The new ABPI Code of Practice
Implications for Pharmaceutical Marketing
The new ABPI Code of Practice will impact on everyone working in healthcare, not just those in the pharmaceutical industry. Here we review the new Code and explore its implications with the help of the eminent faculty of experts who presented at a recent well-attended workshop, organised jointly by the ABPI, the PM Society and the Healthcare Communications Association.
The review process and the working environment
Ongoing headlines in the media show that the pharmaceutical industry is under close scrutiny, largely due to the changing expectations of external stakeholders. In the current working environment the industry is both under the microscope and in the dock. This is the view of Andrew Hotchkiss (Managing Director, Lilly UK), who chaired the ABPI Code of Practice review working group, who believes that the industry will be judged not just on whether it abides by the letter of the Code but also on whether acts within the spirit of the Code at all times.
The Code of Practice is not new. The pharmaceutical industry has had a robust code of practice since 1958, and this has been held up as an example to countries around the world. It is a condition of membership of the ABPI to comply with the Code and accept its jurisdiction. The Code reflects UK law (indeed it extends beyond it) and also reflects international and European codes of practice. The Code is updated approximately every couple of years. The last major review of the Code was in 1992
Started in 2004, the review process had four key objectives: to update the Code, given the changes to EU laws and regulations and a number of UK reforms; to respond to public expectations around the pharmaceutical industry regarding promotion of medicines to physicians and the provision of information to patients; to demonstrate that self-regulation remains the best way of managing promotion of medicines; and to build confidence in the safety of medicines.
Around the same time the MHRA updated its advise by revising the Blue Guide to Advertising and Promotion of Medicines in the UK (finalised in November 2005) and a few months later the Commons Health Select Committee enquiry also made a number recommendations specific to promotion. These included more transparent publishing of data, limits on the quantity of promotional material sent to prescribers (particularly at the time of launch), and stricter controls on promotion to junior doctors, nurses and pharmacists.
As part of the Code of Practice review process a working group was set up comprising 12 companies with a broad representation across the industry. Changes in the European Code of Practice were taken into account to ensure consistent standards across Europe. There was also broad public consultation, as well as outreach market research with key stakeholders, including patient advocacy groups, and consultation with ABPI member companies and key bodies, including the MHRA.
This consultation and research revealed that a clearer format for the Code would be appreciated, setting out only the broad principles in the Code itself with more succinct case reporting included as supplementary evidence to provide specific direction. Stakeholders also wanted a clearer definition of what constitutes information and promotion, with much discussion around hospitality and gifts in particular. It was also felt that the new Code must be transparent, independent and open to verification, and that sanctions should be strengthened to underpin the Code.
While there is no formal plan to assess how effective the changes to the Code have been, there will be ongoing dialogue with all key stakeholders, as well as surveys with the public, members of parliament, and patient groups to ensure that the Code remains fit for purpose. Andrew Hotchkiss admits that human nature means that mistakes will always happen, and these must be dealt with quickly and effectively, but in his view the potential for error can be reduced by communication and training around the Code.
Des Spence of the 'No Free Lunch' campaign has stated that his group is pleased to see from the new Code that the industry is moving in response criticism and that it is now up to the doctors to do the same. As Andrew Hotchkiss says, "Industry needs to be clear as to the standards by which industry will operate and say no when asked to do things outside the Code of Practice. Some doctors may not like the changes but they'll have to get used to flying Economy rather than Club Class when going to congresses."
Andrew firmly believes that everyone in the industry must understand the importance of the Code and be fully committed to it. "The fact that so much attention is being paid to the new Code indicates that a real sea-change in attitudes to the pharmaceutical industry is under way." For Andrew, the Code of Practice is fundamental to the future of the industry. "If the industry does not have good ethical practices our customers in the NHS will not want to work with us. The revised Code provides the entry ticket for the industry to do business in the right way."
Key principles of the Code
According to Heather Simmonds, Director of the Prescription Medicines Code of Practice Authority (PMCPA), the body established by the ABPI in 1993 to administer the ABPI's Code of Practice for the pharmaceutical industry, the principles that apply to medicines promotion remain unchanged from the existing Code. Promotion must be in accordance with marketing authorisation, accurate, balanced and up-to-date, must not mislead or exaggerate, and be substantiable.
More subjectively the Code sets out that promotion must recognise the special nature of medicines and the professional standing of the audience. It must also be of a high standard and not likely to cause offence, be tailored to the audience to whom it is directed, must not bring discredit on the pharmaceutical industry, nor disparage competitors or health professionals. Importantly, promotion must not be disguised.
Heather Simmonds stresses that the Code's complaints procedure remains mostly unchanged. There are decreases to the time periods for providing an undertaking when a company ruled in breach accepts that ruling and when submitting material for appeals. There is now a requirement for attempting to solve intercompany disputes prior to making a complaint. More detail is given about conciliation. The make-up of the Code of Practice Appeal Board has been changed with two additional independent members. The Code of Practice Panel can suspend certain materials and activities immediately in cases affecting patient safety or public health or for serious breaches of the Code, irrespective of whether or not there is an appeal (though material can be reinstated if not breach is ruled by the Appeal Board).
Additional sanctions have also been introduced: the Appeal Board can now publicly reprimand a company in breach of the Code or require a corrective statement, though only the ABPI Board can suspend ABPI membership. There are further sanctions involving the advertising of breaches of the Code, with more frequent publication of case reports, and ongoing cases will now be made public.
The main changes to the new Code are set out by Heather Simmonds in the accompanying Box. For those wanting to know more, the PMCPA runs regular seminars on the Code and the ABPI also has an online training site.
The view of the MHRA
For Beryl Keeley, Unit Manager for product information and advertising at the MRHA, the role of the MHRA is to underpin the well established system of self-regulation within the pharmaceutical industry in the UK. The MHRA regard their own Blue Guide and the new ABPI Code as being complementary: the Blue Guide sets out the MHRA's interpretation of the legislation; the Code provides guidance in areas that go beyond the minimum requirements of the legislation. Beryl Keeley stresses that there is one aim however: to promote consistently high standards in advertising of medicines across the board.
"The MHRA's view is that the new ABPI Code is a major step forward in promoting renewed confidence in the self-regulatory system for the control of advertising medicines," says Beryl. "The positive changes will enhance patient safety and ensure that the Code remains robust and rigorous. It also represents a major milestone in that it takes account the views of all stakeholders."
On the recommendation of the Commons Healthcare Select Committee the MHRA now vet all promotional material for new active substances authorised from the beginning of November 2005. This includes pre-launch and post-launch materials, and all press releases, meaning that extra time needs to be factored in when preparing press materials. Most companies agree voluntarily to vetting (though there are statutory powers). Beryl Keeley stresses that vetting is not intended to delay the launch of a new product, but neither should it provide companies with an opportunity to test the boundaries of what is acceptable in advertising. "Good quality advertising will get through vetting quickly and smoothly currently the target response is five working days."
The MHRA have also recently ruled on how safety information is communicated to doctors and stressed that when conveying complicated messages it is important to use 'real' numbers and to include all the information about a product, not just the positive. The MHRA regard companies as responsible for the content of all promotional material, including that produced by PR agencies.
The next steps
In the view of Ben Hayes, Director of Public Affairs at the ABPI, the pharmaceutical industry's reputation is inextricably bound to promotion and marketing. "But we tend to suffer from 'industry paranoia'. We must remember that reputation is not about who is right and who is wrong. It's a two-way issue. And industry should not forget that perception is indeed reality. It is vital to regard people's opinions in this context."
In 2005 the ABPI researched the image of the industry with MPs, the public and industry journalists. Encouragingly, this revealed that the industry is far from being hated and despised. The message is similar from the public, though there is a general lack of knowledge about the industry among the public which represents a challenge to the industry in terms of communications.
Based on this research, for Ben Hayes the challenge to the industry is to demonstrate an understanding of the healthcare system and to seek to improve the quality of its information to stakeholders. Above all, it is about putting the patient at the centre. Ben firmly believes that the industry must behave in a manner consistent with its key messages, and that these messages need to be communicated in ways that have more impact. A frightening 48% of doctors are not aware of the ABPI Code of Practice (though once they are aware, they are in fact impressed with the Code). And even if they are aware of the Code, 86% of doctors do not know how to make a complaint against the Code. The priority for the ABPI in 2006 in terms of communications is therefore to raise awareness of the Code and to enhance the general appreciation of self-regulation.
Communications activities around the new Code of Practice will centre on the idea of 'it takes two to tango'. As Ben says, it is not just for industry to get its act together: everybody has a role to play. The coverage of the new Code by the media has so far been very positive. 'Code Day' is 25 April and 43 companies have agreed that their representatives will actively promote the Code on that day.
In addition, Heather Simmonds is updating the guide to the Code for health professionals and a guide for patients and the public will be produced. The ABPI will also be working with professional bodies such as the BMA and RCN to share platforms on the issue of the Code and generate media awareness.
For Ben Hayes the bigger picture is the reputation of the industry and the challenge is to maintain and improve that reputation. "But it's not just about shouting louder. It's about the day-to-day work that the industry and PR agencies do in terms of building better relationships. The quality and nature of those relationships is vital and everyone has a part to play in this."
The
principal revisions to the ABPI Code of Practice
Heather Simmonds of the PMCPA outlines the changes clause by clause
Clause 1 has been amended such that the Code now applies to patient information regarding prescription only medicines (POM) only. Supplementary information is included about solicited/unsolicited information, e.g. an abstract on an exhibition stand is NOT unsolicited under the new Code. UK public assessment reports and material supplied to national public organisations such as NICE are exempt as long as the information is factual, accurate and not misleading.
Companies must also appoint a senior employee to ensure compliance with the Code (usually the managing director in the UK). Meetings in the UK must comply with the UK Code, even if they are organised by a US company and no UK health professionals attend. Equally if a UK company holds a meeting in France the meeting must comply with the French code of practice as well as the UK Code.
Clause 2 now includes supplementary information with more detailed examples of what might lead to a breach of the Code in relation to hospitality and meetings, as well as issues of patient safety.
Clause 4 now requires that prescribing information is dated. More information must be given about common and serious side effects, as well as the need to consult the SPC for other side effects. Promotional material must include prominent information about adverse event reporting. Because this means that virtually all printed materials will require changes, there is a transition period from 1 January to 30 April 2006. All materials must comply with the new Code by 1 May 2006.
Clause 5 covers abbreviated advertisements, which should also include prominent information about adverse event report (and consulting the SPC).
Clause 6 now states that no issue of a journal may bear advertising for a particular product on more than two pages.
Clause 7 is the heart of the Code and has been changed to add clarity. Substantiation should now be provided within ten working days. Artwork from published studies must be referenced and faithfully reproduced, and may be modified only to comply with the Code (e.g. taking out an unlicensed medicine or dose). It must also be clearly stated if material has been modified. Care should be taken when using percentages and patient numbers should be included where possible. Under the previous Code it was not permitted to state that a medicine has no side effects, toxic hazard or risks of addiction. The new Code adds that it cannot be stated that a product has no risk of dependence.
Promotional campaigns must encourage the rational use of a medicine. This does not necessarily mean that material must reflect NICE or SMC guidance, as long as the promotion is in accordance with the product's licence. Benefit/risk profile has to be presented in such a way as to com ply with the Code, and this also applies to information for the public. If the data a company is relying on to substantiate their claim is required to be registered in accordance with the Joint Position on Disclosure of Clinical Trial Information, but is not registered, the company will be in breach of the Code.
Clause 9 now includes additional supplementary information advising particular care with regard to the format, size and cost of promotional materials in the first six months after launch. Automated calling systems and other electronic communications have been added to the list of methods of communication which must not be used for promotional purposes without prior permission, i.e. only a letter can be sent to a doctor without prior permission: promotional e-mails and faxes need prior permission.
Clause 10 clarifies the existing Code with regard to disguised promotion. If a company pays for or arranges publication of promotional material in journals, this material must not resemble editorial matter. Also, post-marketing surveillance studies and clinical assessments, etc, must be conducted with primarily a scientific/educational purpose. Under this clause, articles written and produced by a third party, for example the PR agency, but published under a doctor's name, would be in breach of the Code as the material is clearly company produced, i.e. disguised promotion.
Clause 11 requires that quotations are faithfully reproduced, except where modification is needed to comply with the Code, in which case this must be indicated. The precise source must be given.
Clause 12 is modified so that in the first six months following launch a health professional may be sent an initial mailing about the product and no more than three further mailings. They must not receive more than eight mailings per product per year. Mailings solely related to safety are excluded from the above.
Clause 14 deals with certification of material within a pharmaceutical company before use. Under the new Code a practising UK registered pharmacist, under the direction of a medical practitioner, can certify certain promotional materials provided the product/indication has been marketed in the UK for more than a year, if the campaign is not new and novel, and provided the pharmacist has at least one year's experience of working with the product.
Other new requirements under Clause 14 are that certain educational materials relating to diseases and medicines for the public must be certified, as must material relating to working with patient groups, and the provision of medical and educational goods and services (e.g. service implementation, protocols for healthcare professionals). If a company has a strictly 'arm's length' arrangement with a patient group, has no input to the materials and does not use the materials themselves then that material does not have to be certified. The company's involvement with the group must be made clear. However, if the company uses that information on its exhibition stand then it must be certified.
Clause 15 now includes supplementary information spelling out the limits on visits by reps to other prescribers, not just doctors as previously.
Clause 16 has changed considerably. All staff must now be conversant with relevant laws and regulations, and have documented training in pharmacovigilence. This includes third parties retained by contract in relation to the preparation of promotional material or information to the public, i.e. it is the responsibility of the company to ensure all third-parties are up to speed with regard to the Code. If they interact with prescribers, reps must be entered for examination in their first year. Previous exemptions to passing the examination have been deleted.
Clause 18 covers gifts and hospitality. Companies cannot give 'gifts' as an inducement to sell any medicine but can give 'promotional aids'. Items cannot be given for the personal benefit of health professionals. Promotional competitions, quizzes and prizes are no longer permitted. More guidance has been given about promotional items: the perceived value to the recipient must be similar to the limit on the cost to the company of £6 excluding VAT. Prescribing information is not needed on a promotional aid as long as it has no more than the brand name and the company name or the non-proprietary name and company name. Text books can be provided as part of a medical educational goods and services. Clause 18 also includes a new section about the provision of medical and educational goods and services. These must enhance patient care or benefit the NHS whilst maintaining patient care. Switch services are prohibited under the new Code, but therapy review is allowed.
Clause 19 concerns hospitality. This is now limited to appropriate subsistence (meals and drinks), accommodation, registration fees and reasonable travel costs. This clause will now also apply to journalists and patient organisations. Only economy air travel is allowed for delegates sponsored to attend meetings, though speakers are not covered by this requirement. Lavish or deluxe venues cannot be used and venues renowned for their entertainment facilities must be avoided. There is additional guidance on meetings outside the UK, i.e. meetings can be held outside the UK for logistical reasons such as the expertise available.
Clause 20 now covers information to the public about POM products only medicines only - an important change. The supplementary information now defines proactive information provided without a request, e.g. information on diseases, press releases (which should include an SPC), news briefings, mailings etc. Reference information is defined as a comprehensive up-to-date resource for the patient and public to find out more about the product and the disease area, including regulatory information, studies on which the licence was granted, detailed booklets, and NICE submissions, but the package must represent the complete body of evidence for a product (i.e. not leave out a less positive study) and fairly reflect the benefit/risk profile. Reactive information covers requests from the public for information. There is also a framework for working with patient organisations to ensure that the involvement of the company is transparent. Written agreements are needed for ongoing significant activities or ongoing relationships and should set out activities agreed, the level of funding and the approval process.
Clause 21 deals with the internet. Access to promotional material on the internet should ideally be limited to heath professionals. If material is not access-restricted the website must provide information to the public as well as promotion to health professionals, with the sections for each audience separated.
Heather Simmonds of the PMCPA outlines the changes clause by clause
Clause 1 has been amended such that the Code now applies to patient information regarding prescription only medicines (POM) only. Supplementary information is included about solicited/unsolicited information, e.g. an abstract on an exhibition stand is NOT unsolicited under the new Code. UK public assessment reports and material supplied to national public organisations such as NICE are exempt as long as the information is factual, accurate and not misleading.
Companies must also appoint a senior employee to ensure compliance with the Code (usually the managing director in the UK). Meetings in the UK must comply with the UK Code, even if they are organised by a US company and no UK health professionals attend. Equally if a UK company holds a meeting in France the meeting must comply with the French code of practice as well as the UK Code.
Clause 2 now includes supplementary information with more detailed examples of what might lead to a breach of the Code in relation to hospitality and meetings, as well as issues of patient safety.
Clause 4 now requires that prescribing information is dated. More information must be given about common and serious side effects, as well as the need to consult the SPC for other side effects. Promotional material must include prominent information about adverse event reporting. Because this means that virtually all printed materials will require changes, there is a transition period from 1 January to 30 April 2006. All materials must comply with the new Code by 1 May 2006.
Clause 5 covers abbreviated advertisements, which should also include prominent information about adverse event report (and consulting the SPC).
Clause 6 now states that no issue of a journal may bear advertising for a particular product on more than two pages.
Clause 7 is the heart of the Code and has been changed to add clarity. Substantiation should now be provided within ten working days. Artwork from published studies must be referenced and faithfully reproduced, and may be modified only to comply with the Code (e.g. taking out an unlicensed medicine or dose). It must also be clearly stated if material has been modified. Care should be taken when using percentages and patient numbers should be included where possible. Under the previous Code it was not permitted to state that a medicine has no side effects, toxic hazard or risks of addiction. The new Code adds that it cannot be stated that a product has no risk of dependence.
Promotional campaigns must encourage the rational use of a medicine. This does not necessarily mean that material must reflect NICE or SMC guidance, as long as the promotion is in accordance with the product's licence. Benefit/risk profile has to be presented in such a way as to com ply with the Code, and this also applies to information for the public. If the data a company is relying on to substantiate their claim is required to be registered in accordance with the Joint Position on Disclosure of Clinical Trial Information, but is not registered, the company will be in breach of the Code.
Clause 9 now includes additional supplementary information advising particular care with regard to the format, size and cost of promotional materials in the first six months after launch. Automated calling systems and other electronic communications have been added to the list of methods of communication which must not be used for promotional purposes without prior permission, i.e. only a letter can be sent to a doctor without prior permission: promotional e-mails and faxes need prior permission.
Clause 10 clarifies the existing Code with regard to disguised promotion. If a company pays for or arranges publication of promotional material in journals, this material must not resemble editorial matter. Also, post-marketing surveillance studies and clinical assessments, etc, must be conducted with primarily a scientific/educational purpose. Under this clause, articles written and produced by a third party, for example the PR agency, but published under a doctor's name, would be in breach of the Code as the material is clearly company produced, i.e. disguised promotion.
Clause 11 requires that quotations are faithfully reproduced, except where modification is needed to comply with the Code, in which case this must be indicated. The precise source must be given.
Clause 12 is modified so that in the first six months following launch a health professional may be sent an initial mailing about the product and no more than three further mailings. They must not receive more than eight mailings per product per year. Mailings solely related to safety are excluded from the above.
Clause 14 deals with certification of material within a pharmaceutical company before use. Under the new Code a practising UK registered pharmacist, under the direction of a medical practitioner, can certify certain promotional materials provided the product/indication has been marketed in the UK for more than a year, if the campaign is not new and novel, and provided the pharmacist has at least one year's experience of working with the product.
Other new requirements under Clause 14 are that certain educational materials relating to diseases and medicines for the public must be certified, as must material relating to working with patient groups, and the provision of medical and educational goods and services (e.g. service implementation, protocols for healthcare professionals). If a company has a strictly 'arm's length' arrangement with a patient group, has no input to the materials and does not use the materials themselves then that material does not have to be certified. The company's involvement with the group must be made clear. However, if the company uses that information on its exhibition stand then it must be certified.
Clause 15 now includes supplementary information spelling out the limits on visits by reps to other prescribers, not just doctors as previously.
Clause 16 has changed considerably. All staff must now be conversant with relevant laws and regulations, and have documented training in pharmacovigilence. This includes third parties retained by contract in relation to the preparation of promotional material or information to the public, i.e. it is the responsibility of the company to ensure all third-parties are up to speed with regard to the Code. If they interact with prescribers, reps must be entered for examination in their first year. Previous exemptions to passing the examination have been deleted.
Clause 18 covers gifts and hospitality. Companies cannot give 'gifts' as an inducement to sell any medicine but can give 'promotional aids'. Items cannot be given for the personal benefit of health professionals. Promotional competitions, quizzes and prizes are no longer permitted. More guidance has been given about promotional items: the perceived value to the recipient must be similar to the limit on the cost to the company of £6 excluding VAT. Prescribing information is not needed on a promotional aid as long as it has no more than the brand name and the company name or the non-proprietary name and company name. Text books can be provided as part of a medical educational goods and services. Clause 18 also includes a new section about the provision of medical and educational goods and services. These must enhance patient care or benefit the NHS whilst maintaining patient care. Switch services are prohibited under the new Code, but therapy review is allowed.
Clause 19 concerns hospitality. This is now limited to appropriate subsistence (meals and drinks), accommodation, registration fees and reasonable travel costs. This clause will now also apply to journalists and patient organisations. Only economy air travel is allowed for delegates sponsored to attend meetings, though speakers are not covered by this requirement. Lavish or deluxe venues cannot be used and venues renowned for their entertainment facilities must be avoided. There is additional guidance on meetings outside the UK, i.e. meetings can be held outside the UK for logistical reasons such as the expertise available.
Clause 20 now covers information to the public about POM products only medicines only - an important change. The supplementary information now defines proactive information provided without a request, e.g. information on diseases, press releases (which should include an SPC), news briefings, mailings etc. Reference information is defined as a comprehensive up-to-date resource for the patient and public to find out more about the product and the disease area, including regulatory information, studies on which the licence was granted, detailed booklets, and NICE submissions, but the package must represent the complete body of evidence for a product (i.e. not leave out a less positive study) and fairly reflect the benefit/risk profile. Reactive information covers requests from the public for information. There is also a framework for working with patient organisations to ensure that the involvement of the company is transparent. Written agreements are needed for ongoing significant activities or ongoing relationships and should set out activities agreed, the level of funding and the approval process.
Clause 21 deals with the internet. Access to promotional material on the internet should ideally be limited to heath professionals. If material is not access-restricted the website must provide information to the public as well as promotion to health professionals, with the sections for each audience separated.
Held on: 01/03/2006