DRUG manufacturers have been hit with higher charges to help fund our medicines watchdog – and the cost is expected to be passed on to consumers.

Records released to the Mail reveal Health Minister Jennifer Carroll MacNeill approved the increases to prevent a potential bailout of the Health Products Regulatory Authority (HPRA) this year. Medicines For Ireland, an industry group that objected to the increases, has said the hikes risk the supply of generic drugs on shelves and mean customers facing sustained high prices.

The HPRA wrote to the Health Minister seeking an increase to the fees it charges to drug companies to test new products coming to the Irish market, as it anticipated a higher workload in 2026 that would go beyond the scope of its budget.

In submissions to Ms Carroll MacNeill, obtained by the Mail, officials advised that inflation rates and higher costs would create a ‘challenging’ scenario for the authority this year.

The HPRA, which only received €6.6million in public funding last year, is largely self-funded and relies on fees charged to manufacturers to test and classify new products to cover operating costs.

Ms Carroll MacNeill was repeatedly warned in briefing materials by the agency and officials of the ‘significant’ challenges facing the HPRA this year, in an indication it may require additional funds.

The internal documents, released to the Mail last week, highlighted several new roles the HPRA would need to fulfil in a bid to get Ms Carroll MacNeill to approve the 2.5% fee hikes.

This included the expansion of its remit to cover the use of AI in the health sector, as well as new conditions in the critical medicines act.

According to the record of documents, the minister was not provided with a cost impact analysis on the likely outcome of the fee hikes before signing off on them in December. Medicines For Ireland (MFI), a representative group for generic and non-brand-name drug manufacturers, objected to the fees in a public consultation last year over cost concerns.

The manufacturers of generic medicines typically have tighter margins to those of their commercial, brand-name competitors and cannot raise prices to reflect production cost increases.

MFI chairman Donagh O’Leary told the Mail the HPRA fee increases compound the measures preventing price gouging – in place for all drug manufacturers – and could result in patients being met with high costs for a longer period.

He warned that any additional costs placed on manufacturers ‘risk undermining the sustainability of supply’ of generic medicines.

He added that the 2.5% fee rise represented a ‘significant additional cost pressure on an industry unable to adjust its prices to reflect inflation or rising operational costs’.

‘While we recognise the important role of the HPRA, increases of this scale must be carefully balanced against their downstream impact on access, affordability and the continued viability of essential medicines in the Irish market,’ he said. 

Alongside its investigatory powers to prevent the importation of and seize counterfeit or unregulated medicines, the HPRA also conducts complex testing and analysis on new drugs for manufacturers. The cost of classification and testing – required to conduct clinical testing in Ireland – following the fee hike now ranges from €335 to €1,210 per product, depending on the type of test.

Experts from the agency also offer advisory services for manufacturers, to ensure they are compliant with national and European regulations, from €2,935 for ‘swift’ scientific advice to €8,245 for advice in four different areas.

A consultation process was conducted and received responses from five stakeholders, including two human medicines manufacturers’ groups and one veterinary medicines group.

The Irish Pharmaceutical Healthcare Association – representing some of the largest pharma and pharma-tech companies based here – did not oppose the increases.

Dr Eimear O’Leary, director of communications for the organisation, confirmed it only sought to clarify that no new charges were introduced on clinical trials.

Meanwhile, MFI ‘conveyed their opposition to the proposed’ fee hike, according to the public consultation report completed last year.

Fianna Fáil MEP Billy Kelleher, who has campaigned to reduce barriers for clinical trials in Ireland, said it was ‘clear’ the HPRA needed to ensure it had the funds to carry out its role.

‘Beyond that, the key issue is whether or not the costs could distort medicine availability in Ireland,’ he said.

Mr Kelleher said the fee hikes could be seen as a ‘disincentive’ to make particular generic medicines available here and disrupt the supply.

‘My biggest concern is that their [generic medicine manufacturers’] margins become so tight that these medicines would not be made available in Ireland, full stop,’ he added. He also said there should have been an assessment carried out on the potential impact on the price and availability of these medicines before the measures were approved. He said: ‘Medicines should be made available, not based on cost, but based on what is right for the individual patient.’

He said increasing the financial pressures on generic medicine manufacturers ‘does diminish choice’ for consumers and clinicians.

A spokeswoman for the Department of Health said the HPRA carries out a range of activities to ensure the quality, safety, and efficacy of medicines used here and does so without State funding. She said the Health Minister and HPRA are ‘always mindful’ of the impact increasing fees might have. She highlighted a recent agreement with MFI which it hopes will strengthen the security of the supply of all medicines.

Measures included in the agreement plan to encourage further innovation of generic medicines, improve access to these drugs, and improve pricing structures.

The spokeswoman said the decision to increase the fees at 2.5% was done to reflect the 2.9% inflation projection by the Central Bank for 2026.

She explained that the HPRA must match its resources from fee income to its current work volumes to plan for all future activities, including the development of stricter regulatory systems.

The HPRA acknowledged, in its consultation report, that three out of the five responses did not object to the fee increases and noted the ‘budgetary pressures for industry stakeholders’. A spokeswoman said the HPRA is ‘also subject to inflation and is required to meet its costs from fees’.