life sciences | In Principle

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?

Under current Polish law, it is illegal to sell OTC drugs from a motor vehicle. This was acknowledged by the Chief Pharmaceutical Inspectorate and confirmed by the Province Administrative Court in Warsaw in its judgment of 23 March 2021 (case no. VI SA/Wa 2691/20).

The EU’s Single CMO Regulation provides for heavy penalties for use of a form contract with even minor deviations from the formal requirements under that regulation. As a result, the National Support Centre for Agriculture may impose administrative fines of millions of zlotys on businesses.

Nearly two months ago the Ministry of Climate and Environment published a proposal to implement the Single-Use Plastics Directive ((EU) 2019/904) into Polish law. The amendment is supposed to enter into force no later than 3 July 2021, but it is raising many doubts.

On 2 December 2020, the UN Economic and Social Council’s Commission on Narcotic Drugs voted on recommendations from the World Health Organization Expert Committee. This has made some changes in the classification of cannabis, but not as far-reaching as producers and suppliers of cannabis products had hoped.

On 23 October 2020 the European Parliament voted on amendments to the CMO Regulation (1308/2013). Ultimately the lawmakers decided not to ban the use of names alluding to meat in relation to plant substitutes. It will still be possible to buy vegetarian sausage in stores and order veggie burgers in restaurants. But makers of ersatz dairy products may face a tougher time.

This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as a proving ground for the regulatory approach to oversight of algorithms.

The Minister of Health is issuing successive anti-export lists covering an increasingly wide catalogue of products at risk of shortages. This is to ensure access to drugs and medical devices for patients in Poland, especially during the difficult time of the COVID-19 pandemic. However, excessive expansion of the list of products may undermine the economic situation of producers manufacturing such products in Poland, which is probably not in line with the assumptions of the anti-crisis shield.