Healthy Skepticism Library item: 13757

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Publication type: news

The Cost of Code Compliance
PMLive.com 2008 Jun 2
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6772

Full text:

Pharmaceutical companies could face significant restructuring of their policies and processes in light of the new requirements being laid out in the revised Association of the British Pharmaceutical Industry (ABPI) Code of Practice, according to consultant, Steven Gray.

The revised Code will come into effect on July 1, 2008, and will require drug companies to be more open in their transactions and relationships with health professionals and patient groups. Gray, who led a workshop at the King’s Fund in May, has warned that the ‘subtle’ language used in the Code could lead to confusion.

“Careful interpretation is required until we have some Prescription Medicines Code of Practice Authority (PMCPA) cases to help us know what certain phrases mean,” he said. “It says companies should take “reasonable steps” to ensure licensees and partners also comply with the code. What would be reasonable in this case?”

The Code also calls on pharma companies to ensure that patient groups declare all sponsorship on their websites and literature. Gray explained that it is not yet clear whether it will be enough for companies to specify requirements in contracts or if they will need to check all material published by sponsored patient groups.

During the workshop organised by Wellards, a provider of NHS knowledge and e-learning, Gray said that companies might need to undergo big changes to administrative procedure in order to comply with the revised Code. One such example cited by Gray is the creation of detailed contracts fro conference speakers. Under the Code, pharma and speakers, advisory boards or consultants must sign a contract.

“Explaining to speakers why they need to sign detailed contracts where none were needed before will be a key issue for some companies, but an even bigger one is record keeping,” said Gray, who explained that contracts will need to be stored centrally. “Companies will come to different solutions, but they will need to think seriously about this issue.”

To mark the 50th birthday of the ABPI Code of Practice, an awareness week will run in October 2008. It is hoped that it will encourage discussion amongst industry professionals about the Code’s impact on the regulatory environment.