Competent authorities

The Human Medicines Regulations 2012 

Please also see the Global Compliance Guide as it relates to the European Union. Following Brexit, EU legislation as it applied to the UK on 31 December 2020 is now a part of the UK’s domestic legislation.

The UK Bribery Act 2010

The ABPI Code of Practice (ABPI Code) – this code reflects the statutory requirements concerning the engagement of healthcare professionals, whilst also incorporating additional "best practice" guidance from the Blue Guide (see below) and from the ABPI itself. Given its scope, the ABPI Code is the primary source of guidance in this area.

PAGB Code of Practice (PAGB Code) – applies to advertising of over-the-counter medicines, aimed wholly or mainly at persons qualified to prescribe or supply (and people working for them), where the object of the advertising is to influence sales and/or recommendations to the public.

GMC Code of Good Medical Practice (GMC Code) – sets out the standards expected of HCPs themselves in the UK when it comes to accepting/receiving hospitality and other such benefits from industry players.

Blue Guide (Advertising and Promotion of Medicines in the UK) (Blue Guide) – explains the provisions and requirements of UK legislation concerning advertising and promoting medicines.

ABPI Code

Meetings at venues outside the UK are not necessarily unacceptable. There have, however, to be valid and clear reasons for holding meetings at such venues. For example, this may include a situation in which most of the invitees are from outside the UK and, given their countries of origin, it makes greater logistical sense to hold the meeting outside the UK. Another example might include a situation in which, given the location of the relevant resource or expertise that is the object or subject of the meeting, it makes greater logistical sense to hold the meeting outside the UK. Consideration should be given to the use of technology to avoid travel outside the UK e.g., webinars, virtual meetings, etc.

Further to this, companies should remind their affiliates outside the UK that the ABPI Code still needs to be complied with if UK health professionals attend events/meetings which they organise, regardless of whether such events/meetings occur in the UK or abroad.

As a general point to note (which shall be relevant to all entries in this table for the UK), it is advised that HCPs "[r]efuse all but the most trivial gifts, favours or hospitality, if accepting them could be interpreted as an attempt to gain preferential treatment or would contravene your professional code of practice".

Bribery Act

The Bribery Act prohibits the offering, promising, giving, requesting, agreeing to receive or accepting of a financial or other advantage intending to induce or reward or otherwise in exchange for improper performance of a relevant function or activity.  It also prohibits the bribing of a foreign public official with the intention of influencing them in their capacity as a foreign public official and intending to obtain or retain business or an advantage in the conduct of business.

Event location could be considered an “other advantage” in the context of the Bribery Act if it is lavish.  The factors referenced above in connection with the ABPI Code with regard to location would be relevant factors in determining the appropriateness of the location from a bribery perspective.

ABPI Code

Meetings must be held in appropriate venues conducive to the main purpose of the event. Lavish, extravagant or deluxe venues must not be used; companies must not sponsor or organise entertainment (such as sporting or leisure events) and companies should avoid using venues that are renowned for their entertainment facilities.

Consideration must be given to the programme, overall cost, facilities offered by the venue, nature of the audience, subsistence provided and similar. It should be the programme that attracts delegates and not the associated hospitality or venue.

Bribery Act

Similar factors as those referenced under the ABPI Code above will be relevant to an analysis as to whether an event venue constitutes an advantage given to induce, reward etc improper performance of a relevant function or activity. 

The Bribery Act does not place a bar on specific conduct, such as sponsoring or organizing sporting or leisure events, and guidance issued by the Ministry of Justice makes it clear that “for example, an invitation to foreign clients to attend a Six Nations match at Twickenham as part of a public relations exercise designed to cement good relations or enhance knowledge in the organisation’s field is extremely unlikely to engage section 1 as there is unlikely to be evidence of an intention to induce improper performance of a relevant function.” 

That said, HCPs will often be considered public officials, if they engage in work for public bodies or governmental organisations for example, and extra care should be taken given the heightened bribery risks that arise with engagement with such individuals.

ABPI Code

Companies are permitted to offer hospitality, including accommodation, provided the hospitality is limited to the main scientific objective of the event and offered only to HCPs (see Family members for further details).

There are no specific rules on accommodation, but it should be the programme that attracts delegates and not the associated hospitality or venue. The accommodation provided must be appropriate and not disproportionate to the occasion.

Bribery Act

Care should be taken to ensure that the nature of the accommodation is not such that it is so lavish as to appear to constitute an inducement or reward to attendees for the improper performance of a relevant function or activity.  Similar considerations to those set out above under the ABPI Code will apply to this analysis.

ABPI Code

Subject to the below, companies should only offer or provide economy air travel to delegates sponsored to attend meetings. Delegates may organise and pay at their own expense the genuine cost of an upgrade.

For flights that are scheduled to take longer than 6 hours, companies may pay for an upgrade from economy to premium economy or similar.

Bribery Act

Care should be taken to ensure that the nature of the travel is not such that it appears to constitute an inducement/reward to attendees for the improper performance of a relevant function or activity.  Operating in compliance with the requirements of the ABPI Code set out here will support in establishing that the travel is not nor is it intended to be such an inducement/reward.

ABPI Code

Travel costs must be strictly limited to the main purpose of the event/meeting; must be of secondary consideration and must be appropriate and not out of proportion to the occassion.

Travel costs should not exceed that level which the recipients would normally adopt when paying for themselves.

Bribery Act

As above.

ABPI Code

Any subsistence associated with the meeting must be secondary to the nature of the meeting, and must be appropriate and not out of proportion to the occasion.

Bribery Act

As with the other elements set out herein, the Bribery Act does not specifically prohibit or mandate the nature of interactions, but applies more broadly to any advantage which is intended to induce or reward improper performance of a relevant function or activity. Care should therefore be taken to ensure that meals offered are not so lavish as to appear as such. Following the requirements set out in the ABPI Code will support this.  

ABPI Code

The cost of a meal (including drinks) provided by way of subsistence must not exceed GBP75 per person, excluding VAT and gratuities. 

The maximum of GBP75 plus VAT and gratuities is appropriate only in very limited circumstances, such as dinner at a residential meeting for senior consultants, or a dinner at a learned society conference with substantial educational content. The cost of a meal (including drinks) should normally be well below this figure. 

The maximum amount does not apply where the meeting is held outside the UK in a European country where the national association is a member of EFPIA and is thus covered by EFPIA Codes. In such circumstances the limits of the host country would apply.

Bribery Act

As above. There are no set limits under the Bribery Act, but costs should not be so high as to appear lavish.

ABPI Code

Donations in lieu of hospitality are unacceptable. If hospitality is not required at a meeting there is no obligation or right to provide some benefit of an equivalent value.

No payment may be offered or paid to individuals to compensate merely for the time spent in attending events/meetings.

ABPI Code

The payment of travel expenses and the like for persons accompanying the delegate is not permitted. 

Any hospitality provided must not extend to an accompanying person unless that person qualifies as a proper delegate or participant at the meeting in their own right. In exceptional cases of established clear health needs of the delegate (e.g., disability or injury), similar hospitality may be provided for an accompanying person.

Bribery Act

Best practice in connection with anti-bribery procedures has developed such that it is typically considered inappropriate to pay for family members to travel to/stay at an event location and it is not recommended. 

ABPI Code

The guidance as it relates to in-person events/meetings also applies to online conferences.

Bribery Act

The granting of access to an online conference for free, that would otherwise be paid for, could be seen as an “other advantage” under the Bribery Act, depending on the circumstances. As with all of the guidance above care should be taken to ensure that engagemet with HCPs in conenction with an online conference is not such that it could be seen as intending to induce or reward improper performance of a relevant function or activity.

UK Advertising Legislation (including the Blue Guide and PAGB Code)

If broadcasting to a UK audience, then the online conference may fall subject to UK advertising laws. Some key principles set out in UK advertising laws are:

• to ensure that any communications are clear, accurate and not misleading (this includes not exaggerating the capability or performance of the products); and
• to ensure that any claims made are within the scope of the CE marking, align with the intended purpose of the product, and are sustainable by reference to the technical file of the product.

The Blue Guide and PAGB Codes

As well as the Blue Guide, consideration should also be given to the PAGB Code concerning the marketing of over-the-counter medicines (where such marketing is aimed at persons qualified to prescribe and supply, and those working for them).

ABPI Code

Companies should be aware that promotion at international events/meetings held in the UK may, on occasion, pose certain problems with regard to medicines or indications for medicines which do not have a marketing authorisation in the UK (although they are so authorised in another major industrialised country).

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.