After four years of negotiations, European lawmakers have agreed on a new EU Medical Devices Regulation (MDR). The MDR is the alike the US FDA’s CDRH regulations and fundamentally postulates the appropriate rules when introducing m…
THE PHARMACEUTICAL MARKET: IRELAND - REVIEW
Ireland has experienced rapid economic growth over the past 20 years, and has invested in large scale renovation and redevelopment of its healthcare infrastructure. That said, the country is in the midst of a severe economic downturn, with GDP expected to contract in 2012. Due to the recession and Ireland's huge budget deficit, the country has received an 85 billion euro (US$113 billion) bailout from the EU and IMF. As a result, the government faces an extremely tight financial operating environment in the next few years. It has generally sought to protect healthcare, especially frontline services, from the kinds of cuts experienced elsewhere, but health is not unaffected. A progression of measures has been introduced as the economic position has worsened, most recently the Budget 2011 and related National Recovery Plan.
In March 2011, the government announced plans to introduce Universal Health Insurance (UHI) by 2016. Underpinning the UHI system will be the principle of access according to need and payment according to ability to pay. Insurance with a public or private insurer will be compulsory, with insurance payments related to ability to pay. The government is also planning to remove fees for GP care, which will be implemented in phases, firstly for claimants of free drugs under the Long-Term Illness scheme and the High-Tech Drugs scheme, before being extended to all. Under UHI, public hospitals will no longer be managed by the HSE. They will be independent, not-for-profit trusts with managers accountable to their boards. Hospitals will be paid according to the care they deliver and will be incentivised to deliver more care in a money follows the patient' system. The government has also reiterated plans to introduce reference pricing and generic substitution, as cost saving measures.
Most global companies have some manufacturing presence in the pharmaceutical market in Ireland. Drugs are either produced in finished form for export, or exported on to other facilities for finishing. A number of branded drugs go off patent in 2012, including Pfizer's Lipitor and Eli Lilly's Zyprexa, which could have a negative impact on the industry. However, several multinational companies have been moving into the biologic sector in preparation for the loss of profit from these blockbuster drugs. While the multinational presence is very strong, Ireland has very few domestic producers. In September 2011, Alkermes completed its merger with Elan Drug Technologies (EDT) to form a new company, Alkermes Plc., which is headquartered in Dublin. In September 2011, Pfizer announced it was to invest US$200.0 million at its Grange Castle site, to add two processing suites and to expand current production and product testing capabilities. In September 2011, MSD opened its new R&D centre at its Ballydine site, creating 70 new jobs. Previously, in June 2011, MSD opened two new facilities at the site in Brinny.
The competitive landscape section provides comparative company analyses and rankings by US$ sales and % share of total sales - for the total pharmaceutical sector, as well as the OTC, generics, and distribution sub-sectors.