WARSAW, 21 Dec (APM) - After publishing the January reimbursement list on Wednesday, which had numerous discrepancies, Poland's Ministry of Health (MoH) published a new version on Friday, reported Gazeta Wyborcza (p1) on Monday, Wednesday (p5) and Thursday (p6).
The list that was published on 12 December only contained drugs that are available in pharmacies, but not those administered in chemotherapy and through drug programmes.
Reimbursement limits, retail prices and the level of co-payment for many drugs were also inaccurate, which caused turmoil among pharmas and wholesalers. In addition, the list omitted 14 of Adamed’s generics, including Amlozek, Areplex and Xartan, as it had not agreed to further price cuts. It immediately asked the officials to include its missing drugs in the list as soon as possible and the list was re-published on 15 December without the earlier discrepancies, including 46 additional drugs, as well as 12 of Adamed’s drugs.
The MoH claims the original list was corrected because of a mistake in the calculation algorithm, but refuses to comment on the restoration of Adamed’s drugs to the list.
Additional controversies arose after the corrected list was republished, when the MoH’s management spent the weekend at a hotel near Warsaw belonging to Adamed’s owners. The officials claim there was no connection between these two events and the meeting was internal and applied to the organisation of work in 2019. The choice of venue arose from the lack of other options on the selected dates, reported the newspaper on Wednesday and Thursday.
The MoH recently had problems processing the large number of expiring reimbursement decisions, which could explain the discrepancies in the originally published list.
According to PEX PharmaSequence, total sales in Polish pharmacies were 9.4% higher in November this year than in 2017, reaching 3 billion zlotys (€701 million), of which 30% was generated on reimbursable drugs, reported Puls Biznesu (p6) on Wednesday.
PEX PharmaSequence claims the pharmacy market could exceed 34.5 billion zlotys (€8.1 billion) this year, while the value of reimbursement could be almost 9 billion zlotys (€2.1 billion), which would be, respectively, a 5% and 6.2% increase over 2017.
Poland has approximately 14,650 pharmacies, which means their number declined by 2.2% over the past year.
National Health Fund no longer co-finances vaccinations conducted by local authorities
The National Health Fund (NHF) decided to change its policy on co-financing healthcare programmes pursued locally, which means that local authorities may not be able to provide patients with access to additional vaccinations anymore, reported Gazeta Wyborcza (p5) on Tuesday.
Over the past two years, small communities were subsidised with up to 80% and large communities up to 40% of their spending on healthcare programmes.
The Ministry of Health claims the NHF cannot finance non-guaranteed services, when its budget is already insufficient to guarantee appropriate access to those that are guaranteed by the regulations.
The change could result in poorer access to flu vaccinations for the elderly or HPV.
Free drugs for pregnant women
The Ministry of Health (MoH) is working on new regulations to give pregnant women access to free drugs, reported Dziennik Gazeta Prawna (pB10) on Wednesday.
The officials announced their plans for free drugs for pregnant women in April and the MoH wants the regulations to be enacted as soon as possible, which could happen within several months.
The mechanism would be similar to the list of free drugs for patients aged over 65, and would include the medicines needed to maintain the well-being of pregnant women and their children. The initial budget for the initiative would be 20 million zlotys (€4.7 million) in the first year, while the free drugs could be prescribed by family doctors and gynaecologists.
Regulations on clinical trials will be more transparent
The Ministry of Health (MoH) wants to improve the regulations on clinical trials to improve access and make them more transparent, especially with regard to patient compensation claims, reported Rzeczpospolita (pA19) on Friday.
The system currently protects the pharmas and sponsors of the clinical trials better than patients, which is a major barrier to claiming compensation for complications arising from trials. Deputy health minister responsible for drug policy, Marcin Czech, said the officials are talking to insurers to come up with optimal solutions addressing this issue.
The MoH also claims that, while the ethics committees assessing clinical trials are working well, there are too many of them, which makes supervision difficult. Therefore, the system could be centralised under the chief ethics committee at the drug registration office.
The officials are also working on solutions to make knowledge about clinical trials more accessible, including a register with all clinical trials conducted in Poland and globally, legal regulations, statistics and standards.
Approximately 400 clinical trials are held in Poland each year, but only 1-2% of them are non-commercial. This is to be addressed through the establishment of the Medical Research Agency (ABM), which is to facilitate the organisation of more non-commercial trials in Poland. The ABM’s budget is to be gradually increased to 1 billion zlotys (€234 million) in 2029.
Medical cannabis could become available in December
Medical cannabis could become available in pharmacies before Christmas, as seven kilograms of the dried product from Canada is already waiting to be transported to Poland from Germany, reported Rzeczpospolita (pA15) on Thursday.
The importer, Spectrum Cannabis, is currently waiting for the translation of all the necessary documentation. It is not making any specific promises, but said it would be possible for any pharmacy to place orders with wholesalers, as long as they present proof of demand backed by prescriptions written out for patients.
Marek Tomkow from the Supreme Pharmaceutical Council (NRA) said most pharmacies are already technically equipped to prepare cannabis-based drugs and that the NRA will provide access to special training for pharmacists on how to do this.
While the regulations legalising medical cannabis entered into force in October 2017, the process of finding an importer and finalising all the formalities took longer than expected.
Celon Pharma ready to begin clinical trials
Celon Pharma has received permission from the registration office to start Phase I trials of a drug for use in psychotic disorders and Huntington’s disease, reported Parkiet Gazeta Gieldy (p5) on Wednesday.