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SCOTTISH MINISTERS are powerless to prevent the controversial anti-depressant Seroxat being administered north of the border unless their counterparts in England decide to review the drug.
The news comes in the wake of Dundee East MP Stuart Hosie’s campaign to suspend all new prescriptions of the drug in Britain until worldwide concerns over its links to suicide have been fully investigated.
Shadow Scottish health spokesperson Shona Robison wrote to health minister Andy Kerr to ask what measures are being taken to ensure the safety of the drug in Scotland.
The minister replied that all licensing issues are reserved to Westminster and that Holyrood’s hands were effectively tied.
Ms Robison said, “The SNP take the simple view that we want all decisions over the licensing and distribution of drugs in Scotland to be made by Scottish ministers.
“There is an argument that once a drug is licensed in England, there is little point ‘reinventing the wheel’ for Scottish patients.
“However, my argument is that there is sometimes an independent Scottish context for drugs and we need to be able to respond to that.”
A spokesperson for the Scottish Executive confirmed that it would not be able to pursue an independent moratorium on new prescriptions of Seroxat once it had been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency.
The spokesperson added, “Given that all decisions on the licensing of UK drugs is a devolved matter, the Executive would not be able to comment further.”
The Scottish Medicines Consortium (SMC) is responsible for assessing the cost-effectiveness and benefits of all new drugs licensed by the MHRA, while the Scottish Intercollegiate Guidelines Network (SIGN) ensures a standardised practice throughout all health boards.
Meanwhile, the Scottish Health Council (SHC) is supposed to ensure that the views of the public are properly taken into account by health boards.
However, when asked whether they would be able to take a stand against Seroxat independently of Westminster, each of these agencies responded with a negative.
A spokesperson for the SMC said, “We would only take a look at Seroxat again if the manufacturers sought to licence it for some other purpose, other than its current status as an anti- depressant.
“Even then we only look at cost-effectiveness and the potential benefits of what it does, whereas any questions over its safety would be a licensing issue and would therefore be dealt with by the MHRA.”
A similar response was provided by SIGN and the SHC, who both pointed to the age of the drug and limitations of their remit for their inability to act.
In July 2005 the SMC recommended that an experimental drug known as Alimta, designed to treat asbestos-related mesothelioma (cancer), be approved for the treatment of patients within NHS Scotland.
However, the following year the National Institute for Clinical Excellence (NICE), which approves drugs for use in England and Wales, rejected it on cost grounds. A similar disparity occurred with another cancer drug, Velcade, which slows the progress of myeloma (cancer of the bone marrow).
This drug was also approved by Scottish and Northern Irish health authorities but rejected by NICE.
Given that Seroxat has been long established in the UK, NHS Quality Improvement Scotland would not be able to use these cases as precedent for an independent stance in Scotland.
A recent US Food and Drug Administration report found a six-fold increase in the risk of suicidal thoughts and acts in children and a three-fold increase in adults after Seroxat treatment.
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