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Ringing the changes

The commercial, financial and ethical implications of the key changes to the ABPI Code of Practice

A large church bellThe ups and downs of a modern marriage are reflected in the relationship between the pharmaceutical industry and its stakeholders: sometimes it's good and sometimes it's bad. The sacrosanct vows made by the industry to behave ethically are now more important than ever in gaining the trust of stakeholders, and so a renewal of these vows will take place at the end of this year when the new Code is published. This Code contains something old, something new, something borrowed and an awful lot of blue (supplementary information, that is).

Extra information was added to existing clauses to make the amendments to the 2008 Code to include EFPIA Code requirements, but some of the amendments to the new Code have seen a complete rewrite of these clauses for the sake of clarity. Other changes have been derived from the ABPI Trust Imperative – one of the four strategic imperatives for the ABPI – which aims to eliminate behaviours that give credit to the perception that the industry inappropriately influences prescribing and which aspires to make the industry more open and honest.

The key amendments are related to promotional aids, the role of pharmacists and trust and transparency.

Promotional aids
The definition and distribution of promotional aids have been limited so that now only healthcare professionals and administrative staff attending meetings (scientific or promotional) can receive inexpensive pens, pencils and notebooks for use at the meeting. These pens, pencils and notebooks are only permitted to display corporate branding.

Although this may seem harsh, many expected a situation akin to that of the US, where non-educational and practice-related items are prohibited altogether. While some believe that promotional aids offer representatives a solid foundation in-call in terms of strategy and key messages, the general feeling is that the 'cleaning up' of promotion is a welcome move. Philip Barnes, head of new channels at AstraZeneca, is keen that "industry [be] linked to useful items and services rather than 'tacky gifts', so that we are valued because we support healthcare professionals to have better interactions with patients and the patient ultimately benefits from this."

Good news then that some items may be forwarded to patients as part of a formal patient support programme; interestingly, these patient-targeted items are permitted to bear the name of a medicine (and/or information about medicines, but only if such detail is essential for the proper use of the item by patients). The specific criteria for establishing a bona fide 'formal patient support programme' are still unclear, however.

Other factors also to consider are the commercial impact of recall and stock destruction, the lack of 'access items' for routine calls and the availability of potentially non-compliant promotional aids at international meetings and exhibition stands.

The role of pharmacists
Previously, there were caveats to the sign-off capacity of pharmacists as final medical signatories and so this resource may not have been fully embraced by many companies. There have also previously been no Code issues in this area and so the new Code expands the role of pharmacists in the sign-off process.

Pharmacists are well versed with laws and ethics and know the importance of ensuring patient safety is paramount in all decisions. It is therefore proposed that material requiring certification must be duly signed by two final signatories, one of whom must be a registered medical practitioner or a practising UK-registered pharmacist; the other is usually a senior commercial leader.

Pharmacists cannot act as medical signatories in some areas, such as educational material for the public, working with patient organisations, patient support programmes, medical and educational goods and services and material related to joint working.

On the whole, however, there are several commercial advantages to having a greater number of final signatories, including faster approval, smaller signatory workloads and more signatory access. This can benefit medics, allowing them to focus more on clinical responsibilities.

In the short term, resource will be required to train a new function to take on an important role with significant accountability. Inexperienced signatories have to learn to deal with pressures and challenges that cannot be taught but must be acquired over time through varied interactions with commercial colleagues. It will be essential for this group to be mentored closely so the new signatories retain commercial awareness throughout their efforts to comply with the Code.

If companies recruit pharmacists instead of medics for financial reasons, there is a real possibility of more UK medics leaving industry or outsourcing their services and may lead to a further influx of European medics with no previous UK Code experience.

In addition, there is a threat of vast numbers of items being approved (which is often seen when process capability is expanded or streamlined). Commercially, it will be important to ensure that the only items generated are in line with business strategy and are actually going to be used.

Trust and transparency
In March 2009, Andrew Witty, chief executive officer of GlaxoSmithKline, commented that: "Trust is all about our permission to trade." Chris Brinsmead, past president of the ABPI, went further, suggesting: "trust is probably the most vital aspect of how we operate."

So what happens when trust breaks down? In its Innovating for Health report, the Royal College of Physicians concluded that a failure of trust between the NHS and the pharmaceutical industry was a critical threat to clinical research in the UK. Indeed the ABPI Trust Imperative examined transparency as an issue heavily involved with trust. Their outputs have shaped new Code amendments around improved transparency when dealing with consultants and sponsored healthcare professionals.

For example, companies must now make publicly available the fees paid to consultants for certain services (such as chairing, speaking, training, advisory boards and so on). Companies must also disclose the financial details of sponsoring healthcare professionals to attend meetings (including registration fees, accommodation and travel).

Eli Lilly became the first major company to provide a detailed list of consultant fees, disclosing $22m in compensation paid to almost 3,400 US healthcare professionals in the first quarter of 2009.

Although the UK pharmaceutical industry has for some time now made public declarations of which patient groups receive funding, in July 2007 a Which? report concluded that not all companies or patient groups are open about either the extent of funding or what it is used for. This makes it difficult for consumers to get a clear picture.

However, the Code now requires published information to include the monetary value of financial support and/or significant indirect/non-financial support provided to a patient organisation with a value to the organisation of £250 or more (excluding VAT).

In written agreements with consultants, companies must include provisions regarding the obligation of the consultant to declare his relationship when writing or speaking about this or any other subject relating to that company. For those actually implementing, advising on and auditing this area, many answers will need to be prepared for questions such as: how will this 'obligation' be worded in a consultancy agreement? How will the company seek reassurance of this declaration? What are the consequences should a declaration not be made?

Professor Simon Chapman, a professor of public health at the University of Sydney, has observed that: "The risks of odium associated with declaring competing interests have become such that many researchers are now intimidated into refusing industry engagement."

But he compares healthcare professionals disengaging with the industry to "dieticians refusing to have anything to do with the food industry which supplies almost all of the very items that dieticians urge be consumed more" and concludes this to be a 'peculiar kind of hypocrisy'.

Companies have always been slightly nervous about 'dictating' to an esteemed opinion leader, adopting at times a traditional mentality because the consultant is more importantly a customer and the customer is always right. However, patients, the medical community and indeed the industry itself are crying out for improved transparency and so the extent and timing of this proposal are appropriate.

Second honeymoon
So when the vows are renewed and the Code is implemented, it seems that it will be received well.

Chris Brinsmead commented: "The new Code demonstrates an evolution based on what our customers and ABPI members tell us is important."

The industry self-regulates and it, along with others, has made a significant contribution to the changes — confirmation, then, that the 2011 Code will reflect what the industry wants and not just what it needs.

The Author
Rina Newton
is managing director of CompliMed

14th December 2010

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