During August 2011, the European Medicines Agency (EMA) made an announcement that they intend to open to the public the information that is currently held in their EudraVigilance and EudraVigilance Veterinary databases. Since launching in 2001, EudraVigilance has provided a mechanism for a variety of stakeholders to report suspected unexpected serious adverse reactions (SUSARs) which occur during clinical trials.
Open data for all
In a move which echoes other recent global ‘transparency’ initiatives (including various world governments producing open data repositories – see list here), a new and unprecedented level of medicinal product information will soon be available to anyone with an Internet connection.
Combined with the rise of the so-called ‘e-Patient’, an informed and empowered individual who wants to actively engage in their own health care, this announcement will mean new awareness of granular detail about the efficacy and potential side effects of pharmaceutical products; ordinarily confined to industry insiders, or aggregated and simplified for patient literature offline and online.
Not all of the data will initially be available to the extent of other open data stores, however the EMA have adopted a phased approach which commences with a monthly report that will simply summarize all of the information held in EudraVigilance. This level of information provision may be akin to the Food and Drug Administration (FDA)’s MedWatch data, which is similarly provided in report form for both the ‘Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)’ quarterly reports, and for the ‘Adverse Event Reporting System (AERS) Statistics’ yearly reports.
By 2012 it is expected that the EMA EudraVigilance database will also have a capability for ‘searchable’ reports and within the following few years, a more customisable interrogation:
“The Agency plans to make further improvements to the search and data-output functions and to supply the pharmaceutical industry with access to tools allowing the detection and analysis of signals on adverse reactions to human medicines by 2015, subject to budget being available.”
The ‘Transparency’ trend
So why has the EMA taken this position? Aside from their objective of ‘protecting public health’, another stated key driver is apparently to ‘increase its levels of transparency’ whilst maintaining protection of personal data in accordance with European Union legislation.
This concept of ‘transparency’ is becoming very important for all sorts of brands operating in such a hyper-connected world. The now infamous ‘WikiLeaks’ project stunned the world when it made available various corporate and government communications which ordinarily would remain confidential. Add to this the ‘rise and rise’ of social media conversational engagement and you have a significant paradigm shift for pharmaceutical companies in addressing the kinds of questions and crowd interrogation which can happen in a public (always on, forever archived) forum.
Several companies have found that adapting to this real-time, participatory health ecosystem is challenging established organisational protocols and procedures.
Yet these are trends which simply will not reverse or revert to the way things once were. The proverbial ‘genie is out of the bottle’, and it has somewhat ‘left the building’.
Now is the time to prepare.
Developing trust and transparency
It is of course so easy to speak of ‘trust’ or ‘transparency’, but what do they really mean?
Without trying to define them literally, we should all know that trust in a relationship is earned through openness, frequent communication, and through communication which is reciprocal; that is listening and responding. It is earned by not keeping secrets, or even behaving secretively (even when there is no secret).
To earnestly embrace this new landscape and to take advantage of the trends, we need to look at developing a proactive offensive strategy to earn trust by ‘giving’ in the online relationship; to give more than simply information; to give support; to give consistently; and to give without expecting anything in return. These are fundamentals of a strong relationship. It also helps to have some personality, rather than a bland corporate face.
Personality is not something can be easily quantified, but it is certainly something that as humans we are innately able to detect and assess. I sometimes talk with company leaders about the ‘online personality’ of their brand; that is, how the company ‘comes across’ to the individuals and masses that are interested in engaging with them?
Transparency and openness should really be a competitive advantage, supported by an appropriate engagement strategy. Achieving this requires more than simply budget; it requires a corporate commitment and a clear plan for how you will enact on the promise of trust.
A wise man once developed a concise phrase to describe one such strategy, which simply says:
“If you tell the truth, you don’t have to remember anything.”- Mark Twain
So here is a challenge for those readers of the Healthcare Engagement Strategy e-Journal that are still thinking there may be something to all of this:
“Take some time and assess your own perception of your company’s personality online, then ask others whether they see the brand in the same way that you do, and find out whether there are constructive areas where the personality could be improved. This simple act will in itself begin the process of building trust and openness”
It is easier said than done, but I can’t help thinking that whoever truly embraces a strategy for developing trust and transparency in this new age will reap the benefits of the resulting positive online engagement.
Image credit: http://www.sxc.hu/profile/davedufour
Creation Healthcare believes that there are many opportunities for developing trust and transparency online. To speak with a member of our consultant team, please contact us now and we will be pleased to further understand the challenges that you may be facing in your organisation.
If you are a business leader or communicator in healthcare, you can also get your free subscription to the Healthcare Engagement Strategy e-Journal at http://engagementstrategy.tv/
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