A drug solution in a modern syringe like novel food – regulatory issues of a drug, medical device and novel food (a borderline product)

Publication date: April 11, 2023

A drug in a disposable dispenser as a slimming agent – is it legal?

Press controversies related to the use of modern drugs created for the treatment of chronic diseases for procedures with the use of their side effects raise a number of legal problems related to the legality of using such medicinal products for non-dedicated procedures with the use of side effects of the medicinal substance.

Legal assessment on the example of press releases about the use of diabetes drugs, such Ozempic for slimming. Regulatory issues between the drug law and the law of medical devices.



Publication date: March 30, 2023


Corporate Sustainability Reporting Directive

Publication date: March 10, 2023

On 5 January 2023 the Corporate Sustainability Reporting Directive (CSRD) entered into force. In the framework of European green deal and ESG initiatives, this new directive tries to modernize and strengthen the rules about social and environmental information that companies have to report. A broader set of large companies, as well as listed SMEs, will now be required to report on sustainability – approximately 50.000 companies in total. By the previous regulation, the Non-Financial Reporting Directive, only about 11.000 companies were required to report. A consultation carried out by the Commission found that many stakeholders were in favour of extending reporting requirements to additional categories of companies.


Regulations of patent law in relation to generic drugs – international aspects and Polish law

Publication date: February 23, 2023

What is a generic drug?

A generic drug is one that has been created in the same way as a branded drug in terms of dosage, safety, efficacy, route of administration, quality, properties of action and intended use. These similarities help demonstrate adequate bioequivalence, meaning that the medicine will work in the same way as the original medicine. In other words, the original drug is equal to the generic substitute.

Generic drugs typically cost significantly less than their original counterparts because they take much less time to produce and eliminate the costs associated with animal testing and clinical trials. Often such a shortened drug registration path is called “shortened application of a new drug”. As a result of reducing the research costs associated with generic drugs, their final price is much lower than the price of the original product (usually they are 80 to 85% cheaper than the original ones), which makes them much more willingly bought by customers and generate much higher profits than generic products original. According to the IMS Health Institute, these drugs saved more than $2.2 trillion to the healthcare system between 2009 and 2019.


EU lawmakers approve ban on new fossil fuel cars effective as of 2035

Publication date: February 21, 2023

The last Tuesday, the European Parliament formally approved a law to effectively ban the sale of new internal combustion cars, petrol and diesel cars, in the territory of the European Union by 2035. But, it still has to be formally endorsed by the Council. These actions are taken to achieve the landmark of 0% CO2 emissions from new cars sold by 2035 in the 27-country bloc. Furthermore, the law also put a goal cut 55% in CO2 emissions for new cars and 50% for vans sold from 2030 versus 2021 levels. This ban will affect all new cars and vans sold in EU by 2035, not to other types of vehicles.