Executives from the pharmaceutical industry were gathered around a table in the Italian Room inside Government Buildings. It was the middle of May and the prospect of a damaging trade war between Europe and the United States seemed a real and grave possibility.
Tánaiste and then foreign minister Simon Harris assured pharma companies that the Government had their back, both in facing possible US tariffs coming from Washington and on separate reforms being debated in Brussels to overhaul how the European Union regulated the sector.
US president Donald Trump didn’t follow through on threats to levy huge import tariffs on pharmaceutical products.
A deal reached in Brussels in the early hours of Thursday morning saw off the other big threat pharma firms had been anxious about.
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The European Union had proposed to reduce the minimum number of years pharma companies had exclusive rights to sell new medicines they developed before cheaper generic competitors could enter the market.
The changes, proposed by the European Commission in early 2023, would have cut this window of “regulatory data protection” from eight years to six or seven.
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Pharma firms would be able to win back additional years of protection if they met certain conditions such as rolling out the medicines in all 27 EU states. The motivation was to improve smaller or poorer EU states’ access to new drugs coming on to the market.
The proposals set off a big lobbying campaign by the pharmaceutical sector, to push back against the changes. Companies argued the reforms would make Europe a less attractive place to develop new products.
Pharma firms raised the proposed EU regulations in the May 14th meeting with Mr Harris, where companies stressed the “importance of Ireland as a base for their operations”, minutes show.
[ US says EU deal on pharma trade remains in place despite Trump threatOpens in new window ]
The industry accounts for a huge portion of Irish exports. Pharma giants Pfizer, Eli Lilly, MSD and Johnson & Johnson have significant manufacturing plants in the Republic, employing thousands of people and contributing a sizeable chunk of the State’s bumper corporate tax revenues each year.
Pharma firms, and their industry body, the Irish Pharmaceutical Healthcare Association (IPHA), spent the last two years intensively lobbying the Government to oppose planned EU changes.
Internal documents show key meetings with Taoiseach Micheál Martin and Mr Harris earlier this year gave them their first indication that they had been heard.
Those inside the room came away more confident the Government would bat for the industry during upcoming EU-level discussions.
[ Pharma lobbyists cash in on Brussels red tape rampageOpens in new window ]
Mr Martin told top executives from MSD, Sanofi, Bayer and the IPHA that Ireland put “great value” on the sector.
The Taoiseach said he knew the threats of tariffs posed a challenge, according to minutes of the April 16th discussion in Government Buildings. The records were released to The Irish Times under the Freedom of Information Act.
In a similar session the following month, Mr Harris assured the industry of Ireland’s position in the EU “in support of pharma”, notes of the discussion state.
Mr Trump’s tariff agenda had changed matters. Shortly afterwards the Government came out and publicly opposed cutting the level of “protection” companies enjoyed over new drugs.
As a summer of transatlantic tensions wore on, Mr Harris was in the Italian Room again on July 16th, this time to tune into a virtual call with US-based pharma executives.
The Fine Gael leader used the opportunity to get a read on their view of Mr Trump’s ambitions to pressure companies to relocate manufacturing capacity to the US.
Internal records show Mr Harris also met Pfizer chief executive Albert Bourla in early August. Speaking notes suggest he told the Pfizer executive that the EU reforms, already watered down following intense lobbying, would now provide “certainty and stability” for the pharmaceutical sector in Europe.
Concerns that US tariffs could upend a heavily intertwined supply chain, and a bigger focus on economic competitiveness, greatly reduced the appetite in Brussels for a fight with the sector.
[ Ireland’s record-breaking tax month likely driven by big tech rather than pharmaOpens in new window ]
A final deal, negotiated into the early hours of Thursday morning, saw EU officials walk back the most contentious aspects of the proposal. The overhaul of regulations governing the sector left the eight-year window of protection from generic competitors untouched.
Of a further two years protection, one would be dependent on companies meeting pretty achievable conditions such as conducting clinical trials in at least two EU states.
There were some small wins for patient access. It will be easier for generic drug makers to launch products on the day the intellectual property protections over brand name drugs expire.
The result is as close to a total victory as the pharmaceutical industry could have expected to get. Their lobbyists certainly earned their Christmas bonuses this year.
