Dáil Éireann Debate, Thursday - 29 June 2017
221. Deputy Michael Healy-Rae asked the Minister for Health further to Parliamentary Question No. 908 of 2 May 2017, his views on the method of diagnosis of ME; his plans to make the drug ampligen available to persons with the condition; and if he will make a statement on the matter. [30737/17]
View answerThere is currently no specific medical diagnostic test to determine or confirm a correct diagnosis of myalgic encephalomyelitis (ME), nor is there any specific treatment which works for all sufferers. Assessment and interventions need to be tailored to the individual.
Treatment for ME is initiated based on the individuals’ symptoms. In general these treatments are delivered within the context of primary care, with referrals into secondary care for specialist interventions in the areas of Neurology, Rheumatology, Pain Specialists, Endocrinology, Immunology and Cardiology. These services are generally accessed through out-patient clinics at secondary care level by the relevant specialty.
Rintatolimod (brand name Ampligen) is an experimental medicine in development for the treatment of a variety of chronic diseases and viral disorders, including Chronic Fatigue Syndrome or ME. The medicine is not currently authorised in the European Union. Before a medicine can be placed on the Irish market the manufacturer has to seek an authorisation from the Health Products Regulatory Authority (HPRA) or in the case of certain medicinal products, the European Medicines Agency (EMA). In the case of Ampligen, because of the biotechnology nature of the active substance involved, any application for a marketing authorisation must be made to the EMA. I have no information on whether or not such an application has been received by the EMA.
Should the medicine receive marketing authorisation, it would then be open to the marketing authorisation holder to make the medicine available in Ireland and to apply to the HSE to have the product reimbursed under community drugs schemes.
