Clinical research, diagnostic testing and commercialisation under Polish and EU law
Law as at 5 November 2026
Abstract
A change in an epigenetic clock may justify further investigation of a medicine. Its value as evidence of benefit depends on what the clock measures, the population in which it has been validated and whether treatment effects on the score predict effects on health. The same assay may be used to analyse archived samples, select participants for treatment or sell a test to consumers. Each use raises a different legal question. This article traces those questions from trial design through to commercial use, with particular attention to Polish law on medical experiments, performance studies, access to medical records and the use of data from non-commercial clinical trials.
Keywords ageing biomarkers, geroprotectors, clinical trials, IVDR, biobanks, genetic data
From 11 November 2026, telecommunications undertakings in Poland must meet new technical and operational requirements for the interfaces that give law enforcement and security agencies access to communications and related data. Interfaces already running under existing agreements may stay on the previous standard, but for no longer than 36 months. The new rules add 5G standards, real-time delivery and a dedicated interface for retained data.
On 4 November 2026 the Polish statute of 18 September 2026 consenting to the ratification of the Treaty between the Republic of Poland and the United Kingdom on a Security and Defence Partnership, known as the Northolt Treaty, was signed. The remaining steps are ratification and the exchange of notifications between Warsaw and London; the Treaty enters into force 30 days after the later notification.
Technical debt, GDPR and NIS2 – how yesterday’s shortcuts turn into tomorrow’s liability
Why technical debt arises
Technical debt is a phenomenon that sooner or later affects almost every IT project. It consists in choosing a solution that is quicker to deliver but inferior in technical quality. A team usually “takes out” this loan under pressure from the business side, for which the key metric is time-to-market – the sooner the product reaches the market, the better.
In the short term this brings a quick win, but in the future the company has to start paying the “interest”. It shows up as ever higher system maintenance costs, a slowdown in the pace of work, and the mounting frustration of developers who, instead of developing the product, must keep fixing the same defects over and over. Although the term “technical debt” appears nowhere in legislation, concepts such as due diligence and the adequacy of technical measures in practice force companies to keep that debt from spiralling out of control.
The legal framework following the 2021 amendment and the resolution of a panel of seven judges of the Polish Supreme Court of 15 May 2025 (III CZP 22/24)
For years, the summons to a settlement attempt was the cheapest way for creditors to “renew” the limitation period under Polish law – a single application was enough for a claim to gain another full period of actionability. Since 30 June 2022, the rules of the game have changed: the summons no longer interrupts the running of the limitation period, but merely suspends it for the duration of the conciliation proceedings (Article 121(6) of the Civil Code). The effects of applications filed under the former provisions – which the courts will continue to assess for years to come – have meanwhile been settled by the resolution of a panel of seven judges of the Polish Supreme Court of 15 May 2025 (III CZP 22/24). In this article, we explain what exactly has changed, how to defend against instrumental settlement summonses, and what a creditor planning to pursue a claim must bear in mind today.
