ABPI

New ABPI Code for 2011

pharmafile | July 2, 2010 | News story | Medical Communications, Sales and Marketing ABPI, Code of Practice, nhs partnerships 

New guidance on the way pharma companies should approach marketing themselves to doctors are among the key changes in a proposed new version of the ABPI’s Code of Practice.

The planned revisions to the UK industry’s self-regulatory code come into operation on 1 January 2011, and pharma companies will then have a four-month grace period until the end of April next year during which they cannot be in breach of any new requirements.

The biggest areas of change are around clause 18, which deals with promotion: in the past “promotional aids” could be distributed to health professionals and administrators provided they were “inexpensive and relevant to the practice of their profession or employment”.

But now items likes coffee mugs, calendars and surgical gloves are a complete no-no – instead “medical and educational goods and services which enhance patient care, or benefit the NHS and maintain patient care, can be provided”.

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They cannot be of personal benefit to individuals and cannot bear the name of any medicine – but the new Code will say they could “bear the name of the company providing them”.

In the same section there is also a whole new clause on joint working between one or more pharma companies and health authorities and trusts.

This is “acceptable provided that this is carried out in a manner compatible with the Code” but it must always benefit patients.

A formal written agreement must be in place, with an executive summary of the agreement publicly available before any arrangements are implemented.

Reflecting current practice, the new Code also contains newly-minted clauses on the use of risk sharing agreements and patient access schemes.

Some existing guidance has been firmed up, for instance “companies are encouraged” to publish summary details and results of non-interventional studies of marketed medicines is changed to “companies must” do so.

And other changes amplify existing guidance. For example, the existing Code contains a requirement to make publicly available a list of patient organisations to which a company provides financial support or significant indirect or non-financial support.

Under the new proposals, pharma companies will also have to include the monetary value of this where the value is above £250.

While the revisions are wide-ranging, there still appears to be no appetite for formal change to the Code when it comes to digital marketing.

The PMCPA, the “arm’s length” ABPI body that oversees the Code, has already said that new ‘digital-specific’ clauses will not be introduced.

Part of its reasoning is the expected impact of both the European patient information debate and the MHRA’s ongoing review of UK medicines legislation.

Among the online issues that pharma companies want guidance on is user-generated content, for example whether a company could provide or sponsor websites that include such content.

At present the answer to this is ‘no’, which a lot of pharma companies believe limits their ability to tap into social media.

Adam Hill

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