Medicines for Ireland fear a cementing of status quo

Medicines for Ireland, the representative association for generic and biosimilar suppliers in Ireland, has expressed concern that a promised new National Biosimilar Policy will result in no meaningful change in terms of the current lack of competition in the Irish pharmaceutical sector, notwithstanding an ongoing Department of Health public consultation exercise on the issue.

The association went on to describe the State’s existing medicine pricing agreement with IPHA as ‘protectionist’ due to the fact that its terms, through an enforced price entry point, restricts competition in the medicine market, in particular for biosimilar over biologic medicines.

The Minister for Health Simon Harris’s alleged support for “protectionist” medicine policy was the key reason why access to new medicines was restricted, Medicines for Ireland claimed.

The Department of Health (DoH) completed a public consultation on biosimilars in September and Medicines for Ireland is urging the Government Department to resist pressure from vested interests, opposed to change, to maintain the status quo.

The “stated” objective behind the Department’s proposal for a national policy for biosimilars is to ensure that biosimilar medicines, which have been in widespread use across Europe for more than a decade, would be more widely used in Irish healthcare, according to the association’s understanding. However, Medicines for Ireland has expressed its concern that any change will be stifled, based on recent media reports, which have suggested that vested interests are pushing for no reform.

The current poor uptake of biosimilars is having a negative impact on affordability and access to medicines, new and existing, for Irish patients. Ireland spends hundreds of millions of euro each year on, higher cost, biologic medicines to treat conditions such as rheumatoid arthritis and diabetes. Despite the significant and growing cost of treatment, Ireland has failed to move to more affordable biologic medicines as has occurred elsewhere. Instead, 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.

According to Medicines for Ireland, the fault for Ireland’s low uptake of biosimilar medicines lies with the DoH’s failure to create the conditions for genuine competition in the market and the absence of Government policy to shape the market. This approach contrasts with the proactive measures taken by the Department to drive uptake of generic medicines from 2013 onwards, which has resulted in hundreds of millions of euro in savings on medicines, charged Medicines for Ireland. According to the group, the Department of Health has been dragging its feet on biosimilars for years.

Jeffrey Walsh, Joint Chairperson of Medicines for Ireland and Commercial Manager, Pinewood Healthcare, said Irish 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 claimed that exacerbating the dearth of a government policy to drive a viable market in the Irish market is the State’s own pricing agreement reached with the IPHA, whose members represent the biologics industry here. This provides, Walsh claimed, 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,” he concluded.

Sandra Gannon, Joint Chairperson of Medicines for Ireland and General Manager of Teva Pharmaceuticals Ireland, accused this blocker clause of 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 commented.

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