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

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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

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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

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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

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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

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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

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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

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Nominative publication

Obligation to collaborate

for the beneficiaries

Communicate data

required for publication

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- 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

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Registration on

betransparent.be

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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”

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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:

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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

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79

COMMUNICATION

Flyer beneficiaries FAQ’s Infosessions

Articles, Press release 80Face2Face with HCOs/POs

81

Q&A

THANK YOU FOR

YOUR ATTENTION!