dr Ewa Butkiewicz
Scientific advice in clinical trials
Parliamentary work on Poland’s draft Act on Clinical Trials of Medicinal Products for Human Use is coming to an end. According to the bill, entities involved in clinical trials and introduction of new drugs will be able to receive scientific advice from the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. This will enable better preparation of tests and trials and consequently faster registration of safe and effective drugs.
Secondary use of electronic health data
Regulating the secondary use of health data opens up research and analytical opportunities, which can drive scientific progress, new products and devices, digital innovation in the healthcare sector, and improvement of the healthcare system.
Primary use of electronic health data
All EU citizens will have access to their electronic health records by 2030 thanks to the EU’s central eHealth platform linking national contact points to the MyHealth@EU infrastructure and efficient national digital health authorities.
The European Health Data Space
True cross-border healthcare based on medical documentation accessible throughout the EU via interoperative electronic health data systems. Unleashing the potential of health data for science and developing new drugs and treatments. These are among the benefits promised by the European Health Data Space.
Cannabis under different controls
On 2 December 2020, the UN Economic and Social Council’s Commission on Narcotic Drugs voted on recommendations from the World Health Organization Expert Committee. This has made some changes in the classification of cannabis, but not as far-reaching as producers and suppliers of cannabis products had hoped.
Tech versus virus: Remote diagnostics
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.
Doubts about the act on GMO-free products
From 1 January 2020 we could see new labels on the market on food and feed: “GMO-free” and “produced without GMOs.” But considering the requirements producers must meet before using such labelling, it may take longer for these products to reach the market.
In promoting foods, only the consumer’s interests count
The same requirements for nutrition claims and health claims prevail in communications targeted to specialists as in messages aimed at consumers. Consumer protection is the overriding priority.
Contact lenses are not cosmetics
The varying definitions of life science products and applicable provisions of EU directives and regulations can confuse even the most experienced judges, as in the case of a recent preliminary ruling by the Court of Justice sought by the regional court in the German city of Krefeld.
New criterion for evaluating product safety
The Court of Justice of the European Union has held that the probability of a defect can make a product defective.
Market leader: can there be more than one?
In times of fierce market competition, it is becoming increasingly attractive to construct advertising campaigns that contain superlatives, in particular regarding market leadership.
Airport ground services: A new approach
In the area of ground services, there is a battle between the interests of airports, groundhandling agents, staff and consumers. Any legal changes in this field typically represent a compromise between the interests of numerous stakeholders.
