Program: 4:00 – 4:45 Part I 5:15 – 5:30 Break 5:30 – 6:30 Part II 6:30 – Drinks & snacks
Slide Overview 3 Regulatory Framework 5 Misleading Advertising and Comparative Claims (and TM Infringement) 10 Alternatives: Complaint to Advertising Standards Authority or Malicious Falsehood 20 Industry Codes of Practice 26 Cases and Examples 32 Unsolicited Emails and Other Considerations 43 Resources and Definitions 49
Research Use Only IVDs do not need CE Mark if product (MEDDEV 2.14/2):
has no medical intended purpose;
has no medical objective; and
is not intended for performance evaluation purposes.
The exception expires once:
the IVD is intended by Manufacturer to be used for a medical purpose; or
a medical purpose has been established based on sufficient and broadly accepted scientific, diagnostic and clinical evidence.
When the IVD Directive was adopted, the view was:
Will not tolerate the abuse in the US where products with a clear clinical and analytical use are offered for RUO. Should be limited to products that detect analytes that have not yet been assigned a clear clinical meaning by the medical profession.
Marketing and context is crucial – Avoid:
References to launch, medical indications or clinical validation.
Misleading advertising is defined as any advertising:
which in any way, including its presentation, deceives or is likely to deceive the persons to whom it is addressed or whom it reaches and which, by reason of its deceptive nature, is likely to affect their economic behaviour or which, for those reasons, injures or is likely to injure a competitor
Misleading advertising can also constitute ‘off-label’ advertising if the claims go beyond intended purpose and CE certified parameters
likely illegal under local medical devices regulatory regulation
can lead to fines and administrative action by authorities
easy unfair competition case for competitors to bring
The Target Audience may be health care professionals or end users.
In B2B circumstances, the court will “take into account the perception of the average individual who is reasonably observant and circumspect. Account should be taken of the type of persons at whom the advertising is directed”.
Medical device companies can be more robust when advertising to healthcare professionals, however, advertising has to be factually correct.
Dutch courts: when providing promotional material about medical devices the manufacturer has a duty to be extra critical about the factual correctness of the material (even if target audience are experts).
Australian courts: The hypothetical receiver of the information may be a bit naïve, but there is no need to protect the unusually stupid. While some flourish is allowed, be very careful about factual statements and images which may mislead.
The CAP Code requires that ads must not mislead and claims must be substantiated
Section 12 ( Medicines, Medical Devices, Health-Related Products And Beauty Products )
12.1 Objective claims must be backed by evidence, if relevant consisting of human trials. Medical claims must only be made for licensed medicines or, to a very limited extent, CE-marked medical devices in accordance with the approved IFU.
12.2 Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified HCP. Accurate and responsible information about such conditions may, however, be offered.
12.4 Marketers must not confuse consumers by using unfamiliar scientific words for common conditions.
12.5 Marketers inviting consumers to diagnose their minor ailments must not make claims that might lead to a mistaken diagnosis.
12.6 Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
12.7 References to the relief of symptoms or the superficial signs of ageing are acceptable if they can be substantiated. Unqualified claims such as “cure” and “rejuvenation” are not generally acceptable, especially for cosmetic products.
12.8 Marketers must hold proof before claiming or implying that a minor addiction or a bad habit can be treated without effort from those suffering.
12.9 Marketers must not encourage consumers to use a product to excess and must hold proof before suggesting their product is guaranteed to work, absolutely safe or without side-effects.
12.10 Marketing communications must not suggest that any product is safe or effective merely because it is “natural” or that it is generally safer because it omits an ingredient in common use.
Most common sanction: The ad should not appear again in its current form.
Breaches for unsubstantiated claims such as :
Are you depressed? Are you stressed out? Are you ill and tired? Are you fed up with life? Are you experiencing financial difficulties? Are you going through mental and emotional conflict? Do you want more love and harmony in your life? Change your life by using Crystal Bed Therapy.
Copper Back Support: Can help to relieve ligament and joint pain
Magnetic Knee Strap: Helps relieve knee pain and stiffness
Magnetic Back Brace: Helps relieve pain and prevent strain
Effective and Safe Treatment For Fingers and Toes Stop Fungus is a very effective liquid that helps to eliminate fungus, discolouration and odour from fingers and toes …
Correct Bunions Naturally
This non-staining formula is a fast acting spray developed to relieve rheumatic and arthritic complaints such as painful and inflamed joints. Providing pain relief for up to 24 hours
The EUCOMED Code of Ethical Business Practice and ABHI Code of Business Practice and Nefemed essentially only says that:
Members should ensure that all promotional presentations, including product claims and comparisons, are accurate, balanced, fair, objective and unambiguous. They should be justified by appropriate evidence. Statements should not mislead the intended audience.
While the ABPI Code relates to medicines, it is significantly clearer than the ABHI guidance. By way of example, there is commentary about:
References to relative risk and absolute risk ;
Economic evaluation of products;
Emerging clinical or scientific opinion; and
Use of superlatives and the words “ Safe ”, “ The ” and “ Unique ”
Claim based on non-inferiority studies conducted in relation to ABC vis-à-vis XYZ.
The advertisement stated “Well balanced” beneath a set of exactly balanced scales.
Complaint: a claim of equivalence was misleading, exaggerated the facts, could not be substantiated and endangered patients safety:
Non-inferiority is not the same as comparability.
The general reference to safety in the claims implied that the safety profile of XYZ was equivalent/comparable to ABC.
The claims did not specify the dose of ABC which suggested that XYZ was equivalent to any dose of ABC.
The RE-MOBILIZE study, which failed to show non-inferiority of ABC vs XYZ, had not been cited and in this regard the data had been “cherry-picked”. This misled clinicians as to the evidence base.
Result of Case Claim regarding Misleading Conduct Result
Non-inferiority ≠ comparability.
No breach. While non-inferiority studies do not establish comparability and one product may not be as good as another, the differences are not clinically significant.
The general reference to safety in the claims was misleading as it implied that the safety profile of XYZ was equivalent/comparable to ABC which was not so.
Breach. The claims together with the perfectly balanced scales implied that the products had been shown to be unequivocally equivalent.
The “cherry-picking” of data studies (omitting the RE-MOBILIZE study) misled clinicians as to the evidence base supporting the claims.
No breach. As the RE-MOBILIZE study related to a lower dose than the approved indication, the omission was not misleading.
More Claims and Cases Promotional Claim Result
“ Its time for a herpes liabialis cream that works”
Breach. Denigrating comparative statement. Suggestion of superior efficacy and suggestion that other product is not effective at all. Not supported by proof.
“ Most accurate no-coding blood glucose meter”
No breach. Claimant s glucose meter is auto-coding and therefore not in the same market.
“ As effective as other leading AIIAs”
Breach. Readers were unable to understand the clinical relevance of the data presented as the dose ranges were not like for like (there were issues with maintenance dose and maximum dose). The report cited was out of date and did not reflect the current balance of evidence or support the claim
The ABPI Code specifically addresses the words “safe”, “The” and “Unique” (7.9 and 7.10)
The word ‘safe’ must not be used without qualification. This applies equally to grammatical derivatives such as ‘safety’. For example, ‘demonstrated safety’ or ‘proven safety’ are prohibited…
The word ‘the’ can imply a special merit, quality or property for a medicine which is unacceptable if it cannot be substantiated. For example, a claim that a product is ‘The analgesic’ implies that it is in effect the best, and might not be acceptable under this clause.
Great care needs to be taken with the use of the word ‘unique’. Although in some circumstances the word unique may be used to describe some clearly defined special feature of a medicine, in many instances it may simply imply a general superiority. In such instances it is not possible to substantiate the claim as the claim itself is so ill defined.
Consequently, the use of “Silent” is risky
Consider language such as “virtually silent”, “near silent”, “almost silent”, “practically silent” or “as close to silent as possible”.
Another approach is to say “designed to be silent” or “designed to avoid disturbing the patient”.
Consider also “demonstrated superiority re noise” or “the quietest”.
The ABPI Code of Practice - extra care should be taken with:
The use of data derived from in-vitro studies, studies in healthy volunteers and in animals . Care must be taken with the use of such data so as not to mislead as to its significance. The extrapolation of such data to the clinical situation should only be made where there is data to show that it is of direct relevance and significance.
NB: This relates to drugs that have completed 3 phases of human trials.
Allergan claimed that Botox was more potent than Xeomin even though the approved doses were similar.
Allergan’s only data as regards potency was from animals.
In a 2010 study, it was accepted that the animal data did show superior potency.
However, there was no proof that the animal data could be extrapolated to the human clinical situation.
The Privacy and Electronic Communications (EC Directive) Regulations 2003 restricts the transmission of unsolicited communications by email to individual subscribers.
(2) Except as per paragraph (3), a person shall not transmit … unsolicited communications for the purposes of direct marketing by means of email unless the recipient has previously notified the sender that he consents for the time being to such communications being sent by the sender.
(3) A person may send email for the purposes of direct marketing where—
that person has obtained the contact details of the recipient of that email in the course of the sale or negotiations for the sale of a product or service to that recipient;
the direct marketing is in respect of that person ’s similar products and services only; and
the recipient has been given a simple means of refusing (free of charge except for the costs of the transmission of the refusal) the use of his contact details for the purposes of such direct marketing, at the time that the details were initially collected, and, where he did not initially refuse the use of the details, at the time of each subsequent communication.
The ABPI Code (clause 9.9):
The telephone, text messages, email, telemessages, facsimile, automated calling systems and other electronic data communications must not be used for promotional purposes, except with the prior permission of the recipient.
Email Subject New Product Horizon Scanning Information asked if the recipient wanted information regarding the projected introduction of a new product and included:
brief details of the product, describing it as the first of a new class of medicines
statements that the licensing process was considering data for possible use in the treatment of obesity and associated cardiovascular/cardiometabolic risk factors.
The recipient was told that additional information could be provided on request (cost, candidate patient types, a summary of the numbers of such patients in the local PCT and an estimate of the uptake rate).
Conclusion: Breach of Clause 9.9 of the Code
The primary purpose of the email was to elicit interest in the medicine and prompt the recipient to seek further information.
The information in the email was not sufficient to provide an adequate but succinct account of the product ’ s properties. The email did not indicate the likely cost and significant budgetary implications of the product. The email thus failed to meet the requirements of the supplementary information exception.
The information in this presentation is provided for information purposes only. The information is not exhaustive. While every endeavour is made to ensure that the information is correct at the time of publication, the legal position may change as a result of matters including new legislative developments, new case law, local implementation variations or other developments. The information does not take into account the specifics of any person's position and may be wholly inappropriate for your particular circumstances. The information is not intended to be legal advice, cannot be relied on as legal advice and should not be a substitute for legal advice.
Unless otherwise stated, the information is limited to the position in the Germany, the Netherlands and the UK.
medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;
accessory means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.
For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;
device for performance evaluation means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises;
manufacturer means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;
intended purpose means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials;
placing on the market means the first making available in return for payment or free of charge of a device other than a device intended for performance evaluation with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
putting into service means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose.
No promotion for diagnosing, preventing, treating of the following diseases
Diseases that must be notified due to the Infection Protection Act ( Infektionsschutzgesetz ) or that have been caused by an etiologic agent
Addictions, apart from nicotine addictions
Abnormal complications of gestation, the delivery and the childbed
Resources Eucomed Code http://www.eucomed.org/~/media/pdf/tl/2008/portal/abouteucomed/ethics/eucomedcodeofbusinesspractice.ashx ABHI Code http://www.abhi.org.uk/multimedia/docs/code-of-practice/abhi-cobp-december-2009.pdf Eucomed Q&A http://www.eucomed.org/~/media/C751B58FE49D4163B507007EF2F4A3F3.ashx ABPI Code http://www.pmcpa.org.uk/files/ABPI Code 2011.pdf Aust Code http://www.comlaw.gov.au/Details/F2007L00576 The Blue Guide (re advertising of medicines in the UK) http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2022589.pdf The Business Protection from Misleading Marketing Regulations 2008 http://www.legislation.gov.uk/uksi/2008/1276/contents/made