Archive – Life Sciences (2026)

The Ministry of Health has submitted a far-reaching amendment that would revise the Healthcare Digitalisation Act, the Medicinal Products Act, and the Health Services Act. The amendment represents the first stage of implementing the EU Regulation on the European Health Data Space (EHDS). In addition

A German court has banned the sale of smaller Milka chocolate bars in packaging that is virtually identical to the previous one, unless consumers are clearly informed of the change in weight. The Czech legal system does not currently contain an explicit obligation to provide information about change

Companies involved in the development of medicinal products and therapeutic treatments process patients’ health data, yet they often cannot rely on the same legal basis for processing as healthcare providers. Many therefore choose patient consent as apparently the safest route. Supervisory authoriti

Certification mark is still very much a marginal tool in the Czech Republic. And yet, it can be extremely useful for professional chambers, societies, associations and other entities that wish to guarantee a certain standard of quality, origin or production method on the market. And if it highlights

The European Union is introducing new rules on packaging and packaging waste. The PPWR regulation aims to reduce unnecessary packaging waste, harmonise rules across the EU and encourage companies to take a more holistic approach to packaging, “from design to recycling”. The good news is that this is

From what point may a patient suffering from a progressive disease bring a claim for compensation for personal injury caused by vaccination with a defective vaccine? Is the expiry of the ten-year limitation period, regardless of whether the claimant’s medical condition has stabilised, compatible wit

In March 2026, the State Institute for Drug Control (SÚKL) issued a new notice that deserves close attention. The Czech regulator reiterates a key rule: advertising aimed at the general public must not promote medical devices that, under the manufacturer’s instructions, are intended solely for use b

Reimbursement for original medicinal products gradually decreases over time – it “erodes”. A key factor in this process is the entry of the first generic (Gx) or biosimilar (Bx) into the reimbursement system. This usually leads to a broad reduction in reimbursement across the entire reference group

A notable novelty has taken effect as of 1 January 2026. Under an amendment to the Czech Public Health Insurance Act, public health insurance companies can now centrally procure the purchase of selected medicines that are intended for hospitals with the status of highly specialised care centres. The

On 1 January 2026, an amendment to the Public Health Insurance Act entered into force, introducing a completely new reimbursement rules for vaccines and monoclonal antibodies intended for prophylaxis (“vaccines”). Under the new framework, decisions regarding reimbursement for vaccines will be made i

As of 1 January 2026, new price regulations issued by the Ministry of Health of the Czech Republic will come into force, governing the prices of medicinal products, medical devices, and healthcare services. In addition to partial content-related changes, they also introduce a major systemic novelty