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Polish government releases plans for reimbursement incentives system following pharma backlash

WARSAW, 10 May (APM) - Polish pharma companies called on the country's authorities to introduce the long-promised reimbursement incentives system (RTR), warning that, without state support, they will be unable to effectively compete with foreign players, especially those from outside Europe, Rzeczpospolita (pA12) reported on Monday.
The Ministry of Entrepreneurship and Technology (MoEaT) has since released more information on the introduction of the reimbursement incentives system (RTR) encouraging foreign pharma to invest in Poland and improve competitiveness of domestic manufacturers, reported Rzeczpospolita (pA17) on Friday.
Pharma group the Polish Association of Pharma Industry Employers (PZPFF) warned on Monday that, despite the regulations stipulating that the Ministry of Health (MoH) should take account of the investments and R&D activities of companies applying for drug reimbursement, the primary criterion for access is still price, which favours non-European competitors with lower manufacturing costs due to not having to comply with stricter production norms.
The introduction of the RTR was first promised in 2016 by the deputy health minister responsible for drug policy, Krzysztof Landa, and then confirmed by the next deputy health minister, Marcin Czech, in April 2018.
According to the Friday report, MoEaT has now said that companies applying for reimbursement will be assessed on the basis of their investments in production, employment, R&D and data systems, and assigned to one of three groups with different levels of support. There will be a total of ten benefits for such companies and, while the details have not yet been disclosed, the MoEaT claims the group with the least benefits should capture the interest of the pharma.
Monday's article cites a report prepared by IQVIA, which notes that the introduction of the RTR for Polish pharma manufacturers could improve the balance of trade and lead to an increase in the production capacity of domestic companies and new investments, which happened in Spain after the introduction of a similar programme 30 years ago.
The PZPFF claims the RTR is perfectly compliant with EU regulations and, while Poland is believed to be a market specialising in generics, many domestic companies produce unique products which are difficult to manufacture and offer added value, such as eye drops, parenteral drugs or long-acting medicines. The PZPFF says, with additional state support, Polish companies could become more competitive on the market, pool more resources and eventually start manufacturing originator drugs.

Access to modern severe asthma treatment should be improved

Around 1,500 to 2,500 Poles with severe asthma should have access to modern biologic treatment, which is currently only available to less than 600 patients through drug programmes, Gazeta Wyborcza (Tylko Zdrowie supplement, p2) reported on Friday.
Poland has approximately four million asthma patients, many of whom overuse bronchodilators, instead of undergoing therapy with inhaled corticosteroids.

Pharmacy chains are allowed to keep acquiring individual pharmacies

Despite the introduction of more restrictive regulations curbing the expansion of pharmacy chains in 2017, the interpretation of these regulations by the MoH enables chains to expand through the acquisition of individual pharmacies, Dziennik Gazeta Prawna (pB7) on Monday and Rzeczpospolita (pA13) reported on Wednesday.
According to the regulations, only pharmacists have been able to establish new pharmacies since June 2017. However, pharmacy chains have kept expanding by acquiring existing pharmacies to incorporate them into their structures.
The MoH sees these practices as being consistent with the existing regulations. However, the pharmaceutical authorities say such an interpretation is incorrect and the MoH’s officials should not interpret the regulations, as this is the responsibility of the courts.
The Polish pharmacy employers (ZAPPA) claims pharmacy chains have acquired 750 individual pharmacies since the introduction of the anti-concentration regulations in June 2017, which were supposed to curb the expansion of chains by introducing the requirement that new pharmacies can only be run by pharmacists.
Pharmacists say the strategy of the pharmacy chains is inconsistent with the regulations and blame the Chief Pharmaceutical Inspectorate for insufficient supervision over the market.

Pharmacists say Poland has too many pharmacies

According to a report published on Tuesday by ZAPPA, the current number of 14,000 pharmacies is too high and should be reduced to 10,000-11,000, Dziennik Gazeta Prawna (pB4) reported on Wednesday.
According to Statistics Poland, the average pharmacy serves 2,628 patients, while the EU average is 4,350 patients. ZAPPA believes the excessive number of pharmacies on the market generates additional costs, is ineffective, reduces margins and results in higher drug prices. Another problem is the lack of qualified pharmacists to staff all the pharmacies on the market, which is required by the regulations. Finally, ZAPPA claims pharmacies are forced to balance their businesses around sales of high-margin products, such as dietary supplements which should not be overused by patients.
While ZAPPA primarily has the interest of individual pharmacies in mind, pharmacy chains represented by PharmaNET do not agree that the number of outlets on the market should be limited or that there is any correlation between the number of pharmacies and drug prices.

Free HPV vaccinations in Warsaw confirmed

Warsaw’s vice-president, Pawel Rabiej, announced that the HTA agency had issued a positive recommendation for HPV vaccinations, which means that the city will finance them for all 12-year-olds, reported Gazeta Wyborcza (p6) on Tuesday.

Anti-vaxxers are on the attack

While the officials were hoping that the 2018 measles outbreak in Europe would encourage Polish parents to vaccinate their children, the anti-vaxxers are on the attack, and are taking advantage of bureaucratic procedures, Dziennik Gazeta Prawna (pA4-A5) reported on Tuesday.
Anti-vaxxers are bombarding sanitary offices and the Ministry of Health with hundreds of enquiries about vaccinations, all in accordance with the regulations. As the officials do not have the manpower to address all the enquiries, individuals behind these practices are legally allowed to take their cases to courts, which they are doing.
The number of parents refusing to vaccinate their children exceeded 30,000 in 2017, 40,000 in 2018 and could be as high as 50,000 in 2019, whereas the percentage of children vaccinated with the initial and booster MMR vaccines declined from 98% and 94%, respectively, in 2009, to 92.9% and 92.4% in 2018.

Mass malaria vaccinations in Africa

Mass malaria vaccinations began in April in Ghana, Malawi and Kenya, Rzeczpospolita (pA11) reported on Tuesday (APMHE 62782).
The vaccinations with the RTS,S vaccine developed by GlaxoSmithKline in cooperation with the PATH Malaria Vaccine Initiative non-profit organisation supported by the Bill and Melinda Gates Foundation will encompass 360,000 children aged under two. Its phase III clinical trials included 15,000 patients from seven African countries and the results were approved by the World Health Organisation.
The vaccine is only effective in 40% of cases, and its effects fade over time, but no better alternatives are currently available. Malaria results in 435,000 deaths per year.

Lack of regulations in the event of an epidemic

Recent shortages of measles, tuberculosis and MMR vaccines show Poland is lacking proper anti-epidemic regulations, reported Dziennik Gazeta Prawna (pA2-A3) on Wednesday.
Although the MoH started work on such regulations in 2017 and even prepared a bill on financing and stocking up on various vaccines, as well as deploying the necessary vaccinations not only in the event of an epidemic, but also in the case of isolated outbreaks of the most dangerous diseases, the regulations were not passed.
The problem became clear in 2018 during a measles outbreak in Europe which affected 80,000 patients. Since then, Poland has been facing major problems with providing all the necessary vaccines to patients exposed to the disease, while GlaxoSmithKline and Merck Sharp and Dohme - the only suppliers of the product in Europe - are unable to meet the increased demand. GSK has supplied 40,000 doses of its vaccine to Poland over the last three months, some imported from other markets, while only 5,000 doses currently remain in the official reserves.
The MMR vaccine has a similar problem. While 11% of pharmacies stocked it in October 2018, the vaccine was only available in 1% of pharmacies two months later, which shows the system and the state, the main customers of vaccines in Poland, are not prepared for rapid spikes in morbidity.
Poland also has a problem of illegal drug exports, for which the MoH published a list of 250 drugs which cannot be exported due to potential shortages on the market. This list includes 50 to 60 vaccines.

Tuberculosis vaccines may soon be supplied again

The tuberculosis vaccine reserves could be depleted in mid-May, as the only company manufacturing it in Poland has problems supplying it, reported Dziennik Gazeta Prawna (pA1 and pA4) on Monday and Parkiet Gazeta Gieldy (p6) on Friday.
The manufacturer, Biomed-Lublin, realised in December 2018 that its latest batch of the vaccine could be defective and stopped all deliveries. This vaccine can be supplied by another supplier based in Denmark, although experts do not recommend its products due to the higher chance of vaccine complications reported Gazeta Prawna.
Since the beginning of this year, children have been vaccinated mainly from the reserves, but as the vaccine has a relatively short shelf life, the reserves have almost been depleted.
Biomed-Lublin says it should be able to fully resume unimpeded production of its vaccine no earlier than in the third quarter of the year, while the officials say they are watching the situation closely and are ready to take all the necessary steps to provide access to the product reported Gazeta Prawna.
The tuberculosis vaccine is the most widely used vaccine in Poland, as almost every infant receives it in hospital before being released, as long as there are no medical contraindications.
Poland had 5,787 confirmed cases of tuberculosis in 2017 and their number has been gradually declining, although the morbidity rate is still higher than in most EU member states reported Gazeta Prawna.
Biomed Lublin announced that the tests of the latest batch of its BCG10 tuberculosis vaccine are positive, which means the company could resume its sales, reported Parkiet Gazeta Gieldy.
Following these tests, Biomed will be able to supply 100,000 doses immediately, to mitigate the risk of vaccine shortages on the market, as children have been vaccinated mainly from reserves since the beginning of the year, after all deliveries of BCG10 were stopped due to potential quality problems reported Parkiet.

Mabion filed another registration application with the EMA

The Polish biotech, Mabion, recently filed another registration application for its new drug, MabionCD20, with the European Medicines Agency, Parkiet Gazeta Gieldy (p7) reported on Tuesday.
Mabion is hoping this step will help it commercialise the drug faster on markets where MabThera (rituximab) is still under patent protection in the rheumatoid arthritis (RA) indication, as the application applies to another brand name for MabionCD20 without the RA indication.
Mabion believes its new drug should be registered in the EU in 2019, which would enable it to start generating revenues from sales in 2020. However, the exact date will depend on the company’s partner, Mylan. Mabion is currently preparing to start the registration process for the drug in the U.S.
Other than MabionCD20, the company is working on two other drugs, and intends to launch three new projects in the second half of the year.
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