WARSAW, 6 July (APM) - While Poland's National Health Fund’s budget for 2019 will increase by 5 billion zlotys (€1.14 billion) to 82.5 billion zlotys (€18.8 billion) in 2019, the share assigned to drug reimbursement will remain unchanged, reported Dziennik Gazeta Prawna (pA1 - A3) on Wednesday.
The structure of spending will not change, with 47% of total resources spent on hospital treatment, 14% on basic healthcare services, 10% on drug reimbursement, 6% on outpatient specialist care and 23% on all other areas.
The officials still intend to increase the healthcare spending to 6% of Poland's economic output by 2025.
New transparency reports for Polish pharma industry
According to a report prepared by an association of 32 manufacturers of generic and originator drugs operating in Poland, the companies paid 710 million zlotys (€162.1 million) to healthcare professionals and patient organisations in 2017, reported Rzeczpospolita (pA17) on Tuesday.
Pharma companies assigned 454.4 million zlotys (€103.7 million) to R&D activities, such as clinical trials, 137.8 million zlotys (€31.5 million) to healthcare organisations, and 118 million zlotys (€26.9 million) to healthcare professionals.
The reports have been published for the past three years on the initiative of INFARMA, an association of pharma companies operating in Poland.
According to a separate report published by the PZPPF association of pharma employers, its member companies spent a total of 33.5 million zlotys (€7.7 million) on similar activities, of which 51% was paid to healthcare professionals, 40% to healthcare organisations and 9% to patient organisations.
Chief Pharmaceutical Inspectorate suspended sales of 40 hypertension drugs
The Chief Pharmaceutical Inspectorate (GIF) decided to suspend sales of 40 hypertension drugs produced by various companies, as one of their active ingredients, valsartan, supplied from China, might have been contaminated, reported Dziennik Gazeta Prawna on Tuesday (pB1) and of Friday (pA7-A8).
It was still uncertain on Tuesday whether the drugs were, in fact, contaminated and, if so, whether the contamination could be dangerous to patients. Until the case is properly investigated, one of the biggest issues will be to switch patients to safe equivalents of the drugs they use, as almost all Polish and European manufacturers of hypertension drugs were used by the same Chinese supplier.
Polish officials are currently waiting for a recommendation on next steps from the European Medicines Agency, which is handling the crisis.
Some experts say that, even if valsartan proves to be safe, it is high time to discuss the issue of Chinese and Indian suppliers of active ingredients, which are preferred by many pharma companies because of the extremely attractive prices they offer on their products.
Meanwhile, pharmas selling drugs containing valsartan have not noticed any quality problems for at least two years, which is extremely alarming given that the GIF is unable to inspect all drugs before they are placed on the market.
The drugs in question were produced by companies such as Polpharma, Polfarmex, Gedeon Richter Poland, Orion Corporation, Zentiva, EGIS Pharmaceuticals, Bioton, Sandoz, S-Lab and Actavis.
The problem could apply to 20 EU countries, while drugs containing valsartan are taken by up to 500,000-800,000 Polish patients.
On Wednesday, the EMA confirmed that the Chinese valsartan was contaminated with n-nitrosodimethylamine, which resulted in the GIF recalling all suspended drugs from the market. According to an undisclosed Spanish pharma company which discovered the potential contamination, its levels should not endanger patient lives, but simultaneously, the drugs should not be on sale.
Treatment of opioid addictions in Poland should be improved
Opioid addictions experts agree that access to proper opioid replacement therapy in Poland is very limited, reported Rzeczpospolita (pA11) on Thursday.
Poland has approximately 15,000 patients with opioid addictions, but only 15-17% are undergoing opioid replacement therapy, while the World Health Organization (WHO) recommends the achieving at least 50%. The WHO also claims this method is the most effective, while the main type of treatment in Poland is still complete abstinence.
The officials have been working on new regulations enabling opioid addiction treatment since 2016, but the bill is constantly being modified and the most recent version of the regulations does not allow for the reimbursement of drugs outside of the replacement therapy drug programme, to which access is restricted.
Most Polish patients undergoing opioid replacement therapy use methadone, with the minority of them being treated with buprenorphine and buprenorphine/naloxone. While these two last options are much safer for patients, the institutions running the therapies are reluctant to use them, as the contracts with the payer are based on the price of methadone, which is much cheaper.
Experts agree that access to the most effective opioid addiction therapies in Poland is very limited in comparison with countries such as Denmark, Finland, Norway, the Czech Republic, France, Latvia, Sweden, Cyprus, and Croatia. They are also concerned that the officials refuse to approve the reimbursement of prescription drugs used in replacement therapies outside of the dedicated drug programmes, as, with only 25 institutions treating patients throughout Poland free of charge, access to appropriate treatment will remain restricted.
Pharmacies reselling drugs to wholesalers could lose their licences
The Supreme Administrative Court has ruled that the one of the regional pharmaceutical inspectorates was entitled to withdraw the pharmacy licence for a company reselling drugs back to the pharma wholesaler, reported Rzeczpospolita (pA15) on Thursday.
The inspectorate argued that the pharmacy was involved in illegal practices, as it did not have an additional wholesale licence and endangered the well-being of patients by creating the risk of drug shortages for its own profit.
The problem of drug shortages throughout Poland arising primarily from illegal drug exports to Western Europe means that pharmaceutical inspectorates are increasing the number of audits conducted at pharmacies and pharma wholesalers. The officials are also working on additional regulations to curb the problem.
Experts on pneumococci vaccinations
Experts discussed the benefits of pneumococci vaccinations and the decision of the Ministry of Health (MoH) to reimburse a particular type of the vaccine within the schedule of obligatory vaccinations, reported Rzeczpospolita (pA12-A13) on Friday.
The experts agreed that, with the increasing antibiotic resistance of bacteria, it is absolutely imperative to vaccinate children against pneumococci, with the most effective and broadest range of vaccines available.
They estimate that 122 million patients worldwide are only alive today because they were vaccinated and they certainly approve of the MoH’s decision to reimburse it within the schedule of obligatory vaccinations. However, the experts are concerned that the choice of reimbursed PCV10 vaccine was not based on its efficacy and recommendations of paediatricians, but on the lower price than the broader, recommended PCV13, which is also available in Poland, but is not reimbursed.
The experts recommended that the officials should take into account the latest epidemiologic data and conduct a long-term cost-effectiveness analysis of the available choices before ordering the next batch of vaccines within the obligatory vaccination schedule.