In order to speed up delivery of a successful Covid-19 vaccine pharma companies have been urging the EU to relax its rules on providing printed translations of outer packaging, labelling and patient leaflets into all of the languages of its Member States, as covered by Directive 2001/83/EC.
When the European Commission had made its down payment for 300 million doses of a potential Covid-19 vaccines from AstraZeneca, this and other manufacturers were pushing for regulators to relax the rules which state that medicinal products sold in the EU must include documentation in the national languages of the Member States. All 24 of them.
A Reuters report at the beginning of September 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”. Vaccines Europe represents big vaccine manufacturers and was asking the EU to make a quick decision for one single language to be used in the printed accompanying materials, as this was the only way to accelerate the administrative process – and get the vaccine to as many people as possible across all EU member states.
The European Commission is legally responsible for providing the marketing authorisation for any medication coming onto the EU market. It will verify the soundness of all including scientific justifications, product information, educational material to health care professionals, labelling, obligations for the vaccine developer, conditions for use, patient information on possible side effects, etc. Specifically, the Commission is also responsible for ensuring that all necessary information is available to patients and health care professionals across the EU in their national language(s).
In the case of an emergency such as the Covid-19 pandemic, the EU has the instruments to accelerate the authorisation process. Naturally, this cannot be at the expense of efficacy, quality and safety. But it does allow for agility and flexibility, and for exemptions, to ensure rapid deployment. This means among other things: a shorter timeframe for consultation with the Member States, and restricting – at least for an initial phase – printing the required information in one language only.
Needless to say, the one language would be English. All member states plus Norway and Iceland, were then asked whether they would agree to initially allow for the vaccine to be accompanied by English documentation only, on the understanding that this would be a temporary exemption only and that alternative methods of providing access to the leaflet in the national languages would be provided, i.e. publication on the Internet.
Strong counterarguments came from consumer rights groups such as the European Consumer Organization (BEUC). They were adamant that publishing vital information on the Covid-19 vaccines online was not good enough. Monique Goyens, their Director General, said that speed must never be at the expense of safety and could not be “an excuse for cutting consumer-protection measures”. The Organization insisted that making details available online would be detrimental to people living in certain regions where Internet access was not assured, for example, or those with no access to digital information.
The information that I could find does suggest that in the interest of getting populations vaccinated as quickly as possible once vaccines become available, the majority of the Member States have now agreed to allow flexibility, i.e. exemption.
The relevant passage in the Memorandum of Understanding with Member States on regulatory flexibility for Covid-19 vaccines (published in September) is this:
The Commission having considered the above, intends that for the authorisation of Covid-19 vaccines during the pandemic and under accelerated procedures (e.g. conditional marketing authorisations) for a temporary period: a) to alleviate some of the language requirements and limit as a result the information on the immediate and outer packaging to one EU official language, preferably English. In addition, and in order to allow the creation of multilingual labels and facilitate availability, the option of labelling simplification via omission of particulars should also be considered. Details are provided in the relevant published guidance: https://www.ema.europa.eu/en/documents/regulatory-proceduralguideline/recommendations-implementation-exemptions-labelling-packageleaflet-obligations-centralised_en.pdf
It is important to note that the translation exemption applies to printed materials only. Labelling and package leaflets will still be translated in all EU official languages and published on the EMA website. The Member States opposing the request for the exemption are: Belgium, Bulgaria, Croatia, Czech Republic, France and Greece. As the exemption to the translation obligation is handled at national level, I fear that citizens of these countries may need to wait rather longer for their vaccination. Clearly, the right for a product leaflet in your own language is a human right, too.