Pharmaceutical companies have stepped up pressure on the Government to push back against proposed new regulations of the sector, which pharma giant Pfizer privately warned could damage the Irish economy.

Newly released correspondence shows Pfizer told Taoiseach Micheál Martin that Ireland was an “outlier” in not opposing reforms currently being debated at European Union level.

In a January 29th letter, Deb Mangone, head of Pfizer’s Irish operation, said the changes posed a threat to the Irish economy given its heavy reliance on pharmaceutical firms.

The EU reforms would cut the minimum number of years companies can exclusively sell new drugs they produce before cheaper generic competitors enter the market.

The European Commission, the EU’s executive body that proposes laws, is seeking to attach conditions to the length of this period in order to push companies to roll out new medicines in poorer and smaller EU states more quickly.

Pharmaceutical companies have fiercely opposed any reduction in the current eight-year window where they have “protection” over their research and data from clinical trials.

The proposed changes would be “potentially damaging to EU competitiveness and also to the Irish economy which heavily relies on pharmaceutical manufacturing,” Ms Mangone told Mr Martin.

The pharma industry has waged a massive lobbying campaign over recent years, to water down key aspects of the planned overhaul. Other countries with big pharma sectors, such as Germany, Denmark, Italy and Sweden, have backed the industry position.

EU states are due to vote on the contested aspects of the new pharma regulations, potentially in June. A compromise being negotiated in Brussels is understood to scale back the changes, to make them more acceptable to industry.

Pharma giant MSD also pressed the Government to argue against the reforms, correspondence shows.

In a February 11th letter, Samantha Humphreys, head of MSD’s Irish operation, told Mr Martin she appreciated “that Ireland is seeking to arrive at a landing zone between protecting innovation and improving access”.

Maintaining the “status quo” would help Europe to “close the innovation gap with other regions of the world,” she wrote. The correspondence was released to The Irish Times following a Freedom of Information Act request.

The latest round of lobbying comes as pharma multinationals in Ireland brace for disruptive tariffs US president Donald Trump has promised to impose on the sector, to put pressure on firms to relocate manufacturing capacity and jobs back to the United States.

The Government is concerned about the looming tariffs on pharma, given exports from the sector account for much of Ireland’s trade to the US.

Pfizer and MSD employ about 8,000 people between them across several manufacturing sites in Ireland, making them two of the biggest pharma firms in the State.

In a February 28th response, Mr Martin told Pfizer that he recognised the important role the industry played in Ireland.

EU states remained “divided” on the proposed changes to the period of regulatory protection companies enjoyed over new drugs they developed, he said.

“Ireland is very conscious of the importance of retaining a competitive pharmaceutical industry in the EU,” he wrote. “It is clear that the final outcome will contain many elements that will support industry to thrive in Europe,” Mr Martin said.

“I believe that the timely conclusion of these negotiations can provide a renewed, stable and predictable environment for industry,” the Fianna Fáil leader said.