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Is pharma ready and set to move on any potential issue, or is it unknowingly resting on its laurels?

TrackThe pharmaceutical and medical device industries are some of the most regulated industries and also among the most scrutinised by regulators, governments and the media. The industry should be well prepared – having navigated serious adverse events, high-profile therapy withdrawals, scrutiny of marketing practices and other issues. Yet it was only a few years ago that the oil industry was heralded as the master of issue-readiness. In these austere times, any large, profitable corporation needs to be acutely aware of its public image and behaviour. So the question remains, is the industry well prepared or has it become complacent – anaesthetised through the mass production of Q&A documents?

The predicaments pharma faces can be classified into issues of safety and confidence. Although other industries might dread them, pharma is generally well prepared for concerns about the safety of its products and handles these through well-established processes. But the greatest threat to companies comes from issues of confidence – situations where a firm's management is perceived either to make poor decisions or, even worst, be seen to behave unethically.

While an oil firm can plan for an oil leak, can it plan for all the reactions of its potential stakeholders? Companies need to be in a position to make decisions that are right for the organisation and stand the test of public scrutiny. This does not just apply to crises, but also to more slow-burning issues. A company is best prepared when there is a culture of aligning decision-making on issues with its values.

"Though it's not possible to prepare for every potential issue or scenario around an issue, it's critical that companies have a culture of issues awareness and anticipation that extends right through the organisation," says Clive Jones, director of UK corporate affairs, Napp Pharmaceuticals Ltd.

Reputation and behaviour today
What many organisations – and, indeed, many issues plans – struggle to take account of is the instantaneous nature of online information and the fact that all of us are potential digital journalists. While employees, suppliers, friends and family make fantastic corporate advocates, in the event of an issue, they also represent potential opportunities for leaks and informal spokespeople. Some recent examples include employees commenting on Facebook about their potential bed-partners during a mega-merger and co-developer R&D departments criticising each other's practice on an industry blogging page following a negative regulator decision.

Tight controls over employee online access (e.g. software and website blocks) don't constrain the digitally active, though many modern employment contracts have specific clauses around online representation and bringing the company into disrepute. Instead, digitally progressive organisations need to find ways to harness these individuals.

Fiona McMillan, brand communications manager at Bristol-Myers Squibb Ltd said: "The interaction between the digital and traditional media channels is important to recognise and track. Many rumours start online, and many bloggers and Tweeters utilise the online space to comment on and discuss stories that began in the press, and vice versa. Given the new environment, the old approach of 'what we don't know can't harm us' is rightly giving way to an acceptance that online monitoring can act as an early warning system to issues that can be addressed and contained in their earliest stages."

Organisational communications management
So what does the industry need to do to prepare for issues in confidence and issues of safety, and how does it monitor and manage its reputation in today's austere, socially responsible environment? And how do companies ensure that complacency doesn't creep in before the next big crisis? While it's not possible to distil a full issues-preparedness plan into a short article, there are a few key tips to build an issues-aware culture:

1. Monitoring-analysis-preparation-training
Few organisations complete a full cycle of issues preparedness. In addition to on- and offline monitoring, it is important to share internally what is being said and felt – beyond corporate communications and senior management. Scenarios, strategies, messages and communications resources should be developed, reviewed and updated regularly and sense-checked by those in the business. Issues-specific training, including communication skills training and simulations to ensure people understand decision-making and build the right instincts, should be conducted, again with people beyond communications and executives.

2. Understand and engage external stakeholders
In today's multi-stakeholder environment, it is essential to make long-term investments in understanding and building relationships with a range of stakeholders. Clearly, this requires an appropriate investment in developing internal capabilities.

3. Personal versus organisational accountability
In part because of compliance processes or functional responsibilities, a few personnel may be seen as having individual responsibility for potential issues (eg, medical director, R&D heads, senior executives, communications departments). There is a danger that the weight of responsibility and external accountability is seen to be in the hands of one or two individuals. Instead, firms must beware they are not relying on one person as the only corporate face.

4. Openness and control
There are two tendencies for organisations in the event of an issue. Firstly, to say too much too early when facts may still be unclear in an effort to show integrity and to kill the issue off, and secondly, to try to control how the issue is covered and is commented on.

Whatever the truth about what the issue is and the technical details behind it, it is the way it is reported and the way third parties perceive and react that organisations need to prepare for and take action on. A retraction, if it is ever made, often only makes the small print and after the reputational damage has already occurred. There is not necessarily a correct approach and, while the principle of openness is preferable, it is not always appropriate to go to media proactively, and other stakeholders may need to be prioritised for proactive communications.

No organisation can be fully prepared to deal with every issue before it hits, but by seeking to address complacency and going beyond the requirements for regulations and standard operating procedures – companies can seek to manage their communications and navigate issues with their reputation safeguarded.

Be prepared – draw up an issues plan

An example of an effective process is outlined below, though this will vary depending on the organisation.

1.    Have a mechanism in place for early identification of issues and potential triggers
2.    Prepare a process of analysing issues to understand how they evolve
3.    Devise escalation procedures to ensure the right personnel are more aware and appropriately involved
4.    Ensure you have expertise in stakeholder mapping and engagement strategies
5.    Create a process for decision-making to determine the right strategy for managing issues and supporting communications
6.    Ensure effective monitoring of all communications channels and mechanism for sharing internally
7.    Establish a clear process for reviewing communications materials
8.    Devise a plan to equip all personnel involved in external communications with stakeholders, not just media.


The Authors
Sam Barnes
is director and head of the PR Stream at Axon and can be contacted at
Ralph Sutton is managing partner at Axon Communications and can be contacted at

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7th March 2011


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