The European Chemicals Agency has given Novartis potentially significant support in its battle over a toxic chemical that the company uses for making an ingredient found in two medicines.
At a meeting last month, the agency decided to support a Novartis request for a seven-year exemption from a pending ban on diglyme, which is used to make indacaterol, an ingredient in treatments for chronic obstructive pulmonary disorder (see section 23 on page 34). A final decision, however, must still be made by the European Commission, and it is unclear when that will happen. The ban goes into effect in August 2017.
The backing by the agency comes as the pharmaceutical industry at large attempts to balance its use of certain chemicals with a need to improve its image as a concerned corporate citizen. As if to underscore this point, Novartis argued in its application to the agency that the company “continuously conducts case studies to further improve the greenness of (its) production processes.”
But a leading environment group had urged the agency to support the ban.
In comments filed with the agency, the ChemSec nonprofit group insisted the ban should be upheld due to “socioeconomic” costs associated with continued use of the chemical, as well as negative consequences for companies that produce potential alternatives. “In order to get a complete picture of the economic impact, it is necessary to look beyond the costs of the applicant alone,” ChemSec wrote.
A ChemSec spokesman added that alternatives to diglyme have been available, but criticized the drug maker for failing to pursue other possibilities until 2013, given that European Union environmental regulations listed diglyme as a candidate for a ban in late 2011. “Novartis knew this and should have done R&D (for) substitution earlier,” he wrote us.
Nonetheless, the drug maker argued in a report submitted earlier this year that an exemption is “clearly justified” while it pursues a substitute chemical. Novartis maintained that a ban would have an economic impact estimated at about $50 million, in part because patients may not be able to access adequate supplies of the medicine and production jobs may be jeopardized. The product is made at a plant in Ringaskiddy, Ireland.
A Novartis spokesman, meanwhile, wrote us that “the human health impact of continued diglyme use is effectively zero, while the socioeconomic benefits of its continued use are high.” He added that the ECHA “has agreed with this assessment and will propose to the European Commission that authorization for continued use of diglyme at the Ringaskiddy site is granted.”
He added that the company has identified an alternative to replace diglyme and the “substance has been recognized by the ECHA as technically and economically feasible.” As a result, over the next seven years, Novartis plans to obtain needed regulatory approvals and establish an alternative manufacturing process at Ringaskiddy.
“The timeline is due partially to technical scale up … and primarily to the lengthy drug registration processes required in more than 100 countries due to the proposed drug manufacturing process change,” he explained.
We asked the ECHA and ChemSec for comment and will update you accordingly.