Press review

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Work continues on amendment to illegal export regulations in Poland

Country : Brazil, Canada, China, India, Japan, Poland, U.S.

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WARSAW, 28 June (APM) - The draft amendment to the illegal export regulations that will increase the range of medicinal products that pharmacies will be able to legally sell to non-medical entities, will reach the Polish parliament in July, according to Poland's Ministry of Health (MoH), reported Rzeczpospolita (pA10) on Monday.
According to the new regulations that came in on 6 June, pharmacies are only allowed to sell medicinal products to individual patients, while sales to non-medical institutions, such as welfare centres, orphanages and schools, as well as businesses, are illegal and may be punishable with imprisonment for three months to five years.
Appeals from the Supreme Pharmaceutical Council have led to the MoH increasing the range of non-prescription drugs and medicinal products that can be sold to non-medical institutions, other than medicines containing psychoactive ingredients.

Polish pharmacy mafias remain unpunished

Between 2015 and the latest amendments to the illegal export regulations of 6 June, all companies exporting drugs illegally were fined an aggregate sum of 96 million zlotys (€22.5 million), although none of these fines were paid, reported Dziennik Gazeta Prawna (pA1 & pB4) on Tuesday.
According to Marek Tomków, vice-president of the Supreme Pharmaceutical Chamber, in many cases, the fines are unenforceable as the companies are either not registered in Poland or have false data about their board members.
The Ministry of Health admits that such reports show the audacity of the criminals who knew that they would remain unpunished. This led to the recent changes from fines to criminal sanctions enabling the actual person performing the act to be punished, rather than fake company officials.
The value of medicines illegally exported each year from Poland is estimated at 2 billion zlotys (€470 million) and constitutes 57% of the value of all drugs exported from Poland. Consequently, 288 medicines are now almost unobtainable on the market.

Polpharma discusses patient-oriented healthcare system

After being awarded the title of National Champion by Polityka Insight and achieving second place in the innovations sector, Markus Sieger, head of the Polpharma Group, talks about how innovations and synergy between the pharma industry, the Government and the National Health System are required to create a sustainable health programme for Polish patients, reported Rzeczpospolita (pA22) on Monday.
According to Sieger, Polpharma has been innovative in various areas: in 2018 alone, it had the largest number of European patent applications of all Polish companies. It emphasises R&D, investing around 200 million zlotys (€47 million) a year and employing over 400 people specifically in this activity.
As a generic drug producer, it emphasises the importance of prophylaxis, justifying its production of vitamins and other prophylaxis-oriented products, as well as its production of medications combining various drugs in one tablet to make it easier for elderly patients to take medicines.
Sieger says the Polish government needs to work on the reimbursement development system (RTR) to help Polish companies produce medicines locally.

Migraine treatment needs reforms in Poland

Patients suffering from migraine are still misunderstood in Poland and have difficulty in obtaining suitable treatment, reported Gazeta Wyborcza in its Wysokie Obcasy supplement (p36-39) on Saturday and in its Bóle Głowy supplement (p14-17) on Thursday.
Migraine is a genetic illness and, according to the World Health Organization, it is the biggest disability factor in patients of working age, surpassing diabetes, heart diseases and asthma. Around 12% of the world's population suffers from migraine, but despite such a high number, it is often considered a whim and is not treated properly.
The known prevention therapies that focus on treating the pain itself are acute treatments with triptans and non-steroidal anti-inflammatory medicines, such as ibuprofen. Three other methods are also used for treating migraines. The pharmacological method uses medicines from three different groups: cardiological, such as beta blockers or calcium channel blockers, antiepileptic and anti-depressant drugs.
The second method uses botulinum toxin, while the third constitutes preventive injections of calcitonin gene related peptide (CGRP), erenumab, that are reported to have few adverse effects and high efficacy estimated at up to 50-70%, added the newspaper on Thursday.
Nevertheless, none of these therapies cure migraines completely and, unlike in other European countries, they are non-refundable in Poland. The cost of triptans is around 20 zlotys (€4.70) for 2 tablets, while botulinum toxin costs around 2,000 zlotys (€470) per procedure, reported the newspaper on Saturday.
Experts from the Polish Institute of Pain Treatment and Diagnosis emphasise the importance of further research, drug reimbursement and proper diagnoses of migraine within the Polish healthcare system, as this is one of the most misunderstood and underrated conditions leading to long-term suffering of patients.

MoH will add new diabetes drugs to reimbursement list

The Ministry of Health (MoH) plans to add new diabetes therapeutic treatment, flosins, to the reimbursement list to prevent the most serious cardiovascular complications of diabetes, such as cardiac arrests and strokes, reports Rzeczpospolita (pQ3, pQ4) on Friday.
The drugs being considered are medicines containing empagliflozin, canagliflozin, dapagliflozin and semaglutide. The HTA Agency recommended Jardiance (empagliflozin), but, following the opinion of the Economic Commission, the drug's producer needed to present a new, reduced price proposal for the treatment and Jardiance is now waiting for the MoH's final decision to enter the reimbursement list.
Other medications, namely Invokana (canagliflozin), Forxiga (dapagliflozin) and Ozempic (semaglutide) have already received positive recommendations of the HTA Agency and have entered the price negotiations with the Economic Commission.

Court ruling could consolidate the harmful stereotypes about biosimilars

The Supreme Administrative Court agreed with the claim of the ombudsman that a hospital breached patient rights when it replaced the treatment of patients with a biosimilar due to the insufficient supply of the original drug, reported Rzeczpospolita (pA13) on Wednesday.
The patients were treated with an originator biological drug, but due to its shortage, the hospital bought a biosimilar treatment in a regular tender procedure. According to the ombudsman, the hospital should have purchased drugs according to the individual needs of each patient and not the price in the tender. Biosimilars are officially 20% cheaper than the originator drugs and may come on to the market at the end of the 20-year patent protection period.
However, according to experts, the false interpretation of the ruling may be harmful to patients, as producers of originator drugs frequently like to frighten both doctors and patients that using biosimilars may be dangerous. It should be up to the doctor's sole discretion and not economic indicators as to how treatment should continue for a patient.

Polish anti-vax parents try to bypass nursery school regulations

As the anti-vax trend gains momentum among Polish parents, local authorities pass regulations allowing only vaccinated children to be enrolled into nursery schools, whereas anti-vax parents try to bypass these regulations with illegal methods, reported Gazeta Wyborcza (p1) on Tuesday and (p4) in its Gazeta Stołeczna supplement on Wednesday.
The last two weeks alone have brought 200 cases of measles in Poland, which make 1,500 cases from the beginning of the year. According to the Chief Sanitary Inspectorate, this is the highest number of measles infections over the past 30 years, caused by the increasing intensity of the anti-vax movement.
43,000 children were not vaccinated last year, while this number is expected to increase this year. To combat the trend, local authorities are applying regulations to promote the enrolment of only vaccinated children to their nursery schools.
Meanwhile, many anti-vax parents manage to obtain forged health certificates for their children or use certificates belonging to vaccinated children or even obtain a certificate from an allergist excusing the postponement of the vaccination.

Biotts develops new technologies for administering medicines through the skin

Biotts, a Polish start-up from Wroclaw, which conducts research into new technologies for administering medicines through the skin with patches, is currently applying for patents within Europe, the U.S., Canada, China, Japan, India and Brazil, reported Puls Biznesu (p12-13) on Tuesday.
Biotts is currently negotiating with pharmas on the use of the proposed intake method for their medicines. It is conducting pre-clinical trials on biosimilars used in neurology and tissue regeneration, as well as fundamental research for treatments for tick-borne diseases and cancer.
According to Biotts, taking medication through the skin reduces the adverse effects of the treatment and requires smaller amounts of the active ingredients to achieve the same results as in traditional methods.

Polish and U.S. scientists research new cancer treatments

Scientists from the Polish Medical University of Lodz and from University of Pennsylvania in Philadelphia made progress in the innovative research of molecular targeted cancer therapy, reported Rzeczpospolita (pL4) on Tuesday.
According to professor Ireneusz Majsterek, the scientists managed to target the treatment directly to cancers cells that were undergoing PERK kinase, thereby making the treatment more effective and less harmful for the patient. This method means the inhibitors used in the research targeted only cancer cells and left healthy cells unaffected. This process is also being considered for treating neurodegenerative diseases, in which dual-purpose drugs often prove ineffective.

Scientists and Celon Pharma conduct research into new therapies for incurable diseases

Scientists from the Military Institute of Hygiene and Epidemiology in Warsaw, Warsaw University and Celon Pharma are conducting research into two innovative therapies for autoimmune diseases using parasitic nematodes without infecting the patients with parasites, reported Rzeczpospolita (pL4) on Tuesday.
According to Dr Katarzyna Donskow-Lysoniecka, the manager of the research, nematodes supress the development of allergic, autoimmune, neurodegenerative and inflammatory diseases.
One research project encompasses the use of the regulatory CD8 T-cell lymphocytes in patients with multiple sclerosis and psoriasis, while another focuses on the identification of factors generating CD8 Treg lymphocytes to further allow for the creation of lymphocytes in the blood of the patients. Positive results in both research projects would make a breakthrough in effective treatments for today’s incurable diseases.

Electronic prescription will facilitate the specification of the reimbursement rates for drugs

The MoH announced it will have developed an electronic prescription system showing the levels of reimbursement of drugs based on their indication for use according to the summary of product characteristics by the end of the year, reported Dziennik Gazeta Prawna (pB8) on Thursday.
After the indication is entered, the online system will give the doctor the reimbursement rate for the drug and encode it in the e-prescription, thereby shifting the responsibility for establishing the rate of the reimbursement to the government budget, away from the doctors.

Biotech sector one of fastest growing sectors globally, but Poland struggles to keep up

Estimates suggest that by 2025 the global biotech market, the most innovative and fastest growing sector, will be worth $727 billion, while Poland needs to make significant changes to keep up with the trend, reported Rzeczpospolita (pA21) on Thursday.
According to the Biotechnology Committee of the Polish Academy of Sciences, despite well-educated staff, 13,000 biotechnology students and a high level of employment in the bioeconomy, the Polish biotech sector still needs a national programme, appropriate legislation, public acceptance and greater funding to achieve growth.
They estimate that the largest international corporations invest more in their own biotech research projects than all the funding in Poland’s scientific research together, while Polish companies are reluctant to risk investing in biotechnology due to the low rate of return on their investment.
However, Maciej Wieczorek, president of Celon Pharma, and Sanjeev Choudhary, president of Medinice, say investors see a huge potential in biotech research, while investments in Polish R&D are increasing and companies can and do use government subsidies for innovation. Choudhary says pre-clinical and clinical trials in medical technology are much cheaper and shorter than in the case of pharmaceuticals.
Nevertheless, Konrad Palka, president of Pharmena, admits that, even if biotechnology ultimately leads to an improvement in the living conditions of many people, the investments in biotechnology are long-term and capital-intensive.

Bioceltix considers stock market flotation

Bioceltix, a start-up from Wroclaw, specialising in biotech drugs for both humans and animals, is considering a stock market listing, reports Parkiet Gazeta Giełdy (p4) on Friday.
Bioceltix is preparing for its first full registration procedure for medicinal products with the European Medicines Agency for a veterinary treatment using mesenchymal stem cells (MSCs) for degenerative joint diseases. It is looking for additional funding for the process of registering its biotech project.
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