The EU pharmaceutical package: Can access to drugs be reconciled with innovation?
Work on the EU’s pharmaceutical package is just gaining momentum, but it is already clear how highly controversial the project is. The dispute turns around the protection of drug registration data. This protection helps compensate for the huge financial investment in developing new drugs, but on the other hand delays the registration of cheaper counterparts. The reform would change the duration of this protection and require pharma companies to meet additional conditions.
Sale of energy drinks to minors will be banned
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.
Will pharmacy M&A still be possible?
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.
Secondary use of electronic health data
Regulating the secondary use of health data opens up research and analytical opportunities, which can drive scientific progress, new products and devices, digital innovation in the healthcare sector, and improvement of the healthcare system.
Primary use of electronic health data
All EU citizens will have access to their electronic health records by 2030 thanks to the EU’s central eHealth platform linking national contact points to the MyHealth@EU infrastructure and efficient national digital health authorities.
The European Health Data Space
True cross-border healthcare based on medical documentation accessible throughout the EU via interoperative electronic health data systems. Unleashing the potential of health data for science and developing new drugs and treatments. These are among the benefits promised by the European Health Data Space.
Coverage required for third-party liability insurance of healthcare providers
According to Polish and EU law, performance of certain services requires civil liability insurance. Such an obligation is imposed on entities performing healthcare activities, for which Polish law has specified the minimum amount of coverage. Can such coverage be exhausted by a medical loss?
Pharmacies only for pharmacists? The Supreme Administrative Court takes a stance
“Pharmacies for Pharmacists”: this slogan stands for a landmark amendment to the Pharmaceutical Law which has stirred heated debate. Will recent Supreme Administrative Court rulings cut through the controversy surrounding application of the amendment?
Medical assistance in Poland. A guide for citizens of Ukraine
What rights do patients—including patients from Ukraine—have in Poland? What should healthcare facilities do when receiving patients from Ukraine? What about filling their prescriptions? And how are the charges for their healthcare services settled?
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?
