Press review

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New falsified drug regulations come into force in Poland

WARSAW, 25 Oct (APM) - A new amendment to the Pharmaceutical Law leading to the introduction of the EU anti-counterfeiting regulations became effective in Poland on Wednesday, reported Dziennik Gazeta Prawna (p.C14-C16) on Friday.
According to the amendments, pharmacists will be required to verify whether a drug is genuine, while selling a falsified drug will result in penalties, albeit not as high as previously announced. The lawmakers have reduced the level of the fines from the initial 500,000 zlotys (€116,000) to a maximum of 20,000 zlotys (€4,672) and have introduced a mitigation system.
Despite the changes, pharmacists are still concerned about errors in the verification system which could result in their penalisation for selling falsified drugs. The main cause of the distrust of pharmacists in the system are false alarms while verifying an original drug for various reasons, including the manufacturers failing to introduce their products into the system, system communication problems, a failure of the code scanners and problems with the integration of the system within pharmacies.
The doubts raised by the pharmaceutical associations mean that the Ministry of Health (MoH) has introduced a transition period for the fines until 1 July 2020 for correcting the system and giving pharmacists time to prepare for the changes.
The total value of falsified drugs in Poland is estimated at 300 million zlotys (€70 million) a year and 16 billion zlotys (€3.74 billion) within the EU. In Poland, one in two drugs sold online and one in 100 bought in pharmacies are falsified. A third of the falsified drugs do not contain any active ingredients and a fifth contain active ingredients that differ from those specified on the package.

New reimbursement list announced

The MoH has presented a new reimbursement list with 76 new drugs which will take effect from the beginning of November, reported Dziennik Gazeta Prawna (pB11) on Thursday and Gazeta Wyborcza (p10) on Friday.
The list includes diabetes therapies, such as flozins (dapagliflozin, empagliflozin and canagliflozin), annitional insulins, new therapies for children, as well as dressings used for treating chronic wounds, such as diabetic foot ulcers.
Another group of drugs includes therapies used in multiple sclerosis, such as ocrelizumab and cladribine, colon cancer (the Trifluridine/Tipiracil combination used during the third and fourth lines of treatment), all available therapies for Crohn's disease, such as vedolizumab, therapies for chronic lymphocytic leukaemia (venetoclax), familial hypercholesterolemia and denosumab with broader indications for treating osteoporosis, such as its use in cases of male patients aged over 60, reported both newspapers.
Additionally, Novo-Helisen Depot, a house dust mite vaccine for patients suffering from allergies and asthma will also enter the reimbursement list, reducing its price for patients from 1,400 zlotys (€320) for two phials to 485 zlotys (€113), added Gazeta Wyborcza.
According to the MoH, patient co-payment will decline for 631 medicinal products, while the retail price of 587 medicinal products will drop, concluded Dziennik Gazeta Prawna.

Polish drug producers can block changes in drug programmes

According to the current regulations, after a therapy is accepted into a drug programme by the MoH, the producers of drugs already included in the programme can veto newcomers and thus delay their availability to patients, reported Dziennik Gazeta Prawna (pA6) on Tuesday.
The regulations, which have not been changed for years, have caused many conflicts, as in the recent case of Perjeta (pertuzumab), a drug used for treating HER2-positive breast cancer, which could not be included in a drug programme because of a protest from Mylan, a biosimilar of trastuzumab.
Mylan has contested the decision to include Perjeta with Roche's trastuzumab, which Roche promised to include free of charge together with Perjeta, which excluded Mylan's less expensive biosimilar from the programme. Mylan finally agreed to the change for the sake of the patients. Perjeta will become available for patients from November.
Similar intrusions from companies in the drug programmes have appeared in the last seven years, but the MoH has not changed the regulations. While they are understandable from the economic point of view, they cannot be detrimental to patients.
The Employers' Union of Innovative Pharmaceutical Companies INFARMA and patient organisations have appealed to the MoH to amend the regulations. According to the officials, an amendment is already included in the National Drug Strategy accepted by the government in 2018.

New nasal flu vaccine for children available in Poland

A new nasal flu vaccination for children has been included in the Polish Vaccination Programme, reported Gazeta Wyborcza (p17) on Wednesday. The vaccine, containing live attenuated flu viruses, is recommended for children aged between 2-18.
Nasal administration will reduce stress caused by injections, while its price is 80-90 zlotys (€18-21). It is estimated that 20-30% of Polish children catch the flu each year, while vaccinating 20% of children could reduce flu infections within the whole country by half.

Discrimination of patients suffering from rare and ultra-rare diseases in Poland

According to experts, patients suffering from rare and ultra-rare diseases are discriminated against by the regulations, as they often have no access to the therapies they need, unlike other Polish patients, reported Dziennik Gazeta Prawna (pA9) on Thursday.
When deciding on the reimbursement of the orphan drugs, the QUALY (Quality-Adjusted Life Year) criterion is currently taken into consideration in Poland. This factor is three times GDP per capita, which is equivalent to 140,000 zlotys (€32,700).
Meanwhile, there are countries in which it is set, for instance, as five times the QUALY factor used for regular diseases, which corresponding to 15 times GDP per capita (5x3xGPD per capita), experts suggest increasing the cost of the QUALY factor in Poland.
Other ideas include withdrawing from the economic analysis but taking into account the justification of the drug's price and then negotiating with the manufacturer. Another proposal, the multi-territorial analysis, which takes into account ethical and social criteria together with the quality of life of the patient's family, has been included within the National Drug Strategy but the question of whether it will be applied to Poland's orphan drug policy is yet to be determined.

Rotavirus vaccinations not compulsory for children

Despite the HTA Agency's recommendation, vaccinations for rotavirus, the main cause of diarrhoea among infants and children, was not included in the compulsory and fully reimbursable vaccination list for children within the protective vaccinations programme (PSO), reported Rzeczpospolita (pA10) on Tuesday
Nevertheless, experts believe that, after detailed discussions on the harmful effects of rotaviruses, the costs of hospitalisation of patients and their parents, as well as the financial and health benefits of vaccinating children against rotaviruses, the MoH may still add the vaccines to the PSO.

Warsaw's inhabitants suffer from depression

Increasing numbers of Polish citizens, especially those living in Warsaw, are suffering from depression and nervous breakdowns, report Gazeta Wyborcza in its Tygodnik Warszawa supplement (p12) on Friday.
The main causes include stress of everyday life, the inability to adapt to life in a big city, work-related problems and anxiety about future and financial stability. Some 1.5 million packets of antidepressants are reported to be purchased in Poland each month.

Nursery schools can give priority to vaccinated children

According to the ruling of the Voivodship Administrative Court in Olsztyn, a nursery school can check whether a child has been vaccinated and give priority to those who have, reported Rzeczpospolita (pA15) on Tuesday and Dziennik Gazeta Prawna (pB7) on Wednesday.
Despite the voivod's appeal, such differentiation was not ruled as a sign of discrimination. Parents in Poland are legally obliged to vaccinate children and those who do not comply with the rules cannot expect nursery schools to treat children who may pose a threat to vaccinated children on a level pegging reported both newspapers.

Celon Pharma registered Salmex in Spain

Celon pharma has completed the Salmex registration procedure for the Spanish market, where the drug will be distributed by a local partner in the first quarter of 2020, reported Parkiet Gazeta Giełdy (p03) on Saturday.

Ryvu Therapeutics promotes R&D operations

Ryvu Therapeutics, a new company separated from Selvita, is continuing its R&D operations in oncology with 150 scientists, 80 of whom hold doctorate degrees, reported Parkiet Gazeta Giełdy (p03) on Monday.
Ryvu Therapeutics' most advanced project is SEL120, a CDK8 micromolecular enzyme inhibitor, which is in Phase I with patients suffering from acute myelogenous leukaemia or with a high risk of myelodysplastic syndrome (MDS).
Another clinical project is the SEL24/MEN1703 molecule under licence from Italian partner, Menarini Group, which is entering Phase II for cases of acute myelogenous leukaemia (AML). Ryvu is also working on seven different therapies for solid tumours at pre-clinical stage. The company also holds 10% of the shares in Nodthera, a company working on therapies for diseases related to chronic inflammation and developing innovative inflammasome inhibitors.

Mabion has applied for loan for expanding operations

Mabion has agreed the terms for a €30 million loan from the European Investment Bank for the development of infrastructure and for covering the costs of future research, reported Parkiet Gazeta Giełdy (p07) on Tuesday, (p07) on Wednesday and (p04) on Thursday.
Mabion is currently in the process of registering its most advanced product, MabionCD20, on the markets of the European Union and plans to complete the procedure by the end of the year. When the registration is finalised, the company plans to apply for to increase production of the drug. Mabion is currently building a second production line in Poland which is to be completed by the end of 2020, reported Parkiet on Tuesday and Wednesday.
Other Mabion projects are MabionMS, a drug for treating multiple sclerosis and MabionEGFR for treating colon, head and neck cancers. Mylan is Mabion's partner for distributing MabionCD20 within the EU and for registering it on the U.S. market, reported Parkiet both on Tuesday and Wednesday.
Mabion will meet the U.S. Food and Drug Administration on 22 January to confirm the regulatory strategy for filing the registration application for MabionCD20 in the U.S., added Parkiet on Thursday.

Bioton ends cooperation with more partners

Bioton has ended its partnership in the production, distribution and promotion of its medicinal products and medical devices with Sequoia Pharmaceuticals because of unsatisfactory revenue generation, reported Parkiet Gazeta Giełdy (p4) on Thursday.
The company's previous break-ups were the August termination of the contract with Harbin Gloria Pharmaceuticals, a former supplier and distributor of Bioton's insulins on the Chinese market and July's termination of the contract with Brazilian company, Biomm, which was to commercialise recombinant human insulins in Brazil.

Polish start-up will help with innovation of new molecules

Molecule.one is a start-up using AI and deep learning for creating new chemical compounds based on information from U.S. patents and databases containing properties, prices and source information on chemical compounds, reported Puls Biznesu (p10) on Thursday.
The solution uses databases from the public domain from the U.S., the company's partners and its customers. It is currently at the SRP (Sales Ready Product) stage and plans to sign its first contracts shortly. The company is already conducting beta tests with companies such as OncoArendi Therapeutics.
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