr Sheuli Porkess, Vice-President of the Faculty of Pharmaceutical Medicine:

“Ethics and transparency are key principles within pharmaceutical medicine and FPM welcomes ongoing work to promote transparency of collaborations between industry and healthcare professionals.”

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Professor Claire Anderson, President of the Royal Pharmaceutical Society:

“Collaborations between pharmaceutical companies and healthcare professionals are central to the research and development of future treatments. The Disclosure UK database of payments received by healthcare professionals is essential to maintaining transparency in these working relationships.

“We support moves to improve openness around receipt of payments to individuals to maintain confidence in the partnerships between the pharmaceutical industry and healthcare professionals.”

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The companies who used ‘Legitimate Interests’ as their legal basis for 2020 disclosure are: AstraZeneca, Alexion, Boehringer Ingelheim, Eisai, Gilead, Janssen, Lupin, Novo Nordisk, Pfizer, and Sanofi. For more information about each companies’ approach, please review the published Methodological Notes for Disclosure UK.

Some companies switched from using Consent to Legitimate Interests part way through 2020. This could explain why the rate of individuals named using Legitimate Interests was not higher in some cases.

We expect this to be further improved when they have used ‘Legitimate Interests’ for a full year of disclosure data.

Healthcare professionals and other relevant decision makers are only listed by name in Disclosure UK against the values for non-R&D work. The values for R&D work are always listed in aggregate.

For more information about the non-R&D work between companies and healthcare professionals please see our factsheet – How we work with HCPs.

The ABPI has done extensive work with the NHS and professional bodies to encourage agreement from healthcare professionals to be named on Disclosure UK. Disclosure is mandatory for pharmaceutical companies under the ABPI Code, however UK data protection law means individual HCPs can refuse to be named, if asked. Examples:

  • 2017 – ABPI worked with NHS England on their Guidance for managing conflicts of interest in the NHS– with Disclosure UK directly referenced.
  • 2017 – ABPI/NHS England published a joint letter on our shared commitment to 100% HCP disclosure.
  • 2017 - The Academy of Medical Royal Colleges (AoMRC) published statement recommending HCPs agree to be named on Disclosure UK, and in 2020 published the 'Step Up' leaflet for HCPs (as below).
  • 2017 – ABPI provided an engagement and communications toolkit to NHS trusts and wider to support organisations in advocating Disclosure UK to their employees.
  • 2018 – AoMRC publish second statement recommending HCPs agree to be named on Disclosure UK
  • 2019 – ABPI produced best practice disclosure toolkit for companies
  • 2020 – ABPI published 'Step Up' leaflet for HCPs co-branded with professional bodies: the Academy of Medical Royal Colleges, the Faculty of Pharmaceutical Medicine, the Royal Pharmaceutical Society and the Welsh Government. This leaflet encourages HCPs to agree to be named on Disclosure UK.
  • In addition, General Medical Council (GMC) guidance for doctors, Good medical practice explains that doctors must be honest in financial dealings and must declare any conflicts of interest. The GMC has also published a HCP case study on declaring conflicts of interest, which includes being named on Disclosure UK alongside following local processes with their employer or provider and being open and transparent with their patients.

List of stakeholder support:

  • Academy of Medical Royal Colleges
  • British Medical Association
  • British Pharmacological Society
  • British Society of Immunology
  • Chartered Society of Physiotherapy
  • Department of Health and Social Care
  • European Federation of Pharmaceutical Industries and Associations
  • Faculty of Pharmaceutical Medicine
  • Health and Social Care Alliance Scotland
  • Medicines & Healthcare products Regulatory Agency
  • National Pharmacy Association
  • National Voices
  • NHS Confederation + NHS Employers
  • Royal College of Nursing
  • Royal College of Physicians
  • Royal College of Surgeons of England
  • Royal Pharmaceutical Society
  • Welsh Government

The ABPI exists to make the UK the best place in the world to research, develop and use new medicines. We represent companies of all sizes who invest in discovering the medicines of the future. 

Our members supply cutting edge treatments that improve and save the lives of millions of people. We work in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines. Every day, we partner with organisations in the life sciences community and beyond to transform lives across the UK.