EFPIA CODE QUIZ

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1. Why EFPIA developed the Code of Practice?

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In achieving our mission to improve and extend patients’ lives by creating innovative vaccines and treatments, we at EFPIA believe that complying with applicable legal dispositions[1] is not enough.

Our industry has a responsibility towards the health communities, and recognises that society has particularly high expectations on the way we operate.

For this reason, in addition to complying with extensive legal requirements, EFPIA and its Member Associations, have adopted a self-regulation that is stricter than the European Directive, to ensure that our initiatives meet the high standards of integrity that patients, governments and other stakeholders expect from us.

[1] Directive 2001/83/EC of the European Parliament and the Council, on the Community code relating to medicinal products for human use, link.

2. Whom the EFPIA Code applies to?

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The EFPIA Code applies to:

  • Healthcare professionals.
  • Healthcare organisations, such as a hospital, clinic, foundation, university.
  • Patient organisations.
  • Patient organisations’ representative: a person who is mandated to represent and express the collective views of a patient organisation on a specific issue or disease area.

The EFPIA Codes also applies to all EFPIA members, which include:

  • Member companies and trade associations, affiliate member companies and affiliate trade associations, and to Vaccines Europe.
  • Separate members’ entities such as subsidiary companies.

Member Companies are responsible for the obligations imposed under the EFPIA Code even if they commission a Third Party to act on their behalf.

3. Which ethical principle(s) drive a pharmaceutical company’s behaviour?

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All EFPIA member companies work to a set of principles described in the EFPIA Code

  • Patients centricity: We aspire to ensure that everything we do will ultimately benefit patients.
  • Integrity: We interact with all our stakeholders in an open manner and ensure that our communications are accurate, legitimate and balanced.
  • Respect: We value the importance of independent decision making by stakeholders, based on evidence and including patient interest.
  • Transparency: We are open about our activities and interactions and encourage stakeholders to act with the same openness.

4. Which topic(s) are not found in the EFPIA Code?

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B
Answer

Scope of the EFPIA Code

The EFPIA Code covers the following activities:

  • Promotion of prescription-only medicines to healthcare professionals.
  • The provision of informational and educational materials, items of medical utility, hospitality in relation to events and medical samples.
  • Interactions between Member Companies and healthcare professional, healthcare organisations and patient organisations.

The Code does not cover the activities directed towards the public related to non-prescription Medicinal Products.

5. In which of the following situations an employee from a pharmaceutical company does not need to follow the EFPIA Code?

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B
Answer

The Code does not cover the activities directed towards the public related to non-prescription Medicinal Products.

The EFPIA Code applies to:

  • Healthcare professionals.
  • Healthcare organisations, such as a hospital, clinic, foundation, university.
  • Patient organisations.

Patient organisations’ representative: a person who is mandated to represent and express the collective views of a patient organisation on a specific issue or disease area.

6. An Austrian-based pharmaceutical company organises its annual conference in Vienna. Can free entry passes to the Opera be included in the travel contributions to the invited physicians?

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B
Answer

EFPIA Code, Art 10.08

Pharmaceutical companies can only offer hospitality when such hospitality is appropriate and limited to travel, meals, accommodation and genuine registration fees for a professional, promotional, and scientific events.

This hospitality must not include sponsoring or organising entertainment events (e.g. sporting or leisure).

EFPIA is committed to the enforcement of these requirements and for this reason we created e4ethics, an online platform including pre-assessment of events sponsored by industry and attended by the healthcare professionals. This is a support for EFPIA members when deciding about sponsoring, participating or collaborating in an event.

7. A pharmaceutical company is organising an event. Which of the following venue(s) is allowed?

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E
Answer

EFPIA Code, Art. 10.01

All events must be held in “appropriate” locations and venues that are conducive to the main purpose of the event, avoiding those that are “renowned” for their entertainment facilities or are extravagant.

EFPIA is committed to the enforcement of these requirements and for this reason we created e4ethics, an online platform including pre-assessment of events sponsored by industry and attended by the healthcare professionals. This is a support for EFPIA members when deciding about sponsoring, participating or collaborating in an event.

8. An employee from a pharmaceutical company meets a representative from a health authority on an ongoing health dossier. Can they offer a company branded pen, whose value is of less than 5€ to thank for the time spent together?

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B
Answer

EFPIA Code, Art. 11

Since 2013, no gift are allowed under the pharmaceutical self-regulation. This prohibition applies to physicians but also to any medical professions and public officials that can take decisions about medicines.

This provision is stricter than the legal one (Directive 2001/83/EC Art. 94) that allows gifts if they are inexpensive and relevant to the practice of medicine or pharmacy.

9. What are the principles applying to a collaboration with a patient organisation?

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EFPIA Code, Art. 21

The EFPIA principles for partnership, established with patient organizations to ensure that relationships take place in an ethical and transparent manner, are:

  1. Independence of patient organisations in terms of their political judgement, policies and activities
  2. Interactions based on mutual respect, with the views and decisions of each having equal value
  3. No promotion of prescription-only medicines
  4. Transparency in every kind of interactions with a patient organisation such as a program funding, invitation to a conference, declaration of interest, etc.

10. What do we mean with “disclosure” in the EFPIA Code?

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B
Answer

EFPIA Code, Art 23.05 + Art. 24

The Disclosure Code requires Member Companies and companies that are members of Member Associations to disclose transfers of value made to healthcare professionals (HCPs) and healthcare organisations (HCOs).

This disclosure includes, by HCP or HCO, the total amounts of value transferred, by type of activity, which could consist of, for instance, a grant to an HCO, a consultancy fee for speaking or registration fees to attend a promotional, scientific or professional event.

Each Member Company must also disclose a list of patients’ organisations to which it provides financial support and/or significant indirect/non-financial support or with whom it has engaged to provide contracted services for that Member Company.

To discover more, please have a look at our EFPIA page on disclosure.

11. If a renowned medical expert is invited to speak at a scientific event and receives a compensation from a pharmaceutical company, should this amount appear in the company's disclosure statement?

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A
Answer

EFPIA Code, Art. 23.05

A consultancy fee for speaking at an event is in the scope of the disclosure.

12. What happens if pharmaceutical companies do not comply with the EFPIA Code (self-regulation)?

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EFPIA Code, Art. 28 + Annex D EFPIA SOP

  1. To facilitate compliance with the Applicable Codes, each Member Association must establish adequate procedures for ensuring that each of its member companies complies with the requirements of such National Code and any other National Code which may be applicable to its conduct, even if the member company does not belong to the other Member Association. In order to establish adequate procedures for ensuring compliance with the Applicable Codes, Member Associations will be required, among other things, to establish appropriate complaint procedures and sanctions for breaches of their respective codes.
  1. EFPIA can intervene when a company refuse to apply a decision from a national Code authority or refuse to submit itself to applicable Codes.
  2. Any breach of the EFPIA Code, that has consequences for public order, can be brought to a national or European Court

Many thanks for participating in the EFPIA Code Quiz!
To discover more about the Code, do not hesitate to visit www.efpia.eu
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