Algemene Vergadering

Assemblée Generale

1

Welkom – Bienvenue!

9th May 2017

Agenda

2

Agenda

• 14:00 – 15:00 Info session: The new European Regulations regarding medical devices and IVD and their impact on companies

• 15:00 – 15:30 Break

• 15:30 – 17:00 Statutory Part:▪ Financial Results 2016 & Budget 2017

▪ Report of Auditors

▪ Update Articles of Association

▪ Update Ethics & Compliance – Survey and betransparent.be

▪ Update Pact

▪ Main events 2017

▪ Acceptance New Members

• Friendship Drink

3

The new European Regulations regarding medical devices and IVD and their impact on companies

Mr. Annabelle Bruyndonckx – Simmons & Simmons

4

Financial Results 2016 & Budget 2017Paul Soenen

5

2016 Performance

6

kEUR2015

AC2016AC

2016 BUD

Diff. actualsvs BUD Comments

NET REVENUES 1.346 1.407 1.455 -48

Memberships 1.157 1.168 1.180 -12

Net Revenues from Activities(rev.-costs)

221 227 270 -43 Lower revenues Databank (-50k)

Other revenues -32 12 5 +7

FIXED COSTS -1.376 -1.462 -1.455 +7

Personnel costs -1.084 -1.154 -1.155 -1 Including ~70k for transition/new Director

Office costs -172 -182 -167 +15 Underestimated electricity costs (-10k)

Others costs -120 -126 -133 -7

NET PROFIT -30 -55 0 -55 Without transition/new Director: +15k profit

2017 Budget

7

kEUR2016

AC2017BU

Diff. 2017 vs 2016 Comments

NET REVENUES 1.407 1.472 +65

Memberships 1.168 1.230 +62+5% increase in membership fee(fixed cost ‘coverage ratio’ from 80% to 90%!)

Net Revenues from Activities(rev.-costs)

227 242 +15

Other revenues 12 0 -12

FIXED COSTS -1.462 -1.363 -99

Personnel costs -1.154 -1.074 -80 No more transition/new Director

Office costs -182 -160 -22 Building rent renegotiation

Others costs -126 -129 +3

NET PROFIT -55 +109 +164 - Very solid/reliable/predictable upside

Auditor Statement 2016 Ernst & Young

8

Ethics & Compliance Update

9

Update Articles of AssociationPaul Soenen

10

New Board Member

• Nadia Aelbrecht (Biomerieux) to replace Guy Stukkens

11

Feedback around Direct Sponsoring (Survey)

12

www.medtecheurope.org

MedTech EuropeCode of Ethical Business PracticeBeMedTech InfoDay, 27 March 2017

www.medtecheurope.org

HCPs are trained on how to

use technologies

The industry liaises

regularly with HCPs to

ensure that the

technologies are updated

and maintained

HCPs actively participate in

the research to develop

new technologies

This close collaboration is

key to develop innovative

technologies to treat

patients

MedTech

industryHCPs

The MedTech industry and

HCPs collaborate closely

throughout several stages of

the development and use of

medical technologies.

MedTech industry’s special relationship with HCPs

4

www.medtecheurope.org

0

Harmonisation of requirements

worldwide

Potential prevention of new

laws – stringent self-regulation

Transparency will not end DS

challenges by media

and judicial authorities

Reduce

compliance/bribery risks –

unilateral transfer of value

Uphold value and

promote responsible

industry image – Key priority

Industry’s behaviour must respect

high ethical standards & values

5

www.medtecheurope.org

Companies 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.

“Direct sponsorship”

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.

“Educational grants”

Two types of industry support to Third Party Organised Events

8

www.medtecheurope.org

2016 1/1/2017

Transposition of the code by

companies

Companies collect data for disclosure

+

NAs: 1st report on implementation

strategy & plan

Companies start disclosing

+

NAs to report on progress

New Code comes

into force

1/1/2018

End of Direct

Sponsorship

1/1/2020

Transposition at

national level

Timelines for National Associations & Corporate Members

14

Survey

• Replied:71 out of 207 (34%)

• Q1: We are not concerned by this topic, as we do not provide support to Belgian HCP's for their attendance at third party educational events, neither directly nor indirectly:

• Q2: We are in favor of a ban on all types of support to Belgian HCP's for their attendance at third party educational events, both directly and indirectly:

• Q3: We are in favor of the ban on direct sponsorship, in light of protecting the reputation of our medical industry, and we accept the implications of moving to an indirect sponsorship:

• Q4: We are in favor of the ban on direct sponsorship, provided that the framework around indirect sponsorship can be clarified and improved:

• Q5: We are not in favor of the ban on direct sponsorship for Belgian HCP's, as there is a good framework for direct sponsorship upstream (via the Mdeon procedure) and downstream via betransparent.be:

18

3

6

5

15

42

4%

9%

7%

21%

59%

Course of Action decided by Board 28/4

• Share Results with General Assembly

• Communicate to MedTech Europe: beMedTech will not implement the ban on Direct Sponsorship for the “non-corporate” members before 1/1/2020

• Work with FAGG to smoothen the visa procedure and solve the potential liability issues for the indirect sponsoring

• Encourage MedTech Europe to work with EFPIA to converge on Code

19

beTransparent.be

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21

22

23

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Betransparent.be situation on May 8th

• No transfers made in 2016: 42

• Final upload: 126

• Login only: 13

• No reaction: 28

25

209

168 (80%)

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• May 15th: Letter from President and Director to ask remaining companies to comply, between July 1st and July 10th.

• In case of no compliance: request to appear before our ad hoc Ethical Commission

• Joint communication of beTransparent.be in June, together with pharma.be, Febelgen.

26

beTransparent.be – Course of Action

Pact Update

27

Governance of Pact

• Steering Committee:▪ Cabinet – Augustin Coppee

▪ FAGG – Richard Van den Broeck, Katrien Martens

▪ INAMI/RIZIV – Marleen Louagie

▪ beMedTech – Paul Soenen, Marnix Denys

• Meets every 6 weeks, agenda set by Cabinet, points can be added

• Objective is to monitor Pact and look at bottlenecks, issues, decisions

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MDR & IVDR Revision, Implementation• Date last interaction: FAGG, Cabinet, May 3rd

• Latest Status:▪ Final vote in EU on 5/4/2017

▪ Published on May 5th

▪ Enters into force 20 days later

▪ The transitional periods of 3 years (MDR) and 5 years (IVDR) will start then

• Main Conclusion:▪ Unclarity on certain points (implementing acts, UDI, …)

• Action Point beMedTech▪ Infosession on 9/5 for BeMedTech members

▪ Participating in working group around Belgian reprocessing rules. WG to be defined by FAGG

▪ 23/5 infosession FAGG around “ Implementing Acts”

1

OBJECTIVE CHECK

Major Concern No

bMT Owner

Koen Bruylant

Board Owner

TIME CHECK

Started? YES

End 2020 & 2022

On Track? Yes

RISK

Reprocessing Rules in B

Autocontrole + Webportal FAMHP

• Date last interaction: Round III concertation on Monday 24th of April, 2017

• Latest Status:▪ (Continuous) Follow-up progress development auto control (project) and

webportal

• Next Steps:

▪ Testing non-notified distributors and export companies Q2 – 2017

▪ Testing retailers, HCP (distributors) and HTSA* Q3 – 2017

▪ Testing manufacturers* Q4 – 2017

• Main Conclusion: Makes more targeted inspections possible, based on risk-analysis and Good Distribution Practice

• Action Point beMedTech

▪ Monitoring deadlines and work on framework around shared responsibility

2bMT Owner

Hans Hellinckx

Board Owner

TIME CHECK

Started? YES

End

On Track? NO

OBJECTIVE CHECK

Major Concern No

* = registration

RISK

Weak Co-Responsibility

Distribution channels

• Date of last interaction with stakeholders: 24/04/2017

• Latest status▪ MD => Free trade of goods (in the European Union)

▪ Except MD that follows classification rules 8,14 & 21

▪ HCP: access to all MD (in function of their profession)

• Next Steps

▪ FAGG will try to make a final proposition (Deadline Q4 2017)

• Main Conclusion: Every stakeholder has a different opinion; new distribution channels ≠ new reimbursement channels

• Action Point beMedTech

▪ Give feedback on their new proposition (before 15/5/2017)

▪ Follow up KB “depot”

2 bMT Owner

Karel Verlinde

Board Owner

TIME CHECK

Started? YES

End Q4 2017

On Track? Yes

OBJECTIVE CHECK

Major Concern No

Home care

• Date of last interaction with stakeholders: 24/4/2017

• Latest status▪ Feedback White Paper “STHA”: FAGG will use our paper to start discussions

with the different stakeholders (RIZIV, APB, OPHACO, Zorgnet VL, Santhea, …)

▪ Start of pilot projects Acute Care (Antibiotic treatment @home)

• Next Steps

▪ Create guidelines for the STHA

▪ Stakeholder meeting (Q4 2017)

• Main Conclusion: on track but still a long way to go (STHA-guidelines: Q1 2018)

• Action Point beMedTech

▪ Make final remarks on the white paper (deadline 8/5/2017)

▪ Follow-up of the pilot projects

3 bMT Owner

Karel Verlinde

Board Owner

J. Ravelinghien / G. Calviac

TIME CHECK

Started? YES

End Q1 2018

On Track? Yes

OBJECTIVE CHECK

Major Concern No

Working Group Budget and Evaluation of Medical devices• Date of last interaction with stakeholders: Steering committee

on May 3rd

• Latest status for INAMI▪ No information on working group yet

▪ Request for 8.6 mio savings on budget implants – no opening for transversal savings

• Next Steps▪ Continuous follow up through steering committee and INAMI

• Main Conclusion: Approach INAMI is unclear

• Action Point beMedTech▪ Follow up on agreement with INAMI to have monthly 1-1’s on status

8 bMT Owner

Marnix Denys

Board Owner

Paul Soenen

TIME CHECK

Started? YES

End Continuous

On Track? ?

OBJECTIVE CHECK

Major Concern May be

RISK

No Transparency – bad outcome

3D printing

• Date of last interaction with stakeholders: 10/4 KCE

• Latest status▪ KCE to investigate situation and write report

▪ KCE has visited bMT ( 13/3 ) to inform concerned companies (open bMT meeting)

▪ bMT survey to all companies + results to KCE

▪ Individual contacts with KCE open + WG 3D within bMT to monitor next steps

• Next Steps

▪ Open communication KCE <-> bMT <-> bMT members <-> KCE

▪ Report planned for oct-nov 2017

• Main Conclusion : Report = good starting point …..

• Action Point beMedTech

▪ Monitor & help KCE

▪ Next steps end 2017 will depend on conclusions in the report

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RISK

Negative report, orReport = endpoint

bMT Owner

Wim Vandenberghe

Board Owner

Bram Smits

TIME CHECK

Started? YES

End Continuous

On Track? ?

OBJECTIVE CHECK

Major Concern No

Reform CRIDMI

• Date of last interaction with stakeholders: 18/4 IRREQ meeting RIZIV

• Latest status

▪ Mandatory Evaluation of CRIDMI has finished

▪ 1 evaluation point (= problem solving IRREQ) is taken care of

• Next Steps

▪ Implementation Plan of the optimizations: No clarity yet

• Main Conclusion

▪ Slow but some improvement is made

• Action Point beMedTech

▪ Continue the work -> Evolution not revolution

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TIME CHECK

Started? Y

Expected Finish 2018

On Track? ?

bMT Owner

Wim Vandenberghe

OBJECTIVE CHECK

Major Concern No

RISK

Only Evaluation, no reform

Board Owner

Reimbursement procedure IVD• Date of last interaction with stakeholders: April 19, 2017

(Moens) , 26/4/2017 De Ridder, Louagie, steering committee May 3rd

• Latest status▪ 2 procedures

➢ IVD tests

➢ Companion Diagnostics

• Next Steps▪ Royal decree Art. 33 ter (CDx)

• Main Conclusion▪ Evolution IVD reimbursement procedure unclear, no information, no

communication

▪ Procedure CDx on track

• Action Point beMedTech▪ Planning meetings RIZIV

➢ Structural meeting INAMI (Louagie)

➢ Anouk Waeytens

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TIME CHECK

Started? Yes

Expected Finish 2019

On Track? ?

OBJECTIVE CHECK

Major Concern? Yes

bMT Owner

Jules Verrooten

RISK

Huge Delay

Board Owner

Alex Lefevre

Optimisation TRDVM - CTMDS• Date of last interaction with stakeholders: 26/4/2017 (Ri De Ridder)

• Latest status▪ 08.02 Francis.Arickx@riziv.fgov.be “Op dit moment zijn we intern de

principes en procedures verder aan het uitwerken en detailleren, en overleggen we met het Kabinet over de gewenste uitkomst. Zodra we van de Beleidscel een akkoord hebben organiseren we het overleg met alle stake-holders, inbegrepen verzekeringsinstellingen, zorgverstrekkers en industrie (vermoedelijk april/mei). Hartelijk dank alvast voor uw engagement hierin.”

▪ 17.03 Status Planning réalisation volgens Steering Group réalisation INAMI: Finalisation AR Q3 2017, Adaptation du nom Q2 2017

▪ 25.04 Mijn verontschuldigingen voor het late antwoord, gezien bijzonder overladen agenda’s, en we zullen hier zo snel mogelijk op terugkomen. Ik ben bereid om een verder overleg te organiseren relatief korte termijn. We bekijken wat mogelijk is.

• Next Steps▪ Set structural meeting with Marleen Louagie▪ Kick off meeting Riziv-beMedTech before summer

• Main Conclusion: Unclear what’s really happening

• Action Point beMedTech▪ Elevate with Cabinet – Done on May 3rd

▪ Structural Meetings are set up with INAMI

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TIME CHECK

Started? Yes

Expected Finish 2018

On Track? ?

bMT Owner

Hadewijch Van Hoeij

OBJECTIVE CHECK

Major Concern? May be

RISK

Nothing happens

Board Member

Hadewijch Van Hoeij

• Date of last interaction with stakeholders: Multi-stakeholder meeting:

Cabinet, FPS Health (data management), BELMIP + beMedTech on Friday

28th of April, 2017: monitoring register – innovation – protocol 2.0

• Latest status for Cabinet and FPS Health: (Continuous) Follow-up Total

Installed Base (TIB) and New Installations (NI) heavy medical equipment

• Next Steps: Main Conclusion: All beMedTech member companies are

compliant regarding checking of TIB and NI’s heavy medical equipment

• Action Point beMedTech: ▪ Follow-up Federal Moratorium on heavy medical equipment (“replacement policy”)

▪ Involvement in new innovation projects

TIME CHECK

Started? YES

Expected Finish 2017

On Track? YES

bMT Owner

Hans Hellinckx

Registry Heavy Medical Equipment 29

Board Owner

Geert De Gucht

OBJECTIVE CHECK

Major Concern? No

RISK

Economic Impact on Firms

Mobile applications

• Date of last interaction with stakeholders: 26/4/2017 (Ri De Ridder)

• Latest status▪ May 2017: start of 24 pilot projects

▪ Autocontrole: Digital Health-proposition

• Next Steps

▪ Follow-up meeting with FAGG: proposition 2.0

• Main Conclusion: on track but everyone is waiting on the results of the pilot projects

• Action Point beMedTech

▪ Push Autocontrole proposition

▪ Follow-up of the pilot-projects

▪ beMedTech symposium: publication of the Position Paper + new members (spin-offs & companies who are involved in the 24 pilot projects)

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TIME CHECK

Started? Yes

Expected Finish Q1 2018

On Track? Yes

OBJECTIVE CHECK

Major Concern? No

bMT Owner

Karel Verlinde

Conclusion after 7 months

• Projects with FAGG are (more or less) on track

• Projects involving RIZIV/INAMI need additional attention/efforts from beMedTech and Cabinet▪ Action is taken: structural 1-1 between Riziv and beMedTech have

been set up

• Cabinet is driving force, remains ambitious

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Main Events 2017

41

Education – Training Calendar

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Education & Training Calendar

• Algemene wetgeving medische hulpmiddelen La législation générale des dispositifs médicaux

• Productliability

• Financing of hospitals in Belgium 1 & 2

• Stralingsbescherming/ Radioprotection

• Workshop UDI, with GS1

• Extern personeel in het operatiekwartier Personnel externe au Quartier Opératoire

43Please contact Leen Pauwels for more information and registration!

18 Sept 2017

28 Sept 2017

5 & 19 Oct 2017

TBD

TBD

TBD

Main Events

• Symposium on Nosocomial Infections 10 October 2017

• Digital Health Symposium November 2017

• Strategy & Positioning Workshop Fall 2017(for Board Members)

• Next General Assembly 14 November 2017

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Shift taking place at beMedtech

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Services

Policy Making

2016

beMedTechCapacity

2017 Pact execution

Pact drafting

Just some questions to reflect on

• Who is our customer?

• What’s our core-business?

• What else can provide value to our customers?

• What are our main messages?

• Do we stay below the radar?

• What about Digital Health?

• Do we have the right structure?

• Do we partner with other federations? (VOKA, BioWin, Agoria,LifeTech Brussels…)

46

New Members

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2017 New Members

• Arjohuntleigh NV Medical Consumables (Reva)

• Dormoco BVBA Medical Consumables (Respi)

• OneLife Medical Consumables (Infect, Start Up)

• Sprofit bvba Medical Consumbales (Ort)

• Mainstay Medical Distribtion Ltd Implants (Neuro)

• Norgine NV Implants (Gen)

• CADskills BVBA Implants (Start up)

• Qompium NV Extra Muros (Digital Health)

• BBIG Medical Equipment (RadioFarmaca)

• BXTAccelyon Ltd Medical Equipment (Imb)

• Fresenius Medical Equipment (Dialyse)

• SkylineDX IVD (Start up)

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Thank you!

Back Up

50

BeMedTechVZW

Jaarrekening 31 december 2016

Raad van Bestuur, 28 april 2017

Inhoudstafel

1. Balans

2. Resultatenrekening

3. Cash Flow Statement

4. Aandachtspunten

5. Audit verklaring

Balans

Actief 2016 2015

Immateriële vaste activa 17.852 13.038

Materiële vaste activa 1.273 2.847

Financiële vaste activa 23.169 23.167

Vorderingen op minder dan 1 jaar 89.294 87.535

Geldbeleggingen 2.860 7.899

Liquide middelen 73.753 72.062

Overlopende rekeningen 32.687 31.247

Totaal Actief 240.888 237.795

Passief 2016 2015

Bestemde fondsen 100.000 100.000

Overgedragen verlies -157.489 -101.985

Schulden op meer dan 1 jaar - -

Schulden op ten hoogste 1 jaar 298.377 239.481

Overlopende rekeningen 0 299

Totaal Passief 240.888 237.795

Resultatenrekening

Resultatenrekening 2016 2015

Bedrijfsopbrengsten 1.563.317 1.555.229

Diensten en diverse goederen - 813.666 - 766.827

Brutomarge 749.651 788.402

Bezoldigingen, sociale lasten en pensioenen - 788.067 - 800.479

Afschrijvingen en waardeverminderingen op MVA - 15.836 - 17.395

Waardeverminderingen op vlottende activa 0 + 367

Voorzieningen voor risico's en kosten - -

Andere bedrijfskosten - 147 - 402

Subtotaal kosten -804.050 -817.909

Bedrijfsresultaat -54.399 - 29.508

Financiële opbrengsten 133 498

Financiële kosten - 1.238 - 936

Resultaat van het boekjaar - 55.504 - 29.946

Cashflow statement

Cashflow 2016

Resultaat van het boekjaar -55.504

Plus niet kaskosten

Afschrijvingen en waardeverminderingen 15.836

Gegenereerde cash flow uit operaties (1) -39.668

Besteding middelen

Investeringen vaste activa -19.076

Financiële vaste activa -2

Vorderingen op minder dan 1 jaar (excl. Waardeverminderingen) -1.759

Overlopende rekeningen actief -1.440

Overlopende rekeningen passief -299

Totaal besteding middelen (2) -22.576

Herkomst middelen

Schulden op ten hoogste één jaar 58.896

Totaal herkomst middelen (3) 58.896

Totaal herkomst middelen (2)+(3)=(4) 36.320

Netto Cash flow (1)+(4) -3.348

Mutatie liquide middelen en geldbeleggingen -3.348

Aandachtspunten

1. Geactiveerde kosten website Compendium

▪ Voorbereidende werkzaamheden (haalbaarheidsstudie) inzake database voor medical devices

▪ Geactiveerd bedrag = € 15.402▪ Afschrijving over periode van 3 jaar▪ Uitvoering van het project staat op vandaag niet vast doch wel intentie om

dit voort te zetten

2. Afgrenzing kosten en opbrengsten

▪ Opvolging tijdens het boekjaar teneinde materiële correcties per jaareinde te vermijden

Aandachtspunten

3. Bestemde fondsen/over te dragen verliezen

▪ verlies 2016 tbv € 55.504✓ resultaat 2016 negatief beïnvloed door volgende niet-recurrente kosten:

• Kosten aanwerving nieuwe directeur • Vergoeding directeur tijdens periode van overdracht

▪ over te dragen verliezen, na bestemming verlies 2016, overschrijden de bestemde fondsen

4. Budget 2017

▪ Genomen maatregelen✓ Verhoging ledenbijdragen ✓ Hernegotiatie huurovereenkomst

Audit verklaring

Verklaring zonder voorbehoud, onder voorbehoud van goedkeuring van de jaarrekening door de raad van bestuur