YOUR MONTHLY SUMMARY OF ABPI CASES AND NEWS JULY 2020

19 CASES AND THE 2021 CODE

The PMCPA has had a busy month,
reporting on 19 cases and issuing
WEBSITE IN BREACH (1)
the draft 2021 Code. The cases A concerned UK health professional
complained about Lilly’s diabetes
include six from a concerned UK
website. The homepage gave the
health professional focusing on
reader two options: either to declare
websites, one of which was a that s/he was a health professional or
serious breach, and three serious a patient in the UK. There was no
cases relating to Otsuka Europe’s option for the general public. This
control of SPC updates and other would drive a member of the public to
internal processes. Two of the one of the two options which would

www.istockphoto.com/monkeybusinessimages
Otsuka complaints came from a result in product promotion. Lilly said
group of concerned employees. that the Code required companies
The proposed 2021 Code is now with a promotional section on their
website to set up a section for
out for consultation. The new
members of the public who needed to
Code will have a radically different access similar information. The
structure to the current Code with company interpreted ‘need’ as
colour-coded sections focused on referring to patients, carers and family
activities for different audiences members rather than implying a duty
to reflect the European (EFPIA) to inform the world at large. The patient guides. If they confirmed that
Code. And almost all of the clause company cited a previous case they had not been prescribed the
numbers will change. The new (AUTH/2436/9/11) where a similarly medicine, they were redirected to the
Code will be issued in January set-up home page had not been ruled Lilly UK corporate site. The list of
2021 but won’t come into effect in breach. The Panel pointed out that products appeared under a paragraph
the allegation in the previous case had saying that Lilly was a global leader in
until July; until then the current
been that the configuration of the site diabetes care, striving to make life
2019 Code continues to apply.
allowed easy access to promotional better for people with diabetes and
Consultation on the changes claims, not that the material in the determined to provide real solutions
closes in September. It is open to patient section constituted promotion. including medicines. The Panel
everyone though companies are It noted that the page for patients considered that the page promoted
asked to provide a single, included all of Lilly’s diabetes products prescription only medicines to the
consolidated response. by brand name with a prominent public, in breach of the Code. In
The ABPI Consultation Portal can brand logo. If a reader selected ‘learn addition, the website failed to provide
be found here. There is useful more’ about a product they were information for the general public and
additional information the PMCPA asked to confirm that they had been Lilly had failed to maintain high
prescribed that treatment before standards resulting in further
website here.
being taken to specific medicine breaches. AUTH/3252/10/19

CODE NEWS is compiled by Sharon McCullough as a summary of ABPI Code cases and other
useful information for those working with UK pharmaceutical marketing material. Copies are
provided under personal subscription or through your company - no further dissemination is
allowed without permission. Contact: [email protected] +44 7768 574601
The Code News July 2020

EMPLOYEES VOICE CONCERNS

www. istockphoto.com/champc
‘Concerned employees’ at Otsuka Pharmaceuticals
Europe made two complaints. The company had
previously received a public reprimand and had been
audited by the PMCPA for failing to implement timely
changes to SPCs and subsequent updates to
promotional materials.
The first complaint was that the company was still
unable to properly manage updates to the SPC and
prescribing information (PI) for Jinarc. The December
2018 PI was out of date as it had incorrect stages for
chronic kidney disease and missing adverse events
and the process was in chaos. Communications from
senior members of the European team showed they
did not understand the process. The complainants
were concerned about: the level of oversight from promotional in the Otsuka Europe approval system.
Japan; maintenance of internal mailing lists; timings On review, it was clearly promotional and therefore
for updating the SPC in line with SOPs; the lack of a disguised. Other misclassified material had been
central repository for storing PI and no standard identified, content in presentations was not in line
process for creating it. There was a blame culture and with the SPC, presentations did not contain PI, there
climate of fear within the organisation. Otsuka were no formal speaker briefings, some promotional
Europe disagreed that the process was in chaos but material was not certified, and other material was
agreed that the PI sent out in December 2018 was incorrectly certified. Otsuka acknowledged specific
incorrect. However, this PI had not been used. The Code breaches and also that these failings constituted
company acknowledged its failure to address the a Clause 2 breach. In relation to the internal meeting,
issues described in the previous case, and that this Otsuka Europe said that the senior employee’s
was in breach of Clauses 9.1 and 2. It apologised for comments had been taken out of context. The aim
the slow progress. The Panel considered that the had been to promote an open culture of giving and
company had failed to maintain high standards in receiving feedback to individuals and teams. An e-
relation to: clear communication around the mail had been sent after the meeting to clarify this.
calculation of dates for implementation of revised PI; Some members of the leadership team had fedback
circulation of incorrect PI; and the lack of a clear that the comments could have been misinterpreted
process for the creation and revision of PI and SPC and the company acknowledged that it had failed to
updates. However, it did not rule a breach of Clause maintain high standards. The Panel said it was
2. The complainants appealed. The appeal was difficult to understand how the Copenhagen meeting
successful; the Appeal Board considered that the could be classed as anything other than promotional.
cumulative effect of the issues warranted a breach of It was concerned about the other breaches raised but
Clause 2. could not rule on them as they had not been part of
In the second complaint, concerned employees the complaint. High standards had not been
complained about the arrangements for international maintained. In relation to the internal meeting and
meetings which they said had been misclassified and pledging, the Panel considered that the implied
certified as non-promotional when they were message ‘do not complain outside the company’
promotional, rendering them disguised promotion. undermined the Code and self-regulation. A Clause 2
One example had taken place at a congress in breach was ruled. The concerned employees
Copenhagen. In addition, a senior employee had appealed the Panel’s ruling in relation to the
asked attendees at an internal company meeting to misclassification of promotional meetings, saying this
raise their right hand and swear that they would not was a systemic problem with conscious
complain about any individual or department to misclassification of non-promotional meetings and
anyone over the next 6 months, sending out a therefore a Clause 2 breach. Otsuka Europe
message not to whistle blow. Otsuka Europe said that submitted that this was not a conscious
the Copenhagen meeting had been reviewed and misclassification but due to gross incompetence
approved by the local Danish affiliate as being which reduced confidence in the industry. The
promotional. However, the meeting, which was led Appeal Board ruled a Clause 2 breach. AUTH/3151/1/19
by the medical function had been categorised as non- and AUTH/3174/3/19

2
The Code News July 2020

TRAINING SITE OK CROSS BORDER TRADE

A concerned health professional complained that
Otsuka’s Jinarc (tolvaptan) training website was
promotional but did not carry the required
prescribing information and mentioned the MHRA.
Otsuka explained that the website had been created
as part of Additional Risk Minimisation Measures
(ARMMs) required in the regulatory approved risk
management plan (RMP) and pointed out that the
Code stated that the RMP and associated material
approved by the MHRA was non-promotional. As

www. istockphoto.com/Alexandragl1
such, prescribing information was not required and
the prohibition on referring to the MHRA did not
apply. The Panel agreed and no breaches were ruled.
AUTH/3217/6/19

OUT OF DATE SPC An anonymous individual complained that a Merz

Otsuka Europe voluntarily admitted that for a two-
week period an incorrect version of the Jinarc SPC employee had been involved in cross border trading
appeared on the eMC website. The product had of Bocouture (botulinum toxin) from Northern Ireland
undergone two parallel revisions, one to add blisters where it was licensed into the Republic of Ireland
in wallet cards with new MA numbers and one to add where it was not. Merz explained that there had been
gout as a common side effect. The EMA process an error with an order of Bocouture from a customer
required production of two separate amended SPCs who worked in both Northern Ireland and the
which were then consolidated into a third, final SPC. Republic of Ireland. The customer needed the product
Communications to affiliates about this had caused urgently in order to treat patients the following day at
confusion and a version with only the addition of gout his/her Northern Ireland clinic. An Irish member of
had been used. Otsuka Europe also stated that there Merz staff who promoted Merz devices, not
had been a mistake in relation to packing and release medicines, had collected it from the Northern Ireland
of the Jinarc package leaflet in the UK which had warehouse and delivered it to the customer at his/her
meant that a leaflet with incomplete clinic in the Republic of Ireland where s/he was at the
contraindications, indications and adverse reactions time. A deviation CAPA had been raised the next
had been included in the pack. The company had working day and relevant staff had been spoken to
informed the EMA who had agreed that neither a about the matter in relation to Good Distribution
recall nor a ‘Dear Healthcare Professional’ letter was Practice and the ABPI Code. Over the following
needed. The Panel considered that in relation to the months Merz carried out staff training, and the Irish
SPC the company had failed to maintain high member of staff sat the ABPI exam for
standards and had breached a previous undertaking representatives. The Panel considered that Merz had
made following a case relating to communication of not maintained high standards as the company had
SPC changes (AUTH/3123/11/18). This brought not provided this important training previously. The
discredit on and reduced confidence in the industry, employee had also not maintained high standards.
breaching Clause 2. The error with the package leaflet The complainant had also said that Merz staff had
also failed to maintain high standards. AUTH/3169/3/19 been bullying, saying that if product was not
purchased through Merz preferred partners then
product queries and adverse events would not be
supported. Merz denied any unethical behaviour by
staff. Any changes in support to customers who did
not purchase through Merz preferred partner
wholesalers related solely to the provision of certain
commercial offers and training. The Panel
considered that this information about could have
been worded more clearly but ruled no breach.
AUTH/3264/10/19

3
The Code News July 2020

DISCLOSURE ERROR WEBSITE IN BREACH (2)

A concerned UK health professional (HP) alleged that
Diurnal’s website carried a table of pre-licence
promotion and had no prescribing information or
generic names for licensed products. The page was
part of the health professionals’ section of the Diurnal
site and detailed ‘Products and Pipeline’. Under the
heading ‘Clinical Trials' the page listed five products
one of which had been licensed in 2018. The other
four were listed with the indication for which they
were being developed, their clinical trial status and
expected approval date. The introduction on the page
stated that the company was ‘dedicated to bringing
effective high-quality products to the global market
for the life-long treatment of chronic endocrine
A health professional (HP) complained that an entry conditions’. Diurnal denied breaching the Code saying
on the ABPI Disclosure database for 2018 indicated that the table might be referred to by the company in
that s/he had received financial support to attend a response to enquiries from HPs about trials in disease
congress (ESMO) from MSD, but this was not so. MSD areas as part of legitimate scientific exchange and
had previously been found in breach of the Code for contained no claims of efficacy or superiority. The
disclosing incorrect information about the same Panel considered that the page was promotional. It
individual in its annual disclosures for 2017 promoted unlicensed medicines and did not include
(AUTH/3141/12/18). MSD explained that the error obligatory information about the company’s licensed
with the 2017 data had arisen from a mix-up about medicine. High standards had not been maintained.
support to attend a different congress (ASCO) Code breaches were ruled. In addition, the Panel said
provided to another HP with the same name. Before that Diurnal’s response showed a poor understanding
receipt of that complaint, MSD had agreed to fund of the Code. The company had failed to recognise that
attendance at ESMO, and the same identification error the information it had provided was promotional and
was made in information submitted to the ABPI its conduct fell short of competent care; unlicensed
disclosure system for 2018. Once the company medicines had been promoted to health professionals.
received the complaint about the 2017 data, it A breach of Clause 2 was ruled. AUTH/3274/10/19
checked to see whether the ESMO payment had been
linked to the complainant. At the time the company
looked, it was not. However, there had been a delay in
PROMO PANEL
updating the database and the payment subsequently A concerned UK health professional complained that
appeared, linked to the wrong HP. The Panel said that material on the BMJ website for Napp’s Invokana
if MSD had checked to see whether the ESMO support appeared to be promotional but had no prescribing
was linked to the correct HP, it would have known that information or unique identifier so might not have
the database had not yet been updated and that been appropriately approved by the company. The
further checks would be needed. High standards had BMJ hosted page had a number of introductory
not been maintained. Committing the same breach of panels, each of which referred to a pharmaceutical
the Code would have been a breach of undertaking, company or product. The one for Invokana led to a
but MSD had not signed the undertaking for the promotional microsite which carried PI, date of
original complaint until 13 August 2019, after the June preparation and job code. The BMJ had confirmed that
2019 publication date for the 2018 data. However, the the introductory panels were not adverts or
Panel was very concerned that in its undertaking MSD promotional materials. The panel carried the brand
said that the last time its incorrect data had appeared name in logo format above text which read ‘The renal
on the disclosure site was in January 2019 (the 2017 reason to intensify’. At the bottom of the panel text
data), although it had been told about the 2018 error read ‘Diabetes’. It had been certified. The Panel
on 26 July 2019. MSD’s actions reduced confidence considered that the introductory panel was
and brought discredit on the industry and a breach of promotional in its own right and should have carried a
Clause 2 was ruled. AUTH/3236/8/19 link to the PI. A Code breach was ruled. AUTH/3254/10/19

4
The Code News July 2020

MISLEADING CLAIMS
ViiV Health care complained about the claims and
imagery in material used by Gilead Sciences Europe
Ltd to promote Biktarvy in the treatment of HIV. The
material contained the claim that Biktarvy was ‘better
tolerated than DTG-containing regimens’. ViiV
marketed DTG (dolutegravir) and DTG combination
products. ViiV said the claim was all-embracing and
misleading. It was accompanied by a dagger symbol
which referred to a statement in a smaller font saying
there were significantly fewer all grade treatment-

www. istockphoto.com/LiuSol
related AEs versus two specific DTG-containing
comparator regimens (one of which was a ViiV
product) and that this was a secondary endpoint. ViiV
said that this was selected data. The full safety profiles
from the referenced studies showed that the overall
tolerability and safety profiles were similar. One of the
referenced studies showed that AEs leading to
discontinuation were seen in 2% of the Biktarvy group possible…Biktarvy …is now a reality’ which it
and <1% of the group on a DTG-containing regimen. considered implied that no other antiretroviral
Another, comparing Biktarvy with ViiV’s Triumeq, product had those qualities and that Biktarvy had
stated that tolerability differences were driven by some special merit. Gilead said the statement made
agents other than DTG. There were other DTG- no specific claims and the intention was to encourage
containing regimens used in practice. Gilead provided the reader to reflect on subsequent claims. The Panel
detailed information to support their assertion that said that the statement might be acceptable in
the claim was fair and balanced. Tolerability was not isolation but within the context of the material and the
defined by discontinuation rates. The basis on which stand it was misleading and exaggerated the
the claim had been made was clear and capable of properties of the product. Breaches were ruled. Gilead
substantiation. The Panel considered that the appealed the Panel’s ruling and provided further
immediate impression of the claim was that Biktarvy detailed argument in their appeal as to why the claim
would be better tolerated than all DTG-containing ‘better tolerated than DTG-containing regimens’ and
regimens. This was misleading and could not be the rose and thorn image were acceptable, including
substantiated by the referenced studies. Code that they had been reviewed by the MHRA as part of
breaches were ruled. pre-vetting, and had not been found in breach of the
ViiV also complained that imagery used in Biktarvy Irish (IPHA) Code following a complaint in Ireland. The
promotion suggested an overstated tolerability and Appeal Board upheld the Panel’s findings.
AUTH/3137/12/18
safety profile improved versus DTG-containing
regimens. The claim ‘better tolerated than DTG-
containing regimens’ was used in association with an
image of a rose which had lost most of its thorns. COMMERCIAL TERMS
Gilead said the imagery was designed to show that An ex-employee complained about Allergan’s
Biktarvy possessed a favourable profile on multiple commercial policy for Botox (a prescription medicine)
attributes and that the product addressed a number and its medical devices Juvéderm and CoolSculpting.
of limitations seen with other treatments such as The policy bundled the three products together so
efficacy, resistance, tolerability and dosing. Some that large Juvéderm and Coolsculpting customers got
thorns remained on the rose to recognise that the a hugely reduced Botox price and vice versa. Allergan
product was not totally devoid of limitations. The said that it operated a clear and transparent
Panel considered that readers would see the rose as commercial policy. There was a linear relationship
representing Biktarvy and that the thorns would be between product volume and pricing so that higher
seen as injurious implying that Biktarvy was less volume purchases resulted in higher discounts. There
hazardous that DTG-containing regimens which could was no bundling making the price of one group of
not be supported. Code breaches were ruled. products contingent on another. The Panel considered
Finally, ViiV had complained about a header in a video that the arrangements appeared to be terms of trade
on a stand saying ‘the beauty of what is and were not in breach of the Code. AUTH/3243/9/19

5
The Code News July 2020

LACK OF CLARITY ABOUT NON-INFERIORITY

An anonymous GP complained that Novo Nordisk it had been designed to show that Ozempic was not
representatives were promoting Ozempic off-label, significantly worse than placebo (i.e. non-inferior) but
for cardiovascular and weight loss benefits. Ozempic the size of the treatment effect of Ozempic resulted in
was indicated for treatment of insufficiently a significantly lower risk of CV events in treated
controlled type 2 diabetes as an adjunct to diet and patients. Novo Nordisk provided campaign briefing
exercise. The GP also said that representatives were documents and copies of promotional materials. The
making superiority clams based on a study which was Panel concluded that Novo Nordisk had not promoted
not powered for superiority. Ozempic outside the terms of the SPC although it
Novo Nordisk denied the allegations. It said that the considered that the material was not clear enough
indication covered both glycaemic control and clinical about the fact that the study was a non-inferiority
outcomes, and that claims about weight loss and study. Breaches were ruled. The complainant
cardiovascular (CV) benefits were always made in the appealed, continuing to assert that Novo Nordisk were
context of the treatment of type 2 diabetes. The promoting outside the label and that this brought
indication was placed prominently upfront on all discredit on the industry. The Appeal Board said that
materials. The claims were supported by the SPC and representative briefing documents should have been
clinical data. The study was a placebo-controlled CV clearer about the need to set discussions about weight
outcomes trial of patients with type 2 diabetes who loss within the context of the licenced indication but
were on standard management of diabetes and at agreed with the Panel’s rulings. AUTH/3245/9/19
high risk of CV events. As a cardiovascular safety trial,

WHOSE MATERIALS?

www. istockphoto.com/cifotart
An anonymous complainant raised concerns about a Saxenda data. The representatives stated categorically
Novo Nordisk sponsored obesity training course held that they had not used uncertified materials. The
at the offices of a pharmacy and short-line wholesaler. material that was subject of the complaint had been
The course covered Saxenda (liraglutide, indicated for produced by the pharmacy. One of the
weight management) and the complainant said that representatives had been asked whether delegates
two representatives had misled HPs by: saying that needed to be CQC registered to attend the training;
clinics using Saxenda did not need to be CQC both were clear that they had not said that services
registered, producing their own product related could be provided without CQC registration.
material, and by sharing that material with delegates NovoNordisk later stated that it discovered that the
via a shared folder. NovoNordisk explained that it had representatives had been involved with the materials
a contract with the pharmacy to purchase Saxenda produced by the pharmacy. They had provided a blank
sales data, pay for four advertisements in the template, formatted some of the documents and e-
pharmacy price list, and sponsor six obesity training mailed the link to the shared folder containing the
meetings organised and run by the pharmacy. The materials to a small number of external parties. The
pharmacy controlled all meeting arrangements, it Panel said that this meant NovoNordisk was
prepared the agenda organised the sessions and any responsible for the material, which had not been
external speakers and provide material to the certified. The representatives had failed to maintain a
attendees. Two representatives had been invited to high standard of ethical conduct. Breaches were ruled.
present on obesity and its treatment as well as AUTH/3198/5/19

6
The Code News July 2020

MEDICAL PROMOTION WEBSITE IN BREACH (3)

Pharmacosmos complained that UK health A concerned UK health professional complained about
professionals had been proactively contacted by pages for IV irons on the Vifor Pharma UK corporate
members of the Vifor medical team, to discuss a website: the black triangle symbols were blue, grey or
published clinical paper which compared safety white, and it was not clear from downloadable
information on Monofer, a Pharmacosmos product materials whether the site was intended for the public
with Vifor’s Ferinject. Pharmacosmos considered that or HCPs. Vifor accepted that the site was in breach of
the paper was misleading and had not been certified the Code. The errors with the black triangle appeared
for promotional use. The activity was disguised to have arisen when an update to the website was
promotion and failed to maintain high standards. Vifor uploaded incorrectly. There were five downloadable
said that the company’s Chief Medical Officer (CMO), items on the Ferinject product page. Four of these
who was a co-author of the paper, wanted to have a were non-promotional risk management materials
peer-to-peer discussion with selected international and once was a document published by Scottish
professors and senior consultants who were Medicines Consortium (SMC) containing its detailed
investigators and consultants to the company to assessment of Ferinject including comparative
inform them of the purpose and publication of the efficacy, cost of comparators and budget impact. The
paper. The CMO had, as a courtesy, held telephone Panel considered that the SMC document contained
conversations with two UK health professionals, both claims for Ferinject and that by placing it on the
professors, about the paper, explaining the rationale, corporate website Vifor had used it for a promotional
results and limitations of the study in separate non- purpose rendering the website promotional. There
promotional conversations. Vifor considered that was no separation of promotional material from
these were not within the scope of the Code. Both material for the public, in breach of the Code. And the
professors had been members of Vifor advisory black triangles were not black, which was a further
boards in the past and were consultants to the breach. AUTH/3238/8/19
company in relation to NICE HTA procedures. Neither
considered the interaction to be promotional. The
Panel said it had no evidence that the paper was
OUT OF DATE PI
GSK voluntarily admitted that a promotional e-mail for
relevant to the NICE HTA consultancy, and that the
Trelegy Ellipta sent to GPs had contained out of date
Code definition of promotion was likely to be different
prescribing information. The error was identified the
to a lay person’s use of the term. It queried how the
day after the e-mail had been sent out. As the e-mail
proactive discussion of the paper comparing two
could not be recalled, a corrective e-mail was sent out
products in favour of Vifor’s could be anything other
a week later. Two weeks after that GSK found out that
than promotion. The Panel said it had very little
the agency had, incorrectly, only sent the corrective e-
information available about precisely what was said in
mail to GPs who had opened the original e-mail. It
the calls. Vifor had submitted that one of the HPs was
asked the agency to send it to all GPs who had
confused about the purpose of the call. In the Panel’s
received the e-mail as it had originally requested. The
view the promotional nature was disguised. The
error arose because a template e-mail containing the
material should have been certified. Code breaches
old PI had been used. Code breaches were ruled.
were ruled. AUTH/3159/2/19 AUTH/3257/10/19

PROMOTIONAL TWEETS
Having been alerted by another UK pharmaceutical company, AstraZeneca (AZ) voluntarily admitted that a UK based
employee had used his/her Twitter account to re-tweet health professional’s tweets related to Forxiga (dapagliflozin)
and Lynparza. The posts related to a congress where information outside the licensed indications had been
presented. AZ’s social media policy made it clear that product related tweets were prohibited. The posts were
deleted and remedial actions had been put in place. The Panel considered that the tweets promoted dapagliflozin
and Lynparza for unlicensed indications, promoted a prescription medicine to the public and should have been
certified. Breaches were ruled. The Panel noted that AZ positively encouraged employees to post certain work-
related content on their personal social media accounts and commented that it might be difficult for some
employees to balance this with the need to make a judgement about what they might post. The Panel considered
that high standards had not been maintained. AUTH/3248/9/19

7
The Code News July 2020
WEBSITE IN BREACH (4)
A concerned UK health professional complained about linked to Feraccru product information. Shield and
claims on the Feraccru (ferric maltol) website. The Norgine said that although a medicine might have
product had previously been marketed by Shield adverse events, this did not mean it was not well
though Norgine had recently become the marketing tolerated. Use of information about the chemical
authorisation holder. The companies submitted a behaviour of ferric maltol in the GI tract from animal
joint response. The website said that Feraccru was models was reasonable. Shield acknowledged that the
well tolerated, but the complainant said that as it had website promoted Feraccru to the public: information
six common adverse drug effects, it was definitely not intended for patients on treatment was accessible to
well tolerated without a caveat. Information about all readers. The Panel considered that ‘well tolerated’
Feraccru’s absorption and prevention of free radical was acceptable, but that the use of animal data and a
damage in the gastrointestinal mucosa was based on study using a different formulation were misleading,
animal data, and one study cited in support of the and that the link to information about Feraccru on a
product used a different iron formulation. A page public page promoted the product to the public.
about iron deficiency anaemia intended for the public Breaches were ruled. AUTH/3231/7/19 and AUTH/3255/7/19

CASE DETAILS – CLICK FOR LINK TO FULL REPORT

ViiV Healthcare vs Gilead Sciences Anonymous v Vifor
AUTH/3137/12/18 AUTH/3238/8/19
Promotion of Biktarvy. Respondent appeal. Breach Corporate website
Clauses 7.2, 7.3, 7.4, 7.10, 8.1 and 9.1 No appeal. Breach Clauses 4.10 and 28.1
Anonymous Employees vs Otsuka Europe Ex-Employee vs Allergan
AUTH/3151/1/19 AUTH/3243/9/19
SPC changes and PI Commercial policy
Complainant appeal. Breach Clauses 2 and 9.1 No appeal. No breach
Pharmacosmos vs Vifor Anonymous GP vs Novo Nordisk
AUTH/3159/2/19 AUTH/3245/9/19
Promotion of Ferinject Promotion of Ozempic
No appeal. Breach Clauses 12.1 and 14.1 Appeal by complainant. Breaches Clauses 7.2 and 9.1
Voluntary admission from Otsuka Europe Voluntary admission by AZ
AUTH/3169/3/19 AUTH/3248/9/19
Revision of Jinarc SPC Re-tweets
No appeal. Breach Clauses 2, 9.1 and 29 No appeal. Breach Clauses 3.2, 9.1, 14.3 and 26.1
Anonymous Employees vs Otsuka Europe Complainant vs Lilly
AUTH/3174/3/19 AUTH/3252/9/19
Conduct of company Alleged promotion to the public
Breach clauses 2, 9.1, 12.1 No appeal. Breach Clause 9.1, 26.1 and 28.1
Complainant vs Novo Nordisk Complainant vs Napp
AUTH/3198/5/19 AUTH/3254/10/19
Promotion of Saxenda at meetings Introductory panel on BMJ hosted page
No appeal. Breach Clauses 14.1 and 15.2 No appeal. Breach Clause 4.1
Health professional vs Otsuka Voluntary admission by GSK
AUTH/3217/6/19 AUTH/3257/10/19
Jinarc training site Use of outdated PI
No appeal. No breaches. No appeal. Breach 4.1 and 9.1
Complainant vs Shield and Norgine Anonymous vs Merz
AUTH/3231/7/19 & AUTH/3255/7/19 AUTH/3264/10/19
Feraccru website Cross border activity
No appeal. Breach Clauses 7.2, 7.4 and 26.1 No appeal. Breach Clauses 9.1 and 15.2
Health professional vs MSD Complainant vs Diurnal
AUTH/3236/8/19 AUTH/3274/10/19
Information on Disclosure UK Promotion of pipeline products
No appeal. Breach of Clauses 2, 7.2, 9.1 and 24.1 No appeal. Breach Clauses 3.1, 4.1, 4.3, 9.1 and 2
NB: The Author tries to ensure that information published in The Code News is correct but can accept no liability for
losses or damages arising. Seek a second opinion before acting on any information provided!
8