A week after the European Commission (EC) made a downpayment for 300 million doses of a potential Covid-19 vaccine from British drug manufacturer AstraZeneca, pharmaceutical companies have requested regulators to relax the rules that require drugs sold in the EU to come with documents in the bloc’s 24 official languages.
A September 2, 2020 Reuters report quoted the head of regulatory affairs at Vaccines Europe as saying: “We need an early agreement from EU authorities on the language to be used on the packs and labels for Covid-19 vaccines,” before such vaccines are released to the European market.
Vaccines Europe represents AstraZeneca and other vaccine manufacturers, such as Sanofi and GlaxoSmithKline; and big pharma is “pushing EU regulators to quickly choose one language for all 27 EU states for labelling, packaging and instructions on possible Covid-19 vaccines,” the report stated.
Talks of easing up on pharmaceutical documentation requirements have been going on as far back as June 2020, at least, when the EC proposed less stringent language and packaging requirements to speed up the development and distribution of a coronavirus vaccine. But the EC has yet to make a formal proposal.
According to the same Reuters report, such a proposal has been “underway to be flexible without compromising on safety,” and an EU official said they were considering printing information in a limited number of languages and putting other versions online.
The European Consumer Organization (BEUC), however, pointed out that simply publishing information online about the Covid-19 vaccine does not cut it. In a September 3, 2020 Good Morning Europe video interview, BEUC Director General, Monique Goyens, said that speed should never be at the expense of safety, “and certainly not an excuse for cutting consumer-protection measures.”
“Safety includes safe instructions of use. Therefore, it is important that consumers have information available in their language and on paper about possible side effects of vaccines. That is why we believe that online information can be an additional tool but should never be the default option,” Goyens said.
She added that publishing information on the Covid-19 vaccine exclusively online for certain languages runs the risk of excluding those consumers who may not have the digital skills to search the Internet for information, such as safety instructions and possible side effects. She further pointed out that some regions in Europe do not have a strong Internet connection or reliable broadband.
“It is important that consumers have information available in their language and on paper about possible side effects of vaccines” — Monique Goyens, Director General, BEUC
According to Slator’s latest Life Sciences Translation Report, each new drug, on average, takes 12 years and an investment of USD 1.5bn to develop, with many initially promising drugs falling by the wayside during the process. But the protracted process of taking drugs to market is intentionally rigorous to ensure appropriate levels of drug safety and efficacy.