Dr Suresh Kumar Gupta, India

There should be greater transparency in the sharing of concerns related to pharmacovigilance between countries. To this end:

• A secure web-based intranet system should be established that will provide information on case reports, clinical data, evidence and proceedings from regulatory decisions.

• WHO should facilitate the sharing of information between countries.

• Systems should be developed to ensure the confidentiality and integrity of shared data.

• Legislation should be enacted to address concerns about privacy and confidentiality.

• Member States should be encouraged to post information, such as regulatory decisions, as soon as possible and preferably before the information is made public.

The database housed in the WHO Collaborating Centre for International Drug Monitoring could be strengthened by the following actions:

• Reviewing the standardization of definitions, harmonization of terminologies and reporting schemes.

• Assigning unique case identifiers to eliminate duplication of reports.

• Advocating for regular and timely reporting of cases by national centres.

• Opening the database primarily to people with legitimate interests in promoting public health and competence in drug safety monitoring.

• Advocating for a global policy statement on the sharing of information on adverse drug reactions and the need for ADR monitoring to override privacy concerns when the public health interest is paramount.

Pharmacovigilance is a truly global activity both in its conduct and impact; WHO-agreed definitions, tools and practices should be regarded as the sole world standards. The current WHO Programme for International Drug Monitoring should be strengthened in its role as the mandated global pharmacovigilance system. All ICH member states should be encouraged to participate actively in the WHO Programme, and contribute to its development. WHO should continue to review regularly the Programme’s definitions, tools, and procedures in the light of developments in safety in medicine, and the work of other groups.