WARSAW, 29 May (APM) - One in four pharmacies might close because of financial struggles not only because of the pandemic, but because of the changing pharma market, reported Rzeczpospolita (pA16) on Tuesday reported experts as saying.
According to a Polish analytical company, PEX PharmaSequence, five million fewer patients per week visited pharmacies in May than before the pandemic.
The pharma market in Poland has increased 26% over the last decade, while the reimbursable drug sector has declined 5%. A decade ago, reimbursable drugs constituted 51% of pharmacy revenues, which has dropped to 38%. Inflation and rising costs of running pharmacies means 26% of chain pharmacies and 23% of individual pharmacies are unprofitable.
The boom during the pandemic was very short - pharmacies reported 33% sales growth in March, to 4.1 billion zlotys (€930 million), whereas sales plummeted to 2.8 billion zlotys (€630 million) in April.
New amendment to Pharmaceutical Law may disrupt supply chains in Poland
An amendment to the pharmaceutical law preventing pharma wholesalers from outsourcing the wholesale activities they are required to perform for and on behalf of the Marketing Authorisation Holder (MAH) will become effective on 1 July in order to try to control the authenticity of drugs on the Polish market, reported Dziennik Gazeta Prawna (pB4) on Thursday.
According to the same law, a wholesaler may acquire a designated wholesaler status from the MAH, which would exempt him from the requirement to check the authenticity of drugs owned by the MAH. Such a law could cause disruption in supply chains in Poland and another drug crisis, as many Polish wholesalers outsource their wholesale activities, whereas experts say the law should be re-enacted.
Polish pharma industry needs long-term development policy to ensure drug safety
The Covid-19 pandemic has demonstrated the importance of national pharma production and independence of foreign imports to ensure drug safety to Polish patients, while the Polish pharma industry wants the government to prepare comprehensive long-term policies for the development of this sector, reports Puls Biznesu (p8-9) on Friday.
According to analyses, only one in three reimbursable drugs sold in Poland is produced in Poland. Over 60% of active pharmaceutical ingredients (API) used by the pharma industry in Europe are imported from China and India.
The Polish Economic Institute calculated that, if 20% of API imports from Asia are substituted by 50% produced locally and 50% imported from Central-Eastern Europe, the Polish economy would see an increase in added value of $8.3 billion a year.
The pharmacy and the medical sector is among the most innovative branches of the Polish economy generating over 1% of GDP, while the pharma industry receives 7% of all R&D grants. Therefore, the local pharma industry wants a future reimbursement incentives system (RTR Plus) and other R&D incentives to strengthen this industry and move the source of certain APIs to Poland. The Ministry of Health has announced it will resume work on the amendment to the Reimbursement Act during the summer.
The drug crisis caused by the pandemic and API dependence has also provoked discussions on pharma reindustrialisation in Europe. Some 80-90% of APIs used to produce drugs available in the EU were produced in China or India, while 76% of API in innovative drugs come from EU manufacturers, 11% from the U.S. and only 9% from Asia.
According to the European Medicines Agency, 3,000 APIs are registered in the EU, 600 of which are on the Polish reimbursable lists, while only 40 of which (primarily simple APIs) are produced in Poland.
Drug independence has become a priority within Europe, which is now working on a pharmaceutical strategy to organise international cooperation between member states to ensure drug safety and availability for patients throughout Europe. Additionally, the EU is launching a new €9.4 billion EU4Health programme to improve drug safety for EU citizens.
Zolgensma conditionally approved for use in Europe
Zolgensma, also known as onasemnogene abeparvovec or AVXS-101, is an innovative gene therapy used in spinal muscular atrophy (SMA) which has been conditionally approved for use within the European Union, reported Rzeczpospolita (pA5) on Thursday.
This will be the second SMA drug available in Poland; the first was Spinraza (nusinersen) which has been reimbursed for 500 patients. 800 to 900 patients currently suffer from SMA in Poland.
Problems with access to vaccinations for children
Difficulties caused by the Covid-19 pandemic and closed or under staffed health centres mean many Polish children have problems receiving compulsory vaccinations, report Dziennik Gazeta Prawna (pA7) on Tuesday and Gazeta Wyborcza (p16-17) on Friday.
Experts say these are further reasons for the dozen or so percent annual decline in the vaccination coverage levels in the case of Polish children. According to the vaccine producers, problems may arise with the availability of vaccines in the autumn, especially non-compulsory vaccines, such as flu jabs, because of the high demand and delaying the administration of vaccines during the lockdown period reported both newspapers.
According to the United Nations Children's Fund (UNICEF), vaccination programmes have been suspended in dozens of countries, some suffering from the measles epidemic, such as Bangladesh, Brazil, Bolivia, Cambodia, Chad, Mexico and Ukraine, the due to the risk of Covid-19 infections spreading.
This could lead to a return of infectious diseases such as measles and pertussis. An estimated 117 million children in 37 countries could not be vaccinated against measles on time which could lead to another dangerous pandemic, added Gazeta Wyborcza.
Covid-19 vaccine rumours improve global stock markets
The announcement of the start of clinical trials in June by the Japanese AnGes researching a DNA Covid-19 vaccine has improved sentiment on global stock markets and gives hope of conquering the pandemic and rebuilding the global economy, reported Parkiet Gazeta Gieldy (p10) on Wednesday and Dziennik Gazeta Prawna (pA3) on Thursday, unlike the case of chloroquine, which, despite high expectations, did not prove effective against the virus, reported Dziennik Gazeta Prawna (pA2) on Thursday.
The vaccine is said to be safer and easier to produce than traditional vaccines. Other than AnGes, many other companies are striving to produce a working Covid-19 vaccine. These include Moderna, with the most promising vaccine-candidate to date, Merck, with the non-profit organisation IAVI, which announced the start of research on a vaccine based on the technology of one of the Ebola vaccines this Tuesday, and Novavax which has started clinical trials of their vaccine-candidate, reported Parkiet Gazeta Gieldy.
According to the Milken Institute think tank, 141 Covid-19 vaccines and 223 cures are currently being researched. The World Health Organization (WHO) counted 10 vaccine-candidates from the U.S. and China, which will soon enter the clinical trials stage.
Even so, the experts claim the first vaccines could reach global markets no earlier than in 18 months and, according to Moderna, vaccinating the whole global population with their vaccine, if necessary, would last eight years, added Dziennik Gazeta Prawna.
Of the cures, the only proven drug which shortens the infection but does not reduce the mortality rate is remdesivir. Chloroquine, which was approved for use against the virus in the middle of March because of rumours about it effectiveness from hospitals in China, did not prove effective.
The Polish Ministry of Health (MoH) bought 11,000 packs of Arechin (chloroquine) from Adamed for the Material Reserves Agency for 150,000 zlotys (€34,000) intended for Polish hospitals and the company has donated an additional 13,500 packs, but the decision was left to the hospitals as to whether they would use the experimental drug or not.
According to the recent study published in Lancet, the drug did not prove effective against the virus but could also cause heart conditions and increase the mortality rate, concluded Dziennik Gazeta Prawna.
Selvita's share price rises as sales increase due to geopolitical tensions
Despite the pandemic, Selvita reported a very successful first quarter of the year and is expanding in contract research, such as preclinical CRO and will issue 2.38 million new shares, reported Parkiet Gazeta Gieldy (p6) on Wednesday and (p4) on Thursday.
The company has capitalised on the opportunity from the tensions between the U.S. and China, as well as the uncertainty of the situation in the UK caused by Brexit, returning a 175% increase in revenues from services to U.S. companies and 74% increase in revenues from UK clients.
The order book for 2020 is currently estimated at 96 million zlotys (€22 million), which is 41% more than last year.
Mabion prepares for new registration procedure at EMA
The delayed registration of MabionCD20, a rituximab biosimilar, on EU markets and disappointing quarterly results, means Mabion intends to issue shares for up to 1.9 million zlotys (€420,000) in the development of its drug and will enter a new registration procedure with the European Medicines Agency (EMA) for the commercial production of the drug, reported Parkiet Gazeta Gieldy (p4) on Wednesday.
The company plans to research MabionCD20's stability and biosimilarity. Consultations with the EMA are planned for the turn of June/July.
Astellas Pharma overcomes Covid-19 pandemic challenges
Astellas Pharma, which produces oncology, transplant and urology drugs, discussed its safety measures during the Covid-19 pandemic, reported Puls Biznesu in its Weekend supplement (p11) on Friday.
The safety measures include streamlining its supply chain and a six-month supply of drugs for its patients, organising training on subcutaneous administration of drugs for patients to reduce the risk of visits to health centres, introducing a two-shift work system for its employees - one on site and one from home and support of medical personnel with protective equipment.
However, it had to reduce activities in clinical trials and, in some cases completely stop them due to complications with patients visiting health centres.