From Government Buildings to the corridors of the European Parliament – and even a playground in Bray, Co Wicklow – the pharmaceutical industry has been quietly waging a massive lobbying campaign.
The aim is to kill key parts of proposed regulations governing the industry, which have been working their way through the European Union’s policymaking machine.
Ireland has come under particular pressure to bat for the industry, given the large concentration of pharma giants such as Pfizer, Eli Lilly, MSD, Johnson & Johnson and others with manufacturing plants or other sites in the State.
The European Commission, the EU’s executive arm that puts forward new laws, proposed a landmark overhaul of regulations covering the pharmaceutical industry two years ago.
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The idea was to make access to medicines more equal across Europe. Currently, many new drugs come on stream in some EU states much quicker than others.
Big countries such as Germany and France have traditionally enjoyed near immediate access to these medicines, while poorer and smaller states in central and eastern Europe can be waiting for years.
Controversially for the industry, Ursula von der Leyen’s commission proposed to fix this by tying strings to the number of years a company maintains exclusivity over new drugs they produce before cheaper generic competitors can enter the market.
Pharmaceutical companies are currently granted at least eight years’ “protection” over their data from research and clinical trials. When this regulatory data protection runs out, generic producers can then copy the initial homework and start developing their own rival version of the medicine.
The commission wanted to cut the minimum window of protection from eight to six years. Pharma companies would be able to win back more time, for example, by getting an extra two years of protection if they launched their new drug in every EU state.
The changes caused alarm within the pharmaceutical sector. Companies feared their profits would take a hit if generic drugmakers were able to muscle in earlier.
The pharma industry launched a multimillion-euro lobbying campaign, targeting the EU institutions in Brussels and governments in national capitals, to push back on the proposed changes.
Correspondence seen by The Irish Times shows the extensive lobbying effort from pharmaceutical companies aimed at convincing the Government to adopt the industry’s position in EU negotiations on the reforms.
Among those applying pressure were Pfizer, the global pharma giant that employs 5,000 staff in Ireland and is among the biggest contributors to corporate tax receipts the State has come to rely on; Novo Nordisk, the Danish drugmaker that has enjoyed soaring profits on the back of huge demand for its anti-obesity drug Ozempic; and US giant MSD (Merck), which has large plants in Tipperary, Cork, Meath and Dublin.
The industry argued the commission’s plan to tie protection over regulatory data to medicine access would not work. Some of the ways the EU executive envisaged firms earning additional years of market exclusivity, such as launching new products in all member states, were far from straightforward, and not always in the gift of the drugmaker.
The changes would make investing in research to develop new medicines more uncertain, companies said.
The Irish Pharmaceutical Healthcare Association (Ipha), which represents the sector, warned this could lead to a 22 per cent drop in new medicines being developed over the coming decade.
“It would be short-sighted to assume that manufacturing jobs in Ireland and Europe as a whole will ultimately be unaffected by a reduction in the incentives to invest,” the group told then taoiseach Simon Harris in an April 9th, 2024, letter.
Deb Mangone, head of Pfizer in Ireland, told Harris the EU legislation had the potential to shape the pharma sector “for the next couple of decades and Ireland with such significant scale will be heavily impacted by this”.
In her April 12th, 2024, letter, sent shortly after the Fine Gael leader first became taoiseach, Mangone said Pfizer hoped the government would “continue to advocate for pro-innovation policies that maintain a stable environment for investment”.
Lobbying correspondence from MSD to Harris, sent around the same time, called for Ireland to not only seek to oppose any cut to regulatory protection, but to push to “strengthen” intellectual property supports.
[ Pharma regulation reforms would ‘heavily impact’ Ireland, Government toldOpens in new window ]
The US Chamber of Commerce also got in on the act.
Representatives from the powerful business lobby group met officials from the Department of Health and the Department of Enterprise last June. They lobbyists told department officials they had concerns about “the impact of some aspects” of the EU reforms, according to minutes of the meeting.
It is understood the Department of Health was keen on the reforms improving access to new medicines. The Department of Enterprise was more supportive of the arguments being made by industry, according to three sources.
European Parliament
While representations were being made to national governments, a parallel lobbying campaign was being waged in Brussels.
After the commission proposed the changes in April 2023, the legislation moved to the European Parliament, where MEPs had to vote on their position.
Industry called on the parliament to set the minimum period of regulatory protection back to eight years. MEPs were warned the proposed changes could result in companies cutting jobs in Europe.
“The pharma lobby, of course they are a little bit aggressive,” one source involved in the parliament’s negotiations said.
The centre-right European People’s Party (EPP), the largest grouping that includes Fine Gael, backed the industry position, while the centre-left Socialists and Democrats and the Greens initially resisted rolling back the reforms.
A centre-right MEP from Denmark, who was seen as very supportive of industry, Pernille Weiss, was one of the lead negotiators. Parliament logs show Weiss had 17 meetings with Novo Nordisk over the course of the year MEPs were working on the law.
“At the end of the day, it would not matter who from the EPP has the file, because the EPP position is industry-led. They care more about the industry and competitiveness than they do about access for patients,” said a source from the second biggest parliament grouping, the centre-left Socialists & Democrats.
Weiss did not respond to requests for comment.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) marshalled the campaign to rework the regulations in parliament.
Internal emails show the industry group frequently drafted rafts of amendments, sending the proposed changes to MEPs to table.
In some cases MEPs appeared to “copy and paste” the suggested text into amendments they proposed, one source involved in negotiations said.
“Given the deep knowledge of our experts, across multiple topics contained within the pharmaceutical legislation, it is a legitimate right to share this expertise with MEPs,” an EFPIA spokeswoman said.
Medicines for Europe, which represents generic producers, also drafted proposed amendments they then circulated to MEPs, emails show.
Adrian van den Hoven, head of the generic drugmaker lobby group, said making technical suggestions to MEPs for amendments was “part of policymaking in Brussels”. Politicians were “free to choose what suggestions resonate best with them”, he said.
In one December 2023 memo shared with MEPs, Medicines for Europe warned about the direction of travel some were pushing for: to extend, rather than cut, companies’ regulatory protection periods.
“The proposed extensions will have massive cost implications by extending the monopolies for blockbuster drugs well beyond the current legal framework,” the memo said.
Negotiators from the various European political groups were working to a tight deadline. There was a rush to vote on the huge piece of legislation before the parliament’s term ended last spring.
In the end, a large majority in parliament voted to set the minimum amount of regulatory protection at 7½ years, just six months less than the current period. The vote was seen as a win for the pharma industry and a slap in the face for the commission.
Several sources described the behind-the-scenes lobbying by industry as intense. EFPIA spent between €5.5 million and €6 million on its lobbying operation in 2023, according to filings published on an EU transparency register.
Pfizer, Bayer, Sanofi, Novo Nordisk, MSD, Novartis, Gilead Sciences and GSK all separately reported spending more than €1 million on their EU lobbying operations in the same year.
Vulcan Consulting, the lobbying firm set up by former Fine Gael junior minister Lucinda Creighton, was heavily involved in efforts to lobby Irish MEPs. Filings show Vulcan was paid between €100,000 and €200,000 to lobby for the Irish Pharmaceutical Healthcare Association in 2023.
The sector has made its case to von der Leyen as well. In a September 2024 letter to the commission president, Eucope, which represents mid-sized pharma players, said its members needed a “robust, predictable and strong investment and industrial ecosystem”.
Capitals
Since the middle of last year, the EU’s 27 national governments have been debating the reforms, which explains the lobbying being conducted in capitals across the EU.
Member states, the parliament and commission will have to settle on a compromise, before the reforms are voted into law.
A group of countries, led by Denmark and Germany, are firmly on the side of the pharmaceutical sector in the negotiations.
Smaller states in central Europe want to pressure companies to roll out new medicines more widely.
Ireland is sitting in a middle camp between these two groups.
The Danish government has “deep concerns” about cutting the amount of regulatory protection companies have over new drugs, according to an internal paper setting out its position. The proposed changes would make the EU a less attractive place for research and medicine production, it stated.
There is a feeling among pharma companies with big footprints in Ireland that the Government should be in the camp defending the sector, according to multiple sources in the industry. Ireland’s decision to “sit on the fence” has been noted, two sources said.
AstraZeneca, which is headquartered in England, told the previous government that pharma companies were “disappointed and concerned” by the position Ireland had taken.
In an August 2nd, 2024 letter, Alex Wilkes, head of the company’s Irish office, reiterated the “serious concerns” industry had with the proposals. The correspondence was sent to Minister for Enterprise Peter Burke and then minister for health Stephen Donnelly.
The friction between the industry and the Government over the EU reforms comes at a particularly sensitive time. The sector accounts for a huge chunk of the billions of euro worth of exports Ireland sells to the United States.
This trade flow – and the jobs created by US pharma companies in manufacturing sites in Ireland – are in the sights of US president Donald Trump, who has promised sweeping taxes on such exports. His hope is tariffs will pressure companies to reshore intellectual property or manufacturing output from Ireland back to the US.
Oliver O’Connor, head of the Irish pharmaceutical lobby group, said cutting companies' regulatory protection would send the “wrong signal to European and global investors”.
In a June 21st, 2024, letter to the coalition leaders, now Taoiseach Micheál Martin and Tánaiste Simon Harris, O’Connor called for Ireland to join the group of “like-minded” states opposing the changes, which included Germany, Italy, France, Denmark, Sweden and others.
The correspondence was released to The Irish Times, following requests made under the Freedom of Information Act.
Pfizer also ramped up the pressure. The pharma giant’s global executive vice-president, Alexandre de Germay, told Harris and Martin that Ireland was “fast becoming an outlier”, by not expressing concerns about the reforms.
“The best interests of patients, the industrial vitality of Europe and Ireland’s economic growth hinge on maintaining the integrity of the intellectual property system,” he wrote in a June 27th letter.
In reply, Harris said the concerns of industry were understood by the government. Ireland wanted to improve access to medicines, while making sure the sector remained strong and innovative, he said.
The head of Novo Nordisk’s Irish operation managed to get the ear of the Fine Gael leader in person, during the general election campaign late last year. The setting was an unlikely one: a playground in Bray.
Harris was on the campaign trail unveiling new playground equipment at a school in his Wicklow constituency, which had been funded by the Danish pharma company.
In a November 28th letter following up on the encounter, Nina Therese Hovland said it was “critical” that Ireland picked a side in the pharma debate.
A coalition of pro-industry states were signalling their commitment to the sector, she said. What stance Ireland took would be “pivotal to it remaining one of the best places in the world to do business”, the Novo Nordisk executive said.
Though the Government has not been as receptive as companies may have expected, it looks like the pharma sector will get its way anyway.
A source involved in current negotiations said a majority of capitals looked likely to agree to back companies getting seven years of regulatory protection, but with the option to earn a further year of cover much easier than had been previously proposed.
One official inside the European Commission reportedly summed up how things were looking during a recent meeting: industry had largely secured what they wanted, the official said.
