Medicines for Ireland, the representative association for generic and biosimilar suppliers in Ireland, has cautioned that a promised new National Biosimilar Policy may lead to no meaningful change.
The association has expressed concern that the State’s existing medicine pricing agreement with IPHA is “protectionist”, claiming that its terms, including an enforced price entry point, restrict competition in the medicine market, in particular for biosimilar over biologic medicines.
The Department of Health completed a public consultation on biosimilars in September and Medicines for Ireland has called on the Department to resist pressure from vested interests to maintain the “status quo”.
The association has highlighted the current “poor uptake” of biosimilars, claiming that this has resulted in a negative impact on affordability and access to medicines for Irish patients.
The association stated: “Biosimilar medicines, which are subject to the same regulatory checks and standards as biologics, have had negligible uptake in the Irish market. In some cases, as low as 0.2 per cent market share”.
Medicines for Ireland has criticised the Department of Health’s failure to create the conditions for competition in the market and the absence of government policy to shape the market.
Commenting on the submission, Jeffrey Walsh, Joint Chairperson of Medicines for Ireland and Commercial Manager, Pinewood Healthcare, said: “Biosimilar medicines have been around for over 10 years now, yet we’re not seeing any meaningful penetration of the market here. Patients are missing out unfairly in Ireland.
“That has to be a cause for alarm. While we welcomed the Department’s public consultation and commitment to formulate a national policy, we are increasingly concerned that nothing will materialise from this process.
All the while, significant savings which could ensure increased and faster access to medicines for Irish patients, are passing us by”.
He continued: “Exacerbating the dearth of a government policy to drive a viable market in the Irish market, is the State’s own pricing agreement with the Irish Pharmaceutical Healthcare Association, whose members represent the biologics industry here. This provides for a 30 per cent drop in price on biologic medicines when an equivalent biosimilar medicine enters the market.
“While this discount appears attractive at first, in reality, it is creating a false and, inevitably, closed market. It ensures that the dominant position of biologics is maintained as biosimilars either do not launch here at all or fail to secure any real increased patient uptake, which may inevitably lead to their withdrawal from the market”.
According to Sandra Gannon, Joint Chairperson of Medicines for Ireland and General Manager of Teva Pharmaceutical’s Ireland:
“This blocker clause is sending out the message to biosimilar companies that Ireland is closed for business. The long-term implications of this ill-thought out approach will have negative knock-on effects, particularly for patient access.
She stated: “The 30% discount was sewn into the national medicine pricing agreement in an attempt to block genuine competition. Incumbent biologic manufacturers dominant in the Irish market are actively blocking change, while ironically, also calling on the Minister to provide access to new medicines!
“This attempt to block now extends to a proposal in IPHA’s biosimilar consultation submission document to offer the State an automatic discount, without even a biosimilar competitor in the Irish market, going even further that their existing agreement with the Department of Health”.
In its consultation submission to the Department, Medicines for Ireland has recommended that measures to increase biosimilar uptake, including compulsory biosimilar prescribing quotas or gain share schemes whereby hospitals which switch to biosimilars can share in savings realised.
“We need to move beyond a position of protecting higher cost medicines such as biologics when more affordable but equally safe alternatives are available, to a position whereby we are actively supporting measures which attracts biosimilars to the Irish market, increases their usage by patients and creates budget to pay for new medicines”, concluded Ms. Gannon.