WARSAW, 7 June (APM) - Restrictive regulations intended to curb illegal drug exports are came into force on Thursday, reported Dziennik Gazeta Prawna on Tuesday (pC4-C5) and Thursday (pB4) and Rzeczpospolita on Thursday (pA16) and Friday (pA18).
According to the regulations, anyone involved in illegal exports of drugs contained in the list of over 300 drugs to which access is limited will be punishable with imprisonment for up to 10 years. Illegal exports of all other drugs will be punishable with imprisonment for up to five years.
This will be supplemented by fines, in which case the rule of thumb is to double the value of the exported drugs, reported Dziennik Gazeta Prawna. Additionally, wholesalers will be explicitly banned from obtaining drugs from retailers, even if both are owned by the same entity and obstructing the work of the pharmaceutical inspectors could also be subject to criminal liability.
Individuals and entities involved in illegal drug exports to date have only been punished with administrative fines, which has proved highly ineffective, reported both newspapers.
The value of illegal drug exports in Poland is estimated at 2 billion zlotys (€467.3 million) a year, which accounts for 57% of all drug exports from Poland, reported both newspapers.
While the industry in general is in favour of the changes, there are some cases in which the much more restrictive regulations could cause trouble. This applies to institutions such as schools, orphanages, nursing homes or animal shelters, which will not be allowed to legally buy small quantities of pharmacy-exclusive drugs, medicines in particular doses or products required to conduct day-to-day activities, and receive an invoice to account for the spending without the risk of being subject to sanctions.
Therefore, the Supreme Pharmaceutical Council is urging the officials to adjust the regulations as soon as possible, reported Rzeczpospolita.
Cancer treatment in Poland not sufficiently flexible
Cancer patients in Poland have limited access to innovative drugs, which is not only tied to insufficient funding, but also to excessive bureaucracy, reports Rzeczpospolita (pS1) on Friday.
Many cancer patients are forced to use sub-optimal drugs even though more effective medicines are already available and reimbursed by the National Health Fund (NHF) in other indications.
One example is that ovarian cancer patients cannot have breast cancer drugs reimbursed and vice versa, despite studies showing that such treatment might be more effective.
While there are mechanisms allowing for an individual approach to patient needs, such as emergency access to drug technologies (RDTL) or direct imports combined with reimbursement, they are extremely complicated, time- and resource-consuming, require coordination between various institutions and, at the end of the day, do not guarantee that patients will gain access to the most effective therapy in a timely and sustainable manner.
Breast cancer experts say treatment could be significantly improved
Polish doctors say that, while the potential for effective breast cancer treatment has improved significantly, Polish patients still do not have access to innovative drugs which are available in other European countries, reports Rzeczpospolita (pS2) on Friday.
According to the European ABC4 guidelines, combining CDK4/6 inhibitors with hormonal treatment is the preferred therapeutic option in HER2-negative advanced breast cancer. Such treatment is reimbursed in countries such as Hungary, Sweden, Slovenia, Croatia, but not in Poland.
While the Ministry of Health claims that breast cancer patients have access to nine targeted therapies using three active ingredients, namely lapatinib, pertuzumab and trastuzumab, none of them is actually reimbursed in HER2-negative advanced breast cancer, which has a highly negative impact on the life expectancy of patients.
Furthermore, access to a less modern drug, everolimus, dedicated to women after the menopause is restricted, which leads to a situation in which patients are prematurely switched to very taxing chemotherapy treatment.
Data supporting the fact that CDK4/6 inhibitors can slow down the progression of HER2-negative advanced breast cancer is sufficient to reimburse such drugs in most countries, but not in Poland. Furthermore, according to The New York Times, an international group of experts proved that one particular CDK4/6 inhibitor, ribociclib, can also increase the life expectancy of women attacked by cancer before or during the menopause.
It is possible that ribociclib will also become available to Polish patients, as the Ministry of Health has ended the pricing negotiations with its manufacturer and the reimbursement application is waiting to be assessed by the health minister.
Approximately 16,000 women in Poland are diagnosed with breast cancer every year.
Supreme Audit Office questions radiopharmaceuticals used by PET-CT centres
The Supreme Audit Office (NIK) is questioning the practice of many PET-CT centres using self-produced radiopharmaceuticals, reported Rzeczpospolita (pA16) on Wednesday.
NIK says while the services provided by such centres are reimbursed by the state, by using self-produced radiopharmaceuticals they generate revenues from non-certified activity. According to the National Health Fund, self-produced radiopharmaceuticals were used in PET-CT services for which the state paid 295 million zlotys (€68.9 million).
Doctors argue that only three basic PET radiopharmaceuticals are registered in Poland and Europe, while proper diagnostics require 10 additional types, whereas commercial suppliers are not interested in producing them due to their low demand or high production cost. They add that every dose of radiopharmaceuticals produced by PET-CT centres is tested and completely safe to patients.
Number of pharmacies declining
According to PharmaNET, within almost two years of the enactment of the regulations curbing the expansion of pharmacy chains, 1,825 pharmacies have gone out of business, reported Dziennik Gazeta Prawna (pB6) on Monday, as well as Gazeta Wyborcza (p11) and Puls Biznesu (p11) on Tuesday.
While individual pharmacists and the Ministry of Health claimed the pharmacy market should not be entirely free as 39% of all drugs sold in pharmacies are reimbursed by the state, the Antimonopoly Office and the Ministry of Development argued that weakening the position of the pharmacy chains could result in higher prices and unemployment among young pharmacists, reported Gazeta Wyborcza.
PharmaNET, which primarily associates pharmacy chains, claims the biggest problem is that 83 of all pharmacies that closed down operated in rural locations without any competition, which left patients with no alternatives, reported both newspapers.
However, this claim was criticised by the Supreme Pharmaceutical Council (NIA), which said PharmaNET’s data are inaccurate and misleading, as most outlets that closed down in rural areas were not pharmacies, but dispensaries that were not affected by the regulations. The NIA added that, over the past two years, 319 pharmacies opened in rural areas and smaller towns, reported Puls Biznesu.
PharmaNET added that, while the regulations were supposed to help resolve the issue of parallel exports, the entire initiative had failed, proving that individuals conducting such business cooperate with individual pharmacies and not chains, reported Dziennik Gazeta Prawna.
According to IQVIA, the total number of pharmacies in Poland declined from 14,914 in October 2017 to 14,205 in March 2019, reported Gazeta Wyborcza.
E-prescriptions gaining momentum
Although e-prescriptions are not yet obligatory, doctors have already issued 1.5 million to 300,000 patients, reported Dziennik Gazeta Prawna (pA12) on Tuesday.
E-prescriptions are currently being issued by 3,300 doctors at 600 healthcare institutions, but the system is to become obligatory nationally in 2020.
Doctors agree that the system enables access to detailed patient data, helps supervise therapies and reduce the number of mistakes. The officials are still looking for ways to improve the system and remove as much of the burden as possible from doctors, for example by no longer requiring them to specify the reimbursement level of drugs in given indications, which is currently under development.
Bioton's shareholders concerned
Bioton's shareholders are concerned that the company, valued at 365 million zlotys (€85.3 million), reported an accumulated loss of 976.4 million zlotys (€228.1 million), which officially requires them to make a decision about Bioton's future on 28 June, reported Parkiet Gazeta Gieldy (p4) on Wednesday.
Bioton claims the accumulated loss was mainly caused by non-cash factors and that the company is on track to improve its results, especially after selling its subsidiary SciGen for 100 million zlotys (€23.4 million), allowing the entire group to focus on the segment of insulin analogues and stabilise its liquidity.
However, some shareholders believe selling SciGen was a bad decision and the transaction itself was not sufficiently transparent. AIS Investment 2 representing minority shareholders took the case to court in 2018, but the proceedings were adjourned until 30 August 2019.
Mabion promotes its drugs in U.S.
Polish biotech Mabion is promoting its business in the U.S. during the BIO International Convention in Philadelphia and the Jefferies Healthcare Conference in New York, reported Parkiet Gazeta Gieldy (p5) on Thursday.
Mabion is in the process of registering its rheumatoid arthritis drug, MabionCD20, with the European Medicines Agency. The company filed two registration applications for the drug hoping this would accelerate its commercialisation on markets where rituximab (MabThera) still has patent protection in the indication of rheumatoid arthritis.
The aim of the additional application is to obtain a second brand name for MabionCD20 in a limited number of indications excluding rheumatoid arthritis, which is purely a formal step supporting the optimal commercialisation strategy.
The company expects another round of inquiries about MabionCD20 from the EMA in June and hopes to have the drug registered by the end of 2019. Mabion is also working on a clinical trials protocol enabling the organisation of a comparative study between the European MabThera and the U.S. Rituxan, but with the use of Mabion CD20, which could speed up the registration process in the U.S. in the future.
Other than MabionCD20, the company is working on two other drugs, MabionMS and MabionEGFR, and intends to launch several new projects in the areas of immunology and oncology in the second half of the year.