Joanna Krakowiak | In Principle

Until now, the obligation to comply with the EU economic sanctions regime has arisen directly from the EU regulations, in particular Regulation 833/2014 and Regulation 765/2006 containing restrictive measures against Russian and Belarusian entities, but violation of bans has not been subject to fines. This situation should change, as a bill on special solutions to prevent the support of aggression against Ukraine and to protect national security is being taken up in the Polish parliament.

24 February 2022, the day when Russian troops unlawfully invaded the territory of Ukraine, proved to be the beginning of a test of European solidarity, and of the resilience of the European economy. On a macro level, a huge question has arisen: Can the European economy function without eastern markets? At the micro level, businesses are faced with dilemmas of how to deal with counterparties from that region, particularly in the context of existing long-term contracts at an advanced stage of completion.

The EU’s Single CMO Regulation provides for heavy penalties for use of a form contract with even minor deviations from the formal requirements under that regulation. As a result, the National Support Centre for Agriculture may impose administrative fines of millions of zlotys on businesses.

On 23 October 2020 the European Parliament voted on amendments to the CMO Regulation (1308/2013). Ultimately the lawmakers decided not to ban the use of names alluding to meat in relation to plant substitutes. It will still be possible to buy vegetarian sausage in stores and order veggie burgers in restaurants. But makers of ersatz dairy products may face a tougher time.

This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as a proving ground for the regulatory approach to oversight of algorithms.

The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic. However, excessive expansion of the list of products may undermine the economic situation of producers manufacturing such products in Poland, which is probably not in line with the assumptions of the anti-crisis shield.

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?

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?

“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?

A key element of the proposed new Public Procurement Law is to regulate the protection of personal data collected in the course of procurement procedures. Significant exceptions from the general rules of the GDPR are planned. What should they consist of?

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.

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?