Extending the validity of medical device certificates (March 2023)
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.
Scientific advice in clinical trials
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: Pervasive forever chemicals
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.
Judicial revolution allows online alcohol sales
The judgment of the Supreme Administrative Court of 8 September 2022 has broken a relatively uniform line of decisions banning online alcohol sales.
Advertising of medical devices and collaboration with influencers
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.
Information or advertising? What pharmacies are allowed to do
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.
Healthcare Quality Act: Consider the Dutch experience
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.
Information on patients’ health disclosed remotely
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?
Over-the-counter drugs can’t be sold in mobile shops
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).
Contracts for supply of agricultural products under scrutiny
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.
Single-use plastics will disappear, new obligations will be imposed 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.
Cannabis under different controls
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.