CASE AUTH/3904/5/24 NO BREACH OF THE CODE
COMPLAINANT v GEDEON RICHTER
Alleged missing information in an Evra advertisement
CASE SUMMARY
This case was in relation to an Evra advertisement which was allegedly missing some key facets of the indication. The complainant also alleged that a linked webpage did not mention the licensed indication or the significant risks that Evra posed, and that the ‘safety section’ of the linked website did not explicitly call out the contraindications for Evra.
The outcome under the 2021 Code was:
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No Breach of Clause 11.2 (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
A complaint was received about Gedeon Richter (UK) Ltd from a contactable complainant who described themselves as a healthcare professional.
COMPLAINT
The complaint wording is reproduced below:
“Dear PMCPA.
Advert on [URL provided]
This advert missing some key facets of the indication:
Female contraception, intended for women of fertile age. Safety/efficacy established in women aged 18-45 years. The decision to prescribe EVRA should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs (see contraindications and special warning and precautions).
This links through to: [URL provided]
This too does not mention the licenced indication, nor the significant risks that this product poses.
The full section 4.3 is the following:
Combined hormonal contraceptives (CHCs) should not be used in the following conditions. If one of these disorders occurs during the use of EVRA, EVRA must be discontinued immediately.
• Presence or risk of venous thromboembolism (VTE)
• Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]);
• Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency;
• Major surgery with prolonged immobilisation (see section 4.4);
• A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4);
• Presence or risk of arterial thromboembolism (ATE)
• Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris);
• Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA);
• Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant);
• History of migraine with focal neurological symptoms;
• A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
̵ diabetes mellitus with vascular symptoms
̵ severe hypertension
̵ severe dyslipoproteinaemia
This massive section wasn't called out explicitly in the Safety section of the website either [URL provided].
This advert therefore fails to give the full indication of the product, is promoting the use to a wider audience than is licenced and most significantly of all, failing to mention adequate patient safety information is clearly a patient safety issue and could potentially lead to significantly adverse outcomes for patients.
Please investigate
[image of advertisement at issue]"
Further information from the complainant
The case preparation manager wrote to the complainant to request screenshots of the two links provided in their original complaint. In their response, the complainant provided screenshots of the Evra Benefits webpage and the Evra Safety & Tolerability webpage.
[screenshot of Benefits webpage]
[screenshot of Safety & Tolerability webpage]
When writing to Gedeon Richter, the PMCPA asked it to consider the requirements of Clauses 2, 5.1, 6.1 and 11.2 of the 2021 Code.
GEDEON RICHTER’S RESPONSE
The response from Gedeon Richter is reproduced below:
“Thank you for your email dated 31 May outlining the complaint associated with alleged missing information in our Evra advertisement and self-detail aid on [a closed community professional network for doctors] as well as the corresponding complaint and images from [a closed community professional network for doctors] .
Gedeon Richter items in relation to the complaint:
• Evra Self Detail 2023 Digital Driver 3 UK-EVR-2300005
• Evra Self Led Sales Aid 2023 UK-EVR-2300001 (available on [a closed community professional network for doctors]) including ‘Evra Benefits’ and ‘Evra safety’ pages as requested in your letter
Items provided as attachments or electronic link to this communication:
• Evra Self Detail 2023 Digital Driver 3 UK-EVR-2300005
• Signature Page - Evra Self Detail 2023 Digital Driver 3 UK-EVR-2300005
• Evra Self Led Sales Aid 2023 UK-EVR-2300001
• Signature Page - Evra Self Led Sales Aid – 2023 UK-EVR-2300005
• Appendix document which is referred to in the response and should be used when reviewing
• Evra SmPC link on emc [URL provided]
• Evra Prescribing information link [URL provided]
• Evra Patient Leaflet (PIL) on emc [URL provided]
Overview of specific allegations related to Case AUTH/3904/5/24:
From reviewing your letter and the complainant’s complaint, we feel the specific Code-related issues are:
1. By not including the full indication from section 4.1 of the SmPC in the body copy of the digital advert driver and of the 'Benefits' tab of the website, the materials promote Evra in a manner is not in accordance with the marketing authorisation, and is inconsistent with the particulars in its SmPC (Clause 11.2)
2. By not including details of contraindications (section 4.3) and warnings & precautions (section 4.4) in the body copy of the website tabs for 'Benefits' and 'Safety & Tolerability', 'failing to mention adequate patient safety information is clearly a patient safety issue and could potentially lead to significantly adverse outcomes for patients'. (Clause 6.1 & 11.2)
3. Thus, in turn not upholding Confidence in the Industry (Clause 2), and a belief that high standards have not been maintained at all times (Clause 5.1)
Response to Case AUTH/3904/5/24:
The complainant has ignored the availability of information in both items’ digital driver advert (Evra Self Detail 2023 Digital Driver 3 UK-EVR-2300005) and Evra Self-led detail aid ‘Benefits’ and ‘Safety’ pages (available in the Evra Self Led Sales Aid 2023 UK-EVR-2300001); they are accessible as follows:
• Full indication, and details of contraindications and warnings & precautions, are included in the prescribing information, which is available by a prominent direct single click from the Digital Driver and from each page of the website
• A pop-up giving details of the warnings and precautions, and a summary of the contraindications, is prominently linked from the body copy of the 'Introducing Evra' tab; this pop-up summary itself refers the reader to the full SmPC hosted on the eMC, for full safety information.
• The SmPC is also linked from the 'Safety & Tolerability' tab, using the text 'For full safety information, please refer to the EVRA® Summary of Product Characteristics' and this is repeated on the linked pop-up giving details of common and very common adverse events associated with Evra.
We strongly reject all elements of this complaint and in this response will refute all evidence of suggested potential breaches of The Code.
The complainant appears to have taken the view that unless the initial ‘Benefits’ page viewed contains all the information on indication, contraindications and warnings & precautions, per the SmPC, this fails to meet the requirements of the Code. They have either missed or failed to access the linked PI and SmPC and have selectively ignored the availability of this information when writing the complaint. Furthermore, they have ignored other relevant information outlined in [a closed community professional network for doctors] Evra Self Led Sales Aid, which we believe has clear navigation at the top of the page directing users to find relevant information.
The Code requires that for digital advertisements, the PI must be a single click away. This is the standard that meets the requirement in Clause 6.1 that 'Material must be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine'. Thus, the Code anticipates that reasonable use of a promotional item might include clicking on a link (clearly identified as PI) to access more information on the medicine. Not to do so when such a link is prominently shown, appears to be peculiar and we feel this is an unjustified complaint and view of our promotional material (Evra Self Detail 2023 Digital Driver 3 UK-EVR-2300005’ and ‘Evra Self Led Sales Aid 2023 UK-EVR-2300001’).
The other requirements of Clause 6.1 are that 'Information, claims and comparisons must be accurate, balanced, fair, objective, and unambiguous and must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly. They must not mislead either directly or by implication, by distortion, exaggeration, or undue emphasis.' We believe the information presented in both items meets these criteria by providing:
• Clear and prominent links to the PI throughout the items.
• A summary of ‘Special warnings and precautions for use’ based on section 4.3 and 4.4 of the Evra SmPC which is available in the pop-up of the 'Introducing Evra page’, and further links to the SmPC.
• Clear navigation at the top of the self-detail showcasing the ‘safety and tolerability page’, which provides a balanced overview of the safety profile of Evra in the page as well as corresponding pop-up ‘Adverse events associated with Evra’.
The full indication and warnings/precautions and contraindications are available in both items, as part of PI which is accessed by a direct single click per Code requirements.
The Code does not require that all this information is made available on the body copy of the first page viewed and clearly anticipates that users may need to click on a link to access further information e.g., PI.
If the complainant clicked these links, they would see that this information is readily available in the items subject to the complaint.
As the information is readily available, and there are no claims that Evra is suitable for all women, the medicine has not been promoted outside of its licenced indication so meets Clause 11.2; equally, the information available to the reader reflects the SmPC and meets the requirements of Clause 6.1 in this respect.
Summary and overall conclusion
We do not believe the complainant has demonstrated that on balance of probabilities, The Code has been breached. By ignoring the various links to PI / SmPC and the information on ‘Special warnings and precautions for use’ which included contraindications, available in the Introducing Evra' tab and pop-up, we feel that we are not in breach of any of The Code Clauses 6.1 and 11.2 outlined in the complaint letter. As a learning, we can link to the ‘Special warnings & precautions’ pop-up page, currently on the ‘Introducing Evra’ page, so it can be accessed from the ‘Safety & tolerability’ page for additional clarity. We do however feel this information is accessible in its current form, via the links to the Prescribing information, in line with Code requirements.
Based on our above response, we believe that we have not failed to meet high standards or bring discredit upon, or reduce confidence in, the pharmaceutical industry, Code Clauses 5.1 and 2 respectively.
In summary, we have provided you with a comprehensive response to each of the items outlined by the complainant. To the best of our abilities, we have answered your questions in relation to this complaint and have provided all relevant materials for your review. Please do not hesitate to ask for further clarification of any part of our response. We hope that this response will serve to highlight our robust processes and an overall high standard of materials, overseen by experienced members of our team”.
PANEL RULING
This complaint about Gedeon Richter was received from a complainant who described themselves as a concerned health professional. The complaint related to an advertisement for Evra that appeared on the website of a closed community professional network for doctors in the UK. The complainant provided a screenshot of the advertisement and alleged that this advertisement was “missing some key facets of the indication”, and listed what appeared to the Panel to be the full indication for Evra from the summary of product characteristics (SPC).
The complainant also alleged that the webpage that the advertisement linked to did not mention the licensed indication or the significant risk that Evra poses. The complainant subsequently listed a selection of the contraindications from the Evra SPC and alleged that the ‘Safety’ section of the website also did not explicitly call out these contraindications.
The Advertisement
The complainant alleged that the advertisement was missing some key facets of the indication and in doing so was promoting the use of Evra to a wider audience than it was licensed for.
The advertisement consisted mostly of text, alongside a small image of a young woman’s face and contained:
1. A title in large bold text “In a study of 943 women, 47% reported missing at least one contraceptive pill per treatment cycle”.
2. A statement, asking “Do your female patients comply with their contraceptive regimens? Find out how the once-weekly application schedule of Evra (norelgestromin/ethinyl estradiol) transdermal patch could encourage high compliance rates”
3. A statement that this was “Promotional information from Gedeon Richter”.
4. A link labelled “Learn more” in bold font.
5. A link to the prescribing information
6. An adverse event reporting statement
7. An internal job code and a date of preparation.
The Panel noted Gedeon Richter’s submission that the full indication for Evra was included in the prescribing information, which was available by a prominent direct single click link from the advertisement. However, the Panel considered it a well-established principle of the Code that claims in promotional material must standalone and could not rely on qualification in the prescribing information.
The Panel noted the following information from the Evra SPC.
Section 4.1, Therapeutic Indications, stated:
“Female contraception
EVRA is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
The decision to prescribe EVRA should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs (see sections 4.3 and 4.4).”
The Panel noted the clear reference to female contraception, which was the licensed indication for Evra, in both the title and body of the advertisement. In the Panel’s view, the image which featured alongside the text appeared to be that of a woman of child-bearing potential and within the licensed age range for which Evra’s safety and efficacy had been established. The advertisement made no reference to the use of Evra outside that of female contraception.
Whilst it might have been helpful to include the full indication within the advertisement, the Panel considered that it did not imply that Evra could be used in all women, and considered that the complainant had not established that failing to include all facets of the indication within the particular material at issue, meant that the advertisement promoted Evra to a wider audience than it was licensed for. The Panel ruled no breach of Clause 11.2.
The Linked Website – ‘Benefits’ page
The advertisement included a link, in bold font, to “Learn more”. Upon clicking this link, readers would arrive at the ‘Benefits’ page of the Evra Detail Aid, a website hosted on [a closed community professional network for doctors]. The complainant alleged that this webpage did “not mention the licensed indication for Evra, nor the significant risks that the product poses”.
The ‘Benefits’ page of the Evra Detail Aid contained:
1. A banner at the top of the webpage stating “Promotional information from Gedeon Richter for UK HCPs only. This was created by a third party”, with links to adverse reporting information, references, prescribing information, and to request more information.
2. The brand logos for Evra, which included the active ingredients, and Gedeon Richter.
3. A navigation toolbar with buttons titled ‘Home’, ‘Introducing EVRA’, ‘Benefits’, ‘Safety & tolerability’, ‘Summary’ and ‘Prescribing information (external link)’.
4. Claims about the compliance benefits of Evra and its efficacy in a single-arm, open-label study.
5. A banner about the Richter Resource Centre and a link to access it.
6. A pop-up via which a viewer could contact the Gideon Richter team.
The Panel noted that the bottom of the webpage appeared to have been cut off in the screenshot provided by the complainant. In the version provided by Gedeon Richter, an adverse reporting statement and references appeared at the bottom. The Panel also noted that a table showing the contraceptive efficacy of Evra, which appeared in the screenshot of the webpage provided by the complainant, was missing in the version provided by Gedeon Richter and instead featured an image of a young woman. The Panel was unclear as to the reason behind this discrepancy but made its rulings based on the version provided by the complainant.
Licensed Indication
The Panel noted Gedeon Richter’s submission that the full indication for Evra was available in the prescribing information, which could be accessed via a prominent link on each page of the website. It further submitted that “the Code anticipates that reasonable use of a promotional item might include clicking on a link (clearly identified as PI) to access more information on the medicine”. The Panel considered that the Code required material to be capable of standing alone with regard to the requirements of the Code and to be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of a medicine. Therefore, while links and the like, including prescribing information, could provide additional information about a medicine, any information required to ensure Code compliance should form part of the material itself.
The Panel noted that the ‘Benefits’ page did not include the indication for Evra. The webpage contained no reference to using Evra in a specific patient population. Taking account of the content of the advertisement which linked to the webpage and the content of the webpage itself, in the Panel’s view readers would have expected the ‘Benefits’ page to have included data which focused on treatment compliance with Evra, which appeared to the Panel to be the main purpose of this specific webpage.
The Panel noted that the full indication as laid out in the SPC was clearly presented on the ‘Home’ page of the Evra Detail Aid website. In the Panel’s view, the appearance of the indication on the homepage of a product promotional website would be a reasonable and expected position for it to appear, taking into consideration the intended audience. In addition, the Panel considered that the Evra Detail Aid website included a clear navigational toolbar, allowing for health professionals to easily navigate to the ‘Home’ page.
Whilst the Panel considered it may have been helpful to include the indication for Evra on the ‘Benefits’ webpage, it considered that the page did not imply that Evra could be used in all women, and that the complainant had not established that the omission of the indication for Evra meant that the ‘Benefits’ webpage promoted the use of Evra to a wider audience than it was licensed. The Panel ruled no breach of Clause 11.2.
Significant risks
The complainant further alleged that the ‘Benefits’ webpage did not mention the significant risks that Evra poses and referred specifically to a selection of contraindications in Section 4.3 of the SPC for Evra. Based on this, the Panel considered the ‘significant risks’ stipulated by the complainant to mean certain contraindications of the product.
The Panel noted Gedeon Richter’s submission that the contraindications for Evra were included in the prescribing information, which could be accessed via a prominent link on each page of the website. Additionally, Gedeon Richter submitted that a summary of contraindications and details of special warnings and precautions for use were available in a pop-up in the ‘Introducing Evra’ page of the website. This pop-up also referred readers to the full SPC hosted on another third-party website for full safety information.
The Panel noted the following information from the Evra SPC:
Section 4.3, Contraindications, listed the following:
“Combined hormonal contraceptives (CHCs) should not be used in the following conditions. If one of these disorders occurs during the use of EVRA, EVRA must be discontinued immediately.
• Presence or risk of venous thromboembolism (VTE)
o Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]);
o Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency;
o Major surgery with prolonged immobilisation (see section 4.4);
o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4);
• Presence or risk of arterial thromboembolism (ATE)
o Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris);
o Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA);
o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant);
o History of migraine with focal neurological symptoms;
o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
diabetes mellitus with vascular symptoms
severe hypertension
severe dyslipoproteinaemia
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
• Known or suspected carcinoma of the breast
• Carcinoma of the endometrium or other known or suspected oestrogen-dependent neoplasia
• Abnormal liver function related to acute or chronic hepatocellular disease
• Hepatic adenomas or carcinomas
• Undiagnosed abnormal genital bleeding
• Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, medicinal products containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 4.5).”
The Panel noted that the pop-up in the ‘Introducing EVRA’ webpage included two prominent headings in bold font: “Special warnings and precautions for use” and “Contraindications”. The text “The use of EVRA is associated with an increased risk of certain conditions. In the event of aggravation, or first appearance, of any of the conditions below, the woman should be advised to contact her doctor to determine if EVRA should be discontinued” appeared beneath the first heading, followed by a table listing the conditions (venous thromboembolism, arterial thromboembolism, tumours, alanine transaminase elevations and psychiatric disorders). The table provided brief details of each condition.
The text beneath the second heading, Contraindications, stated “CHCs should not be used in the following conditions: presence or risk of VTE, presence or risk of ATE; hypersensitivity to the active substances or to any of the excipients. For a full list of contraindications and excipients, please refer to the EVRA Summary of Product Characteristics [link]”.
A References section appeared immediately beneath the contraindications, and included a second link to the Evra SPC.
The Panel acknowledged that Clause 6.1 of the Code did not require expressly for contraindications to be included in materials. However, Clause 6.1 did require that information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous, that they must not mislead, and that material must be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine. Further, the Supplementary Information to this clause required that claims in materials must be capable of standing alone as regards accuracy, etc.
The Panel considered that whether a contraindication needed to be highlighted within promotional material, in addition to the requirement for it to be included within the prescribing information that was required on all promotional material, depended on a consideration of all the circumstances. This would include taking account of the therapy area, the nature of the contraindication, as well as the content, layout, audience and intended use of the material.
Taking account of the content of the advertisement which linked to the webpage and the content of the webpage itself, in the Panel’s view, readers would have expected the ‘Benefits’ page to have included data which focused on treatment compliance with Evra, which appeared to the Panel to be the main purpose of this specific webpage. The Panel noted Gedeon Richter’s submission that information regarding contraindications for Evra was available on the ‘Introducing Evra’ page of the website, and considered that, on the balance of probabilities, a health professional would be unlikely to expect contraindications to be present on a webpage focussing on the ‘benefits’ of a product.
The Panel noted that the metadata for the Evra e-detail aid and the e-detail traffic drivers stated, “Targeted promotion will be managed via bulletins and portlets, these will be targeted to GPs”.
Given that the advertisement was directed to a specific audience of GPs, the Panel considered that, on the balance of probabilities, they would be aware that all contraceptives had contraindications, would likely exercise caution before prescribing contraceptives to the relevant patient population, and would be unlikely to rely on a ‘Benefits’ page of a website in isolation to make a prescribing decision.
The Panel considered that in the particular circumstances of this case, noting the therapy area of contraception, and that contraindication information was available on a different webpage of the website, the webpage at issue did not imply that there were no contraindications or safety considerations for Evra. In the Panel’s view, the complainant had not established that it was misleading to not include Evra’s contraindications on the ‘Benefits’ webpage, and the Panel ruled no breach of Clause 6.1 accordingly.
The Linked Website – ‘Safety’ page
The complainant referred to the “safety section” of the website, and alleged that this webpage also did not explicitly call out contraindications with Evra.
The ‘Safety & tolerability’ page of the Evra detail aid contained:
1. A banner at the top of the webpage stating “Promotional information from Gedeon Richter for UK HCPs only. This was created by a third party”, with links to adverse reporting information, references, prescribing information, and to request more information.
2. The brand logos for Evra, which included the active ingredients, and Gedeon Richter.
3. A navigation toolbar with buttons titled ‘Home’, ‘Introducing EVRA’, ‘Benefits’, ‘Safety & tolerability’, ‘Summary’ and ‘Prescribing information (external link)’.
4. Claims about the comparable safety profile of Evra to oral contraceptives.
5. A pop-up button stating “ADVERSE EVENTS ASSOCIATED WITH EVRA”
6. A banner about the Richter Resource Centre and a link to access it.
7. Adverse reporting information
8. A pop-up via which a viewer could contact the Gideon Richter team.
The Panel noted that the bottom of the webpage appeared to have been cut off in the screenshot provided by the complainant. In the version provided by Gedeon Richter, references appeared at the bottom. The Panel made its rulings based on the version provided by the complainant.
The Panel noted Gedeon Richter’s submission that the contraindications for Evra were included in the prescribing information, which could be accessed via a prominent link on each page of the website. Additionally, Gedeon Richter submitted that a summary of contraindications and details of special warnings and precautions for use were available in a pop-up in the ‘Introducing Evra’ page of the website. This pop-up also referred readers to the full SPC hosted on another third-party website for full safety information.
The Panel noted its principles on the necessity to include contraindications in promotional material as laid out above. In the Panel’s view, the purpose of the webpage in question was to communicate the safety and tolerability of Evra with particular focus on the comparison with oral contraceptives, and the overall incidence of the most common adverse events in the comparative study.
Whilst the Panel considered it would have been helpful if information on contraindications had been included in the ‘Safety & tolerability’ webpage, it considered that in the particular circumstances of this case, noting the therapy area of contraception, and that contraindication information was available on a different webpage of the website, the webpage did not imply that there were no contraindications or safety considerations for Evra. In the Panel’s view, the complainant had not established that it was misleading to not include Evra’s contraindications on the ‘Safety & tolerability’ webpage, and the Panel ruled no breach of Clause 6.1 accordingly.
Overall
Given its rulings of no breaches of Clauses 11.2 and 6.1, the Panel considered that Gedeon Richter had not failed to maintain high standards. The Panel ruled no breach of Clause 5.1.
Clause 2 was a sign of particular censure and was reserved for such use. Noting its rulings of no breaches above, the Panel ruled no breach of Clause 2.
Complaint received 15 May 2024
Case completed 4 June 2025
