Medical devices

Relevant statutory laws and industry codes:

• Belgian Law of 25 March 1964 on medicinal products
• Belgian Act of 18 December 2016 on other provisions concerning health (so-called Sunshine Act)
• Belgian Royal Decree of 14 June 2017 implementing the Sunshine Act
• Belgian Royal Decree of 23 November 2006
• Belgian Royal Decree of 10 June 2006
• Mdeon Code of Ethics
• beMedTech Code of Ethics

Competent authority/authorities enforcing the above statutory law(s) and codes:

• FAMHP
• beMedTech

Summary of the applicable rules:

The rules regarding hospitality offered to HCPs/HCOs by medical device companies are mostly the same as those for pharmaceutical companies. Minor differences may exist if the company is a member of beMedtech or subscribes to its ethics code.

Statutory Laws

No specific rules. Any specifics must be assessed on the case-by-case basis.

INTERFARMA

The Companies and Adherents’ representatives must transmit accurate and complete information about the Products Subject to Health Surveillance to Healthcare Professionals, always limited to the information and characteristics of the product registered with ANVISA.

SINDUSFARMA

No specific rules. Any specifics must be assessed on the case-by-case basis.

ACESSA

See Medtech Canada Code of Conduct and  Guidance for Meals and Travel.

With regards to medical devices, the Chilean Medical Devices Association (“ADIMECH”)’s Code of Ethics allows only the delivery to HCPs of Samples and Demos of medical devices, but not ready-to-market products, and only for familiarization and/or education purposes. The provision of Samples and Demos shall not improperly promote the purchase, lease, recommendation, or prescription of the company’s products, nor shall it be understood as payment or compensation, of any kind, with respect to any service.

Samples shall be provided free of charge, with a delivery frequency and quantities that shall not exceed what is reasonably necessary for an adequate evaluation of the products.

Demos are intended for HCPs to learn about and educate themselves on the features and use of a particular piece of equipment or device. These products will not be intended for use on patients or for marketing and shall bear some marking that identifies them as such (e.g., "not for human use" or similar). The loan of Demos should be properly documented in advance and should be extended for a reasonable period of time.

See the above discussion about the rules in AdvaMed China Code.

ANDI's Chamber of Medical Devices and Health Supplies Code of Ethics of 2020 is the document that guides the relations of the members with the different stakeholders: HCP, health system actors, patients, health service providers and governmental entities. It also enshrines the ethical and transparent practices of the sector to promote better business environments for companies, better positioning, participation in international markets, and the safe and effective use of medical devices for the benefit of patients.

Within the framework of the events, the companies will not organize or sponsor activities such as prizes, tournaments, and other activities of chance, raffles and similar. When an event includes these types of activities in its agenda, companies shall define contractual mechanisms to ensure that their sponsorship resources are not being used for such activities.

Regarding interaction with HCP, the Code establishes guidelines on the following topics: i) Support for educational events organized by third parties; ii) Educational and commercial sponsorships; iii) Scholarships; iv) Scientific and clinical research; v) Contracts, payments and royalties with HCP; vi) Medical utility items; vii) Promotional items; viii) Meals associated with interactions with HCP; ix) Business meetings, among others.

Finally, the rules on engaging or interacting with HCPs in regard of medical devices about event location, event venue, accommodation, transportation, meals, family members, online conferences and promotional events are deployed in the above sections.

No specific rules.

Regulatory framework: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EU) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC,

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Industry code(s) of conduct: MedTech Europe Code of Ethical Business Practice

EU legislation

No specific legal rules at the EU level.

MedTech Europe Code

• the event location and venue should not become the main attraction of the event. The perceived image of the location and venue must not be luxury, or tourist/holiday-oriented, or that of an entertainment venue,
• the selected time of year for an event must not be associated with a touristic season for the selected geographic location,
• only actual and reasonable travel costs may be reimbursed, and they may not cover a period of stay beyond the official duration of an event.
• If the flight time, including combined flights, is more than 5 hours, only then business class travel may be refunded. First class is never appropriate.
• no hospitality for family members / third persons,
• no food deliveries during events, including the virtual ones.

For medical devices the relevant statutory law is the Medical Devices Act 719/2021.

Industry code is the MedTech Finland Ethical Code.

The Medical Devices Act does not include any specific rules on hospitality offered to HCPs.

The MedTech Finland Ethical Code is fully aligned with the MedTech Europe’s Ethical Code, except with two exceptions: 1) It is not accepted to serve any kind of alcohol in booths etc. in normal working hours in Finland. 2) Winter season ends 30.4. in Finland.

On a European level, clinical investigations of medical devices are governed by the provisions of the EU Regulation 2017/745, also known as MDR. It should be noted that the MDR Directive has been amended as of March 15 2023, by Regulation (EU) 2023/607, as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

On a national level, clinical investigations of medical devices are governed by Article 15 of the Medical Devices MD. According to Article 15, in conjunction with the EOF's Circular No. 42353/2011,14 applications for the initiation of clinical investigations of medical devices shall be submitted to the EOF in case the contemplated medical device does not bear the CE mark or if the device, despite bearing the CE mark, is to be tested for new uses not covered by the CE mark. Clinical investigations on in vitro diagnostic medical devices, if the product is intended to come into direct or indirect contact with the human body, must also be submitted to the EOF.

PBO: No rules.

HKAPI Code of Practice: Other than pharmaceutical products as provided hereunder, the spirits and principles of the Code shall apply to the dealings of medical devices and nutritional productions by member companies to the extent possible. (para 1.8)

Code of Conduct: No specific rules.

[1] Medical aid means any medical device made available for personal use to patients suffering in a temporary or persistent health impairment or disability (including in vitro diagnostic medical devices for self-testing purposes), and other technical devices for nursing and caring purposes, which are not treated as medical devices, designed for use without the continued presence of a healthcare professional. Personal use shall mean where the medical aid is worn, applied or administered in body cavities with exterior opening, whether natural or artificial, or on the body, including the use of in vitro diagnostic medical devices for self-testing purposes on specimens derived from the human body, and the use of equipment for supporting or moving the body for diagnostics purposes or for the purpose of therapy, rehabilitation or nursing.

There are no specific rules in the regulatory framework dealing with engagement with HCPs.

The Ethics Code of Confindustria Dispositivi Medici establishes the framework applicable to medical device companies.

Events should be held in appropriate premises such as clinics, laboratories, training centres, conference venues or other facilities that can be easily reached by the participants.

Companies may not organize events at seaside or mountain resorts during the holiday season.

Companies may only bear travel and accommodation costs for the HCPs invited to the events (i.e., no accompanying persons).

Flights must be in economy class, except for intercontinental flights, for which business class tickets are allowed.  First class tickets are forbidden.

Meals must be reasonable, while hotels may not be higher than a four-star category.

5-star venues are prohibited.

For training and educational events organized by third parties, companies should not provide direct financial support to cover attendance costs to individual HCPs

HCP are subject to restrictions related to free samples (Articles 25 and 26 of the Grand-Ducal Regulation of 15 December 1992 on the placing on the market of medicinal products)

No specific rules.

Inducements are prohibited unless it is within the frameworks set forth by law. Not all relationships can be considered as inducements. The basic principle is that no undue influence is allowed. There are four exceptions to the prohibition on inducement, including the reimbursement of participation costs. These participation costs are the costs of participating in meetings or manifestation, including the associated travel and accommodation costs. In assessing whether reimbursement or noncharging is acceptable, there are three criteria that apply to both meetings and manifestations:

- participation fees must be strictly limited to the main purpose of the meeting or manifestation;

- the meeting or manifestation must take place at an appropriate location;

- the reimbursement must be limited to what is strictly necessary to participate in the meeting or manifestation.

In addition, the criterion for meetings is that there must be:

- transparency about the links between speakers and supplier or third parties.

The Code of Conduct Medical Devices uses the term ‘supplier’ with regard to hospitality rules. It states that a supplier is the (legal) person who manufactures, markets, imports, stocks, resells and/or delivers a medical device, or provides services related to a device.

The Code of Conduct Medical Devices defines healthcare professionals as follows: The natural person who, whether employed or not or in cooperation with others, uses medical devices in the context of care or support himself and/or decides on the purchase or use thereof and/or is involved in the process of prescribing, selecting, fitting and/or advising on the use of medical devices.

Involvement of suppliers in meetings for healthcare professionals is permitted, in the sense that suppliers may organize or financially facilitate meetings, or make it possible for an individual healthcare professional to participate, and in this context bear the costs, on the provision that the following conditions are met:

• the program is balanced and reasonable in terms of program structure, and does not include recreational and social activities that are not related to the meeting and
• the location is justified in terms of location and facilities and
• the costs are reasonable

This is detailed per category of meeting in the code of conduct for medical devices.

It is not permitted that suppliers directly or indirectly bear the costs of others than healthcare professionals.

The costs reimbursed by the provider should be reasonable. This means that if there is reimbursement of expenses to an individual healthcare professional, only the following expenses may be reimbursed (so no other costs related to participation in meetings):

1. registration fees/ the cost to the organization (depending on the type of meeting/manifestation);
2. one or more reasonably priced meals;
3. necessary overnight accommodations, to the extent reasonably priced;
4. reasonable travel expenses.

It is assumed that reimbursement of the aforementioned costs is reasonable if: a. the supplier does not contribute more than EUR75 or EUR500 (depending on the type of meeting/manifestation) per meeting per healthcare professional to a maximum of EUR375 or EUR1,500 (depending on the type of meeting/manifestation) per year, or b. the healthcare professional pays at least 50% of the aforementioned costs themselves.

The program of the meeting is:

1. aimed at gaining knowledge and/or skills related to (the improvement of) health care and/or medical progress, and

2. is of a sufficient substantive level, and

3. balanced and reasonable in terms of program structure and time allocation (and focused solely on the purpose of the meeting).

The abovementioned requirements differ per type of meeting, so should be assessed on a case-by-case basis.

Agreements regarding reimbursement of expenses of individual healthcare professionals must be captured in writing. Part of these arrangements is that the healthcare professional involved, reports these arrangements to the board of the institution or their employer. The data relating to hospitality are made public in a register. 

The program of a meeting must be understandable and acceptable. Coffee and tea breaks, lunches and dinners must be logical breaks in the program. Not logical are other program elements unrelated to the scientific part, such as recreational and social activities. Of course, some time may be spent on recreation, if reasonable and time proportionate.

The location of the meeting should be justified, both in terms of facilities and geographical location.

The question whether the location is permitted concerns two aspects: location and facilities. Both must be justified, and whether they will vary per type of meeting. The facilities must not be too attractive that they are likely to be the reason for the healthcare professional to attend the meeting. In addition, the geographical location must be objectively justified. This may be the case if the location is a logical choice in view of the origin of speakers and invited participants, or the accessibility. There may also be a direct relationship between the topic and/or purpose of the meeting and the location, making it logical for the meeting to take place there.

The criterion that the meeting or manifestation must take place at an appropriate location is intended to keep the reimbursement of participation fees modest and to prevent excesses. The economic value of travel and accommodation plays a role in this. When assessing the justification for the location, the nature of the specific medical devices to which the meeting/ manifestation relates, plays a role.

It is prohibited to directly or indirectly account for the expenses of other people than healthcare professionals, including partners or children. 

Regulatory framework:

Wet medische hulpmiddelen

Beleidsregels gunstbetoon Wet medische hulpmiddelen 2018

Gedragscode Medische hulpmiddelen

Competent authorities:

Stichting GMH (Medical Devices)

MTANZ Code of Ethics - MTANZ - Medical Technology Association of New Zealand

• In all dealings with HCPs a company should undertake and encourage ethical business practices and socially responsible Industry conduct and should not use any inappropriate inducement or offer any personal benefit or advantage in order to promote or encourage the use of its products.
• A company's provision of services or support for the provision of services to HCPs, or sponsorship, grant or donation that benefits an HCP, should not be used as a means of inappropriate inducement for the HCPs to purchase the company's products or cause company's products to be purchased.
• A Company should not pay for the hospitality, travel, or other expenses of any person who does not have a genuine professional interest in the information being shared at the programme.

Company-sponsored Training and Education and Medical Technology demonstrations

• A company may provide training of HCPs on product specific device deployment, use and application to facilitate safe and effective use, and education on topics concerning or associated with the use of the company's technologies. Training and Education should be conducted by properly qualified personnel with appropriate technical expertise and in a setting that is conducive to the effective transmission of knowledge ensuring that the location is appropriate for the form of the training.
• A company may pay for an attending HCPs reasonable travel and modest lodging costs. This should be documented in a simple written agreement for each attending HCP (or, where a modest event, a detailed programme or agenda) setting out the nature of the programme and services provided by the company.

Third Party Educational Conferences

• Company support of Third Party Educational Conferences should preserve the independence of medical education.
• A company may provide sponsorship or a grant to the Conference Sponsor (Professional Association or Training Organisation independent of the company) of a Third Party Educational Conference. The conference must be primarily dedicated to promoting objective medical, scientific and educational activities.
• Any sponsorship or grant must be proportional to the overall cost of the conference. It must be used to reduce conference costs, provide for attendance by a HCP (selected by the Conference Sponsor) or provide for a speaker's or panel member's (Faculty Member) reasonable honorarium, travel lodging and Hospitality (i.e., food and beverage) expenses.
• The Conference Sponsor will select the recipient of the sponsorship/donation, make the arrangements for travel and accommodation, and select the programme content, Faculty Members, educational methods and materials.
• A company may conduct a company-sponsored symposium as part of a Third Party Educational Conference. The symposium must use a Faculty Member, Consultant or employee of the company to speak at or facilitate the symposium. The company may not pay the costs of any attendees at a company-sponsored symposium except those of a Faculty Member, Consultant or employee speaking at or facilitating the symposium.

Virtual Events

• A company may organise a virtual third-party or educational event, including filmed panel discussions, presentations, or live clinical procedures, to an audience not physically in attendance.
• The event should be relevant to the HCPs attending virtually and a detailed programme made available to them prior to the event.
• All supporting promotional materials must be consistent with the scientific or promotional nature of the programme content and otherwise comply with the Code.

HCPS acting as Consultants

• A company may engage a HCP as a Consultant to provide valuable genuine consulting services, including research, participation on advisory boards, presentations at Company-sponsored training, and product collaboration. Such an engagement may take place only where a legitimate need and purpose for the services is identified and documented in advance. The Promotion of a Medical Technology to the Healthcare Professional must not be a purpose for the engagement. The selection of the consultant should be based on their qualifications and expertise in dealing with the subject matter of the engagement, and not on the volume or value of business they generate or will potentially generate, and be based on factors that preserve the objectivity of medical decision-making and avoid the potential for improper influence. The company may pay the HCP a reasonable compensation consistent with fair market value for performing consultancy services. The arrangement should be documented in writing and should specify all services to be provided (including research protocol, if relevant) and compensation to be paid (including the calculation of any royalties payable in exchange for intellectual property arising from the services, based on factors that preserve the objectivity of medical decision-making and avoid improper influence). Any meetings between the company and Consultant should be in appropriate location and circumstances to the subject matter of the engagement and conducive to the effective transmission of information, and any food and beverages provided by the company should be modest in value and subordinate in time and focus to the primary purpose of the meeting. The company may pay the Consultant's reasonable and actual expenses incurred in carrying out their engagement.

Market Research with HCPs

• A company may conduct Market Research with a HCP. The sole purpose must be data collection and it must not be used to promote to or reward the HCP. The Market Research must be identified as such to the HCP. Any compensation should be minimal and not exceed a level commensurate to the work performed by the HCP.

Hospitality

• The provision of Hospitality in the course of presenting scientific, educational, or commercial information to HCPs must be incidental to presenting that information, take place in a setting conducive to bona fide scientific, educational, or business discussions, be modest in value and limited to those actually participating in the meeting who have bona fide professional interest in the information shared. The provision of food and beverages must not include Entertainment (which means sporting events, musical and other entertainment).
• A company may provide food and beverages at Third Party Educational Conference so long as they are provided in a manner that does not interfere with attendance at conference functions.
• If funding is provided to a Conference Organiser to support the provision of food and beverages at a Third Party Educational Conference, the company must enter a written agreement with the Conference Organiser that specifies the nature and conditions of the food and beverages and requires the Conference Organiser to account to the company for the use of the funding.
• Delivery of food or beverage is not permitted for Virtual Events.

Gifts

• Companies should not provide HCPs with gifts (including cash, food, alcohol, gift baskets, gift cards or flowers). This extends to any type of branded or non-branded promotional item, even those of minimal value which are related to the HCPs work or is for the benefit of patients. Companies should not provide, organise or pay for any recreational or entertainment activities for HCPs. 
• Occasionally providing a HCP with an item that benefits patients or serves a genuine education function for the HCP provided the item has a fair market value of less than USD100, except in the case of medical textbooks or anatomical models, is permitted.
• A company may also provide an HCP with a medical device which is marketed only to consumers.
• A company may not accept a gift from a HCP which is beyond the level of what is reasonable and customary in the circumstances of the relationship.
• A company should ensure that sales of medical devices are made solely on the basis of efficacy, safety, quality, price and service, and never on the basis of a HCP receiving payments, gifts, food or beverages.
• The legitimate practice of providing appropriate samples for genuine training, education or evaluation purposes is permitted.

Grants & Donations

• A company may provide specified research and educational grants and charitable donations, provided that:
  • objective criteria are used to decide such grants and donations;
  • appropriate procedures are implemented to ensure that such grants and donations are not used as a condition to purchase the company's products; and
  • all grants and donations are appropriately documented.

Regulation on HCPs availabilty to receive gifts of 29 August 2005 no. 941:

The general prohibition on HCP receiving benefits that are likely to influence health personnel's official actions in an inappropriate way means that healthcare personnel must assess the legality of receiving the benefit if it is given or offered on their own behalf or on behalf of others, for example:

k) remuneration for or other benefit for the use of certain medicines or certain medical equipment, etc.

h) remuneration for participation in trials of medicines, medical equipment etc., including coverage of expenses incurred in connection with the assignment.

The Regulation for medical devices MDR and the Regulation for in vitro diagnostic medical equipment, IVDR​:

It is permitted to advertise medical equipment in Norway both aimed at healthcare personnel and the general public. No distinction is made between advertising aimed at healthcare personnel and the general public, in contrast to the way it is done for pharmaceuticals.

In general, advertising for medical equipment must be objective, truthful and provide sober and factual information about the equipment. Advertising must always comply with the manufacturer's instructions for use, which inform about purpose, correct use and precautions.

LMI industry rules:

12.1 Information and educational materials

Informational and educational materials can be distributed to healthcare personnel provided the material has little value, is of direct professional importance for medical treatment or pharmacy practice, and of direct benefit to the treatment of patients.

12.2 Medical devices

Medical devices can be distributed in the purpose of promoting education of healthcare personnel and better patient care, provided that it is of little value, is of direct professional importance for medical treatment or pharmacy practice, and directly useful for the treatment of the patients and is not part of the recipient's ordinary professional activities, such as consumables and other things that are necessary for the operation of the Health Personnel's activities.

12.3 Assistive devices for patients

Healthcare personnel can receive information and educational materials or device of small value to be passed on to the patient.

12.4 Company name and logo

Such material/device may be branded with company name and logo, but must not be labelled with product name, logo or distinguishing mark unless it is necessary for the correct use of the material/device and is part of the material/the function or purpose of the device.

For devices, this will typically apply to "dummies" (e.g. empty inhalers) which must also be applied "for demonstration" and "does not contain active ingredient".

12.5 No conditions

Material and devices cannot be offered or distributed with conditions of consideration of any kind from Health Personnel, e.g. execution of a meeting.

Regulatory framework: the Act of 7 April 2022 r. on medical devices

Industry code of conduct: MedTech Code of Ethical Business Practices

Competent authority: The President of the Office for Registration of Medical Products, Medical Devices and Biocidal Products (Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych - URPL)

Polish Act on Medical Devices

No specific rules.

MedTech Code (Poland)

• the event location and venue should not become the main attraction of the event. The perceived image of the location and venue must not be luxury, or tourist/holiday-oriented, or that of an entertainment venue,
• the selected time of year for an event must not be associated with a touristic season for the selected geographic location,
• only actual and reasonable travel costs may be reimbursed, and they may not cover a period of stay beyond the official duration of an event.
• If the flight time, including combined flights, is more than 5 hours, only then business class travel may be refunded. First class is never appropriate.
• no hospitality for family members / third persons,
• no food deliveries during events, including the virtual ones.

Please refer to our answers above, which are applicable to medical devices in general terms. Please find below some further specific information although not exhaustive.

Regarding virtual events, APORMED’s Code of Good Commercial Practices states that the associated companies may provide financial or in-kind support to virtual events.

The location and space of the events should not be the main attraction and the events and shall take place in or near cities that are a recognized scientific or business centre, appropriate for the organization of the event. The choice of location and venue should always consider the following:

• possible negative public perception regarding the location and space of the event;
• the image associated to the location and venue must not be of tourism/holidays or entertainment (and the time of the year chosen must not be associated with a touristic or festive season);
• the image associated to the location and venue must not be of luxury;
• the location and venue of the event shall be central taking into consideration the residence of the majority of the invited participants;
• the need for easy access by the participants, which presupposes that the events are organised in locations near airports and/or train stations with appropriate connections to the participants point of origin.
• the location of international events shall be approved by the Conference Vetting System.

Entertainment includes, among other, programmes where dancing or live music are the main attraction, sightseeing tours, excursions such as trips to the theatre, sporting events such as skiing, golf or football matches, and other recreational and leisure programmes.

No payments and reimbursements of accommodation costs in top-end or luxury hotels are allowed (nor shall be accepted that HCP’s pay the difference to a reasonable tariff).

Promotional meetings for sales and other commercial purposes (i) shall take place, as general rule, within the place where the HCP performs its activity or nearby; (ii) supporting transportation and accommodations costs is not allowed except if necessary for purposes of demonstration of non-portable equipment.

Specific regulation emanating from the Slovenian Medical Devices Act (Zakon o medicinskih pripomočkih, ZMedPri), available in Slovene; and the Slovenian Rules on Medical Devices (Pravilnik o medicinskih pripomočkih), available in Slovene applies.

Promotion of medical devices is allowed under the conditions of the Medical Devices Act. The medicinal devices need to fulfil specific criteria. When advertising medical devices to the HCPs, it is prohibited to give, offer or promise gifts, financial benefits or material advantages, unless these are occasional gifts of a small value (under 100EUR) or of insignificant value (under 50EUR). According to the rules on Rules on Medical Devices, HCPs may be given samples of medical devices if the following criteria is met: (i) the medical device sample must comply with all regulatory requirements for medical devices, (ii) the sample medical device must be labelled to indicate that it is a sample, (iii) the medical device samples must be in the smallest packaging, (iv) the business operator distributing the samples must keep records of the type, quantity and recipients of the medical device samples, and (v) the recipient of the medical device samples must not sell them.

In the case of Medical Devices, different criteria apply as it is regulated by the Fenin Code of Conduct (available here).

For example:

• The location and venue of the Event must be close to an airport or train station with adequate connections depending on the point of origin of the Attendees, and with adequate ground transportation infrastructure for travel to the event.
• The seasonality criteria shall be considered, being forbidden for summer destinations, between 1 June and 30 September, and for winter destinations between 1 December and 31 March.
• In Spain, a meal (lunch or dinner) that does not exceed EUR80 per diner, including taxes, is considered moderate. For Events held outside Spain, the maximum established by law or by the national association of the country hosting the Event shall apply.
• For flights, the Companies will only pay for economy or tourist class, unless the flight lasts more than 5 hours (including connection times), in which case the use of business class will be allowed. The use of first class will not be permitted under any circumstances. The Companies may cover the cost of access to the Executive or Preferential Lounge, if not covered by the ticket, for connections or delays of more than three hours. Train travel must be made in tourist/tourist plus, except for journeys of more than 1 hour, in which case the preferential fare may be used, excluding in any case Club or Grand Class.

ABPI Code

HCPs can be provided with materials and items for patient support which are to be passed on to patients, provided they are appropriately documented and certified in accordance with the ABPI Code. These items must not be given out from exhibition stands (although they can be displayed on such, and HCPs can make requests for later delivery). Likewise, items for patient support can be provided to HCPs by representatives during the course of a promotional call and such items can be delivered to HCPs upon request. Such items which may be acceptable include a peak flow meter as part of a scheme for patients to regularly record readings, or a pedometer as part of a scheme to encourage exercise.

In addition, provided they are appropriately documented and certified in accordance with the requirements of the ABPI Code, items which allow for patient support enabling them to gain experience in using their medicines whilst under the supervision of a healthcare professional may be available for the use of health professionals even though they are not to be passed on to patients for them to keep. This might include an inhalation device (with no active ingredient) and devices intended to assist the patient to learn how to self-inject.

Items for patient support must be inexpensive and directly benefit patient care. Items may bear the name of the company providing them but must not be product branded, unless the name of the medicine is essential for the correct use of the item by the patient.

Bribery Act

Provision of samples should be monitored and reviewed to ensure that it does not reach a level of being capable of constituting a financial or other advantage intended to induce or reward improper performance.