Press review

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Pharmacists in Poland afraid of new regulations on illegal drug exports

WARSAW, 14 June (APM) - Restrictive regulations intended to curb illegal drug exports, which came into force on 6 June, are troubling pharmacists, as they could unknowingly become criminals in some cases, reported Dziennik Gazeta Prawna (pB6) on Monday.
According to the regulations, pharmacies are only allowed to sell drugs directly to individuals under the risk of being criminally liable. Similarly, institutions such as schools, orphanages, nursing homes and animal shelters are not allowed to legally buy small quantities of pharmacy-exclusive drugs, medicines in specific doses or products required to conduct day-to-day activities and receive an invoice to book the costs without the risk of being subject to sanctions.
Although the representatives of the pharmacists asked the health minister to provide a ruling on the regulations, even if such a ruling is reasonable, it is unknown whether it will be respected by the courts.

Access to innovative cancer treatment in Poland must be improved

While the global oncology market is growing rapidly and Polish biotechs are working on their own products, access to modern therapies in Poland is still very limited, reported Rzeczpospolita (pA19) on Monday.
According to the Alivia foundation, which supports Polish cancer patients, only 44 out of 93 cancer drugs recommended in Europe are available in Poland, while 100,000 Poles die of cancer every year and only 43% of patients live longer than five years after diagnosis.
Polish biotechs operating in the oncology sector include NanoGroup, which is developing a polisacharide nanoparticle epirubicin drug, Biomed-Lublin, which sells Onko BCG, its non-invasive bladder cancer drug, and Biotts, a start-up focusing on the development of products increasing bioavailability of active ingredients used in cancer treatment.
The global oncology market is expected to grow from $80.3 billion in 2015 to $190 billion in 2022.

Free drugs for pregnant women

The National Health Fund (NHF) will spend 10 million zlotys (€2.4 million) in 2019 and 22 million zlotys (€5.2 million) in 2020 on free drugs for pregnant women, reported Dziennik Gazeta Prawna (pB10) on Tuesday.
The list will be limited to selected Rx drugs and prescriptions will be provided by gynaecologists with a valid contract with the NHF, family doctors and specialist doctors.
The list of free drugs for pregnant women will be published within several months and the NHF is expecting to spend 316 million zlotys (€74.2 million) on them by 2028.

Controversy around radio-pharmaceuticals used by PET-CT centres

Although the Supreme Audit Office (NIK) is questioning the practices of many PET-CT centres using self-produced radio-pharmaceuticals, the centres claim this is completely safe and necessary, reported Rzeczpospolita (pA11) on Wednesday.
The PET-CT centres using self-produced radio-pharmaceuticals say the claim of their practice being dangerous to patients is absurd. They add that the officials did not have any problems with this until 2017, when the NIK inspectors started auditing PET-CT centres to check whether subsidies for cyclotrons were being properly used.
The PET-CT centres say they confronted the Ministry of Health (MoH) about the matter a year ago and it was agreed that some regulatory changes are needed to account for rare radiopharmaceuticals which are not freely available on the market and must be self-produced.
The PET-CT centres say they need to continue producing rare radio-pharmaceuticals to be able to diagnose difficult cases and save lives, although they cannot afford having them officially certified, as the procedure costs 200,000-300,000 zlotys (€46,948-€70,423) per case, whereas they use a dozen or so custom radio-pharmaceuticals.

Patients need better access to biosimilars

Experts claim access to biosimilars in Poland is restricted because of unnecessary bureaucracy and that their reimbursement path should be faster to improve the situation of patients, reported Rzeczpospolita (pA15) on Thursday.
According to the International Generic and Biosimilar Medicines Association, by 2020, generics and biosimilars will account for 80% of the pharma market by volume and 28% by value.
The IGBA believes that, although such drugs are a great opportunity for many patients, access to them is limited due to price pressure and bureaucracy. Meanwhile, although biosimilars entering the market after the expiry of the patents of their originator equivalents are 25-50% cheaper, it is extremely difficult to quickly include them in the reimbursement list due to excessive formalities.
Experts say the officials should consider a faster reimbursement path for biosimilars, which would improve the situation of patients and ultimately also reduce spending by the NHF.

Access to pain treatment in Poland inadequate

According to the Atlas of Palliative Care in Europe report prepared by the European Association of Palliative Care, Poles proportionally use analgesics of a third of the potency of the EU average and a tenth of the strength of those used by Germans, reports Rzeczpospolita (pA15) on Friday.
Experts say the problem arises from patients being unaware that their pain could be reduced more effectively, while doctors are generally not accustomed to and afraid of prescribing the strongest analgesics, which require special forms and specific knowledge on dosage.
Poland currently has 476 active palliative care doctors only, while only half of all medical schools have separate classes for this, run by 13 professors, even though innovative opioid drugs are included in the reimbursement list.

Measles spreading throughout Poland

According to the National Institute of Public Health, there have been 1,044 confirmed cases of measles in Poland so far this year, which is the highest number since 1990, reported Gazeta Wyborcza (p6) on Wednesday.
The MoH claims the disease was brought to Poland by foreigners, mainly workers from Ukraine where the majority of people are not vaccinated against measles. However, it is clear that the increasing number of cases of measles has a lot to do with anti-vaxxers and the fact that the number of parents refusing to vaccinate their children reached 40,000 in 2018.

Celon Pharma's drug to return to pharmacies

The Chief Pharmaceutical Inspectorate (GIF) has decided to restore the marketing authorisation for Celon Pharma's Valzek in Poland, reported Parkiet Gazeta Gieldy (p3) on Saturday.
Celon Pharma announced that all analyses confirmed that Valzek meets the quality criteria for its active ingredient, valsartan. However, the GIF decided the originally suspended series of the drug will be completely withdrawn from the market, which, according to the company, will not result in losses of more than its financial reserve of 650,000 zlotys (€152,582).
Valzek's sales were suspended in August 2018 at the request of Celon Pharma, while the company is now in the process of implementing the analytical procedures recommended by the EU for the production of valsartan.

NanoVelos working on innovative cancer drug

NanoVelos, owned by NanoGroup, is continuing research and development of its innovative cancer drug and could soon begin clinical trials on Polish patients, reported Parkiet Gazeta Gieldy (p3) and Rzeczpospolita (pA19) on Monday.
NanoVelos claims it has successfully developed a polisacharide nanoparticle system, which safely delivers epirubicin directly to cancer cells without destroying healthy cells. The company has already produced its first GMP batch of the drug and could soon start administering it to Polish patients.
Around 500,000 Poles suffer from cancer, while 185,000 new cases are diagnosed annually.

Biomed-Lublin's production back on track

Biomed-Lublin seems to be back on track with the production of its Onko BCG and BCG 10 products after passing quality tests approved by the National Institute of Public Health, reported Parkiet Gazeta Gieldy (p8) on Wednesday.
Biomed-Lublin's production problems started early this year, when the company notified the registration office in January that it has to temporarily suspend sales of BCG 10 because of irregularities in the manufacturing process.
As none on the three batches of either Onko BCG or BCG 10 produced so far in 2019 have had any quality problems, the company is continuing to produce them at 100% capacity.
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