life sciences | In Principle

On 28 August 2023, an amendment to the Public Health Act was published, including an important change impacting the food industry. After lengthy debate, it was decided to impose an absolute ban on the sale of energy drinks to minors. Ultimately, proposed advertising restrictions were dropped, but new labelling requirements for beverages containing caffeine or taurine remain. Starting 1 January 2024, the new regulation will force manufacturers and vendors to adjust their internal procedures for marketing energy drinks in Poland.

On 17 August 2023 the parliament held its final vote on a bill to tighten the section of the Pharmaceutical Law known as “Pharmacies for Pharmacists.” Now the act will be sent to the President of Poland, who will decide whether to sign it into law. The amendment (known as “Pharmacies for Pharmacists 2.0”) is stirring a lot of controversy. Its entry into force would significantly restrict the possibility to buy and sell pharmacies, and would require the Pharmaceutical Inspectorate to scrutinise franchise agreements. Pharmacy chains are concerned that the new provisions will lead to expropriation.

For some time, the initial marketing of certain types of foods in Poland has required notification of the Chief Sanitary Inspector. The notification system for dietary supplements and functional foods has been in place in Poland for more than 20 years, and a similar system is in place in most EU member states. The most questions arise from the initiation of explanatory proceedings involving the classification and compliance of the notified product. Further doubts began to arise at the beginning of 2023, when a long-expected bill amending the regulations governing the procedure for reporting and advertising dietary supplements was published.

On 13 May 2023, a new regulation with detailed requirements for advertising of medical devices enters into force. Advertisers of such products, including influencers, must include warnings in advertising messages, similar to those familiar from drug advertisements.

On 20 March 2023, an amendment to the Medical Device Regulation was published in the Official Journal of the European Union, extending the validity of certificates for medical devices issued under the earlier regulations. The amendment was adopted as a matter of urgency and went into effect immediately (on the date of publication). The extension is intended to prevent shortages of medical devices on the market.

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.

PFAS is a collective name for some 5,000 chemical compounds widely used in industry and everyday items. They have a harmful effect on the environment and human health. Recently, they have been the subject of intense research by the European Chemicals Agency and the US Environmental Protection Agency. This is reflected in the growing number of regulations restricting their use. However, awareness of the harmfulness of these compounds seems to remain low, as evidenced by the small number of court cases in this area.

The judgment of the Supreme Administrative Court of 8 September 2022 has broken a relatively uniform line of decisions banning online alcohol sales.

Significant changes are coming for medical device advertising. The rules will be much stricter than before, but still more lenient than drug advertising regulations. For the first time, the new Medical Devices Act regulates influencer advertising. It is already clear that sponsored content will be deemed to be advertising and thus must meet specific requirements under the Medical Devices Act. Companies have until the end of the year to sort out their relationships with influencers.

In 2012, a restrictive ban on advertising by pharmacies was introduced into Polish law. According to Art. 94a of the Pharmaceutical Law, it is only permissible to provide information on the location and working hours of a pharmacy or a pharmacy outlet. Violation of the ban can draw a heavy fine, up to PLN 50,000. In practice, the advertising ban is strictly enforced by the province pharmaceutical inspectors, which results in numerous administrative fines imposed on businesses.

The proposed changes in healthcare in Poland would not only impose new obligations of healthcare providers, but also seek to raise the quality and safety of medical services. Periodic external audits and mandatory reporting of adverse events are to be introduced. This represents an organisational change, but also a cultural one. Every hospital employee would have to be aware of their responsibility towards patients, and all processes would be designed to focus on the patient. The idea of a patient-centred system has been discussed in Poland many times, but not even a uniform definition or principles for such an approach have been adopted to date. It is worth taking a look at how others are doing it.

The law in Poland is quite precise about who can be given information about a family member’s health, and in what situations. But when contacted by a family member by phone, how can the healthcare provider verify the caller’s identity? And can a hospital in principle refuse to provide information by phone?