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TOGETHER WE IMPROVE PEOPLE'S HEALTH Shaping the Industry, Keeping the Patient First. www.mecomed.com Arwa Asiri CVS Compliance Officer 23 rd February 2017

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DID YOU KNOW MEDICAL DEVICES COMPANIES MEMBERS OF MECOMED COULD NOT HAVE BEEN PRESENT TODAY IF ARAB HEALTH WAS NOT COMPLIANT?

TOGETHERWE IMPROVE PEOPLE'S HEALTHShaping the Industry,Keeping the Patient First.

www.mecomed.com

Arwa AsiriCVS Compliance Officer23rd February 2017

arwa asiri (aa) -

Agenda

Mecomed - Who we are and what we do Key Facts about MedTech Industries in MENAMecomed membersCompliance within MecomedConference Vetting System- CVS

WHOWEAREMECOMED is the medical devices, imaging and diagnostics trade associationserving as the voice of international medical technology (MedTech) manufacturers forcountries across the Middle East and North Africa21

Mecomed aim to bring all healthcare stakeholders together to improve the quality of peoples health through the timely introduction of MedTech innovations, which ultimately benefits the MENA region community.

We foster good citizenship and promote ethical business behavior, working proactively with governments, regional bodies and healthcare professionals to deliver quality solutions for better patient outcomes.WHOWEARE

MENAMEDTECHMARKETKey Facts about MedTech in the Middle East and North Africa5 most common uses of medical devices in MENA

Imaging & DiagnosticsPatient SafetyVascularDisposablesOrthopaedics

MENAMEDTECHMARKETKey Facts about MedTech in the Middle East and North AfricaCirca 140,000Medtech employeesin MENA

650 Million population

MENAMEDTECHMARKETKey Facts about MedTech in the Middle East and North Africa

$7bnThe annual value of MedTech Marketin MENA$11bnThe expected MedTech market size by2021

MENAMEDTECHMARKETKey Facts about MedTech in the Middle East and North AfricaOur Stakeholders

PatientsHealthcareprofessionalsGeneral publicGovernmentsRegulatorsInsurance companiesMedTech companiesDistributors

OURMEMBERS2017

STEERINGGROUPSMecomed has six Steering Groups that serve distinct purposes:

LegalComplianceHR RegulatoryMarketingMarket AccessLeadership- Board members

STEERINGGROUPSCOMPLIANCEMembers Benefit from:The Conference Vetting System(http://www.ethicalmedtech.com) Established escalation process and successfulconflict resolution Instilling the Code of Ethics, based on principles of separation, transparency, equivalence and documentationAccess to defined minimum requirements for distributors due diligenceThe Group is Currently Working on

Updating Mecomed Code of EthicsDeveloping training modules for the Code of EthicsReaching out to the Authorities to get the Codes endorsement

Completing implementation for CVS for the third-party events to include booth, education grants etc.

Increased external scrutiny

CVS

ARE YOU COMPLIANCE READY?THE CONFERENCE VETTING SYSTEM

A unique initiative in the healthcare industry

HCPs actively participate in the research to develop new technologies

MedTechs Collaboration with HCPsThe MedTech industry and HCPs collaborate closely throughout several stages of the development and use of medical technologies.Need for industry to adhere to high ethical standards and to comply with all applicable rules, laws and regulations.

MedTech industryHCPs

This close collaboration is key to develop innovative technologies to treat patients

HCPs are trained on how to use technologies

The industry liaises regularly with HCPs to ensure that the technologies are updated and maintained

Two types of industry support to Third Party Organised Events

Direct sponsorshipEducational grantsIndirect sponsorshipCompanies select individual HCPs and financially support their participation to Third Party Organised Events.Companies provide educational grants to hospitals, medical societies and other third parties to support genuine medical education.

Such financial support typically covers some or all of the travel, lodging and registration costs of the HCP.These include educational grants provided to support HCP participation to Third Party Organised Event. HCPs are selected by the receiver of the grant.

CONFERENCEVETTINGSYSTEMCVSCVS reviews the compliance of third-party educational events with the Mecomed Code of Business Practice (the Code) to determine the appropriateness for companies which are members of Mecomed to sponsor Healthcare Professionals to participate in such events.CVS reviews International and Cross-Boarder third party educational conferences only.

UniqueDecisions are binding on Mecomed and MedTech Europe members.IndependentThe system operates independently with a separate website & visual identity:www.ethicalmedtech.comEligibilityMecomed & MedTech Europe corporate membersProfessional Conference organizersMedical societiesScopeAll cross-country conferences to which participants are coming from 2 or more of the countries in Mecomed geographical scope.

CVS Whats in it for me?Fair game to all members, Alignment. A Centralized system.A level playing field with the concept of equal chances to succeed and everyone plays with the same set of rules.

21ROLE OF THE COMPLIANCE PANELProvides guidance on interpretation of the Code;Handles complaints directly in various instances;Oversees the Conference Vetting System (CVS) in Europe and the Middle East:Supervises the Compliance Officers;Ensures treatment of requests in full compliance with competition rules;Hears appeals of C.O. decisions.

Independent Implementation of the Code

21

Two types of industry support to Third Party Organised Events

Direct sponsorshipEducational grantsIndirect sponsorshipCompanies select individual HCPs and financially support their participation to Third Party Organised Events.Companies provide educational grants to hospitals, medical societies and other third parties to support genuine medical education.

Such financial support typically covers some or all of the travel, lodging and registration costs of the HCP.These include educational grants provided to support HCP participation to Third Party Organised Event. HCPs are selected by the receiver of the grant.

The Conference Vetting System

20172018Objective To assess third-party events to determine the appropriateness for industry to directly support HCPs attendance.To assess third-party events to determine the appropriateness for industry to provide a grant and have commercial activities.(Indirect Sponsorship)

ScopeMiddle-East, North- Africa, Iran & PakistanMiddle-East, North- Africa, Iran & Pakistan

UniquenessMandatory submissions and binding decision to be respected by all Meomed members. Mandatory submissions and binding decision to be respected by all Meomed members.

Assessed criteriaGeo. Location, conference venue, accommodation, guest packages, hospitality, scientific programme, communication support.Geo. Location, conference venue, accommodation, guest packages, hospitality, scientific programme, communication support, speakers, booth.

The Conference Vetting System

IF THESE ARE COMPLIANT:

Geographic location

Conference venue

Proposed accommodation

Scientific programme

Guest packages

Social Programme

CommunicationYOU WILL GET

AN ETHICAL LABEL MEDICAL INDUSTRY REALLY VALUES!

KEYCONTACTS

Rami [email protected] NadelwaisExecutive [email protected] AsiriCompliance Officer CVS- [email protected]+971555637973

www.Mecomed.comwww.ethicalmedtech.com