Press review

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Poland's Supreme Administrative Court allows only personal drug imports

WARSAW, Mar 16 (APM) - The Supreme Administrative Court (NSA) in Warsaw recently ruled that, while patients do not need permission to personally bring prescription drugs for their own use into Poland, they cannot have them delivered by post or courier, reported Rzeczpospolita (pA13) on Monday.
The case applied to a woman who had ordered several packets of anti-menopause hormones in the form of creams, pills and capsules from the U.S. The parcel was then seized by the customs agency, which refused to release it and notified the woman that she had to return it to the country of origin. The woman argued that the drugs were for her personal use and were equivalent to the prescription drugs available in Poland, with the only difference being that they were not synthetic, but natural.
The NSA, however, ruled that any attempt to import prescription drugs to Poland and not bring them into the country personally is a breach of the regulations.

Surplus pneumococci vaccines will not be wasted

The Ministry of Health has agreed to use the surplus pneumococci vaccines that had not been administered to children born in 2017, to vaccinate children born between 2013 and 2016, reported Rzeczpospolita (pA17) on Tuesday.
The conditions for receiving these vaccines are being under the age of five and the receipt of a positive doctor’s assessment by April 20.
According to the Chief Sanitary Inspectorate, 20-30% of parents choose non-reimbursable, combination vaccines for their children, which could result in the standard vaccines being wasted.

Patients want to be treated with donated drugs

Bartlomiej Chmielowiec, the Patients’ Ombudsman, is asking the health minister to enable patients who apply for emergency access to drug technologies (RDTL) to be treated with donated drugs, reported Rzeczpospolita (pA18) on Monday and Dziennik Gazeta Prawna (pA4) on Wednesday.
The enquiry is a result of complaints filed by patients, who claim that absurd regulations result in medical institutions refusing to treat them with non-reimbursable drugs offered through donations, if they are in the process of applying for RDTL financed by the state.
Chmielewski says the situation is critical, as medical institutions are bound by defective regulations and most doctors agree that patients applying for RDTL should be able to benefit from donated drugs, reported both newspapers.
The Ministry of Health (MoH) has already appointed a special commission that will decide whether patients should have the right to receive drugs from donations. This mainly applies to cancer patients, as most of them require drugs that are not reimbursed in Poland.
While the MoH issued a statement in January stating that it sees no legal problems with this solution, the national health fund claims otherwise. The Alivia Foundation says Polish cancer patients have restricted access to 70% of all drugs that are recommended in modern cancer treatment, reported Dziennika Gazeta Prawna.

Pharmacists could become responsible for determining the reimbursement discount

According to the new regulations prepared by the Ministry of Health, in some cases, pharmacists could become responsible for determining the reimbursement discount on drugs, reported Rzeczpospolita (p18) on Monday and Dziennik Gazeta Prawna (pB11) on Thursday.
This would apply to cases in which doctors fail to specify the reimbursement discount on the prescription. Pharmacists are outraged, saying they not only lack the rights and knowledge to be able to accurately assess individual cases, but they are also not compensated for the additional work and could face the consequences of making wrong decisions, reported both newspapers.
Doctors have recently been arguing that they should not be forced to waste time on excessive bureaucracy and that the responsibility to define the reimbursement discount should be shifted entirely to pharmacists, reported Rzeczpospolita.

Polish scientists working on new glaucoma therapy

Scientists from the Medical University of Silesia in Katowice are working on a new glaucoma therapy using the HuR protein, reported Puls Biznesu (p14) on Wednesday.
The research conducted by a team headed by professor Joanna Lewin-Kowalik proved that patients suffering from glaucoma have lower levels of the HuR protein, which could be one of the mechanisms behind the development of the disease. The scientists conducted experiments on rats, in which they supplied an additional gene responsible for producing the HuR protein. Their results were very promising, slowing the development of glaucoma and enabling the rats to retain their sight for 50% longer.
The scientists received a 1.2 million zloty (284,000 euro) grant from the National Science Centre to continue the development of their experimental therapy until 2021.

Pharmena presented Phase II results to potential partners

Pharmena, a Polish pharma listed on the NewConnect alternative stock exchange, presented the Phase II results of its 1-MNA particle to potential partners, reported Parkiet Gazeta Gieldy (p5) on Tuesday.
The company announced that the potential partners are interested in two new indications for which the molecule could be used and for which Pharmena already has patent protection.

Mabion could soon file MabionCD20 in EU

Artur Chabowski, Mabion’s chief executive, said the company should soon have all the documentation required to file MabionCD20 with the European Medicines Agency, reported Parkiet Gazeta Gieldy (p7) on Thursday.
Although the company previously claimed the application should be filed in March or April, Chabowski said the exact date will depend on how fast the registration dossier will be compiled and on the EMA’s schedule.
He added that several external entities are responsible for preparing the analyses required for the application and that it is important to provide the most complete and accurate data possible to the EMA in order to speed up the registration process, which is extremely important to both Mabion and its partner, Mylan.

OncoArendi Therapeutics plans to float

Polish biotech, OncoArendi Therapeutics, specialising in R&D and commercialisation of innovative drugs to be used in inflammatory diseases and cancer, is planning an initial public offering at the turn of March/April, reported Parkiet Gazeta Gieldy (p3) and Puls Biznesu (p7) on Monday.
Some 90% of the shares are to be sold to institutional investors, while the company intends to collect 53-66 million zlotys (12.6-15.6 million euros) from the market. The money will be used entirely on R&D of new drugs, reported both newspapers.
OncoArendi started clinical trials of its innovative chitinase inhibitor, OATD-01, which could be used in asthma therapy, in 2017. The company does not currently generate revenues and has obtained 33.4 million zlotys (7.9 million euros) to date in three rounds of financing, reported both newspapers.
OncoArendi is also working on arginase inhibitors that could be used for treating bowel and lung cancer, reported Puls Biznesu.
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