Sanctions

Undertaking

In each case where a breach of the Code is ruled, the company concerned must provide a written undertaking that the practice will cease forthwith and that all possible steps will be taken to avoid a similar breach of the Code in the future.

This undertaking must be accompanied by details of the actions taken by the company to implement the undertaking, including the date on which the material was finally used or appeared and/or the last date on which the activity took place.

The company must also pay an administrative charge based on the number of matters ruled in breach of the Code.

Breaches of Clause 2

Following publication of the relevant case reports, the PMCPA will advertise in the medical, pharmaceutical and nursing press brief details of cases in which:

• companies were ruled in breach of Clause 2 of the Code

• companies were required to issue a corrective statement

• companies were the subject of a public reprimand.

The advertisements are also published on the PMCPA website and a press release is issued to the media and other stakeholders.

Additional sanctions

Prior to publication, copies of all case reports must be submitted to the Code of Practice Appeal Board for review as part of its supervisory role in relation to the operation of the complaints process.

The Panel may also report a company to the Code of Practice Appeal Board if its conduct in relation to the Code warrants consideration by the Appeal Board, whether in relation to a particular case, or because repeated breaches of the Code raise concerns about the company’s procedures.

The Appeal Board considers whether additional sanctions may be appropriate:

• The Appeal Board may require an audit (by the PMCPA) of a company’s procedures in relation to the Code. Following the audit, the Appeal Board decides whether to impose requirements on the company to improve its procedures, which could include a further audit, a specific scope audit, a requirement that the company provides updates regarding implementation of its commitments to improve and/or a requirement that promotional material be submitted to the PMCPA for pre-vetting for a specified period.

• The company may be required to take steps to recover items from those to whom they were given.

• A public reprimand may be published.

• The company may be required to issue a corrective statement.

• The Appeal Board may take other administrative steps, such as inviting a senior representative of the company to future meetings of the Appeal Board to report on progress, or requesting written confirmation that appropriate action has been taken.

• The Appeal Board may report a company to the ABPI Board, who may suspend or expel the company from the ABPI.