Policing pharma

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The British pharmaceutical industry deserves credit for introducing a tougher code of practice last year, which has set a strong example for its peers around the world. Now it needs to do more to ensure that this guidance is adequately enforced.

The revised UK code of the Association of the British Pharmaceutical Industry, the main trade body, rightly clamps down on excessive hospitality and other marketing efforts that promote medicines for reasons other than their scientifically-proved effectiveness.

The guidelines have helped inspire similar changes elsewhere, including a revised set of guidelines adopted by the International Federation of Pharmaceutical Manufacturers and Associations in Geneva, in turn providing a template for other national trade bodies.

Furthermore, the Prescription Medicines Code of Practice Authority, the ABPI’s self-regulatory body, which scrutinises compliance with the UK code, has taken some promising steps to tighten up enforcement of the code. It has hired more staff, issued reprimands to companies and communicated its judgments more swiftly and widely.

But the authority currently acts as prosecutor, judge, jury and executioner combined, with just three staff on a modest budget (and housed in the ABPI’s headquarters), considering and ruling on complaints. Only appeals are then scrutinised by outsiders.

The problem is compounded by the body’s lack of investigatory powers. It takes submissions from companies and critics, but does not even interview directly (let alone cross-examine) aggrieved parties who are cited in media reports to get their viewpoint.

A better structure would be enhanced resources to create a more powerful self-regulatory authority with experienced staff who actively investigate and even seek out disciplinary breaches. Judgment would be made by a panel of outsiders, the majority of whom should be independent of industry.

When it does identify breaches of the code, the authority’s principal sanction today is a public reprimand – which includes in extreme cases exclusion from the ABPI. While that has a powerful shaming effect on companies, it has little financial impact.

Enforcement bodies in other countries have gone further by formally referring any legal breaches to statutory bodies for action and by levying substantial fines on companies as a way both to penalise management and to quantify the gravity of the offence. Such a model merits further discussion in the UK.

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