HL Deb 23 April 2002 vol 634 cc26-7WA
Lord Alton of Liverpool

asked Her Majesty's Government:

Whether companies who want their drugs to be approved by the Medicines Control Agency have to disclose all information about their products, including evidence relating to safety; and, if not, on what grounds are they entitled to withhold information. [HL3807]

Lord Hunt of Kings Heath

Companies who want to obtain a marketing authorisation for their new medicinal product must disclose all known information on that product, including all evidence related to safety, to the Medicines Control Agency for evaluation. There are no grounds on which companies are entitled to withhold such information from the Medicines Control Agency.

Lord Alton of Liverpool

asked Her Majesty's Government:

Whether they consider that all the information involving public health related to the drug paroxetine is in the public domain. [HL3808]

Lord Hunt of Kings Heath

As with all medicines, the safety of paroxetine is continually monitored by the Medicines Control Agency (MCA) and the independent expert advisory body, the Committee on Safety of Medicines (CSM). Issues that arise which have a possible impact on public health are communicated to health professionals and the public.

The MCA/CSM carried out a major review of the safety profile of paroxetine and other selective serotonin reuptake inhibitors (SSRIs), which was completed in 2000 and resulted in product information being updated and an article being published in the drug safety bulletin Current Problems in Pharmacovigilance which is available on the CSM website.

Also in 2000, the European scientific advisory committee, the Committee on Proprietary Medicinal Products, carried out a detailed review of the issue of withdrawal reactions and possible dependence with paroxetine and other SSRIs. The results of this review are available on the European Medicines Evaluation Agency website.

All licensed medicines have an approved summary of product characteristics (SPC), a document which is in the public domain and is provided to doctors and pharmacists. In addition the patient information leaflet reflects the information that is in the SPC.