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Contracts for supply of agricultural products under scrutiny
administration, contract, life sciences
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.
Veggie burgers will still be a thing
life sciences, project
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.
Tech versus virus: Remote diagnostics
coronavirus, life sciences, new technologies
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.
Drug exports in a time of pandemic
coronavirus, life sciences
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.
Drug distribution: New regulations in the Pharmaceutical Law
already in force, life sciences
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?
Will there be more transactions on the pharmacy market?
life sciences, M&A
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?
Food law 2019: GMO-free labelling
life sciences, project
“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?
Data protection and public procurement
new provisions, data protection, public procurement
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?
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?
Transportation service applications to be regulated?
Major changes to the Road Transport Act are in the pipeline. The changes are intended to regulate the activities of firms that act as go-betweens in passenger services, for instance by providing mobile applications or computer software.
Can the name of an alcoholic beverage be misleading?
life sciences, intellectual property
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.