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Table 3 Summary of code of practice sanctions and provisionsa,b[14]

From: Ethical pharmaceutical promotion and communications worldwide: codes and regulations

Sanction or requirement Comments
Requirement to cease non-compliant activity A universal requirement. Often associated with a written undertaking not to repeat the non-compliant or similar activities, claims etc. The company may be required to recover and destroy offending material. Repetition may result in severe penalties.
Publication of the outcome or public reprimand Undertaken if local legal considerations allow. May consist of detailed reports or more concise summaries. Offending company is usually identified. In some countries, serious offences may be publicised in the medical press.
Monetary penalties The amount is usually graded according to the number and/or seriousness of the offences, generally from thousands to hundreds of thousands of dollars.
Additional pre-screening requirements In countries where pre-screening is optional.
Requirement for a formal audit of company procedures This is particularly useful if a company’s procedures or training may be the cause of a serious or repeated shortcoming.
Suspension or expulsion from membership of the local trade association Expulsion may mean that the code regulatory system will not apply to the company and external legal and regulatory controls will therefore take effect routinely. Suspension may mean that the company is still required to comply with the national association code.
Issue a corrective communication This provision is particularly useful if recipients of the material may have been misled. It will be at the expense of the company.
  1. aIn most countries, regulatory bodies and legal court proceedings provide additional (or exceptionally the only) sanction options.
  2. bNot all sanctions are applied in all countries.