WARSAW, 8 Mar (APM) - The involvement of Poland's tax authorities is helping curb the problem of illegal drug exports, reported Dziennik Gazeta Prawna (pA1 & pB6) on Monday.
While the Ministry of Finance (MoF) claims illegal drug exporters are not afraid of pharmaceutical inspectors and prosecutors, they have certainly been on the look-out since the introduction of regulations involving the fiscal authorities.
The MoF draws this conclusion from the fact that, since the involvement of the fiscal authorities in auditing potential illegal exporters, the revenues of pharma wholesalers have dropped by an average of 41%, while the whole of the legal market is constantly growing.
The value of illegal drug exports is estimated at 2 billion zlotys (€465 million) a year and experts agree that, while the involvement of the fiscal authorities is a step in the right direction, more tools are needed for the pharmaceutical inspectors to systematically eliminate organisations involved in illegal activities from the market, as their actions are harming patients who have difficulty in obtaining drugs from pharmacies.
EU falsified medicines regulations raise controversies
The EU falsified medicines regulations, which took effect in Poland on 9 February, are raising a great deal of controversy, primarily due to the additional responsibilities of organisations handling drug distribution and fines, reported Rzeczpospolita (pA11) on Tuesday.
Pharmacists have demonstrated that they are not properly prepared for adapting to the new regulations and responsibilities.
Piotr Merks from the European Association of Employed community Pharmacists in Europe, says the system needs two more years to operate as intended and that the coordination of activities leading to its launch, as well as access to educational materials should have been better. Pharmacists are also concerned about potential fines for not complying with the regulations, which can be as high as 500,000 zlotys (€116,000).
According to the regulations, certain drugs must have special barcodes on their packs to enable their authenticity to be checked, while pharmacists are required to scan those codes before dispensing the drugs to patients.
A similar procedure applies to medical institutions, although many of them, both in Poland and other member states, still do not have the IT systems in place to make this possible. Additionally, the regulations require pharmacies, wholesalers and medical institutions to check every questionable batch of drugs, which, according to Business Centre Club, could lead to the paralysis of imports and drug distribution in Poland.
NHF owes hospitals money for medicines
Numerous hospitals are sounding the alarm bells that the National Health Fund (NHF) owes them money for drugs, which could result in some of them stopping treatment, reported Gazeta Wyborcza (p3) on Monday, Dziennik Gazeta Prawna (pA3) on Tuesday and Rzeczpospolita (pA14) on Wednesday.
The situation is dramatic, as the NHF did not pay hospitals across Poland 102 million zlotys (€23.7 million) in December 2018 for drugs administered mainly to cancer patients in drug programmes and many hospitals can no longer support the situation and are already or will soon be forced to discontinue treatment with drugs for which the NHF is not paying, reported Dziennik Gazeta Prawna.
Experts say it appears the NHF underestimated the value of drugs it was supposed to reimburse to hospitals and did not plan its spending on drugs would reach the maximum 17% threshold of its total budget, as specified by the Reimbursement Act. The problem could have a great deal to do with the fact that Polish patients gained access to many new therapies in 2018, including long-acting drugs for schizophrenia, modern drugs for lung cancer, leukaemia and spinal muscular atrophy, as well as free flu vaccines for patients aged over 65, reported Rzeczpospolita.
Former director of the Masovian division of the NHF, Adam Twarowski, says the medicines' budget has never been exceeded since the introduction of the Reimbursement Act, while the funds left over have always been used to pay the hospitals for surplus services. He believes that, this time, the NHF should use the excess from the public health insurance contributions for 2018, estimated at 900 million zlotys (€209.3 million), reported Rzeczpospolita.
Experts say public spending on drugs in Poland is too low. According to IQVIA, it is among the lowest in Europe, amounting to only 0.5% of GDP, which is much less than the Central and Eastern European average of 1% of GDP.
IQVIA estimates that a 10% increase in spending on drugs would give a similar short-term effect to a 10% increase in overall healthcare spending, while increasing spending to the European average would help increase the life expectancy of women by 12 months and men by 14 months, reported Rzeczpospolita.
Shortages of antibiotics in hospitals
Hospitals are warning they are struggling with shortages of cephalosporins, extremely popular and effective antibiotics to be administered daily to about 12,000 patients, reported Dziennik Gazeta Prawna (pA1 & pA4) on Thursday.
The shortages started around two weeks ago and, while the Ministry of Health claims the problem has been already resolved, Polpharma, the main supplier of cephalosporins, admits the problems with deliveries should be addressed at the beginning of April.
Doctors say the administration of other antibiotics instead of cephalosporins could be risky, which is why hospitals are postponing non-urgent admissions.
The reason for the shortages is the EU falsified medicines directive, which requires manufacturers to label certain drugs with special barcodes. These procedures are taking longer than expected and there is a risk that pharma companies will try to compensate for their investment by increasing the prices of non-reimbursable drugs later.
NHF will have additional money at its disposal
The MoF agreed on Wednesday for the NHF to use the additional 900 million zlotys (€209.3 million) left over from 2018, reported Dziennik Gazeta Prawna (pA5) on Thursday.
The money could be used to increase financing for hospitals and salaries of medical staff, reduce patient waiting times, improve access to glaucoma treatment and CAT scan services and, importantly, reimburse hospitals for drugs used in drug programmes, as the NHF currently owes more than 100 million zlotys (€23.3 million) from December 2018 alone.
Medical Research Agency to open shortly
The Medical Research Agency (ABM) is to start operating in the third week of March and organise its first tenders in the second half of the year, reported Rzeczpospolita (pA17) on Thursday.
The first tenders will apply to oncology, cardiology and rare diseases. The ABM is expected to help increase the percentage of non-commercial clinical trials organised in Poland from the current 1% of all trials up to as much as 30%, as in the U.S.
The officials also hope the ABM will help increase the value of the Polish clinical trials market, currently estimated at 1.2 billion zlotys (€279 million). During the first year, the agency will have 50 million zlotys (€11.6 million) at its disposal, but its budget is to be increased to 1 billion zlotys (€232.6 million) over 10 years. The ABM will be financed from the state’s and NHF’s budgets.
Medical authorities clamp down on doctors supporting 'anti-vaxxers'
Medical authorities are starting disciplinary proceedings against doctors supporting people who oppose vaccination, so-called anti-vaxxers and spreading information about vaccines that are inconsistent with current medical knowledge, reported Dziennik Gazeta Prawna (pA2) on Tuesday.
No licence has so far been revoked for any doctors and all cases assessed have resulted in reprimands or warnings. Some doctors and experts are outraged that the medical authorities are applying pressure to doctors supporting anti-vaxxers and claim the authorities are overstepping their powers.
OncoArendi Therapeutics preparing to agree partnership
Polish biotech OncoArendi Therapeutics is intending to sign a partnership agreement for its OATD-01 molecule by the end of 2020, which could bring it €200-400 million, reported Puls Biznesu (p8) on Tuesday.
OncoArendi entered Phase 1b with OATD-01 in February. While this molecule was initially planned to be developed as an asthma drug, there is also potential for its use in sarcoidosis. Phase 1b is being conducted in Germany on healthy patients receiving increasing doses of the drug and is supposed to end in August. If OATD-01 proves too toxic, the company has backup particles that it could continue developing, but the risk of such a scenario is low.
OncoArendi is looking for major players from the U.S., Japan and the EU to sign a partnership agreement, but is not ruling out partners from China or India.
The company is also running pre-clinical trials for another molecule, OATD-02, which could be used in cancer immunotherapy. In this case, the potential commercialisation willdepend strongly on the toxicology tests and the developments of its U.S. competitor, Callthera, which is running more advanced clinical trials for a similar particle.
Celon Pharma continues developing anti-depressant
Celon Pharma is continuing to develop its esketamine-based drug for treating drug-resistant depression, reports Parkiet Gazeta Gieldy (p4) on Friday.
The company is very optimistic about the project, especially as another esketamine-based drug, Spravato produced by Janssen, that could be used in unipolar depression, has recently been approved in the U.S.
Celon Pharma claims its drug could also be used in bipolar depression, with a more convenient and potentially more effective form of administration as an inhalant. Celon Pharma’s drug is currently in Phase II and could be launched four to five years after Spravato. The company intends to sign a partnership agreement in 2020 to continue developing and then commercialising the drug.