Press review

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About 350 drugs still missing from the Polish market

Country : China, France, Germany, Poland, UK

Keywords :
WARSAW, 11 Oct (APM) - Some 350 drugs, mainly anticoagulants, insulin, diabetes therapies and psychotropic drugs, as well as flu, HPV, type A hepatitis and measles vaccines were still unobtainable on the Polish market in September, reports Gazeta Wyborcza (p05) on Thursday and (p11) on Friday.
Some vaccine producers cannot currently keep up with production, making some cities suspend their vaccination programmes, the paper added.
600 hypertension, thyroid, asthma and diabetes drugs were missing from Polish pharmacies in July. The Polish government claims the root of the problem lies in the lack of active ingredients produced in China or illegal drug exports.
According to a report by Gdziepolek.pl, an internet portal which compiles data from 1,100 pharmacies of mainly medium-sized chains, which are visited by 10,000 people daily, 44 drugs are missing from pharmacy shelves. These include antibiotics, Parkinson's disease medications, eye drops for severe eye inflammations and epilepsy drugs, Aripsan 5 (Aripiprazole) for schizophrenia, Irprestan (irbesartan) for hypertension, Jodid (Iodine) and Glucophage XR (Metformin) for type 2 diabetes, which affects three million people in Poland, two million of whom are undergoing treatment, adds Gazeta Wyborcza on Friday.
According to Marek Tomków, vice president of the Polish Pharmaceutical Chamber, the problem of drug shortages is affecting the whole of Europe, according to which the main cause lies in the high dependency (60-80%) of regional drug producers on active ingredients from China.
Tentative proposals have been suggested to establish a non-profit production line of active ingredients within the European Union, but these are currently just ideas. Another problem is the policy of individual pharmas, which produce a new drug with similar effects after a patent expires, which has a new patent and a higher price. Another problem is the difference in price between EU markets and how the pharma companies favour richer markets because of higher profits, adds Gazeta Wyborcza.
While Germany is building up drug reserves and France has increased the penalties for pharmas for not holding stock, the Polish Ministry of Health (MoH) may also penalise the producers of reimbursable drugs or even remove them from the reimbursement lists and the National Health Fund (NFZ) can impose fines for not securing deliveries. However, the question of whether the MoH has exercised any of these options remains unanswered by the MoH, concludes Gazeta Wyborcza.

Polish breast cancer patients do not have access to Perjeta

The MoH amended the legislation on the reimbursement of Perjeta (pertuzumab), a drug used for treating HER2-positive breast cancer, at the end of September, making it available not only for new patients, but also those who started the therapy, financing it themselves, from November, reported Dziennik Gazeta Prawna (pA8) on Thursday.
Roche offered to sell the treatment to hospitals for a symbolic 1 zloty in October but many hospitals declined this offer for fear of a lack of reimbursement funding for therapies started before November. In such a case, continued treatment would require financing from hospital budgets or by the patients themselves.

Price of medical cannabis too high for Polish patients

According to the Polish Central Statistical Office (CSO), medical cannabis was categorised as a pharmaceutical ingredient and received a 23% rate of VAT, against which its importer appealed to the administrative court to reduce its price per gram, reported Dziennik Gazeta Prawna (pA18) on Thursday.
Spectrum Therapeutics, requested a ruling from the National Treasury Information (KIS) hoping to reduce the VAT to 8% as for medicinal products, but KIS upheld the CSO’s decision, which was then upheld by the court. Spectrum Therapeutics will continue to request a reduction in VAT.
A gram of medical cannabis currently costs 50 zlotys net (€11.56) plus 15 zlotys VAT (€3.47), which together proves to be quite expensive for patients. Patients may also face additional problems with availability of medical cannabis as Spectrum has still not received permission to import a further supply of medical cannabis, while the current stock is estimated to be depleted next week.

Polish cardiac insufficiency patients need coordinated healthcare and innovative drugs

Experts say many more cardiac insufficiency patients than the officially reported 800,000 need coordinated healthcare and access to innovative treatments, reported Rzeczpospolita (pA9) on Tuesday.
The experts are now waiting for the pilot launch of an innovative comprehensive care programme for patients suffering from cardiac insufficiency (KONS) initiated by professor Piotr Ponikowski, former president of the Polish Cardiac Society. The programme is to assure constant medical supervision from diagnosis to rehabilitation and is planned to start in the coming months.
However, in addition to the globally-innovative programme, patients who did not respond well to other therapies also need access to innovative drugs such as sacubitril/valsartan. The monthly therapy costs 600 zlotys (€139) and is not reimbursed.

Colorectal cancer patients need access to innovative therapies

Colorectal cancer patients have had access to innovative drugs in the first and second stages of treating colon cancer since 2017, but, after a successful treatment, cannot enter the third or fourth stage and use Trifluridine/Tipiracil, a clinically proven therapy with high efficacy which is a healthcare standard for patients in 26 other European countries, reported Rzeczpospolita (pA9) on Tuesday.
Patients with advanced colorectal cancer have sent numerous appeals and petitions to the Ministry of Health (MoH) with no response. The drug’s producer has even reduced the price of the therapy by 50% compared to the European level to increase the chances of reimbursement by improving its cost-effectiveness. The therapy has been proved effective by renowned HTA Agencies, including the UK National Institute for Health and Care Excellence (NICE).
Colorectal patients have no available alternative therapy. 17,000 new cases of rectal cancer are diagnosed in Poland each year, of whom around 1,500 patients need therapy. The mortality rate in Poland is 63% which is next to last in the EU.

Polish politicians have signed a 'Healthcare Treaty'

Polish politicians of various political parties have signed a 'Healthcare Treaty 2030' consisting of 11 points, for which the politicians undertook to vote regardless of their political affiliation, reported Dziennik Gazeta Prawna (pA1-A3) on Tuesday.
The points include the amendment of the reimbursement system to increase the availability of drugs for rare diseases and improve the standard of vaccinating children by using fully reimbursable up-to-date combined vaccines. The treaty was signed by Health Minister Lukasz Szumowski, Civic Coalition (KO) prime minister candidate, Malgorzata Kidawa-Blonska, the leader of the Polish Peasants' Party (PSL) Wladyslaw Kosiniak-Kamysz and Robert Biedron, the head of electoral staff of the Democratic Left Alliance (SLD).
The amendments discussed include Malgorzata Kidawa-Blonska's proposed engagement of 35,000 pharmacists to help with healthcare, for example, in vaccinating children and that the vaccinations should be fully reimbursable, up-to-date and combined. Robert Biedron proposed limiting the price of every prescription drug to 5 zlotys (€1.15) and introducing fully reimbursable drugs for children, pensioners, pregnant women and transplant patients.

E-prescriptions may be valid for full year

According to the proposed amendments, when marked accordingly by a doctor or a nurse, e-prescriptions may be valid not for the normal 30 days but for 365 days for all drugs, excluding narcotics and psychotropics, reported Dziennik Gazeta Prawna (pB10) on Tuesday

No legal act for pharmacists

The bill on pharmacists supported by the pharmacist associations and individual pharmacists and questioned by pharmacy chains and doctors will not be enacted during this term of office, reported Dziennik Gazeta Prawna (pB5) on Thursday.
The bill was supposed to introduce pharmaceutical care, enabling pharmacists to advise, monitor and possibly optimise a patient's drug consumption and to perform basic diagnostic tests.
Such a solution was questioned by the doctors, as the pharmacists could influence the doctor's therapies without bearing any liability. The pharmacy chains were questioning the proposed criteria that the pharmacy manager needs to satisfy and giving pharmacy associations too much authority in the staffing of private pharmacies.

Bioton recorded substantial half-year losses

Bioton recorded a consolidated net loss of 82.3 million zlotys (€19 million) in the first half of the year, reported Parkiet Gazeta Giełdy (p07) on Thursday.
The consolidated loss was caused by the losses generated by Biolek, Bioton's subsidiary producing Suilectin, a product for pig breeders which was not launched on the Chinese market because of the African swine fever (ASF) break-out. The company is now planning to optimise its operations and expenditure.
Bioton has also partnered with Yifan in the production of active insulin analogues. Yifan itself is responsible for production, while Bioton holds the exclusive rights to the intellectual property, production and distribution on the Polish market. The Insulin analogue is planned to reach the market by 2023.

Biomed will distribute ONKO BCG in Germany with a partner

Biomed's share price rose on the stock market as it signed an agreement with a German partner for the delivery and distribution of ONCO BCG on the German market, reported Parkiet Gazeta Giełdy (p04) on Saturday.

Łukasiewicz Research Network joins forces with Amgen

Amgen and Łukasiewicz Research Network have signed a letter of intent that could lead to clinical trials with Polish biobanks and the analysis of data with machine learning and AI, reported Puls Biznesu (p2) on Tuesday.
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