Government inaction leading to unlicensed MS therapy, says TD

GOVERNMENT inactivity on several fronts has led MS sufferers to seek unlicensed and unregulated treatment, Green Party TD Dan Boyle said yesterday.

The Irish Examiner yesterday revealed how a Swiss company was providing stem cell therapy through a doctor’s surgery in Co Cork.

The Irish Medicines Board (IMB) is now investigating the situation because the controversial therapy - costing €18,500 for a three-hour session - is unlicensed here.

Mr Boyle said the Government had failed to progress a key medical bill, failed to complete its consultation process on stem cell research, and failed to identify treatment processes that could meet the ongoing needs of those with MS.

“It’s in this final regard that the Government stands most indicted,” Mr Boyle stated. “MS is a condition that causes great pain to its sufferers. Government policy has not kept pace with the need to introduce new technologies and better resources to relieve the strains of this condition.”

The Cork TD was speaking after he raised the matter in the Dáil with Finance Minister Brian Cowen.

Speaking on the Government’s behalf, Mr Cowen said treatments based on stem cell research were not licensed here because they were at an “early and experimental stage”.

He said the EU would address the issue in the coming months. The EU is examining how to improve patients’ safe access to advanced therapies by increasing research, development and authorisation of gene therapy, somatic cell therapy, and tissue-engineered products.

The first step in that process was EU directive 2004/23/EC, which sets binding requirements for the safety and quality of human tissues and cells from donor to patient, and which must be transposed into Irish law by April 6.

The EU expects to propose a second directive, addressing the issues of storage and processing of tissues and cells, later this year.

“The introduction of treatments (such as cell therapy) in future will depend on the evidence base for their effectiveness and safety,” Mr Cowen said. “Directive 2004/23/EC, which sets standards of quality and safety for tissues and cells, will address this issue. The Tánaiste has appointed the IMB as the competent authority under the directive and it will have responsibility for ensuring that the specified standards under the directive are met.”

Tánaiste and Health Minister Mary Harney, meanwhile, told an Oireachtas committee she only heard of the therapy’s availability through the Irish Examiner. Department of Health officials will contact the IMB on the issue, she added.