Please note that this Code of Conduct applies to the Diagnostic Imaging and Oncology Care sectors. The Pharmaceutical sector is governed by the ABPI Code of Practice for the Pharmaceutical Industry 2016.
1. Introduction
This Code of Conduct governs AXREM members’ (“Members”) interactions with Healthcare Professionals. It supersedes all previous editions and becomes effective from December 2023.
“Healthcare Professionals” refers to individuals (and the institutions for which they work) involved in decision-making processes relevant to the procurement of Members’ products or services. This includes medical staff, professions associated to medicine, nurses, healthcare managers, procurement agencies and external consultants employed by hospitals in the UK.
As participants in an industry largely funded from public funds, AXREM members recognise that adherence to the highest levels of integrity and ethical standards and compliance with all industry and procurement laws are critical and essential for the conduct of business.
Members welcome the guidance provided to Health Service staff by the Department of Health and Social care and the Common Service Agencies for Scotland, Wales and Northern Ireland in documents such as Standards of Business Conduct for NHS Staff. Members also fully endorse the Code of Conduct issued by COCIR, the European trade association for the industry, and have incorporated its provisions into this national code.
Members agree to commit any of their dealers and agents to abide by the principles contained in this Code.
This Code sets a minimum standard of conduct, but is not intended to supplant or supersede supranational, national, or local laws or regulations or professional codes (including company codes) that may impose particular requirements upon Members or Healthcare Professionals.
2. Basic Principles
The following fundamental principles form the foundation of this Code:
2.1. The Principle of Separation: A clear separation must exist between any advantages or benefits granted by Members to Healthcare Professionals or Procurement staff and the decision-making process resulting in the procurement of Members’ products or services. The purpose of this principle is to ensure that such advantages or benefits do not influence business transactions between Members and Healthcare Professionals or Procurement staff.
2.2 The Principle of Transparency: Advantages or benefits to Healthcare Professionals or Procurement staff should be disclosed to their institution’s administration or management.
2.3 The Principle of Proportionality: Any consideration given to a Healthcare Professional in exchange for a service provided or other performance should not exceed fair market value as defined in the COCIR Code of Conduct 2020 https://www.cocir.org/fileadmin/4.1_Business_and_Innovation/Code_of_Conduct/COCIR_Code_of_Conduct_2020.pdf Also, with respect to entertainment, the value must be reasonable and appropriate to the position and circumstances of the recipient, and the occasion on which it is given.
2.4 The Documentation Principle: The granting of any advantages or benefits to Healthcare Professionals by Members should be documented.
Members are aware of the provisions of the UK Bribery Act (2010), and the following clauses (whilst not being exhaustive) shall also serve as a reference with regard to the expected and acceptable approach compliant with this Act. https://www.legislation.gov.uk/ukpga/2010/23/contents
3. Meetings – Organised by Members
3.1 Purpose: The meeting should have a genuine educational, scientific or business purpose as its primary purpose and there must be a legitimate reason for inviting each Healthcare Professional to the relevant event.
3.2 Meeting locations: All Member organised meetings should be conducted at an appropriate location and venue.
3.3 Permitted Expenses: Members may pay for reasonable travel and lodging costs incurred by Healthcare Professionals for attending Member organised meetings.
3.4 Separation from Sales: It is always inappropriate for Members to organise hospitality for the purpose of inducing Healthcare Professionals to enter into a business transaction. It is also inappropriate for Members to arrange hospitality contingent upon past, present or future business transactions.
3.5 Guests: It is inappropriate for Members to invite to a meeting any other person without a professional interest in the meeting, such as the spouse or guest of a Healthcare Professional. Members will ensure that their invitations will not be interpreted as extending to such individuals. It will always be inappropriate for Members to pay for the travel or lodging expenses for such individuals. In addition, it will be inappropriate for Members to pay for the expense of meals and hospitality for such individuals.
It is recommended that Members include the following paragraphs with any Meeting Invitation:
(a) Commensurate with the AXREM (Association of Healthcare Technology Providers for Imaging, Radiotherapy and Care) Code of Conduct, <<INSERT COMPANY NAME>> would like to stress that this invitation has not been extended to you for purposes of influencing your actions or persuading you to do or fail to do any act in violation of your lawful duties, in order for <<INSERT COMPANY NAME>> to obtain or retain business or gain any other improper advantage or benefit in the conduct of business.
(b) In accepting this invitation, we understand that you have verified your compliance with all applicable legal requirements.
(c) Where appropriate, we also recommend, as a precautionary measure and only insofar as you consider it to be reasonable, that you seek approval from your Employer relating to your acceptance of this invitation.
—————————————————————————————————————
1) This section applies to business events that also involve Hospitality or Entertainment. This does not apply to business meetings that in the normal course of business do not include Entertainment or Hospitality. Attendance at a business meeting with meal would not be covered by this Code, unless the meal was accompanied by attendance at a Hospitality or Entertainment event, and the nominal value of the Hospitality or Entertainment component exceeded the value of the meal.
4. Conferences – Organised by Third Parties
4.1 Financial Support to Conferences: Members may support conferences organised by third parties. Members may provide financial support to third parties under the following conditions:
(a) The conference is primarily dedicated to promoting objective scientific and educational activities.
(b) The third party is responsible for and controls the selection of program content, faculty, educational methods, and materials.
(c) The third party independently invites and selects individual Healthcare Professionals who will participate in the conference or training and determines the payment of their expenses, as the case may be.
(d) The third party independently selects speakers and determines the payment of their expenses.
(e) the support of a conference by a Member is clearly stated in advance of and at the meeting.
(f) The support is not specifically granted for any entertainment or hospitality.
4.2 Financial Support to Individual Healthcare Professionals: Members may not provide financial support to any individual Healthcare Professional for his/her passive attendance or active participation as a speaker in a third-party conference. Therefore, Members may neither pay for the registration fee, travel, and lodging costs nor for honoraria for a speaking engagement.
However, Members may provide financial support to an individual Healthcare Professional for the Registration fee, travel, and lodging costs to:
(a) Attend a hands-on procedure training, organised by a third party, which is performed in a clinical environment or
(b) Speak or provide professional training at a satellite symposium organised by a Member in the margins of a third-party conference; in this case, Member may also pay honoraria for a speaking engagement.
5. Hospitality
5.1 In Connection with Meetings or Conferences: Members may pay for reasonable hospitality in the form of meals, drinks, receptions and entertainment (e.g. a music, sports or theatre event) in connection with the programme of a meeting or conference. However, any such hospitality should be in accordance with local law, subordinate in both time and focus to the purpose of the meeting or conference.
5.2 Unconnected with Meetings or Conferences: Members may pay for business meals and drinks, that take place in a setting that is conducive to business discussions and is not selected because of its leisure or recreational facilities. However, Members may not pay for any other kind of hospitality, for example in the form of entertainment as described in 5.1.
6. Clinical/Supplier Site Visits
6.1 Modality Procurement: The industry recognises the need to provide, for potential users, procurement officers or their scientific and technical advisers, opportunities to visit working installations of innovative equipment for the purpose of assessing, testing, or forming subjective opinions on the suitability of the equipment to meet clinical needs. Such visits may include attending Supplier’s research and/or manufacturing facilities.
Bearing in mind that manufacturers and suppliers are committed at all times to minimise costs as an essential part of ensuring optimum value for money in providing equipment to the Health Service, AXREM member companies have established procedural guidelines for such visits as follows:
(a) Before any action is taken with regard to a proposed visit, permission will be requested from the management of the institution/customer contemplating purchase, that the manufacturer may proceed with the arrangements.
(b) Should permission be given, the institution/customer will be asked whether it wishes to pay the costs, e.g. travel and hotel accommodation, or, if that should not be the case, that it is in order for the manufacturer to bear these costs. Generally, the most economical and sustainable means of transport shall be booked, as appropriate for the distance travelled, i.e. Economy within UK and Europe, Premium Economy for long-haul.
(c) The industry recognises the changing nature of procurement and the complexity of multi-unit and multi-site procurements of complex technical solutions. AXREM recognises the growing breadth of technical solutions offered by Member companies. The number of visitors shall always be restricted to the absolute minimum compatible with achieving the objective of the visit. This is important, not only for the potential users but also for, and in respect of the hosting site/facility.
The number of visitors accommodated by Members will vary dependent on the nature and complexity of the proposed procurement, however, to ensure consistency amongst Member companies and to meet our stated commitment of minimising costs, the number of visitors funded by Members will not exceed three (per procured system) unless the equipment is radiotherapy equipment where this could be increased to four to accommodate an engineering presence.
The costs of additional visitors will be borne by the institution/customer.
(d) For each project only one supplier funded visit per equipment shall usually be made to a clinical or reference site.
6.2 IT Procurement (e.g. PACS, RIS, VNA): For modality Capital Equipment the above guidelines have been widely accepted but for IT Solutions, particularly over multiple sites, there can be a need to cater for an increased number of different departmental specialists. Therefore, for IT Solutions the above guidelines will apply although the recommended maximum number of attendees funded by Members is
7. Consultancy Agreements
7.1 Agreements in Writing: Consultancy agreements between Members and Healthcare Professionals must be written, signed by both parties, and specify all services to be provided.
7.2 Separation from Sales: Consultancy agreements between Members and Healthcare Professionals should not be made on the basis of the volume or value of business generated by the consultants or their affiliates or be contingent on past, present or future business transactions.
7.3 Management Approval: Consultancy agreements between Members and Healthcare Professionals must be approved by the administration or management of the institution with which the Healthcare Professional is affiliated.
7.4 Fair Market Value Compensation: Compensation paid to Healthcare Professionals for consultancy should not exceed fair market value for the services provided.
7.5 Legitimate Need: Members should only enter into consultancy agreements where a legitimate need and purpose for the contracted services has been identified in advance.
7.6 Consultant Qualifications: Selection of consultants should be made on the basis of the Healthcare Professionals’ qualifications and expertise to address the identified purpose. Selection should not be made on the basis of the volume or value of business generated by the consultants or their affiliates (see Section 7.2).
8. Gifts
Members may provide gifts such as branded promotional items to Healthcare Professionals. Any gift from a Member to a Healthcare Professional should be modest and occasional in nature and not exceed any amounts specified by the relevant law. Gifts may not be given in the form of cash or cash equivalents. 2)
9. Charitable Donations
9.1 Charitable Purpose & Recipient: Members may make donations for a charitable purpose. Donations should be made only to charitable organisations and never to individuals.
9.2 Separation from Sales: It is inappropriate for Members to make charitable donations for the purpose of inducing Healthcare Professionals to enter into a business transaction. It is also inappropriate for Members to make charitable donations contingent upon past, present or future business transactions.
9.3 Transparency: The recipient of the donation and the recipient’s planned use of the donation should be documented. Members must be able to justify the reason for the donation at all times.
9.4 Evaluation & Documentation: It is recommended that Members will establish a process whereby they can ensure that requests for Charitable Donations are evaluated separately to the Member’s commercial activities and are consistently documented.
2) This section is not intended to address other types of interactions between Members and Healthcare Professionals that are addressed more specifically elsewhere in this Code or address the legitimate practice of providing appropriate sample products and opportunities for product evaluation
10. Public Procurement
10.1 Main Principles: Members value the main principles of public tendering laws: transparency of tendering processes and fair and equal treatment of all bidders.
10.2 Improper influencing: It is always inappropriate for Members to offer, directly or indirectly, gifts or other benefits in order to improperly influence Healthcare Professionals in the public tendering process. Members shall refrain from any activities that are likely to be seen as aimed at improperly influencing Healthcare Professionals.
10.3 Technical Specifications: Members acknowledge that it is important that Contracting Authorities formulate open and objective technical specifications to afford fair and equal access to bidders.
10.4 Exemptions from Public Tendering procedures: Members understand that Contracting Authorities have only limited possibilities to exempt themselves from public tendering procedures. Members should not encourage Contracting Authorities to unduly seek such exemptions.
10.5 Consultants, use of Third Parties: Where a Member, as part of a technical dialogue or otherwise, acts as an independent consultant for the Contracting Authority, that Member shall do so only in a way that would not violate the principle of equal treatment of bidders.
10.6 Notice of Future Tenders: More specifically, where a Member, acting in a role of an independent consultant for the Contracting Authority, is or reasonably should be aware of the likelihood of a future tender arising as a result of the consulting services the Member provides to the Contracting Party, and which the Member intends to participate in, that Member shall request that the Contracting Authority issues an appropriate notice of any such future tender so that all potential bidders may have equal and fair notice of that tender opportunity and are aware of the role of the Member in a transparent way.
10.7 Amendments to Contract or Scope of Supply. Members understand that during or after the tendering procedure, Contracting Authorities will have only limited possibilities to make changes to tender documentation, contractual terms, or scope of supply.
11. Research Agreements
11.1 Research Services: When a Member contracts with a Healthcare Professional for research services, there must be a written agreement specifying all services to be provided and a written protocol for a genuine research purpose.
11.2 Research to be Legitimate & Documented: The research should be legitimate scientific work. Well-defined milestones and deliverables must be documented in a detailed written agreement. Selection of the Healthcare Professional should be made on the basis of qualifications and expertise to address the identified purpose.
11.3 Separation from Sales: The research funding should not be linked to or contingent upon past, present or future sales of the Member’s products or services to the Healthcare Professional. Conditions linking the research funding with the Health Professional’s purchase of products or services from the Member are only permissible if the said products or services are being purchased for specific use within the research or are requested as part of a tender.
11.4 Management Approval: Research Agreements must be approved by the administration / management of the institution with which the Healthcare Professional is affiliated.
11.5 Fair, Market Compensation: Compensation paid to Healthcare Professional should be consistent with fair market value for the services provided.
12. Loan Equipment
Members may offer equipment for demonstration and evaluation to Healthcare Professionals for a reasonable period of time. Written approval by Healthcare Professionals’ administration or management is required and should be filed alongside the appropriate loan documentation.
13. AXREM Data collections
AXREM operates confidential, anonymous market data collections where the aggregated reports are only available to participants. We take the sensitive nature of our members data very seriously and take great care to maintain confidentiality and eliminate disclosure.
Acknowledging the consolidated results of these collections are a member benefit, members agree not to share the data with any parties outside of the contributor community or put in the public domain.
14. Monitoring the Code
Anyone concerned that a Member may have breached this Code should report such issues directly to the Chief Executive Officer of AXREM. Such concerns will be referred to senior legal or compliance officers within the relevant Member for proper investigation, handling, and resolution. AXREM shall be informed of the resolution and consider whether further activity is required which may include referral to the Governance Sub-Committee to consider the matter and make recommendations to the Executive Committee. At this stage, the process is transparent, with all AXREM parties aware of the issue and those involved.
AXREM has established the structure and composition of the Governance Sub-Committee.
The Governance Sub-Committee Convenor shall chair the Committee and other Members may be invited to join the Governance Sub-Committee such as legal counsel or compliance officers from at least two Member companies. The Governance Sub-Committee may co-opt other healthcare professionals to support/advise the committee. Member companies involved or implicated in any breach who are also members of the Governance Sub-Committee shall not be directly involved in the matter to be adjudicated. Therefore, the
structure of the Governance Sub-Committee will have impartial representation and will be attended by the Chief Executive Officer of AXREM.
The Governance Sub-Committee will continue to develop a policy to address non-compliance with this Code of Conduct. This policy has already enacted and will continue to include, publication of the Governance Sub-Committee decision/rationale, as one of a range of sanctions, to ensure compliant behavior and sustain the reputation of the industry.
Last updated 8th January 2024