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| Are patient case studies promotional? | The term patient case study is broadly used to describe material about the medicinal treatment of a particular patient with a certain disease, including outcomes.As with any material, item or activity, developed by a pharmaceutical company, much will depend on the content, how it is used, who uses the case study, the intended audience, method of dissemination, etc. Each use of a case study should be considered and categorised accordingly.SeeClause 1.17.
The term patient case study is broadly used to describe material about the medicinal treatment of a particular patient with a certain disease, including outcomes.
As with any material, item or activity, developed by a pharmaceutical company, much will depend on the content, how it is used, who uses the case study, the intended audience, method of dissemination, etc. Each use of a case study should be considered and categorised accordingly.
SeeClause 1.17. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/are-patient-case-studies-promotional/ |
| Are individuals representing patient organisations considered to be members of the public? | These individuals are defined in the Code to be mandated to represent and express the views of a patient organisation.Clause 1.16
These individuals are defined in the Code to be mandated to represent and express the views of a patient organisation.Clause 1.16 | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/are-patient-organisation-representatives-considered-to-be-members-of-the-public/ |
| Are transcripts needed for audiovisual material? | In certifying audio and audiovisual material and promotional material on databases, interactive systems and the internet, companies must ensure that a written transcript of the material is available, including reproductions of any graphs, tables and the like that appear in it. In the event of a complaint, a copy of the written material will be requested.Alternatively, companies may certify material on interactive systems by means of producing an electronic copy, for example, on a CD-ROM or data stick, if the electronic copy is write protected and unable to be changed.See also the supplementary information toClause 8.1regarding the certification of promotional material.
In certifying audio and audiovisual material and promotional material on databases, interactive systems and the internet, companies must ensure that a written transcript of the material is available, including reproductions of any graphs, tables and the like that appear in it. In the event of a complaint, a copy of the written material will be requested.
Alternatively, companies may certify material on interactive systems by means of producing an electronic copy, for example, on a CD-ROM or data stick, if the electronic copy is write protected and unable to be changed.
See also the supplementary information toClause 8.1regarding the certification of promotional material. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/are-transcripts-needed-for-audiovisual-material/ |
| Can a company pay for its press release to be published? | Once a press release is issued, a company should have no control over the placement of any subsequent article and nor should it, or its agent, make any payment in relation to an article’s publication. Whether and where articles appear in the press should be solely at the publisher’s discretion and articles should be printed wholly at the publisher’s expense. If a company, or its agent, controls or in any way pays for the placement of an article about a product, then that article will be regarded as an advertisement for the product. Similarly it is likely that any payment will be regarded as turning the resulting article into an advertisement.
Once a press release is issued, a company should have no control over the placement of any subsequent article and nor should it, or its agent, make any payment in relation to an article’s publication. Whether and where articles appear in the press should be solely at the publisher’s discretion and articles should be printed wholly at the publisher’s expense. If a company, or its agent, controls or in any way pays for the placement of an article about a product, then that article will be regarded as an advertisement for the product. Similarly it is likely that any payment will be regarded as turning the resulting article into an advertisement. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-a-company-pay-for-its-press-release-to-be-published/ |
| Can a company proactively notify a patient organisation of recruiting clinical trials? Does this depend on the phase of the study? | The Code does not prohibit companies notifying patient organisations about clinical research projects. The purpose of such notification needs to be considered. The European Federation of Pharmaceutical Industries and Associations (EFPIA) publication 'Working Together with Patient Groups' provides some additional information:https://www.efpia.eu/
The Code does not prohibit companies notifying patient organisations about clinical research projects. The purpose of such notification needs to be considered. The European Federation of Pharmaceutical Industries and Associations (EFPIA) publication 'Working Together with Patient Groups' provides some additional information:https://www.efpia.eu/ | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-a-company-proactively-notify-a-patient-organisation-of-recruiting-clinical-trials-does-this-depend-on-the-phase-of-the-study/ |
| Can a company promote to a non-medical prescriber? What about MPs, patient organisation personnel, medical students - can they attend pharmaceutical company exhibition stands? | Companies can promote to an individual whose role meets the definition of a health professional (Clause 1.9)or, where applicable, an other relevant decision maker(Clause 1.13). If the individual's role does not meet either definition, then they are likely to be considered a member of the public.Prescription only medicines (POMs) must not be advertised to the public, which might include MPs, patient organisation personnel and medical students. The individual circumstances would need to be considered very carefully.Where medical students are a member of a multidisciplinary team, it might be appropriate to include them in meetings for their health professional colleagues. Promotion of prescription only medicines to a group of medical students is unlikely to be acceptable. Exhibition stands must be suitable for the audience and if this includes members of the public, POMs must not be advertised.
Companies can promote to an individual whose role meets the definition of a health professional (Clause 1.9)or, where applicable, an other relevant decision maker(Clause 1.13). If the individual's role does not meet either definition, then they are likely to be considered a member of the public.
Prescription only medicines (POMs) must not be advertised to the public, which might include MPs, patient organisation personnel and medical students. The individual circumstances would need to be considered very carefully.
Where medical students are a member of a multidisciplinary team, it might be appropriate to include them in meetings for their health professional colleagues. Promotion of prescription only medicines to a group of medical students is unlikely to be acceptable. Exhibition stands must be suitable for the audience and if this includes members of the public, POMs must not be advertised. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-a-company-promote-to-a-non-medical-prescriber-what-about-mps-patient-organisation-personnel-medical-students-can-they-attend-pharmaceutical-company-exhibition-stands/ |
| Can a pharmaceutical company distribute pens/pencils and notepads from an exhibition stand? | No. Pharmaceutical companies should not distribute any items, other than promotional or educational literature, from exhibition stands.Clause 10.6
No. Pharmaceutical companies should not distribute any items, other than promotional or educational literature, from exhibition stands.Clause 10.6 | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-a-pharmaceutical-company-distribute-penspencils-and-notepads-from-an-exhibition-stand/ |
| Can a pharmaceutical company provide pens/ pencils and notepads with clinical trial materials? If so, can they bear the name of the trial as well as, or instead of, the company? | Pens/pencils and notepads can be provided with clinical trial materials. They should not be provided on anad hocbasis. It could be argued that such materials are not promotional because they are not provided for a promotional purpose. They must not be provided by a representative. Bearing in mind the spirit of the Code, it might be best to followClause 10.5. Thus the pens/pencils and notepads should not bear the name of the trial but could bear the name of the company providing them. They should not bear the name of a medicine or any information about medicines. The total cost of the items provided to an individual recipient must not exceed £6, excluding VAT. The perceived value to the recipient must be similar.
Pens/pencils and notepads can be provided with clinical trial materials. They should not be provided on anad hocbasis. It could be argued that such materials are not promotional because they are not provided for a promotional purpose. They must not be provided by a representative. Bearing in mind the spirit of the Code, it might be best to followClause 10.5. Thus the pens/pencils and notepads should not bear the name of the trial but could bear the name of the company providing them. They should not bear the name of a medicine or any information about medicines. The total cost of the items provided to an individual recipient must not exceed £6, excluding VAT. The perceived value to the recipient must be similar. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-a-pharmaceutical-company-provide-penspencils-and-notepads-with-clinical-trial-materials-if-so-can-they-bear-the-name-of-the-trial-as-well-as-or-instead-of-the-company/ |
| Can a pharmaceutical company put an interactive programme on an exhibition stand that requires an attendee to make a series of judgements and choices regarding a treatment pathway? When would such a programme become a quiz, if it was not one already? | Although such a programme may be regarded as simply educational material, depending on its content it could also be considered to be a quiz and thus subject to the requirements relating to quizzes inClause 10.7. Any assessment or evaluation of the delegates’ decisions may mean that the interactive programme is a quiz.A quiz would be acceptable if it related to the subject matter of the meeting and formed part of the meeting’s formal proceedings. Exhibition stands are not considered to be a formal part of a meeting’s proceedings.
Although such a programme may be regarded as simply educational material, depending on its content it could also be considered to be a quiz and thus subject to the requirements relating to quizzes inClause 10.7. Any assessment or evaluation of the delegates’ decisions may mean that the interactive programme is a quiz.A quiz would be acceptable if it related to the subject matter of the meeting and formed part of the meeting’s formal proceedings. Exhibition stands are not considered to be a formal part of a meeting’s proceedings. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-a-pharmaceutical-company-put-an-interactive-programme-on-an-exhibition-stand-that-requires-an-attendee-to-make-a-series-of-judgements-and-choices-regarding-a-treatment-pathway-when-would-such-a-programme-become-a-quiz-if-it-was-not-one-/ |
| Can a pharmaceutical company sponsor conference lanyards, badges and bags, etc. by paying the organiser for them and in return getting the company name on the item? | No.Clause 10.6of the Code sets out what can be provided in conference bags and states pens/pencils and notepads provided in conference bags at independently organised meetings must not include the name of the donor company, the name of any medicine or any information about medicines. The total cost to the donor company of all such items provided to an individual attending an event/meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar. Pens/pencils and notepads must not be given out from exhibition stands.
No.Clause 10.6of the Code sets out what can be provided in conference bags and states pens/pencils and notepads provided in conference bags at independently organised meetings must not include the name of the donor company, the name of any medicine or any information about medicines. The total cost to the donor company of all such items provided to an individual attending an event/meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar. Pens/pencils and notepads must not be given out from exhibition stands. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-a-pharmaceutical-company-sponsor-conference-lanyards-badges-and-bags-etc-by-paying-the-organiser-for-them-and-in-return-getting-the-company-name-on-the-item/ |
| Can any non-monetary item be provided at meetings? | The supplementary information toClause 10.5states: "Pens/pencils and notepads are the only items that can be provided to health professionals and other relevant decision makers for them to keep and then only at bona fide meetings."For attendees of company organised events/meetings,Clause 10.5states that such items "must not bear the name of any medicine or any information about medicines" but they may bear the name of the donor company. No individual attendee should receive more than one pen or pencil and one notepad.For pens/pencils and notepads provided in conference bags at independently organised meetings,Clause 10.6applies. It states that the pens/pencils and notepads "must not include the name of the donor company, the name of any medicine or any information about medicines". Pens/pencils and notepads must not be given out from exhibition stands.In both circumstances, the total cost to the donor company of all such items provided to an individual attending an event/meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar.
The supplementary information toClause 10.5states: "Pens/pencils and notepads are the only items that can be provided to health professionals and other relevant decision makers for them to keep and then only at bona fide meetings."
For attendees of company organised events/meetings,Clause 10.5states that such items "must not bear the name of any medicine or any information about medicines" but they may bear the name of the donor company. No individual attendee should receive more than one pen or pencil and one notepad.
For pens/pencils and notepads provided in conference bags at independently organised meetings,Clause 10.6applies. It states that the pens/pencils and notepads "must not include the name of the donor company, the name of any medicine or any information about medicines". Pens/pencils and notepads must not be given out from exhibition stands.
In both circumstances, the total cost to the donor company of all such items provided to an individual attending an event/meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-any-non-monetary-item-be-provided-at-meetings/ |
| Can appointment cards be provided as a material or item for patient support? | Pharmaceutical companies cannot provide appointment cards or other general items of stationery.Appointment cards do not appear to be in line with the examples of items for patient support set out in the supplementary information toClause 19.2. However, it might be possible to provide an appointment card where, to complete a treatment course, the patient will need more than one visit. This is more likely to be acceptable if other materials for patient support are provided, which are to be passed on to patients, the details of which must be appropriately documented and certified in advance as required byClause 8.3.
Pharmaceutical companies cannot provide appointment cards or other general items of stationery.
Appointment cards do not appear to be in line with the examples of items for patient support set out in the supplementary information toClause 19.2. However, it might be possible to provide an appointment card where, to complete a treatment course, the patient will need more than one visit. This is more likely to be acceptable if other materials for patient support are provided, which are to be passed on to patients, the details of which must be appropriately documented and certified in advance as required byClause 8.3. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-appointment-cards-be-provided-as-a-material-or-item-for-patient-support/ |
| Can companies employ bloggers to talk about disease and general management techniques as long as treatments are not mentioned? How best can this be done - what should companies bear in mind? | This is a difficult area and one which needs very careful consideration by companies. Where companies consider this is appropriate it is important to be transparent about arrangements so that readers are clear about the company's role. The company will be responsible for the content.Clause 24should be complied with if bloggers are contracted by companies.
This is a difficult area and one which needs very careful consideration by companies. Where companies consider this is appropriate it is important to be transparent about arrangements so that readers are clear about the company's role. The company will be responsible for the content.
Clause 24should be complied with if bloggers are contracted by companies. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-companies-employ-bloggers-to-talk-about-disease-and-general-management-techniques-as-long-as-treatments-are-not-mentioned-how-best-can-this-be-done-what-should-companies-bear-in-mind/ |
| Can companies engage in pre-licence activity? | A medicine must not be promoted prior to the grant of its marketing authorisation which permits its sale or supply.Clause 3.1and its supplementary information provide more information.
A medicine must not be promoted prior to the grant of its marketing authorisation which permits its sale or supply.
Clause 3.1and its supplementary information provide more information. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-companies-engage-in-pre-licence-activity/ |
| Can companies lobby or undertake PR activity with politicians? | Interactions companies have with politicians will vary. Companies need to consider the aims and objectives of such interactions and if the interaction is appropriate. Whether such interactions fall within the scope of the Code will depend on the aims and objectives and how these are implemented. In some circumstances politicians may be defined as other relevant decision makers (Clause 1.13).
Interactions companies have with politicians will vary. Companies need to consider the aims and objectives of such interactions and if the interaction is appropriate. Whether such interactions fall within the scope of the Code will depend on the aims and objectives and how these are implemented. In some circumstances politicians may be defined as other relevant decision makers (Clause 1.13). | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-companies-lobby-or-undertake-pr-activity-with-politicians/ |
| Can companies make press releases available directly to the public via social media channels and websites rather than via a journalist? | Pharmaceutical companies need to ensure that proactive distribution of material meets the requirements of the Code, particularly the prohibition on advertising prescription only medicines to the public. It is difficult to see how the proactive distribution of a press release about a medicine to an individual member of the public would meet all the requirements ofClause 26.
Pharmaceutical companies need to ensure that proactive distribution of material meets the requirements of the Code, particularly the prohibition on advertising prescription only medicines to the public. It is difficult to see how the proactive distribution of a press release about a medicine to an individual member of the public would meet all the requirements ofClause 26. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-companies-make-press-releases-available-directly-to-the-public-via-social-media-channels-and-websites-rather-than-via-a-journalist/ |
| Can companies participate in exhibition passport schemes or treasure hunts proposed by conference organisers? | The idea is usually that delegates are given a conference 'passport' upon which they can collect stamps from each exhibitor by visiting their stands. Passports with a full set of stamps are then placed in a raffle – typically a Kindle or iPad mini, etc.Pharmaceutical companies participating in passport competitions, treasure hunts or the like risk breaching the Code as delegates will be required to visit their stands, which will almost certainly be promoting medicines, to collect passport stickers. In the Authority's view such schemes are unacceptable under the Code.Clause 10.7states 'Quizzes which are intended to gauge attendees’ understanding of the subject matter of a meeting, are acceptable provided that such quizzes are non-promotional and genuine tests of skill or knowledge; they must respect the professional standing or otherwise of the audience and no prizes can be offered. To be acceptable a quiz must form part of the meeting’s formal proceedings. Quizzes must not be conducted from or on exhibition stands. The use of competitions, quizzes and suchlike are unacceptable methods of promotion. The giving of prizes in association with quizzes and competitions is always unacceptable irrespective of the nature of the gift.'That a passport scheme or treasure hunt is organised by a third party would be immaterial as pharmaceutical companies are responsible under the Code for any activity undertaken by themselves, or with their authority, which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of their medicines (Clause 1.17of the Code refers). By participating in such schemes, companies would be giving their authority for the schemes to be conducted on their behalf.
The idea is usually that delegates are given a conference 'passport' upon which they can collect stamps from each exhibitor by visiting their stands. Passports with a full set of stamps are then placed in a raffle – typically a Kindle or iPad mini, etc.
Pharmaceutical companies participating in passport competitions, treasure hunts or the like risk breaching the Code as delegates will be required to visit their stands, which will almost certainly be promoting medicines, to collect passport stickers. In the Authority's view such schemes are unacceptable under the Code.Clause 10.7states 'Quizzes which are intended to gauge attendees’ understanding of the subject matter of a meeting, are acceptable provided that such quizzes are non-promotional and genuine tests of skill or knowledge; they must respect the professional standing or otherwise of the audience and no prizes can be offered. To be acceptable a quiz must form part of the meeting’s formal proceedings. Quizzes must not be conducted from or on exhibition stands. The use of competitions, quizzes and suchlike are unacceptable methods of promotion. The giving of prizes in association with quizzes and competitions is always unacceptable irrespective of the nature of the gift.'
That a passport scheme or treasure hunt is organised by a third party would be immaterial as pharmaceutical companies are responsible under the Code for any activity undertaken by themselves, or with their authority, which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of their medicines (Clause 1.17of the Code refers). By participating in such schemes, companies would be giving their authority for the schemes to be conducted on their behalf. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-companies-participate-in-exhibition-passport-schemes-or-treasure-hunts-proposed-by-conference-organisers/ |
| Can companies sponsor patient organisation meetings? | Clause 1.22defines sponsorship as a contribution, financial or otherwise, in whole or in part provided by or on behalf of a company, towards an activity (including an event/meeting or material) performed, organised, created, etc. by a healthcare organisation, patient organisation or other independent organisation.Clause 10sets out the requirements for events/meetings. Among other things, companies should review the venue, the agenda, the hospitality (where applicable), delegate selection criteria, value of sponsorship, etc. and ensure it is appropriate.Sponsorship provided to patient organisations must be disclosed in accordance withClause 29.Further information can also be found inClause 27and its supplementary information.
Clause 1.22defines sponsorship as a contribution, financial or otherwise, in whole or in part provided by or on behalf of a company, towards an activity (including an event/meeting or material) performed, organised, created, etc. by a healthcare organisation, patient organisation or other independent organisation.
Clause 10sets out the requirements for events/meetings. Among other things, companies should review the venue, the agenda, the hospitality (where applicable), delegate selection criteria, value of sponsorship, etc. and ensure it is appropriate.
Sponsorship provided to patient organisations must be disclosed in accordance withClause 29.
Further information can also be found inClause 27and its supplementary information. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-companies-sponsor-patient-organisation-meetings/ |
| Can life science PhDs be signatories to the Code? | The European Federation of Pharmaceutical Industries and Associations (EFPIAhttps://www.efpia.eu/) sets out the requirements for signatories and this does not include individuals with a PhD.The professional codes of registered medical practitioners and UK registered pharmacists include obligations to patients which is an important factor.Further information on signatories to the Code can be found inClauses 8.1and8.2.
The European Federation of Pharmaceutical Industries and Associations (EFPIAhttps://www.efpia.eu/) sets out the requirements for signatories and this does not include individuals with a PhD.
The professional codes of registered medical practitioners and UK registered pharmacists include obligations to patients which is an important factor.
Further information on signatories to the Code can be found inClauses 8.1and8.2. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-life-science-phds-be-signatories-to-the-code/ |
| Can meetings be held in restaurants? | The Code of Practice Panel is likely to rule any meeting held in an area of a restaurant, which at the same time is open to members of the public, in breach of the Code. A useful criterion in determining whether the arrangements for any meeting are acceptable is to ask ‘Would I and my company be willing to have these arrangements generally known?’ The impression that is created by the arrangements for any meeting can be as important in determining its acceptability under the Code as the arrangements themselves. It might be possible to use a private room at a restaurant.Further information on the requirements of events/meetings and hospitality seeClause 10.
The Code of Practice Panel is likely to rule any meeting held in an area of a restaurant, which at the same time is open to members of the public, in breach of the Code. A useful criterion in determining whether the arrangements for any meeting are acceptable is to ask ‘Would I and my company be willing to have these arrangements generally known?’ The impression that is created by the arrangements for any meeting can be as important in determining its acceptability under the Code as the arrangements themselves. It might be possible to use a private room at a restaurant.
Further information on the requirements of events/meetings and hospitality seeClause 10. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-meetings-be-held-in-restaurants/ |
| Can patient campaigns mirror health professional campaigns? | There is no reason why materials for patients cannot have something in common with material for health professionals; for instance the material may have a similar colour scheme. Patients and the public should not see the promotional material for health professionals.
There is no reason why materials for patients cannot have something in common with material for health professionals; for instance the material may have a similar colour scheme. Patients and the public should not see the promotional material for health professionals. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-patient-campaigns-mirror-health-professional-campaigns/ |
| Can pharmaceutical companies give notepads, pens and pencils to conference organisers for them to put in conference bags? | Yes, pens/pencils and notepads are the only items that can be provided to health professionals and other relevant decision makers for them to keep and then only at bona fide meetings. Pens/pencils and notepads provided in conference bags at independently organised meetings must not include the name of the donor company, the name of any medicine or any information about medicines. The total cost to the donor company of all such items provided to an individual attending an event/meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar.More information can be found inClause 10.6.
Yes, pens/pencils and notepads are the only items that can be provided to health professionals and other relevant decision makers for them to keep and then only at bona fide meetings. Pens/pencils and notepads provided in conference bags at independently organised meetings must not include the name of the donor company, the name of any medicine or any information about medicines. The total cost to the donor company of all such items provided to an individual attending an event/meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar.
More information can be found inClause 10.6. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-pharmaceutical-companies-give-notepads-pens-and-pencils-to-conference-organisers-for-them-to-put-in-conference-bags/ |
| Can pharmaceutical companies host meetings at country embassy offices? | The use of any venue has to meet the requirements of the Code. There should be valid and cogent reasons for using the venue. In addition it should be the educational content and not the venue which is the draw to the meeting, which in this instance may not be so.Clause 10provides further information on events/meetings and hospitality.
The use of any venue has to meet the requirements of the Code. There should be valid and cogent reasons for using the venue. In addition it should be the educational content and not the venue which is the draw to the meeting, which in this instance may not be so.
Clause 10provides further information on events/meetings and hospitality. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-pharmaceutical-companies-host-meetings-at-country-embassy-offices/ |
| Can pharmaceutical companies respond to enquiries from patients? | Yes, provided the requirements of the Code are met, including the prohibition on advising on personal medical matters as set out inClause 26.5.For example, a company could answer a question about whether a medicine could be taken with milk or kept in a fridge.
Yes, provided the requirements of the Code are met, including the prohibition on advising on personal medical matters as set out inClause 26.5.
For example, a company could answer a question about whether a medicine could be taken with milk or kept in a fridge. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-pharmaceutical-companies-respond-to-enquiries-from-patients/ |
| Can promotional stands be put in the same room as a meeting? | The view is expressed from time to time that it is in breach of the Code to have a promotional stand in the same room as the meeting.This is not so.It may be that local organisers do not want promotional stands in the same room, in which case sponsoring companies would have to respect their wishes, but there is nothing in the Code to prohibit such a practice.
The view is expressed from time to time that it is in breach of the Code to have a promotional stand in the same room as the meeting.
This is not so.
It may be that local organisers do not want promotional stands in the same room, in which case sponsoring companies would have to respect their wishes, but there is nothing in the Code to prohibit such a practice. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-promotional-stands-be-put-in-the-same-room-as-a-meeting/ |
| Can refreshments be provided from exhibition stands and, if so, what would be appropriate? | The Code allows the provision of hospitality at scientific meetings, promotional meetings, training and the like and there is no reason why this should not be offered from an exhibition stand. Obviously companies would have to be certain that the hospitality overall complied with the Code and that any hospitality provided from an exhibition stand was subsistence only and not at a level such as to induce a delegate to visit the stand.In the PMCPA's view, companies should provide no more than non-alcoholic beverages, such as tea, coffee and water, and very limited quantities of sweets, biscuits or fruit. The PMCPA does not consider that hot dogs, ice cream, yoghurt, waffles, etc. should be provided from exhibition stands.
The Code allows the provision of hospitality at scientific meetings, promotional meetings, training and the like and there is no reason why this should not be offered from an exhibition stand. Obviously companies would have to be certain that the hospitality overall complied with the Code and that any hospitality provided from an exhibition stand was subsistence only and not at a level such as to induce a delegate to visit the stand.
In the PMCPA's view, companies should provide no more than non-alcoholic beverages, such as tea, coffee and water, and very limited quantities of sweets, biscuits or fruit. The PMCPA does not consider that hot dogs, ice cream, yoghurt, waffles, etc. should be provided from exhibition stands. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-refreshments-be-provided-from-exhibition-stands-and-if-so-what-would-be-appropriate/ |
| Can representatives use visit request forms? | The purpose of pharmaceutical representative visit request forms is for the representatives to provide, for example, the medicines management teams with a brief outline of what they want to talk to them about. Although the precise detail of the forms differ slightly, the information typically requested consists of the representative’s name, contact details, etc., the name of the medicine, its indication and the reason for the visit. The medicines management teams, etc. use the information provided to decide whether they want to see the representative. The forms may be a valuable tool but, in complying with a request to complete one of the forms, representatives may be unwittingly creating a piece of promotional material which is unlikely to comply with the Code.Companies could consider pre-approving material which will provide the medicines management teams, etc. with the brief overview that they need and ensure that the representatives do not create their own pieces of promotional material. It would be helpful if, on such material, it is explained to the medicines management teams why their forms cannot be completed by the representative.
The purpose of pharmaceutical representative visit request forms is for the representatives to provide, for example, the medicines management teams with a brief outline of what they want to talk to them about. Although the precise detail of the forms differ slightly, the information typically requested consists of the representative’s name, contact details, etc., the name of the medicine, its indication and the reason for the visit. The medicines management teams, etc. use the information provided to decide whether they want to see the representative. The forms may be a valuable tool but, in complying with a request to complete one of the forms, representatives may be unwittingly creating a piece of promotional material which is unlikely to comply with the Code.
Companies could consider pre-approving material which will provide the medicines management teams, etc. with the brief overview that they need and ensure that the representatives do not create their own pieces of promotional material. It would be helpful if, on such material, it is explained to the medicines management teams why their forms cannot be completed by the representative. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-representatives-use-visit-request-forms/ |
| Can sport and leisure venues be used for meetings? | Clause 10.1sets out the criteria for the content and arrangements for any event or meeting and includes that companies must not sponsor or organise entertainment (such as sporting or leisure events).When large numbers of delegates are to be invited to a meeting, it may be impossible to hold it at a business-style hotel. A conference centre within a football stadium or the like may have to be used instead. Companies organising, or sponsoring, meetings at such high profile venues should be satisfied that no other venue is large enough to accommodate the meeting and that the overall impression given by the proposed arrangements would not be unacceptable. Gratuitous use of sporting or leisure venues is unacceptable. It must be the programme that attracts delegates to a meeting, not the venue. Further, companies must ensure that no sporting events take place at the venue immediately before, during or immediately after the meeting. Venues must not be used so as to knowingly take advantage of any entertainment/sport that has been organised/subsidised by a third party.
Clause 10.1sets out the criteria for the content and arrangements for any event or meeting and includes that companies must not sponsor or organise entertainment (such as sporting or leisure events).When large numbers of delegates are to be invited to a meeting, it may be impossible to hold it at a business-style hotel. A conference centre within a football stadium or the like may have to be used instead. Companies organising, or sponsoring, meetings at such high profile venues should be satisfied that no other venue is large enough to accommodate the meeting and that the overall impression given by the proposed arrangements would not be unacceptable. Gratuitous use of sporting or leisure venues is unacceptable. It must be the programme that attracts delegates to a meeting, not the venue. Further, companies must ensure that no sporting events take place at the venue immediately before, during or immediately after the meeting. Venues must not be used so as to knowingly take advantage of any entertainment/sport that has been organised/subsidised by a third party. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-sport-and-leisure-venues-be-used-for-meetings/ |
| Can third parties be used to organise meetings? | Yes. Where meetings are organised by a third party (as defined inClause 1.24), the company is responsible under the Code.
Yes. Where meetings are organised by a third party (as defined inClause 1.24), the company is responsible under the Code. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/can-third-parties-be-used-to-organise-meetings/ |
| Constitution and Procedure - Can the Panel's ruling be changed? | It is sometimes the case that, having been informed of the Code of Practice Panel’s ruling in a case, one or other of the parties will request further information from the Panel as to the reasoning behind its ruling. Occasionally amendments to the Panel ruling might be suggested.Once the Panel has completed its consideration of a case and informed the parties of the outcome, it has no further role to play in that case. The Panel ruling provides a complete account of the factors in the case that the Panel considered were important in making its ruling. There is no provision in the Constitution and Procedure for the Panel to comment on the reasoning set out in its ruling. Similarly there is no way for the Panel ruling to be changed.If either party considers that the Panel has made the wrong ruling for whatever reason then their only recourse is to appeal.See theConstitution and Procedure in the Code of Practice
It is sometimes the case that, having been informed of the Code of Practice Panel’s ruling in a case, one or other of the parties will request further information from the Panel as to the reasoning behind its ruling. Occasionally amendments to the Panel ruling might be suggested.
Once the Panel has completed its consideration of a case and informed the parties of the outcome, it has no further role to play in that case. The Panel ruling provides a complete account of the factors in the case that the Panel considered were important in making its ruling. There is no provision in the Constitution and Procedure for the Panel to comment on the reasoning set out in its ruling. Similarly there is no way for the Panel ruling to be changed.
If either party considers that the Panel has made the wrong ruling for whatever reason then their only recourse is to appeal.
See theConstitution and Procedure in the Code of Practice | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/constitution-and-procedure-can-the-panels-ruling-be-changed/ |
| Do companies need to certify the final form of all invitations, e.g. where the date or name has changed or automated tailored email content? | All promotional materials must be certified in their final form to which no subsequent amendments should be made, and companies need to meet these requirements for all materials, items, etc. If the invitation is not promotional then the final form does not need to be certified. If the invitation is promotional, the addition of a name and/or date is not part of the promotional materials and can be added after certification. The supplementary information toClause 8.1provides more information on the certification of the final form.
All promotional materials must be certified in their final form to which no subsequent amendments should be made, and companies need to meet these requirements for all materials, items, etc. If the invitation is not promotional then the final form does not need to be certified. If the invitation is promotional, the addition of a name and/or date is not part of the promotional materials and can be added after certification. The supplementary information toClause 8.1provides more information on the certification of the final form. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/do-companies-need-to-certify-the-final-form-of-all-invitations-eg-where-the-date-or-name-has-changed-or-automated-tailored-email-content/ |
| Do representatives have to report adverse events for competitor products? | Pharmaceutical companies must ensure that their staff are trained including on relevant pharmacovigilance requirements. If a representative is advised of an adverse event with a competitor medicine they should as a minimum advise the health professional that this should be reported via the yellow card scheme.Clause 9.2
Pharmaceutical companies must ensure that their staff are trained including on relevant pharmacovigilance requirements. If a representative is advised of an adverse event with a competitor medicine they should as a minimum advise the health professional that this should be reported via the yellow card scheme.Clause 9.2 | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/do-representatives-have-to-report-adverse-events-for-competitor-products/ |
| Do risk minimisation materials need prescribing information? | See supplementary information toClause 1.17Risk Minimisation Plans and Materials.Prescribing information must be provided in a clear and legible manner in all promotional material for a medicine. If a company cannot demonstrate that the material is approved as risk management material, which is part of its pharmacovigilance obligations, then it should consider the material to be promotional and prescribing information will be needed.
See supplementary information toClause 1.17Risk Minimisation Plans and Materials.
Prescribing information must be provided in a clear and legible manner in all promotional material for a medicine. If a company cannot demonstrate that the material is approved as risk management material, which is part of its pharmacovigilance obligations, then it should consider the material to be promotional and prescribing information will be needed. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/do-risk-minimisation-materials-need-prescribing-information/ |
| Do the financial arrangements for joint working need to be included in the Executive Summary? | Yes. Joint working is a form of 'collaborative working', which requires the publication by the company of a summary of the collaborative working agreement. The agreement should include an outline of the financial arrangements.Clause 20and its supplementary information provide more details on collaborative working.
Yes. Joint working is a form of 'collaborative working', which requires the publication by the company of a summary of the collaborative working agreement. The agreement should include an outline of the financial arrangements.Clause 20and its supplementary information provide more details on collaborative working. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/do-the-financial-arrangements-for-joint-working-need-to-be-included-in-the-executive-summary/ |
| Do the requirements of the Code apply to third parties working on behalf of a pharmaceutical company? | Yes. Companies are responsible for third parties working on their behalf or under their instruction, paid or otherwise.The definition of third party is set out inClause 1.24and means a legal person/entity or individual that represents a company or interacts with other parties on behalf of a company or relating to a company’s medicine, such as distributors, wholesalers, consultants, contract research organisations, professional congress organisers, contracted sales forces, market research companies, advertising agencies, media buyers, providers of services related to events, public relations services, non-clinical services, non-interventional studies management services, etc.Companies are responsible under the Code for the acts and omissions of their third parties which come within the scope of the Code, even if they act contrary to the instructions which they have been given.
Yes. Companies are responsible for third parties working on their behalf or under their instruction, paid or otherwise.
The definition of third party is set out inClause 1.24and means a legal person/entity or individual that represents a company or interacts with other parties on behalf of a company or relating to a company’s medicine, such as distributors, wholesalers, consultants, contract research organisations, professional congress organisers, contracted sales forces, market research companies, advertising agencies, media buyers, providers of services related to events, public relations services, non-clinical services, non-interventional studies management services, etc.
Companies are responsible under the Code for the acts and omissions of their third parties which come within the scope of the Code, even if they act contrary to the instructions which they have been given. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/do-the-requirements-of-the-code-apply-to-third-parties-working-on-behalf-of-a-pharmaceutical-company/ |
| Does the PMCPA provide training for signatories? | The PMCPA provides general training on the Code and can run seminars for companies, etc. The PMCPA does not provide specific training for signatories.Further information on training can be accessed inTraining.
The PMCPA provides general training on the Code and can run seminars for companies, etc. The PMCPA does not provide specific training for signatories.
Further information on training can be accessed inTraining. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/does-the-pmcpa-provide-training-for-signatories/ |
| Does material have to be certified for each platform it appears on, eg computer, tablet and mobile? | Companies must ensure that the final form viewed is not distorted and the requirements of the Code are complied with, e.g. the legibility of the prescribing information.If companies have the technology to ensure that that which is viewed irrespective of the platform will be appropriately formatted and are confident the final form will be identical on each platform then these do not require separate certification.Clause 8.1
Companies must ensure that the final form viewed is not distorted and the requirements of the Code are complied with, e.g. the legibility of the prescribing information.
If companies have the technology to ensure that that which is viewed irrespective of the platform will be appropriately formatted and are confident the final form will be identical on each platform then these do not require separate certification.
Clause 8.1 | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/does-material-have-to-be-certified-for-each-platform-it-appears-on-eg-computer-tablet-and-mobile/ |
| How can I find out about the work of the PMCPA, numbers of cases, who makes complaints, how many cases are found in breach? | Information regarding complaints and the work of the PMCPA is published in the PMCPA annual report. Copies of the annual reports can be found inPublications.
Information regarding complaints and the work of the PMCPA is published in the PMCPA annual report. Copies of the annual reports can be found inPublications. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-can-i-find-out-about-the-work-of-the-pmcpa-numbers-of-cases-who-makes-complaints-how-many-cases-are-found-in-breach/ |
| How can photographs of health professionals be used in promotion? | If a health professional's photograph is used in advertisements for a medicine this is likely to be a breach of the Code. A small photograph of a health professional presenting at a meeting included in a report for that meeting is less likely to be seen as the health professional advertising or endorsing that medicine.Clause 5.4
If a health professional's photograph is used in advertisements for a medicine this is likely to be a breach of the Code. A small photograph of a health professional presenting at a meeting included in a report for that meeting is less likely to be seen as the health professional advertising or endorsing that medicine.Clause 5.4 | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-can-photographs-of-health-professionals-be-used-in-promotion/ |
| How should companies publish data about deceased health professionals? | Data protection legislation only applies to information which relates to an identifiable living individual. Information relating to a deceased person does not constitute personal data and therefore is not subject todata protection legislation.However, whilst it might be lawful to publish this information on Disclosure UK, companies will rightly wish to remain sensitive to such a case. If a company is contacted by next-of-kin or employer regarding information published on Disclosure UK about a deceased health professional, the company will need to handle these on a case-by-case basis, and should include its approach in the relevant methodological note.The ABPI and PMCPA expect companies to react sensitively, while also balancing transparency in their interactions with health professionals, against the nature of the request, and the ToV in question.
Data protection legislation only applies to information which relates to an identifiable living individual. Information relating to a deceased person does not constitute personal data and therefore is not subject todata protection legislation.
However, whilst it might be lawful to publish this information on Disclosure UK, companies will rightly wish to remain sensitive to such a case. If a company is contacted by next-of-kin or employer regarding information published on Disclosure UK about a deceased health professional, the company will need to handle these on a case-by-case basis, and should include its approach in the relevant methodological note.
The ABPI and PMCPA expect companies to react sensitively, while also balancing transparency in their interactions with health professionals, against the nature of the request, and the ToV in question. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-should-companies-publish-data-about-deceased-health-professionals/ |
| How do I apply for an extension to take or pass an examination for representatives? | Representatives have to take an appropriate examination within their first year of their employment as a representative and must pass it in full within two years of starting such employment.The one- and two-year periods are calculated on the basis of the time employed as a representative, whether continuous or otherwise and whether with one company or more than one company.Maternity or paternity leave does not count towards the specified time periods.The Chief Executive of the PMCPA is empowered by the supplementary information toClause 9.4to extend the one- or two-year periods in the event of extenuating circumstances, such as prolonged illness or no, or inadequate, opportunity to take the examination. Companies are reminded that the 'examination clock' starts to tick from the day an individual is first employed as a representative, not from their first day on territory.If a representative fails to take an appropriate examination within the first year it does not prevent him or her continuing to work as a representative in the second year. What it does mean is that an extension must be agreed.Application for an extension should be made using the formhere.It should preferably be made by the company rather than the representative. The application should be made before the one- or two-year period expires.The extenuating circumstances, etc. must relate to the particular representative rather than the company. A company cannot justify an extension by pleading, for example, that the problem arose because its systems were inadequate.If a representative fails to pass the relevant examination within the two-year period allowed, he or she cannot continue to work as a representative in the absence of an extension.Here again, an application for an extension should be made using the form available from the PMCPA and should preferably be made by the company rather than the representative. The applications should be made before the two years expire. As the representative's career might be at stake in such circumstances, in considering an application for an extension the Chief Executive will, if possible, try to ensure that no individual is prejudiced by the failures of the employer.Companies should have in place operating procedures which keep under review the examination status of all of their representatives, including contract representatives.Companies are reminded thatClause 1.19defines the term ‘representative’ as meaning a representative calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines. Thus the term ‘representative’ is defined by role and is wholly independent of company job title.
Representatives have to take an appropriate examination within their first year of their employment as a representative and must pass it in full within two years of starting such employment.
The one- and two-year periods are calculated on the basis of the time employed as a representative, whether continuous or otherwise and whether with one company or more than one company.
Maternity or paternity leave does not count towards the specified time periods.
The Chief Executive of the PMCPA is empowered by the supplementary information toClause 9.4to extend the one- or two-year periods in the event of extenuating circumstances, such as prolonged illness or no, or inadequate, opportunity to take the examination. Companies are reminded that the 'examination clock' starts to tick from the day an individual is first employed as a representative, not from their first day on territory.
If a representative fails to take an appropriate examination within the first year it does not prevent him or her continuing to work as a representative in the second year. What it does mean is that an extension must be agreed.
It should preferably be made by the company rather than the representative. The application should be made before the one- or two-year period expires.
The extenuating circumstances, etc. must relate to the particular representative rather than the company. A company cannot justify an extension by pleading, for example, that the problem arose because its systems were inadequate.
If a representative fails to pass the relevant examination within the two-year period allowed, he or she cannot continue to work as a representative in the absence of an extension.
Here again, an application for an extension should be made using the form available from the PMCPA and should preferably be made by the company rather than the representative. The applications should be made before the two years expire. As the representative's career might be at stake in such circumstances, in considering an application for an extension the Chief Executive will, if possible, try to ensure that no individual is prejudiced by the failures of the employer.
Companies should have in place operating procedures which keep under review the examination status of all of their representatives, including contract representatives.
Companies are reminded thatClause 1.19defines the term ‘representative’ as meaning a representative calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines. Thus the term ‘representative’ is defined by role and is wholly independent of company job title. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-do-i-apply-for-an-extension-to-take-or-pass-an-examination-for-representatives/ |
| How do I become a signatory? | It is the responsibility of pharmaceutical companies to decide who certifies material. Companies need to ensure such staff are experienced and trained to a sufficient standard as set out inClause 8.1of the Code.
It is the responsibility of pharmaceutical companies to decide who certifies material. Companies need to ensure such staff are experienced and trained to a sufficient standard as set out inClause 8.1of the Code. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-do-i-become-a-signatory/ |
| How do I notify the PMCPA about changes to signatories? | In accordance withClause 8.4, the names of those nominated as signatories must be notified in advance to the Advertising Standards and Outreach Unit, Vigilance and Risk Management of Medicines Division of the MHRA and to the PMCPA. Changes in the names of nominees must be promptly notified. When notifying the PMCPA of any changes, it would be helpful to use the PMCPANominated signatories form.
In accordance withClause 8.4, the names of those nominated as signatories must be notified in advance to the Advertising Standards and Outreach Unit, Vigilance and Risk Management of Medicines Division of the MHRA and to the PMCPA. Changes in the names of nominees must be promptly notified. When notifying the PMCPA of any changes, it would be helpful to use the PMCPANominated signatories form. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-do-i-notify-the-pmcpa-about-changes-to-signatories/ |
| How does the Code fit in with UK law? | The promotion of medicines is specifically set out in the Human Medicines Regulations 2012 (2012 No.1916). Companies must adhere to many other relevant UK laws, including but not limited to the Bribery Act 2010. The ABPI Code of Practice for the Pharmaceutical Industry incorporates the requirements of the Human Medicines Regulations and other relevant laws and regulations and also goes beyond the requirements of UK law.
The promotion of medicines is specifically set out in the Human Medicines Regulations 2012 (2012 No.1916). Companies must adhere to many other relevant UK laws, including but not limited to the Bribery Act 2010. The ABPI Code of Practice for the Pharmaceutical Industry incorporates the requirements of the Human Medicines Regulations and other relevant laws and regulations and also goes beyond the requirements of UK law. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-does-the-code-fit-in-with-uk-law/ |
| How should companies disclose transfers of value to HCOs with no physical address? | HCO records must be published with the contact address for where the HCO is registered. HCO bank accounts will require an address. It could be appropriate for companies to include a ‘c/o [separate organisation]’ address if, for example, the HCO is online only.
HCO records must be published with the contact address for where the HCO is registered. HCO bank accounts will require an address. It could be appropriate for companies to include a ‘c/o [separate organisation]’ address if, for example, the HCO is online only. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-should-companies-disclose-transfers-of-value-to-hcos-with-no-physical-address/ |
| How should the value of digital items, for example apps, provided to patients as patient support be worked out? What are the other considerations? | This is a difficult area. It is more challenging to put a value on information than physical items. Factors to consider include:- Is the app available for purchase?- Does the app provide personalised output?Companies will need to certify materials for patients/public; documenting the rationale for the provision of information and/or items is often useful in justifying the approach taken.Clauses 19.2and26.3provide further information on patient support.
This is a difficult area. It is more challenging to put a value on information than physical items. Factors to consider include:- Is the app available for purchase?- Does the app provide personalised output?
Companies will need to certify materials for patients/public; documenting the rationale for the provision of information and/or items is often useful in justifying the approach taken.
Clauses 19.2and26.3provide further information on patient support. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/how-should-the-value-of-digital-items-for-example-apps-provided-to-patients-as-patient-support-be-worked-out-what-are-the-other-considerations/ |
| I need more information about the ABPI examination for representatives | The ABPI oversees the examination and all relevant information can be found on itswebsite.
The ABPI oversees the examination and all relevant information can be found on itswebsite. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/i-need-more-information-about-the-abpi-examination-for-representatives/ |
| If a company has an advertisement in an electronic journal where the prescribing information is provided via a link and a pop-up appears to notify the reader that they are leaving the journal's site does this mean that the direct single click link requirement has not been met? | The necessary appearance of a pop-up alerting the user that they are about to access a different third-party website will not affect compliance with the requirement to access the prescribing information via a direct single click link.
The necessary appearance of a pop-up alerting the user that they are about to access a different third-party website will not affect compliance with the requirement to access the prescribing information via a direct single click link. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-a-company-has-an-advertisement-in-an-electronic-journal-where-the-prescribing-information-is-provided-via-a-link-and-a-pop-up-appears-to-notify-the-reader-that-they-are-leaving-the-journals-site-is-the-direct-single-click-link-requiremen/ |
| If a dialogue is established upon receipt of a promotional email, is there a requirement to provide both prescribing information and an unsubscribe option with each email response? | Yes. The provision of prescribing information would depend on the content of the enquiry and the response. Where the prescribing information is required on the original email then reference to its availability at the bottom of the email chain and/or a hyperlink to that part of the email should be provided with each response in that email chain, irrespective of the content of the response. It might be better in certain circumstances to start a new standalone email. The requirement to unsubscribe is required on all promotional emails.Clauses 12.1and15.5provide further information
Yes. The provision of prescribing information would depend on the content of the enquiry and the response. Where the prescribing information is required on the original email then reference to its availability at the bottom of the email chain and/or a hyperlink to that part of the email should be provided with each response in that email chain, irrespective of the content of the response. It might be better in certain circumstances to start a new standalone email. The requirement to unsubscribe is required on all promotional emails.
Clauses 12.1and15.5provide further information | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-a-dialogue-is-established-upon-receipt-of-a-promotional-email-is-there-a-requirement-to-provide-both-prescribing-information-and-an-unsubscribe-option-with-each-email-response/ |
| If a generic representative calls on a dispensing pharmacist about discounts available for medicines - is this a promotional call? | The requirements set out for representatives inClause 17apply to representatives promoting generic medicines. When a representative calls on a pharmacist to discuss the purchase of a medicine and any discounts, etc., this would be a promotional call.
The requirements set out for representatives inClause 17apply to representatives promoting generic medicines. When a representative calls on a pharmacist to discuss the purchase of a medicine and any discounts, etc., this would be a promotional call. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-a-generic-representative-calls-on-a-dispensing-pharmacist-about-discounts-available-for-medicines-is-this-a-promotional-call/ |
| If a health professional works for a patient organisation (e.g. is a trustee/chairperson) and provides some work specifically in relation to their representation of the PO, would the disclosure be against the PO? Should the monies be paid to the PO? | Clause 1.16defines an individual who represents a patient organisation as a person who is mandated to represent and express the views of a patient organisation.Clause 27.5states where companies contract with individuals representing patient organisations to provide services, such contracts should be made with the patient organisation and payment should be disclosed as a payment to the patient organisation. Such payments must be publicly disclosed annually as required byClause 29.
Clause 1.16defines an individual who represents a patient organisation as a person who is mandated to represent and express the views of a patient organisation.Clause 27.5states where companies contract with individuals representing patient organisations to provide services, such contracts should be made with the patient organisation and payment should be disclosed as a payment to the patient organisation. Such payments must be publicly disclosed annually as required byClause 29. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-a-health-professional-works-for-a-patient-organisation-eg-is-a-trusteechairperson-and-provides-some-work-specifically-in-relation-to-their-representation-of-the-po-would-the-disclosure-be-against-the-po-should-the-monies-be-paid-to-the-p/ |
| If a representative gained agreement to deliver approved risk minimisation materials to a health professional and then used this as an opportunity to promote medicines to the health professional would this be acceptable? | Risk minimisation materials might be required as part of a medicines marketing authorisation and a company might be required to provide certain risk minimisation materials to health professionals. If a representative were to deliver such material to a health professional and also use this as an opportunity to promote the medicine or any other medicine it would be likely that the company had not met the requirements ofClause 3.6which states: 'Materials and activities must not be disguised promotion'.
Risk minimisation materials might be required as part of a medicines marketing authorisation and a company might be required to provide certain risk minimisation materials to health professionals. If a representative were to deliver such material to a health professional and also use this as an opportunity to promote the medicine or any other medicine it would be likely that the company had not met the requirements ofClause 3.6which states: 'Materials and activities must not be disguised promotion'. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-a-representative-gained-agreement-to-deliver-approved-risk-minimisation-materials-to-a-health-professional-and-then-used-this-as-an-opportunity-to-promote-medicines-to-the-health-professional-would-this-be-acceptable/ |
| If a second medicine is mentioned in promotional material for another medicine does the prescribing information for both need to be provided? | If both medicines are the company’s then prescribing information for each should be included. If the second medicine is a competitor medicine, or a medicine which is not the company's, then prescribing information for that medicine does not need to be provided.
If both medicines are the company’s then prescribing information for each should be included. If the second medicine is a competitor medicine, or a medicine which is not the company's, then prescribing information for that medicine does not need to be provided. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-a-second-medicine-is-mentioned-in-promotional-material-for-another-medicine-does-the-prescribing-information-for-both-need-to-be-provided/ |
| If a template has been certified for employees to complete certain fields eg an invitation to a meeting in the UK where date, venue etc needs to be added, does the final form of each invitation need to be certified prior to issue? | If a company provides a list of approved venues, and the only other information to be added is a date then it is likely to be acceptable not to certify the final form of each invitation. If, however, the agenda can be amended this could require further examination or even certification, depending on the wording added.
If a company provides a list of approved venues, and the only other information to be added is a date then it is likely to be acceptable not to certify the final form of each invitation. If, however, the agenda can be amended this could require further examination or even certification, depending on the wording added. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-a-template-has-been-certified-for-employees-to-complete-certain-fields-eg-an-invitation-to-a-meeting-in-the-uk-where-date-venue-etc-needs-to-be-added-does-the-final-form-of-each-invitation-need-to-be-certified-prior-to-issue/ |
| If the MHRA yellow card address changes how quickly should materials be updated? | As soon as possible and within a year of the change.See supplementary information to Clause 12.6
As soon as possible and within a year of the change.See supplementary information to Clause 12.6 | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/if-the-mhra-yellow-card-address-changes-how-quickly-should-materials-be-updated/ |
| Is a contract with an individual representing a patient organisation still needed if the engagement involves no remuneration but provides travel/accommodation? | Yes a contract or agreement is required which must be agreed in advance, specifies the nature of the services to be provided and the basis for remuneration where relevant and what, if any, expenses will be reimbursed.Clause 24provides more information on such contracted services.If expenses are to be reimbursed this should be stated in the agreement/contract and disclosed as required inClause 24.6and29.
Yes a contract or agreement is required which must be agreed in advance, specifies the nature of the services to be provided and the basis for remuneration where relevant and what, if any, expenses will be reimbursed.
Clause 24provides more information on such contracted services.
If expenses are to be reimbursed this should be stated in the agreement/contract and disclosed as required inClause 24.6and29. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/is-a-contract-with-an-individual-representing-a-patient-organisation-still-needed-if-the-engagement-involves-no-remuneration-but-provides-travelaccommodation/ |
| Is it acceptable to have both promotional and non-promotional content on a website? | The first consideration is the intended audience for the website. If it is to be solely for health professionals then the website must be restricted to health professionals only and how this is achieved is for companies to determine. If the website is for both health professionals and the public/patients, the website must be clearly signposted for each audience, with sufficient content, volume and detail, in each area to provide adequate information. See supplementary information toClause 26.2.
The first consideration is the intended audience for the website. If it is to be solely for health professionals then the website must be restricted to health professionals only and how this is achieved is for companies to determine. If the website is for both health professionals and the public/patients, the website must be clearly signposted for each audience, with sufficient content, volume and detail, in each area to provide adequate information. See supplementary information toClause 26.2. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/is-it-acceptable-to-have-both-promotional-and-non-promotional-content-on-a-website/ |
| Is the black triangle symbol required on press releases? | There is no requirement in the Code to include the black triangle symbol on a press release; however, it might be seen as best practice to do so. For information about the black triangle symbol, seeClause 12.7 and its supplementary information.
There is no requirement in the Code to include the black triangle symbol on a press release; however, it might be seen as best practice to do so. For information about the black triangle symbol, seeClause 12.7 and its supplementary information. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/is-the-black-triangle-symbol-required-on-press-releases/ |
| Provide some examples of Risk Minimisation Materials? | Risk Minimisation Materials might be required to guide appropriate patient selection, to support treatment monitoring, etc. Examples are educational programmes for health professionals or patients; controlled access programmes; or other risk minimisation measures, e.g. administration guide, checklist for prescribing, alert card, educational leaflet for the patient.
Risk Minimisation Materials might be required to guide appropriate patient selection, to support treatment monitoring, etc. Examples are educational programmes for health professionals or patients; controlled access programmes; or other risk minimisation measures, e.g. administration guide, checklist for prescribing, alert card, educational leaflet for the patient. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/provide-some-examples-of-risk-minimisation-materials/ |
| Should pharmaceutical companies disclose Transfers of Value made for market research? | Clause 24.5requires that companies must publicly disclose annually, details of payments made to contracted individuals in relation to market research (unless the company concerned does not know the identities of those participating in the market research). The supplementary information to Clause 24.5 qualifies this and states that it relates only to market research using contracted individuals where the pharmaceutical company knows the identity of the contracted individuals. This is because the focus of the requirements concerning transparency is on areas where there are direct relationships between the parties and that is not so where the company does not know the identity of the participants.
Clause 24.5requires that companies must publicly disclose annually, details of payments made to contracted individuals in relation to market research (unless the company concerned does not know the identities of those participating in the market research). The supplementary information to Clause 24.5 qualifies this and states that it relates only to market research using contracted individuals where the pharmaceutical company knows the identity of the contracted individuals. This is because the focus of the requirements concerning transparency is on areas where there are direct relationships between the parties and that is not so where the company does not know the identity of the participants. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/should-pharmaceutical-companies-disclose-transfers-of-value-made-for-market-research/ |
| Should Transfers of Value to patient organisations be disclosed on Disclosure UK? | The disclosure requirements for patient organisations is set out inClause 29. This information must be disclosed on the company website either on a national or European level. Each reporting period shall cover a full calendar year.For transfers of value made in 2024 and publicly disclosed in 2025, and for each calendar year thereafter, companies should submit a link via the relevant Disclosure UK gateway. The link should take visitors from Disclosure UK to patient organisation disclosure information published on the company’s website.Each company must include a note of methodologies used by it in preparing the disclosures and identifying support and contracted services provided.A template to disclose the information required in relation to patient organisations is available from thePublicationssection of the PMCPA website www.pmcpa.org.uk. The use of this template is optional.
The disclosure requirements for patient organisations is set out inClause 29. This information must be disclosed on the company website either on a national or European level. Each reporting period shall cover a full calendar year.
For transfers of value made in 2024 and publicly disclosed in 2025, and for each calendar year thereafter, companies should submit a link via the relevant Disclosure UK gateway. The link should take visitors from Disclosure UK to patient organisation disclosure information published on the company’s website.
Each company must include a note of methodologies used by it in preparing the disclosures and identifying support and contracted services provided.
A template to disclose the information required in relation to patient organisations is available from thePublicationssection of the PMCPA website www.pmcpa.org.uk. The use of this template is optional. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/should-transfers-of-value-to-patient-organisations-be-disclosed-on-disclosure-uk/ |
| What are arm's length arrangements? | It is possible for a company to sponsor material produced by an independent organisation which mentions its own products and not be liable under the Code for its contents, but only if, inter alia, there has been a strictly arm’s length arrangement between the parties.In practical terms, the arrangements must be such that there can be no possibility that the pharmaceutical company has been able to exert any influence or control over the final content of the material.Factors which might mean there had not been a strictly arm’s length arrangement would include, but not be restricted to:• Initiation of the material, or the concept for it, by the pharmaceutical company• Influence from the pharmaceutical company on the content/balance/scope of the material• Choice/or direct payment of the authors by the pharmaceutical company• Influence from the pharmaceutical company on the list of persons to whom the material is sent.Companies should remember that use of material for a promotional purpose will mean that material is subject to the Code.
It is possible for a company to sponsor material produced by an independent organisation which mentions its own products and not be liable under the Code for its contents, but only if, inter alia, there has been a strictly arm’s length arrangement between the parties.
In practical terms, the arrangements must be such that there can be no possibility that the pharmaceutical company has been able to exert any influence or control over the final content of the material.
Factors which might mean there had not been a strictly arm’s length arrangement would include, but not be restricted to:
• Initiation of the material, or the concept for it, by the pharmaceutical company• Influence from the pharmaceutical company on the content/balance/scope of the material• Choice/or direct payment of the authors by the pharmaceutical company• Influence from the pharmaceutical company on the list of persons to whom the material is sent.
Companies should remember that use of material for a promotional purpose will mean that material is subject to the Code. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-arms-length-arrangements/ |
| What are examples of forms of sales promotion? | Promotion, whether termed sales promotion or under some other name, can take many forms and the most common are listed in the Code (Clause 1.17). The term is used broadly and could include: face-to-face interactions, meetings, participation in exhibitions, the use of audio or video recordings in any format, broadcast media, non-print media, the internet, digital, interactive data systems, social media and the like.
Promotion, whether termed sales promotion or under some other name, can take many forms and the most common are listed in the Code (Clause 1.17). The term is used broadly and could include: face-to-face interactions, meetings, participation in exhibitions, the use of audio or video recordings in any format, broadcast media, non-print media, the internet, digital, interactive data systems, social media and the like. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-examples-of-forms-of-sales-promotion/ |
| What are risk minimisation measures? | Risk minimisation measures are interventions required by the licensing authority intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of pharmacovigilance.See also the supplementary information to Clause 1.17.
Risk minimisation measures are interventions required by the licensing authority intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of pharmacovigilance.See also the supplementary information to Clause 1.17. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-risk-minimisation-measures/ |
| What are the Code requirements in respect to travel? | Thesupplementary information to Clause 10.1states that companies should only offer or provide economy air travel to delegates attending events/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 six hours companies may pay for an upgrade from economy to premium economy or similar.With regard to rail travel and other types of travel companies need to consider all the relevant factors including their own policies when making their decisions.The cost of travel must be included in a company's public disclosure of the amount it has paid to support or sponsor individuals and organisations for meeting attendance (Clauses10.4,10.11,10.12,29.2and the supplementary information to28.2refer).
Thesupplementary information to Clause 10.1states that companies should only offer or provide economy air travel to delegates attending events/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 six hours companies may pay for an upgrade from economy to premium economy or similar.
With regard to rail travel and other types of travel companies need to consider all the relevant factors including their own policies when making their decisions.
The cost of travel must be included in a company's public disclosure of the amount it has paid to support or sponsor individuals and organisations for meeting attendance (Clauses10.4,10.11,10.12,29.2and the supplementary information to28.2refer). | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-code-requirements-in-respect-to-travel/ |
| What are the expectations with regard to using data on file? | Claims, comparisons, etc. must be capable of substantiation and such substantiation must be provided as required byClauses 6.2,14.3and18.2.When reviewing data on file, companies should be confident it is consistent with the summary of product characteristics. There is an expectation that the results are not dissimilar to those in the registration trials. Care needs to be taken to ensure the data on file meets all other requirements of the Code includingClauses 6,14and18as applicable.
Claims, comparisons, etc. must be capable of substantiation and such substantiation must be provided as required byClauses 6.2,14.3and18.2.
When reviewing data on file, companies should be confident it is consistent with the summary of product characteristics. There is an expectation that the results are not dissimilar to those in the registration trials. Care needs to be taken to ensure the data on file meets all other requirements of the Code includingClauses 6,14and18as applicable. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-expectations-with-regard-to-using-data-on-file/ |
| What are the relevant requirements for meetings when UK health professionals/other relevant decision makers are supported by pharmaceutical companies as delegates to a meeting outside the UK not organised by a pharmaceutical company? | Before sending any UK health professional/other relevant decision maker to an event/meeting held outside the UK, companies should ensure the event/meeting itself meets the requirements ofClause 10.1 and its supplementary information. As with any meeting, it should be the programme that attracts delegates and not the associated hospitality or venue.Where a company provides support to an individual health professional or other relevant decision maker to attend an event/meeting there must be a written agreement in place setting out what has been agreed, including the categories of cost such as registration fees, accommodation and/or travel. The rationale for the decision to provide support to an individual health professional or other relevant decision maker to attend an event/meeting should be documented prior to the provision of the support.All events/meetings which involve travel outside the UK must be certified in advance, as set out inClause 8.2 and its supplementary information. This should be carried out as set out inClause 8.1or by an appropriately qualified person signatory (AQP signatory). When certifying arrangements for events/meetings which involve travel outside the UK, all the relevant documents and arrangements must be considered, including the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.Clause 28in relation to disclosure of transfers of value will also need to be followed.
Before sending any UK health professional/other relevant decision maker to an event/meeting held outside the UK, companies should ensure the event/meeting itself meets the requirements ofClause 10.1 and its supplementary information. As with any meeting, it should be the programme that attracts delegates and not the associated hospitality or venue.
Where a company provides support to an individual health professional or other relevant decision maker to attend an event/meeting there must be a written agreement in place setting out what has been agreed, including the categories of cost such as registration fees, accommodation and/or travel. The rationale for the decision to provide support to an individual health professional or other relevant decision maker to attend an event/meeting should be documented prior to the provision of the support.
All events/meetings which involve travel outside the UK must be certified in advance, as set out inClause 8.2 and its supplementary information. This should be carried out as set out inClause 8.1or by an appropriately qualified person signatory (AQP signatory). When certifying arrangements for events/meetings which involve travel outside the UK, all the relevant documents and arrangements must be considered, including the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.
Clause 28in relation to disclosure of transfers of value will also need to be followed. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-relevant-requirements-for-meetings-when-uk-health-professionalsother-relevant-decision-makers-are-supported-by-pharmaceutical-companies-as-delegates-to-a-meeting-outside-the-uk-not-organised-by-a-pharmaceutical-company/ |
| What are the relevant requirements for meetings when UK health professionals/other relevant decision makers attend a company organised meeting outside the UK as delegates? | Before sending any UK health professional/other relevant decision maker to a company organised event/meeting outside the UK, companies should ensure that the event/meeting itself meets the requirements ofClause 10.1 and its supplementary information. As with any meeting, it should be the programme that attracts delegates and not the associated hospitality or venue.Where a company provides support to an individual health professional or other relevant decision maker to attend an event/meeting there must be a written agreement in place setting out what has been agreed, including the categories of cost such as registration fees, accommodation and/or travel. The rationale for the decision to provide support to an individual health professional or other relevant decision maker to attend an event/meeting should be documented prior to the provision of the support.Clause 8.2 and its supplementary informationis relevant - all events/meetings involving travel outside the UK, unless the company’s only involvement is to support a speaker to present at the meeting, must be certified in advance as set out inClause 8.1or by an appropriately qualified person (AQP) signatory. That person does not need to be either a registered medical practitioner or a pharmacist registered in the UK. When certifying arrangements for events/meetings which involve travel outside the UK, all the relevant documents and arrangements must be considered, including the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.Clause 28in relation to disclosure of transfers of value will also need to be followed where relevant.
Before sending any UK health professional/other relevant decision maker to a company organised event/meeting outside the UK, companies should ensure that the event/meeting itself meets the requirements ofClause 10.1 and its supplementary information. As with any meeting, it should be the programme that attracts delegates and not the associated hospitality or venue.
Where a company provides support to an individual health professional or other relevant decision maker to attend an event/meeting there must be a written agreement in place setting out what has been agreed, including the categories of cost such as registration fees, accommodation and/or travel. The rationale for the decision to provide support to an individual health professional or other relevant decision maker to attend an event/meeting should be documented prior to the provision of the support.
Clause 8.2 and its supplementary informationis relevant - all events/meetings involving travel outside the UK, unless the company’s only involvement is to support a speaker to present at the meeting, must be certified in advance as set out inClause 8.1or by an appropriately qualified person (AQP) signatory. That person does not need to be either a registered medical practitioner or a pharmacist registered in the UK. When certifying arrangements for events/meetings which involve travel outside the UK, all the relevant documents and arrangements must be considered, including the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.
Clause 28in relation to disclosure of transfers of value will also need to be followed where relevant. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-relevant-requirements-for-meetings-when-uk-health-professionalsother-relevant-decision-makers-attend-a-company-organised-meeting-outside-the-uk-as-delegates/ |
| What are the requirements for keeping prescribing information up to date? | Some companies believe that there is a three-month grace period in which to update prescribing information to reflect changes to the summary of product characteristics (SPC) and that during that period the provision of the updated SPC with promotional material bearing outdated prescribing information will regularise the position. Neither of these propositions is true.The general principle is that the prescribing information (defined inClause 12.2) must be up to date, must comply withClauses 12.1and12.2of the Code and must be consistent with the particulars given in the SPC.Some changes to an SPC however may not necessarily have to be reflected in the prescribing information. For example, the prescribing information must include at least one authorised indication consistent with the SPC. If a new indication is not being promoted in a particular piece of promotional material then it need not be mentioned in the prescribing information in that material. Similarly, information about dosage and method of use and about side effects, precautions and contraindications has to be relevant to the indications being promoted and thus SPC changes relating to other indications do not need to be included in the prescribing information.Apart from such special circumstances, prescribing information must be updated so that it does not become inconsistent with the SPC. For example, a new indication must be included in the prescribing information in an item of promotional material promoting that indication. If a representative is promoting the new indication, they must not leave promotional material which does not include it in its up-to-date prescribing information.Clause 12.5may also apply - Promotional material other than advertisements in professional publications must include the date on which the promotional material was created or last revised.When a company chooses to rely on the SPC as part of the prescribing information, the SPC so provided must be the current one.
Some companies believe that there is a three-month grace period in which to update prescribing information to reflect changes to the summary of product characteristics (SPC) and that during that period the provision of the updated SPC with promotional material bearing outdated prescribing information will regularise the position. Neither of these propositions is true.
The general principle is that the prescribing information (defined inClause 12.2) must be up to date, must comply withClauses 12.1and12.2of the Code and must be consistent with the particulars given in the SPC.
Some changes to an SPC however may not necessarily have to be reflected in the prescribing information. For example, the prescribing information must include at least one authorised indication consistent with the SPC. If a new indication is not being promoted in a particular piece of promotional material then it need not be mentioned in the prescribing information in that material. Similarly, information about dosage and method of use and about side effects, precautions and contraindications has to be relevant to the indications being promoted and thus SPC changes relating to other indications do not need to be included in the prescribing information.
Apart from such special circumstances, prescribing information must be updated so that it does not become inconsistent with the SPC. For example, a new indication must be included in the prescribing information in an item of promotional material promoting that indication. If a representative is promoting the new indication, they must not leave promotional material which does not include it in its up-to-date prescribing information.Clause 12.5may also apply - Promotional material other than advertisements in professional publications must include the date on which the promotional material was created or last revised.
When a company chooses to rely on the SPC as part of the prescribing information, the SPC so provided must be the current one. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-requirements-for-keeping-prescribing-information-up-to-date/ |
| What are the requirements for materials and activities initiated and developed by teams with global or regional headquarters in the UK which are not directed at UK health professionals? | Supplementary information to Clause 3.4sets out the applicability of codes and requirements for such activities and materials. It states: Pharmaceutical companies must ensure that they comply with all applicable codes, laws and regulations to which they are subject.This is particularly relevant when activities/materials involve more than one country or when a pharmaceutical company based in one country is involved in activities in another country.Activities carried out and materials used by a pharmaceutical company located in a European country must comply with the national code of that European country as well as the national code of the country in which the activities take place or the materials are used.Activities carried out and materials used in a European country by a pharmaceutical company located in a country other than a European country must comply with the European Federation of Pharmaceutical Industries and Associations Code as well as the national code of the country in which the activities are carried out and materials are used.Examples: a company located in the UK carrying out an activity outside the UK but within Europe, such as in France, must comply with the UK Code and the French Code regardless of whether or not UK health professionals or other relevant decision makers are involved.Conversely a company located in France carrying out an activity in the UK must comply with the ABP! Code regardless of whether or not UK health professionals or other relevant decision makers are involved.Details of the various codes can be found on the EFPIA website,National codes (efpia.eu)Materials developed in the UK to be used outside the UK with non-UK health professionals, etc. are likely to be exempt from the ABPI Code.
Supplementary information to Clause 3.4sets out the applicability of codes and requirements for such activities and materials. It states: Pharmaceutical companies must ensure that they comply with all applicable codes, laws and regulations to which they are subject.
This is particularly relevant when activities/materials involve more than one country or when a pharmaceutical company based in one country is involved in activities in another country.
Activities carried out and materials used by a pharmaceutical company located in a European country must comply with the national code of that European country as well as the national code of the country in which the activities take place or the materials are used.
Activities carried out and materials used in a European country by a pharmaceutical company located in a country other than a European country must comply with the European Federation of Pharmaceutical Industries and Associations Code as well as the national code of the country in which the activities are carried out and materials are used.
Examples: a company located in the UK carrying out an activity outside the UK but within Europe, such as in France, must comply with the UK Code and the French Code regardless of whether or not UK health professionals or other relevant decision makers are involved.
Conversely a company located in France carrying out an activity in the UK must comply with the ABP! Code regardless of whether or not UK health professionals or other relevant decision makers are involved.
Details of the various codes can be found on the EFPIA website,National codes (efpia.eu)
Materials developed in the UK to be used outside the UK with non-UK health professionals, etc. are likely to be exempt from the ABPI Code. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-requirements-for-materials-and-activities-initiated-and-developed-by-teams-with-global-or-regional-headquarters-in-the-uk-which-are-not-directed-at-uk-health-professionals/ |
| What are the requirements for declaring sponsorship? | Pharmaceutical companies need to ensure they and their third parties (refer to Clause 1.24 for the definition of third party) meet the requirements of the Code including the need to declare sponsorship (refer to Clause 1.22 for the definition of sponsorship). This is also required when a pharmaceutical company provides sponsorship for an activity to an independent organisation. The declaration must name the pharmaceutical company and provide the exact details of the nature of the sponsorship. Further information can be found inClauses 5.6and10.10, including their supplementary information.
Pharmaceutical companies need to ensure they and their third parties (refer to Clause 1.24 for the definition of third party) meet the requirements of the Code including the need to declare sponsorship (refer to Clause 1.22 for the definition of sponsorship). This is also required when a pharmaceutical company provides sponsorship for an activity to an independent organisation. The declaration must name the pharmaceutical company and provide the exact details of the nature of the sponsorship. Further information can be found inClauses 5.6and10.10, including their supplementary information. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-requirements-for-declaring-sponsorship/ |
| What are the requirements relating to the qualifications and registration of signatories? | Signatories must be a registered medical practitioner or a pharmacist registered in the UK or alternatively, in the case of a product for dental use only, a UK registered dentist.The supplementary information toClause 8.1sets out the qualifications of signatories, it states, that when deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outwith the industry, length of service and seniority. In addition, signatories must have an up-to-date, detailed knowledge of the Code.The registered medical practitioner should be capable of being registered in the UK without the need for additional tests of medical/clinical knowledge. Details of signatories and their qualifications have to be provided to the Medicines Healthcare products Regulatory Agency (MHRA), as well as the PMCPA.
Signatories must be a registered medical practitioner or a pharmacist registered in the UK or alternatively, in the case of a product for dental use only, a UK registered dentist.
The supplementary information toClause 8.1sets out the qualifications of signatories, it states, that when deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outwith the industry, length of service and seniority. In addition, signatories must have an up-to-date, detailed knowledge of the Code.
The registered medical practitioner should be capable of being registered in the UK without the need for additional tests of medical/clinical knowledge. Details of signatories and their qualifications have to be provided to the Medicines Healthcare products Regulatory Agency (MHRA), as well as the PMCPA. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-are-the-requirements-relating-to-the-qualifications-and-registration-of-signatories/ |
| What disciplines do the Health Professionals' Codes of Conduct cover? | The professional bodies for health professionals have various codes, guidance, regulations, etc. Reference is made to some of these in the supplementary information toClause 10.1, e.g. the General Medical Council, the General Pharmaceutical Council and the Nursing and Midwifery Council. The supplementary information to 10.1also refers to the expectation of the Professional Standards Authority.
The professional bodies for health professionals have various codes, guidance, regulations, etc. Reference is made to some of these in the supplementary information toClause 10.1, e.g. the General Medical Council, the General Pharmaceutical Council and the Nursing and Midwifery Council. The supplementary information to 10.1also refers to the expectation of the Professional Standards Authority. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-disciplines-do-the-health-professionals-codes-of-conduct-cover/ |
| What does the Code cover? | The Code covers the promotion of medicines to health professionals and other relevant decision makers. As well as covering promotional material, it covers other interactions, materials and activities including: samples; meetings; collaborative working which includes joint working, donations, grants; outcome or risk sharing agreements; patient access schemes; the conduct of non-interventional studies and contracted services provided by health professionals, other relevant decision makers, individuals representing patient organisations and member of the public including patients and journalist.The Code also sets standards relating to the provision of information to patients and the public as well as standards for relationships with patient groups. The industry considers that provided the requirements of the Code are met, working with patients and patient organisations can bring significant public health benefits. These requirements also apply to working with all user organisations and other organisations such as disability associations, relative and carer associations and consumer associations.
The Code covers the promotion of medicines to health professionals and other relevant decision makers. As well as covering promotional material, it covers other interactions, materials and activities including: samples; meetings; collaborative working which includes joint working, donations, grants; outcome or risk sharing agreements; patient access schemes; the conduct of non-interventional studies and contracted services provided by health professionals, other relevant decision makers, individuals representing patient organisations and member of the public including patients and journalist.
The Code also sets standards relating to the provision of information to patients and the public as well as standards for relationships with patient groups. The industry considers that provided the requirements of the Code are met, working with patients and patient organisations can bring significant public health benefits. These requirements also apply to working with all user organisations and other organisations such as disability associations, relative and carer associations and consumer associations. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-does-the-code-cover/ |
| What does the Code state about meeting venues? | Venues for meetings must be appropriate and conducive to the main purpose of the meeting and should be approved according to the type of meeting to be held and the target audience. For example, a venue which is suitable for a two day meeting of international thought leaders might not be suitable for an evening meeting of local GPs. Similarly, successful use of a venue does not guarantee its suitability for future meetings.
Venues for meetings must be appropriate and conducive to the main purpose of the meeting and should be approved according to the type of meeting to be held and the target audience. For example, a venue which is suitable for a two day meeting of international thought leaders might not be suitable for an evening meeting of local GPs. Similarly, successful use of a venue does not guarantee its suitability for future meetings. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-does-the-code-state-about-meeting-venues/ |
| What is an expert patient and how do companies interact with them? | The ABPI Code does not define an expert patient. Patients can be contracted by pharmaceutical companies to deliver a service as set out inClauses 24.1and24.2and such services must comply with other applicable requirements of the Code. Companies should ensure any patient contracted is a typical patient as far as this relates to a disease or response to any medicine. Details of fees and expenses paid to patients must be disclosed annually as required by Clauses24.2,24.6,30and31.
The ABPI Code does not define an expert patient. Patients can be contracted by pharmaceutical companies to deliver a service as set out inClauses 24.1and24.2and such services must comply with other applicable requirements of the Code. Companies should ensure any patient contracted is a typical patient as far as this relates to a disease or response to any medicine. Details of fees and expenses paid to patients must be disclosed annually as required by Clauses24.2,24.6,30and31. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-an-expert-patient-and-how-do-companies-interact-with-them/ |
| What is meant by 'a clear and legible manner which assists readability'? | The following would support the prescribing information to be clear and legible. Legibility is not simply a question of type size. These recommendations would support readability:• type size should be such that a lower case “x” is no less than 1mm in height• lines should be no more than 100 characters in length, including spaces• sufficient space should be allowed between lines to facilitate easy reading• a clear style of type should be used• there should be adequate contrast between the colour of the text and the background• dark print on a light background is preferable• emboldening headings and starting each section on a new line aids legibility.SeeClause 12.1 supplementary information
The following would support the prescribing information to be clear and legible. Legibility is not simply a question of type size. These recommendations would support readability:
• type size should be such that a lower case “x” is no less than 1mm in height
• lines should be no more than 100 characters in length, including spaces
• sufficient space should be allowed between lines to facilitate easy reading
• a clear style of type should be used
• there should be adequate contrast between the colour of the text and the background
• dark print on a light background is preferable
• emboldening headings and starting each section on a new line aids legibility.
SeeClause 12.1 supplementary information | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-meant-by-a-clear-and-legible-manner-which-assists-readability/ |
| What is promotion? | The definition of promotion inClause 1.17,is very broad and far reaching. Promotion is any activity undertaken by a pharmaceutical company, or with its authority, which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.There are exemptions listed in Clause 1.17. As companies are commercially interested parties, it is often helpful to consider how you would demonstrate or explain why a material, item, activity or interaction is not promotion.
The definition of promotion inClause 1.17,is very broad and far reaching. Promotion is any activity undertaken by a pharmaceutical company, or with its authority, which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.
There are exemptions listed in Clause 1.17. As companies are commercially interested parties, it is often helpful to consider how you would demonstrate or explain why a material, item, activity or interaction is not promotion. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-promotion/ |
| What is representatives' briefing material? | When a complaint is received about how a representative promoted a medicine, the PMCPA may request a copy of the relevant briefing material. Briefing material must comply with the appropriate requirements of the Code and must be certified. It must not advocate, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code. The detailed briefing material referred to in the Code consists of both the training material used to instruct representatives about a medicine and the instructions given to them as to how the product should be promoted.Companies are reminded that briefing material can come from a number of sources including, among other things, the marketing, training and sales departments. Even memorandum or emails written by field managers to their representatives could, according to content, be viewed as briefing material. All briefing material, whatever its source, is subject to the Code and must be certified before use.
When a complaint is received about how a representative promoted a medicine, the PMCPA may request a copy of the relevant briefing material. Briefing material must comply with the appropriate requirements of the Code and must be certified. It must not advocate, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code. The detailed briefing material referred to in the Code consists of both the training material used to instruct representatives about a medicine and the instructions given to them as to how the product should be promoted.
Companies are reminded that briefing material can come from a number of sources including, among other things, the marketing, training and sales departments. Even memorandum or emails written by field managers to their representatives could, according to content, be viewed as briefing material. All briefing material, whatever its source, is subject to the Code and must be certified before use. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-representatives-briefing-material/ |
| What is self-regulation within the pharmaceutical industry? | Self-regulation is generally defined as an industry which regulates itself without intervention from an external body. It is a process whereby an industry-level organisation, such as a trade association, e.g. the Association of the British Pharmaceutical Industry (ABPI), as opposed to a government organisation, sets and enforces rules and standards, which compliment and often go beyond that of the law, to govern behaviours and uses 'self-policing' as the primary mechanism to ensure compliance and provide remediation.The arrangements in the United Kingdom for the regulation of the promotion of medicines for prescribing and interactions with health professionals and other relevant decision makers are subject to two complementary systems of control: self-regulation by the pharmaceutical industry by means of the ABPI Code of Practice for the Pharmaceutical Industry which is administered by the PMCPA, and UK law. The Code also applies to a number of areas which are non-promotional including information made available to the public about prescription only medicines.The advertising law is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the UK Health Ministers. The control of medicines advertising in the UK is thus based on the long established system of self-regulation supported by the statutory role of the MHRA. The relationship between the MHRA, ABPI and PMCPA is set out in a memorandum of understanding which can be found on the PMCPA website.
Self-regulation is generally defined as an industry which regulates itself without intervention from an external body. It is a process whereby an industry-level organisation, such as a trade association, e.g. the Association of the British Pharmaceutical Industry (ABPI), as opposed to a government organisation, sets and enforces rules and standards, which compliment and often go beyond that of the law, to govern behaviours and uses 'self-policing' as the primary mechanism to ensure compliance and provide remediation.
The arrangements in the United Kingdom for the regulation of the promotion of medicines for prescribing and interactions with health professionals and other relevant decision makers are subject to two complementary systems of control: self-regulation by the pharmaceutical industry by means of the ABPI Code of Practice for the Pharmaceutical Industry which is administered by the PMCPA, and UK law. The Code also applies to a number of areas which are non-promotional including information made available to the public about prescription only medicines.
The advertising law is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the UK Health Ministers. The control of medicines advertising in the UK is thus based on the long established system of self-regulation supported by the statutory role of the MHRA. The relationship between the MHRA, ABPI and PMCPA is set out in a memorandum of understanding which can be found on the PMCPA website. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-self-regulation-within-the-pharmaceutical-industry/ |
| What is the aim of the Code? | The aim of the Code is to ensure that the promotion of medicines which can be prescribed to health professionals and to other relevant decision makers and other activities, many of which are non-promotional, are carried out within a robust framework to support high quality patient care and to ensure that pharmaceutical companies operate in a responsible, ethical and professional manner. Whilst the industry has a legitimate right to promote medicines to health professionals, the Code recognises and seeks to achieve a balance between the needs of patients, health professionals and the public, bearing in mind the political and social environment within which the industry operates and the statutory controls governing medicines.
The aim of the Code is to ensure that the promotion of medicines which can be prescribed to health professionals and to other relevant decision makers and other activities, many of which are non-promotional, are carried out within a robust framework to support high quality patient care and to ensure that pharmaceutical companies operate in a responsible, ethical and professional manner. Whilst the industry has a legitimate right to promote medicines to health professionals, the Code recognises and seeks to achieve a balance between the needs of patients, health professionals and the public, bearing in mind the political and social environment within which the industry operates and the statutory controls governing medicines. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-the-aim-of-the-code/ |
| What is the definition of a sample? | The supplementary information toClause 21defines a sample and what is not a sample.
The supplementary information toClause 21defines a sample and what is not a sample. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-the-definition-of-a-sample/ |
| What is the difference between the ABPI and the PMCPA? | The Association of the British Pharmaceutical Industry (ABPI)exists to make the UK the best place in the world to research, develop and access medicines and vaccines to improve patient care. It represents companies of all sizes which invest in making and discovering medicines and vaccines to enhance and save the lives of millions of people around the world. In England, Scotland, Wales and Northern Ireland, the ABPI works in partnership with governments and the NHS so that patients can get new treatments faster and the NHS can plan how much it spends on medicines. The ABPI and its members partner with healthcare professionals, academics and patient organisations to find new solutions to unmet health needs.The Prescription Medicines Code of Practice Authority (PMCPA)was established by the ABPI in 1993 to administer the ABPI Code independently of the ABPI itself. The PMCPA is responsible for the provision of advice, guidance and training on the ABPI Code, as well as for the operation of the complaints procedure whereby complaints about a pharmaceutical company's materials or activities are considered in relation to the requirements of the ABPI Code.
The Association of the British Pharmaceutical Industry (ABPI)exists to make the UK the best place in the world to research, develop and access medicines and vaccines to improve patient care. It represents companies of all sizes which invest in making and discovering medicines and vaccines to enhance and save the lives of millions of people around the world. In England, Scotland, Wales and Northern Ireland, the ABPI works in partnership with governments and the NHS so that patients can get new treatments faster and the NHS can plan how much it spends on medicines. The ABPI and its members partner with healthcare professionals, academics and patient organisations to find new solutions to unmet health needs.
The Prescription Medicines Code of Practice Authority (PMCPA)was established by the ABPI in 1993 to administer the ABPI Code independently of the ABPI itself. The PMCPA is responsible for the provision of advice, guidance and training on the ABPI Code, as well as for the operation of the complaints procedure whereby complaints about a pharmaceutical company's materials or activities are considered in relation to the requirements of the ABPI Code. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-the-difference-between-the-abpi-and-the-pmcpa/ |
| What is the purpose of abbreviated advertisements? | Abbreviated advertisements were particularly popular when printed advertisements were more common and space in journals was restricted.
Abbreviated advertisements were particularly popular when printed advertisements were more common and space in journals was restricted. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-the-purpose-of-abbreviated-advertisements/ |
| What is the spirit of the Code? | The spirit of the ABPI Code is about individuals and companies ensuring high ethical standards are applied in addition to following the literal interpretation of the Code. The impression created by materials, items and activities should be borne in mind.
The spirit of the ABPI Code is about individuals and companies ensuring high ethical standards are applied in addition to following the literal interpretation of the Code. The impression created by materials, items and activities should be borne in mind. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-the-spirit-of-the-code/ |
| What is the web address for the MHRA yellow card scheme site? | The web address is www.mhra.gov.uk/yellowcard or reports can also be made or via the Yellow Card app. Download the app via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices.
The web address is www.mhra.gov.uk/yellowcard or reports can also be made or via the Yellow Card app. Download the app via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-is-the-web-address-for-the-mhra-yellow-card-scheme-site/ |
| What joint working material requires certification? | Joint working is a form of collaborative working and the requirements for each collaborative working project, including the certification requirements are set out inClauses 20.1,20.2and20.3.Clause 20.4 and its supplementary informationset out additional requirements for joint working.
Joint working is a form of collaborative working and the requirements for each collaborative working project, including the certification requirements are set out inClauses 20.1,20.2and20.3.Clause 20.4 and its supplementary informationset out additional requirements for joint working. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-joint-working-material-requires-certification/ |
| What material relating to working with patient organisations requires certification? | The requirements for working with patient organisations are incorporated in the respective clauses of the Code, those which need to be certified are set out inClause 8.3. In brief, donations, grants and sponsorship should be certified; contracted services do not need to be certified.
The requirements for working with patient organisations are incorporated in the respective clauses of the Code, those which need to be certified are set out inClause 8.3. In brief, donations, grants and sponsorship should be certified; contracted services do not need to be certified. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-material-relating-to-working-with-patient-organisations-requires-certification/ |
| What needs to be certified or examined with respect to arrangements for events/meetings when contracted services are delivered? | What needs to be certified or examined with respect to the arrangements for events/meetings when contracted services are delivered will first and foremost depend on where the meeting takes place. If the event/meeting is in the UK, companies should ensure there is adequate oversight of the event/meeting arrangements (the venue, agenda, hospitality and accommodation as applicable), which should be examined as set out in the supplementary information toClause 10.1(certification and examination of events/meetings). Events/meetings which involve travel outside the UK must be certified as set out inClause 8.2.
What needs to be certified or examined with respect to the arrangements for events/meetings when contracted services are delivered will first and foremost depend on where the meeting takes place. If the event/meeting is in the UK, companies should ensure there is adequate oversight of the event/meeting arrangements (the venue, agenda, hospitality and accommodation as applicable), which should be examined as set out in the supplementary information toClause 10.1(certification and examination of events/meetings). Events/meetings which involve travel outside the UK must be certified as set out inClause 8.2. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-needs-to-be-certified-or-examined-with-respect-to-arrangements-for-eventsmeetings-when-contracted-services-are-delivered/ |
| What procedures should companies have in relation to use of email by employees? | Companies should remind staff that if they email a health professional, other relevant decision maker or others about a matter which relates to their professional role, then they should take great care to ensure that the email does not breach the Code through the use of exaggerated claims, immoderate language and the like.The requirements ofClause 15.5and its supplementary information should also be kept in mind.
Companies should remind staff that if they email a health professional, other relevant decision maker or others about a matter which relates to their professional role, then they should take great care to ensure that the email does not breach the Code through the use of exaggerated claims, immoderate language and the like.
The requirements ofClause 15.5and its supplementary information should also be kept in mind. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-procedures-should-companies-have-in-relation-to-use-of-email-by-employees/ |
| What should pharmaceutical companies do if a health professional/HCO donates their transfer of value to a third party, e.g. a charity, charitable trust or other institution? | The purpose of disclosure is to bring greater transparency to the relationships between the pharmaceutical industry has with, amongst others, health professionals, other relevant decision makers and healthcare organisations. Companies are required to document and publicly disclose transfers of value made to health professionals, other relevant decision makers and healthcare organisations (Clause 28.1). They should disclose, where lawfully able, those individuals or organisations to whom a transfer of value was made, regardless of what happens to that transfer of value afterwards. Recipients should be aware of the process.
The purpose of disclosure is to bring greater transparency to the relationships between the pharmaceutical industry has with, amongst others, health professionals, other relevant decision makers and healthcare organisations. Companies are required to document and publicly disclose transfers of value made to health professionals, other relevant decision makers and healthcare organisations (Clause 28.1). They should disclose, where lawfully able, those individuals or organisations to whom a transfer of value was made, regardless of what happens to that transfer of value afterwards. Recipients should be aware of the process. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-should-pharmaceutical-companies-do-if-a-health-professionalhco-donates-their-transfer-of-value-to-a-third-party-eg-a-charity-charitable-trust-or-other-institution/ |
| What should pharmaceutical companies do if a healthcare professional wishes to disclose some, but not all, transfers of value against their name? | The purpose of disclosure is to bring greater transparency to the relationships the pharmaceutical industry has with, amongst others, health professionals, other relevant decision makers and healthcare organisations. It is therefore desirable for companies to publish as fully as possible, details of transfers of value at a named, individual level where they are lawfully able to do so.Clause 28.5and its supplementary information allows for companies to operate an 'all in' or 'all out' policy with regards to individuals who wish to disclose only some of the transfers of value they receive from a company.Companies should make it clear in their methodological note the number of individuals who have agreed to some payments being disclosed individually and some in aggregate.
The purpose of disclosure is to bring greater transparency to the relationships the pharmaceutical industry has with, amongst others, health professionals, other relevant decision makers and healthcare organisations. It is therefore desirable for companies to publish as fully as possible, details of transfers of value at a named, individual level where they are lawfully able to do so.
Clause 28.5and its supplementary information allows for companies to operate an 'all in' or 'all out' policy with regards to individuals who wish to disclose only some of the transfers of value they receive from a company.
Companies should make it clear in their methodological note the number of individuals who have agreed to some payments being disclosed individually and some in aggregate. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-should-pharmaceutical-companies-do-if-a-healthcare-professional-wishes-to-disclose-some-but-not-all-transfers-of-value-against-their-name/ |
| What should pharmaceutical companies do if cross-border payments have not been provided by affiliates by end of March? | Disclosures must be made in the first six months after the end of the calendar year in which the transfers of value were made (Clause 31.1). This means a company should have a full disclosure published by the end of June annually. In order to ensure that disclosures are made on the central platform, Disclosure UK, transfer of value data needs to be submitted to the ABPI by the end of March annually. If a full disclosure is not made by the end of March the ABPI cannot guarantee that a full disclosure will be made within the timeframe required. The exact date in March varies year on year. Details are available at www.disclosureuk.org.uk. Information to be published on Disclosure UK must be submitted in line with the operational timelines of the platform.
Disclosures must be made in the first six months after the end of the calendar year in which the transfers of value were made (Clause 31.1). This means a company should have a full disclosure published by the end of June annually. In order to ensure that disclosures are made on the central platform, Disclosure UK, transfer of value data needs to be submitted to the ABPI by the end of March annually. If a full disclosure is not made by the end of March the ABPI cannot guarantee that a full disclosure will be made within the timeframe required. The exact date in March varies year on year. Details are available at www.disclosureuk.org.uk. Information to be published on Disclosure UK must be submitted in line with the operational timelines of the platform. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-should-pharmaceutical-companies-do-if-cross-border-payments-have-not-been-provided-by-affiliates-by-end-of-march/ |
| What should pharmaceutical companies include in a Methodological Note for Disclosure? | Guidance on what information should be included in a company's Methodological Note can be found in theGuidancesection of the PMCPA website.
Guidance on what information should be included in a company's Methodological Note can be found in theGuidancesection of the PMCPA website. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-should-pharmaceutical-companies-include-in-a-methodological-note-for-disclosure/ |
| What wording should be used for email agreements used by third parties? | Clause 15.5of the Code prohibits the use of email for promotional purposes unless with the prior permission of the recipient. If companies use a third party (third party as defined inClause 1.24) to email promotional material it is essential that they scrutinise the wording of the agreement used to gain permission to send such material. The agreement should form part of the relevant job bag and must be such that health professionals were able to give fully informed consent. The wording must make it abundantly clear that agreement would result in the receipt of promotional emails. Lack of clarity in the wording is likely to lead to a breach of the Code.
Clause 15.5of the Code prohibits the use of email for promotional purposes unless with the prior permission of the recipient. If companies use a third party (third party as defined inClause 1.24) to email promotional material it is essential that they scrutinise the wording of the agreement used to gain permission to send such material. The agreement should form part of the relevant job bag and must be such that health professionals were able to give fully informed consent. The wording must make it abundantly clear that agreement would result in the receipt of promotional emails. Lack of clarity in the wording is likely to lead to a breach of the Code. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/what-wording-should-be-used-for-email-agreements-used-by-third-parties/ |
| When a conflict of requirements in different country codes happens, the most stringent is always applied. Where is this set out in the ABPI Code and are there any situations where this is not so? | The supplementary information toClause 3.4. paragraph 1 states, that 'Compliance with all applicable codes, laws and regulations to which a pharmaceutical company is subject is particularly relevant when activities/materials involve more than one country or when a company based in one country is involved in activities in another country.' There is a potential exemption with respect to subsistence limits in European countries where the national association is a member of The European Federation of Pharmaceutical Industries and Associations. In such circumstances, the subsistence limits of the host country code would apply. Note: If a scientific event is being held in the UK, the UK limit of a maximum of £75 plus VAT and gratuities applies in certain circumstances however there are some countries where this may not be compliant with their applicable codes, laws and regulations. Where applicable, companies should liaise with the affiliates of the attendees and ensure arrangements are suitable for all health professional attendees.
The supplementary information toClause 3.4. paragraph 1 states, that 'Compliance with all applicable codes, laws and regulations to which a pharmaceutical company is subject is particularly relevant when activities/materials involve more than one country or when a company based in one country is involved in activities in another country.' There is a potential exemption with respect to subsistence limits in European countries where the national association is a member of The European Federation of Pharmaceutical Industries and Associations. In such circumstances, the subsistence limits of the host country code would apply. Note: If a scientific event is being held in the UK, the UK limit of a maximum of £75 plus VAT and gratuities applies in certain circumstances however there are some countries where this may not be compliant with their applicable codes, laws and regulations. Where applicable, companies should liaise with the affiliates of the attendees and ensure arrangements are suitable for all health professional attendees. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/when-a-conflict-of-requirements-in-different-country-codes-happens-the-most-stringent-is-always-applied-where-is-this-set-out-in-the-abpi-code-and-are-there-any-situations-where-this-is-not-so/ |
| When are references and/or links to third party websites in company materials not covered by the Code? | Much would depend on the content of the linked site and the reasons for the link. If for example links to all relevant patient organisations were chosen this might not be third party websites covered by the Code. If links were to patient organisations with whom the company works then this might be covered by the Code. Companies should consider whether a link is product related does the link constitute advertising a medicine?
Much would depend on the content of the linked site and the reasons for the link. If for example links to all relevant patient organisations were chosen this might not be third party websites covered by the Code. If links were to patient organisations with whom the company works then this might be covered by the Code. Companies should consider whether a link is product related does the link constitute advertising a medicine? | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/when-are-references-andor-links-to-third-party-websites-in-company-materials-not-covered-by-the-code/ |
| When are representatives' call rates excessive? | The supplementary information toClause 17.3includes that a representative may call on a doctor or other prescriber no more than three times on average in a year. The number of contacts with that health professional may be more than that, provided it is made clear that only three of these contacts can be cold calls. Briefing materials should clearly distinguish between expected call rates and expected contact rates. The Code does not prohibit ‘call-backs’ or bonusing representatives on contact rates. However, if representatives are bonused on contacts, their targets must be realistic so that representatives are not put under unacceptable pressure to solicit gratuitous ‘call-back’ opportunities, use items as inducements to gain interviews or hang around in corridors hoping to bump into a customer.The PMCPA considers it helpful if all briefing material relating to call/contact rates either reminds representatives of the requirements of the Code in that regard or refers them to another relevant document.
The supplementary information toClause 17.3includes that a representative may call on a doctor or other prescriber no more than three times on average in a year. The number of contacts with that health professional may be more than that, provided it is made clear that only three of these contacts can be cold calls. Briefing materials should clearly distinguish between expected call rates and expected contact rates. The Code does not prohibit ‘call-backs’ or bonusing representatives on contact rates. However, if representatives are bonused on contacts, their targets must be realistic so that representatives are not put under unacceptable pressure to solicit gratuitous ‘call-back’ opportunities, use items as inducements to gain interviews or hang around in corridors hoping to bump into a customer.
The PMCPA considers it helpful if all briefing material relating to call/contact rates either reminds representatives of the requirements of the Code in that regard or refers them to another relevant document. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/when-are-representatives-call-rates-excessive/ |
| When certifying dynamic content what should be considered by signatories? | The requirements of the Code apply to all materials, items, etc. irrespective of the platform they have been developed for or the way they are utilised. Dynamic content, as with all other materials, items, etc., must meet these requirements as a standalone item. A company is responsible for all possible viewing scenarios but does not have to certify each possible combination.
The requirements of the Code apply to all materials, items, etc. irrespective of the platform they have been developed for or the way they are utilised. Dynamic content, as with all other materials, items, etc., must meet these requirements as a standalone item. A company is responsible for all possible viewing scenarios but does not have to certify each possible combination. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/when-certifying-dynamic-content-what-should-be-considered-by-signatories/ |
| Where healthcare organisations receive monies from companies, should the disclosure be against individual institutions (hospitals) or at a Foundation Trust level? | The payment should be disclosed to the entity to which it is paid. If payment is to a department in the hospital then this is who it is disclosed against.
The payment should be disclosed to the entity to which it is paid. If payment is to a department in the hospital then this is who it is disclosed against. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/where-healthcare-organisations-receive-monies-from-companies-should-the-disclosure-be-against-individual-institutions-hospitals-or-at-a-foundation-trust-level/ |
| Why are regional public organisations not included in the exemptions for NICE, SMC, AWMSG? | The exemption only applies to national public organisations. Providing information for health technology assessments can be done by means of the exemption inClause 1.17of the Code for replies made in response to individual enquiries. There is of course nothing to stop companies using promotional material which complies with the Code for discussions with regional evaluation groups.
The exemption only applies to national public organisations. Providing information for health technology assessments can be done by means of the exemption inClause 1.17of the Code for replies made in response to individual enquiries. There is of course nothing to stop companies using promotional material which complies with the Code for discussions with regional evaluation groups. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-are-regional-public-organisations-not-included-in-the-exemptions-for-nice-smc-awmsg/ |
| Why are there requirements within the ABPI Code that go beyond UK law and the European Federation of Pharmaceutical Industries and Associations/ International Federation of Pharmaceutical Manufacturers and Associations Codes? | The ABPI Code sets out rules and standards agreed by ABPI members as part of their commitment to self-regulation. The ABPI Code incorporates and goes beyond relevant UK Law. European Federation of Pharmaceutical Industries and Associations (EFPIA) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have an expectation that member trade associations will set further and/or more stringent requirements as applicable for their country to ensure self regulation meets external stakeholders expectations.
The ABPI Code sets out rules and standards agreed by ABPI members as part of their commitment to self-regulation. The ABPI Code incorporates and goes beyond relevant UK Law. European Federation of Pharmaceutical Industries and Associations (EFPIA) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have an expectation that member trade associations will set further and/or more stringent requirements as applicable for their country to ensure self regulation meets external stakeholders expectations. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-are-there-requirements-within-the-abpi-code-that-go-beyond-uk-law-and-the-european-federation-of-pharmaceutical-industries-and-associations-international-federation-of-pharmaceutical-manufacturers-and-associations-codes/ |
| Why can companies not mention the MHRA in materials for a medicine with a conditional licence? | Clause 15.2states that promotional material must not include reference to amongst others the Medicines and Healthcare products Regulatory Authority 'MHRA' unless specifically required by the licensing authority. This is because the use of an official body's names implies they are aware and agree to the use of their name and could be interpreted to imply some form of endorsement which may not be the case.
Clause 15.2states that promotional material must not include reference to amongst others the Medicines and Healthcare products Regulatory Authority 'MHRA' unless specifically required by the licensing authority. This is because the use of an official body's names implies they are aware and agree to the use of their name and could be interpreted to imply some form of endorsement which may not be the case. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-can-companies-not-mention-the-mhra-in-materials-for-a-medicine-with-a-conditional-licence/ |
| Why do the arrangements for a meeting where a UK health professional is speaking outside the UK with no UK delegates and the UK company has no role whatsoever in relation to the meeting or presentation not need certification or examination? | Companies are responsible for all activities, materials, items, etc. under the Code. A company's responsibilities under the Code are clear irrespective of whether there are specific requirements for certification or examination. Not mandating certification or examination under the Code does not mean a company is not responsible for ensuring the Code is complied with in this regard.
Companies are responsible for all activities, materials, items, etc. under the Code. A company's responsibilities under the Code are clear irrespective of whether there are specific requirements for certification or examination. Not mandating certification or examination under the Code does not mean a company is not responsible for ensuring the Code is complied with in this regard. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-do-the-arrangements-for-a-meeting-where-a-uk-health-professional-is-speaking-outside-the-uk-with-no-uk-delegates-and-the-uk-company-has-no-role-whatsoever-in-relation-to-the-meeting-or-presentation-not-need-certification-or-examination/ |
| Why does the Code not specifically mention other relevant laws such as the General Data Protection Requirement? | The Code covers the main legal requirements applicable to interactions and activities carried out by a pharmaceutical company in relation to the promotion of their medicines and a number of areas which are non-promotional.Clause 3.4requires companies compliance with applicable codes, laws and regulations. It would not be possible for the Code to cover every relevant law or regulation; ensuring the Code was up to date in this regard at all times would not be feasible.
The Code covers the main legal requirements applicable to interactions and activities carried out by a pharmaceutical company in relation to the promotion of their medicines and a number of areas which are non-promotional.Clause 3.4requires companies compliance with applicable codes, laws and regulations. It would not be possible for the Code to cover every relevant law or regulation; ensuring the Code was up to date in this regard at all times would not be feasible. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-does-the-code-not-specifically-mention-other-relevant-laws-such-as-the-general-data-protection-requirement/ |
| Why does the Code still refer to promotional aids when product branded items were stopped many years ago? | The information on promotional aids is helpful to those that are new to the Code. Given the wording of the legal requirements, it is important to retain so that it is still permissible to give items such as memory sticks, pens and pads to health professionals and other relevant decision makers in certain circumstances.
The information on promotional aids is helpful to those that are new to the Code. Given the wording of the legal requirements, it is important to retain so that it is still permissible to give items such as memory sticks, pens and pads to health professionals and other relevant decision makers in certain circumstances. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-does-the-code-still-refer-to-promotional-aids-when-product-branded-items-were-stopped-many-years-ago/ |
| Why is self-regulation important to the pharmaceutical industry? | Self-regulation of the promotion of medicines and other activities is important to the pharmaceutical industry as it allows the industry to set agreed standards (ABPI Code of Practice) to ensure the appropriate use of medicines and support the provision of high quality patient care. Self-regulation includes arrangements for enforcement including publication of cases. Self-regulation demonstrates the industry's commitment to high standards, increasing public trust and combating negative public perceptions.
Self-regulation of the promotion of medicines and other activities is important to the pharmaceutical industry as it allows the industry to set agreed standards (ABPI Code of Practice) to ensure the appropriate use of medicines and support the provision of high quality patient care. Self-regulation includes arrangements for enforcement including publication of cases. Self-regulation demonstrates the industry's commitment to high standards, increasing public trust and combating negative public perceptions. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-is-self-regulation-important-to-the-pharmaceutical-industry/ |
| Why is there a limitation on calls per representative, and what is the time period? | Limitations are helpful in demonstrating that the industry understands the pressures on health professionals, in particular prescribing health professionals as well as other relevant decision makers and the NHS. The requirements in the Code (Clause 17.3and its supplementary information) helps balance these with the legitimate right for industry to inform and promote. It is generally understood to be a rolling twelve months.
Limitations are helpful in demonstrating that the industry understands the pressures on health professionals, in particular prescribing health professionals as well as other relevant decision makers and the NHS. The requirements in the Code (Clause 17.3and its supplementary information) helps balance these with the legitimate right for industry to inform and promote. It is generally understood to be a rolling twelve months. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-is-there-a-limitation-on-calls-per-representative-and-what-is-the-time-period/ |
| Why is there no separate clause for medical education? Can a pharmaceutical company run a medical educational meeting which is wholly non-promotional, even if a company medicine is mentioned? | The purpose of every meeting must be educational. The definition of promotion is very broad and far reaching and, as such, if a company organised meeting discussed its medicines, the company should consider how this would not be defined as promotion under the Code. The supplementary information toClause 10.1Continuing Professional Development (CPD) Meetings and Courses is also relevant.
The purpose of every meeting must be educational. The definition of promotion is very broad and far reaching and, as such, if a company organised meeting discussed its medicines, the company should consider how this would not be defined as promotion under the Code. The supplementary information toClause 10.1Continuing Professional Development (CPD) Meetings and Courses is also relevant. | https://www.pmcpa.org.uk/guidance-and-qas/2024-qas-by-topic-or-clause/why-is-there-no-separate-clause-for-medical-education-can-a-pharmaceutical-company-run-a-medical-educational-meeting-which-is-wholly-non-promotional-even-if-a-company-medicine-is-mentioned/ |