Regulatory Focus™ > News Articles > New Rules to Voluntarily Restrict Prescription Drug and Device Marketing in Ireland

New Rules to Voluntarily Restrict Prescription Drug and Device Marketing in Ireland

Posted 12 October 2012 | By Alexander Gaffney, RAC

Pharmaceutical and medical devices industries doing business in Ireland may soon find it more difficult to market their products under new guidance developed by the Irish Medical Council aimed at redefining the terms of acceptable conduct between doctors and members of industry.

The guidance, a supplement to earlier guidance on the same topic, is specifically aimed at reducing real or perceived conflicts of interest, the majority of which are caused by gifts and other payments given to physicians and prescribers by the pharmaceutical and medical device industries.

"The public need to be confident that their doctor's professional opinion is not influenced by marketing or promotional activities," said Kieran Murphy, president of the Irish Medical Council, in a statement. "This supplementary guidance provides clarification for both the medical profession and patients on the standards expected of doctors in their dealings with the pharmaceutical and medical device industries." 

In a separate document released to physicians, the Medical Council clarifies that doctors should no longer accept gifts, including the gift of hospitality, from industry.

"The Medical Council advises doctors not to accept direct hospitality from pharmaceutical, medical devices or other commercial companies so that their professional judgment is not affected by the hospitality," they said.

These "hospitality" sessions commonly include continuing medical education (CME), which are often used to promote a particular product. Such promotions may be unbalanced, and the council warned doctors "not to rely solely on promotional literature," and to instead refer to independent and evidence-based advice before prescribing.

Even low-value gifts may have the effect of influencing prescriber behavior and should be strongly discouraged, notes the council. Doctors may, however, accept "reasonable fees" for work done on behalf of companies.

Another recommendation impacts physicians involved in regulated clinical trials.

"Doctors have a responsibility to make sure their work is not influenced in any way as a result of sponsorship or any other relationship with a pharmaceutical, medical devices or other commercial company," the council wrote.

This is particularly important if a doctor is involved in conducting a clinical trial on behalf of a particular company, they said. "The doctor must make sure that the relationship does not influence the study, design or interpretation of any research data or affect the research or education in any way. The doctor should also tell the relevant ethics committee about the relationship."

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