WARSAW, 15 June (APM) - The Polish parliament’s amendment to the pharmaceutical law will reduce illegal drug exports, which could be worth as much as 2 billion zlotys (€470,000) a year reported Rzeczpospolita (pA16) on Monday.
The amendment prevents combining wholesaling and medical activity, which will block the ability to obtain legal prescriptions for purchasing drugs for illegal exports. The Chief Pharmaceutical Inspector (GIF) will also gain authority over permits for the production or import of drugs used in advanced therapy.
The amendment also requires drug distributors to comply with Good Distribution Practices, which, according to the European Commission’s guidelines prevents the introduction of falsified medicinal products into legal distribution chains.
It will also allow the Chief Pharmaceutical Inspectorate (CPI) to inspect dubious medicinal products at the premises of the manufacturer, distributor, marketing authorisation holder (MAH) and the MAH’s representative. Pharmacy managers will also be required to report suspicious products to the CPI.
The amendment will also make it easier for companies to hold clinical trials in Poland, by waiving the requirement to attach signed contracts with investigators and study centres with the application to conduct the trials, and only requires a description of the financing of the study, as well as the compensation for the participants, investigators and study centres.
New regulations mean paramedics can administer analgesics
A new regulation will provide clear instructions for administering analgesics to patients in ambulances, reported Rzeczpospolita (pA15) on Thursday.
Only 16% of patients suffering from single injuries and 26.6% of patients suffering from multiple organ injuries currently receive analgesics before reaching the hospital. The new regulations will provide a clear 10-grade classification of pain with instructions for ambulance staff on the choice of one out of eight analgesics, such as fentanyl, morphine, ibuprofen, ketoprofen, paracetamol and metamizole.
Difficulties in obtaining rhesus incompatibility treatment in Polish hospitals
Rhesus disease treatment has been free for Polish patients since January, not only during labour but also during pregnancy, but is difficult to obtain from many Polish hospitals, reported Dziennik Gazeta Prawna (pA8) on Thursday.
The medications, which are fully reimbursed by the Ministry of Health, need to be purchased by the hospitals themselves, but difficulties in forecasting the demand of a specific medication, as well as shortages in wholesaler supply mean the treatment is often unavailable to patients. As treatment needs to be applied during specific terms of the pregnancy, patients travel from hospital to hospital in search of the required medication.
The problem arises from the fact that treatments such as immunoglobulins 50 and 150 are not available on the market. Also, every batch of another treatment, anti-D immunoglobulins, needs to be individually authorised. Therefore, in order to counteract the shortages, every purchase needs to be planned at least two or three months in advance, which is difficult due to the high migration of patients between hospitals.
Bioton has chosen an investor for SciGen
Bioton’s Supervisory Board has recommended the conclusion of an investment agreement for SciGen with a Chinese investor, Yifan International, reported Parkiet (p04) on Saturday and Puls Biznesu (p3) on Tuesday.
The transaction is planned for almost 100 million zlotys (23 million euros), which, according to Bioton’s president, Robert Neymann, will be invested in R&D work, as well as the registration of new products over the coming four years - until the company is ready to launch its new insulin analogues, reported Puls Biznesu.
Mabion received 63 million zlotys for R&D facility
Mabion has concluded an agreement with the Polish Ministry of Investment and Economic Development for a subsidy of 63.25 million zlotys (14.8 million euros) to finance a research and development facility, reported Parkiet (p04) on Tuesday.
The total project cost will be 172.88 million zlotys (40.45 million euros) and will be invested in the construction of an R&D facility, as well as test equipment for innovative medicines, the latest generation biotech medicines, monoclonal antibodies.
Mabion’s current priority is to launch MabionCD20 - a treatment for lymphoma and leukaemia. The application for marketing authorisation for the treatment, which has been under development for the last 10 years, was filed with the European Medicines Agency on 4 June.