practical guidelines for disclosure of transfers of value · pursuant to article 42 of the unamec...

UNAMEC v.z.w. – a.s.b.l. - Koning Albert I-Laan 64 Avenue du Roi Albert I - 1780 WEMMEL - België - Belgique Tel +32 2 257 05 90 - fax +32 2 252 43 98 - www.unamec.be - [email protected]

1

1. BeTransparent.be

Pursuant to Chapter 4 of the UNAMEC Code of deontology, Medical Device companies, (hereinafter

referred to as UNAMEC members) shall disclose transfers of value they make, directly or indirectly, for

the benefit of a healthcare professional (“HCP”) or organisation (“HCO”) on the central disclosure

platform (“BeTransparent”) set up for this purpose, using the template that can be downloaded from the

central platform website betransparent.be.

2. Methodology for disclosure

Pursuant to article 42 of the Unamec Code of Ethics, each member company is expected to publish an

individual methodology note summarising the methodologies used by it in preparing the disclosures

and identifying Transfers of Value (“ToV”) for each category mentioned in the code. The note should

describe the recognition methodologies applied, and should include the treatment of multi-year

contracts, VAT and other tax aspects, currency aspects and other issues related to the timing and

amount of ToV. The members’ individual methodology notes will be published on the BeTransparent

platform.

UNAMEC was asked by its members to create a methodology document with general recommendations

(the “Practical Guidelines”). This will allow the UNAMEC members to apply a uniform methodology. The

Practical Guidelines will regularly be updated in order to keep track of the developments of the platform

and any further questions that may arise.

Version 24-04-2015

Practical Guidelines

for disclosure of Transfers of value

UNAMEC v.z.w. – a.s.b.l. - Koning Albert I-Laan 64 Avenue du Roi Albert I - 1780 WEMMEL - België - Belgique

Tel +32 2 257 05 90 - fax +32 2 252 43 98 - www.unamec.be - [email protected]

2

2



The Practical Guidelines can be used as guidelines by the UNAMEC members, but it does not constitute

a binding interpretation. Those members who wish to deviate from the approach suggested in this

document can do so, but are required to indicate this in their own methodology document and provide

for an alternative solution.

3. Glossary template Q&A

A “flat” template for uploading data is available on the BeTransparant and the UNAMEC websites. This

template must be used for filling in data and for the upload onto the central BeTransparent platform.

Please find below a detailed overview of the columns included in the template for disclosure:

Q. Indication column Guidance

I.1. Consent Code –

Subject code

This code will be placed before every line in order to indicate (i)

whether the line can be published on an individual or aggregate basis

and (ii) whether a HCP/HCO or R&D is concerned.

The following codes will be used:

- HCPi = HCP individual

- HCPa = HCP aggregate

- HCOi = HCO individual (i.e. all HCOs, with the exception of self-

incorporated HCPs that have not given consent for disclosure.

- HCOa = HCO aggregate (i.e. self-incorporated HCPs that have

not given consent for disclosure: these must be disclosed in an

aggregate way, without further identification.

- RD = R&D (always aggregate disclosure)

As soon as the HCPa or HCOa codes are mentioned, the columns

concerning the identification of the HCP/HCO and the unique identifiers

will no longer need to be filled in.

Please note that consent is a crucial element for compliance with

Privacy Law. The way in which the ToV can be disclosed in the template

will depend on the category (and code) listed in this column.

I.2. Full name HCP: (1) surname and (2) first name (in this order - must be the

same name as indicated on the identity card of the HCP). Do not

mention the title (e.g. prof., dr.): this will not be recognised by the

system;

HCO:

- full official name (must be the same name as indicated in the

KBO/BCE database);

- Optional: further specification. Some ToV are intended for a

specific department/subdivision of a large HCO, which does not

have an individual account. In such cases, the ToV is transferred

http://www.pharma.be/newsitem.aspx?nid=4814


http://kbopub.economie.fgov.be/kbopub/zoeknummerform.html?lang=en

3

3



to the account of the over-arching HCO, that will receive a large

number of ToV which can – in the end - add up to a significant

amount. Therefore, if members would like to provide further

specification in order to differentiate between ToV on general

accounts, they can do so in this column.

This can e.g. be the case for hospitals: it is recommended to further

specify which department is the recipient of the ToV if the ToV is made

on a general account.

I.3. City The location of the HCP/HCO must be included:

- For HCPs, this is the city of principal practice;

For HCOs, this is the city where the Belgian registered legal entity is

located.

I.4. Country of principal

practice

Always mentioned as Belgium.

I.5. Principal practice

address

Further details of the address that are not yet included in the preceding

columns.

I.6. HCPs: profession This is necessary in order to determine which of the two following

boxes will need to be ticked: the box (i) “RIZIV/INAMI” for HCPs with a

profession that is subject to a RIZIV/INAMI number, or (ii) National

Register Number for those that are not.

If the HCP has a RIZIV/INAMI number, there is no need to mention the

profession. This can be deduced by the platform operator by means of

the RIZIV/INAMI number, and will be filled in automatically upon

publication on the BeTransparent platform. However, if the HCP does

not have a RIZIV/INAMI number (see professions indicated in orange in

the list of the Technical Specifications Document), the profession must

be mentioned when uploading the data.

For a list of HCP professions to be indicated in this column, see the

Technical Specifications Document.

I.7. HCPs: INAMI/RIZIV For HCPs with a profession that is subject to a RIZIV/INAMI number, the

number must be provided. This number can be found on the

RIZIV/INAMI website.

I.8. HCPs: National

Register Number (on

ID-card)

If it is not possible to obtain or use the RIZIV/INAMI number because

the HCP does not have one or has several, the national registration

number should be provided. This number must be provided by the HCP



https://www.inami.fgov.be/webprd/appl/pDownloadCenter/default.aspx?lang=nl

4

4



to the members.

I.9. HCOs: enterprise

number (KBO/BCE)

The company number (KBO/BCE) is the same as the VAT number (but

without mention of the “BE” prefix), and can be consulted on the

KBO/BCE website.

I.10. Donations and

grants to HCOs

See Article 42 – 2 - I of the UNAMEC Ethical Code.

I.11. Contribution to

costs of events

See Article 42 – 2 – II a of the UNAMEC Ethical code.

I.12. Fee for service and

consultancy

See Article 42 – 2 – II b of the UNAMEC Ethical code.

I.13. Total The total per line, as calculated by the company uploading the

completed template.

4. Technical guidance Q&A

Q. Issue Guidance

II.1. One line per

HCP/HCO

Data will be uploaded according to the principle “one line per

HCP/HCO”. This will allow for a correct calculation of the number of

Recipients in aggregate disclosure and the percentage of the number of

Recipients included in the aggregate disclosure in the total number of

Recipients disclosed.

II.2. Number of

Recipients in

aggregate disclosure

- % of the number of

Recipients included

in the aggregate

disclosure in the

total number of

Recipients disclosed

The (i) number of Recipients in aggregate disclosure and the (ii)

percentage of the number of Recipients included in the aggregate

disclosure in the total number of Recipients disclosed, do not need to

be indicated by the members. This will be calculated by the platform

operator.

II.3. Unique identifier The following data are used as unique identifiers:

- For HCOs: the company number (KBO/BCE - same as VAT

number but without the prefix “BE”);

http://kbopub.economie.fgov.be/kbopub/zoeknummerform.html?lang=en

5

5



- For self-incorporated HCPs (“one person legal entities”): the

company number (KBO/BCE - same as VAT number but without

the prefix “BE”). Please note that in this case, a consent must be

obtained before processing of the data

- For HCPs: if possible the RIZIV/INAMI number, if it is not

possible to obtain/use that number because the HCP does not

have one or has several, the national registration number needs

to be used1;

- Factual associations: UNAMEC is currently checking with the IT

provider of the central platform how such associations can be

identified. If the number of factual associations is limited, the IT

provider will create its own unique identifier system for use

within the platform. Until such an identifier system is

developed, the full name of the factual association must be

given.

It is recommended that members ask for the data that will be used as

unique identifiers when concluding contracts with HCPs/HCOs. They

should include these details in the template that is uploaded to the

central platform. These can then be verified for consistency at the level

of the platform.

II.4. Temporal scope of

declaration:

benchmark for

disclosure

The relevant date for disclosure will depend on the accounting system

of the members: date of the activity vs. date of the invoice/payment.

All members must clarify this in their own methodological note.

II.5. Language of

disclosure

Members can provide data in one language, which will in turn be

available on the platform in 3 languages (NL, F, ENG).

II.6. Excel/csv file format An excel file or csv format (free choice) will be used for data input. This

will be downloadable from the BeTransparent website.

II.7. Data input – content

file

Information will be uploaded to the system by means of files containing

one line per HCP/HCO.

In some lines, the name of the HCP (if prior consent was obtained) will

be indicated while others will be anonymous (if no prior consent was

obtained)

If no consent was obtained, the data will be disclosed in an aggregate

way. This means that per category of ToV a total amount for all the

HCPs combined (“grouped disclosure”) will be disclosed, together with

1 BeTransparent received a positive advice from the Privacy Commission to consult the INAMI and National Register database

(Rijksregister/Registre national).

http://www.privacycommission.be/sites/privacycommission/files/documents/beraadslaging_RR_78_2014.pdf

http://www.privacycommission.be/sites/privacycommission/files/documents/d%C3%A9lib%C3%A9ration_RN_78_2014.pdf

6

6



the number of the recipients in this category as well as the percentage

of aggregate disclosure compared to the total number of recipients

disclosed.

However, the data must be uploaded (via the template) as one amount

per HCP, but of course without further identification of the HCP (“one

line per anonymous HCP”)2.

In addition, it is recommended to compile detailed data internally in

order to be ready for detailed reporting should this be necessary in the

future.

II.8. Registration for

members internally

It is recommended that the UNAMEC members compile files wherein

each HCP is identified on a nominative basis, and that unique

identifiers are obtained systematically, even when these details are not

disclosed on the website.

This will allow the members to continue to work with the same file (and

thus prevent having to start again from scratch) should a law on

transparency be made in the future.

II.9. Registration There will be an account per legal entity. This registration has several

benefits:

- If a law on transparency were to be introduced in the future, it is

likely that any obligation to disclose will be directed towards the

legal entities and not towards the global company. Hence, if the

principle of disclosure per legal entity is already introduced now,

the members will be prepared for any possible future legislative

initiatives;

- It will be easier to dispatch any requests for modifications or

corrections considering that every entity will have its own contact

person;

- The identification of legal entities is relatively easy (company or

VAT number), whereas identification of global companies is more

difficult.

Please be informed that for the purpose of disclosure, the list will be

similar to the list for visa requests with Mdeon (1 to 3 companies per

country), with the difference that there will be a single account/contact

2 E.g.: publication = a total aggregate amount of 10.000 € in a certain category but Upload = HCP 1: 1.000 € - HCP 2: 500 € -

HCP 3: 500 € - HCP 4: 8.000 €.


7

7



person (general company e-mail address) per legal entity.

II.10. Account e-mail

address

In the BeTransparent account, a contact e-mail address will need to be

indicated. Members are strongly recommended to create a general e-

mail address that is supervised by a determined person, rather than

including a personal e-mail address linked to a specific employee. This

way, the address will not need to be changed if an employee leaves the

company.

This e-mail address will a.o. be used for confirmations of receipt.

Moreover, there will be a possibility for HCPs/HCOs to react to a

publication on the BeTransparent website. The HCP’s/HCO’s comment

will be sent directly to the company that published the ToV, via the e-

mail address linked to the company’s account.

II.11. Search engine

The system will allow for search results to be grouped per company,

and also per HCP/HCO. This will allow the user to assess how many

ToV (and for which amounts) a HCP/HCO has received over a specific

period of time.

II.12. First publications in

2017.

The platform will disclose all the transfers of value of 2016 (as a whole

– not one by one with intervals) at the same time in Q2 2017.

Transitional Period of one year :

For the first year of publication (2017), the companies who for

technical reasons are not ready, will not publish:

- the registration fees for scientific events (column M of the template)

(art. 42, 2, II, a, I of the Code of Ethics)

- the travel and accommodation cost (columns N and P of the

template) (article 42, 2, II, a, ii of the Code of Ethics).

In any case, all the companies will in 2017 at least publish:

- the transfers of values regarding the HCO (columns K, L and O of the

template) article 42, 2, I of the Code of Ethics)

- the consultancy fees for HCP (column O of the template) (article 42,

2, II, b of the code of Ethics)

- the transfer of values re Research and Development (column Q of the

template) (art. 42, 5 of the code of Ethics)

This transitional measure is only applicable for the transfers of values

in 2016. The transfers of values of 2017 will be published entirely in

8

8



2018.

The companies will specify in their methodological Note which figures

they will publish during this transitional period (all the transfers or only

the values of columns K, L, O and Q).

The BeTransparent platform will perform the consolidation and

consistency checks prior to publication on the platform. Prior to that,

members will be able to review final data.

Please be aware that the template as well as this guidance can be

subject to change following the programming of the platform website

and the test phase (foreseen for May 2015).

5. Guidance on the content Q&A

Q. Issue Guidance

III.1. Questions/

definitions about

Indirect transfer of

value

- Foundation:

Definition: a ‘Foundation’ is one of the legal forms in which

HCPs/HCOs may operate and organise relationships with Member

Companies.

Member companies will need to determine on a case-by-case basis

whether a particular Foundation falls within the definition of a HCO

under the Code, taking into account factors such as the

foundation’s characteristics, members, bylaws and purpose.

Where Member Companies engage, provide a Transfer of Value etc.

to a Foundation, due diligence would be to ensure all such support,

engagements and the like are appropriately documented in a writing

(preferably a contract), that may also include a clause consenting

the individual disclosure of the Transfer of Value.

- Research organisation:

Question: Are research organisations considered HCOs for purposes

of the Code?

Answer: A Medical research Organisation should be classified as a

HCO. As with any Transfer of Value, the purpose and intent of any

payment made to the research organisation should be considered to

establish if such payments are in scope of the Code. If they are,

they should then be disclosed under the appropriate category for a

HCO. Where member companies engage, provide a Transfer of

Value to a research organisation, due diligence would be to ensure

all such support, engagements and the like are appropriately

9

9



documented in a writing (preferably a contract), that may include a

clause consenting the individual disclosure of the Transfer of Value.

- University - teaching organisation:

Question: Should Transfers of Value to universities or teaching

institutions be disclosed under the Code?

Answer: As a general matter, the Code does not provide for the

disclosure of interactions between Member Companies and teaching

institutions (such as support of or involvement in a management

programme). However, where such support or involvement

ultimately benefits a HCP, then such Transfer of Value should be

disclosed under the Code identifying the recipient, in this instance

the teaching institution, of such transfer of Value.

As such, Transfers of Value to a Faculty of Medicine at a university

or to a University Hospital should be disclosed under the relevant

category. Collaboration with such entities will be company-specific

and each Member Company should organise its disclosures

accordingly and provide additional information in its Methodology

note.

Where member Companies engage, provide a Transfer of Value etc..

to a university or a teaching institution, due diligence would be to

ensure all such support, engagements and the like are appropriately

documented in a writing (preferably a contract), that may also

include a clause consenting the individual disclosure of the Transfer

of Value.

Question: We have recently engaged a university to provide some

services. We knew that the individual employee at the university

who would be involved in the provision of those services was a

specific doctor, but understand that none of the payment for those

services will be provided to the doctor, who would simply be

performing the work as part of his role and paid his normal salary.

Is it consistent to view this as a payment made to the HCO and not

an indirect payment to the HCP in question?

Answer: Yes, in this example the Recipient of the payment will be

the HCO, and the payment should be disclosed as ‘Fee for Service

and Consultancy’ paid to an HCO.

- Legal entity owned by a physician - clinic where a physician is

employed:

Question: When a Fee for Services is provided to a legal entity that is

owned by a physician should this be disclosed as a Transfer of

Value to an HCP or an HCO? Similary, how should a payment to a

clinic where a physician is employed be disclosed?

10

10



Answer: Disclosure is made on the Recipient’s name. The Fee for

service paid to a legal entity owned by a physician should be

disclosed under the name of the legal entity (considered an HCO

under the Code), as this is the Recipient of the payment. Similarly,

payments to a clinic, when disclosed on an individual basis, will be

disclosed in the name of the clinic.

The code requires that Member Companies will make individual

disclosures in the name of the person/ legal entity that receives the

Transfer of value (i.e. the recipient).

- Market research:

Question: In market research studies the identity of the respondents

is usually not known and such research is often performed through

market research companies. However, Member Companies usually

know how many HCP’s will participate and how much they get paid.

In such case, should Member Companies disclose related Transfers

of Value in aggregate?

Answer: The code does not require disclosure of the transfers of

value made to market research companies when the identity of the

HCPs/HCOs participating in the market research study is not known.

As a rule, one of the basic tenets of market research is the right of

the respondents to remain anonymous, which is also enshrined in

market research definitions and relevant code of conduct. However,

where the Member Company knows the identity of the HCP/HCO

participating in activities defined as market research the Member

Company should disclose it in the ‘Fees for Service and Consultancy’

category. In such exceptional cases, it is expected that the Member

Company will secure the consent to disclosure through contract.

- Clinical research organization (CRO):

Definition: A CRO is not a HCO. A clinical research organization

(CRO) is an organization that provides support to the

pharmaceutical, biotechnology, and medical device industries in the

form of research services outsourced on a contract basis. However,

Member Companies may make Transfers of Value to HCP’s /HCOS

through CROs – such indirect payments are within the scope of the

Code.

As a rule, each Member Company will decide on the inclusion of

Transfers of Value to CROs into the different categories of

disclosure.

If activities contracted to CROs fall within the scope of the definition

of R&D Transfers of Value, they will be part of the aggregate

disclosure under that category. Otherwise, they will be reported

under the relevant category.

11

11



In their written contracts with CROs, Member Companies are

encouraged to include provisions relating to the CROs’ consent to

disclose transfers of Value that will ultimately benefit HCPs/HCOs.

In addition, companies are encouraged to renegotiate existing

contracts at their earliest convenience to include such consent to

disclosure.

The Member Company are encouraged to provide additional

clarification on the nature of the Transfers of Value included.

- Professional Congress Organisers (PCOs):

Question: How should Member Companies disclose Transfers of

Value through contracted third parties, which may include e.g.

Clinical Research Organisations (CROs), Professional Congress

Organisers (PCOs), travel agencies?

Answer: Member Companies would be expected to collect details

from third parties to disclose following the disclosure requirements

of the Code (category of disclosure, individual or aggregate).

Individual disclosure, where applicable, should be under the name

of the HCO on whose behalf the third party is operating. The

process followed to collect the information should be described in

the Methodological Note.

- Travel agencies:

See – PCOs.

- Steering Committee:

Question: How should the Transfers of Value to HCPs/HCOs that

participate in a Steering Committee supporting the organisation of

an international event be disclosed?

Answer: Unless the activity is within scope of the R&D Transfers of

Value (in which case it will be part of the aggregate disclosure), the

Transfers of Value are to be disclosed in the name of the Recipient

HCP/HCO.

If the HCO is paid “in lump” for organising a meeting of experts the

Transfers of Value attached will be disclosed in the name of the

HCO organising the international event. However, if members of

the Steering Committee receive direct compensation for their

support, the Transfers of Value will be disclosed individually, in the

name of the individual HCP/HCO, as will be the case.

III.2. Subcontracting

issues

- General principle

“Follow the money”, i.e. the name of the HCO/HCP that is the holder

of the bank account on which the money is transferred (the

12

12



“Recipient”), must be disclosed.

- Additional principle in the case of subcontracting

How to disclose ToV made to HCOs/intermediaries for the (indirect)

benefit of determined HCPs/HCOs?

It is suggested to apply the following principle: disclosure of the

ToV in name of the first entity in the chain that is subject to the

disclosure obligations, e.g.:

o Company -------------- HCO ----------------- HCP

o Company----contract----- 3rd party -------HCO/HCP

(The contract should contain a provision re the obligation for

the 3rd party to obtain the HCP’s consent for disclosure by the

company)

o Company----------------- self-incorporated HCP

(Consent must be obtained in accordance with the Privacy

Commission’s opinion)

This way, the obligation to disclose cannot be circumvented by

using a third party/intermediary as cover. However, as it is often in

practice impossible for members to verify who the ultimate

beneficiary of the ToV is, it suffices to disclose in name of the first

entity that falls within the scope of the Disclosure Code.

Members can require further specification in their individual

methodology note if required.

III.3. Self-incorporated

HCP (“éénpersoons

BVBA”/”sprl

unipersonnelle” -

“one person legal

entity”)

A self-incorporated HCP is considered a HCO for the purpose of

disclosure. However, these entities are subject to a regime that differs

from the rules applicable to HCOs in general.

- Company name – deontological rule

Pursuant to the Code of the College of Physicians (“Orde van

geneesheren”/”Ordre des médecins”), self-incorporated HCPs

must mention the legal form of their company, their own

(personal) name and their specialty in external relations. As a

consequence, in almost every self-incorporated HCP’s company

name, the name of the HCP is mentioned. The HCP “behind” the

company can thus easily be identified.

- Consent requirement – Privacy Commission

The Privacy Commission confirmed that insofar it is possible to

http://ordomedic.be/nl/code/hoofdstuk/de-professionele-samenwerking-tussen-artsen

http://ordomedic.be/nl/code/hoofdstuk/de-professionele-samenwerking-tussen-artsen

http://ordomedic.be/fr/code/chapitre/la-collaboration-professionnelle-entre-m%E9decins

13

13



identify the HCP by means of the company name, the Privacy Act

applies. Hence, the HCP’s consent must be obtained before the

processing of his/her data. This consent can be given either in

name of the company, or in name of the HCP who is the only

“partner” of his/her own company. Contracts with self-

incorporated HCPs should thus include a provision with respect

to consent for disclosure.

- Unique identifier

An important nuance must be made with respect to the unique

identifier. A self-incorporated HCP is considered a HCO for the

purpose of disclosure, and will thus be identified by the

company number (KBO/BCE - same as VAT number). The

Privacy Commission stresses that the consent to use the

national register number can under no circumstances be given

by a self-incorporated HCP. This number can only be used in

cases where a company addresses a HCP directly and when the

RIZIV/INAMI number cannot be used.

Please note that, when the self-incorporated HCP has not given

his/her consent for disclosure, details must be disclosed in an

aggregate way (category HCOa), without further identification.

This means that neither the company name, nor the company

number can be disclosed.

Question: Under the code, would a self-incorporated HCP (where

he/she is the only employee of the corporation) be considered a HCO?

Answer: Yes, HCO is defined as ‘any legal person (i) that is a healthcare,

medical or scientific association or organisation (irrespective of the

legal or organisational form) such as a hospital, clinic, foundation,

university or other teaching institution or learned society whose

business address, place of incorporation or primary place of operation

is in Europe or (ii) through which one or more HCP’s provide services”.

III.4. What if the HCP

does not consent?

The members are strongly encouraged to include provisions relating to

the recipients’ consent to disclose ToVs in their contracts with HCPs or

HCOs. When no consent was obtained, the ToVs must be disclosed on

an aggregate basis.

UNAMEC cannot make a recommendation about the consequences for

non-consenting HCPs. Individual members will have to decide about

their own response in such cases.

Question: What must a Member Company do if it does not obtain a

consent from a HCP (or a HCO, where applicable) for disclosure on an

individual basis?

14

14



Answer: Member Companies should make their best efforts to obtain

the consents necessary to disclosure of Transfers of Value at the

individual level, with aggregate disclosure being permitted in

exceptional circumstances only.

Where Transfers of Value occur in the context of a contract, the

contract provides an opportunity to obtain the HCP’s /HCO’s consent to

the processing of his/her/its personal data for the purpose of meeting

the Member Company’s obligations under the Code. It is recommended

that Member Companies (data controllers) create and retain evidence

showing that such consent has been requested / obtained.

Where Member Companies would be required by national laws and

regulations to obtain the consent of the Recipient for individual

disclosure and the Recipient does not consent to such disclosure

following Member Companies repeated efforts, the relevant Transfer of

Value may be disclosed on an aggregate basis. The Member Companies

are also required to indicate the number of Recipients included in the

aggregate disclosure in the total number of Recipients disclosed

(respectively under the HCPs and HCOs disclosures).

Question: How should disclosure be managed where the Recipient gives

partial consent? For example, where consent is given for the

consultancy fees to be disclosed, but not associated payments for travel

& accommodation, what would be the disclosure requirement?

Answer: Member Companies are encouraged to include a consent

notice in their contracts that would prevent, wherever possible,

Recipients from “cherry picking” which Transfers of Value they consent

to be disclosed. If notwithstanding the Member Company’s efforts a

Recipient gives only partial consent to any aspect of disclosure (i.e. the

Recipient does not allow for disclosure of all categories or of all

Transfers), all Transfers of Value of the Member Company made to that

Recipient should be declared in the aggregate disclosure (not in the

individual disclosure category), subject to applicable laws. Partial

disclosure under the individual disclosure category would be

misleading with respect to the nature and scale of the interaction

between the Member Company and the Recipient, and would as such

not fulfil the intent of the Code. Information on how this is managed

should be considered in the Methodological Note.

III.5. Revocation of

consent

What are the obligations of a company when a HCP’s consent is

revoked?

15

15



A difference must be made between the case wherein (i) the HCP

provided a legitimate consent for publication and comes back on it,

and (ii) the HCP signed a contract wherein the consent declaration is

not in accordance with the privacy legislation (e.g. not specific enough,

…) and contests that his/her consent was given.

(i) Revocation of legitimate consent

In the current state of the privacy legislation, it is sufficient to stop

disclosing the relevant ToV on an individual basis going forward.

This means that information that was already disclosed on the

platform should not be amended or restated. However, any

information that was already obtained by a company but not yet

disclosed on the platform can as from the revocation of the consent

no longer be publicly disclosed on an individual basis. From that

moment on, the information should be disclosed on an aggregate

basis.

Please note that the data protection framework is currently under

revision, so the members’ obligations with respect to revocation of

consent may change in the future.

(ii) Lack of legitimate consent

When no legitimate consent is provided, the data cannot be

published on an individual basis. If a HCP signed a contract wherein

the consent declaration was not in accordance with the privacy

legislation and his/her individual data were subsequently placed on

the BeTransparent platform, it must be considered that this was

done without his/her consent. Hence, the data must be retroactively

removed.

III.6. Privacy notification

obligations for

individual

companies under

Belgian law

Mdeon, the organisation that will host the disclosure platform, has

obtained an authorisation from the Belgian Sectorial Committee for the

National Register (part of the Belgian Privacy Commission) to have

access to the database of the national register and to use the HCPs’

national register number as a unique identifier for disclosure in the

disclosure system (in addition to the HCPs’ INAMI/RIZIV number). This

allows the UNAMEC member companies to ask for HCPs’ national

register numbers and to use these in the framework of the disclosure

system, without having to apply for an (additional) individual

authorisation in this respect.

However, in the framework of disclosure, members will also process

other personal data of HCPs. For this processing, the members must

notify the supervisory authorities (in Belgium: the Privacy Commission),

unless the processing is already covered by an existing notification

http://www.privacycommission.be/sites/privacycommission/files/documents/beraadslaging_RR_78_2014.pdf

http://ec.europa.eu/justice/data-protection/data-collection/obligations/index_en.htm

http://ec.europa.eu/justice/data-protection/data-collection/obligations/index_en.htm

16

16



made by the data controller. For more information about this

notification, see the website of the Belgian Privacy Commission.

III.7. Can UNAMEC

provide examples of

a standard consent

clause?

Unfortunately not, as the correct formulation will very much depend on

the specifics of the contract at hand.

III.8. Payment to a

hospital department

In the case of payment to a hospital (department), it must first be

verified whether the money is transferred on the account of the

university3, the hospital, the department, or a doctor’s association

active in (or acting as) the department.

If the money is transferred on the account of a hospital (i.e. a HCO),

disclosure in name of the hospital would suffice according to the

“follow the money” rule.

However, a further split by department can be considered in order to

enhance transparency of such payments. Each company will have to

detail in its individual methodological note whether it requires a further

specification to be made.

III.9. Qualification issues

re the relevant

category

Can come later on.

III.10. Payment for

advertising

Does payment for advertising fall within the scope of the transparency

obligations (e.g. sponsoring of the leaflet of a HCP association)?

Payment for advertising does not as such fall within the scope of the

transparency obligations. Please note that in the template for

disclosure, no place was foreseen for such costs. When payment for

advertising does not fall within the scope of any of the categories

included in the template, it should not be disclosed on the central

platform.

However, when payment for advertising is included in a ToV that can be

qualified as a “contribution to costs of scientific events – sponsorship

agreements with HCOs/third parties appointed by HCOs to manage a

scientific event”, “fee for service and consultancy”, or “donations and

grants to HCOs”, it should be disclosed in the relevant category.

Members can further specify how payment for advertising is organised

3 Please note that a medical/healthcare department of a university is considered a HCO.

http://www.privacycommission.be/nl/aangifte


17

17



in their individual methodology note.

III.11. Disclosure of meals

and drinks

In principle, meals and drinks do not fall within the scope of the

transparency obligations and should thus not be disclosed.

But what about meals and drinks that make up an integral and

sometimes inseparable part of contributions to the cost of scientific

events or sponsoring? Can these be disclosed as a part of the total, or

should these costs be filtered out of the total amount?

As it is not always easy to filter out costs for meals and drinks offered

to HCOs/HCPs, meals and drinks that make up a part of a sponsorship

agreement and cannot easily be identified as part of the total, can be

disclosed without being filtered out of the total.

It must be clarified in each member’s individual methodological note

how this will be organised, and whether such costs are filtered out or

not.

III.12. What about OTC

products?

ToVs that are solely related to over-the-counter medical devices

(“OTCs”) are excluded from the disclosure obligations. Members are

however strongly encouraged to comply with the disclosure

obligations, even for products falling outside of the scope of these

obligations.

III.13. R&D transfers of

value

“Research and Development” transfers of value include transfers of

value to healthcare professionals or healthcare organisations related to

the planning or conduct of (i) non-clinical studies (as defined in OECD

Principles on Good Laboratory Practice); (ii) clinical trials (as defined in

European Directive 2001/20/EC); or (iii) non-interventional studies as

defined in article 44 of the Code.

III.14.F Tax issues Should the amounts be disclosed with or without VAT? It is assumed

that it is easier to disclose without VAT as different VAT rates and

systems can apply to various ToVs.

However, all members must clarify whether it is disclosed with or

without VAT in their own methodological note.

6. Useful links

Template for disclosure

UNAMEC Code of Ethics

The Technical Specifications Document



18

18



7. Contact details

For questions relating to the UNAMEC code and the content of disclosure, please contact

[email protected].

For questions relating to the technical aspects of the template or the website, please contact

[email protected] or [email protected].

8. Format of the template that will be publicly available on the BeTransparent platform

See following pages.

mailto:[email protected]

mailto:[email protected]

UNAMEC v.z.w. – a.s.b.l. - Koning Albert I-Laan 64 Avenue du Roi Albert I - 1780 WEMMEL - België - Belgique Tel +32 2 257 05 90 - fax +32 2 252 43 98 - www.unamec.be - [email protected]

Code pour le

consentement

HCP: Commune

du cabinet

principal

HCO: Commune

où enregistrée

Pays du cabinet

principal

Adresse du

cabinet principalHCP: profession HCP: n° INAMI

HCP: numéro du

régistre national

(cfr. carte

d'identité)

HCO: numéro

d'entreprise (BCE)

(HCPi/ HCPa/

HCOi/ HCOa)Nom officiel

Spécification HCO

(optionnel)

Conventions de

sponsoring avec

HCO / des tiers

désignés par HCO

pour gérer un

événement

scientifique

Coûts d'inscription Frais de voyage et

de séjour Honoraires

Frais liés inclus

dans la

rémunération ou

convenus dans la

convention de

consultance, y

compris frais de

voyage et de

séjour liés à la

convention

HCPi Dr A N/A N/A N/A Montant annuel Montant annuel Montant annuel Montant annuel

HCPa Dr B N/A N/A N/A N/A N/A Montant annuel Montant annuel Montant annuel Montant annuel

HCPi etc. N/A N/A N/A Montant annuel Montant annuel Montant annuel Montant annuel

N/A N/A Montant agrégé Montant agrégé Montant agrégé Montant agrégé

N/A N/A nombre nombre nombre nombre

N/A N/A % % % % N/A

HCOi HCO 1 N/A N/A N/A Montant annuel Montant annuel Montant annuel Montant annuel Montant annuel Montant annuel

HCOi HCO 2 N/A N/A N/A Montant annuel Montant annuel Montant annuel Montant annuel Montant annuel Montant annuel

HCOa etc. N/A N/A N/A Montant annuel Montant annuel Montant annuel Montant annuel Montant annuel Montant annuel

Montant agrégé Montant agrégé Montant agrégé Montant agrégé Montant agrégé Montant agrégé

nombre nombre nombre nombre nombre nombre

% % % % % % N/A

MONTANT TOTAL

PUBLICATION INDIVIDUELLE NOMINATIVE - une ligne par HCP (tous les transferts de valeur durant l'année effectués au profit d'un HCP seront additionnés : une publication détaillée ne devrait être rendue disponible que pour le bénéficiaire concerné ou pour les autorités compétentes, selon le cas)

Annexe 1 - SCHEMA DE PUBLICATION DES TRANSFERTS DE VALEUR

TOTAL

Date de publication: ..................................

Donations et

subventions à

HCO

Contributions aux frais relatifs à des événements

scientifiques

Honoraires pour services et

consultance

Nom complet

R&D

PUBLICATION AGREGEE

Transferts de valeur concernant la recherche et le développement

AUTRES, NON INCLUS CI-AVANT - Si les informations ne peuvent être publiées sur une base individuelle pour des raisons légales

Montant agrégé afférent aux transferts de valeur à ces bénéficiaires

Nombre de bénéficiaires publié sur une base agrégée

% du nombre de bénéficiaires inclus dans la publication agrégée dans le nombre total de bénéficiaires publié

PUBLICATION INDIVIDUELLE NOMINATIVE - une ligne par HCO (tous les transferts de valeur durant l'année effectués au profit d'une HCO seront additionnés - une publication détaillée ne devrait être rendue disponible que pour le bénéficiaire concerné ou pour les autorités compétentes, selon le cas)

AUTRES, NON INCLUS CI-AVANT - Si les informations ne peuvent être publiées sur une base individuelle pour des raisons légales

Montant agrégé afférent aux transferts de valeur à ces bénéficiaires

Nombre de bénéficiaires publié sur une base agrégée

% du nombre de bénéficiaires inclus dans la publication agrégée dans le nombre total de bénéficiaires publié

20

20



Code voor

toestemmin

g

HCP: Gemeente en

postcode van het

hoofdkabinet

HCO: Gemeente

en postcode van

de hoofdzetel

Land van

hoofdactiviteit

Adres van

hoofdactiviteitHCPs: beroep

HCPs: RIZIV nr.

HCPs: nationaal

register nummer

(cfr.

Identiteitskaart)

HCOs:

ondernemingsnu

mmer (KBO)

(HCPi/HCP

a/HCOi/HC

Oa)

Officiële naam Specificatie HCO

(optioneel)

Sponsoringcontrac-

ten met HCO/ met

derden door HCO

aangeduid om een

wetenschappel.

bijeenkomst te

beheren

Inschrijvingskoste

n

Reis- en

verblijfskosten Honoraria

Gelieerde kosten

begrepen in de

vergoeding of

overeengekomen

in de

consultancyover-

eenkomst,

inclusief reis- en

verblijfkosten

verbandhoudende

met de

overeenkomst

HCPi Dr A NvT NvT NvT Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag

HCPa Dr B NvT NvT NvT NvT NvT Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag

HCPi etc. NvT NvT NvT Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag

NvT NvT Geaggr. bedrag Geaggr. bedrag Geaggr. bedrag Geaggr. bedrag

NvT NvT aantal aantal aantal aantal

NvT NvT % % % % NvT

HCOi HCO 1 NvT NvT NvT Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag

HCOi HCO 2 NvT NvT NvT Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag

HCOa etc. NvT NvT NvT Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag Jaarbedrag

Geaggr. Bedrag Geaggr. Bedrag Geaggr. Bedrag Geaggr. Bedrag Geaggr. Bedrag Geaggr. Bedrag

aantal aantal aantal aantal aantal aantal

% % % % % % NvT

TOTAAL

BEDRAG

NOMINATIEVE INDIVIDUELE PUBLICATIE - één regel per HCP (alle transfers van waarden tijdens het jaar verricht ten gunste van een HCP worden samengeteld - een gedetailleerde publicatie moet slechts worden bezorgd aan de betrokken begunstigde of aan de bevoegde overheid die erom verzoekt - indien gepast)

ANDERE, NIET HIERBOVEN INBEGREPEN - Wanneer de informatie om wettelijke redenen niet op een individuele basis openbaar kan worden gemaakt

Geaggregeerd bedrag van de transfers van waarden aan deze begunstigden

Bijlage 1 - SCHEMA VAN DE OPENBAARMAKING VAN TRANSFERS VAN WAARDEN

Schenkingen en

toelagen aan

HCOs

Bijdragen in de kosten van wetenschappelijke

bijeenkomsten

Honoraria voor diensten en

consultancy

TOTAAL

Publicatiedatum:

Volledige naam

GEAGGREGEERDE PUBLICATIE

Aantal begunstigden in aggregate openbaarmaking

% van het aantal begunstigden inbegrepen in de geaggregeerde publicatie in het totale aantal gepubliceerde begunstigden

NOMINATIEVE INDIVIDUELE PUBLICATIE - één regel per HCO (alle transfers van waarden tijdens het jaar verricht ten gunste van een HCO worden samengeteld - een gedetailleerde publicatie moet slechts worden bezorgd aan de betrokken begunstigde of aan de bevoegde overheid die erom verzoekt - indien gepast)

R&D

Transfers van waarden inzake onderzoek en ontwikkeling

ANDERE, NIET HIERBOVEN INBEGREPEN - Wanneer de informatie om wettelijke redenen niet op een individuele basis openbaar kan worden gemaakt

Geaggregeerd bedrag van de transfers van waarden aan deze begunstigden

Aantal begunstigden

% van het aantal begunstigden inbegrepen in de geaggregeerde publicatie in het totale aantal gepubliceerde begunstigden

21

21



practical guidelines for disclosure of transfers of value · pursuant to article 42 of the unamec...

Documents