14-­‐09-­‐2012 PROMOTION AND
SALE OF IVDS IN EU
Axon Seminar
12 September 2012
Carine van den Brink
www.axonadvocaten.nl
Content
• EU legislation applicable on promotion/advertising of IVDS
• Promotion should be distinguished from providing information that is
not intended to promote use, prescription, sale or delivery of IVDs
• Eucomed Code of Ethical Business Practice
• National legislation and codes of practice
• Permitted as long as promotion of IVDs is not harmonized and
national rules are in conformity with Treaty on European Union
provisions on free movement of goods and services (art. 34 TFEU)
• Sales of IVDs via internet (case law)
1 14-­‐09-­‐2012 EU legislation on promotion of
medicinal products
• Directive 2001/83/EC relating to medicinal products for human use
• Article 86 – 100 contain provisions regarding promotion of medicinal
products, such as:
• Promotion of medicinal products without marketing authorisation is
prohibited
• Promotion shall not be misleading and encourage rational use
• Promotion to general public is prohibited for medicinal products for
which a prescription is required
EU legislation
• Promotion to general public of medicinal products that are subject to
reimbursement may be prohibited by members states
• Advertisements should be clearly labeled as such
• Advertising should contain name, information on correct use, not
include guarantees on effects, not include statement that health can be
enhanced, not include information that could lead to erroneous selfdiagnosis
• When promoted to health professionals, no gifts or other benefits may
be offered unless they are inexpensive and relevant to practice
2 14-­‐09-­‐2012 Directive 98/79/EC (IVDD)
• IVDD does not contain specific provisions for promotion/advertising of
IVDs (nor does MDD).
• No consensus whether promotional activities prior to CE are allowed:
o No: definition of “placing on the market” includes pre-market promotion
o Yes: allowed as long as product is not offered for sale and supplier does
not suggest that the IVD can be placed on the market lawfully
o Research-use-only IVDs do not need CE approval (but see MEDDEV
2.14/2)
Directive 98/79/EC (IVDD)
• Promotion at trade fairs, exhibitions, demonstrations and scientific
gatherings is allowed if not using human specimen and clearly labeled
that they can not be placed on the market until they are validly CE
marked (4.3 IVDD)
• IVDs can only be promoted for their intended use (art. 2(h) IVDD). So no
off-label use promotion.
• Language requirements (art. 4(4) IVDD)
3 14-­‐09-­‐2012 Other EU legislation relevant for
promotion of IVDs
• EU Directive 2006/114/EC concerning misleading and comparative
advertising
• Not specific to medical devices but applies directly to their promotion
• Article 2(b) defines misleading advertising 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”
Other EU Legislation relevant for
promotion of IVDs (II)
• Whether advertising is deceiving depends on target group (f.e. health
care professionals versus general public)
• manner in which the goals in directive are achieved can vary per
member state
• EU Directive 2005/29/EC concerning unfair business-to-consumer
commercial practice
• Limited in application (gives consumer protection, competitors can not
invoke directive or implemented national legislation)
4 14-­‐09-­‐2012 Other EU Legislation relevant for
promotion of IVDs (III)
• Not specific to IVDs but applies directly to their promotion
• Unfair commercial practices include
• misleading practices by act or ommission;
• aggressive practices
• blacklisted practices
• e.g. “displaying a trust mark, quality mark or equivalent without
having obtained the necessary authorisation” (such as CE).
Eucomed Code of Ethical
Business Practice
• Only for Eucomed members
• “Promotion and interaction which takes place in Europe must comply with
applicable laws and regulations as well as codes of conduct and legal
requirements which apply to healthcare professionals”.
• Principles of Guidelines on interaction with healthcare professionals:
• • Separation (no influence through undue or improper advantages,
guidelines on gifts, educational grants, financial support of conferences,
etc)
• Transparancy (prior notificiation to hospital administration, health care
professional’s superior or other competent authority of purpose and
scope of interaction
5 14-­‐09-­‐2012 Eucomed Code of Ethical
Business Practice (II)
• Equivalence (remuneraton paid to consultants must represent fair
market value for services performed, no payment contingent upon
past or future prescription or purchase of goods)
• Documentation (written agreement, reference to research protocol)
France (I)
• Law on Strenghtening of Health Protection for Medicinal and Health
Products (“loi relative au renforcement de la sécurité sanitaire du
médicament et des produits de santé) of December 29, 2011.
• Enters into force on January 1, 2013
• Clear definition of advertising (all information aimed at promotion the
prescription, delivery, sale or use…). Usual carve outs (answering of
a particular question, labeling, instructions / precautions for use)
• Advertising must present the IVD, its functions, conformity to safety
and health requirements as defined by CE in an objective manner.
Encourage rational use of the product, not be disceptive and not
endanger public health (all same as for medicinal products)
• No explicit prohibition of advertising for non-CE marked IVDs.
6 14-­‐09-­‐2012 France (II)
• Unlike other medical devices, promotion to public of reimbursable
IVDs is allowed (other MDs: only when low risk and included on list of
Minister of Health). However, advertisements can not include
statements regarding reimbursement.
• Prior approval required by National Security Agency for Medicines
and Health Products (NSAMH) for promotion of IVDs which defect
is likely to cause a significant risk to human health and that are
included on a list of the Minister of Health. Approval may be granted
for a (renewable) period of 5 years
• Violation of new requirements are subject to administrative and
criminal santions: (a) administrative fine of 10% on turnover up to € 1
mio plus daily penalties, (b) criminal penalty up to 150K, up to 2
years prison, (c) publication, (d) temporary closing of facilities or
prohibition to manufacture
Germany (I)
• Medical Devices Act (Medizinproduktegesetz, MPG) 1995 does not
contain provisions for advertising medical devices (but for
implementation of 4.3 IVDD)
• German Medical Products Advertising Act (Heilmittelwerbegesetz,
HWG). Since 2001 clear that it also applies to medical devices
• Many provisions in HWG are ony applicable to medicinal products but
not to medical devices:
• No prohibition for public marketing of prescription-only medical
devices (§ 10)
• No prohibition for marketing of non-CE medical devices (§ 3a)
• No probition on use of images for medical devices (§ 11).
7 14-­‐09-­‐2012 Germany (II)
• The following provisions of HWG are applicable to medical devices
(§§ 3, 7 and 11.6-9, 11 and 12):
• No misleading commercials
• No gifts etc. unless of little value
• No foreign terms or professional jargon
• No statements that cause patients distress or fear
• No manipulative advertising claims
• No advertisement aimed at children under 14
• No letters of endorsement or recommendation
• Act against Unfair Competition (UWG)
Netherlands (I)
• No specific provisions in laws regarding promotion of medical devices
• no prohibition on promotion of non-CE IVDs
• No prohibition on promotion of prescription-only IVDs
• Act on Misleading and Comparative Advertising (artt. 6:194 ev DCC)
• Act on Unfair Business Practices (artt. 6: 193a ev DCC)
• Mainly arranged through Self Regulation
8 14-­‐09-­‐2012 Netherlands (II) Self regulation
• KOAG/KAG Code Public promotion of self-care medical devices
• Many provisions similar to HWG
• But: not applicable to IVDs (only to medical devices on a pharmaceutical basis with
a physical application, e.g. nail fungus cream, nose drops)
• Code of Conduct Medical Devices (January 1, 2012)
• Statements regarding medical devices in general:
• May in no way be misleading
• Must be accurate, up to date and truthful
• Must be correct and verifiable
• May not harm the accepted norms of good taste and decency
Netherlands (III) Self regulation
• Strict regulations on interactions between suppliers and health care
professionals
• Almost similar to the Eucomed Code
• Gifts (only when little value (<€50 incl. VAT and related to business of
healthcare professional)
• Service agreements (in writing, limited duration, consideration in line with
market practice, subject to approval of board institution/employer, no
payment contingent on past or future prescription or purchase)
• Financial contributions to meetings (<€500/meeting/pp, reasonable costs)
9 14-­‐09-­‐2012 On-line Sales of IVDs (I)
• Treaty on the Functioning of the European Union (TFEU)
• General principle: free movement of goods and services.
• Article 34: “Quantitative restrictions on imports and all measures
having equivalent effect shall be prohibited between Member
States”
• Article 36: “The provisions of articles 34 and 35 (export, CvdB) shall
not preclude prohibitions or restrictions on imports [..] justified on
grounds of […] the protection of health and life of humans […]
Such prohibitions or restrictions shall not, however, constitute a
means of arbitrary discrimation or a disguised restriction on trade
between Member States”.
On-line Sales of IVDs (II)
• EU Directive 2000/31/EC on certain legal aspects of information society
services, in particular electronic commerce (e-Commerce Directive)
• Only applicable to promotion and sale but not to delivery of goods
• Not applicable to services that can not take place at distance
• Article 3.12 Member States may not, for reasons falling within the
coordinated field, restrict the freedom to provide information society
services from another Member State
• Article 3.4: Member States may take measures to derogate from
paragraph 2 if they are
• necessary for, a.o. the protection of public health;
• proportionate to those objectives; AND
• Only after the member state has asked the “exporting” member
state to take measures which request was not rewarded; AND
• after the European commission has been notified of the intention
to take such measures
10 14-­‐09-­‐2012 Case Law ECJ (I)
• ECJ December 11, 2003 (Deutscher Apothekerverband vs. DocMorris)
• German legislation (Arzneimittelgesetz (AGM) and HWG) prohibited
offering for sale of medicinal products on-line or by post-order
• (a) for which no marketing authorisation in Germany was obtained;
and/or
• (b) for “pharmacists-only” medicinal products.
• DocMorris, a Dutch fully licensed pharmacist, offered medicinal
products on-line, also in Germany (in German language).
• Deutsche Apothekerverband requested injuction for violation of AGM
and HWG.
Case Law ECJ (II)
• Decision ECJ Deutscher Apothekerverband vs. DocMorris
• Offering for sale of medicinal products not yet fully harmonized
• Member states may, therefore, take local measures if not in violation
with 34 TFEU.
• German prohibition on on-line sales and post-order sales is a
measure ex art. 34 TFEU now that the effect is that products coming
from other member states are treated less favourable than domestic
products, even though the rules apply to all products (appliance of
criterium set in older ECJ case law)
• Such measures can be justified if necessary for protection of
human health (art. 36 TFEU) and proportionate.
11 14-­‐09-­‐2012 Case Law ECJ (III)
• Decision ECJ Deutscher Apothekerverband vs. DocMorris
• Prohibition for non-authorised medicinal products fully in line with
Directive 2001/83/EC, so not 34 TFEU measure
• Prohibition for prescription-only medicinal products is 34 TFEU
measure but justified to protect human health (proper check of
prescription)
• Prohibition for other “pharmacists-only” medicinal products in
violation of TFEU now that aim can be reached by less stretching
measures (so not proportionate)
Case Law ECJ (IV)
• ECJ December 2, 2010 (Ker-Optika)
• Hungarian law dictated that medical devices can only be sold at
specialist shops (with quality requirements attached to that).
Exception for certain medical devices but regulation applies to i.a.
contact lenses
• Ker-Optika offers contact lenses via its Internet set. Hungarian
agency prohibited that activity.
• Ker-Optika argued that Hungarian law provision is in violation of 34
TFEU and e-Commerce Directive
• Hungarian agency argued that (a) e-Commerce Directive is not
applicable, that (b) regulation is not a 34 TFEU regulation and that (c)
regulation is justified to protect human health
12 14-­‐09-­‐2012 Case Law ECJ (V)
• Decision ECJ December 2, 2010 (Ker-Optika)
• On-line sales of medical devices falls within scope of e-Commerce
Directive. Although physical examination may be required, that can
be separated from actual sales of contact lenses
• Regulations regarding offering for sale falls within e-Commerce
Directive
• Regulations regarding delivery of goods falls outside e-Commerce
Directive (but within scope of art. 34 TFEU, see DocMorris)
Case Law ECJ (VI)
• Decision ECJ December 2, 2010 (Ker-Optika)
• Regulation is proporpionate for first sale of contact lenses but is not
proportionate for follow-up orders of contact lenses (information and
advice can also be provided through internet)
• Not yet decided but conceivable that ECJ will sanction prohibitions of
internet sales of pre-scription medical devices only as being
proportianate (DocMorris)
• 13 14-­‐09-­‐2012 Consequences Ker-Optic
• Apps and stand alone software can be medical device.
• Software (that is sold and delivered through internet) is not a good but a
service
• Consequence:
• Both the sale and the “delivery” (downloading) of the software fall
within the scope of the e-Commerce Directive
Consequences Ker-Optic
• National measures can only be taken if:
• necessary to protect public health;
• proportionate; AND
• “exporting” member state does not implement requested
measures and European commission has been notified of
intention to implement measures
• Incentive for forum shopping
14 14-­‐09-­‐2012 • THANK YOU
• Carine van den Brink
• www.axonadvocaten.nl
15