To support increasing regulatory pressures and to achieve good governance, organisations must tighten up their marketing approvals processes says Andrew Yates, EMEA Managing Director for Enterprise Marketing Management (EMM) leader, Aprimo.

Never has it been such an exciting time for the marketing profession with the proliferation of channels and opportunities to target and touch so many customers. Conversely, never has it been such a demanding, frustrating and difficult time for the marketer as regulations get tighter. Breaching these regulations can not only have a damning effect on the brand as a whole, but also the marketing department and its internal credibility.

In the first quarter of 2006 Eli Lilly was reprimanded in the UK by The Medicines and Healthcare products Regulatory Agency (MHRA) for producing a professional advice leaflet*1 for doctors that failed to mention the potential side effects of its drugs. The company had also failed to reveal that it had written and paid for the leaflet - which it had sponsored and produced on behalf of the charity, Diabetes UK.
When questioned about the incident, an Eli Lilly spokesperson was reported to have said, “That’s an oversight from Lilly – we do have processes in place to pick up on this sort of thing but that didn’t happen in this instance.”*2
This example highlights the importance of maintaining good governance and rigorous processes for reviewing, approving and tracking materials produced by the marketing department.

Regulatory pressures

The marketing department, and materials it produces, is under more and more scrutiny with the instigation of specific regulations. For example, the US Food and Drug Administration’s (FDA’s) 21 CFR Part 11, requires organisations to demonstrate that marketing materials have been properly reviewed and approved by the required departments within the organisation. And the UK Financial Services Authority (FSA) has similar regulations relating to the marketing of financial products.

Yes, we must all comply with regulations set out by governing bodies, the penalties if we don’t can be crippling. But quite apart from the importance of complying with regulations, it is also important to avoid errors and inaccuracies in marketing literature because they can be potentially damaging and costly to the brand.

Having said this, many organisations still rely on manual, paper-based approval systems for reviewing and approving marketing materials. Hardcopies of draft materials are sent to the representatives from the various departments – the corporate, marketing, regulatory and legal - to review and approve. Constituents are asked to provide feedback and amendments and to provide a handwritten signature to verify that they have reviewed the content. Often, a reviewer will need to reference other documents when conducting the review, these references must be recorded in a robust fashion to ensure the route to approval is fully documented.

Manual processes slow and cumbersome

Such manual processes can be extremely slow and cumbersome and, with so many people involved, there can sometimes be difficulties in ensuring that constituents are reviewing the most up to date version of a document. Moreover with many constituents incorporating notes, checklists, amendments and external references in a lengthy approval process, it is not impossible for errors to creep in.

An alternative method adopted by some organisations is to arrange regular face-to-face compliance meetings during which the constituents who need to approve materials are all present in one place. But with today’s geographically dispersed management teams and busy schedules it is not always easy to bring all the necessary people together. And as organisations look to reduce the cycle time, reliance solely on these meetings creates a challenge to delivering marketing materials faster.

Digital approvals are fast and efficient

Recognising the inherent difficulties of manual systems, organizations in many industry sectors are turning to digital approval systems which are designed to provide a faster, more efficient alternative. Many of these systems, which automate much of the process, are specifically designed to comply with industry regulations as well as to speed up the approval cycle.

At the core of most digital systems is a computerised workflow chain which can be configured to systematically present the unapproved materials – in digital format - to the required constituents. For security and confidentiality purposes, the constituents may be required to log onto a secure online portal where they can view the materials and are given the facility to incorporate annotations, comments and references to external documents.

At the close of the process the constituents sign a checklist using a digital signature to confirm their approval.

The system ensures that the most up-to-date version – incorporating any recent annotations and references from other constituents - is presented to the next person in the approval chain. If someone in the chain fails to view the materials within a predefined timeframe, the system can be configured to move on to the next person in the chain or to fire an alert to whoever is managing the process.

By maintaining version control and retaining full electronic audit trails of previous versions histories, including constituents’ comments and annotations along with corresponding electronic signatures, digital approval systems can help to reduce errors. They can also speed up the process and generate the necessary documentation for regulatory compliance.

Peace of mind

The story does not end there. Digital systems can be set up to provide an ongoing check by automatically alerting the marketing department when a piece of current marketing collateral is due to be reviewed again. Peace of mind for marketing, compliance and legal departments!

A case in point : Bringing auditable process and discipline to marketing

One organisation reaping the rewards of a digital approval system is Skandia UK Group. Skandia is part of Old Mutual Group, one of the top seven insurance companies in Europe. In the UK, Skandia UK Group is one of the country’s top ten life and pensions companies and one of the largest fund ‘supermarkets’. Managing approximately £5 billion of assets, it employs 2000 people and operates internationally, providing 80 products, supported in eight languages, which it sells exclusively through intermediaries.

The company’s marketing communications department employs 50 people working on the full gamut of marcoms activity from advertising and email shots to web sites, newsletters, product marketing literature and PR. It manages and maintains approximately 900 pieces of print and its in-house studio records show 2,400 different design and production jobs over the course of a year.

Skandia has implemented a digital approvals system from Aprimo to define and maintain clear auditable processes for the creation and approval of every piece of marketing literature. Its processes had to demonstrate compliance with the stringent regulations laid down by the UK Financial Services Authority (FSA).

The results have exceeded Skandia’s expectations as Giles Elliott, Head of Marketing explained: “The compliance department loves the system. It provides 100 per cent of the audit information required by the FSA. Our marketing approval process now facilitates controlled comments across a broader community within the company than we ever imagined. And has really helped us get to grips with accurately tracking and allocating spend. EMM has helped marketing raise its credibility at the executive level.”

By Andrew Yates

Phone: +44 (0)118 977 9700
Email: Andrew.Yates@aprimo.com

*¹ Source - Financial Times, 15 February 2006
The Medicines and Healthcare products Regulatory Agency forced Eli Lilly to withdraw a leaflet providing advice to doctors that it wrote and sponsored on behalf of the charity Diabetes UK. Eli Lilly was accused of misleading patients by not showing that it had written and paid for the leaflet, which carried only the Diabetes UK logo. It was also criticised for not highlighting the risk to patients of hyperglycaemia and diabetes when taking schizophrenia medicines including Eli Lilly’s drug Zyprexa, which generated $4.2bn (£2.4bn) in sales last year.

*² Source - PMLive.Com, 15 February 2006