PROMOTION AND SALE OF IVDS IN EU

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PROMOTION AND SALE OF IVDS IN EU Axon Seminar 12 September 2012 Carine van den Brink www.axonadvocaten.

1 PROMOTION AND SALE OF IVDS IN EU Axon Seminar 12 September 2012 Carine van den Brink 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

2 EU legislation on promotion of medicinal products Directive 2001/83/EC relating to medicinal products for human use Article 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

3 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

4 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

5 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

6 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, 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

7 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

8 Germany (II) The following provisions of HWG are applicable to medical devices ( 3, 7 and , 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

9 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

10 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

11 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

12 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

13 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 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

15 THANK YOU Carine van den Brink 15

on the advertising of medicinal products for human use

30. 4. 92 Official Journal of the European Communities No L 113 / 13 COUNCIL DIRECTIVE 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use THE COUNCIL OF THE EUROPEAN COMMUNITIES,