e4ethics

Why have e4ethics and CVS been created? What risks are we trying to address and what was the prevalence of breaches to these risks?

Both European Federation of Pharmaceutical Industries and Associations (EFPIA) and MedTech Europe (MTE) Codes’ purpose is to regulate interactions between member companies and Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs), in order to ensure that industry’s support of certain activities does not fuel inaccurate perceptions regarding the relationship between industry and HCPs (e.g. clinicians, physicians, and nurses). These relationships should not raise questions regarding their bona fide nature and industry should ensure that these cannot be construed as inappropriate value transfer and illegal financial ties between industry and HCPs. In that regard, the Codes cover all types of interactions, such as research and consulting agreements as well as supporting HCPs to attend company Events (e.g. product trainings) or ThirdParty Organised Educational Events. In the latter case, because HCPs are often supported by healthcare companies to attend conferences, it is critical that this support is conducted in the most ethical, consistent and transparent manner. In that framework, the two systems e4ethics and CVS have been created to centralise the decision making for the industry for the international congresses.

What is CVS?

The Conference Vetting System (CVS) is an independently managed system which reviews the compliance of Third-Party Organised Educational Events (TPOEs) with MedTech Europe Code of Ethical Business Practice and Mecomed Code of Business Practice to determine the appropriateness for companies which are members of MedTech Europe and Mecomed to provide financial support to such Events in the form of Educational Grants or commercial activities (booths, advertising, satellite symposium). CVS was designed similarly to e4ethics and reviews the same aspects of Third-Party Organised Educational Events (TPOEs).

What is EthicalMedTech?

EthicalMedTech is the compliance portal of MedTech Europe. It features all compliance initiatives carried by the association. e4ethics will be integrated to that platform to centralise the assessment process and information related to it for both EFPIA and MedTech Europe members.

What is e4ethics?

Through e4ethics EFPIA supports monitoring of multinational events in Europe, by pre-assessing events with regard to the EFPIA Code of Practice. Companies belonging to the EFPIA membership need to have a positive assessment, in order to sponsor, participate or collaborate in an event.  

Why the migration of e4ethics with CVS?

In a context of EFPIA/MedTech Europe respective broad ethical programs, both associations decided to link the assessments of the EFPIA’s e4ethics and MedTech Europe’s CVS. An EFPIA Board decision in March 2020 endorsed binding nature of the e4ethics assessments for EFPIA members and alignment with the MTE criteria. Building on existing capacities to create efficiency, the objective of such a move is to ensure consistency and harmonisation across the healthcare industry, for the benefit of all stakeholders involved.  

What does that integration mean for EFPIA members?

The key changes for EFPIA members are the following:

• The assessments will be single composite assessment, either compliant (green) or non-compliant (red). As such, e4ethics will move away from the colour-code for of each of the 5 criteria in place previously.
• Assessments will be binding. From 1 January 2021, e4ethics assessments will no longer be recommendations but will be binding, meaning that sponsoring, participating or collaborating in an Event that has not been approved or has been qualified as non-compliant by e4ethics, would be considered a breach to the EFPIA Code which could be enforced by the competent national Code authorities.
• Submission to e4ethics will be mandatory from 1 January 2021. This means that EFPIA Member companies will have to have a positive assessment if they want to collaborate and/or sponsor directly or indirectly. Submissions can be made either by conference organisers or by Members themselves.
• Assessment criteria are slightly amended (Annex I).
• There will be an appeal’s process managed by an independent Compliance Panel.

 

What does this integration mean for EFPIA stakeholders?

The advantage for HCOs and PCOs is that there will be consistency among both sectors and there will be a substantial efficiency gain as only one team will review the conferences and one contact point, and one process, instead of two with slightly different rules.

What is the scope of the assessment’s decisions?

The decisions are binding on both EFPIA and MedTech Europe members, meaning a Third-Party Organised Event assessed as not compliant cannot receive any form of support by the member company, including Educational Grants, satellite symposia and/or booth rental. This stems from an EFPIA Board decision of March 2020 which rendered the e4ethics platform binding, meaning that sponsoring, participation or collaboration in an Event that has not been approved or has been qualified as non-compliant by e4ethics is considered as a breach to the EFPIA Code and could be enforced by the competent national Code authorities. In view of the rationale of the CVS/e4ethics system, the binding nature is mostly relevant to Member Companies, as the member companies would typically support such Event but if there was a situation where a member association would also consider support a TPOE, the assessment would be binding for them as well.  

What type of Events need to be submitted to e4ethics?

The Events qualifying for assessments under e4ethics remain unchanged, i.e. major international Events taking place in Europe – i.e. Events in which Healthcare Professionals of 5 different countries may take part, and which are expected to attract a significant number of participants (at least 500). This qualification needs to be made by the submitter. As such, exceptionally, it could happen that national congresses which are out of scope, would qualify because the submitter knows that HCP attendants come from 5 different countries and therefore submits the Event. For avoidance of doubt, please note that Company Organised Events are out of the scope and so are national Events  

Are Patients Organisations’ congresses in scope of e4ethics?

Events organised by Patients Organisations for a patients’ audience are out of scope of the system.  

What about Virtual Events, how are they defined and are they in scope? In addition, what about congresses, which have not yet decided if they do it life, virtual or hybrid?

Virtual Third Party Organised Educational Event (“Virtual Event”) are not subject to the e4ethics/CVS. A [standalone] Virtual Event is defined as the filming of presentations, panel discussions or live clinical procedures (e.g., hands-on sessions, surgery simulations, live surgeries, etc.) and their broadcasting (whether immediate or deferred) to an audience which is not physically in attendance. A Virtual Event is distinguished by the absence of HCP attendees, as the only HCPs physically present at a Virtual Event would be those involved in its creation, i.e. presentation. As a result, a Virtual Event will not be connected in any way with a physical Third Party Organised Educational Event. For the avoidance of doubt a Virtual Event can also have all or part of its speakers/presenters take part virtually. Conversely, the filming of presentations, discussions, etc. made during a Third Party Organised Educational Event (“Broadcasted Event”), and its broadcasting to audiences not present at the physically attended Event — whether contemporaneously or after the Event — do not qualify as a Virtual Event. The congress organiser needs to decide on the format before the applicability of CVS/e4ethics can be considered.  

How will companies approach the issue of meals & drinks threshold?

Meals and drinks are not part of the criteria assessed by both e4ethics and CVS. Where specific obligations exist, member companies need to ensure compliance by their own means. For avoidance of doubt, under the criterion “hospitality” will be assessed the following elements:

1. The reasonableness of hospitality, given that hospitality should be limited to reasonable hotel accommodation and meals, coffee breaks, and a conference dinner or cocktail reception to which all HCP delegates are expected to attend.
2. The hospitality offered to spouses, partners, family and/or guests, as this category of person may not benefit from hospitality sponsored by EFPIA/MedTech Europe members.
3. The appropriateness of accommodation.

Who is doing the actual assessment?

EFPIA has outsourced the assessment of TPOEs in the Pharma industry to the Compliance Officers of the CVS. The CVS Compliance Officers operate independently from EFPIA and MedTech Europe to ensure objectivity and unbiased analysis of the different element of the Event. The CVS Compliance Officers operate under the supervision of the independent MedTech Europe Compliance Panel.  

What is the MedTech Europe Compliance Panel?

The MedTech Europe Compliance Panel commonly referred to as the Compliance Panel, is an independent body composed of three members, former professionals which role is to ensure the impartiality, independence, competence, and integrity of the decision-making process and to prevent conflicts of interest. The Compliance Panel also hears appeals made by the stakeholders on an existing CVS assessment. They act as a last decision-making instance an any appealed assessment. Their role is defined in the Code’s Procedural Framework and Internal Procedure document

What’s the relation between the Compliance Panel, EFPIA and MedTech Europe?

The Compliance Panel members are independent. Their role is defined in the MedTech Europe Code’s Procedural Framework and Internal Procedure document. They oversee the CVS and its day-to-day management on which neither MedTech Europe Secretariat/Members nor EFPIA Secretariat/Members has a say. They also provide guidance and interpretation of MedTech Europe Code’s provision however they do not provide such services to EFPIA members. For guidance and disputes relating to the EFPIA Code of Practice, EFPIA members need to refer to EFPIA procedural requirements.  

What will the role of Member Associations, members of EFPIA be, under the new system?

Under the new system, the Member Associations will not have a formal role anymore in the process. However,in particular in difficult cases, for example in an appeal review process, the Compliance Panel may, at their discretion, consult the relevant member association for additional information. In addition, both the Compliance Panel members as well as the CVS Compliance Officers are available to meet and discuss with member associations, on any relevant topic, but in particular where an association is considering setting up its own national vetting system, mainly to ensure clear boundaries.  

Was it envisaged to have Compliance Officers and/or Compliance Panel members with pharma experience going forward?

Yes, this has been considered in the design of the collaboration. In addition, the three CVS Compliance Officers and three members of the Compliance Panel have been specifically trained on the EFPIA Code of Practice. In addition, even though not a requirement, one of the Compliance Officers has relevant pharma experience and both of the incoming and outgoing members of the Panel have had extensive work experience as employees of pharmaceutical companies before retiring and joining the Panel.

Who is eligible to make submissions?

Submissions can be made in the system by MedTech Europe members, EFPIA members, the Healthcare Organisations (e.g. scientific societies) or a Professional Conference Organisers. The CVS Compliance Officers cannot proactively make submissions in the syste  

How do I ensure that an Event my company wants to support is assessed?

For an Event to be assessed, it must be submitted by an EFPIA member, a Professional Conference Organiser, a Scientific Society or Healthcare Organisation. The CVS Compliance Officers will not proactively make submissions in the system (i.e. one of the differences with the e4ethics system prior to 2021)  

Are submissions mandatory?

Yes, from 1st January 2021, EFPIA members will not be allowed to support a TPOE that has not been prior assessed and been deemed compliant and published as such on e4ethics website. It however does not matter who makes the submission and a company may decide to contract this obligation to for example a PCO.  

What is the difference between mandatory submission and binding decision?

A mandatory submission means that EFPIA and MedTech Europe members must verify that a positive assessment is available before proceeding with any type of support of a TPOE. A binding decision means that once the TPOE has been assessed, the EFPIA and/or MedTech Europe member has to abide by it. In other words, a member would be in infringement of the applicable Code if they provide support to an Event assessed as not compliant. The decision on an Event can be appealed by any stakeholder to the Compliance Panel. However, the Compliance Panel’s decision is final and binding.  

Specifically for EFPIA members, if direct sponsorship is prohibited in a country (e.g. Sweden), is the assessment nevertheless binding for other types of support?

Yes. The scope of the assessments covers direct and indirect types of support to a TPOE (e.g. direct sponsorship of an HCP, Educational Grant, satellite symposium). Clarification can be found in Annex E of the EFPIA Code of Practice.  

Where will I find the assessments decisions?

All TPOEs submitted for assessment will be posted in the online calendar. All stages of the assessment process can be monitored through the publications in the online calendar

What are the possible status of an Event?

Intermediary status

• To be reviewed (in purple): the Event submitted is in the review process and no decision has yet been rendered by the Compliance Officers.
• Provisionally Compliant (in blue): means the most challenging criteria of an Event, namely the geographic location and conference venue, have been assessed compliant. The Compliance Officers are waiting for additional information from the submitting party to finalise the assessment.
• Correction Notice (in orange): means that a non-compliant aspect of an Event has been identified by the Compliance Officers. A communication has been sent to the organisers with a proposed correction. The organiser have 10 days to implement that correction and provide proof of the change to the Compliance Officers to avoid having their Event assessed as not compliant.

Final Status

• Compliant (in green): the Event presents no liability for EFPIA/MedTech Europe members and is eligible to receive appropriate support from members.
• Not Compliant (in red): a flag is raised. Different forms, as per the respective Codes, of support to an Event should be suspended, withdrawn, or cancelled as per the agreement with the conference organising party.
• Not assessed (in grey): the Event submitted is not eligible to be assessed under CVS/e4ethics. For example, Policy Conferences as well as National Events (with only local HCPs participating to this national event) are out of scope.

 

Will we be able to see if someone has already submitted an Event for assessment, in order to avoid duplication?

Yes. The Event will appear on the online calendar in purple, i.e. to be reviewed. Please refer to the question above on the different possible status of an Event.  

How long does the review process take, as this is important in view of companies’ booking good slots and exhibit space?

The CVS Compliance Officer will endeavour to render assessment decisions within 30 days of receipt of a complete online submission form. Submissions must be made via the online submission form no later than 75 days prior to the TPOE starting date. All decisions will be published on the ethicalmedtech website, specifically on the Events calendar. However, there is an additional feature called “Pre-Clearance” which provides Third Party Educational Event Organisers the possibility to seek the advice on whether or not the minimum required criteria to initiate discussions with companies on their financial support to an event are compliant with the relevant Code(s). Such advice can also be sought by Third Party Educational Event Organisers before they sign any contracts or make any financial commitments with suppliers regarding the Event, meaning potentially yeas in advance. Once the Event is listed as “Provisionally Compliant (in blue)”, this means the most challenging criteria of an Event, namely the geographic location and conference venue, have been assessed compliant. The Compliance Officers are waiting for additional information from the submitting party to finalise the assessment, however companies can already engage in planning considerations, as other criteria are much more straightforward to change, if they presented any non-compliant element.  

What is an appeal?

A member or a stakeholder in disagreement with an assessment decision can choose to challenge the assessment with supporting evidence. These requests will be reviewed by the Compliance Panel. The Compliance Panel can decide to overturn the decision or not.

What is the exact meaning of the pilot phase is starting on Jan. 1st? Is it a « probationary » period or a transition period during which the current e4ethics assessment will survive in parallel with CVS?

Starting on 1 January 2021, 6-months pilot will be launched to monitor the efficiency of both platforms merge and to test the system “in the field” so that if there is a need, issues may be rectified. In addition, since this alignment has process related changes for some of the EFPIA members, as well as some PCOs and HCOs, this pilot gives all stakeholders a chance to adapt their own processes. As mentioned previously, e4ethics decided to align its assessed criteria with CVS’s including the online proactive submissions by member companies, scientific societies or PCOs. Both platforms will operate independently from EFPIA and MedTech Europe, via a common Compliance team, to ensure objectivity and independence in conference assessments. In addition, the submission procedure, assessed criteria and appeal’s process will be identical. The Events qualifying for review will stay different, at least during the pilot phase, but assessment outcomes will become binding for all member companies and, as it is already the case for MTE members, all companies need to have a positive assessment if they want to support an Event.  

What are the main changes for EFPIA members?

The key changes are the following:

• Website of e4ethics: the e4ethics website will now be embedded in the www.ethicalmedtech.eu platform.
• These assessments will be single composite assessment, either compliant (green) or non-compliant(red). As such, e4ethics will move away from the colour-code for of each of the 5 criteria in place for the moment.
• Assessments will be binding. In January 2021, e4ethics assessments will no longer be recommendations, meaning that sponsoring, participating or collaborating in an Event that has not been approved or has been qualified as non-compliant by e4ethics, would be considered a breach to the EFPIA Code which could be enforced by the competent national Code authorities.
• Submission to e4ethics will be mandatory from 1 January 2021. This means that EFPIA Member companies will have to have a positive assessment if they want to collaborate and/or sponsor directly or indirectly. Submissions can be made either by conference organisers or by Members themselves.
• Assessment criteria are slightly amended (see Annex I).
• Appeal’s process managed by an independent Compliance Panel.
  • An appeal of a e4ethics decision may be filed by the Third Party Educational Event Organiser with the Compliance Panel provided that certain requirements are respected.

 

What is not going to change for EFPIA members?

• Scope of Events: At least for the duration of the 6-months pilot, starting from 1 January 2021, the Events qualifying for assessments stay unchanged, i.e. major international events taking place in Europe – i.e. events in which Healthcare Professionals of 5 different countries may take part, and which are expected to attract a significant number of participants (at least 500).
• Type of support and participation will not change. The type of support stays regulated under the respective EFPIA and MedTech Europe Codes. As such, what and how EFPIA member companies can support Events and Healthcare Professionals will differ from MedTech Europe member companies, the latter having to abide by different rules, as they can never sponsor Healthcare Professionals directly. EFPIA controversially can financially support the cost of travelling, registration and lodging of individual European healthcare professionals to attend international third-party conferences in accordance with the EFPIA Code, and from 1 January 2021, as long as the Event has been vetted as compliant.

 

At present, i.e. mid-November 2020, what happens to the congresses already approved by e4ethics and/or companies, for 2021 and co-related question, how to deal with engagements taken before today?

Conferences submitted in e4ethics under the former process have already been transferred and analysed through the lens of the new rules, and mostly the assessments were aligned. Practically, the binding nature of the assessments means that from 1 January 2021, EFPIA member companies will be able to support only TPOE assessed as compliant by CVS/e4ethics. A contrario, where commitments are taken and a TPOE is eventually assessed as not compliant, members will need to withdraw from any kind of support to such a TPOE. As such, going forward, companies are advised to include a standard contractual clause allowing them to withdraw without penalties where assessments are non-compliant (in Annex II an example of a standard contractual clause). For avoidance of doubt, leniency may be considered for contractual arrangements signed by EFPIA members if signed before a certain date, which cannot be later than 31 December 2020.

Annex I – Assessment criteria

• Event Programme Schedule/Relevance – no difference
• Venue and Exhibition Area – minor variation, mainly relating to differentiating Venue and Location.
• ospitality – minor variation, mainly relating to the hospitality offered to spouses, partners,family and/or guests and the choice of accommodation offered.
• Other Activities and prohibition of entertainment (e.g. sporting or leisure) – no difference in substance but assessed under a different criterion.
• Accompanying Persons – same principle but assessed under a different criterion.
• New criterion – Event registration package, looks at the following aspects:
  • Registration Packages: The registration fee should cover only the scientific programme, authorised activities and hospitality.
  • Spouses, partners, family and/or guests’ packages may not be paid for by EFPIA/MedTech Europe Members – This category of person may not register for the Event or participate in the scientific programme (unless he or she is a qualified HCP with a legitimate interest in the programme).
  • Social programme – Any social, sporting and/or leisure activities or other forms of entertainment must be outside of the programme schedule and paid for separately by the HCP delegates. They should not dominate or interfere with the overall scientific content of the programme and must be held during times that do not overlap with scientific session.
• New criterion – communication support, i.e. Advertising support (brochures, website and other materials) should highlight the scientific nature of the programme content.

 

Annex II: Example of a standard contractual clause

Disclaimer

This Template has been prepared by EFPIA and MedTech Secretariats as a suggested guide only and should not be construed as legal advice for any particular facts or circumstances. Use of this Template or any parts thereof shall be at the sole discretion and risk of the user parties. EFPIA and MedTech shall not be held liable for any loss or damage that may result from use of this Template or any parts thereof. EFPIA and MedTeh reserves the right to change or amend the Template or any parts thereof at any time without notice.

Article XX – Ethics and Compliance X.1 The HCO/PCO shall ensure that all use of sponsorship funds: a) comply with the EFPIA Code of Practice and all relevant local laws, regulations and industry codes of conduct; and b) comply with applicable disclosure requirements of the support as well as any other obligation relating to any beneficiaries of the supports to any professional body, institution, or government agency that requires such disclosure. X.2 Where applicable, a Third Party Organised Educational Event (the “Event”) must be approved by the Ethical MedTech Conference Vetting System and/or e4ethics prior to any of the support being used to support the Event. The HCO/PCO undertakes to submit the Event, specified under the Programme for the assessment under the Ethical MedTech Conference Vetting System and/or e4ethics. X.3 The Parties specifically agree that the provision of the Agreement is not implicitly or explicitly linked to an agreement for the HCO/PCO to purchase, lease, recommend, prescribe, use, supply or procure the Company’s products or services or used to reward past purchases, uses, orders recommendations, or referrals.