WARSAW, Oct 13 (APM) - According to the local pharmaceutical inspectorates, pharma wholesalers are restricting deliveries to Polish pharmacies and demanding copies of prescriptions, which is in breach of the regulations, reported Rzeczpospolita (pC6) on Monday.
This primarily applies to drugs from the list of medicines that are subject to excessive exports, such as anticoagulants, certain types of insulin, aerosol inhalants and some transplant drugs.
The Chief Pharmaceutical Inspectorate says pharmacies are not allowed to provide prescription data to anyone except the pharmaceutical inspectorate or the national health fund, as this could result in their licences being revoked.
The list of drugs to which access is restricted in pharmacies due to excessive exports currently contains almost 200 medicines and pharma wholesalers are trying to protect themselves by asking pharmacies for proof that their orders are meant to cover domestic demand.
Wojciech Kozlowski, a legal expert, says the situation shows that the officials should finally develop systemic solutions to ensure full transparency of drug distribution in Poland.
Officials working on new regulations on drug financing
The Ministry of Health (MoH) is working on new regulations on drug financing to make the reimbursement system clearer and more efficient, reported Dziennik Gazeta Prawna (B10) on Wednesday.
Deputy health minister Marcin Czech said the regulations will not be introduced directly by the MoH, but should be passed by parliament to ensure political support. The biggest challenge will be to increase funding on reimbursable drugs from the current 14% of the national health fund’s budget to the long-promised 17%.
The officials are also considering the establishment of additional sub-funds financed, for example, from cigarette excise tax, taxes imposed on unhealthy consumer goods, possible drug insurance and risk-sharing mechanisms for pharma companies.
New regulation on pharmacies triggered higher drug prices
PharmaNET claims drug prices increased after the introduction of the regulations curbing the expansion of pharmacy chains, which is being negated by the officials, reported Dziennik Gazeta Prawna (pB1) on Monday.
PharmaNET’s statement is based on the data collected by PEX Pharma Sequence, according to which the prices of over-the-counter and non-reimbursable prescription drugs increased by 4.1% and 6.4% respectively between June and August, compared with the corresponding period of 2016.
Marek Tomkow, vice president of the Supreme Pharmaceutical Council, said the data is inaccurate and there is no connection between the new regulations and drug prices, especially since the number of pharmacies owned by pharmacy chains in the last few months had increased.
However, PharmaNET claims the regulations have restricted competition on the market, which naturally led to higher drug prices.
New regulations on compensation for vaccination complications
The Ministry of Health (MoH) intends to start compensating victims of vaccination complications from 2018, reported Dziennik Gazeta Prawna (pA9) on Wednesday.
According to the new regulations, patients with vaccination complications will be compensated up to 70,000 zlotys (16,393 euros) from a special fund financed by vaccine producers. In 2018, the fund could be as high as 5 million zlotys (1.2 million euros), with the total sum amounting to 1%-2% of total spending by the MoH on vaccines.
Pharma companies criticise the officials, saying they are constantly being pressured to reduce margins, whereas, given an average of three to six cases of severe vaccination complications a year reported by the National Institute of Public Health, most of the funding will not be used for compensation.
However, experts say the contributions to be paid by the pharmas are not excessive, as the number of complications reported will certainly increase with growing patient awareness and the introduction of obligatory pneumococci vaccinations.
The main criterion for receiving compensation will be the need for hospitalisation for more than 14 days following vaccination complications. The experts add that the proper functioning of the compensation system will require greater focus on educating doctors about vaccination complications.
Selvita’s trials suspended
The U.S. Food and Drug Administration suspended Phase I/II of Selvita’s SEL24 molecule to be potentially used in acute lymphoblastic leukaemia following the death of a patient, reported Rzeczpospolita (pB11) and Parkiet Gazeta Gieldy (p3) on Tuesday.
The patient, who had previously taken part in SEL24 trials, died of a stroke and the doctor assessing the case said the death could potentially be related to SEL24.
Ireneusz Otulski, Selvita’s clinical trials director, said the acute lymphoblastic leukaemia patient was suffering from numerous additional conditions, including respiratory, cardiac, liver and kidney disorders, which substantially increased the risk of a stroke, reported both newspapers.
Marek Przewiezlikowski, Selvita’s chief executive, said that, according to the company’s information, the trials are expected to resume shortly, reported Parkiet.
OncoArendi starts trials of asthma drug
Polish biotech OncoArendi is starting trials of its potential asthma drug, OATD-01, in Germany, reported Puls Biznesu (p6) and Parkiet Gazeta Gieldy (p4) on Tuesday.
OncoArendi intends to reach Phase II with OATD-01 within two years, when it plans to commercialise the product and sell its licence to a bigger partner for continuing the development, reported both newspapers.
The results of Phase I, when the particle will be administered to around 50 patients at a cost of one million euros, should be published in the second quarter of 2018, reported Parkiet.
Marcin Szumowski, OncoArendi’s chief executive, believes this drug has a good chance of being commercialised and, as this compound will be administered to humans for the first time, it will be more profitable to sell it at a more advanced stage of development, reported Puls Biznesu.
The company is also working on another drug for use in cancer immunotherapy, which is currently at a pre-clinical stage and could enter clinical trials at the turn of 2018, reported both newspapers.
Pelion says going private will give it more freedom
Pelion, one of Poland’s largest pharma wholesalers, is satisfied with the decision to exit from the Warsaw Stock Exchange because of the introduction of restrictive regulations on pharmacies curbing the expansion of pharmacy chains, reported Puls Biznesu (p5) on Tuesday.
Pelion’s decision was made because the group also owns the biggest pharmacy chain in Poland, Dbam o Zdrowie (DOZ), with 580 its own and 270 franchised pharmacies. According to Pelion, being a private company will give it more freedom and flexibility in adapting to the new regulations, preserving the number of pharmacies and building its business.
While the company is not disclosing the exact effects of the new regulations on its business, Jacek Szwajcowski, Pelion’s chief executive, strongly believes the restrictive regulations will have an adverse effect on the pharmacy market as a whole.
He added that the biggest problem today is that the state does not support pharmacies as a place where patients can receive comprehensive care, as is the case in many other European countries.
Moleculin Biotech to carry out trials in Poland
U.S. company Moleculin Biotech signed an agreement with Neuca’s subsidiary, Bioscience, to organise trials of its molecule to be potentially used in remitting and drug-resistant acute lymphoblastic leukaemia in Poland, reported Parkiet Gazeta Gieldy (p4) on Thursday.