WARSAW, 25 Jan (APM) - Poland's Supreme Audit Office (NIK) claims the Chief Pharmaceutical Inspectorate (GIF) did not impose fines of up to 1 billion zlotys (€233 million) on organisations involved in illegal drug exports in 2016 and 2017, reported Dziennik Gazeta prawna (pA1 & pB6) on Monday.
The GIF did not use its primary tool, namely fining wholesalers involved in illegal activities up to 5% of their annual net profit, simply because these organisations refused to disclose their financial results.
In such cases, rather than asking the tax authorities for assistance, the GIF failed to act at all. Michal Trybusz from the GIF claims NIK’s conclusion is unfair, as the more restrictive regulations that were supposed to curb illegal drug exports were introduced in 2015, but they were not followed up by additional regulations giving proper authority and tools to the GIF.
Additionally, the tax authorities only recently started to cooperate with the GIF, which resulted in the imposition of the first fine of 47 million zlotys (€11 million) on 12 September 2018.
The value of illegal drug exports is estimated at 2 billion zlotys (€466 million) per year.
Prosecutor to probe questionable reimbursement decisions
The public prosecutor responded to the reports of the Razem party and the Sejm’s Health Commission and will investigate the alleged irregularities regarding reimbursement decisions at the Ministry of Health (MoH), reported Gazeta Wyborcza (p6) on Saturday.
The issue primarily applies to the MoH’s decisions to increase the official prices of two anticoagulants, Xarelto and Pradaxa, by 25% just before their patent protection was due to expire, when the official prices should be reduced by at least 25%. Additionally, the MoH issued a similar decision for the multiple sclerosis drug Gilenya and doubled the price of the flu vaccine Vaxigrip.
While the MoH’s officials assured the public prosecutor in December 2018 that all the decisions were made in accordance with the regulations, the investigation officially started on 15 January because of the suspicion of potential bribery.
Legal experts criticise reimbursement regulations and NHF
Legal experts from the KRK Kieszkowska Rutkowska Kolasinski law firm, Natalia Lojko and Zuzanna Chromiec, have criticised the reimbursement regulations and the fact that increasingly more power is given to the National Health Fund, reported Dziennik Gazeta Prawna (pB11) on Thursday.
The experts say the NHF gained additional powers in 2018 regarding joint tenders for hospital drugs, but the regulations are still imprecise and do not define the whole process, which often results in disorganisation, double-checking all decisions by officials and wasted resources.
Furthermore, the NHF compares the prices of medicines bought by hospitals for drug programmes with the country average and makes decisions about future levels of financing based on these results. This is extremely problematic for hospitals, as they have no tools for tracking their spending compared with other hospitals and feel forced to use cheaper, potentially less effective drugs.
The experts conclude that the NHF should not assume the role of health minister in influencing the reimbursement policy, but should finance healthcare services and medicines the minister classifies as being guaranteed, which is not reflected in the regulations and current practice.
Mabion could register its MabThera biosimilar in 2019
Polish biotech Mabion, which filed the registration documentation for its MabThera biosimilar, MabionCD20, with the European Medicines Agency in mid 2018, could receive marketing authorisation for it in the second quarter of 2019, reported Parkiet Gazeta Gieldy (p4) on Monday.
Mabion has already received $5 million from its partner Mylan as a milestone payment for submitting the documentation for its drug, and could receive an additional $30 million on completion of the registration process.
Mabion is also preparing to file the documentation for MabionCD20 in the U.S., but that depends on the outcome of additional clinical trials required by the U.S. Federal Drug Administration. Artur Chabowski said Mabion is in the process of negotiating partnerships in the U.S. and in other regions of the world where the drug could be distributed in the future.
Chabowski claims the sales potential of its biosimilar depends entirely on how fast the company manages to register it. Mabion reported a net loss of 52.3 million zlotys (€12.2 million) after the first three quarters of 2018.
Synektik working on cardiac radiopharmaceutical
Synektik completed Phase II trials of its innovative cardiac radiopharmaceutical in December 2018 and is hoping to start Phase III when the results are filed by an external partner by the end of the second quarter of this year, reported Parkiet Gazeta Gieldy (p4) on Wednesday.
Cezary Kozanecki, Synektik’s CEO, said the cardiac radiopharmaceutical is the company’s flagship project and completion of Phase III could have a positive impact on Synektik’s financial results. He added that numerous large players from the healthcare market are interested in the project and that the company could sign a partnership agreement at some point with one of them to continue developing the product.