HC Deb 04 December 2002 vol 395 cc903-4W
Mr. Hunter

To ask the Secretary of State for Health whether it is his policy that the Medicines Control Agency should limit the maximum number of authorisations for imports of MMR SepVax (Mumps) doses; what the equivalent is in daily individual doses of the number of authorisations of MMR SepVax (Mumps) vaccines which the MCA is approving; and if he will make a statement on(a) the availability of MMR SepVax (Mumps) in relation to demand for vaccination and (b) the delays which customers are experiencing in obtaining supplies of MMR SepVax (Mumps) vaccines. [82704]

Ms Blears

Single mumps vaccines being prescribed and administered, as part of single measles, mumps and rubella vaccination programmes such as MMR SepVax, are unlicensed imported medicines. Medicines legislation allows a doctor or dentist to prescribe an unlicensed medicine to meet the special clinical needs of his individual patients, on his direct personal responsibility. Importers of all unlicensed medicines, who are licensed by the Medicines Control Agency (MCA), must notify the agency on each occasion they intend importing an unlicensed medicine and there is a legal restriction on the maximum quantity they may import per notification. The MCA can object to importation if it has safety concerns or if an equivalent licensed medicine is available. This applies to all imported unlicensed medicines; there is no policy of specifically restricting unlicensed single measles and mumps vaccines.

The average numbers of notifications per month received by the MCA to import all brands of single mumps vaccine during the last three years were as follows.

Year Doses
2000 69
2001 1,483
2002 3,014

These are the numbers of doses notified to the MCA for importation and do not necessarily relate to the number of doses actually imported.

The current shortage of unlicensed single mumps vaccine and delays in their reaching patients are believed to be due to: An international shortage of single mumps vaccine, resulting from the halting of production by a major supplier, combined with; Safety concerns about vaccines containing the Urabe and Leningrad-Zagreb strains of mumps virus; Efficacy concerns about vaccines containing the Rubini strain of mumps virus; The recent need to obtain further information on the safety and efficacy of another unlicensed single vaccine claiming to contain a Jeryl Lynn strain of mumps virus.