CASE/0521/03/25 and CASE/0522/03/25 NO BREACH OF THE CODE
COMPLAINANT v SANOFI
Allegations about two collaborative working projects
CASES SUMMARY
These cases were considered together as they concerned similar allegations about the intent and execution of two collaborative working projects. The allegations related to:
- disguised promotion of Sanofi’s unlicensed medicine Tzield (teplizumab),
- potential commercial influence, and
- the transparency of the projects.
The outcome under the 2024 Code was:
CASE/0521/03/25
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Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
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No Breach of Clause 3.1
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No Breach of Clause 3.6
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No Breach of Clause 5.1
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No Breach of Clause 20.2
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No Breach of Clause 20.3 (x2)
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CASE/0522/03/25
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No Breach of Clause 3.1
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No Breach of Clause 5.1
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No Breach of Clause 20.2
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No Breach of Clause 20.3 (x2)
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This summary is not intended to be read in isolation.
For full details, please see the full case report below.
FULL CASE REPORT
Two complaints about Sanofi were received from a contactable complainant who described themselves as a health professional.
COMPLAINTS
The complaints’ wording is reproduced below with some typographical errors corrected:
Case/0521/03/25
“I am writing as a concerned healthcare professional regarding a collaborative project between Sanofi and [named] NHS Foundation Trust, as outlined in the publicly available project summary [URL provided]. Upon reviewing the project, I have significant concerns that it may not be fully compliant with the ABPI Code of Practice and would appreciate a formal review of its intent and execution. The project is described as a pilot to screen first-degree relatives of patients with Type 1 diabetes for pre-symptomatic disease. While the concept of early detection is important for patient care, there are aspects of this collaboration that raise serious questions about Sanofi’s commercial intent and whether this initiative is truly independent of its business interests. Concerns Regarding Compliance with the ABPI Code of Practice 1. Potential Disguised Promotion of an Unlicensed Medicine • The screening pathways promoted in this project closely align with the intended indication of Tzield (teplizumab), a Sanofi product that is not yet licensed in the UK. • If this initiative lays the groundwork for the future adoption of Teplizumab within the NHS, it could be considered disguised promotion of an unlicensed medicine. 2. Lack of Transparency and Potential Commercial Influence Over NHS Pathways • The project has the potential to reshape NHS clinical pathways, potentially normalising screening practices that could later facilitate Teplizumab uptake. • If this initiative has been presented to NHS partners as a neutral public health measure, without clarity on the potential future commercial implications, it raises concerns about transparency and whether NHS clinicians have full visibility of Sanofi’s strategic interests. 3. Promotional Activities Disguised as a Collaborative Working • The ABPI Code strictly prohibits promotional activities being conducted under the guise of Collaborative Working. • While this project does not explicitly mention Teplizumab, the alignment between screening and its future indication suggests an indirect marketing strategy. It is not made clear that Teplizumab currently has no MA. 4. Indirect Promotion Through NHS Healthcare Professionals • If NHS clinicians involved in this project later advocate for Teplizumab, it could suggest undue influence stemming from this collaboration. • Additionally, there is concern that Sanofi is strategically engaging with HCPs who have supported its past medicines, with a view to securing future advocacy for Teplizumab, introducing commercial bias. Request for Formal Review I have serious concern regarding the proactive involvement of Sanofi’s commercial team in the development of these projects. Pharmaceutical companies must maintain a clear separation between commercial and non promotional activities to prevent undue influence on clinical decision-making. I believe Sanofi’s commercial team played an active role in shaping these initiatives, As this project has the potential to impact clinical decision-making, patient care, and the ethical conduct of pharmaceutical industry collaborations, I urge the PMCPA to conduct a thorough review and take appropriate action to ensure full compliance with the ABPI Code. I appreciate your time in considering this matter and would welcome any further information on how this project is being assessed for compliance. Please do not hesitate to contact me should you require further details.”
Case/0522/03/25
“I am writing to formally request an investigation into Sanofi UK’s collaborative working project with the [named health professional membership organisation], titled ‘Co-development and roll out a National educational programme on the monitoring and management of patients with islet autoantibody-positive pre-stage 3 type 1 diabetes.’ [URL provided] After reviewing the publicly available executive summary, I have serious concerns regarding whether this initiative complies with the ABPI Code of Practice, particularly in relation to transparency, undue commercial influence, and the potential for indirect promotion of an unlicensed medicine. The purpose of this collaboration is stated as providing education for healthcare professionals on the monitoring and management of islet autoantibody-positive patients. The programme seeks to increase awareness of screening studies, confirmatory testing services, and the importance of early diagnosis. However, the way in which this initiative has been structured raises significant concerns regarding its true intent and whether it primarily serves Sanofi’s future commercial interests rather than being a neutral, independent educational programme. Sanofi is currently developing and preparing to launch Tzield (Teplizumab), a medicine specifically designed to delay the onset of type 1 diabetes in at-risk patients. This educational programme places strong emphasis on screening for pre-stage 3 type 1 diabetes, despite the fact that there are currently no approved treatments for this condition in the UK. By directing healthcare professionals towards identifying and monitoring a patient population that currently lacks treatment options, there is a clear risk that this initiative is laying the groundwork for the future adoption of Teplizumab, rather than serving as an unbiased educational effort. If the programme has been designed to familiarise healthcare professionals with the concept of early intervention in a way that aligns with Sanofi’s commercial objectives, it could be seen as an indirect promotional effort rather than a purely medical initiative. Another significant concern is the extent of Sanofi’s influence over [named health professional membership organisation] in shaping this programme. Ethical collaboration between pharmaceutical companies and healthcare organisations requires clear independence, ensuring that medical education is not driven by commercial interests. If Sanofi has had a direct role in determining the focus or content of the programme, this could suggest an inappropriate level of influence over an independent medical body. There is also concern that this initiative may constitute indirect promotion of an unlicensed medicine on the UK. While Teplizumab is not explicitly mentioned in the project summary, the focus on screening and monitoring pre-stage 3 type 1 diabetes could create awareness and demand for an intervention that currently lacks approved treatment options—except for the product Sanofi is seeking to bring to market. If the programme is effectively conditioning healthcare professionals to adopt a treatment pathway that aligns with Sanofi’s forthcoming product, this would raise serious regulatory and ethical concerns regarding pre-licence promotion. I also have serious concern regarding the proactive involvement of Sanofi’s commercial team in the development of these projects. I believe Sanofi’s commercial team played an active role in shaping these initiatives, rather than limiting involvement to transparent, non-promotional support, this raises questions about whether the projects were designed to serve genuine clinical needs or commercial objectives. Such involvement risks compromising the independence of healthcare professionals and could constitute indirect promotion under the [text missing]. As this project has the potential to impact clinical decision-making, patient care, and the ethical conduct of pharmaceutical industry collaborations, I urge the PMCPA to conduct a thorough review and take appropriate action to ensure full compliance with the ABPI Code. I look forward to your response and would be happy to provide any additional information if required.”
When writing to Sanofi, the PMCPA asked it to consider the requirements of Clauses 2, 3.1, 3.6, 5.1, 20.1, 20.2 and 20.3 of the 2024 Code for both cases.
SANOFI’S RESPONSE
The response from Sanofi is reproduced below:
“We are writing in response to two complaints received under Case/0522/03/25 and Case/0521/03/25 regarding our current collaborative working projects with [named health professional membership organisation] and [named] NHS Foundation Trust.
As both complaints contained very similar allegations and our responses are subsequently similar, we have responded with one letter covering both cases.
Sanofi is proud of our strong heritage in the conduct of Collaborative Working Projects and recognise the tremendous value of such collaborations for patients, healthcare organisations, the NHS and the Pharmaceutical Industry. We take these matters very seriously and appreciate the opportunity to address the concerns outlined by the complainants.
In order to facilitate a complete response, we would like to outline our understanding of the various allegations made as follows:
Allegations made with respect to the [named health professional membership organisation] collaboration:
• Lack of transparency
• Undue commercial influence over [named health professional membership organisation]
• Indirect promotion of an unlicensed product (teplizumab)
• Disguised activity to serve Sanofi’s future commercial interests
Allegations made with respect to the [named] NHS Foundation Trust collaboration:
• Unlicensed/disguised promotion of teplizumab
• Lack of transparency
• Commercial influence over NHS pathways to facilitate teplizumab uptake
• Choosing to work with HCPs who will later advocate for teplizumab
Strategically engaging with HCPs who have previously supported Sanofi medicines
• Inappropriate involvement of a commercial team in the project
We strongly refute all of these allegations which have not been supported with any evidence. Please find below the evidence that substantiates our position and demonstrates how we have complied with the requirements of the applicable clauses of the 2024 Code outlined by the PMCPA Case Manager i.e. clauses 3.1, 3.6, 20.1, 20.2, 20.3, 5.1, and 2 with respect to these collaborations.
We refute the allegations based on the following tenets:
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- Sanofi has robust processes in place for the planning and execution of collaborative working projects which are fully aligned with ABPI principles including the need for transparency. Enclosed evidence supporting this includes our collaborative working SOP, and the agreements we have in place with the relevant parties.
- Sanofi staff involved in collaborative working do so in a non-promotional capacity and are highly qualified and trained to ensure Code compliance. Their reporting line does not involve any links to the Sanofi sales function, and they are not bonused on sales performance.
- Teplizumab is an unlicensed agent. It is not a licenced Prescription-Only Medicine and therefore cannot be promoted in a disguised manner under the Code.
- Autoimmune type I diabetes (aT1D) can now be diagnosed in early stages before it becomes symptomatic in both adults and children. Early detection through screening for autoantibodies offers the opportunity to prevent serious complications and misdiagnosis, as well as to offer education and counselling to those affected and their families. The benefits of screening to patients do not require a licensed product to be available.
- The screening process for aT1D is independent of the staging process which is required to determine eligibility for teplizumab. The collaborative working projects in question are firmly limited to screening only. They do not in any way involve the staging process and are therefore not able to identify patients who might be eligible for teplizumab.
- The Code and ABPI collaborative working guidelines do not preclude a company from benefiting from a collaborative working project provided that it is done to enhance or maintain patient care or benefit the NHS. Our projects clearly fulfil these requirements.
Alleged breaches of Clauses 20.1, 20.2 and 20.3
Collaborative projects are encouraged and welcomed by the NHS. At the end of January 2025 Sanofi had 54 collaborative working projects with NHS partners either at implementation or completion across multiple disease areas. Sanofi has a rigorous process in the approval of any collaborative working projects from the point of concept. These concepts are brought to an internal Collaborative Working Governance Committee (CWGC) whose role is to critically assess all projects to ensure they stand up to external scrutiny and ensure they meet the requirements of the ABPI Code. The committee meet every two weeks to discuss new concepts, review Project Initiation Documents (PIDs) before review and certification and share the outputs from completed projects. Decisions in relation to this, and all collaborative working projects are captured in meeting minutes and/or email communications and stored for future reference. We have attached the meeting minutes in regards to both the collaborative working projects mentioned in these complaints..
Our internal CWCG includes:
• Healthcare Compliance Representative
• Country Medical Chair or delegated Medical lead
• Head of Market Access
• Legal Business Partner for CW as required
• Program Managers
• Head of Ethics and Business Integrity
• Director/Lead role representative from Business Units (for relevant projects)
• Medical Lead / Final Medical signatory
The pooling of skills, experience and/or resources from all of the parties involved in the joint development and implementation of these patient centred projects are clearly documented in detail across all stages within the certified project initiation documents (PIDs). This shows a shared commitment to successful delivery from all parties, and that each party is making a significant contribution to the projects (as required by clause 20.2).
All relevant material have been certified in accordance with the relevant code at the time of creation in accordance with code 20.3. The signed agreement documents explicitly require all parties to agree and acknowledge that commitments and contributions provided by Sanofi remain independent of all decisions relating to drug choice made by them.
The agreements also clearly document Sanofi’s commercial interests within Type 1 Diabetes and state that Sanofi has an unlicensed product in development which may lead to a potential benefit for Sanofi (the product was not explicitly named in the published executive summary as it is freely available to the general public). The documents we are submitting support full compliance with the requirements of clause 20.3 and we refute all allegations of a lack of transparency.
Sanofi personnel who have had an active role in these projects sit within aT1D (autoimmune type 1 diabetes) medical team and the NHS Engagement Manager’s (NEM’s) team. The NEM team are managed by an NHS Engagement Lead who reports directly to the General Manager for General Medicines UKIE, they do not receive bonuses for sales of product on a specific territory. They are trained and validated on the ABPI Code to the highest level within the company and all have extensive project management expertise.
The specific role of the NEM team in each of these collaborative working projects is clearly documented in the PIDs for [named health professional membership organisation and named NHS foundation Trust] projects (see enclosed PIDs).
We do not accept that any of these arrangements are in breach of clauses 20.1, 20.2 or 20.3.
Alleged breaches of Clauses 3.1 & 3.6
Sanofi has established a significant presence in the field of diabetes care over three decades, with a portfolio that includes several marketed products for the management of both type 1 and type 2 diabetes. This underlines Sanofi’s commitment to diabetes research and treatment reflecting a long-standing dedication to improving patient outcomes in this therapeutic area. Sanofi currently markets six products which are licensed for use in type I diabetes.
It is now widely accepted that Type 1 diabetes is an autoimmune disease characterised by three stages:
• Stage 1: Initiation of the autoimmune process (presence of two or more islet autoantibodies); Importantly, currently early- stage is associated with normoglycaemia. Stage 1 is associated with a 44% risk of progression to stage-3 within five years of developing stage-3.
• Stage 2: Persistence of islet autoantibodies with further loss of βcell function and development of dysglycaemia. Stage 2 is associated with a 75% risk of progression to a diagnosis of T1D within 5 years, and a lifetime risk nearing 100%.
• Stage 3: Stage 3 type 1 diabetes with hyperglycaemia which meets ADA criteria. In the absence of early testing, most patients present in this stage.
Approximately 40% of aT1D patients present with diabetic ketoacidosis (DKA) at diagnosis. DKA is a medical emergency and can be fatal without prompt treatment. It is the leading cause of death in people under 50 years with T1D, contributing to 29% of male deaths and 22% in women.
Consequently, increasing the detection of aT1DM before it reaches stage 3 has been an area of focus for scientific committees, patient organisations and industry partners around the world for some time. The benefits to patients of screening or early detection are not disputed and the American Diabetes Association and ISPAD have now published recommendations on screening for pre-symptomatic type I diabetes.
One of the complainants stated that there were no treatments for pre-symptomatic aT1D and appeared to make the assumption therefore that any education or activity to promote screening or early detection in this area must indirectly promote the unlicensed agent teplizumab. This is wholly inaccurate since the processes of screening and staging are completely separate. Successful screening does not necessarily require a licensed medicinal treatment. Conversely identifying eligibility for teplizumab requires comprehensive staging after the screening process (see below for more information). There are many good clinical reasons to screen for autoantibodies and detect aT1D early, regardless of any therapeutic pipeline, including:
· Identifying children before they present with symptoms (using IAb (autoantibody) alone or in combination with genetic testing) has been shown to reduce the occurrence of DKA (diabetic ketoacidosis) by 90%. DKA is a consequence of insulin deficiency. One advantage of DKA reduction is in avoiding the associated comorbidities, such as cerebral oedema, neurocognitive deficits, shock, arrhythmias, and lengthy hospitalisation.
· Early detection allows time for education of patients and their families and has been shown to result in better glycaemic control in affected individuals when they reach stage 3.
· Antibody testing can help prevent misdiagnosis – up to 40% of patients diagnosed with aT1D above the age of 30 years are initially misdiagnosed as having type II diabetes.
Published in June 2024, Consensus Guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes provides recommendations for the monitoring of individuals who have screened positive for at least one islet autoantibody.
We therefore believe that both collaborative working projects will clearly enhance patient care regardless of a lack of availability of a specific medicinal treatment in line with ABPI guidance and the requirements of clauses 20.1 and 20.3.
Role of teplizumab
Teplizumab is a pipeline product that is not yet licensed in the UK and has been investigated for use to delay the onset of Stage 3 type 1 diabetes in adults and children with Stage 2 type 1 diabetes. Stage 2 is asymptomatic (although the process of beta pancreatic cell destruction has already started at this stage), meaning that progression to symptomatic type I diabetes will occur later. Its proposed indication is to delay the onset of stage 3 T1D in adults and paediatric patients aged 8 years and older with stage 2 T1D.
As an unlicensed agent (and not yet a Prescription only Medicine) we do not accept that it can be promoted, and therefore has not been promoted in a disguised manner in breach of clause 3.6.
It is important to note that there is no national screening programme for aT1D currently in place in the UK. Screening of certain populations through antibody testing is recommended by the ADA (American Diabetes Association) and ISPAD but it is not routine practice in the UK. There are however two large screening research trials ongoing – ELSA (for paediatrics) and T1DRA (adults)- designed to assess the feasibility of national screening.
Assuming a national screening programme were to be implemented in the UK at some point in the future, of those people who might be screened and identified as having positive autoantibodies only a small proportion (those with 2 positive antibodies and dysglycaemia on staging) could be potentially eligible for treatment with teplizumab (assuming licensing and reimbursement).
The Code does not preclude a pharmaceutical company from benefitting from a collaborative working project. Whilst increasing early detection rates may eventually lead to identification of people eligible for teplizumab, there are still a number of hurdles to overcome before this could be translated into any commercial sales for Sanofi. Licensing, reimbursement and the existence of a funded screening programme have already been mentioned. Licensing is expected to take place this year. It is not known whether reimbursement will follow, and an NHS funded screening programme is probably years away. In addition, the NHS would need to make service changes to accommodate teplizumab as it requires 14 intravenous infusions on consecutive days. There is no infrastructure in place in any UK centres outside of the research setting to accommodate this at present. Finally teplizumab will have a number of conditions to fulfil prior to use (see later section on NHS pathways for details).
In terms of the specific projects: the [named health professional membership organisation] project is focussed on screening education and raising awareness of autoantibody testing and the potential benefits to patients of early diagnosis. It does not in any way encroach into the area of staging or therapeutics. Its outputs are slide decks and infographics. It does not seek to educate on the different approaches to management once diagnosis is made. Therefore we do not believe that it can be seen in any way as indirect or pre-licence promotion of teplizumab and is therefore not in breach of clause 3.1.
Similarly, the [named NHS Foundation Trust] project is focussed on screening a defined population to identify those at risk of developing stage 3 aT1D. It does not involve any staging tests and therefore cannot identify eligible patients for teplizumab.
Given all of the above we strongly believe that these collaborative projects are sufficiently distanced from the part of the patient pathway that could eventually involve teplizumab prescriptions and are therefore not in any way promoting an unlicensed product. We deny any breach of clause 3.1.
Alleged commercial influence over NHS pathways to facilitate teplizumab uptake
In order for us to address this concern we need to provide more detail on the different points in the patient pathway that might (at some time in the future) lead to a prescription for teplizumab, and indeed the very clear separation between ‘screening’ or early detection, and ‘staging’ to determine eligibility for teplizumab.
The process of screening a population for pre-symptomatic aT1D stops at the point of antibody testing. Screening simply detects the entire pool of people taken from a defined population who are at risk of developing symptomatic or stage 3 aT1D. Both collaborative working projects pertain to this part of the patient pathway only.
Once identified by screening, people at risk need to undergo staging investigations which involve further antibody tests and monitoring of blood glucose. Neither of the collaborative working projects in question pertain to the staging process in any way and therefore cannot possibly influence the uptake of teplizumab after it is licensed.
After staging, only a proportion of the screened pool confirmed to be in stage 2 would be potentially eligible for teplizumab.
Upon identification of a potentially eligible stage 2 patient there are a number of additional conditions that must be fulfilled before such a person can be offered teplizumab. The following instructions are taken from the US label as there is currently no UK SmPC:
• Confirm Stage 2 T1D by documenting at least two positive pancreatic islet autoantibodies in those who have dysglycaemia without overt hyperglycaemia using an oral glucose tolerance test (OGTT) or alternative method if appropriate and OGTT is not available.
• In patients who meet criteria for a diagnosis of Stage 2 type 1 diabetes, ensure the clinical history of the patient does not suggest type 2 diabetes.
• Prior to initiating teplizumab, obtain a complete blood count and liver enzyme tests. Use of teplizumab is not recommended in patients with the following laboratory abnormalities
§ Lymphocyte count less than 1,000 lymphocytes/mcL
§ Haemoglobin less than 10 g/dL
§ Platelet count less than 150,000 platelets/mcL
§ Absolute neutrophil count less than 1,500 neutrophils/mcL
§ Elevated ALT or AST greater than 2 times the upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
§ Active serious infection or chronic active infection other than localized skin infections
• Administer all age-appropriate vaccinations prior to starting teplizumab
• Administer live-attenuated (live) vaccines at least 8 weeks prior to treatment.
• Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment.
Further to fulfilling the clinical criteria for teplizumab, the NHS centre would also need to be set up to provide the infusion service required for administration. An infusion protocol, capable of delivering 14 intravenous infusions on consecutive days (including weekends) must be in place within a healthcare organisation prior to administration of teplizumab.
Prior to receiving teplizumab patients need to be premedicated with a nonsteroidal anti-inflammatory drug (NSAID) or paracetamol, an antihistamine, and/or an antiemetic before each teplizumab dose for at least the first 5 days of the 14-day treatment course.
As already mentioned, the adoption of teplizumab nationally even after licensing and reimbursement would require fundamental changes across the NHS in terms of infusion services in order to deliver treatment to eligible patients.
It is therefore clear, given the focus of these collaborative projects on screening only, that they do not have the scope to exert any influence on subsequent national or local uptake of teplizumab. The [named NHS Foundation Trust] project does not involve any staging and therefore cannot possibly be used to identify potential teplizumab patients. Similarly the [named health professional membership organisation] project provides screening and monitoring education for those involved in paediatric care. It does not cover staging and eligibility for teplizumab (which will only be licensed for children over 8 years of age). We therefore strongly refute the allegation of improper influence over NHS pathways through these collaborative working projects to facilitate teplizumab uptake or to promote it.
Allegations about HCP advocacy
The complainant for the [named NHS Foundation Trust] project has expressed concern that Sanofi has chosen to work with HCPs that will later be advocates for teplizumab or have previously supported Sanofi medicines.
We can confirm that the HCPs in question have had no prior experience with teplizumab either through research or their own clinical use. They are therefore not likely to be able to advocate for the product when launched without some clinical experience. The collaborative working project does not involve staging and therefore does not even give these HCPs experience in identifying teplizumab eligible patients.
The lead clinician involved has in the past spoken about Sanofi medicines at scientific meetings as well as the products of other pharmaceutical companies in the field of diabetes, metabolism and endocrinology. This is common practice for opinion leaders and we do not accept that this constitutes any particular or inappropriate advocacy for Sanofi products.
Allegation of undue commercial influence over [named health professional membership organisation]
We strongly refute this allegation and the complainant has not provided any evidence to support it. Our supporting documents clearly demonstrate that this is a truly collaborative project with adequate pooling of skills and resources- such that neither party can be seen as exerting any undue influence over the other.
Clauses 5.1 and 2
The complainants have offered no evidence to support their various allegations. We have provided substantial evidence that these collaborative working projects have been set up and are being conducted to the highest standards by appropriate and qualified Sanofi employees. We contend that all of the requirements of the Code have been fulfilled and therefore deny any breach of clauses 5.1 and 2.
The signatory for the certified items attached is [Name and qualifications].”
PANEL RULING
The Panel noted Sanofi had submitted a single response in respect of two complaints about two collaborative working projects as it considered that both complaints contained very similar allegations.
Case/0521/03/25 (complaint 1) related to Sanofi’s collaborative working project with an NHS Foundation Trust to screen first degree relatives of patients with Type 1 diabetes and Case/0522/03/25 (complaint 2) concerned Sanofi working collaboratively with a health professional membership organisation to co-develop and roll out a national educational programme on the monitoring and management of patients with islet autoantibody-positive pre-stage 3 type 1 diabetes.
The Panel noted that at the time of the complaints Tzield (teplizumab) did not hold a marketing authorisation, although Sanofi had submitted applications for regulatory approval and NHS reimbursement and the complaint was considered on this basis. Having accessed the SPC via the emc (medicines.org.uk) in November 2025 the Panel observed that in August 2025 Tzield had been licensed in the UK to delay the onset of Stage 3 Type 1 diabetes in adult and paediatric patients aged 8 years and older with Stage 2 Type 1 diabetes (T1D).
The Panel noted that the Constitution and Procedure stated that the complainant had the burden of proving their complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties. The Panel noted that the complainants’ evidence was limited to two published executive summaries. The Panel was mindful that its role was not to infer reasons on behalf of the complainant.
The Panel noted the requirements for collaborative working set out in Clause 20. It particularly noted that Clause 20.3 and the accompanying supplementary information confirmed, among other things, that collaborative working arrangements must not constitute an inducement to health professionals or other relevant decision makers to prescribe, supply, recommend, buy or sell any medicines. The supplementary information further provided that collaborative working must be conducted in an open and transparent manner and must enhance patient care or be for the benefit of patients, or alternatively benefit the NHS and, as a minimum maintain patient care. It was expected that the arrangements would also benefit the NHS and the pharmaceutical company involved. The Code did not prohibit collaborative working if a company had a medicine in the area provided all parties were satisfied that the use of the medicine was appropriate and that the requirements for collaborative working were met. The Panel considered that the same principle was likely to apply where a company had a product in development. Transparency was key in such circumstances and activities would be assessed within the context of the overall arrangements satisfying the requirements of Clause 20.
In the absence of detailed evidence the Panel undertook only a top-line perusal of the documents provided by Sanofi and noted the following:
· Autoimmune Type 1 diabetes could now be diagnosed before it became symptomatic
· The project in complaint 1 aimed to assess the feasibility of a screening programme of first-degree relatives of diagnosed Type 1 diabetic patients to detect if they had pre-symptomatic Type 1 diabetes.
· The project in complaint 2 aimed to co-develop and roll out a national educational programme on the monitoring and management of patients with islet autoantibody-positive pre-stage 3 type 1 diabetes.
· Early detection through screening and increased clinician awareness and knowledge through education had clear benefits for the people screened, and health professionals educated.
· The Collaborative Working Agreements and Project Initiation Documents for each project set out clear benefits for patients, the NHS and Sanofi, including for Sanofi in that it had a product that was scheduled for regulatory and reimbursement review in 2025.
· The published summary documents for each project indicated a pooling of resources with both parties making a significant contribution.
· The agreements and summaries appeared to contain sufficient detail in relation to the requirements of the Code.
In response to the complainant’s concerns that the projects provided Sanofi with an inappropriate level of influence over the shaping of an NHS pathway and a national educational programme Sanofi submitted that it had been transparent about its commercial interests in Type 1 diabetes and that it had an unlicensed product in development which could lead to a commercial benefit for Sanofi. In this regard the Panel noted that the collaborative working agreement for each project stated among other things that the arrangements were not an incentive or reward for a person’s present or future willingness to prescribe, administer, recommend, purchase, use, pay for, reimburse any product sold or provided by Sanofi. The Trust acknowledged that commitments and contributions provided by Sanofi would remain independent of all decisions relating to drug choice. The agreements also referred to the principles of collaborative working including transparency.
The Panel noted that the product was not named within the written agreement or the associated summary for either project. The Panel observed that there was no reason why teplizumab could not have been identified in the written agreement as there was a contractual relationship between Sanofi and the NHS Foundation Trust in the first project and Sanofi and the health professional membership organisation in the second. However, the Panel considered that the statement in each of the collaborative working agreements that ‘Sanofi has a product in autoimmune Type 1 Diabetes that is scheduled for Regulatory and reimbursement review in 2025’, which was reflected in the respective executive summaries, was sufficiently transparent.
The Panel noted that there were some similarities between the allegations for each case although the collaborative working projects themselves were different.
Promotion of an unlicensed medicine
Complaint 1
The Panel considered the allegation that Sanofi had used the collaborative working project to disguise the promotion of teplizumab, which was unlicensed at the relevant time, as the screening pathways promoted by the project aligned with the intended indication of teplizumab.
The Panel took account of the broad definition of promotion in Clause 1.17 of the Code, which referred to any activity which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines. The Panel also considered that it was an accepted principle under the Code that it was possible (given the broad definition of promotion), for material to be promotional without mentioning products by name.
The Panel considered that its general comments above were relevant here.
The Panel noted Sanofi’s submission that it was now widely accepted that Type 1 diabetes was an autoimmune disease characterised by 3 stages and that after staging, only a proportion of the screened pool confirmed to be in stage 2 would be potentially eligible for teplizumab.
Upon identification of a potentially eligible stage 2 patient there are a number of additional clinical conditions that must be fulfilled before such a person can be offered teplizumab, once licensed.
The Panel considered that it was permissible under the Code for companies to provide genetic or other biomarker/specific testing in relation to the rational use of their medicine so long as its provision complied with the Code. It did not entirely agree with Sanofi’s submission that the screening process was independent of the staging process which was required to determine eligibility for teplizumab. The Panel considered that both collaborative working projects were linked to teplizumab but noted as referred to above that this alone would not render the collaborative working an inducement so long as the arrangements complied with the Code. Further the Panel noted that the product was not available for prescribing at the time and that it did not appear to have a licensed or unlicensed competitor. Overall, the Panel had no evidence before it that the project constituted an inducement.
The Panel further noted in relation to its comments about Sanofi’s submission regarding the distinction between screening and staging that an organogram to Annex 1 of the Collaborative Working Agreement, which outlined the anticipated project flow, provided that if the first antibody test was positive, a repeat blood test was performed. If that second test showed ‘ >2Ab positive’ the patient was seen again in the clinic. At that stage the patient had their second Diabetes Specialist Nurse contact and first consultant contact, each funded by Sanofi. In the Panel’s view it was therefore clear that the collaborative working project included identifying patients at stage 1 of the staging process.
The Panel accepted that the project would positively impact the development of NHS pathways within the Trust to reflect the new clinical understanding of the development of Type 1 diabetes. The Panel considered that it was important that companies were cautious when the company’s unlicensed product was the only relevant product and the grant of its marketing authorisation was anticipated. In the Panel’s view the materials provided by Sanofi were clear about the expected benefits of screening to the NHS and patients.
Having considered the submissions of the parties and noting its comments above the Panel was not satisfied that the complainant had established that the collaborative working project promoted teplizumab on the narrow ground alleged, namely that the screening pathways promoted by the project aligned with the intended indication of teplizumab. The Panel noted the broad benefits of screening for patients as set out by Sanofi, that the project did not identify patients at stage 2, the product was unavailable at the relevant time, that a link to a specific medicine alone was not unacceptable so long as the arrangements complied with the Code, and the additional clinical hurdles prior to prescription identified by Sanofi. On the basis that the complainant had not established that the collaborative working project was promotional it therefore followed that it could not be disguised promotion of an unlicensed medicine and the Panel ruled no breach of Clauses 3.1 and 3.6 in relation to complaint 1.
Complaint 2
The Panel was not clear on the rationale for undertaking the project to provide a national education programme as collaborative working rather than Sanofi medical education. In the Panel’s view collaborative working implied the project was about building relationships with healthcare professionals which the Panel noted was reflected as a benefit for Sanofi in the summary document.
The complainant had alleged that the project amounted to indirect promotion of an unlicensed medicine on the grounds that: the educational programme placed strong emphasis on screening for pre-stage 3 type 1 diabetes, despite the fact that there were currently no approved treatments for this condition in the UK; by directing healthcare professionals towards identifying and monitoring a patient population that currently lacks treatment options, there is a clear risk that the project was laying the groundwork for the future adoption of teplizumab: and the programme has been designed to familiarise healthcare professionals with the concept of early intervention in a way that aligns with Sanofi’s commercial objectives, it could be seen as an indirect promotional effort rather than a purely medical initiative.
The Panel noted Sanofi’s description of the educational materials but did not have a copy of the materials created as a result of this project. The complainant had based their concerns on the executive summary.
The Panel considered that its general comments above were relevant here.
The Panel accepted that the project would positively impact the development of NHS pathways to reflect the new understanding of the development of Type 1 diabetes. The Panel considered that it was important that companies were cautious when the company’s unlicensed product was the only relevant product and the grant of its marketing authorisation was anticipated. The materials provided by Sanofi were clear about the expected benefits of the materials to the NHS and patients.
Having considered the submissions of the parties and noting its comments above the Panel was not satisfied that the complainant had established that the collaborative working project promoted teplizumab on the narrow grounds alleged. On the basis that the complainant had not established that the project was promotional and therefore it followed that it was not promoting an unlicensed medicine and the Panel ruled no breach of Clause 3.1 in relation to complaint 2.
In the Panel’s view the complainant had not alleged in relation to complaint 2 that the promotional activity was disguised and thus made no ruling in relation to Clause 3.6.
Clause 20
Complaint 1
The complainant alleged that if NHS clinicians involved in this project later advocate for teplizumab, it could suggest undue influence stemming from this collaboration.
The Panel noted that Clause 20.3 required, among other things, that the arrangements must not constitute an inducement to health professionals to prescribe, supply, recommend, buy or sell a medicine.
The Panel considered that its general comments above applied here including in relation to the requirements of collaborative working and further noted its finding above that the arrangements did not promote an unlicensed medicine. Bearing in mind all of the material before it and the hypothetical nature of the allegation the Panel considered that the complainant had not established that the arrangements constituted an inducement for health professionals to later advocate for teplizumab as alleged. No breach of Clause 20.3 was ruled on this point.
The complainant referred to a lack of transparency stating that if this initiative had been presented to NHS partners as a neutral public health measure, without clarity on the potential future commercial implications, it raises concerns about transparency and whether NHS clinicians have full visibility of Sanofi’s strategic interests.
The Panel noted that Clause 20.3 further required, among other things, that collaborative working must be carried out in an open and transparent manner.
The Panel considered that the executive summary provided sufficient detail about the benefits to Sanofi including its product interest. The Panel considered that the complainant had not established that Sanofi had not been transparent about its commercial interests and ruled no breach of Clause 20.3.
In relation to the implied allegation that the project was not a genuine collaborative working arrangement the Panel noted the relevant requirements of Clause 20.2. For the above reasons and having considered the circumstances of the case the Panel concluded that while it had some concerns described above it did not have evidence before it that the project was an unacceptable collaborative working project in relation to the matters raised. Further the narrow matters raised by the complainant were not Clause 20.2 matters. Accordingly, it ruled no breach of Clause 20.2.
The Panel noted that the Case Preparation Manager had raised Clause 20.1 when asking Sanofi to respond to the allegations. The Panel noted that Clause 20.1 was an explanatory clause which built on the definition of collaborative working as set out in Clause 1.3. It was not a clause which was capable of infringement. The Panel thus made no ruling on Clause 20.1.
Complaint 2
The complainant stated that they had serious concerns regarding whether this initiative complied with the Code, particularly in relation to transparency, and queried whether the role of the commercial team had been too broad rather than Sanofi limiting its involvement to transparent, non-promotional support.
The Panel noted that Clause 20.3 required, among other things, that collaborative working must be carried out in an open and transparent manner.
The Panel considered that the executive summary provided sufficient detail about the benefits to Sanofi including its product interest. The complainant had provided no evidence in relation to the role of the commercial team. The Panel considered that the complainant had not established that Sanofi had not been transparent about its commercial interests and ruled no breach of Clause 20.3.
In relation to the complainant’s allegation that the programme was effectively conditioning healthcare professionals to adopt a treatment pathway that aligns with Sanofi’s forthcoming product, and that the project has the potential to impact clinical decision-making the Panel noted that Clause 20.3 required, among other things that the arrangements must not constitute an inducement to health professionals to prescribe, supply, recommend, buy or sell a medicine.
The Panel considered that its general comments above applied here including in relation to the requirements of collaborative working and further noted its finding that the arrangements did not promote an unlicensed medicine. Bearing in mind all of the material before it the Panel considered that the complainant had not established that there was an impact on clinical decision making such that the arrangements constituted an inducement for health professionals to advocate for teplizumab as alleged. Whilst the educational programme would be delivered by health professionals there was no evidence before the Panel that their role went beyond educating the audience about the development of Type 1 diabetes. No breach of Clause 20.3 was ruled on this point.
In relation to the implied allegation that the project was not a genuine collaborative working arrangement the Panel noted the relevant requirements of Clause 20.2. For the above reasons and having considered the circumstances of the case the Panel concluded that while it had some concerns described above it did not have evidence before it that the project was an unacceptable collaborative working project in relation to the matters raised. Further the narrow matters raised by the complainant were not Clause 20.2 matters. Accordingly, it ruled no breach of Clause 20.2.
The Panel noted that the Case Preparation Manager had raised Clause 20.1 when asking Sanofi to respond to the allegations. As noted above Clause 20.1 was an explanatory clause which was not capable of infringement and therefore Panel thus made no ruling on Clause 20.1.
High standards and Clause 2- complaints 1 and 2
The Panel noted the complainant in each case had expressed concerns that Sanofi’s commercial team were proactively involved in developing the projects. Further the complainant alleged that Sanofi was strategically engaging with healthcare professionals who had previously supported its medicine with a view to securing future advocacy for teplizumab (complaint 2 only). The Panel interpreted these comments as raising general concern about Sanofi’s governance procedures for collaborative working.
In the Panel’s view transparency in relation to collaborative working was an important means of building and maintaining confidence in the pharmaceutical industry. Companies were expected to have a robust governance framework in place to support Code compliance. The Panel bore in mind its rulings above of no breach of the Code.
The Panel perused the company’s standard operating procedure governing collaborative working and the documentation supporting the projects in question and concluded that these appeared satisfactory and in the absence of further evidence to the contrary the Panel ruled no breach of Clause 5.1 in respect of each project on the basis that the complainant had not established that Sanofi had failed to maintain high standards in relation to the matters raised by the complainant.
Given its no breach rulings above it followed that the complainant had not established that Sanofi had brought discredit upon, and reduced confidence in, the pharmaceutical industry and the Panel ruled no breach of Clause 2 in relation to each project.
Complaint received
Case/0521/03/25 21 March 2025
Case/0522/03/25 21 March 2025
Cases completed 13 February 2026
