Embed Size (px)
Citation preview
Information
Session
Sunshine Act
WELCOME !
Marc-Henri CornélyChairman of Mdeon
2
AGENDA
CONTENT
✓ Platform betransparent.be
✓ From selfregulation to Sunshine Act
✓ Sunshine Act Goal
✓ Sunshine Act Scope
✓ Nominative publication
✓ Privacy
Q&A’s
3
NOTIFICATION
✓ Registration on betransparent.be
✓ Preparation of the file to notify
✓ Notification procedure
✓ Rectification procedure
✓ Demonstration
TRANSPARENCY REGISTER
CONTROL & SANCTIONS
COMMUNICATION
Q&A’s
! Slides are available in
pdf on the homepage of
betansparent.be !
4
CONTENT
✓ Platform betransparent.be✓ From selfregulation to Sunshine Act✓ Sunshine Act Goal✓ Sunshine Act Scope✓ Nominative publication✓ Privacy
betransparent.be
Platform
Stéphanie Brillon Mieke Goossens Director Mdeon Management Committee BTB
5
Agreement by Royal
Decree d.d. 31.07.2017
Platform betransparent.be 26 associations
Industry Medical Pharmacists
Veterinary Paramedical Hospital technicians
Nurses Wholesalers Physiotherapists Dental
6
From
Selfregulation to
Sunshine Act
7
Law France
From selfregulation to Sunshine Act
Sunshine Act
Law Denmark
Law RomaniaLaw Slovakia
2010 2011 2013 2014 2015 2016 2017
Law Portugal
BELGIAN
SUNSHINE ACT
18.12.2016
ROYAL DECREE
SUNSHINE ACT
14.06.2017
Royal Decree
RECOGNITION
Mdeon
31.07.2017
8
All the pharmaceutical/medical
devices companies
Only the pharmaceutical/medical device
companies members of
Building Transparency
in Healthcare Relationships
From selfregulation to Sunshine Act
Publication 2016
Data 2015
Publication 2017
Data 2016
Publication 2018
Data 2017
9
Sunshine Act
Goal
10
Sunshine Act Goal
PREMIUMS
& BENEFITSIndustry
Healthcare
professionals
Healthcare
organisations
Patient
organisations
Respond to
societal demand
Transparency of
interactions
Trust
11
Sunshine Act
Scope
12
✓ Companies subject to notification
✓ Beneficiaries of premiums and benefits
✓ Premiums and benefits
Sunshine Act Scope
Companies subject to notification
◦ Art. 41, §1, 1°, Sunshine Act: “Any entity that carries out an economic activity,
irrespective of its legal form and the manner in which it is financed, as referred to in Title
VII of the Treaty concerning the functioning of the European Union, more specifically
HOLDERS of placing on the market of medicinal products for human or veterinary use,
IMPORTERS, MANUFACTURERS and DISTRIBUTORS of medicinal products for human or
veterinary use, persons engaged in the brokering of medicinal products for human or
veterinary use, and distributors, retailers and manufacturers medical devices”
◦ = all the pharmaceutical and medical devices companies
◦ Established in Belgium or abroad
◦ Even if no product on the Belgian market !!!
◦ Even if no premium or benefit granted to HCP/HCO/PO
13
Sunshine Act Scope
Beneficiaries of premiums and benefits
HealthCare Professionals
(HCP)
HealthCare Organisations
(HCO)
Patient Organisations
(PO)
Doctor / Dentist / Nurse /
Paramedic / Veterinarian /
Hospital director / etc.
With (main) practice
in Belgium
See list of professions in our
Practical Modalities
Hospital / Medical practice /
Scientific association / PCO
Faculty of medicine / etc.
With seat or fixed place
in Belgium
Also umbrella associations
grouping several patient
organisations
With seat or fixed place
in Belgium
14
See definitions in art. 1
Sunshine Act (+RD)
Sunshine Act Scope
Premiums and benefits
HealthCare Professionals
(HCP)
HealthCare Organisations
(HCO)
Patient Organisations
(PO)
Fees, payment and reimbursement of costs for SERVICES AND CONSULTANCY
Contributions to PARTICIPATE
in SCIENTIFIC EVENTS
Contributions to ORGANISE
SCIENTIFIC EVENTS
DONATIONS AND GRANTS
that support healthcare
Financial or other SUPPORT
SCIENTIFIC RESEARCH
15Pecuniary or in kind
Directly or indirectly offered
Nominative
publication
16
Nominative publication
RULE: the premiums and benefits – granted directly or indirectly - are
disclosed on behalf of the beneficiary
on an individual basis
EXCEPTION: premiums and benefits granted in the context of scientific
research are disclosed on an aggregate basis
Experiments on the human person (includes clinical trials, prospective non-
interventional studies)
Clinical trials with veterinary medicinal products
Non-clinical studies as defined in the OECD Principles on Good Laboratory
Practice (“Non-clinical health and environmental safety study, henceforth referred to simply as "study", means an
experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to
obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities”)
Data disclosed annually on betransparent.be
Data remain online for a period of three years, after
which they will be erased 17
Nominative publication PO
E.g. :
• Support to organise
info day for patients
• documentation for
patients
18
Nominative publication HCP - fees
E.g.:
• Lectures
• Advisory boards
• Scientific articles
• …19
Nominative publication HCP congress
By 31.12.17
Identity
20
Nominative publication HCO - fees
! If no
retrocession
to HCP
21
Nominative publication HCO - congress
!!! If HCO uses funds to pay
hospitality to HCPs
disclosure at HCP’s name
22
Nominative publication HCO - grants
23
Nominative publication
Obligation to collaborate
for the beneficiaries
Communicate data
required for publication
24
- Unique ID’s
- Nominative list of
indirectly
sponsored HCPs
- Etc.
Sunshine Act: info session,
Data protection aspects
Annabelle Bruyndonckx,
Counsel, Simmons & Simmons
12 September 2017betransparent.be, Woluwe-Saint-
Lambert
11 September 2017. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.© Simmons & Simmons LLP
26
Sunshine Act: info session | Data protection aspects
Processing HCP’s personal data
Required to ensure compliance with a legal obligation to which data controllers
are subject (and no longer with industry codes, which are of an ethical or
deontological nature)
Obtaining the HCPs’ consent prior to the processing of their personal data
is no longer required
Before 1 January 2017 After 1 January 2017
Obligation to obtain
consent from HCOsNo No
Obligation to obtain
consent from HCPsYes No
HCPs’ refusal to
provide consentDisclosure in aggregate
Irrelevant
(refusal may be overridden)
Obligation to inform
HCPsYes Yes
11 September 2017. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.© Simmons & Simmons LLP
27
Sunshine Act: info session | Data protection aspects
Information requirement when personal data are obtained – GDPR
Content of information notice (check-list)
▪ Identity + contact details of the controller, data protection officer (and where
applicable controller’s representative)
▪ Purposes of the processing (publication on betransparent.be) + Legal basis (Act of
18 December 2016 and RD of 14 June 2017)
▪ Recipients or categories of recipients of the personal data (Mdeon, FAMHP, the
general public)
▪ 10-year retention period (whereas data are publicly disclosed during 3 years)
▪ HCPs’ rights (data access, data rectification / erasure, data portability, restriction of
processing, right to lodge a complaint with the Belgian Privacy Commission or any
other competent authority)
▪ Acknowledgement that (i) the provision of personal data is a statutory requirement,
(ii) the HCP is obliged to provide the personal data, and (iii) failure to provide such
data may result in a fine
11 September 2017. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.© Simmons & Simmons LLP
28
Sunshine Act: info session | Data protection aspects
Security Advisor
HCP without NIHDI no. or having several NIHDI nos.
Identification via HCP’s national registration no.
Triggers currently a strict legal regime, with an obligation
to obtain an authorisation from the BPC’s Sectoral
Committee for the national register
Compliance with the current general BPC authorisation
implies that companies subject to disclosure nominate a Security Advisor
▪ Consulent voor de veiligheid en de bescherming van de persoonlijke levenssfeer /
Conseiller en sécurité de l’information et en protection de la vie privée
▪ Route to comply with the current general BPC authorisation
(Guidelines: link – betransparent.be)
New Deliberation coming end September FOLLOW UP!
▪ Security rules will probably be much easier than under the autoregulation system
▪ Foreign companies can use NRN
Current regime
General authorisation
provided by BPC
Decision (RN no. 51/2015
of 2 September 2015)
– to be reviewed –
Key takeaways
Sunshine Act: info session | Data protection aspects
4
Consent No longer necessary
▪ Interaction with HCPs for the first time
Collect all necessary data on time (and by 31/12/2017 at the latest for
the first reporting period)
Inform HCPs in line with data protection laws when collecting their data
▪ Interaction with known HCPs (personal data previously collected)
Information requirements remain applicable – however, the information
to be provided is extended under the GDPR
Add / update data protection clauses in agreements with HCPs
Follow up new Deliberation Privacy Commission
© Simmons & Simmons LLP 2017. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.
Thank you for your attention
Questions ?
Key Contact
Annabelle Bruyndonckx
Counsel
T +32 254 209 64
E annabelle.bruyndonckx
@simmons-simmons.com
Key Contacts
Follow us on Twitter @Simmons_LLP
Q&A
31
32
NOTIFICATION
✓ Registration on betransparent.be
✓ Preparation of the file to notify
✓ Notification procedure
✓ Rectification procedure
✓ Demonstration
33
Registration on
betransparent.be
34
Registration on betransparent.be
Homepage: “I am a company”
Create one account per company:
◦ Choose login (e-mail) + password
◦ 1 account per legal entity and per country
= 1 account per VAT-number
◦ Companies outside EU affiliate or legal representative
Acknowledgement of receipt of registration’s
application by email + activation link
Activate the account (via the provided link)
Wait for the validation of your account by
betransparent.be (confirmation by email)
35
Preparation of the
file to notify
36
Preparation of the file to notify
Use (new) Flat Template downloadable from the Extranet
Format: Excel or csv file
Content file: 1 line per beneficiary per year
Nominatively (! no more anonymously)
Exception: scientific research
One total amount per category
In EURO, excluding VAT
Disclosure year = year of the financial transaction
Always respect the Technical Modalities as well as the following legal notification modalities
(see Chapter 3 of the Royal Decree implementing the Sunshine Act)
37
Preparation of the file to notify
Flat Template
38
Keep the 4 lines of title
Fill the file in from line 5
Preparation of the file to notify
Type of beneficiary / Premium - Benefit
HCP = healthcare professional
HCO = healthcare organisation
PO = patient organisation
RD = scientific research
NPB = no premiums nor benefits granted
(empty file)
39
Preparation of the file to notify
Flat Template
40
Write the official name, as
mentioned on
- identity card/NIHDI DB (for
HCP)
- CBE database (for
HCO/PO)
Profession only if Nat. Reg. nr
(No column “Facultative
name HCO” anymore)
Preparation of the file to notifyUnique Identifiers
CBE nr. (DB available on
Extranet!)
NIHDI nr. (DB available on
Extranet!)
If no NIHDI or several
national registration
number
(to be provided by the
HCP)
If none of these ID
communicated by BTB
41
Preparation of the file to notify
Categories of premiums and benefits
42
Technical Specifications
Preparation of the file to notify
43
Technical Specifications
Preparation of the file to notify
44
Notification
procedure
(file upload)
45
Notification procedure
1. UPLOAD of the draft file to notify
2. ANALYSIS of the draft file (automatically)
• Template complete?/Unique ID correct? (check via external databases)
• If data incomplete/incorrect report/error message (web or email)
3. CORRECTION of potential errors
• When all data are complete/correct confirm the file by clicking « I wish to
receive the draft file for validation by email”
4. Reception of PRE-REPORT FOR VALIDATION purposes total amount of uploaded premiums and benefits
pdf file showing the data as they will be made public
status on the extranet: “awaiting notification”
46
Notification procedure
5. FINAL NOTIFICATION of the file
Extranet: “NOTIFY”
Email: general conditions + link to confirm final submission
Confirmation of final submission by clicking the link
Confirmation by email Extranet status: “Sent for publication ”
6. ACKNOWLEDGEMENT OF RECEIPT
47
Extranet
Analysis
Email 1
Draft file
Extranet
“NOTIFY”
Email 2
Link to confirm
Email 3
Acknowl. of receipt
Status file: Awaiting notification Sent for publication
Notification procedure - Timeline
48
Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec
NOTIFICATION01.01. 31.05
Dead calm +
PUBLICATION
RECTIFICATION
as from 01.07
Period of reference: 01.01 31.12
Disclosure process
Notification procedure - Timeline
49
First Period of reference: 01.01.2017 – 31.12.2017
! Exception: premiums and benefits for
medicinal products for veterinary use
first reference year = 2018
first notification = 2019
First NOTIFICATION
01.01.2018 – 31.05.2018PUBLICATION RECTIFICATION
Rectification
procedure
50
Rectification procedure
Update of the Transparency Register: 1st and 15th of each month (due to
Privacy legislation)
Modify the file where necessary
Upload the entire file again (not only the modified lines)
Corrective file: as from the 1st of July
Privacy corrections:
51
Demonstration
of notification procedure
52
53
2
1
54
1. Upload draft file
6 STEPS
55
2. Analyse of the draft file
56
3. Correction of potential errors
57
4. Reception of pre-report for validation purposes
58
4. Reception of pre-report for validation purposes
Once January 1, status will be Awaiting for notification Notify 59
5. Final notification of the file
60
5. Final notification of the file
61
5. Final notification of the file
Only when you have received this
email, the notification procedure is
completed !
62
6. Acknowledgement of receipt
Sent for publication
You have already submitted your basic file 2017. This file can no longer be changed. From 1 July 2018, you can re-upload the totality of your file 2017 after making
possible corrections. This new file will be published during the next update of the transparency register.
63
6. Acknowledgement of receipt
64
TRANSPARENCY
REGISTER
The
Register
1. Public Register
2. Info beneficiaries
3. Extranet
Companies
1 32
65
How?
What do I find?
(yearly amounts)
Why can I not
find my HCP?
The
Register
66
Building Transparency
in Healthcare Relationships
3 ways to
search
Per year
Search
criteria?
The
Register
67
Transparent
Search Engine
The
Register
68
Transparent
Search
Engine
The
Register
69
Security:
Googling not
possible
Captcha: robot
The
Register
70
Search result
HCO
71
Search result
HCP
First NameLast nameProfession(Speciality)
City
NIHDI nrNational Register nr
Street
72
Search result
Company (1)
73
Search result
Company (2)
74
PATIENT ORGANISATIONS
Button to ask questions
or a data correction
Form to identify HCP
Email sent to company
75
Rectification procedure
Update of the Transparency Register: 1st and 15th of each month (due to
Privacy legislation)
Modify the file where necessary
Upload the entire file again (not only the modified lines)
Corrective file: as from the 1st of July
Privacy corrections:
76
77
CONTROL &
SANCTIONS
Control and sanctions
FAMHP is competent to control the respect of the Sunshine Act
Sanctions
◦ Sunshine Act provides penal fines from 1.600 up to 120.000 EUR
78
79
COMMUNICATION
Flyer beneficiaries FAQ’s Infosessions
Articles, Press release 80Face2Face with HCOs/POs
81
Q&A
THANK YOU FOR
YOUR ATTENTION!
