Five drugs manufactured in Ireland for the treatment of cancer and heart disease are not sanctioned for use here, even though they are exported from Ireland for use in other European countries.
The drugs are among a group of nine that have been awaiting approval for more than two years, on average. They have all gone through the health technology assessment, which examines the clinical effectiveness and safety of new drugs as well as their cost-effectiveness and budget impact. But they have still not been approved.
They have fallen victim to budgetary constraints at the HSE and have been forwarded for decision to the Department of Health. The medicines are made at plants in Dublin and Cork.
They are understood to include Keytruda, a cancer drug made by US group MSD, that is approved in Ireland for some forms of cancer but not yet for others. It was in the news recently when Limerick cervical cancer campaigner Vicky Phelan was given access to the drug.
‘Outlier’
The Irish Pharmaceutical Healthcare Association (Ipha), which represents the major drug companies, said Ireland was in danger of being seen as an "outlier" in relation to access new therapies.
Ipha chief executive Oliver O’Connor warned the pharma industry, “whose significant ongoing investments in operations is spurring economic growth in Ireland, is questioning the capacity of the system to deliver medicines efficiently to patients”.
This comes against a backdrop of the economic threat to the Irish economy from Brexit.
Three of the drugs are designed to address forms of cancer while the other two are treatments for cardiovascular disease, which Ipha notes are “Ireland’s two biggest killer diseases”.
‘No sense’
“Irish patients are not getting access to medicines quickly enough, even those made in their own country,” Mr O’Connor said. “This makes no sense. It begs the question: if patients in [other] countries can get the medicines, why can’t we?”
The drugs industry feels aggrieved at the slow pace of approval for new drugs, as access was one of the key issues for the industry when it agreed a four-year pricing deal with the Government in 2016.
Attempts to comment the Department of Health for comment yesterday were unsuccessful. Minister for Health Simon Harris previously said the cumulative cost over five years for the nine drugs waiting for decision by his department would be €120 million.
