As healthcare stakeholders gather together today (Monday) as part of a Health Products Regulatory Authority (HPRA) initiative to develop solutions to the growing problem of medicine shortages in the Irish market, a leading pharm body has warned that unless urgent reforms are introduced the problem will worsen post-Brexit.

Medicines for Ireland, the representative body for the generic medicine industry in Ireland, voiced its concerns that medicines shortages which have been growing in Ireland are likely to increase further once the UK leaves the EU.

Currently there are over 120 medicines which are out of stock. These medicines cover a wide range of conditions, which impact upon tens of thousands of Irish patients, including asthma, thyroid conditions, oral contraception, angina and schizophrenia.

Medicines shortages have become a growing feature of the Irish healthcare landscape in recent years, prompting bodies such as the HPRA to now move to develop solutions to the problem.

However, industry groups such as Medicines for Ireland point out that the unsustainably low reimbursement price set by the HSE for many of these medicines is often a major driver for shortages.

Many generic medicines are now priced so low as to render them unattractive to global suppliers, who direct these products away from Ireland to higher priced markets.

According to Owen McKeon, Chair of Medicines for Ireland and Country Manager for Mylan: “While everyone is supportive of a reduction in medicines prices from the historic high prices paid for branded medicines in the past, balance is still needed.

Ireland has now reached a tipping point whereby the price of some generic medicines has fallen to such an extent that often a month’s supply can cost less than a bar of chocolate. This is unsustainable over the longer-term. These low-cost medicines continue to be used by tens of thousands of Irish patients but are also often most vulnerable to shortages”.

“This unsustainable pricing has made the Irish market unattractive to global suppliers, who have to factor in development, production, regulatory and staffing costs before supplying the market here”, noted Mr. McKeon.

Medicines for Ireland has also pointed out that the continued long-standing practice of medicine ‘batch sharing’ with the UK is now unclear.

Under the latter system, because of the small volumes of medicines required for the market here, medicines packed in the UK are often marketed and supplied to the Irish market. However, after the UK leaves the EU, its’ medicine regulatory regime may diverge from the existing European regime and by extension Irish regime. This could mean that medicines approved for use in the UK may not be approved for use in the EU and Ireland.

“The risk of an end to batch sharing is a concern for the pharmacy sector. It has always worked in favour of Irish patients who can access medicines here marketed for the much larger UK market by availing of a smaller portion of the UK’s supply. If this practice cannot continue post-Brexit continuity of supply is threatened, leaving patient’s and our health system exposed to shortages.

Medicines for Ireland welcome the HPRA’s lead on this issue. However, we would urge both it and wider decision makers such as the HSE and Department of Health not to explore this issue in isolation from the untenable pricing of some medicines in the Irish market. This, more than anything, is exacerbating medicine shortages here. Brexit will add to the problem of medicines shortages, so we must develop comprehensive solutions which address all the root causes of shortages in advance of the UK’s departure from the EU”, added Mr. McKeon.