Introduction

The Association of British Healthcare Industries (ABHI) is a UK medical technology trade association. It champions the use of safe and effective medical technologies to support high quality patient outcomes and health system efficiency.

The ABHI places ethical compliance at the heart of the medical technology industry. Healthcare professionals (HCPs) and patients must feel they can be confident in its ethical standards at all times so that they can work with industry.

It is a condition of ABHI membership that a company adheres to the ethical standards in the ABHI code of ethical business practice. The code stipulates minimum standards for members’ business practices in the UK, Europe and elsewhere.

Compliance to the code is a condition of ABHI membership, however, you do not need to be a member of the ABHI to abide by the code. Non-members may sign up to the code in order to demonstrate their commitment to good ethical practice.

The code was last updated in May 2017.

Code Principles

The ABHI defines five principles that underpin the code:

  • Image and perception
    Companies should consider the image and perception of the medical technology industry that will be projected to the public when interacting with healthcare professionals (HCPs) and healthcare organisations (HCOs).
  • Separation
    Interaction between industry and HCPs/HCOs must not be misused to influence through undue or improper advantages, purchasing decisions, nor should such interaction be contingent upon sales transactions or use or recommendation of companies’ products.
  • Transparency
    Interaction between industry and HCPs/HCOs must be transparent and comply with national and local laws, regulations or professional codes of conduct. In countries where specific provision is not made, companies shall nevertheless maintain appropriate transparency by requiring prior written notification to the hospital administration, the HCP’s superior or other locally-designated competent authority, fully disclosing the purpose and scope of the interaction.
  • Equivalence
    Where HCPs are engaged by a company to perform a service for, or on behalf of a company, the remuneration paid by the company must be commensurate with, and represent a fair market value for, the services performed by the HCP.
  • Documentation
    For interactions between a company and a HCP there must be a written agreement setting out the purpose of the interaction, the services to be performed, the method for reimbursement of expenses as well as the remuneration to be paid by the company. The activities envisaged by the agreement must be substantiated and evidenced by activity reports and the like. Adequate documentation such as the agreement, related reports, invoices, etc, must be retained by the company for a reasonable period of time to support the need for, and materiality of, the services as well as the reasonableness of the remuneration paid.

 

Code Principles

Q: Does the definition of a HCP include purchasing professionals employed in the retail sector (eg, purchasing professionals employed by a supermarket chain)?
A: No, the definition of HCP does not include a purchasing professional employed in the retail sector unless that individual purchases or arranges for the purchase of companies’ medical devices for or on behalf of medical or clinical personnel. 

However, if the medical devices are sold in a retail pharmacy (even when located within a supermarket), interactions between the company and the responsible purchasing professional fall under the code.

Events

Part 1: Guidelines on the Interactions with Healthcare Professionals and Healthcare Organisations

Events

Companies may invite HCPs to company events and third party organised educational events.

Event programme
The programme should directly relate to the specialty and/or medical practice of the HCPs who attend the event or be relevant to justify the attendance of the HCPs. For third party organised events, the agenda should be under the sole control and responsibility of the third-party organiser.

For third party organised educational events, entertainment must be outside of the educational programme schedule and paid for separately by the HCPs. Entertainment should not dominate or interfere with the overall scientific content of the programme and must be held during times that do not overlap with a scientific session. The entertainment should not be the main attraction of the event.

Any event should be relevant to the HCP attendees – a detailed programme should be available in sufficient time prior to the event and present a clear schedule.

Event location and venue
The event location and venue should not be the main attraction of the event. Companies must consider the following:

  • Potential adverse public perceptions of the location and venue for the event. The perceived image of the location and venue must not be luxury, or tourist/holiday-oriented, or that of an entertainment venue.
  • Event location and venue should be centrally located when regard is given to the place of residence of the majority of invited participants.
  • Need for ease of access for attendees.
  • Event location and venue should be in or near a city/town which is a recognised scientific or business centre, suitable for hosting an event which is conducive to the exchange of ideas and the transmission of knowledge.
  • Companies must consider the season during which the event is held. The selected time of year must not be associated with a touristic season for the selected geographic location.

Events

Q: Can a company organise or support an event at a hotel that offers leisure facilities such as golf, casinos or ski/water sports?
A: No, it would not be appropriate for companies to organise or support such an event.

An important factor in evaluating a hotel is its suitability for business meetings, including the availability of conference facilities. For hotels which include minor leisure and sporting facilities (ie, a spa), while it would not be reasonable to exclude these venues if otherwise appropriate, companies must exercise caution.

The agenda should be arranged in such a way that HCPs attending the event would not be free to make use of the leisure and sporting facilities during any significant part of a normal working day. Where hotels require additional payment to enable guests to use the leisure and sporting facilities, companies may not make such payments on behalf of HCPs.

Guests
Companies are not permitted to facilitate or pay for meals, travel, accommodation or other expenses for guests of HCPs, or for any other person who does not have a bona fide professional interest in the information being shared at the event.

Reasonable hospitality
Companies may provide reasonable hospitality to HCPs, but any hospitality offered must be subordinate in time and focus to the event purpose. Companies must in any event meet the requirements governing hospitality in the country where the HCP carries on their profession and give due consideration to the requirements in the country where the event is being hosted.

In the UK, the NHS England document Managing conflicts of interest in the NHS sets the upper limit for meals and refreshments that may be accepted by NHS HCPs at £75. While this only directly applies to the NHS in England it should be taken as indicative of what is acceptable in the rest of the UK, including in relation to HCPs working in the non-NHS sector.

Companies may not pay for or reimburse HCPs’ lodging expenses at top category or luxury hotels. For the avoidance of doubt, if the event venue is a hotel which complies with the requirements of the code, it would be acceptable for companies to offer participants meals and accommodation at the same hotel. However, accommodation and/or other services provided to HCPs should not cover a period of stay beyond the official duration of the event.

Events

Travel
Companies may only pay or reimburse for reasonable and actual travel. Travel provided to HCPs should not cover a period of stay beyond the official duration of the event. For air travel, in principle, this means that companies can only pay or reimburse economy or standard class unless the flight time is of a duration of greater than five hours including connection flights, in which case business class can be considered. First class is never appropriate.

Transparency
Companies must ensure full compliance with national laws regarding the disclosure or approval requirements associated with such financial support and where no such requirements are prescribed, shall nevertheless maintain appropriate transparency, as a minimum, by requiring employer notification is made prior to the event.

Company events
Companies may invite HCPs to company events, such as:

  • Product and procedure training
  • Education events
  • Sales, promotional and other business meetings

Where there is a legitimate business purpose, company events may take place in a company’s manufacturing plant.

Events

Q: Is it appropriate for companies to invite HCPs on company plant or factory tours where the HCPs reside outside the country of location of the plant or factory?
A: Yes, it is appropriate for companies to invite HCPs to tours in countries outside their country of residence if there is a legitimate business purpose and the tour complies with the code in all respects.

Q: Can a company use a meeting venue outside Europe?
A: Yes, provided the participants are from multiple countries outside Europe. If the participants are primarily from within Europe, the venue should be in Europe. It is expected that the country selected (and the state, if the location is in the United States) is the residence of at least some of the participants of the product and procedure training and education event.

Conference vetting system (CVS)
The centralised decision-making process which reviews the compliance of third party organised educational events with the code and which is managed independently of ABHI under the supervision of the MedTech Europe compliance panel.

Grants and Charitable Donations

General principles
Grants and charitable donations shall not be contingent in any way on past, present or potential future purchase, lease, recommendation, prescription, use, supply or procurement of the company’s products or services. It is important that support of charitable and/or philanthropic programmes and activities by companies is not viewed as a price concession, reward to favoured customers or as an inducement to purchase, lease, recommend, prescribe, use, supply or procure companies’ products or services.

A company shall not provide grants or charitable donations to individual HCPs. Grants and donations must be provided directly to the qualifying organisation or entity. Grants and donations shall not be provided in response to requests made by HCPs unless the HCP is an employee or officer of the qualifying organisation or entity and submits the request in writing on behalf of the qualifying organisation or entity.

The payment (or provision of other support) by way of any grant or donation shall always be made out in the name of the recipient organisation and shall be paid directly to the organisation. A company shall not provide grants or donations in the name of any HCP. In addition, all grants and donations shall identify the company as the provider.

Grants and Charitable Donations

Charitable donations
Companies may make unrestricted charitable donations for genuinely charitable or other philanthropic purposes. “Unrestricted” in this context means that companies shall have no control over the final use of funds (or other support) they provide as donations beyond general restrictions to ensure that the funds (or other support) are applied for charitable and/or philanthropic purposes.

Donations may be made only to charitable organisations or other non-profit entities which have charitable and/or philanthropic purposes as their main purposes and which are objectively engaged in genuine charitable or philanthropic activities.

Q: Under the code, can a company make a charitable donation to support the general running of hospital or other HCO?
A: No, a company cannot make available a donation to support the general running of a hospital or other HCO. A charitable donation shall only be given to a legal entity or body which has charitable and/or philanthropic purposes as its main purposes

Grants and Charitable Donations

Educational grants
Companies may provide restricted grants for the advancement of genuine medical education. “Restricted” in this context means that companies shall specify the intended purpose of the grant in the agreement. A company shall also ensure that the grant agreement with the recipient organisation includes rights to enable it to verify that the grant is used for the agreed intended purpose. Companies shall document and publicly disclose all educational grants in accordance with the code’s disclosure guidelines. Companies may provide grants for the following purposes:

  • Support for third party organised educational events
  • Scholarships and fellowships
  • Grants for public awareness campaigns

Grants and Charitable Donations

Research grants
Where permitted by national laws, regulations, national guidelines and professional codes of conduct, companies may provide restricted research grants to support clearly defined third party-initiated research studies for clinical or non-clinical research programmes in therapeutic areas in which the company is interested and/or involved. Grants may include in-kind or financial support for legitimate, study-related, documented expenses or services, and/or reasonable quantities of single-use and/or multiple-use free of charge product/s for the limited duration of the research.

Companies providing grants shall ensure that they do not influence the research. However, to ensure that grants are provided on a “restricted” basis, companies shall clarify the intended research scope and purposes for which the grant is requested and shall ensure that the written grant agreement with the recipient organisation includes rights for the company to verify that the grant is applied solely for the agreed intended research use. Such verification may include a request for study-related documentation, eg, copies of the research protocol, ethics committee and/or regulatory approvals or the study report upon completion or earlier termination of the research.

Sponsored Posts

Safeguards are required to ensure that the deployment of sponsored posts does not cause a conflict of interest between the aims of the sponsoring company and the aims of the HCO, particularly in relation to procurement and competition.

Where a company sponsors part or all the salary of a HCP employed by a HCO, they must have due regard to national rules or relevant codes of practice that may apply. Sponsorship must be with the HCO not the HCP and must be in response to a request from the HCO through a formal and transparent procurement process. Written agreements should detail the circumstances under which the HCO may exit from the sponsorship arrangement if conflicts of interest which cannot be managed arise.

There should be written affirmation that the arrangements will have no effect on purchasing decisions or prescribing and dispensing habits and no pressure must be exerted.

Arrangements with Consultants

General principles
Companies may engage HCPs as consultants and advisers to provide bona fide consulting and other services, including but not limited to research, participation on advisory boards, presentations at company events and product development. Companies may pay HCPs reasonable remuneration for performing these services. In all cases, consulting arrangements must be permitted under the laws and regulations of the country where the HCP is licensed to practise and be consistent with applicable professional codes of conduct in that country.

Consulting arrangements shall not be contingent in any way on the prospective consultant’s past, present or potential future purchase, lease, recommendation, prescription, use, supply or procurement of the company’s products or services.

Research

Company-initiated research
Where there is a legitimate business need to do so, companies may initiate, conduct, manage and finance scientifically valid research to generate data, whether pre- or post-market. In this context, legitimate business needs for data include:

  • Medical needs, including patient safety
  • Research and development
  • Scientific purposes (eg, performance indicators, comparing objective scientific parameters)
  • Regulatory, including post-market surveillance (PMS) and post-market clinical follow up (PMCF)

Where companies engage third party intermediaries for research (eg, contract research organisations), they shall ensure that the research conducted by these third parties on behalf of the company is carried out in accordance with all applicable legal and ethical requirements, including the applicable requirements of the code.

Company post-market product evaluation
Where there is a legitimate business need to do so, companies may initiate post-market third party evaluation of their products, therapies and/or related services and may therefore provide evaluation products under a written contract for services to obtain defined user evaluation by HCOs in relation to the products.

Evaluation products may be provided on a no-charge basis in return for the requested user feedback from HCPs at the HCO, which shall be formally described in a written protocol or questionnaire forming part of the contract.

Royalties

HCPs, acting individually or as part of a group in which they are an active participant, often make valuable contributions that improve products or medical technologies. They may develop intellectual property, eg, patents, trade secrets, or know-how, under a product or technology development or intellectual property licensing agreement.

A royalty arrangement between a company and a HCP should be entered into only where the HCP is expected to make or has made a novel, significant or innovative contribution to, for example, the development of a product, technology, process, or method, such that the HCP would be considered to be the sole or joint owner of such intellectual property under applicable laws and regulations. The foregoing is without prejudice to companies’ obligations to comply with any applicable obligations to pay royalties which may arise under applicable laws and regulations in some countries.

Educational Items and Gifts

Companies exceptionally may provide inexpensive educational items and/or gifts, in accordance with national laws, regulations and industry and professional codes of conduct of the country where the HCP is licensed to practise. Companies may only provide such educational items and/or gifts in accordance of the following principles:

  • Educational items and/or gifts may be provided but these must relate to the HCP’s practice, or benefit patients, or serve a genuine educational function.
  • No educational items and/or gifts should be provided in response to requests made by HCPs.
  • Educational items and/or gifts must not be given in the form of cash or cash equivalents.
  • Educational items and/or gifts must be modest in value, and can be branded or non-branded items.
  • A company may occasionally provide educational items of greater value to a HCO always provided that the item serves a genuine educational function for the HCPs at that HCO and is of benefit to patients. Such items shall not be provided to HCPs for their personal use. The item shall also be related to the therapeutic areas in which the company is interested and/or involved. For higher value educational items, companies must maintain appropriate records of their provision of such educational items to HCOs. Such items should not be part of the HCO’s normal overheads or routine costs of operation.
  • Provision of educational items and/or gifts must not improperly reward, incentivise and/or encourage HCPs to purchase, lease, recommend, prescribe, use, supply or procure the company’s products or services.

Educational Items and Gifts

Prize draws and other competitions at events are permissible if the prize awarded complies with the code. In addition, it must comply with national laws, regulations and industry and professional codes of conduct.

In the UK, the NHS England document Managing Conflicts of Interest in the NHS sets the limit for such items at £6. While this only directly applies to the NHS in England it should be taken as indicative of what is acceptable in the rest of the UK, including in relation to HCPs working in the non-NHS sector.

Q: What are examples of items of modest value that are “related to the HCP’s practice or for the benefit of patients”?
A: Stationery items, calendars, diaries, computer accessories for business use and clinical items such as wipes, nail brushes, surgical gloves and tourniquets are examples of modest value items that could be appropriately provided as gifts to HCPs provided their value falls within the maximum value prescribed under national laws, regulations and industry and professional codes of conduct. Food, alcohol and items which are primarily for use in the home or car are not appropriate as they are not related to the HCP’s practice nor are they for the benefit of patients.

Educational Items and Gifts

Q: May a company provide a small gift to a HCP to mark significant life events such as a marriage, birth, birthday or death?
A: The code restricts the types of gift that may be given to a HCP and it would not be appropriate to give gifts to mark significant life events such as a marriage, birth or birthday. However, in the case of death, it is for each company to determine the appropriateness of making a tasteful gift as a mark of respect.

Q: Where HCPs engaged by companies as consultants or speakers decline a professional fee for their services, would it be appropriate for the company to show its appreciation by giving the HCP a small gift such as a bottle of wine or a bouquet of flowers?
A: No, it would not be acceptable for the company to make such a gift because to do so could be open to misinterpretation and would be likely to breach the principle of image and perception.

Demonstration Products and Samples

General principles
Companies may provide their own products as demonstration products and/or samples at no charge in order to enable HCPs and HCOs to evaluate and/or familiarise themselves with the safe, effective and appropriate use and functionality of the product and/or related service and to determine whether, or when, to use, order, purchase, prescribe or recommend the product and/or service in the future.

Demonstration products and samples may be either single- or multiple-use products. Companies may also provide products from another company in conjunction with the company’s own demonstration products and/or samples on an exceptional basis if those other company’s products are required to properly and effectively demonstrate, evaluate or use the company’s products (eg, computer hardware and software produced by another company).

Provision of demonstration products and samples must not improperly reward, induce and/or encourage HCPs and/or HCOs to purchase, lease, recommend, prescribe, use, supply or procure companies’ products or services. Any offer and/or supply of such products shall always be done in full compliance with applicable national laws, regulations and industry and professional codes of conduct.

Companies shall in all cases maintain appropriate records in relation to the provision of demonstration products and samples to HCPs and/or HCOs (eg, recording proof of delivery and receipt of return).

Disclosure Guidelines

Part 2: Disclosure Guidelines

The disclosure guidelines apply to companies in their interactions with HCOs based or registered in the ABHI Europe geographic area.

Separate entities belonging to the same multinational company (“affiliates”) – which could be the parent company (eg, the headquarters, principal office or controlling company of a commercial enterprise), subsidiary company or any other form of enterprise or organisation – shall be deemed to constitute a single company, and are as such committed to compliance with guidelines.

General obligation
Subject to the terms of guidelines, each company shall document and disclose all payments related to educational grants that it makes to a HCO based or registered in Europe, without limitation of value. The disclosure of grants provided by affiliates of a company described above, but which are not registered in the MedTech Europe Geographic area shall be made by any of the affiliates comprising said company that are registered in the MedTech Europe geographic area.

Disclosure Guidelines

Reporting period disclosures shall be made on an annual basis and each reporting period shall cover a full calendar year.

Disclosures shall be made by each company within six months after the end of the relevant reporting period. Companies are liable for the accuracy of the disclosed data.

Q: When will the first reporting period start?
A: The first disclosure shall occur no later than the end of the transition period, which ends on 31 December 2019. The first reporting period is the calendar year 2019, starting on 1 January 2019 and ending on 31 December 2019.

Disclosures shall be made on the EthicalMedTech website unless the company is already bound by other national laws, regulations or professional codes.

Advertisements and Promotions

Part 3: Guidelines on Advertisements and Promotions addressed solely or primarily to Healthcare Professionals

These guidelines are published by ABHI because under current UK law and other advertising codes it is difficult to take legal action or to complain against a person or company who publishes misleading promotional material directed solely or primarily at HCPs.

Consumer advertising is governed both by legislation (the main legal instruments being listed in Section 1) and by the codes of advertising practice issued by the Committee of Advertising Practice and the Broadcast Committee of Advertising Practice and administered by the Advertising Standards Authority. However, Advertising directed at HCPs is not clearly caught by these provisions.

The intention of these guidelines is to set out principles to be applied to advertising directed solely or primarily at HCPs.

Advertisements and Promotions

Accuracy and substantiation of claims and information

Information, claims and comparisons included in or as part of any advert must be accurate, balanced, fair, objective and unambiguous and must be based on a fair evaluation of appropriate evidence and reflect that evidence clearly. They must not mislead the intended audience either directly or by implication, by distortion, exaggeration or undue emphasis. All reasonable efforts must be used to ensure that the substantiation for all information, claims and/or comparisons in an advert is in accordance with an up to date evaluation of all the relevant clinical and scientific evidence.

Advertisements and Promotions

Some general pointers to follow:

Different types of evidence are permissible to support claims in adverts. The evidence may include clinical data (which could be pre- or post-market data, including registry data); the results of a clinical investigation; laboratory data and testing, including in vitro test data; engineering data; and historical post-market experience.

Claims or comparisons made, or information included, in adverts must accurately reflect the balance of all relevant evidence.

Testimonial evidence on its own is not sufficient substantiation for objective claims. However, provided the overall effect is not misleading, it may be sufficient to use testimonial evidence to justify subjective claims (eg, based upon subjective perception) or opinions.

If engineering data or in vitro or other laboratory test data is used to substantiate claims made in adverts it must be directly relevant to, and significant for, the product being advertised.

Information and claims about side-effects used in or as part of any advert must reflect available evidence or be capable of substantiation by clinical experience. It must not be stated that a product has no side-effects. The word “safe” must not be used without qualification.

Adverts must encourage the appropriate use of a device (or related service) by presenting it objectively and without exaggerating its properties. Exaggerated or all-embracing claims must not be made, and superlatives must not be used except for those limited circumstances where they relate to a clear fact about a device.

The word “new” must not be used for more than twelve months from the date on which a device or an intended purpose of that device or any related service has been generally available in the UK in the form referred to in the advert.

Advertisements and Promotions

Comparative advertising

A comparison used in or as part of any advert is only permitted if:

  • It is not misleading
  • Devices or services for the same needs or for the same intended purpose are compared
  • One or more material, relevant, substantiable and representative features are compared
  • No confusion is created between the device or service advertised and that of a competitor or between the advertiser’s trademarks, trade names, other distinguishing marks and those of a competitor
  • The trademarks, trade names, other distinguishing marks, products, services, activities or circumstances of a competitor are not discredited or denigrated
  • No unfair advantage is taken of the reputation of a trade mark, trade name or other distinguishing marks of a competitor
  • The advertiser’s devices or services are not presented as imitations or replicas of goods or services bearing a competitor’s trade mark or trade name

Advertisements and Promotions

Requests for substantiating data
If a bona fide request is made to an advertiser to substantiate any information, claim or comparison used in or as part of any advert, the enquiry must be acknowledged within ten working days of the date when the advertiser has sufficient information to understand the nature of the enquiry or complaint. The initial response should where relevant indicate when a full response will be provided.

No disparagement
The products and activities of other medical device companies must not be disparaged in an advert. HCPs and the clinical and scientific opinions of HCPs must not be disparaged in any advert.

Quotations
Quotes from medical and scientific literature or from personal communications must be accurate and must reflect the meaning of the author. The precise source of the quotation must be identified.

Quotations relating to devices taken from public broadcasts (eg, on radio and television, and from private occasions, such as medical conferences or symposia), must not be used without the formal permission of the speaker.

Where references are made to medical and scientific literature or to personal communications these must accurately reflect the author’s meaning.

All reasonable care must be taken to avoid ascribing claims or views to authors when these no longer represent the current views of the authors concerned.

Complaints

Part 4: Complaints Principles, Procedure & Panel Constitution

Complaints under the ABHI code may be referred to a complaints adjudication panel. Complaints can be made by companies, healthcare institutions, individual HCPs or members of the public.

The code is administered by a panel of independent individuals and an independent chairman. The panel is not an investigatory body as such. It asks the company whose activities are the subject of a complaint for a complete response and may ask the parties to a case for further information in order to clarify the issues.

The company or individual making the complaint has the burden of proving their complaint on the balance of probabilities.

Complaints

Any company wishing to make a complaint must initially attempt to reconcile any dispute with that company through conciliation, mediation or mutual settlement first. Any individual wishing to make a complaint must initially attempt to resolve the complaint utilising that company’s internal or external whistleblowing and/or dispute resolution procedures.

If, in either case, this does not prove possible then complaints are initially considered by the chairman who will determine, if appropriate in consultation with the complainant and/or respondent, whether there is a case to answer.

Anonymous complaints (where the complainant does not disclose their identity to the panel or chairman) may be accepted in exceptional circumstances at the discretion of the chairman, however the weight to be attached to any evidence may be adversely affected if the source is anonymous, and thus in many instances it will not be possible for such a complaint to proceed.

Confidential complaints (where the complainant does disclose their identity to the panel or chairman but requests (whether at the outset or during the course of the complaint) that their identity remains confidential) are not encouraged but may be accepted at the discretion of the chairman, however the ability of the respondent to properly respond to information or matters put to them and therefore the panel’s ability to properly adjudicate on any particular complaint may be adversely affected if the identity of the complainant is kept confidential, and therefore in certain instances it will also not be possible for such a complaint to proceed. Confidential complaints will not be accepted from applicable companies.

Exam

This ends the course. You can now continue to the exam. 

Take Exam

Page of - Completed