One of Ireland’s largest pharmaceutical companies has warned of job losses at its Kinsale plant if the EU does not exempt it from a forthcoming ban on a carcinogenic chemical.
Eli Lilly, a US multinational with 800 employees in Ireland, uses the chemical to produce raloxifene, marketed as Evista, a prescription drug to prevent osteoporosis in post-menopausal women. The drug is currently used by 1.7 million patients worldwide.
Ethylene dichloride (EDC) will be banned within the EU from November next year but the company has applied for a 12-year derogation, or exemption, as it has yet to identify a “technically and economically feasible alternative”.
If a derogation is not granted manufacturing of the drug would be moved outside the EU, the company warned the European Chemicals Agency.
The raloxifene unit at Kinsale would be decommissioned at a cost of €5 million to €10 million. The loss of sales while manufacturing was being moved and the consequent loss of market share would cost Eli Lilly from €100 million to €1 billion between 2018 and 2031, the company said.
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Some workers could lose their jobs when EDC is banned, with further job losses two years later when production of raloxifene in Kinsale stopped, the company said in its submission. Contracts with local service providers would also be terminated after 2019.
The company has not revealed the exact number of job losses.
“An intangible consequence of the relocation of the EDC process from Kinsale would be the loss of confidence in the site as a reliable worldwide supplier of quality medicines, a reputation built over 35 years,” it added.
Evista came off patent in Europe in 2013, putting pressure on sales. It accounts for 4 per cent of the EU osteoporosis treatment market. Production of the active ingredient for Evista accounts for 5 to 10 per cent of turnover for the Kinsale plant.
Eli Lilly argues that the risk to workers and locals of additional cancer cases caused by the use of EDC in Kinsale is negligible.
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“The statistical excess cancer risk is approximately one cancer case every 317,000 years, whilst the total socio-economic benefits to workers, the local community near Kinsale, Eli Lilly, and Eli Lilly’s suppliers have been calculated to be in the range of hundreds of millions of euros,” the company added.
The application will be assessed by the European Chemicals Agency. The final decision on whether to authorise continued use will be decided by the European Commission after a vote by member states.
An increasing number of hazardous chemicals, many of them used in the manufacture of drugs, are scheduled to be banned by the EU in the coming years.
Ireland, with its large pharmaceutical sector, is likely to be the member state most affected by the bans, according to figures compiled by the European Federation of Pharmaceutical Industries and Associations last year.