WARSAW, 18 Jan (APM) - Monday’s Gazeta Wyborcza (Duzy Format supplement, p4-5) published an interview with the former manager in the drugs policy department at Poland's Ministry of Health (MoH), Edyta Matusik, on the reimbursement and pricing irregularities at the ministry.
Matusik, who was dismissed around six months ago, claims the decision was driven by the fact that she had reported illegal action regarding reimbursement decisions to the health minister, Lukasz Szumowski.
She added that, since then, the MoH’s officials have been trying to discredit and prevent her from revealing the irregularities in the department. These irregularities applied to preferential treatment of large pharmas, by restricting reimbursement indications for generics newly added to the reimbursement list or artificially increasing prices of originator drugs just before their patent protection was due to expire, at which time the official prices should be reduced by 25%.
Matusik said all reimbursement decisions should be made in accordance with the regulations, whereas this was not always the case. She added that the biggest faults with the healthcare system in Poland are the fact that important reimbursement decisions are often made by individual officials (instead of by commission) and the lack of clear information and guidelines for patients, especially those suffering from chronic diseases.
Matusik added that the irregularities started in November 2015, when the deputy health minister, Krzysztof Landa, took charge of the drugs policy department. The disregard for procedures and regulations which then started resulted in 20 employees resigning because of being afraid of the ensuing chaos and future consequences.
Matusik said the black PR campaign conducted by the MoH against her is resulting in difficulties with finding a new job in public healthcare institutions and the pharma industry despite her experience and skills. The Sejm’s health commission is currently analysing Matusik’s reports which may lead to a vote of no confidence for the health minister.
Controversies around new regulations for online drug sales
The prime minister’s chancellery and pharmacists are questioning the new regulations on online sales of prescription drugs and medical devices for disabled patients prepared by the Ministry of Health (MoH) and Ministry of Justice, reported Dziennik Gazeta Prawna (pB7) on Monday (pB7) and on Thursday (pB10).
Pharmacists are concerned that, after the new regulations take effect, they will be required to personally deliver prescription drugs ordered online by the disabled, while ensuring proper storage and delivery conditions of the medicines.
They say the regulations are unclear and do not specify their responsibilities regarding such deliveries, but the MoH claims pharmacists will not be obliged to deliver drugs personally, although they will be able to choose to do this or not. Lukasz Waligorski from the Supreme Pharmaceutical Council said delivery services should only be local, as drugs only in such a case can only be delivered safely and cost-effectively in such a case.
The prime minister’s chancellery is also concerned that the new regulations will only strengthen the position of pharmacy chains, which have more staff and resources for conducting both regular and online sales that need to be delivered.
Finally, it is still unknown how the disability of patients ordering drugs online is to be verified. The regulations state that patients will have to submit a simple declaration confirming they are disabled but the chancellery suggests that perhaps they should provide a scan of their official disability documentation. Both solutions are criticised by Waligorski as being either naïve or cumbersome. He suggests the issue should be corrected by adapting the e-prescription IT system to take this into account.
Access to holistic diabetes therapy restricted
Although diabetes increases the chance of a heart attack or stroke fivefold, access to holistic therapy preventing cardiovascular complications is restricted, reported Rzeczpospolita (pA10) on Tuesday.
Experts say despite the proven effectiveness of GLP-1 receptor agonists and SGLT2 inhibitors, the drugs are not reimbursed in Poland and are only available to patients who can afford to pay, respectively, 600 zlotys (€140) and 120-150 zlotys (€28-35) for the drugs per month, which often proves to be too much.
Patient organisations warn that incorrectly treated diabetes leads to much higher social costs and, according to a report prepared by the Medical University of Gdansk, the battle against diabetes in Poland costs 7 billion zlotys (€1.6 billion) per year, of which 2 billion zlotys (€466 million) is spent on treating complications.
Around three million Poles could already have diabetes and an additional three million could be in a pre-diabetic condition.
No discounts for large families in pharmacies
The officials decided to back out from the idea of including pharmacies in a discount programme available to large families, reported Rzeczpospolita (pA21) and Dziennik Gazeta Prawna (pB4) on Wednesday.
The discount programme itself is accessible to all families with at least three children and is currently enjoyed by two million Poles, with 5,000 business partners participating in it. While pharmacy chains were very interested in joining the programme and the officials initially added the necessary regulations to the amendment to the Pharmaceutical Law currently being processed, they were later removed.
This decision is supported by the Supreme Pharmaceutical Council (NIA) protecting the interests of individual pharmacies, believing that the programme would be used by chains to promote their businesses. Marek Tomkow from the NIA said there is nothing wrong with discounts for patients, but the officials first need to ensure that the programme is adjusted to the regulations prohibiting pharmacy advertising.
Meanwhile, Marcin Piskorski from the PharmaNET Association of Pharmaceutical Employers claims the advertising prohibition is already out of hand, as its regulations are currently among the most restrictive in Europe and effectively obstruct appropriate communication between pharmacies and patients.
Poland currently has around 14,000 pharmacies in Poland, while PMR estimates that pharmacy sales will increase from 34.7 billion zlotys (€8.1 billion) in 2018 to 39.6 billion zlotys (€9.2 billion) in 2021.
Medical cannabis finally available in Poland
Medical cannabis can at last be ordered by patients in pharmacies, reported Gazeta Wyborcza (p8) on Thursday.
The first shipment from Canada, which was repackaged in Germany and imported by Spectrum Cannabis to Poland, contained 7 kgs of dried product. The cannabis will not be readily available in pharmacies and will have to be ordered by patients against prescriptions that can be written out by any doctor.
The importer believes 300,000 Poles could benefit from the treatment, mainly those with multiple sclerosis, drug-resistant epilepsy, chronic neuropathic and cancer pain, but also glaucoma, Parkinson’s, Alzheimer’s, AIDS or Tourette’s.
The cannabis available in pharmacies is available at around 65 zlotys (€15.2) per gram, is not reimbursed and contains 19% THC and 1% CBD, which makes it very strong. There are no strict guidelines regarding dosage, but, based on Israel’s example, patients could take 15 grams per month. This means that monthly therapy in Poland would cost around 1,000 zlotys (€233), whereas the first shipment of seven kilograms would be sufficient to treat only 500 patients for a month.
Big fines to prevent sales of counterfeit drugs
According to the new regulations preventing sales of counterfeit drugs, any entity failing to install all the hardware and software required to verify the legitimate origin of medicines by 9 February could be fined up to 500,000 zlotys (€116,550), reported Rzeczpospolita (pA17) on Tuesday.
This applies to manufacturers, importers, wholesalers, pharmacists and some health centres. The regulations are especially criticised by pharmacists, who say they are not responsible for external factors or malfunctions of either the hardware or software, which can result in some pharmacies being fined.
New regulations for pharmacists
The Ministry of Health is working on new regulations for pharmacists to increase their qualifications, reported Dziennik Gazeta Prawna (pB10) on Monday.
The bill is being prepared in cooperation with the Supreme Pharmaceutical Council and is supposed to list all the responsibilities pharmacists already have and provide formal grounds for additional duties, such as monitoring whether patients follow all the treatment guidelines specified by doctors and whether the drugs they take do not interact, thereby causing potential dangers. Additionally, pharmacists could be granted the right to extend prescriptions for patients with chronic diseases and conduct seasonal vaccinations.
Pharmacists are hoping that the new regulations will make them more independent in terms of decision-making and free them from pharmacy owners pressuring employees into maximising drug sales instead of taking proper care of patients.