Poland’s Ministry of Health wants to place medicines with different active substances in a single reimbursement limit group where they work in a similar way, and to reward hospitals for choosing the cheapest therapy available. The change is meant to bring prices down and free up funds for innovative treatment, but clinicians warn that cost equivalence is not the same as clinical equivalence. We examine how the proposed baskets of equivalent therapeutic technologies could affect physicians’ autonomy, patients’ rights and competition in the pharmaceutical market, and what safeguards the legislation should contain. KG LEGAL KIELTYKA GLADKOWSKI supports international pharmaceutical, biotechnology and healthcare businesses operating in Poland. For legal assistance with pharmaceutical regulation, reimbursement and market access, contact our team at office@kg-legal.pl.
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.
