WARSAW, 1 Nov (APM) - Despite the arrests of two criminal groups, Polish politicians and the Ombudsman are questioning the effectiveness of the recent amendments to the Pharmaceutical Law, which has not halted the illegal drug exports that are causing medicines' shortages in pharmacies, reported Dziennik Gazeta Prawna (pB6) on Wednesday and Rzeczpospolita (pA12) on Thursday.
According to the Ministry of the Interior and Administration, the police have detected 153 criminal offences and pressed charges against 24 people since 2015, which is decidedly insufficient for Polish MPs.
Minister of Justice Zbigniew Ziobro announced this number would increase substantially after the recent amendments to the Pharmaceutical Law, giving the prosecutors the required means to fight drug mafias, reported Rzeczpospolita.
In his letter to health minister Łukasz Szumowski, the Polish Ombudsman, Adam Bodnar, suggests introducing a detailed tracking system for drugs that are on the brink of unavailability and to ensure closer cooperation between the authorities.
He suggests the voivodship governors need to scrutinise the medical care facilities to which they issue licences, as they could be established as intermediaries for illegal drug exports.
He added that the local pharmaceutical inspectorates, which are in the front line in the battle with illegal drug exports, are dramatically underfunded and understaffed. He also emphasised the importance of closer cooperation of the inspectorates with the National Revenue Administration, especially regarding the disclosure of documents and invoices of wholesalers related to the drug trading and illegal drug sales in order to impose appropriate penalties, reported Dziennik Gazeta Prawna.
Bodnar emphasised the importance of the cooperation between the pharmaceutical inspectorates and the fiscal authorities, as the announcement of intensified fiscal audits of pharmaceutical wholesalers in the middle of last year led to an average decline in wholesale revenues of 41% and as much as 99% in one case.
This suggests that wholesalers are concerned about the discovery of illegal exports during audits and shows the magnitude of the problem added Dziennik Gazeta Prawna.
It is estimated that drugs worth a total of 2 billion zlotys (€469 million) are illegally exported from Poland each year, concluded Rzeczpospolita.
No flu vaccines available in Warsaw
Flu vaccines for patients aged over 65, which were were added last year to the reimbursement lists, are not obtainable in clinics, pharmacies or wholesalers, reported Gazeta Wyborcza in its Stoleczna supplement (p1) on Tuesday.
The only flu vaccine that is 50% reimbursable for pensioners in Poland is produced by Sanofi, which has been announcing possible difficulties with supply since September, because of the World Health Organization's delay on their recommendation regarding content. 6,000 patients die from flu complications in Poland each year.
Rheumatoid arthritis patients need quick diagnoses
Seven innovative rheumatoid arthritis (RA) therapies are reimbursable and available through drug programmes in Poland, but, according to specialists, the main problem is the correct and early diagnosis of the disease, reported Rzeczpospolita (pA9) on Tuesday.
RA affects patients aged between 30 and 50, who can avoid or delay disability and occupational exclusion with early diagnosis, 12 weeks from the initial symptoms and the immediate start of treatment.
Five innovative biological drugs and two JAK kinase inhibitors are available in drug programmes in Poland. Patients need to undergo two traditional therapies with disease modifying antirheumatic drugs (DMARDs), such as metotreksat, leflunomide or sulfasalazine, for four months each without any visible effects, in order to qualify for innovative RA treatment.
Warsaw initiates HPV vaccination programme for teenagers
Some 43 medical centres sponsored by Warsaw will provide HPV vaccinations to boys and girls aged between 12 and 13 from the beginning of November, reported Gazeta Wyborcza in its Stołeczna supplement (p5) on Wednesday.
Two thirds of the facilities involved in the programme have already received vaccines which were recently on the brink of unavailability.
Polish lung cancer patients need access to innovative drugs
Pulmonology and oncology experts, cardiothoracic surgeons, patomorphologists and clinical geneticists have prepared a strategy of fighting lung cancer in Poland, reported Gazeta Wyborcza in its Tylko Zdrowie supplement (pp21-22) on Wednesday.
The doctors developed the strategy because of the increasing rate of growth of lung cancer patients in Poland. They emphasise the need for the Ministry of Health (MoH) to introduce a coordinated system of diagnostics and treatment of the disease.
They also highlight the need to include innovative lung cancer treatments, such as advanced immune-directed and molecularly targeted therapies in the reimbursable programmes.
An example is nintedanib, an innovative antiangiogenic used for treating non-small-cell lung cancer, often used with docetaxel, which is already registered on EU markets, but only partially reimbursed in Poland. It is reported that 22,000 cases of lung cancer were diagnosed and 24,000 deaths related to lung cancer were reported in Poland in 2016 alone.
Call for government support for Polish pharmas
During a debate on the pharma industry in Poland, experts discussed the changes in legislation, the investments needs of local pharmas and the possibilities of the future reimbursement incentives system (RTR), reported Dziennik Gazeta Prawna (pA9) on Wednesday.
The experts emphasised the incessant need for investments in both research and development, as well as production to increase revenues from drug exports. The pharma industry generates 4.35 billion zlotys (€1 billion) for the state budget in Poland and, after subtracting the National Health Fund's spending of 2.5 billion zlotys (€587 million) on reimbursable drugs, the state gains 1.8 billion zlotys (€422 million).
However, apart from the financial benefits, the experts say that pharma industry provides jobs, drives other sectors of the economy and guarantees regular supplies of drugs in Poland. Polpharma is an example of such beneficial businesses: 250 of their products are reimbursable and their 42 often life-saving products are the only ones available of their kind on the Polish market. Investing in local producers is the only way to become independent from supplies of ingredients from China.
Maciej Miłkowski, undersecretary of state in the MoH, announced future changes in the reimbursement policy and declared an intention to increase investments and include new drugs in the reimbursement lists. He also discussed the use of generics and the need to report to the registration office every time the use of a generic drug causes adverse events. If this takes place, the hospital is responsible for providing the best treatment for patients individually.
According to pharma representatives, the RTR programme is one of many needs of the Polish pharma sector. Katarzyna Kacperska, general manager of Novo Nordisk Pharma, expressed concerns about the lack of budget increase in the reimbursement plans for next year.
She quoted OECD research stating that 73% of cases of the extension of life is due to innovative drugs. Krzysztof Kępiński from GlaxoSmithKline expressed his regret that less than 15% of funds are intended for drug reimbursement, while the plans that were announced initially suggested 17%.
Pure Biologics working on six biologics
In addition to developing a diagnostic system and medicinal products, Pure Biologics is working on six simultaneous original biologic drugs in immunobiology, reported Parkiet Gazeta Gieldy (p3) on Monday.
The company is considering several ways of commercialising the products, including a transaction partnership or co-development for pre-clinical and Phase I products.
Newly-split Selvita moves to improve transparency
After its split into service-oriented Selvita and R&D-oriented Ryvu Therapeutics, which re-debuted on the Polish stock market on 16 October, the Selvita group is reorganising to improve transparency, reported Parkiet Gazeta Giełdy (p7) on Thursday.
Two subsidiaries, including BioCentrum, which specialises in the production of highly purified and highly active enzymes, inhibitors and other biologically active ingredients, will merge with Selvita Services.
The merger will simplify the formalities related to GLP (good laboratory practice) and GMP (good manufacturing practice) certificates for its laboratories. Other subsidiaries of Selvita Services are a Polish bioinformatic company, Ardigen, the U.S.-registered Selvita Inc. and the UK-registered Selvita Ltd.
Polfa to invest in new drugs
Polfa Tarchomin, a state-owned company specialising in the production of antibiotics, central nervous system (CNS) and dermatological drugs, human insulins and dietary supplements, plans to sell its excess land to finance its investment programme, new drugs and expand in foreign markets, reported Puls Biznesu (p6) on Thursday.
Polfa plans to expand in western markets to generate up to half of its revenue through exports. It also plans to obtain 30 million zlotys (€7 million) from selling some of its land and to acquire another Polish company to broaden its drug portfolio.
The company's R&D division is developing over a dozen projects in diabetology, dermatology and psychiatry. Additionally, Polfa plans to fully use its production capacity and its innovative technologies of drug administration (aerosol dermatology and lyophilized injection lines or the synthesis of active pharmaceutical ingredients), through contract production for other pharmaceutical companies.