Dr Muiris Houston, Medical Correspondent, examines the legal and ethical issues surrounding the use of unlicensed treatments for multiple sclerosis.
There is no scientific evidence that the administration of stem cells intravenously can either cure or slow progression of multiple sclerosis (MS).
Multiple sclerosis is a progressive neurological disease in which the protective coating that lines nerve cells in the brain and spinal cord is destroyed. It is conceptually unlikely that a substance injected into a vein would selectively travel to the brain and repair damage within the central nervous system.
At present, the Irish Medicines Board (IMB) has no jurisdiction over the importation or use of human cells in the Republic.
However, an EU cells and tissue directive comes into force on April 7th. It sets out guidelines for the donation, procurement, testing, storage and distribution of human cells and tissues within the EU.
For the directive to become law here, it must be transposed on to a statutory instrument by the Department of Health.
Once the EU directive becomes law, the IMB is empowered to visit any premises and inspect any process by which stem cells are stored or distributed. However, the licensing of a premises under the EU cells and tissue directive is separate from seeking a product licence from the IMB.
Pharmaceutical companies must go through a rigorous process, which takes an average of 40 weeks, when seeking a licence to market a drug or treatment in the State. Evidence of a medication's safety and efficacy must be presented to the IMB; the board's medical, toxicology and pharmaceutical experts will want to see convincing evidence from extensive clinical trials that the treatment does what it is designed to do with minimal side effects.
Notwithstanding this licensing process, doctors are permitted to use any medicinal product on what is termed an "off-licence" basis. For example, reports may appear in medical journals that an established blood pressure drug is effective in the treatment of migraine.
A doctor here is entitled, based on his clinical judgment, to begin to use the drug in migraine patients in advance of a formal licensing of the product for the new disease.
However, in taking such action, a doctor must be prepared to defend his prescribing to the fitness to practise committee of the Medical Council. Should a complaint be made to the regulatory authority for doctors, an individual practitioner would need to be able to substantiate his decision, based on clinical evidence, in order to avoid professional censure.