WARSAW, 24 Apr (APM) - The European Commission (EC) wants changes to the pharma industry, including access to innovative technologies, access to drugs, independence of active ingredients from outside Europe and resolution of the problem of drug shortages, as part of its strategy for 2020, reported Rzeczpospolita on Tuesday.
According to the EC, such a programme is needed to ensure the system is secure and crisis-proof, providing access to safe, high-quality and effective drugs, especially in the light of the Covid-19 pandemic.
EC vice president Věra Jourová claims the EU should produce as many drugs as possible locally. Although many originator drugs are already made within the EU borders, they are produced mainly from active ingredients imported from China, while most generic drugs come from India.
The coronavirus pandemic and closure of factories in Asia meant there was a high risk of the supply chains with Asia breaking, which could have led to catastrophic drug crises for EU patients.
Meanwhile, the EU needs harmonised regulations even within its borders, such as open trading of drugs between countries, regulations on stockpiling of drugs within countries and starting production of generic drugs locally.
Polish government plans free medication for pregnant patients
The Polish government has announced a new 'Pregnancy Plus' programme to fully reimburse specific medications for pregnant patients, reported Dziennik Gazeta Prawna (pB11) on Monday.
The Government is planning to spend 11 million zlotys (€2.5 million) this year, 24.2 million zlotys (€5.5 million) in 2021 and an additional 2 to 4 million zlotys (€440,000-885,000) per year, up to 51.2 million zlotys (€11.5 million) in 2029.
The politicians from the Left Party used these figures to calculate that each pregnant patient will be eligible for reimbursement of 65 zlotys (€14.50) for the whole term of a pregnancy.
The financing is allegedly calculated on the average spent by a pregnant patient on drugs, while the list of drugs available in the programme will be revealed in the same manner as the reimbursable drugs for senior citizens. 'Pregnancy Plus is planned to start from July.
OncoArendi progressing with clinical trials
OncoArendi Therapeutics' OATD-01 molecule has successfully passed Phase Ib in the 50 mg dosage, reported Parkiet Gazeta Giełdy (p07) on Tuesday and Puls Biznesu (p3) on Tuesday.
The Polish biotech has been developing the OATD-01 molecule, a drug-candidate for treating asthma and sarcoidosis, both a severe lung illness and one of the coronavirus symptoms and has successfully passed Phase Ib in the 50 mg dosage.
The company decided not to continue testing the 75 mg dosage, so it can used the resources it saves to finance further analyses of therapeutic dosages in Phase II.
Ryvu Therapeutics applies for NCBiR fast track grant
Ryvu Therapeutics' project called 'novel small molecule immunomodulatory therapies in refractory cancers' has been selected for funding in the fast track grant programme by the National Centre for Research and Development (NCBiR), reported Parkiet Gazeta Gieldy (p6) on Tuesday.
The aim of the project is to develop a drug candidate which is characterised within Phase I. This is a small molecule modulator of the patient’s immune response to his own cancer cells. The cost of the project is estimated at over 35.8 million zlotys (€8 million) and the recommended funding is almost 22.4 million zlotys (€5 million). The end of the project is planned for December 2023.
Financial experts warn biotech bubble could burst
Recent reports of the Polish stock market have shown a huge increase in the value of biotechs and experts believe such escalation might be just the formation of a bubble caused by the Covid-19 pandemic, reported Parkiet Gazeta Gieldy (p6) and Rzeczpospolita (pA17, pL1) on Tuesday.
Together with e-commerce companies and game developers, biotechs have profited the most during the coronavirus pandemic.
However, experts advise caution in investing, as many companies can be highly overvalued. Numerous Polish pharmas have announced investments in research and development of a Covi-19 vaccine or drug, but such products will most probably come to Poland from larger, better-financed companies from abroad which have more experience in developing drugs and have a larger registered drug portfolio.
The only stock price increases that are justified by actual company operations are of those companies making products that are currently most needed during the Covid-19 pandemic, namely diagnostic tests and protective gear used in healthcare.
Polish healthcare workers need access to Covid-19 tests
The Senate's proposal of universal Covid-19 tests for every healthcare worker was rejected by the Polish government, while some hospitals are buying tests from an increasing number of companies offering tests commercially on demand with their own money to protect their staff and patients, reported Gazeta Wyborcza (p3) on Saturday, (p1) on Monday, (p2) and in its Stoleczna Supplement (p1) on Tuesday, Dziennik Gazeta Prawna (pA4) on Monday and Rzeczpospolita (p5) on Tuesday.
Medical experts are alarmed that Poland has no concerted policy for diagnosing and isolating healthcare workers or asymptomatic hospital patients when infected healthcare workers represent a third of all Covid-19 cases in Poland.
They may now become a major cause of the spread of the virus. Some hospitals are proactively testing their staff with their own funds or are co-funded by local authorities and private donors.
Experts recall the good example from Germany, where, frequent screening of healthcare workers and hospital patients meant medical staff only account for 5% of infections, reported Gazeta Wyborcza. However, according to Katarzyna Pikulska, president of the Surgeons Alliance, Scalpel, 17% of Polish doctors and nurses are infected by the virus and twice as many are quarantined, added Rzeczpospolita.
On the other hand, commercial testing for Covid-19 is a growing business in Poland. 80 laboratories are capable of conducting 20,000 tests a day and some companies use these capabilities for testing customers privately. The price per test is around 580 zlotys (€130), where, according to experts, the real cost of such a test is 200-250 zlotys (€44-€55).
Equipment and tests imported from China frequently do not meet medical standards
Many countries are currently competing for medical equipment, masks and Covid-19 tests, while health experts warn the huge demand means Chinese exporters are shipping equipment that is often sub-standard, reported Parkiet Gazeta Gieldy (p13) on Monday.
In the initial stages of the pandemic, China was importing enormous amounts of protective masks and clothing (2 and 2.5 billion units respectively), but, after the initial wave, the Chinese government reopened factories and production of medical equipment increased by 1600%, which resulted in a dramatic reduction in their quality and the failure to meet safety standards.
This resulted in a supply of Covid-19 tests imported into the UK being infected by the virus and a batch of thermometers imported by Thailand not having a temperature measuring component. This situation shows the dangers of global dependence on China in terms of the production of the necessary equipment and should serve as an encouragement to move to local production.
Research into new revolutionary Covid-19 drug in Brazil
According to Jair Bolsonaro, the President of Brazil, research is being conducted into a new highly-effective Covid-19 drug in the Laboratory of Immunology Heart Institute of University of São Paulo, reported Rzeczpospolita (pA7) on Monday.
The drug, which is claimed to have 94% efficacy in in-vitro tests, will enter its four-week clinical trials on 500 patients in five Brazilian hospitals in May. It is reported to be based on a different methodology than the research conducted worldwide so far.
The World Health Organization (WHO) reports 70 vaccine-candidates being researched around the globe, from which the most advanced is being produced by CanSino Biologics from Hong Kong and Beijing Institute of Biotechnology, which has recently entered Phase II.
Pharmena applied for a patent for its potential Covid-19 drug
Pharmena, a Polish dermocosmetics and dietary supplement producer, has applied for a Polish and US patent for its 1-MNA molecule in new indications, such as viral and Covid-19 related infections, reported Parkiet Gazeta Giełdy (p5) on Wednesday.
All medications must have unique serial numbers during pandemic
The Chief Pharmaceutical Inspectorate wants no loosening of regulations on unique EU serial numbers under the so-called Falsified Drug Act because of difficulties arising from the Covid-19 outbreak, especially in the light of Europol reports stating that the falsified drug business has been increasing since the outbreak of the pandemic, reported Dziennik Gazeta Prawna (pB5) on Thursday.
Inno-Gene will administer in-field Covid-19 tests
Inno-Gene's subsidiary, DNA Research Centre, has started working with Gremedig, which will manage mobile Covid-19 sample collection points, reported Parkiet Gazeta Gieldy (p5) on Thursday.
Gremedig will use 10 ambulances with qualified medical staff to collect and send samples to DNA Research Centre.
The samples will be tested there in accordance with the WHO's standards using serological IgM and IgG antibody tests. Gremedig claims it is able to produce 1,000 genetic tests and 2,500 serological tests a day and is listed as a regional laboratory of the Ministry of Health (MoH).
Biomed will test its tuberculosis vaccine in the battle against the coronavirus
Biomed Lublin, a Polish tuberculosis vaccine producer, in conjunction with the University of Rzeszów, will start research into the effect of using its Bacillus Calmette-Guérin (BCG) vaccine on morbidity and the course of SARS-CoV-2 infection, reported Parkiet Gazeta Gieldy (p4) on Friday.
Surge of false therapies and faith healers in Poland
The Covid-19 pandemic has brought an increase in faith healers and false therapies marketed to cure the virus in Poland, reported Gazeta Wyborcza (pp18-19) on Tuesday.
Medical experts warn the public not to believe and buy miraculous therapies claiming to quickly cure the virus, such as sea algae and colloidal silver. The increase in such practices is alarming, as Poland currently has an estimated 100,000 faith healers.