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.


Electronic cross-border health services – MyHealth@EU

publication date: December 13, 2022


Undoubtedly, the need to exchange IT data has been increasing for several years. One of such areas is medicine, which has already become a relatively computerized field during the COVID 19 pandemic, e.g. obtaining a referral for vaccination in Poland consisted in issuing it in the Internet IT system, it could not be obtained in a traditional written form. This is a procedure that speeds up all medical procedures, which the European Union strives to achieve by creating and disseminating the MyHealth@EU program.


MyHealth@EU is a program that accelerates the exchange of health informatics data and can be defined as the European Health Digital Service Infrastructure. The most important assumption is that E-prescriptions and patient cards will be available in all EU countries by the end of 2025.

Personal data as the basis for action


3D bionic pancreas – great potential to be used. A team of scientists from Poland is looking for investors

What is a 3D bionic pancreas?

publication date: December 13, 2022

It is a ready-made medical device made of living cells and biomaterials, i.e. biological elements, and printed using 3D technology. It will primarily apply to patients with type 1 diabetes who experience severe complications. This is a huge breakthrough and an original idea of Polish scientists led by Dr. Michał Wszoła. This is an opportunity for patients as effective as transplantation, and at the same time less invasive compared to pancreatic islet transplantation. As a result, it will require neither a deceased donor nor immunosuppressive treatment.

An alternative to a transplant


European Medicines Regulatory Network adopts EU common standard electronic product information

publication date: November 29, 2022

Dissemination of impartial and up-to-date information on all medicines available to patients in the EU through electronic channels

The European medical market currently offers many substances with various medicinal properties, coming from many sources, often purchased from foreign distributors. Medicines are imported by the Member States of the European Union depending on the demand. Due to the multitude and variety of substances available on the medical market, in order to ensure consumer safety, it is necessary to provide access to comprehensive information on the substance admitted to the market, its properties, effects and possible side effects. Both the persons responsible for dispensing the medicine and the consumers purchasing them should have such knowledge.

The European Medicines Regulatory Network has adopted a common standard for electronic product information (ePI) on medicines in the European Union, the initiative aims to provide better and wider access to the database containing data on a specific medicinal substance. The information made available via electronic channels is primarily to be reliable, up-to-date and available to all interested parties. The establishment of common EPI standards in the European Union will streamline the process of providing and updating information provided to patients, consumers and healthcare professionals, thanks to which decisions regarding the consumption of a given substance will be more informed.