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Code of Conduct

Key Research Stages - Before Fieldwork

H. Recruitment

Screening Questions and Questionnaires

4.14

Screening questions MUST only be used pre-screen potential MR subjects for participation in the research, they MUST NOT be used to collect additional data.


Physician Recruitment of Patients

4.15

Physicians may act as intermediaries to recruit patients by inviting patients to take part or passing on questionnaires on behalf of the agency, they MUST however:

Ensure that patients understand that their participation is voluntary

Not disclose the patient’s identity to the agency until the patient has consented to this.

Reimbursement should not be dependent on the number of patients successfully recruited.  Agencies should beware of placing pressure upon patients and try to minimise this e.g. by issuing a written rather than a face to face invitation.


4.16

If the patients reply directly to the agency, which is preferable, the doctor should not be told which patients are going to/have participated.


4.17
In Germany and Brazil, physicians are only allowed to pass on and return completed questionnaires if there are no means by which to identify the patients detailed (e.g. name or address).

In the Netherlands, MOA affiliated researchers MUST make sure that an invitation to a patient to participate in market research that is given via a HCP must be in writing (mail or email).

Snowballing – MR subject supply of Potential MR subjects' Names

4.18

When asking people to supply other people's names for the purposes of developing a list from which to draw a sample (a technique commonly referred to as 'snowballing' and used to identify opinion leaders) to meet the obligation to be transparent, the person being recruited MUST be told how their name was obtained. This means for example that when trying to recruit an opinion leader the recruiter MUST tell the doctor that they were suggested by another physician but there is no need to name the source of the nomination.


Recruitment – Information that MUST be Communicated

4.19

At recruitment MR subjects MUST be told: 

  • Type of organisation sponsoring the market research e.g. a pharmaceutical company
  • Subject and the purpose of the market research
  • Approach/methodology to be taken/used
  • If there is to be observation and/or recording, what sort and types of observers
  • Contact details - Name of the researcher, recruiter or research or fieldwork agency conducting the discussion, telephone number or email address as appropriate
  • Location, date, start time and length of the interview (as appropriate to the methodology)
  • Of their rights – confidentiality, anonymity, that they can withdraw or withhold information at any time
  • What will happen to their data (including personal data) and how it will be used
  • Incentive offered – both the nature and the rate of remuneration.
  • If the individual healthcare professionals will become known to the commissioning client company the need for disclosure should be explained and consent to pass on their personal data for this purpose requested (see section 4.25 for further detail)  
  • Healthcare professionals MUST be informed of the need to report adverse events uncovered during the study where this need exists.  Templates for a standard text are available in Germany (http://www.akdae.de/Arzneimittelsicherheit/UAW-Meldung/index.html and http://www.akdae.de/Arzneimittelsicherheit/UAW-Meldung/UAW-Berichtsbogen.pdf) and the UK (http://www.bhbia.org.uk/guidelines/abpiadverseeventguidelines.aspx).  Furthermore in the UK non-healthcare professionals MUST be informed that if adverse events are discussed during the research, then the details will be collected and forwarded to the commissioning pharmaceutical company.
  • In Mexico, the privacy disclaimer (aviso de privacidad) has to be provided (in writing or read) to the MR subject, or a source for it given (i.e. hyperlink).  MR subjects must consent to the terms of the privacy disclaimer.

4.20

If the potential MR subject/MR subject requests the name of the sponsoring client it is not necessary to provide this information unless the sponsoring client company provided the list from which the potential MR subject/MR subject’s name/contact details have been drawn.  The requirements for naming the client when observation and recording are taking place are detailed at 11.4.


4.21

In Germany, the FSA Code recommends to members that employer permission (Dienstherrengenehmigung DHG) is sought and granted for healthcare professionals to participate in market research.  There is no over-arching legal requirement for a DHG, however if you have to include healthcare professionals and/or federal civil servants e.g. payers (Bundesbeamte) within the market research sample and are committed to adhering to the FSA Codex, you have to check that a DHG is in place.  You may do this by including suitable questions within the recruitment screener and ensuring potential MR subjects only participate if they have their employers’ permission.  The DKG have also stated that employer permission is required unless participation in market research is a one-off or rare and the incentive does not exceed 100 euros.  German market research associations have no such requirements.

 
For more detail, please see http://www.ephmra.org/Country-News
 
In Italy, the Transparency Act (art. 53 165/2001) requires that:
  • Physicians employed by public entities should have the permission of their employers before they participate in market research if they are paid an incentive.  If no incentive is paid (even if expenses e.g. for travel, are reimbursed), employer permission is not required but the employer should be informed.  It is the responsibility of the physician to gain their employer’s permission (not the market research agency).
  • Market research should take place outside public entities office/clinic hours and not on a public employer’s premises unless the premises are used for private practice too.

Data Collected at Recruitment

4.22

Data collected at recruitment MUST NOT be used for any purpose other than the purpose for which consent was granted. Seeking consent for other uses retrospectively is not allowed.


Scheduling of Fieldwork Appointments

4.23
In Germany, Italy, Norway and Sweden, the ADM/BVM, ASSIRM, and LIF respectively, recommend that market research appointments with healthcare professionals (HCPs) should be made outside working hours and that those HCPs that are employees are not interviewed on their employer’s premises.  However the preferences of the HCPs can be taken into account.  In Italy this refers to HCPs when employed by the national health service (SSN) only.
 
Guideline for Studies in Public Health Service for Purposes of Market and Social Research Guideline on Interviewing Physicians for Market and Social Research Purposes www.adm-ev.de/richtlinien Aug 2009
ASSIRM, Directive on the interviews with medical staff for purposes of market research and social


Recruitment Agreements and Disclosure

4.24

EFPIA members and members of EFPIA-affiliated associations MUST document an agreement between agency or client company and the healthcare professional MR subject in advance of fieldwork (i.e. at recruitment) for all market research carried out face to face.  Longitudinal studies and panels MUST also be covered by a written agreement irrespective of methodology.  Single stage market research studies conducted online, by telephone or by post that involve only minimal remuneration do not require a written agreement in advance of fieldwork.  EFPIA member associations provide guidance on the meaning of minimal.  This ruling is based upon Article 14 of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals.

http://transparency.efpia.eu/uploads/Modules/Documents/efpia-hcp-code-2014.pdf  

When written agreements are required, the following information MUST be given and agreed:
  • Subject and purpose of the market research discussion
  • Methodology and approach
  • Location, duration of fieldwork 
  • Date and time of fieldwork
  • Incentive offered – both the nature and the rate of remuneration.
Records of the agreement MUST be kept in line with data protection and privacy legislation records as well as primary market research records (containing personal data) and MUST be destroyed when the purpose of the market research study is redundant.

In Denmark, nurses must be treated as non-HCPs.

In Germany the FSA requires that if the incentive is not ‘marginal’ (which is defined as over 50 euros) written contracts are required for all forms of market research with HCPs.

In the UK the BHBIA states that to conform to Clause 20 of the ABPI’s Code of Practise 2014, all study types irrespective of methodology require a written agreement; although different mechanisms to capture the agreement may be needed for different methodologies.  For full details see the BHBIA Guidelines.

4.25

Disclosure Requirements

Disclosure Code requirements apply to EFPIA and EFPIA affiliated association members and all those that have agreed to adhere to EFPIA or national associations’ code of practice.  The Disclosure Code applies to prescription only medicines and only to over the counter medicines if they are dispensed on prescription.

Consequently pharmaceutical companies will need to disclose payments made to healthcare professionals (HCPs) for a range of activities including participation in market research (MR) when (and only when) the pharmaceutical company is aware of the identity of the HCP.  These payments are referred to in the Disclosure Code as Transfers of Value (ToV).

For the full EFPIA Disclosure Code go to http://transparency.efpia.eu/the-efpia-code-2

 

When disclosure is required
4.25.1 For market research disclosure is required when pharmaceutical companies are aware of the identities of those participating in MR it has commissioned and ToVs i.e. MR-related payments (incentives and expenses) have been made to HCPs.  In these cases the payments made to individual named HCP MR subjects MUST be disclosed, whether they’ve paid them directly or indirectly via an agency.  This information will be made publicly available.

4.25.2 National data protection legislation may require the HCP’s consent for their data to be used in this way.  If this consent is not given, MR payments MUST still be disclosed but on an aggregate basis.  So if HCP MR subjects do not consent to their personal data being used for disclosure they may still participate in the MR.

When disclosure is not required
4.25.3 If the HCP’s identity is not known to the pharmaceutical company disclosure is not required.

EFPIA have stated that if a HCP’s identity becomes known to the company only as a result of an adverse event where reporter contact details are provided, disclosure is not required.

Similarly if during viewing of non-anonymised fieldwork, a MR subject is recognised (and identified) by client company personnel, disclosure may not be required.
 
4.25.4 If a sample is to be drawn from a list of HCPs supplied by the pharmaceutical company, the identity of those actually interviewed will not be known and so disclosure is not required.  However if all those on the list are to be interviewed, then the company will be aware of the identity of the HCPs involved in the MR and disclosure will be required.

Reporting format and Information to be disclosed
4.25.5 EFPIA have provided a ‘Model of a Standardised Template’ – the suggested reporting format for disclosure data: http://transparency.efpia.eu/EFPIA%20DISCLOSURE%20CODE%20Schedule%202%20Template%20-%2013%20Template.pdf  EFPIA country associations may provide their own template based upon the EFPIA one.

4.25.6 The following types of data MUST be recorded for a full calendar year on the appropriate template and disclosed:
  • For each individual HCP that gives consent for their personal data to be used in this way:
    • Full name and address of principal practice
    • Fee for service and consultancy – MR incentive
    • MR-related expenses 
  • Where only aggregate data can be given (where consent has not been given for personal data to be used in this way):
    • Aggregate amount attributable to transfers of value to recipients i.e. the incentives and expenses (separate totals) for MR
    • Number of recipients in the aggregate disclosure
    • % of recipients included in the aggregate disclosure as a proportion of the total number of recipients disclosed (individual and aggregate)
Country of disclosure
4.25.7 Disclosures MUST comply with the national (EFPIA member) code of the country where the HCP receiving payment has their principal practice.  The address of the HCP’s principal practice should be used as the reference when determining in which country the data should be disclosed.

Public disclosure
4.25.8 EFPIA have advised that public disclosure can be via either:
I.  the relevant Member Company’s website or
II. a central platform provided by a government, regulatory or professional body or an EFPIA member/country association
 
Individual country/member associations decide upon the route.

Disclosed data will be publicly accessible in the country where the HCP has their practice.

Reporting responsibility
4.25.9 Pharmaceutical companies MUST complete and post the disclosure data on their company website or forward it to a central platform – as required in their country.

Reporting timetable
4.25.10 Disclosures MUST be made in the first six months after the end of the calendar year in which the MR payment was made.

Consent and record keeping required
4.25.11 HCPs whose identity will be known to the commissioning pharmaceutical company MUST be advised that disclosure will take place and asked for their consent to pass on their personal data and payment information for this purpose.  This must take place as soon as practical, generally at recruitment.  As with any request for consent for the use of personal data, the following must be made clear:
  • The purpose for which the individual’s personal data will be used – why it is requested
  • The consequences of giving (how their personal data will be used) or not giving consent
  • MR subjects’ agreement or refusal must be recorded.

MR agencies MUST keep records of the required disclosure information to pass to the pharmaceutical company.

Pharmaceutical companies MUST keep records of the required disclosure information, collate it, then complete and upload the appropriate data collection template.

Pharmaceutical companies may need to review their disclosure policy and procedures for MR payments with their legal and/or compliance departments.

4.26
In Denmark legislation stipulates that any non-double-blinded (i.e. the identity of the commissioning client company in not known to the HCP MR subject and the identity of the HCP is not known to the commissioning client company) and the contact between a HCP and a pharmaceutical company or manufacturer of medical devices must be declared to the Danish Health authorities as consultancy.  The registration of contact must be made by both the HCPs and the end-client (Pharmaceutical Company or Medical Device Manufacturer).


4.27
In France Loi Bertrand imposes a general disclosure obligation on companies manufacturing or commercialising health products or services.  It applies to market research carried out with healthcare professionals that takes place in France, whether commissioned from inside or outside France and requires that agreements between market research agencies and healthcare professionals are publically reported.  
http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000028339198&dateTexte=&categorieLien=id

It is the responsibility of the commissioning client company to report that they have an agreement with a named market research agency, its date and the purpose of the agreement (i.e. market research).

It is the responsibility of the market research agency (or if used, their sub-contractors) to report:
 
1. That an agreement with individual named HCPs exists (including a number of key details such as title, speciality, qualifications, RPPS or equivalent number, professional address)
2. The purpose of the agreement e.g. market research
3. The law states that when a benefit valued over 10 euros (including VAT) is to be given it has to be reported by named individual.  Market research incentives are considered ‘benefits’ (based on the Conseil d’Etat decision 1ère / 6ème SSR, 24/02/2015, 369074).  So incentives exceeding 10 euro (including taxes where applicable) have to be reported by named physician.  All market research studies involving healthcare professionals that take place in France have to be declared irrespective of whether a benefit or an incentive (or neither) is offered.
4. It should be noted that:
The agreed market research incentive should not be disclosed
The sponsoring company (and product) should not be named
HCP MR subjects MUST be informed of the processing of their personal data
This applies whether or not the client company is aware of MR subject identity.
 
EphMRA suggests that the agency with whom the healthcare professional has the agreement will be the reporting agency.

Reports should be made to the central public website https://www.entreprises-transparence.sante.gouv.fr/flow/login.xhtml;jsessionid=ECCC896876F382F19E1EB0AF367B227A.sunshine-entreprise
 
Reporting for January to June data should be done by 1 Aug and for July to Dec data by 1 Feb.

In France Loi Anti Cadeaux/Loi DMOS (Diverses Mesures d\'Ordre Social) requires that the relevant national association/board e.g. the CNOM (physicians) or the CNOI (nurses) etc., is informed of agreements between companies/agencies and healthcare professionals including market research studies, one month before they begin.  A reporting template does exist and is available on the ASOCs website. It is possible for organisations to apply for annual approval from CNOM in advance of carrying out market research with physicians, rather than on a project by project basis.  
 
The terms and conditions of the annual process and the access arrangements are detailed in the July 2016 article ‘New and Simplified CNOM Approval System’ which is available within the Country News, France section of EphMRA’s website http://www.ephmra.org/Country-News
http://www.legifrance.gouv.fr/affichCodeArticle.do?idArticle=LEGIARTI000006688680&cidTexte=LEGITEXT000006072665&dateTexte=20100914
 
Further information upon Loi Bertrand and Loi Anti-Cadeaux may be found within the Country News, France section of EphMRA’s website http://www.ephmra.org/Country-News

4.28

In the USA generally speaking the federal Sunshine Act does not include mandatory disclosure of survey incentives made by drugs companies or their agents to doctors.  While survey payments were included in initial versions of the law and have been the subject of ongoing debate in Congress, the law generally excludes thank you payments for taking part in surveys provided the company sponsoring the research is unaware of the MR subjects’ identity.  However some state laws are different.  The CASRO, PMRG and the MRA Association have advised that to their knowledge the Sunshine Act does not require agencies to identify to client companies the names of healthcare professionals who report adverse events.  For further information see: http://www.casro.org/news/137727/Physician-Payment-Sunshine-Act-Alert.htm 


For further details upon US state Sunshine laws see:

http://www.policymed.com/2014/04/physician-payments-sunshine-act-review-of-individual-state-reporting-requirements.html


Re-contacting MR Subjects

4.29

Informed consent requires that if it is necessary to contact a MR subject again to ask further questions (other than for quality control purposes), consent for re-contact MUST be sought at the time of the recruitment interview or during the interview; even if only simple clarification is needed.  When children are researched consent for re-contact should be sought from the responsible adult and the child separately.


4.30

MR subjects agreeing to re-contact MUST be fully informed of the purpose of re-contact and who will make it.  Re-contact questions should reflect the possible reasons for the re-contact, such as for a second stage of the study, to ask a question missed or further explore a particular issue.  The question "May we contact you for future research?” is not sufficient to allow re-contact, this type of standard question is really panel building question as it asks about any other projects occurring at an unspecified future time.



4.31



In Germany, if personal data is stored for re-contact for which informed consent has been given, the personal data MUST be stored separately from any additional data about the individuals.  The merging of data for the specific selection of MR subjects is done by means of a code number.


https://www.adm-ev.de/index.php?eID=tx_nawsecuredl&u=0&file=fileadmin/user_upload/PDFS/R07_E.pdf&t=1478612980&hash=eb1af16263929c08fef4bb4f5aa54f80570cc8c1



Transferring Personal Data outside the European Economic Area (EEA)

4.32
Transferring personal data outside the European Economic Area (EEA)
You must not transfer personal data outside the EEA unless there are adequate data protection measures in place.  The EU Commission provides a list of countries or territories providing adequate protection for data subjects in connection with the processing of their personal data, see the European Commission’s data protection website at: http://ec.europa.eu/justice_home/fsj/privacy/thridcountries/index_en.htm 
If you have to transfer personal data to counties outside the EEA or that are not listed as having adequate protection you may consider other means of guaranteeing the personal data you transfer is adequately protected by:
  • Using other legal grounds, such as unambiguous and explicit consent from individuals for the transfer of their personal data for processing
  • Using Model Contract Clauses (as approved by the European Commission)
  • Implementing binding corporate rules (BCR’s) for transfers within a corporate Group.

When transferring data outside of the EEA you must comply with all data protection principles.  Fair and lawful processing will in most cases require you to inform individuals about transfers of their transfers of their personal data to third parties overseas.


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