WARSAW, 12 July (APM) - Illegal exports, problems with importing active ingredients from China and strict EU import regulations, are the causes of shortages of more than 500 drugs in Poland and a further 300 are at risk of not being available, according to pharmacists, reported Dziennik Gazeta Prawna (pA1, pB4) on Tuesday, (pB3) Thursday and (pA6-A8) Friday, Rzeczpospolita (pA14) on Tuesday and (pA24) Friday, Puls Bi
The drugs that are not obtainable by Polish patients are medications for oncological, neurological and thyroid diseases, chronic obstructive pulmonary disease (COPD), hypertension, asthma, allergies, HIV and diabetes reported all the newspapers.
According to pharmacists, one of the biggest and most reported problems is the lack of availability of Euthyrox used for hypothyroidism, Valsartan for hypertension, Symtuza for HIV treatment and Metformax 500 SR and Glucophage XR 500, which are convenient therapies for diabetes with prolonged release of metformin.
The Ministry of Health (MoH) added Euthyrox to the list of drugs at risk of being unavailable on 5 July, but also announced there is no risk of Euthyrox not being available on the same day, added Dziennik Gazeta Prawna on Tuesday and Rzeczpospolita on Wednesday.
This confusing communication may be caused by discrepancies between actual stock levels and outdated pharmacy reports issued to the Integrated System for Monitoring Trade in Medicinal Products (ZSMOPL), said Rzeczpospolita on Tuesday and Gazeta Wyborcza on Wednesday. The MoH promised to analyse the situation of missing drugs case by case, added Dziennik Gazeta Prawna on Tuesday.
The Supreme Pharmaceutical Council has already issued an open letter to the MoH. According to the pharmacists, the situation is more difficult than ever: first, there were shortages mainly in more expensive originator drugs, possibly caused by the closure of active ingredient factories in China, but the current problems even affect generic drugs. According to Dziennik Gazeta Prawna on Tuesday, 80% of drugs sold in Poland have active ingredients originating from China.
According to experts, the shortages in the supply of generic drugs cannot be explained by illegal exports of drugs, which is estimated at 2 billion zlotys (€470 million) a year, because the margins would be too small to be profitable. Pharmacists are blaming the counterfeit drugs directive that became effective in February, which prolongs drug delivery due to complicated procedures related to issuing correct serial codes, added Dziennik Gazeta Prawna on Tuesday.
Another aspect would be drug producers, such as Bayer and Boehringer Ingelheim, which are rationing supply among pharmacies to impose different prices in different outlets. The antimonopoly office (UOKIK) is investigating whether such practices distort competition, reported Dziennik Gazeta Prawna on Tuesday.
The situation is forcing patients to travel around the country in search of medications and pharmacists to offer appropriate substitutes which are becoming increasingly scarce. Another cause of such a state may stem from the fact that many reimbursement decisions expire this year and experts see this situation as favourable circumstances for pharmas to negotiate prices, concluded Gazeta Wyborcza on Wednesday.
Despite everything, health minister Łukasz Szumowski says claims about serious shortages of drugs in pharmacies are an overstatement and while there were initially some problems with availability, availability is now restored. Pharmacists criticise this claim, stating this is not the case. Pharmacists and pharmas have long been warning that the Polish market is too dependent on Chinese suppliers of active ingredients, while the government should introduce incentives for manufacturers to produce them locally.
It appears the current situation shows those warnings should have been heeded when there still was time to address it without exposing patients to the risk of not having access to medications, reported Dziennik Gazeta Prawna on Thursday and Rzeczpospolita, Dziennik Gazeta Prawna and Gazeta Wyborcza on Friday.
Szumowski said a nationwide helpline would be launched for patients looking for particular drugs on Monday, claiming the problem applies to a handful of drugs only, reported Rzeczpospolita, Dziennik Gazeta Prawna and Gazeta Wyborcza on Friday.
Problems with drug availability have also been reported in other European countries, such as France, Belgium, Bulgaria, Romania and Slovakia.
It is rumoured that the problem will require the EU officials to step in and introduce regulations helping prevent drug shortages in Europe in the future. 60% of all active ingredients used to produce drugs are currently produced outside Europe, which is a 40 percentage-point increase over the 1990s.
France believes the EU Commission should start incentivising manufacturers of active ingredients to produce them in Europe. Meanwhile, large pharmas are primarily interested in selling innovative, expensive drugs and often stop production of medicines that are no longer patent protected, which become much cheaper when generics are launched.
Finally, with the principle of free movement of goods within the EU, companies prefer to allocate more drugs to markets with higher prices, which means countries where drugs are cheaper, such as those in Central Europe, have to deal with lower supply, reported Rzeczpospolita (pA24) on Friday.
Problems with access to drugs due to dependency on active ingredients manufacturers from outside Europe are only escalated by illegal drug exports, a problem affecting the Polish market mainly since the enactment of the Reimbursement Act in 2012, when the prices of drugs in Poland dropped significantly compared to other EU member states, encouraging the low-risk, high-reward practice of illegal sales of drugs by pharmacies, wholesalers and even private outpatient clinics set up solely for this purpose, reported Dziennik Gazeta Prawna on Friday.
Analysis of reimbursement incentives system
The government intends to spend 400 million zlotys (€95 million) on the reimbursement incentives system (RTR), encouraging foreign pharmas to invest in Poland and improve competitiveness of domestic manufacturers, but potential beneficiaries have not been sufficiently consulted on the proposed solutions, reported Dziennik Gazeta Prawna (pB1) on Thursday and Rzeczpospolita (pA15) on Friday.
According to the regulations, companies applying for the (RTR) will be categorised into three groups (A, B, C) depending on their three-year score based on the number of scientists they employ in research centres located in Poland, R&D conducted, patents and patent applications, cooperation with foreign research institutions and Polish biotech start-ups, taxes paid and the value of reimbursement of drugs manufactured in Poland.
The value of additional RTR financing for groups A and B will range from 20 to 60 million zlotys (€5-15 million) for three years on top of the preferential status in reimbursement negotiations, while companies classified into the C group will gain the title of Partner of the Polish Economy, giving them the preferential treatment, reported Dziennik Gazeta Prawna.
However, pharmas have not been sufficiently consulted on the regulations and say the objectives of introducing the RTR are unclear. The Employers' Union of Innovative Pharmaceutical Companies INFARMA says that, while the primary objective of the RTR is to increase innovation within the Polish pharma industry and multiple factors taken are into account when scoring pharmas, there is insufficient information on which factors are most important.
Another problem is that a great deal of attention is being placed on clinical trials, and INFARMA believes this is already a strength in Poland, which means that incentives in an area that works well will not bring any major changes to how companies operate. Finally, INFARMA claims the RTR should not be tied to the reimbursement process, reported Dziennik Gazeta Prawna.
Unofficially, it is rumoured that the regulations proposed by the Ministry of Entrepreneurship and Technology are not in line with the way in which the Ministry of Health would like to see them, which creates the situation in which there is a very slim chance that the RTR will be introduced before the coming parliamentary elections, reported both newspapers.
Polish scientists researching innovative analgesic
Scientists from the Faculty of Chemistry at the University of Warsaw and the Institute of Pharmacology of the Polish Academy of Sciences are conducting research into an innovative analgesic which has passed animal tests and will soon undergo Phase I, reported Rzeczpospolita (pA21) on Tuesday.
The substance is intended to be used for treating neuropathic pain, acute traumatic states, and palliative care for use in smaller doses than traditional opioids but without the risk of addiction.
Vaccine shortages in pharmacies
Patients are warning that there is a serious shortage of various vaccines in Polish pharmacies, reported Gazeta Wyborcza (p1) on Thursday.
The problem applies to such vaccines as Havrix for adults and Havrix Junior for children inoculating against hepatitis A, Priorix inoculating against measles, Cervarix inoculating against HPV, Menveo inoculating against meningococci and Rabipur inoculating against rabies.
The problem arises from higher than expected morbidity rates, difficulties with increasing manufacturing capacity quickly and the fact that pharmacies and pharmas have always been reluctant to overstock such products because of their seasonality.
Scepticism of science fosters antivax movement
According to Wellcome Global Monitor 2018, almost 10% of Europeans do not believe in the integrity of scientists or trust science in general, reported Gazeta Wyborcza (p10) in Nasza Europa supplement on Saturday.
Ukraine, with the largest measles outbreak in 2018, leads the vaccination disbelievers, whereas, the leading disbelievers in Europe are France, followed by Latvia and Lithuania.
Scientists claim the lack of trust in vaccinations may arise from their effectiveness, as their effects are completely unnoticeable. The world's biggest vaccination supporters are in Rwanda and Bangladesh, where the vaccinated populations have increased since 1995 from 30% to 95%, proving effective and saving thousands of lives.
Pharmacy licence may be revoked solely by pharmaceutical inspector
According to a ruling of the Supreme Administrative Court, a pharmacy licence may be revoked solely by the regional pharmaceutical inspectorate without an opinion from the regional pharmaceutical council, reported Dziennik Gazeta Prawna (pC8) on Tuesday.
Patient's online account will streamline Polish healthcare system
New regulations on improvements to the e-health system introduced on Wednesday will streamline the system for patients, pharmacists and doctors, reported Dziennik Gazeta Prawna (pB10) on Tuesday and (pB8) Wednesday, Rzeczpospolita (pA17) on Wednesday and Puls Biznesu (p5) on Thursday.
The system will combine solutions for the e-prescription system establishing the reimbursement rate of the drug according to its list of indications, issue referrals to specialists and confirmation of appointments for patients in primary health centres if they have a trusted profile, help patients book appointments or search for specialists in health centres, as well as streamline information flow between the National Health Fund (NHF) and the Social Insurance Institution (ZUS), reported Dziennik Gazeta Prawna on Tuesday.
The system will also help older people obtain fully reimbursable prescribed drugs from doctors, added Dziennik Gazeta Prawna on Wednesday.
The additional budget for developing the system between 2020 and 2022 is 150 million zlotys (€35 million), concluded Dziennik Gazeta Prawna on Wednesday.
6,500 doctors have issued 2.6 million e-prescriptions to 550,000 patients to date, reported Puls Biznesu.
Nanogroup develops new targeted cancer therapy
Biotech Nanogroup is developing a "supergeneric" targeted therapy for cancer to minimise side effects of the treatment, reported Rzeczpospolita (pA25) and Parkiet (p04) on Monday.
According to Grzegorz Burtan, president of Nanogroup, unlike traditional chemotherapies, the new therapy only fights cells affected by cancer, leaving healthy cells unaffected.
Cancer cells are attracted to the sugars in the drug and, when the drug is absorbed by the cancer cells, it fights the aberration from the inside. After tests on animals, this method proved to be cheaper, more effective and caused almost no adverse effects compared to traditional cancer treatments. The method is expected to be launched onto the market in three to four years.
Another project from one of Nanogroups companies, Nanosanguis, is a blood substitute that can carry oxygen for administration to accident victims. Nanogroup is also conducting research with the Warsaw Medical University into an innovative method of administering drugs for treating gliomas.
Pharmena completes pre-clinical trials of its 1-MNA molecule
Pharmena has successfully completed pre-clinical trials of its 1-MNA molecule in the non-alcoholic steatohepatitis (NASH) indication, reported Parkiet Gazeta Gieldy (p4) on Thursday.
Test results confirmed the 1-MNA molecule affects key parameters responsible for the development of the disease.