Ella one image

Six Code breaches for HRA Pharma

pharmafile | February 6, 2014 | News story | Medical Communications, Sales and Marketing ABPI, HRA Pharma, PMCPA, code, ella one 

HRA Pharma has been slammed by the PMCPA after breaching six clauses of the ABPI Code of Practice in its promotion of morning after pill ellaOne.

The company itself subsequently referred to an email sent by one of its representatives on the subject as ‘inappropriate and appalling’ – but the apology was not enough to save HRA from the PMCPA’s verdict that it had breached the Code’s clause 2, a mark of ‘particular censure’. 

The complaint came from a ‘Page Content ​senior public health specialist’ who said that the rep’s email cast doubt on the quality of sexual health services provided in the local area.  

The rep had expressed concern that emergency contraception (EC) brand ellaOne (ulipristal acetate) was not available through the complainant’s local area pharmacy scheme for EC.  

She said women in the area were “actually receiving a poorer service than in other areas with a less well used pharmacy scheme” and implied that by visiting a pharmacy, women were not being offered EC in line with Faculty of Sexual & Reproductive Healthcare guidance.  

The rep referred to a named product which was being offered as ‘the least effective medicine’, and said 120 unintended pregnancies could have been prevented during the two years she had tried in vain to get ellaOne into the scheme. 

The rep’s conduct was considered to have brought discredit upon, or reduced confidence in, the pharma industry (clause 2). 

HRA was found to have breached two clauses about claims for the drug, which “must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly” (7.2). 

Also, “promotion must encourage the rational use of a medicine by presenting it objectively and without exaggerating its properties” (7.10). 

The PMCPA also found that there was a problem with suggesting that local EC standards were below par: “The health professions and the clinical and scientific opinions of health professionals must not be disparaged” (8.2). 

And finally, HRA was also found in breach of the catch-all clauses about maintaining high standards at all times (9.1) and the ethical conduct of reps (15.2). 

HRA’s appeal against the judgment – and what the PMCPA called its ‘fulsome and sincere’ apology – was unsuccessful.

The PMCPA’s findings are published in the February 2014 Review.

Adam Hill

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