FREQUENTLY ASKED QUESTIONS ON THE EUCOMED ETHICAL BUSINESS LOGO

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1 Rue Jseph II, 40 FREQUENTLY ASKED QUESTIONS ON THE EUCOMED ETHICAL BUSINESS LOGO Q1: What is the Eucmed Ethical Business Lg? A1: The Ethical Business Lg is a Lg licensed by Eucmed, the Eurpean medical technlgy industry assciatin, which can be btained by any medical technlgy manufacturing r distributing cmpany r prduct, distributr r healthcare related service rganisatin. A cmpany r rganisatin using the Lg has t cmmit t the fllwing three criteria: 1. Establishment and implementatin f written plicies and prcedures cnsistent with the Eucmed Cde; 2. Identificatin and appintmen a senir cntact persn respnsible fr the cmpliance with the Eucmed Cde and/r the cmpany's internal plicies and prcedures transpsing the Cde internally ("Cmpliance Officer"); 3. Prvisin f cmprehensive and regular trainings t emplyees n the Eucmed Cde r the Cmpany plicies transpsing the Cde internally. Hereinafter referred t as the Three Criteria. The Lg is based n the self-certificatin by the cmpany CEO, EMEA President (r equivalent). He/she certifies that his/her cmpany is cmmitted t the ethical standards embdied by the Eucmed Cde f Ethical Business Practice and has adequate gvernance in place demnstrating that his/her cmpany is in cmpliance with the Eucmed Cde. Q2: What is the purpse f the Eucmed Ethical Business Lg? What is its added value? A2: Eucmed and its members are cmmitted t prmte a culture f integrity and ethical business practices in all interactins between the industry and healthcare prviders. The Ethical Business Lg is a visual sign that shws the cmmitment f the licensed cmpany t the high ethical standards embdied by the Eucmed Cde f Ethical Business Practice. The Lg scheme: Increases visibility f ethical cmmitments. With the adptin f new anti-bribery laws in a number f cuntries, increasing enfrcement and new pressures cming frm scially respnsible investrs and the general public which frame the daily activities f any business, it has becme crucial fr rganisatins t prve their cmmitment t ethical principles. Strengthens public cnfidence in the integrity f the industry, and Prmtes clear and identifiable [Eucmed] ethical standards. With the Lg scheme, cmpanies and mre widely rganisatins, which have implemented a cmpliance gvernance can cmmunicate their determinatin t ban crrupt practices als prve in a cncrete, credible and psitive way that their effrts meet Eucmed standards. Prvides standard target bjectives fr cmpliance gvernance. In rder t btain the Lg, rganisatin plicies must meet certain best practices standards that are measurable and recrdable thrugh time. The lg has an initial effect f raising and frmalising standards within the rganisatin (t btain certificatin); it then creates incentives fr the rganisatin t maintain r, if best practices have evlved, reinfrce prcedures (necessary fr renewal). 1

2 Rue Jseph II, 40 Q3: Des the Ethical Business Lg certify an effective prgramme under the Freign Crrupt Practice (FCPA) r any ther legislatin? A3: N, this Lg is nt intended t certify an effective cmpliance prgramme under Freign Crrupt Practices Act (FCPA) r any ther natinal legislatin. Under FCPA, an effective cmpliance system is left up t prsecutrial discretin, even thugh the Office f the Inspectr General (OIG) Cmpliance guidelines, Department f Justice (DOJ) pinin prcedure, and Prsecutin Guidelines in the United States Attrney s Manual prvide sme guidance fr cmpanies as t the characteristics f an effective cmpliance system. Q4: Hw may I use the Eucmed Ethical Business Lg? A4: A cmpany that signed the Licence Agreement and self-certifies that the Three Criteria prvided under the Agreement are implemented may use the Lg n print r electrnic materials t illustrate their cmmitment t the ethical standards included in the Eucmed Cde. Fr example, they may print the Lg n annual reprts, prmtinal material, business cards, statinery and cnference banners and signs. Hwever, the Lg cannt be used in a manner r assciated with text which implies that Eucmed has endrsed r apprved a cmpany s prducts, technlgy r individual cmpliance plans r practices. Specific infrmatin n hw t use the Lg is prvided in the Brand Guidelines ensuring that it is used prperly, in particular with reference t clur and size. Q5: Why is there a pilt phase f the Ethical Business Lg? A5: The pilt phase f the Ethical Business Lg was launched in This intrductin phase f the Ethical Business Lg is designed t allw Eucmed t establish the brand at Eurpean level and assess sme practical aspects (e.g. the apprpriate fee, the interest by nn-members). The pilt phase is als imprtant in determining hw t strengthen the system and give it additinal credibility. As f March 2013, an independent third-party was asked t evaluate the prcesses by which Eucmed grants a lg t an rganisatin/cmpany requesting it. This verificatin aims at ensuring the credibility f the Ethical Business Lg system, designed t deliver real value and underpin stakehlder cnfidence. As f 1 July 2013, the self-certificatin system will be pen up t any medical technlgy manufacturers, distributrs r healthcare related service rganisatins. Q6: Wh can btain the right t use the Eucmed Ethical Business Lg? A6: During the pilt phase the Ethical Business Lg system is nly pen t the member cmpanies f Eucmed. As f 1 July 2013, the self-certificatin system is pen t any medical technlgy manufacturers, distributrs r healthcare related service rganisatins such as hspitals. The annual licence fee may hwever differ fr Eucmed members and nn Eucmed members. Q7: What is the applicatin prcess t btain the license t use the Eucmed Ethical Business Lg? 2

3 Rue Jseph II, 40 A7: The applicatin prcess t btain the licence t use the Lg differs depending n whether the applicant is a Eucmed r a nn-eucmed member. Q8: What is the applicatin prcess if yu are a Eucmed member? A8: The Applicant must return the cmpleted Cmpliance Questinnaire as well as their internal cmpany cde f cnduct (r equivalent) t the Eucmed Secretariat. The applicatin will nly be apprved when: Cmpliance Questinnaire is fully cmpleted; and Infrmatin prvided in the Cmpliance Questinnaire is clear; and Infrmatin prvided shws gvernance f cmpliance with the three applicatin criteria. The Secretariat apprpriately maintains recrds f all submitted dcuments. The Secretariat reviews the submitted questinnaire, including its cnsistency t ensure that there is n bvius infrmatin r pattern that indicates the pssible existence f an issue ("red flag") in the design f the training prgram r any ther elements f the three applicatin criteria. If infrmatin is incmplete r unclear, the Secretariat cntacts the applicant fr clarificatin and/r supprting dcuments. If the applicant fails t prvide the requested infrmatin within 60 days f the Eucmed request, the applicatin will be rejected. In any case, the Secretariat will always justify a refusal in writing and will include advice n hw t remediate and re-apply. If necessary, the Secretariat may fllw up the written cmmunicatin with a call r a meeting. Q9: What is the applicatin prcess if yu are nt a member f Eucmed? A9: In its applicatin, the Applicant must demnstrate that it has implemented the Three Criteria: Prvide supprting dcuments t the Secretariat: Cmpleted Questinnaire; Cmpany Cde f Cnduct Other dcuments demnstrating the implementatin f Criteria 1 (e.g. cpies f cmpany cdes (r equivalent), cmpliance prcedures, Standard Operating Prcedures etc.); Dcuments demnstrating the implementatin f Criteria 3 (e.g. recrds f such trainings etc.). A senir Cmpliance Officer (r equivalent) is t meet the Eucmed Secretariat facet-face in rder t discuss cmpliance cmmitment f the Applicant and specifically the Lg Scheme (Criteria 2). As mentined abve, als here the Secretariat maintains recrds f all submitted dcuments. The Secretariat examines all submitted dcumentatin and apprves the applicatin nly when: (a) the applicatin steps mentined abve are cmpleted; and (b) Cmpliance 3

4 Rue Jseph II, 40 Questinnaire is cmplete; and (c) dcuments adequately demnstrate the implementatin f Criteria 1 t 3. Eucmed can refuse the applicatin if: (a) supprting dcuments are cnsidered t be insufficient and the applicant fails t prvide sufficient dcumentatin within 60 days f the request; r (b) the review by the Secretariat indicates pssible existence f an issue ("red flag") in the design f the Cmpanies cmpliance prgram r any ther elements f the applicatin criteria. Eucmed cmmits t finalise the review within 20 wrking days. Eucmed may hwever, in case the number f applicatins is t high, agree with the Applicant t an extended timeline t review the applicatin. If the applicatin is refused, Eucmed will prvide a written justificatin. Q10: What shuld I d if my applicatin is refused? A10: If yu are a Eucmed member, yu may re-apply thrugh the applicatin prcedure applicable t nn-eucmed members (See Q&A9). If yu are a nn-eucmed member, yu may re-apply next year. Q11: Wh must execute/sign the Licence Agreement f the Eucmed Ethical Business Lg? A11: It is the Chief Executive Officer (CEO) r the highest ranking Eurpean r EMEA crprate executive having authrity ver the Eurpean peratins f the legal entity seeking the licence wh must sign the Licence Agreement, that will als be c-signed by the Cmpliance Officer, whse name will be published n the Eucmed website. Q12: What is the fee fr the use f the lg and hw much will it cst a cmpany? A12: The annual licence fee will depend n the glbal annual turnver f the rganisatin. The fee will be established as fllws: Glbal Annual Turnver (GAT) Eucmed cmpany member Nn-Eucmed member 25 mil < GAT mil < GAT 25 mil GAT 5 mil Eucmed reserves the right t change the abve-mentined fee fr granting the licence at any time. Q13: Wh is managing this self-certificatin system? Wh verifies that the different criteria are indeed implemented by users? A13: The Eucmed Secretariat will be managing the requests fr the Eucmed Ethical Business Lg. 4

5 Rue Jseph II, 40 In rder t strengthen the credibility f the self-certificatin system, designated t deliver real value and underpin stakehlder cnfidence, the Secretariat has established tw prcedures: the Quality Review prcedure and the Annual Renewal prcedure. Q14: What is the Quality Review Prcedure? A14: In rder t verify the cmpliance t the Three Criteria required t btain the Ethical Business Lg the Secretariat peridically reviews that certified member cmpanies cntinue t cmply with the Three Criteria. In particular, 20% f licensed Member cmpanies are systematically and impartially selected fr review each year. The review includes the fllwing steps (the Review Steps ): Eucmed t request frm selected cmpanies, within 60 days, t prvide supprting dcuments: Dcuments demnstrating the implementatin f Criteria 1 (e.g. cpies f cmpany cdes, cmpliance prcedures, SOPs etc.) Dcuments demnstrating the implementatin f Criteria 3 (e.g. recrds f such trainings, quantitative data, etc.) A senir Cmpliance Officer (r equivalent) f the cmpany t meet the Eucmed Secretariat (e.g. face-t-face meeting), if nt met in persn befre (Criteria 2). Additinally, an independent third-party will perfrm a quality review f a sample f Eucmed cmpleted verificatins t verify the prcesses by which Eucmed grants a lg t an rganisatin requesting it. Q15: What is the Annual Renewal Prcedure? A15: All certified cmpanies have t re-new the certificatin n an annual basis and update, if necessary, infrmatin prvided in the pervius year. The Secretariat will return t a renewing applicant its cmpleted questinnaire frm the previus year and request t prvide infrmatin n any changes that have been made in the previus year. In the event f any changes in the previus year, these shuld be submitted t Eucmed, including, if changed, its latest cde f cnduct (r equivalent). The Secretariat may als cnsider any public dmain adverse publicity and reserves the right t refuse r pstpne the use f the lg t a renewing applicant (e.g. pending the results f an investigatin). Q16: What if I ntice an abuse in r vilatin f the Eucmed self-certificatin system and its Ethical Business Lg? Hw can I ldge a cmplaint? A16: Any individual, cmpany, rganisatin can ldge a frmal cmplaint if they ntice an alleged abuse in r vilatin f the Eucmed self-certificatin system and its Lg. The frmal cmplaint must be ldged with the Eucmed Secretariat. Where the Secretariat cnsiders that the cmplaint warrants investigatin, it may frward the cmplaint fr the cnsideratin f the Eucmed Cmpliance Panel. Where the Panel rules that there is an abuse r vilatin f the Eucmed self-certificatin system and its Ethical Business Lg, sanctins will be impsed at the discretin f the Panel (e.g. withdrawal f the ethical business lg, written reprimand, publicatin f the Panel's decisin). Any cmplaints shall be handled in accrdance with the rules established by the Eucmed Cmpliance Panel Internal Prcedural Rules. 5

6 Rue Jseph II, 40 Q17: Is the Lg prtected (trademark)? A17: Yes, the Lg is prtected under trademark law. In case infringement f the registered trademark, Eucmed may cmmence legal prceedings fr trademark infringement t prevent unauthrised use f that trademark. Q18: Wh can I ask if I have any additinal questins n the Eucmed Ethical Business Lg? A18: Fr any cmment r questin cncerning the Eucmed Ethical Business Lg, yu may cntact Kristina Smailyte, Legal and Cmpliance Officer at Eucmed ). 6

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