Are you ready for 1 May?

Review of the new ABPI Code

By 1st May 2011, all activities and materials must be compliant with the latest edition of the ABPI Code of Practice for the Pharmaceutical Industry (other than the requirements that come into operation in 2012/13). Do you fully understand the implications of the most recent changes to the Code? Do you know how the changes affect the use of promotional material? Do you understand the changes required to your standard operating procedures? This PM Society Meeting, held at Church House, London, discussed the implications of the key changes to the Code, as well as providing delegates with the opportunity of asking questions during a lively Q+A session. 


What is changing in 2011?

After welcoming everyone on behalf of the PM Society, Committee member Steve Gray (Managing Director of Compliance Hub) began with the fundamental question: Are you ready for 1st May? While in reality the changes to the Code are relatively minor compared to other changes going on in healthcare, there are some fundamental paradigm shifts in the new Code. And Steve stressed that as an industry we should never forget that it is the pharmaceutical industry's Code – we write it, and we all have a say in how it is shaped.

Over the last few years there have been many complaints about the way the industry inappropriately influences prescribing and, even though as an industry Pharma works to very high standards, there is still criticism. Most recently the publication Innovating for Health, a joint report on the industry's influence from the Royal College of Physicians, academia and industry, has driven much of the thinking in the new Code, and feedback shows that many organisations welcome the changes.

The Code is live now, but it must be fully in place by 1st May. Summarising the changes, Steve outlined that:

• Branded promotional aids are now banned
• Patient support items are now formally incorporated in the Code
• There is more about joint working
• There must be transparency and clear documentation so Pharma must declare levels of expenditure on grants to organisations, travel grants and registrations at congresses for sponsored individuals, and payments to and expenses for consultants (both health professionals and administration staff). There are longer implementation dates for some of these changes

Medical educational goods and services (MEGS)
MEGS are provided to the NHS by pharmaceutical companies, though companies badge them in different ways. The new Code prohibits branded promotional aids to doctors, nurses and pharmacists. This also means that the industry cannot advertise in diaries, and cannot give out diaries or data sticks to individual health professionals. However, the industry can give out pens and pads for use at meetings. Data sticks are not in fact banned as an item, so information can be provided to customers on a data stick, but the data stick itself must be incidental, and its size has to be relative to the size of the data it contains (so no 20 GB data stick for a 6KB file).

MEGS cannot now be given to individuals. This means a textbook, or support for printing for example, can be provided but they must be for the healthcare organisation, i.e. the GP practice rather than the individual GP.

Literature however does not come under MEGS, so information about disease area and product can be given out. But a number of questions do arise. What is the difference between literature and a small book? When does a book become MEGS rather than literature and then require a written agreement? Can you give a practice with six GPs six books? Where does everything that was previously signed off as promotional aids (under £6) but which served a very useful purpose fit now, e.g. anatomical models? And what about apps?

Steve went on to stress that the fundamental shift is that now industry must be seen to support the development of patient care. As part of a formal patient support programme the industry can provide literature that helps patients understand the disease area and the product, and that will help them continue with their treatment. Technically this means deciding exactly what the patient support programme comprises, and writing it up in a job bag. Currently the Code only notes that patient support programmes exist, however, and that items can be given out as part of these programmes. In Steve's view, it will take time to work out the defined rules around patient support programmes.

The Code does list the kind of items involved in patient support, e.g. peak flow meters and pedometers. These items are for health professionals to pass to patients and items cannot carry product names (though the brand name can be included for safety reasons). Technically these items are promotional aids, so still need to be under £6 in value. Questions therefore arise as to what items are acceptable. As long as an item can be justified in the interest of patient care, and is valued under £6, the Code allows scope for flexibility and a wide range of items could be included.

Regarding exhibition stands, the Code now states that these:

• Cannot include pens and pads
• Cannot distribute patient items, though display copies are allowed
• Literature can be included but not quizzes

For Steve, the challenge now is how to make an exhibition stand interesting when potentially all you have to distribute is literature.

Promotional material
Very little has changed in the Code regarding promotional material and promotional claims. Two things have shifted however. There was already some confusion as to what should be included and what could be omitted from abbreviated advertisements, e.g. the exact size of the black triangle. The Code now clarifies that abbreviated advertisements should not contain marketing authorisation numbers or references, and should not normally contain dosage particulars, details of pack sizes or cost.

There are also changes around relative and absolute risk. It can be misleading to talk only about relative risk so the Code now requires that, in the context of outcome data, relative risk should never be referred to without also declaring the absolute risk, though the absolute risk can be talked about in isolation. The challenge is that previously many clinical papers did not state the absolute risk.

With regard to digital marketing, technology changes so quickly. When the Code was first drafted iPad 1 did not exist, now there is iPad 2. Digital marketing is therefore very much still on the agenda for the Code to address. One thing has changed in the latest Code however. There have always been rules requiring permission to be obtained from the recipient before they can receive a promotional e-mail. Now recipients need to have an opt out, so there must be an 'unsubscribe' facility.

Transparency
On the topic of transparency, the Code has been clarified so that if the industry sponsors anything to do with human health or disease then the Pharma company's involvement must be declared. Also, the wording of the declaration has to be unambiguous so the reader is immediately aware of the true extent and nature of the Pharma company's influence. For example, did the company just pay for the printing, or did they pay the speakers and the authors?

By 2013, industry must declare the total costs in the previous year for sponsoring delegates to attend meetings organized by third parties including registration fees, overseas travel, and accommodation. Total donations to healthcare organisations must also be declared. Pharmaceutical companies must make publicly available details of fees paid to consultants in the UK for certain services such as chairing and speaking at meetings, participation in advisory boards, etc.  The total amount paid in a calendar year and the number of consultants must be disclosed.  There is no requirement to name individuals. These rules do not just cover money spent by the UK Pharma company, but money spent in the UK by the global team. Putting all this information together will require quite a logistical exercise.

It is already necessary to declare involvement with patient groups, and from 1st May 2011 companies will be required to declare specifically how much money groups are given and/or significant indirect non-financial support with a value of £250 per project or more. This must be listed in detail on the Pharma company's website.

Joint working
Joint working was first covered in the 2008 Code. The 2011 Code includes much more information. Joint working is defined by the Department of Health where, for the benefit of patients, one or more pharmaceutical companies and the NHS pool skills, experience and/or resources for the joint development and implementation of patient centered projects and share a commitment to successful delivery.

Basically, the Code now stipulates that all those participating have to put something on the table in terms of resource. It also states that a project has to be genuinely about benefits for patients and that outcomes must be measured. An executive summary of the agreement must be made publicly available before arrangements are implemented. In addition, there must always be a formal written agreement.

Joint working provides a massive opportunity for projects that can genuinely shift patient care forwards, but with the scope for flexibility, in Steve's view. It is not about sponsorship or providing financial grants and a pharmaceutical company can be upfront about expecting a return on its investment. 


Amendments to the ABPI Code in more detail

Heather Simmonds, Director of the PMCPA (Prescription Medicines Code of Practice Authority), began by noting that the Code of Practice has gone through many versions, indeed it is rather like painting the Forth Bridge. Feedback is always useful in making changes, and there has been extensive consultation within the industry and outside (and via the website), always with the aim of making the Code better. There is always a danger of talking the industry down, in Heather's view, when in fact in the UK perception of the industry's reputation is good.  Codes of practice are seen as the means of improving the reputation of the industry. The European Federation of Pharmaceutical Industries and Associations (EFPIA), whose President is Andrew Whitty of GSK, is now very much working on improving the industry's reputation via codes of practice.

The 2011 ABPI Code of Practice was agreed in November 2010, with changes to three main areas (full details available on the PMCPA website as a downloadable PowerPoint presentation):

• Increased transparency. The UK industry gets a lot of credit for its self-regulatory system because it is so transparent. But there is also a responsibility on health professionals to be more transparent.
• Joint working is now covered in more detail.
• The issue of branded promotional aids has been discussed extensively, with a decision to cease their use and move away from the previous perceived transactional relationship.

Branded promotional aids
For promotional aids the focus of the 2011 Code has been on a pragmatic solution, with the emphasis on patient benefit. As Steve already outlined, the main changes (Clause 18) are that:

• Branded promotional aids for health professionals are no longer permitted.
• However, pens and pads (total cost no more than £6 excluding VAT) can be given to health professionals and appropriate administration staff attending scientific meetings and conferences and promotional meetings.
• Pads and pens cannot bear a brand name but can have a company name.
• Pens and pads cannot be provided by representatives calling on health professionals.
• Items can be supplied for health professionals to pass to patients as part of a formal patient support programme. They should cost no more than £6 excluding VAT.
• Patient support items may be made available for health professionals to use when the purpose is to allow patients to gain experience in using their medicines, while under the supervision of a health professional.

Exhibition stands, meetings and hospitality
Changes to Clause 18.1 of the Code include what can be given out from exhibition stands, and also the whole area of meetings and hospitality. There has been a view that more could be done to increase the focus on genuine education and information sharing, and that exhibition stands should not be a means for health professionals to stock up on stationery. The intention of the changes to the Code is that the educational content should attract people to a stand, not anything else. Examples can be displayed, but quizzes cannot be conducted from stands, though a non-promotional quiz can be used at promotional meetings to check knowledge. EFPIA is also looking at this issue in relation to European meetings.

Clause 20.2 covers the use of consultants. The industry must declare fees paid to consultants in the UK for services such as speaking at meetings, participation in advisory boards etc. In 2013 certain payments made in 2012 must be disclosed (total amount and number of consultants). There has been discussion about how the health professionals' codes etc could include more transparent practices with regard to payment. For market research and accommodation and travel payments (Clause 20.3) 2013 payments will need to be disclosed.

As for meetings (Clause 19), the RCP report Innovating for health wanted pharmaceutical industry support for continuing professional development to stop, but it has now been recognised that the industry has a role in providing education. It is important that the requirements of the Code are more widely understood as these answer many of the criticisms regarding the role of industry in such activities. The education must be the prime attraction for attendance. In 2013 the Code will require declaration of registration fees paid by pharmaceutical companies in 2012 for health professionals to attend meetings organised by third parties. Costs of accommodation and travel will also have to be declared. 

For patient organisations (Clause 23.7), while in the UK the Code requires declaration of monetary support over £250, EFPIA is looking at everything having to be declared, whatever the value.

Joint working
With regard to joint working (Clause 18.5), covered in more detail by Steve above, Heather believes this area is a good demonstration of how the Code has evolved. There have been very few complaints about joint working, though there have been many enquiries and clearly there have been some difficulties related to getting approval in multi-company projects.

Reputation
The ABPI Trust Imperative has been doing interesting work with the Reputation Institute looking at drivers for reputation. The plan is to address the gaps between industry scores on drivers of reputation and the importance of each driver to stakeholders (the general public and healthcare professionals). As a result of this research the Code is seen as very important in relation to the healthcare professionals' perception of reputation.

Digital marketing
With regard to digital marketing Heather stressed that the PMCPA is anxious to help in this area, but cannot fully understand the issues unless industry asks questions. Heather's bête noir is why companies are reluctant to do what they can do under the 2011 Code? What it is that companies want to do that they cannot do now? Another issue is the impact of the proposed EU Directive on information to patients, The UK actually is one of the easier countries in which to provide information to the public about prescription only medicines – in some other European countries they assume everything a Pharma company does is for a promotional purpose so no information can be provided.

Heather conceded that technology has moved on quickly, but just because technology is new it does not necessarily mean it is not covered by the existing Code. The Code applies to communication, as a whole so in principle there is no element of communication that is not covered by the existing Code. Heather's advice is to look at what can actually be done. The MHRA is supportive of the industry's role in providing information that meets the requirements of the Code.

The reason the 2011 Code does not include anything specifically relating to digital activity is that as yet there have not been many cases. It was felt the better way forward was instead to produce guidance to include Q&As. This was the approach taken with the Internet and that guidance was eventually included in the Code of Practice. [Since the meeting the PMCPA has published on its website guidance on digital communication.]

Horizon scanning – the challenges
The MHRA is consolidating and reviewing all the medicines legislation in the UK and this may mean that changes will be required to the Code. Certain EFPIA decisions will also impinge on the Code and might require changes. 'Code awareness week' (4-8 April) aims to ensure that health professionals are aware of the Code and understand it, both in terms of the requirements for pharmaceutical companies and also as it applies to health professionals.

Heather outlined that there have been concerns about the impact of the Bribery Act 2010. It has far-reaching implications for pharmaceutical companies, particularly when employing third-party agents. The Act is due to come into operation shortly. The PMCPA, ABPI and the Serious Fraud Office (SFO) have agreed a Memorandum of Understanding, which will be published shortly.  The ABPI hopes to publish some example scenarios.

Heather closed by mentioning that the PMCPA is currently putting together an E-learning module for health professionals on the Code of Practice which will be available via the PMCPA website.


Talking points

A detailed discussion followed.  The PMCPA can give informal guidance only and in the event of a complaint being received it would be dealt with in the usual way.

Data sticks
On the topic of data sticks, Heather confirmed that the Code states that their storage capacity must be commensurate with the amount of data to be stored. The spirit of the Code is not to hand out free memory sticks for health professionals' personal use, but the PMCPA is prepared to be reasonable on this. Currently the Code only covers the amount of information that can be stored on a memory stick. Heather's view is it would not be in breach of the Code to print the company name on the memory stick. As to whether the name of a meeting could go on a memory stick containing data from that meeting, or whether a memory stick can carry the name of a medicine if it contains a slide set about that medicine, Heather noted that the Code does not cover this point but given that no promotional aids can bear the name of any medicine it would be best not to print any information in that regard on the actual data sticks.

Heather was also asked whether promotional and non-promotional (i.e. patient) material could be stored on the same data stick. She stressed that while this is not necessarily in contravention of the Code, it would be necessary to give clear instructions to the health professional as to the intended audience for each piece of material. Rather than distributing memory sticks Heather suggested referring health professionals to a secure website instead. Steve Gray stressed that, in his view, if the company gives the information to the doctor to give to the patient, then the Pharma client (i.e. the doctor) is responsible, whereas the company is solely responsible for data on any website. He added that memory sticks are clearly a grey area, and more guidance is required. Heather's view is that material provided to a health professional by a pharmaceutical company for passing to patients is the responsibility of the pharmaceutical company.

Patient support items
Clause 18.2 allows a company name to appear on patient support items such as a peak flow meter. The Code also required material sponsored by a pharmaceutical company to clearly indicate such sponsorship.

Gifts and promotional aids
Heather was asked if there is a difference between products and educational literature and whether both are still allowed. Also, does educational literature need to be part of a patient support programme? Heather noted that it is assumed that any material for a health professional has to meet the requirements for promotional material under the Code. For product-specific material for the health professional to give to the patient on a company's medicine the health professional must be clearly instructed to give the material only to those patients on the medicine (i.e. not to put it in the waiting room). The provision of patient material to a health professional to pass on to the patient is likely to be seen as a promotional activity and thus prescribing information has to be included for the health professional. It should not be included in the patient material as this has to be non promotional.

Relative and absolute risk
Heather was asked whether relative and absolute risk have to be given equal weight in any literature, and whether there is any guidance on how absolute risk should be presented, e.g. are footnotes acceptable, and what happens if a clinical paper does not include the absolute risk? She noted that often the bad news is presented as absolute risk and the good news as relative risk, exaggerating the differences between them. Clearly it is about people understanding the absolute risk, in Heather's view, and putting the relative risk in context. The relative and absolute risk could be given neatly in one sentence. If the calculation for the absolute risk was never done in the original scientific paper it might be difficult to send this out unsolicited (Clause 10.1 refers).

Patient websites
Regarding websites associated with patient support programmes, it was pointed out that these may be subsets of a bigger website, and Heather was asked whether this patient section needs to be access controlled, say via a password or pack batch number, or whether can it be 'open' access. Heather confirmed that Clause 24 of the Code allows open access if the general website has sections clearly labelled for the public and the health professional. As there is no mention of websites for patients on the company's medicines, Heather advises that it is probably a good idea to restrict access. Allowing a member of the public who was not taking the relevant medicine to see this section of a website might be viewed as promoting or stimulating demand for that particular medicine. For that reason it is probably better to password protect, then the company will have a good defence against accusations of promoting to the public. Heather also stressed that it is best to put all reference information on the website (supplementary information to Clause 22.2), noting that the amount of information that can be included as references on a website is enormous, yet very few companies use this option.

Declaring relationships
Asked how a Pharma company, a creative agency, and a patient group working together on non-branded patient education material should be declared Heather stressed that all the certification requirements would apply and there would need to be a written agreement to declare the interaction. The important point is that a Pharma company cannot get an agency to do something on their behalf that they cannot do themselves. Heather felt it is always best to declare all relationships so that people cannot be misled as to what the interactions are.

Payments to individuals
Thinking about different ways that Pharma companies sponsor individuals, Heather was asked how far a company needs to go when declaring its involvement with an individual whose post is funded for by the Pharma company and who then speaks for the company at a sponsored meeting or advisory board. Her view was that first the company would have to declare the payment to the organisation employing the individual (Clause 18.6) and if that individual then agreed to provide additional services to the pharmaceutical company these would also have to be declared under the consultancy agreements covered by Clause 20 of the Code.

Transparency declarations
Heather confirmed that there is no defined format for the 2013 declaration of payments made in 2012, though there has been discussion as to what would be appropriate. As long as the Code is followed and everything is declared that needs to be and can be easily understood, format does not matter.

Transparency declarations should cover pharmaceutical companies sponsoring health professionals or organisations ? it is not about agencies employed by a company to prepare a detail aid. However the Code does cover employing an agency to get doctors to attend an advisory board. Then the payment to the health professional or administrative staff (e.g. finance people on PCTs) should be declared, but not the payment to the agency.

Heather confirmed that the Code requires that the company to declare the total amount it has paid to all those employed as speakers (as well as providers of certain other services) and the number employed. The company does not have to name individuals, or how much they have been paid individually. There are requirements in the Code as to how companies select these people, for example they must be able to deliver the service, and choosing them should not be an inducement to prescribe. They should also be paid a fee commensurate with the work they have done. Steve Gray noted that the device industry has similar rules regarding interaction with health professionals and their payment, but they have never had a published Code case and are a long way behind the way the PMCPA works.

Steve also noted that some pharmaceutical companies monitor internally how much it pays each individual health professional so it never has to explain why Dr Smith drives a Lamborghini and just happens to be a big prescriber of its product.

On accommodation and travel, Heather outlined that this is an area of interest externally – the industry has been criticised in the past for flying doctors round the world to meetings at expensive hotels and this one of the reasons that the new transparency requirements were added to the Code.

Adverse event monitoring
Asked whether a pharmaceutical company is responsible for following up all the adverse event reports on websites that it sponsors Heather stressed that if a company becomes aware of an adverse event, it must have procedures in place to ensure that its pharmacovigilance experts are informed and whether the event also needs to be reported to the MHRA.

Steve Gray added that this is an example of where the Code overlaps with other legislation and there is only so much that sits within one remit. Guidance from the MHRA's pharmacovigilance unit implied that the MHRA had taken advice from government lawyers that stated that while the pharmaceutical company must follow up adverse event reports on its own sites, and those it becomes aware of from third-party sites, there was no obligation to monitor the entire Internet.

It was pointed out by Steve that if a company has sponsored a site, say for a patient group, the contract generally specified that the hosts should monitor for safety issues, and that they would be notified of any discussion about their medicine.

MEGS
On the question of anatomical models Heather confirmed they can be given out as medical items and do not necessarily require a written agreement, but cannot be given to individuals for personal benefit.  Steve noted that in the context of Clause 18.4 it would be in order to give an anatomical model or a large textbook by giving written briefing instructions, which make clear that it is for the practice and not for the individual. As such, it does not necessarily need to be signed for. However companies are worried about this. Heather confirmed there have been a lot of questions on this, including those at this meeting, and she will look at publishing Q&As on this and other areas in more detail.


Apps and iPads
Steve Gray raised the question of whether apps are literature, software, gifts, or patient items. Heather stressed apps are a classic case of 'it depends'. Each app has to be assessed as to what it is used for, how people obtain it, and its benefit to patients. Heather confirmed that an electronic diary app to detail symptoms could be given away as part of a patient support programme.

Another question is when an app for a health professional becomes a medical device. A cardboard cut-out with a window to calculate the dose of a medicine based on a patient's weight would, in some people's view, become a medical device if provided as an app or on an iPad. Heather stressed that it is useful to have tangible examples such as this, and asked that people let her know of similar situations. She will then raise these issues with the MHRA, noting that the industry would clearly prefer these to be regarded similarly to paper items rather than as devices.

Regarding iPad details (which do not work in the same way as a website) Heather was asked what length the pathway can be between the mention of the product and the references and the prescribing information. Steve Gray noted that in the context of a website for a medical journal the PI might be part of the same server as the journal, or it may be on the pharmaceutical company's own website, which would mean that you might be able to read an advertisement in the journal but if the company website goes down, the PI is lost. Heather agreed this would probably be an issue. Under Clause 4.6 of the Code an advertisement included in an independently produced electronic journal must have a direct link between the first page of the advertisement and the PI. In Heather's view this covers the iPad, which should still have a reference to the PI on each section of any advertisement.
 
Joint working
Heather confirmed that one issue that comes up consistently is the overlap between joint working, grants and sponsorship. In Heather's view it comes down to the commitment from the NHS to the pooling of resources, i.e. the NHS must make a significant contribution for a project to constitute joint working. There are examples on the ABPI and DOH website of ongoing joint working projects. Steve highlighted that different companies are approaching joint working in different ways.

Giveaways
Given that the new Code states 'no giveaways' Heather noted that under the Code a company could make a complaint about another company flouting the rules. She stressed that the Code is a commitment that the whole industry is signed up to.

Meeting close
Heather concluded that making the Code work is a real test for the industry.  The changes were agreed by ABPI member companies and in order to maintain credibility in the future, the industry has to deliver.

Held on: 23/03/2011