Annex 1 – Consumer Vulnerability: Two Types
Dealing with vulnerable customers
For over 100 years, the British Healthcare Trades Association (BHTA) has brought together hundreds of healthcare and assistive technologies organisations to facilitate business, raise industry standards, and protect consumers. The BHTA seeks to bring the industry together to support and improve the health and care of the nation. The BHTA and its members continue to come together to help the industry overcome its challenges.
BHTA’s Code of Practice is approved under the Chartered Trading Standards Institute Consumer Codes Approval Scheme. This means Code Members have the right to display the combined BHTA CTSI logos and customers can be confident they will be treated fairly. The BHTA Code is the only Trading Standards approved code in the healthcare sector.
The Code is reviewed regularly, with input from external organisations.
By entering into their BHTA Membership Agreement, every member commits to the Code. Membership of BHTA and adherence to the Code shows customers, suppliers and employees that BHTA members’ businesses operate to higher standards of customer protection than the law requires.
Current relevant statutory and regulatory requirements referred to in the Code include, but are not limited to:
All members must ensure they are compliant with all relevant legislation (see Annexes 1-7). Members whose business places them in contact with the NHS, its divisions (e.g. NHSSC), and/or its commissioning bodies (e.g. ICS’s, NHS Trusts, NHS Hospitals) must ensure their processes and practices do not contravene the NHS Managing Conflicts of Interest in the NHS – Guidance for Staff and Organisations.
Individual persons working in the industry may be registered as competent individuals with a relevant body, such as the Health and Care Professions Council (for qualified occupational therapists, physiotherapists, orthotists, prosthetists), or Trusted Assessors (staff trained to make holistic assessments in a variety of health and social care settings – hospital-to-home discharge, home adaptations to foster independent living, mobility equipment needs analysis – of a non-clinical nature). Such registrants may be required to follow a personal Code of Conduct, which will be available on application to the relevant organisation (see Useful Contacts below).
The Directors, Senior Managers, Shareholders, Owners, Partners and other persons exercising significant controlling functions of the member shall be fit and proper persons for discharging their responsibilities under this Code of Practice.
Members are directly responsible for the behaviour and conduct of their staff. All customer-facing staff must be adequately trained to deal with consumers and act in accordance with their training at all times.
All BHTA members commit to the 10 key principles and objectives of the Code of Practice:
1) Ensure that they are compliant with all relevant legislation (see Annexes 1-7). They will comply with all relevant legislation relating to advertising and marketing, the sale of goods and services, the safety of goods, consumer rights, disability rights, and data protection.
2) Ensure that they do not offer, stipulate, infer or imply anything in their terms and conditions of contract which provides the customer with less protection or a worse deal than that provided by law.
3) Ensure that all goods are of satisfactory quality and fit for the purpose specified. Their selling techniques will be ethical and they will deliver high standards of service.
4) Be honest and truthful in all dealings with customers. Any claims made by the company and its employees will not give rise to false expectations. Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous. They must not mislead directly, by implication or omission.
5) Respect the confidentiality of information obtained and not disclose such information without the consent of the customer concerned or a person entitled to act on their behalf, except where such disclosure is required by law.
6) Products and services will only be supplied where they fulfill a genuine need.
7) All communications, verbal and/or written, will be made in plain language.
8) The vulnerable nature of the customer or that the customer is in a vulnerable situation will be respected. No customer will be coerced in any way. All customers will be given information in an appropriate format and will have their particular needs taken into account.
9) Where complaints cannot be resolved directly with the member, the customer must be made aware of the mediation and arbitration services offered under the Code and how to make use of this service.
10) Members will not disparage the products and activities of other healthcare and assistive technology companies; nor the clinical and scientific opinions of health professionals.
Advertisements (which include websites & leaflets/brochures) must comply with any relevant legislation and:
· The UK Code of Non-Broadcast Advertising
· The UK Code of Broadcast Advertising
· The Phone-Paid Services Authority Code (for content, goods and services charged to a phone bill)
Advertisements must not give misleading indications or omissions about price, value or quality or any benefit that may be derived from the product or service offered or about the organisation placing the advertisement.
The consequence of responding to any advertisement should be clear. Clear pricing should be given for the products shown in all promotional material intended for consumers, including on websites. If VAT-exclusive prices are given, this must be made clear.
Code members must not use the logos of other organisations (such as charities, public bodies, and other businesses) without express permission of those other organisations.
Code members must ensure any gifts related to purchase of a product or service are directly relevant to that purchase and of a nature that cannot be construed as inappropriate or disproportionate.
Staff must always clearly identify themselves to consumers and give their reason for calling. They must never claim or imply to have medical training where this is not the case, nor claim that the product is endorsed by a trusted body unless this can be evidenced
Training of Staff / Ongoing Development
All staff must be made aware of any legislation pertinent to their role, especially in relation to health and safety, equality and consumer rights.
They must give due regard to infection prevention where relevant.
They must also be informed of any regulations to which they must give due regard in the course of their work, such as building regulations and Lifting Operations and Lifting Equipment Regulations 1998.
Staff should not work unsupervised until considered competent to do so nor carry out tasks for which they have not received training. Regular refresher sessions are advised.
Registered professionals, such as occupational therapists, physiotherapists, nurses, orthotists and prosthetists, and any individuals registered with the Health and Care Professions Council and/or as a Trusted Assessor are required to receive on-going training to keep their knowledge up-to-date and such registration is an indicator of competence. On-going training must be facilitated.
Staff must have the appropriate product knowledge to advise and assist purchasers. Where
clinical advice is given by staff, they must be appropriately qualified.
All staff, in particular those in direct contact with the customer, trained in the content of this Code and be aware that the member is required to adhere to the provisions.
Members must maintain a record of training for each member of staff.
Members must make a copy of this Code available free of charge to customers on request.
A copy of the BHTA leaflet How to Buy Healthcare Equipment Safely should also be given to consumers, particularly during a home visit.
Retailers must display the BHTA Code of Practice poster and the BHTA and the CTSI Approved Code logo (these are supplied when joining; members may ask for additional copies any time).
All Code members must display their BHTA membership certificate in an accessible location.
All members should display the BHTA Code logo and the CTSI Approved Code logo on their websites; member websites should carry the “Click to Verify” version of the BHTA/CTSI Approved Code logo to enable independent, 3rd-party verification of BHTA membership.
Inappropriate or high pressure selling tactics must not be used by members. Examples of high
pressure selling techniques include:
Subjecting a consumer to a lengthy presentation in their own home
Contacting a consumer after they have indicated that they do not want the goods or services on offer
High initial price followed by the offer of a discount (often followed by a telephone call to the “manager”)
Discount on the condition that the consumer agrees to the sale that day (when the discount will actually continue to be available)
Withholding price information until the end of the sales discussion/visit
Claiming limited availability of a product when this is not correct
Refusing to leave a consumer’s home when asked to do so and claiming that the salesperson faces financial difficulty or will lose their job if they don’t achieve a sale are Banned Practices under consumer protection regulations (see Annex 2 for more detail).
Members and their staff must not misrepresent the product, its price or any contractual details.
Where a customer’s ability, well-being, environment, and/or activities have an effect on the safe use and suitability of a product for the customer’s stated purpose, a full assessment of a customer’s ability, well-being, environment, and/or activities and the suitability of a product for the customer’s stated purpose (e.g. use on public transport, or use in their home) must be carried out prior to a sale. It is recommended that a record of this assessment be retained and a copy be made available to the customer on request. This applies to all sales, in store, off premises (e.g. at the customer’s home), online, via mail order catalogue or by telephone. Any clear disparity between a customer’s stated requirements and the nature of the goods and/or services to be purchased must be pointed out and detailed in writing.
Potential customers should be made aware, where appropriate, of services offered by Local Authorities, NHS, the Employment Service, major charities and other agencies. Where professional / medical advice should be considered by the customer before purchasing, details of where this assistance might be obtained should be given. If a practitioner is recommended who is contracted to the advising vendor/salesperson, this should be made explicit.
Where VAT relief or reduced rate VAT can apply, it should be brought to the attention of the customer, along with details of how this can be obtained.
Terms and conditions of members’ contracts must be available in writing and must be legible, comprehensive and written in plain language. BHTA recommends larger bold print for important terms such as cancellation rights and instructions.
Also see Annex 6 for the details of what information must be provided to consumers in relation to cancellation rights.
If it appears that a customer is visually impaired or are confused by paperwork, the salesperson should go through the paperwork with them. A version in large print, Braille, or on audio tape must be provided if requested, within a reasonable timescale. Members should consider whether these customers should consider having a relative, friend or other advisor/carer with them. See Annex 1 for more detail.
Cancellation Rights / Protection of Deposits (see Annex 6 for more detail)
Where cancellation rights apply or are offered, the customer must be informed under what circumstances they may cancel and these instructions should be plainly visible in the paperwork given to the customer, for example next to the signature box, and be in large bold type. Where a customer has indicated they have poor eyesight or are confused by paperwork, the salesperson should go through the paperwork with them.
If a member chooses to offer a cancellation period longer than required by the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 (14 days) or to offer other/additional cancellation rights to a customer, these rights should be clearly detailed by the member on their website and in their paperwork; any other/additional rights offered do not undermine a customer’s statutory rights.
Where cancellation rights apply, to comply with the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 a cancellation form must be provided setting out:
That a cancellation period applies and the date from which it starts
The length of the cancellation period
How to cancel
Deposits
If a deposit will not be refundable, or will be only part-refundable, this must be made clear when the customer places the order and the reasons for this must be laid out in writing.
Where an order cannot be fulfilled and the customer does not wish to accept substitute goods or services, refund of any deposit must be made speedily.
Where deposits or advance payments are taken, members must use a payment protection mechanism to ensure that consumers are returned their money without undue delay should the member be unable to fulfil the contract to supply goods or a service.
Incidents must be reported to the manufacturer of the product, and where a company becomes aware of an incident involving a product that resulted in, or could have resulted in, serious injury or death of a customer, they must report that incident to the appropriate authority – either the Health & Safety Executive (HSE), or (if the product is a medical device) the Medicines & Healthcare products Regulatory Authority (MHRA); please see Useful Contacts below. It is advisable to quarantine the item for inspection by the manufacturer.
Each company must maintain records sufficient to identify to whom they have sold a product, to ensure it can be traced and recovered in the event of a recall for safety purposes, or given appropriate attention if a safety warning is issued necessitating preventive action. Distributors and retailers must comply with manufacturer instructions for product recalls and safety work and must act on these without delay.
Companies selling to agencies such as the NHS and local authorities should advise them of the need to track products, to ensure this can occur.
Sponsorship
Where a company sponsors part or all of the salary of a professional employed by the NHS or Social Services, they must have due regard to the employing body’s rules regarding sponsorship. No pressure must be exerted on the sponsored individual to favour the sponsoring company’s products over any other. At all times, the product supplied should be that which a clinical professional considersis best suited to the needs of a patient or client.
Sub-Contractors / Third Parties
Companies must ensure any sub-contractor, third party, or person carrying out work or representation on the company’s behalf upholds the same standards as required herein.
Service/Product Support
Retailers who sell into an area of the country where they cannot service/support the product themselves in a prompt and adequate manner, must have in place a third party agreement with an organisation in that area, which meets comparable standards, or there must be a return to manufacturer provision for the product concerned (ie there must be consistent support for the product / customer, whether the customer is local or geographically distant from the seller).
Members are reminded that they are responsible for the quality, performance and safety of the products they place on the market and consider whethercompliance with relevant safety and testing standards is appropriate. Statements and claimson performance and safety contained in their published literature must comply with anystandards they claim to meet.
Members that are manufacturers must be able to evidence to the Code Administrator, on request, thatany of their products carrying a CE and/or UKCA mark to indicate compliance with EU or UK regulation[s], domeet the essential requirements of the relevant regulation[s]. They must be able to provide (access to) a technical file for inspection.
Members that manufacture and/or import medical devices should ensure spare parts are available for at least five years from date of final manufacture. For all other products, companies must be mindful of their obligation to stock spare parts for a reasonable period of time from date of final manufacture.
Members must provide technical training, spare parts lists, and preventative maintenance schedules to anyone requesting them, providing they are satisfied that the enquirer meets any objective criteria they have set for such provision.
Where training is booked by telephone via administrative staff, those staff must be given a checklist of the minimum information the trainer will require to proceed.
Companies must give due respect to any codes, regulations, procedures operated by the
Authority and to those adhered to by members of the health and care professionals with whom they interact.
They should be aware of complaints procedures in these organisations, so they can advise customers accordingly should there be a problem.
Due regard must be given to the Bribery Act 2010, ie care must be taken to ensure no bribe of any kind (including for example, and without limitation, a facilitation payment, a donation, or excessive hospitality or commission payments) is offered, given to, or placed upon any public servant (e.g. Local Authority or NHS staff member), or their employer, as an inducement to prescribe, supply, administer, recommend or buy any product or service.
Gifts in the form of promotional aids and prizes, whether related to a particular product or of general utility, may be distributed to members of the health professions and to appropriate administrative staff, provided that the gift or prize is inexpensive and relevant to the practice of their profession or employment. All activity involving sponsorship and hospitality must be considered carefully and steps be taken to ensure it is legal, relevant, proportionate and reasonable. Code members must abide by any guidance issued by the UK public sector on these matters, plus the guidelines on “Interactions with Healthcare Professionals and Healthcare Organisations” set out in Part 1 of the Medtech Europe Code of Ethical Business Practice. (If these conflict with each other, the UK guidance will take precedence for activity in the UK.)
In addition to giving due regard to the Pharmaceutical Services Regulations and the current arrangements in each country, BHTA members involved in the supply and/or dispensing of appliances are required to abide by the Patients Industry Professionals (PIPs) Forum Collaborative Standards (which complement both the service requirements and this Code of Practice); to give due regard to BHTA’s Guidance for DACs on advertisements, competitions and marketing; and to adhere to the DAC Code of Ethical Business Practice.
All Code members must have in place a speedy, responsive and user-friendly procedure for the resolution of complaints. Code members should strive to resolve complaints within one calendar month. Information should be readily available about where to sendcomplaints, what information should be provided and the timescales that will apply to dealing with the complaint.
The procedure must include targets for initial acknowledgement of a complaint:
Phone call = 2 working days
Letter or email = 5 working days
If a satisfactory resolution is not reached within 56 calendar days (i.e. two months), the complainant should be informed that they have the right to contact the BHTA who will assist in resolving the issue. See Annex 7 for more detail.
Code members should offer maximum co-operation with consumer advisers or any other intermediary acting on behalf of the complainant, such as a Citizens Advice Bureau, or Trading Standards Officer.
Staff must be professional, courteous, prompt and fair when dealing with a complainant.
If a Code member has a claim against a consumer and wishes to institute court proceedings, the consumer should be given the opportunity to choose to bring the matter to BHTA for resolution.
BHTA will investigate all alleged breaches of this Code.
An independent Disciplinary Committee ensures that matters relating to breaches of Code are enforced effectively and disciplinary procedures are fair and impartial. In addition the Committee deals with serious cases of noncompliance with the Code. Where a potential breach of the Code has been identified during the course of investigating a consumer complaint, BHTA will normally endeavour to resolve the complaint before addressing the alleged breach.
Where an identified breach of the Code is minor, the BHTA will issue a warning and suggest action, if appropriate, to prevent repetition.
Any serious, or repeated, breaches of the Code may result in the Code member to appear before the Disciplinary Committee.
This will consist of a panel of three people, one drawn from the relevant industry sector and two from appropriate external organisations, with a Chair drawn from the external organisations. The Chair will have the casting vote in the event of a hung decision.
If BHTA is notified that a Code member has been convicted of an offence (or signed a formal caution) under the Consumer Protection from Unfair Trading Regulations 2008, they will be referred to the Disciplinary Committee.
The nature of the alleged breach will be identified to the Code member in writing and they will be given the opportunity to offer any evidence in writing in advance of the hearing. The hearing will be on a date arranged with the Code member.
The Committee’s decision may include one or more of the following:
· No further action
· The Code member be required to undertake a specified course of remedial action
(e.g. re-training of a particular salesperson)
· The Code member be issued with a formal warning
· A financial penalty, relating tothe amount of work incurred by BHTA and the Independent Arbitrator regarding a complaint, the cost of the Disciplinary hearing, and/or the nature of the breach
· Suspension for a stated period from BHTA (and the register of companies signed up to the Code)
· Expulsion of the Code member from BHTA
Where expulsion occurs, a period of twelve months must pass before any application to re-join BHTA, and the register of companies signed up to the Code, will be considered. If any complaints against the company have been made to BHTA during that time, such application may be rejected for a further period.
From establishing that a breach has occurred through to final decision of the Disciplinary Committee and instigation of any action should take no more than 90 days. A summary of the decision will be published on the BHTA website and may also be published in other member communications (e.g. newsletters).
Every Code member selling goods and/or providing services to consumers will be monitored periodically by at least one of the following means:
· Regular compliance checks
· Independent retail experience assessments
· Customer satisfaction surveys
All other Code members will be monitored by regular compliance checks.
BHTA will keep Code members apprised of Code operations, including the number and nature of complaints received, the remedies recommended and implemented, and the results of any referrals to the Disciplinary Committee.
To find an Approved Code member: https://www.tradingstandards.uk/consumers
To check the status / credentials of a health professional or individual working in the industry:
Health and Care Professions Council
Tel: 0300 500 6184 or visit www.hpc-uk.org
Nursing & Midwifery Council
Tel: 020 7631 7181 or visit www.nmc-uk.org
To find out more about Trusted Assessors:
Foundations UK
Tel: 0300 124 0315 or visit https://www.foundations.uk.com/guides/trusted-assessors/
Trusted Assessing and Care Training (TACT)
Tel: 01626 879 528 or visit https://trustedassessing.com
To source a product:
Disabled Living Foundation
Tel: 0300 999 0004 or visit www.dlf.org.uk
To access driving advice and assessment:
Driving Mobility
Tel: 01872 672520 or visit www.drivingmobility.org.uk
For assistance relating to consumer rights:
The Citizens Advice Consumer Service
Tel: 03454 04 05 06 or visit www.citizensadvice.org.uk/consumer/
Equality and Human Rights Commission
Tel: 0808 800 0082 or visit www.equalityhumanrights.com
Disability Law Service (DLS)
Tel: 020 7791 9800 (10am-1pm then 2pm-5pm Mon-Fri) or visit www.dls.org.uk
Trading Standards
Look in your Yellow Pages under “local authority” or visit https://www.tradingstandards.uk/consumers/support-advice
To make an adverse incident report:
For medical devices: Medicines & Healthcare products Regulatory Authority (MHRA)
Tel: 020 3080 6000 (switchboard) or visit
https://www.gov.uk/report-problem-medicine-medical-device
For machinery: Health & Safety Executive
Tel: 0845 300 9923 or visit www.hse.gov.uk/riddor/index.htm
Healthcare Industry – Companies in the healthcare industry, as defined for the purposes of this Code of Practice, will be involved in one or more of the following:
· Supply of assistive technologies, particularly those for elderly and/or disabled consumers
· Supply of externally applied medical devices, and/or services relating to the fitting of those devices
· Supply of equipment and related services necessary for medical and health professionals to carry out their various specialist functions
· Training in the use of assistive technologies
· Training relating to health and safety, such as first aid at work, and manual handling.
For the purposes of this Code of Practice this does notinclude:
· Pharmaceuticals
· Alternative medicines or therapies
· Dentistry
· GP practice
· Ophthalmology
· Implants
Assistive Technology – An assistive technology is a product or service that enhances independent living.
Company – The term “company” includes organisations or firms with a commercial, profit-making, interest i.e.
· Limited companies
· Partnerships
· Sole traders
· Franchises
· Wholly-owned subsidiaries
· Community interest companies
· Trading arms of charities
Customer – Customers may be private individuals, businesses, charities or authorities/agencies such as the NHS as well as private consumers.
Code Member – Any BHTA member company undertaking to abide by this Code of Practice.