WARSAW, 22 Mar (APM) - Poland's Ministry of Health (MoH) said that, although the Ministry of Entrepreneurship and Technology has already chosen the company to be responsible for devising the system of incentives for pharma companies investing in Poland, details are still unknown, reported Dziennik Gazeta Prawna on Tuesday.
Lukasz Szmulski of the Ministry of Health (MoH) was speaking at a recent Health Challenges Congress.
Szmulski said pharma companies are concerned that the parliament will not manage to introduce the new regulations before the forthcoming parliamentary elections, which could put the changes on hold. He added that the MoH is still waiting with the amendment to the Reimbursement Act, which could incorporate the regulations on incentives.
Companies such as GlaxoSmithKline and Adamed are hoping the regulations are passed on time, as an incentive system for firms investing in the Polish pharma industry was promised several years ago.
Katarzyna Dubno from Adamed said Polish pharmas are most interested in being exempt from the reimbursement payback mechanism, which currently requires them to compensate the National Health Fund if predefined spending on drugs is exceeded. Additionally, companies want clearer price-setting criteria for reimbursement drugs and less frequent price negotiations.
According to the preliminary plans, the incentives would be based on such criteria as R&D spending, clinical trial projects, new IT solutions or production processes, the scale of the business, the level of employment and the value of taxes paid in Poland.
Psoriasis treatment should be improved
Experts agree that, with almost a million Poles suffering from psoriasis, the treatment standards for the disease should be improved to reduce its social costs and improve the quality of life of patients, reported Rzeczpospolita (pA11) on Tuesday.
The National Health Fund spent 129.3 million zlotys (€30.1 million) on the treatment of 226,500 psoriasis patients in 2017, which was 9.2% more than in 2015. Furthermore, 107.9 million zlotys (€25.2 million) was spent on hospitalisations and 64.8 million zlotys (€15.1 million) was spent on drug programmes, which benefited just 2,100 patients.
Experts say it is high time to introduce coordinated treatment, which is compliant with the recommendations of the Polish Dermatological Society.
It is estimated that psoriasis and psoriatic arthritis reduced Polish GDP by 2.3 billion zlotys (€536.1 million) and a 2.5 billion zlotys (€582.8 million) in 2016 and 2017 respectively.
Regulations on medical cannabis criticised by some experts
Some experts criticise the way medical cannabis was introduced into Polish pharmacies and say access to it is too easy for individuals consuming it for non-medical purposes, reported Dziennik Gazeta Prawna (pA1-A3) on Thursday.
Experts and pharmacy employees admit the preparations for launching medical cannabis were insufficient, as most pharmacists have not been properly trained, are required to dispense it to everyone with a valid prescription, the product is available in the highest possible concentration of 19% THC, there is no system of monitoring its sales or use and it even has no leaflet providing information on the potential adverse effects, dosage and indications for use.
Spectrum Cannabis, the only importer of medical cannabis in Poland, admits that demand for the product is extremely high and the first shipment sold out within a few days.
The company claims the 19% THC variety of the product was chosen as having the most potential applications in Poland and being very good for patients suffering from chronic pain. It added that the reference market was Germany, where 60% of patients use the same variety of the drug. Spectrum Cannabis intends to introduce two additional varieties of the product for multiple sclerosis patients (10% THC) and those suffering from adverse effects of chemo and radiotherapy (9% CBD).
Poland has 'too many pharmacies'
According to the association of Polish pharmacy employers (ZAPPA), Poland has too many pharmacies to ensure their profitability and the number should be reduced by around 25%, reported Rzeczpospolita (pA17) on Friday.
Poland currently has 14,420 pharmacies, whereas the optimal number would be closer to 10,000-11,000, which would ensure profitability and provide jobs for 27,000 pharmacists throughout the country.
ZAPPA claims that reducing the number of pharmacies would also help curb illegal drug exports and flooding the market with dietary supplements. Marcin Wisniewski from ZAPPA said pharmacy chains started to expand 12 or so years ago, which resulted in the degradation of the market.
He added that, despite very good sales of drugs in Poland, the regulatory prerequisites and low margins on reimbursable drugs lead to low profitability, which can only be sustained by pharmacy chains selling large quantities of dietary supplements and not paying taxes in Poland.
The scale of the problem is demonstrated by the average monthly turnover of a single pharmacy being only 199,000 zlotys (€46,387) on a pharmacy market worth 34.5 billion zlotys (€8 billion) in 2018. Additionally, 8,200 individual pharmacies, representing 57% of all pharmacies in Poland generated 14.2 billion zlotys (€3.3 billion) and paid 215-280 million zlotys (€50.1-65.3 million) in taxes, while pharmacy chains constituting 43% of all pharmacies generated 20.3 billion zlotys (€4.7 billion) in 2018, which translated to an average monthly turnover of 273,500 zlotys (€63,753).
According to the Central Statistical Office, Poland has 2,600 patients per pharmacy, while the EU average is 4,350 patients.
The Supreme Administrative Office recently ruled that a pharmacist with at least five years’ experience or three years’ experience and an academic specialisation must be present at the pharmacy at all times for it to be open for business. The ruling means that the number of pharmacies in Poland could soon decline.
Celon Pharma’s export sales gaining momentum
Polish biotech Celon Pharma increased exports of its asthma drug by over 200%, to 21.6 million zlotys (€5 million) in 2018 after going into new markets, reported Parkiet Gazeta Gieldy (p7) and Puls Biznesu (p8) on Thursday.
The company expects sales of Salmex to continue growing in the coming years and that the drug will also be registered in France and Spain by the end of the year, reported both newspapers.
Celon Pharma is currently working on 12 innovative projects in neuropsychiatry, metabolism, inflammatory diseases and oncology. Its most advanced project applies to esketamine therapy in drug-resistant depression, which has already entered Phase II, reported the newspapers.
While the U.S. Food and Drug Administration recently approved the first drug based on a similar particle developed by Johnson & Johnson, Celon Pharma is not afraid that the competitor will dominate the market. It says its molecule will have broader applications, such as bipolar depression, and a more effective form of administration as an inhalant, reported both newspapers.
Celon is also negotiating partnership agreements for several projects, but admits the most important negotiations are for esketamine therapy, while the results of Phase II should be available in the second quarter of the year, reported both newspapers.
Celon would ideally like to sell the rights to its new drug in the U.S. and non-EU countries, but retain them to handle sales on its own within the EU, reported Puls Biznesu.
Celon’s two other projects which have started trials are of Celonko, an FGFR kinase inhibitor for use in bladder, stomach or squamous cell cancer, and a PDE10a inhibitor, for use in schizophrenia, Parkinson’s or Huntington disease.
Phase I for both drugs should be completed in the second and third quarters of 2020, respectively. Celon Pharma also wants to begin trials of two to three new projects by the end of the year, reported Puls Biznesu.
Celon Pharma reported revenues of 125.2 million zlotys (€29.2 million) and a net profit of 29.7 million zlotys (€6.9 million) in 2018, which was respectively a 17% and 16% increase over 2017, reported Puls Biznesu.