life science

No supplementary protection for a new form of an active substance

In a judgment of 21 March 2019 (C-443/17) the CJEU reiterated the need for a precise and concise interpretation of the term “protected product” under Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products. The CJEU stressed that this term only applies to an active ingredient of a medicinal product, and not combination with other substances that do not have an independent therapeutic effect.

Food law 2019: GMO-free labelling

“GMO-free” offers a strong and appealing marketing message. The use of this claim is not regulated at the EU level. Individual member states, including Poland, are adopting national criteria that must be met by products for the manufacturer to call them GMO-free. What are these criteria, and what products do they apply to?

Food law 2019. Double standards in food

The European Parliament has specified areas in which measures are to be taken to prevent unreasonable variation in product quality on the single EU market. Varying quality in this way will be a prohibited market practice. This is the main change planned for 2019, but not the only change.

Food Law 2019. Vegan food—what does it really mean?

The controversial judgment of the Court of Justice of the European Union in TofuTown (C-422/16) triggered a long-delayed discussion on the proper labelling of vegetarian and vegan food. This issue, which for a long time has not been a priority for the European Commission, is just becoming one. Will the time of regulatory uncertainty, to the detriment of producers, consumers and regulators, come to an end?

Can the name of an alcoholic beverage be misleading?

Alongside the trademark, the label of a product must also identify the product itself, so that consumers know what type of product they are being offered. But in the European Union alone, there may be a dozen or more legal definitions of certain alcoholic beverages, such as cider or perry. This means that the qualitative requirements differ across various member states, presenting a huge challenge for producers, particularly when the EU policy agenda has taken up the fight against double standards for foods offered in different parts of the EU.

CJEU on transparency of medicine registration data

On 5 February 2018 the CJEU issued long-awaited judgments in three cases in one day concerning release to third parties of medicinal product registration documentation. These rulings confirm the European Medicines Agency’s current data transparency policy. How are conflicting interests weighed regarding release of medicine registration data?