Friday, April 8, 2011

UK gets social media guidance. Are we next?

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The UK’s Code of Practice regulator has issued guidance on social media and other digital communications tools.

It is the first time an industry regulator has addressed the area so directly and comes ahead of US guidelines from the FDA, which have once-again been delayed. The PMCPA has put together a Q&A document to explain how digital communication fits into its existing regulations. It took this step, rather than amend UK pharma’s self-regulatory Code, because “there have been few complaints about digital communication”.

The Q&A document explains the place of digital communication tools within the existing rules, which ultimately comes down to companies can use digital media if they stick to the Code. It also adds particular emphasis on the Code’s existing ban on promoting prescription-only medicines to the public. “Therefore, pharmaceutical companies need to identify ways of utilising digital communications whilst complying with this restriction."

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The Code of Practice applies to the promotion of medicines to healthcare professionals and to the provision of information about prescription-only medicines to the general public. It covers any kind of communication – from sales rep visits to doctors to public awareness campaigns. The PMCPA’snew Q&A document covers the use of Twitter, blogs, meta data in search engine optimisation, online meetings and linking to non-company websites. It introduces to the Code a “limited new use for [providing] reference information – a proactive use rather than a reactive use”. This is in the context of allowing a company to refer Wikipedia readers to its own information about a medicine via a link to “an appropriate landing page”. The document also notes that digital communication is a developing area and counsels pharma to bear in mind not just the letter of the Code but also the spirit in which it is intended.

Some highlights from the document include:

Can pharma use social media to communicate with healthcare professionals?

This is “very likely” to be seen as promotion under the Code if it covers prescription-only medicines. This would be allowed on social media, as it is in a face-to-face meeting with a sales rep, but companies would have to ensure only healthcare professionals could see the communications and the recipients would need to have agreed to receive the information. Singling out Twitter for special attention the PMCPA said: “Given these restrictions and the character limit on Twitter, it is highly unlikely that the use of this medium to promote prescription-only medicines would meet the requirement of the Code.” It also notes that using Twitter to alert  healthcare professionals about “the publication of a study on a medicine is likely to be considered promotion of that medicines”.

Can pharma use social media to provide information to the public?

“Yes, providing the material complies with the Code – particularly Clause 22.” Clause 22 of the Code deals with relations with the public and the media and includes bars on advertising prescription medicines to the public and responding to individuals’ requests for with medical advice.

Can companies correct Wikipedia articles?

“Simple cross referring to the regulatory documents such as SPCs and PILs either on a company site or to the eMC, would not be considered to be unreasonable.” It suggests a simple “more information is available in the SPC or PIL” is probably better than referring to a particular section of those documents.

A pdf of the Q&A document can be found here.
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