A recent research by Mulinari et al (2015) suggests that UK’s self-regulatory system which is controlled by the PMCPA, who are responsible for detecting and sanctioning pharmaceutical companies, who break marketing regulations by promoting drugs off-label should be reformed. Mulinari et al (2015) carried out a qualitative analysis of data gathered between 2004-2012 from constitutions in the UK and Sweden. This data included information regarding rulings and complaints. The researchers found that in Sweden, 47% of complaints came from active monitoring, whilst in the UK only 0.2%. Now, this begs the question, are we doing less to regulate off-label promotion in the UK. The article also highlights that the majority of the violation relates to complaints regarding people who felt misled by a promotion. The article highlights, that the charges incurred by these violations, accounted for 0.014% (Sweden) and 0.0051% (UK) of annual sales revenues. A few examples of serious areas of violations pertained to diabetes drugs in the UK and Urologics in Sweden, the article included the following:
- promotion of prescription drugs to the public
- off-label promotion
Mulinari et al (2015) concluded by stating, that ‘the prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry’. Therefore, they proposed pre-vetting, intensified active monitoring, larger fines and greater publicity to rulings.
I personally feel that patient care should be paramount, and core to all acts within the pharmaceutical industry. However, Mulinari (2015) findings suggest a need for tightening the processes in the industry. However, care should be taken, not to indirectly have a negative impact on patient care. Finally, the data was gathered from 2004-2012, a lot has changed since then, the ABPI code has been revised. And, the industry has learnt from the huge fines, and recent regulations levied against it (i.e. transparency rules).
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Created by A.Tojuola MPharmS
Zetterqvist, Anna V., Juan Merlo, and Shai Mulinari. “Complaints, Complainants, And Rulings Regarding Drug Promotion In The United Kingdom And Sweden 2004–2012: A Quantitative And Qualitative Study Of Pharmaceutical Industry Self-Regulation”. PLoS Med 12.2 (2015): e1001785. Web. 7 Feb. 2016.