Regulatory Reforms
/ Poland
All legal aspects surrounding the regulatory reforms in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119.
1. Are there proposals for reform or significant change to the healthcare system?
Act on Medical Devices
In May 2022, a new Act on medical devices went into effect. Nevertheless, it has not entered into force in its entirety. Regulations on medical device advertising will take effect on 1 January 2023, while regulations on the list of distributors and information systems maintained in this regard will take effect on 1 July 2023.
Proposed legislation on clinical trials
Legislative work is underway on a new bill on clinical trials, which will regulate, among other things, issues concerning the system of ethical evaluation of clinical trials of medicinal products, the civil liability of the investigator and the sponsor, and, above all, will ensure that Poland complies with the European legal order. The most important solutions to be introduced in the proposed legislation concern safeguarding the interests of the patient, for example through the establishment of a Guarantee Fund, which will make it easier to receive compensation. In addition, not only doctors, but also nurses or midwives with a university degree will be able to be the principal investigators of clinical trials.
Proposed legislation on veterinary medicinal products
At the beginning of 2022, Regulation 2019/6, which deals with veterinary medicinal products, came into force. It is not yet known whether the changes resulting from the EU regulation will be implemented at the domestic level in the Pharmaceutical Law, or whether a separate act will be created to cover only veterinary medicinal products. This also applies to new veterinary good distribution practice.
2. When are they likely to come into force?
Probably within the next one or two years, but this has not been decided yet.
