Life Sciences Seminar

©2009, Greenberg Traurig, LLP. Attorneys at Law. All rights reserved.

GREENBERG TRAURIG, LLP ▪ ATTORNEYS AT LAW ▪ WWW.GTLAW.COM

[June 8, 2011]

Germany, the Netherlands and the UKAlex Denoon, Mathias Klümper & Erik Vollebregt

A Guide to Promotion of Medical Devices

[2]

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

Medical Device Promotion

1. Regulatory – Only approved devices within approved indications

2. Unfair Commercial Practices Directive– Local Implementation Inconsistent

3. IP issues – especially Trade Mark Infringement and – Unfair comparisons – Unfair advantage L’Oréal SA v. Bellure NV [2010] EWCA Civ 535

4. Industry Codes of Practice – (EUCOMED, ABHI, NEFEMED and ABPI)

5. Public Procurement considerations (if any)6. Professional body restrictions (e.g. HCP testimonials)7. Unsolicited emails

Information vs Advertising• Critical distinction between the provision of information and advertising

(or promotional material)• Is the material promotional in nature, was it presented in a manner which

is promotional or merely “informational”?• Distinction is coming under pressure and the “information” safe harbour

is getting smaller in respect of pharmaceuticals – Information provided by independent journalist was promotional (Damgaard case ECJ).– Thus information distributed by patient groups must be susceptible.

• These distinctions can be difficult when hosting an educational event– Is this promotional or Informational?– Difficult decision as regards reviewing material presented at these events?

• Tension if competitors address the same indication (e.g. fungal infection) differently, e.g. one is a medicine and the other is a medical device

• Novo Nordisk v Ravimiamet: Case-by-case approach, not limited to SPC

Regulatory Framework and Enforcement

Regulatory Requirements

Medical Device Directives focuses on Claims and CE Mark

• Is promotional activity alone placing on the market?– Safe view: the prohibition extends to “promotional” activities– Robust view: advertise but clearly state that it will not be available until CE Mark

• ABPI Code of Practice encourages giving procurement teams advance notice of the launch of a relevant novel medicine for budgeting (cluase 3.1)

Restriction Article

Devices may only be placed on the market (or put into service) if they are CE marked 2

Devices may only be placed on the market for their intended purpose (IFU & marketing) 1(2)

Limited exceptions for exhibiting at trade fairs, exhibitions & demonstrationsVisible sign that device cannot be sold or put into service until the device has CE mark

4(3)

Regulatory Enforcement

• The MHRA can investigate complaints, though tend to focus on safety issues and the sale of non-compliant devices

• The MHRA does not have a strong interest in misleading advertising of medical devices, unless:– there are safety issues– the device is non-compliant– the company is trying to take advantage of an exception to CE Marking; or– a medical claim (or a quasi-medical claim) is made

• While enforcement is patchy, sale of a non-compliant device is criminal• Notified Body may address• The MHRA publishes the Blue Guide regarding the Advertising and

Promotion of Medicines in the UK. No guidance for medical devices• Similar position in the Netherlands and Germany (with some specific

protections, e.g. advertising of treatments for addictions).

Regulatory Enforcement (2)

• Enforcement is more rigorous if medical claims are made– Will be a medicinal product even if it only claims to operate as a medicine– Over-enthusiastic marketing teams can convert legitimate claims regarding medical

devices into medicinal claims: • Ingredient added for cosmetic purposes, but marketing suggested that the

ingredient aided efficacy• Pharmacological Ingredient added as secondary mode of action, but marketing

suggested that the mode of action was primary

• Private enforcement by competitors is a risk in some jurisdictions• Marketing teams must know your approved indications (and competitors’)• Beware claims that relate to a pharmacological, immunological or metabolic

means of action (primary vs. secondary mode of action)• Monitor competitors’ claims – They will be monitoring yours!

Exceptional Uses: Extra Care• 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.– Standardised approach to medical diagnosis.

Misleading and Comparative Advertising

Misleading Advertising

• Multiple Sources of Law prohibit misleading advertising– Misleading and Comparative Advertising Directive, 2006/114– Unfair Commercial Practices Directive, 2005/29– Local Implementation Acts and Regulations

• Protects traders against competitors engaging in unfair conduct by issuing misleading advertising

• Touchstone: advertisements should be factual, fair and capable of substantiation (WHO guidance)

Misleading Advertising

• 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

Misleading Advertising –Target Audience

• 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.

Misleading Advertising –Target Audience & Facts

• 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.

Comparative Advertising

• Comparative advertising is very broadly defined as any advertising• which explicitly or or by implication identifies a competitor or goods or

services offered by a competitor

• Concept of comparative advertising has a very wide scope• “Identification” does not even require a comparative context or

comparative intent – an indirect reference is sufficient• “Competitor” can be any company active on the same relevant market

(including market entrants) or with a possibly competing therapy

• Regular source of dispute in medical devices sector, particularly • Incomplete comparisons, selective use of information and hanging

comparisons• Failure to identify source

Misleading and Comparative Claims

– Particular care should be given to:• Material from ongoing clinical trials or clinical investigations • Material from animal studies• Data from preclinical studies or studies on healthy volunteers• Emerging clinical or scientific opinion or practice• Use of pricing information, economic evaluations and statistical information• References to absolute risk and relative risk• References to efficacy in relation to weight

Burden of Proof

• The burden of proof of correctness of the statements concerned will normally fall on the advertiser– Where this is not the case, it is easy to shift the burden onto the advertiser

• Make sure that substantiation of claims is ready and (clinically) evaluated before approving advertisement for publication– Hard copies may need to be provided at short notice and some publishers

will require copies prior to publication

National Differences

• As a result:• In the UK, claims often based on TM infringement or malicious falsehood (trade libel)• Controversial pan-European marketing campaigns often litigated outside the UK

• Consider where to commence controversial marketing

Germany & The Netherlands UK

Enforcement of MCAD?

Competitor can bring action directly against a competitor

Report to:• Advertising Standards Authority; • Office of Fair Trading; or• MHRA

Injunctive Relief

Readily available as no requirement for:• balance of convenience• irreparable (or non-compensable) harm or • undertakings as to damages

Challenging

Alternatives:Trade Mark Infringement, Complaint

to Advertising Standards Authority or Malicious Falsehood

Trade Mark Infringement

• Use of a competitor’s trade marks (name, name of product) may be trade mark infringement if the advertisement:– is misleading and/or – does not meet criteria comparative advertising

• Some countries may have specific case law on ‘proportionality’ of reference to a competitor’s trade mark– Refer to name only, or also to visual element of trade marks?

• Recently the ECJ expanded the protection for trade marks in L’Oréal SA v Bellure– Bellure promoted “smell-alike” perfumes by reference to famous registered marks.– L’Oréal successfully sued for infringement and won despite the Court agreeing that

the advertisement was not misleading and no sales were diverted.– Court held that as Bellure’s products were held out to be imitations or replicas, they

were promoted by reference to and took unfair advantage of L’Oreal’s marks.

ASA – Committee of Advertising Practice

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.

ASA – Committee of Advertising Practice

• The ASA works to ensure that ads are legal, decent, honest and truthful• Virtually no cost associated with a complaint to the ASA• The ASA is not a forum for rapid resolution of disputes (usually investigated

within 3 months) – theoretically, advertisements can be pulled at the direction of the ASA pending the investigation

• If there is a complex technical debate, the ASA may not have the skill set to address the issue and may refer the matter to the MHRA

• The ASA’s remit is limited to certain types of advertising (such as TV, radio, newspapers and magazines) and only recently extended to websites and email

• The ASA would not ordinarily take an interest in, for example, a powerpoint presentation given by a sales rep

ASA Sanctions and Examples• 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

Malicious Falsehood• Difficult cause of action because it requires:

– a subjective element (namely malice);– Falsehood; and – specific denigration.

• Malice can be established by knowledge that the statement is false or without considering or caring whether the statement was true.

• The statement must specifically denigrate the claimant’s goods.– The defendant’s goods are the best. – While such a statement implies that a competitor’s goods are not as good,

it does not denigrate them. – General praise of the defendant’s goods will usually not be actionable.

Malicious Falsehood - Case• In 2010, Ajinomoto (the world’s largest manufacturer of the

Aspartame) successfully sued the ASDA as a result of the use of the following expression on a range of ASDA’s own brand products: – “No hidden nasties … no artificial colours or flavours and no aspartame”.

• A substantial number of people would interpret the words as meaning that there is a risk that aspartame is to be avoided

• Example– Claim in a detailed reimbursement dossier that drew comparisons with the three

existing treatments– Only one reference to the competing product (in a footnote)– Would it make a difference if there was only competing product or if there was a

clear market leader?

Industry Codes of Practice

Codes of Practice (UK)

• EUCOMED, ABHI and Nefemed• 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.

ABPI• 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”

ABPI Code

7.2 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. Claims must not mislead either directly or by implication, by distortion, exaggeration or undue emphasis.Material must be sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of the medicine.

7.4 Any information, claim or comparison must be capable of substantiation.7.6 When material refers to published studies, clear references must be given.

ABPI Code (continued)

7.3 A comparison is only permitted in promotional material if:– it is not misleading– medicines or services for the same needs or intended for the same purpose are compared– one or more material, relevant, substantiable and representative features are compared– no confusion is created between the medicine advertised and that of a competitor or between the

advertiser’s trade marks, trade names, other distinguishing marks and those of a competitor– the trade marks, trade names, other distinguishing marks, medicines, services, activities or

circumstances of a competitor are not discredited or denigrated– no unfair advantage is taken of the reputation of a trade mark, trade name or other distinguishing

marks of a competitor– medicines or services are not presented as imitations or replicas of goods or services bearing a

competitor’s trade mark or trade name

Industry Codes in Germany

• Codes of Conduct of the German medical device industry quite old

• Deal only with critical co-operations from an anti-corruption perspective

• No rules for advertising or promotion of medical devices

Therapeutic Goods Advertising Code

The relevant Australian Code applies to all therapeutic goods and is a reasonable summary An advertisement for therapeutic goods must not: (a) be likely to arouse unwarranted and unrealistic expectations of product effectiveness(b) be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases(c) mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions(d) abuse the trust or exploit the lack of knowledge of consumers or contain language which could bring about fear or

distress(e) contain any matter which is likely to lead persons to believe:

(i) that they are suffering from a serious ailment; or (ii) that harmful consequences may result from the therapeutic good not being used. Sunscreen is exempted from (ii) if the claims made in the advertisement are consistent with public health

messages.

(f) encourage, or be likely to encourage, inappropriate or excessive use(g) contain any claim, statement or implication that it is infallible, unfailing, magical, miraculous, or that it is a certain,

guaranteed or sure cure(h) contain any claim, statement or implication that it is effective in all cases of a condition(i) contain any claim, statement or implication that the goods are safe or that their use cannot cause harm or that

they have no side-effects(j) be directed to minors, except the therapeutic goods listed in Appendix 5

Cases

GP v Boehringer Ingelheim• ABC is therapeutically equivalent to XYZ. • 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 CaseClaim 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.Claimants 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

“Substitutable” Example• The New Company made various claims when launching:

• Why pay £12,000, when you could save £10,000?• The Incumbent makes very large profits• Substitutable for existing products

• Claims were primarily made in confidential corporate presentations

• The Incumbent doubted the legitimacy of the CE Mark classification

• Considerations re UK position (cf Germany and the Netherlands)• Little prospect of trade mark infringement as the New Company did

not name the market leading product• Report suspicions to MHRA: unsupported claims or incorrect CE

Mark• Unlikely that ASA would investigate a corporate presentation• Consider claim to OFT on the basis of unjustified comparisons• Considered a trade libel claim• Complain to EUCOMED or ABHI

Claims – Avoid Absolutes• 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”.

Specific Comparison Claims• Repairs the Wound Bed Three Times as Fast• Cuts Treatment costs by X%• Y% more Effective in reducing wound area• Significantly Improves Patient Quality of Life

• What is the subject of the comparison?• Competitor’s product or leading product or conventional therapy?• Are these claims applicable to all pathologies?• Is a comparison with “conventional therapy” clinically relevant?

• When these claims are all made together, is it a consistent comparison?

• Is the supporting material representative or an “abnormal” result?

• Has the clinical environment changed/evolved?• Similar to the law re misrepresentation by silence once facts change

Claims re Company, not Product• Target audience • What might a consumer conclude?• Possible to identify the competitor to

whom the advertisement alludes?• Is this positive about Novarad or

negative about the competitor?• Is the competitor identified by

association (no use of Trade Marks)?

Animal Data• 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.

Case•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.•Allergan breached the Code.

Animal Data (2)• Graft revascularization supports resistance to graft infection• Exaggerated inflammatory response may promote rapid mesh

degradation with resultant weakening or failure of the mesh material• Collagen deposition by fibroblast infiltration has been shown to

increase tensile strength of an incisional wound X% more effective in reducing wound area

• All of the clinical data was based on animal studies or in vitro studies. This was well known in the industry

Issues• Do these suggest a mode of action that is pharmacological, immunological or

metabolic?• These claims relate to substitute endpoints. Is it appropriate?• Is it clear that this is based on data from animal or in vitro studies?Suggestions• Explain why this animal data is being used – both as regards the animals and

the nature of the studies. Ideally refer to regulatory or clinical criteria.• Use disclaimer: Correlation of these results to results in humans is not

established. Consider prominence of disclaimer.

General Suggestions re Slides• Provide links to studies, additional data and IFU• Ask presenter to confirm that:

• consent to use images has been obtained; and • the information is factual, fair and properly representative

• Use disclaimers such as:• Results of these tests are not necessarily indicative of clinical results. • The information presented in these slides represents the presenter’s

personal view/clinical experience.• All histology is representative of study results.

• If the presenter is not willing to provide the disclaimer, then discuss• Consider prominence of Disclaimer (e.g. animal data)• Disclose commercial relationships• Where using “proprietary data” or “own slides” or “company

information” prominently disclose what and why

Unsolicited Emails and Other Considerations

Unsolicited Emails• 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—

(a) 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;

(b) the direct marketing is in respect of that person’s similar products and services only; and(c) 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.

Unsolicited Email – Case ABPI Code

• 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.

Other Considerations

1. Public Procurement considerations– Be careful about claims provided in material provided in response to tender requests

– particularly where the tender requirements lack clarity– Consequences for breaching public procurement requirements can be onerous

1. Professional body restrictions– Testimonials from Healthcare Professionals or hospitals

2. The new UK Bribery Act has a very broad reach and is very uncertain– Virtually all interactions with healthcare professionals need to be more carefully

considered than previously– All corporate hospitality is now suspect

AcknowledgementThis presentation is based on an article written by the presenters that was published in Regulatory Affairs Journal – MedTech in March 2011.

Thank YouThe 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.

Alex Denoon: Mathias Klümper:+44 20 3441 0908 (office) +49 40 987613 28 (office)+44 7540 123 519 (mobile) +49 151 15138615 (mobile)

alex@lawforddaviesdenoon.com mathias.kluemper@luetzeler.eu

Erik Vollebregt: +31 20 30 17 436 (office)+31 6 47 180 683 (mobile)vollebregte@eu.gtlaw.com

Some Definitions• 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;

Some Definitions• 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.

German Healthcare Advertising Law (I)

• Act on Advertising in the Healthcare Sector covers only „promotional advertising“ and not so called „image advertising“

• Promotional advertising means advertising for a sepcific product

• Image advertising covers advertising with the name of the company or the entire range of products without any reference to a specific product

German Healthcare Advertising Law (II)

• HWG provides for a number of general restrictions that apply to both, medicinal products and medical devices:– Prohibition of misleading advertising– Detailed requirements for advertising with expert opinions,

certificates, etc. – Limitation of promotional goods (gifts and other benefits) that may be

provided in the distribution chain of a medicinal product or a medical device

German Healthcare Advertising Law (III)

• Many restrictions for the promotion of medicinal products to the general public and to HCP’s foreseen in the HWG

• No specific restrictions in the HWG for the promotion of medical devices to HCP’s

• Only very few restrictions exist for the promotion of medical devices vis-à-vis the general public, i.e. the use of – foreign language or technical terms that are not usually used in German

language;– advertising claims that may cause anxiety;– advertising that is intended to collect (email) addresses;– publications that cannot clearly be identified as being advertisement;– statements of third parties, e.g. letters of thank, appreciation or

recommendation;– advertisements that are exclusively or predominately addressed to children

under 14 years.

German Healthcare Advertising Law (IV)

• 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

Resources

Nefemed code http://www.nefemed.nl/attachments/007_Nefemed%20gedragscode%202009.pdf

Nefemed code Q&A http://www.nefemed.nl/attachments/007_Gedragscode%20Begeleidingsdocument%20Q&A.pdf

Nefemed flyer http://www.nefemed.nl/attachments/007_Nefemed%20Flyer%20Gedragscode.pdf