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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
20
21
22
23
24
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%)
41
• 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
28
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
9
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
20
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
24
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 [email protected] “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
28
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)
31
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
40
Main Events 2017
41
Education – Training Calendar
42
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
44
Shift taking place at beMedtech
45
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
47
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)
48
49
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