Fearing EU language-access requirements may slow vaccine development, drugmakers call on officials to soften rules. Some worry a rule change could hurt the effectiveness of a vaccine.
As drugmakers race to develop a COVID-19 vaccine, lawmakers in the European Union face calls to loosen rules that require medicines sold in the bloc to include full documentation in 24 separate languages. Those calling for the exception fear that the current the current rules could slow the deployment of hundreds of millions of vaccines.
“We need an early agreement from EU authorities on the language to be used on the packs and labels for COVID-19 vaccines,” said Michel Stoffel, head of regulatory affairs at Vaccines Europe, which represents big vaccine makers including GlaxoSmithKline, Sanofi, and AstraZeneca.
Although the criticism undermines calls worldwide for broader language access to COVID-19 information, the EU has considered temporarily softening language requirements for vaccines since June. In lieu of full inclusion on multilingual labels, an EU official said Brussels has considered alternatives, like printing a limited set of languages on the labels and publishing remaining versions online.
However, concerns have arisen that labels may not have enough space to include more than two versions. Furthermore, consumer groups have raised the warning that leaving any languages off packaging could have a negative impact on patients, especially those less computer literate.
“The urgency of getting a vaccine should not be an excuse for companies to cut corners on consumer protection,” said Monique Goyens, the head of BEUC, which represents major European consumer organizations. “Safety includes instructions of use in the user’s language and on paper about possible side effects of vaccines. That’s why we believe that online information can be an additional tool, but should never be the sole option.”
The dilemma raises questions about how to balance expedience with access during the pandemic, specifically relating to how best to disseminate life-saving information in an effective, inclusive way. The news comes after reports that the European Commission announced it would provide 400 million euros to an initiative led by the World Health Organization to buy COVID-19 vaccines.