Stores will combat the waste of food
According to recent estimates by FUSIONS (Food Use for Social Innovation by Optimising Waste Prevention Strategies), some 88 million tonnes of food is wasted every year in the European Union, and the related cost may be about EUR 143 billion. Although most food waste (c. 50%) occurs in households, distribution accounts for about 5%, or over 4 million tonnes of wasted food per year.
Manufacturing waiver weakens SPCs
Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products entered into force on 1 July 2019. The regulation introduced a “manufacturing waiver” excluding certain acts by drug manufacturers in the EU from the protection awarded under supplementary protection certificates.
Drug distribution: New regulations in the Pharmaceutical Law
For many years, drug distribution has been a strictly regulated business. Entities participating in the trade are licensed, the direction of permitted sales is strictly defined, and the market is subject to control by the Pharmaceutical Inspectorate. Nevertheless, the phenomenon of the “reverse drug distribution chain” still exists. Does the “anti-export” amendment of the Pharmaceutical Law have a chance of eliminating irregularities without paralysing legal trade?
Use of criminal law to combat drug distribution
On 6 June 2019, another amendment to the Pharmaceutical Law came into force. Its aim is to reduce the occurrence of non-availability of medicines. According to the authors of the changes, only more severe penalties and broader penalisation can limit the undesirable occurrence of the reverse distribution chain. However, the first comments on these changes show that the threat of penalties alone may not be enough to achieve this goal. It has been known for some time now that the inevitability of punishment is an indicator of the effectiveness of criminal policy.
Will there be more transactions on the pharmacy market?
There have been few transactions on the pharmacy market in Poland since 25 June 2017, when the amendment to the Pharmaceutical Law popularly known as “Pharmacies for Pharmacists” entered into force. The transactions that did occur carried significant regulatory risk. This situation may change due to a recent interpretation by the Ministry of Health. Will we witness a gradual departure from the restrictive limitations under the 2017 amendment?
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?
Medical data—keep or delete?
From 25 May 2018 Polish healthcare institutions will face conflicting rules on how to handle medical documentation under the EU’s General Data Protection Regulation and Polish healthcare laws. The inconsistencies could be eliminated by the new Personal Data Protection Act, but it appears unlikely that work on the new act will end on time. So what should institutions do to limit their regulatory risk?
