Press review

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Poland’s largest pharmacy chain does not accept conscience clause

Country : Austria, Croatia, France, Germany, Latvia, Lithuania, Poland, U.S.

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WARSAW, Sep 22 (APM) - Poland’s largest pharmacy chain, Dbam o Zdrowie (DOZ), managing almost 1,000 pharmacies, claims the 'conscience clause' for pharmacists is in breach of the regulations, reported Gazeta Wyborcza (p5) on Monday.
Olga Roslonek from DOZ said the Polish regulations do not allow pharmacists to use the conscience clause as an excuse not to sell particular medicinal products to patients. The company notified all its employees about this during the latest quarterly meeting in September and passed on this declaration to the Chief Pharmaceutical Inspectorate and the Ministry of Health (MoH).
According to the association of catholic pharmacists of Poland, around 15% of all pharmacists are concerned about how to deal with the fact that they are forced to sell particular medicinal products, such as contraceptives, in conflict with their religious beliefs.
The Ordo Iuris organisation, however, claims the conscience clause is not in breach of the regulations and offers free legal counselling to pharmacists suffering from workplace problems due to their beliefs.
While the main pharmaceutical chamber supports the pharmacists and says they should not be forced to act against their will, the MoH supports the claim that taking advantage of a conscience clause is in breach of the regulations.

Polish pharma companies increasing investments in Poland

The Mikolaj Kopernik Economy Centre prepared a report on the healthcare industry analysing capital expenditure of domestic pharma companies on new investments, reported Dziennik Gazeta Prawna (Forum Ekonomiczne supplement, p1) on Wednesday.
According to the report, Polish pharma companies spent almost 714 million zlotys (166.4 million euros) on investments in 2016, which was 11.4 million zlotys (2.7 million euros) growth on 2015. The two biggest spenders were Polpharma, with 186 million zlotys (43.4 million euros), and Biomed, with 160 million zlotys (37.3 million euros). Polpharma also spent 267.4 million zlotys (62.3 million euros) on R&D in 2016, which means that the company’s combined spending on new investments and R&D reached 20% of its revenues.
Polpharma’s key investment in 2016 was the establishment of a new biotech plant in Duchnice, which will enable the company to significantly increase production capacity of biologicals.
So far, Polpharma has spent 520 million zlotys (121.2 million euros) on biotech investments and intends to spend an additional 1.26 billion zlotys (293.7 million euros) on biotech R&D and production in the near future.
Furthermore, the company works closely with Dutch biotech Biceros, which it acquired in 2016, and started to establish a new, 120 million zloty (28 million euros) plant in Sieradz, in which it will have four modern production lines for drugs in the form of non-sterile liquids.
Polpharma is also Poland’s largest investor in Kazakhstan, where it has invested $80 million to date in the SANTO plant in Shymkent. The company intends to complete another investment in a new biologicals plant shortly.
Polpharma is also the only Polish pharma company producing active ingredients on a large scale. These products are exported to 60 countries on six continents and the company intends to invest an additional 20 million zlotys (4.7 million euros) to expand its portfolio.
Tomasz Starzyk from Bisnode Polska said pharma exports from Poland reached 1 billion euros in the first four months of the year, which was a 10% increase on the corresponding period of 2016. The pharma industry currently accounts for 1% of Polish economic output, making Poland the largest market in the Central Europe and the sixth largest market in the EU.

Parents refusing to vaccinate their child accused of crime

The public prosecutor in Bialogard is accusing parents, who first refused to vaccinate their newly-born infant and then removed the child from hospital against the decision of the local court, of committing a crime, reported Gazeta Wyborcza (p1) on Tuesday.
The child was born prematurely and its parents refused to allow the medical staff to perform basic hygienic procedures, vaccinate it, administer vitamin K or put it under heat lamps. The parents claimed they were strong believers of natural methods and, despite the decision of the local court which partially limited their parental rights, they took the child from the hospital.
Despite police efforts, the parents could not be found and even released a video in which they claimed that they felt oppressed by the system.
While the anti-vaccination organisations claim the parents were fully entitled to do this, legal and health experts say the consequences of their decisions could have been tragic.
The number of anti-vaccination supporters is currently increasing, with 29,000 families refusing to vaccinate their children in 2016, despite the risk of being fined or having their parental rights limited.

Cannabis-based drug controversy

The Helsinki Foundation for Human Rights (HFfHR) claims that the ministry of health’s (MoH) decision to not reimburse a cannabis-based drug imported for a specific patient was unconstitutional, reported Dziennik Gazeta Prawna (pB11) on Tuesday.
A patient was suffering from a disease causing a severe pain in her leg, which prevented her from functioning normally. The MoH agreed to import a cannabis-based drug which is not available in Poland, but then refused to reimburse it.
The HFfHR says the MoH’s decision is in breach of the Constitution and the regulations on patient rights, as the drug was the only medicine that could have relieved the pain in this particular case.

Melatonin could help cancer patients undergoing chemotherapy

According to research conducted by scientists from the universities in Edinburgh and Aberdeen, melatonin could prove useful in minimising discomfort in patients undergoing chemotherapy, reported Rzeczpospolita (pA15) on Tuesday.
Tests conducted on rats proved that administering melatonine before starting chemotherapy reduces nerve damage arising from aggressive treatment and does not affect its efficacy.
Adverse effects of chemotherapy affect up to 70% of patients undergoing the treatment and significantly reduce their quality of life. The scientists now intend to conduct clinical trials to confirm whether melatonine can be used with similar results on human patients.

Poland could become global biotech centre

Experts, officials and representatives of pharma companies debating the state of the Polish biotech sector, agree that Poland could become a global biotech centre, reported Rzeczpospolita (pB8) on Thursday.
The list of participants of the debate included Aleksandra Moscicka-Studzinska from the National Centre for Research and Development, professor Marcin Czech from the Ministry of Health, professor Tomasz Ciach from the Warsaw University of Technology, Bartosz Sokolinski from the Industrial Development Agency, Boguslaw Sieczkowski from Selvita, Pawel Wisniewski from Helix Immuno-Oncology, Mateusz Gaczynski from the Ministry of Science and Higher Education, and Jarek Oleszczuk from AstraZeneca Pharma Poland and INFARMA.
Czech and Gaczynski agreed that Poland satisfies all the requirements for becoming the leading global biotech centre, having all the necessary infrastructure, qualified employees, competent educational institutions and support of the state officials.
Moscicka-Studzinska believes the Polish clinical trials market has large growth potential, as many patients are willing to participate in the trials.
Poland has a good reputation for quality standards, and the existing research facilities are still not fully utilised. Ciach, however, said it is difficult for smaller biotechs to come to an agreement with educational institutions on using their equipment and laboratories, which is why Poland should focus on creating special biotech incubators that could be leased by such companies.
Sokolinski replied that the officials are already considering the establishment of a life sciences accelerator programme, which could help smaller companies with the initial development of their products.
Sieczkowski admitted that, while smaller biotechs may indeed face some difficulties with access to specialised equipment and labs, Selvita has shown that success is possible. He added that it is important to invest more in new laboratories which could be used to the benefit of the entire sector, and that Selvita is currently establishing its own centre with the support of the Ministry of Development, which is to be completed in 2019.
The experts agree that access to funding is very good, but it is important to provide university researchers and smaller companies with access to partners with more experience, which could help steer them in the right direction. They add that, while Poland has many qualified experts, the educational system should be improved to focus more on knowledge and skills of use at early career stages in the biotech industry.

MasterPharm could acquire an OTC company

MasterPharm is considering an acquisition of a company with eight over-the-counter drugs in its portfolio, reported Parkiet Gazeta Gieldy (p3) on Monday.
MasterPharm is a manufacturer of dietary supplements with two plants in Lodz and Mielec, where the company produces soft capsules and micropellets.
Jacek Franasiak, MasterPharm’s CEO, says he is not concerned about the recently enacted regulations curbing the expansion of pharmacy chains. He believes there are no signs that the demand for dietary supplements and drugs among the company’s customers will decline, especially since the market is constantly growing.
The company’s name has not been disclosed, but MasterPharm could finalise the deal by the end of the year.

Stock market is waiting for Celon Pharma to expand with Salmex onto new markets

Celon Pharma’s share price declined by almost 6% to 35.1 zlotys (8.2 euros) on Thursday, after the company published its half-year results, reported Parkiet Gazeta Gieldy (p3) on Friday.
In the first half-year, Celon Pharma reported revenues of 57 million zlotys (13.3 million euros) and a net profit of 13.4 million zlotys (3.1 million euros), compared with, respectively, 71.9 million zlotys (16.8 million euros) and 22.7 million zlotys (5.3 million euros) in the corresponding period of 2016.
While Salmex, the company’s most important revenue generator used in asthma, is already sold in Austria, Lithuania, Croatia, Bosnia, Ukraine and the Dominican Republic, and was recently approved in Guatemala, Salvador, Azerbaijan and Latvia, investors are still waiting for the drug to be approved on some other large European markets.
Celon Pharma claims the approval procedures are on schedule and are at an advanced stage in Germany and Scandinavia.
The company is currently focusing on the development of innovative drugs and claims its three new drugs should enter clinical trials by the end of the year, followed by 12 further projects in the following years. Celon Pharma is hoping to reach phase IIA for up to three drugs by the first half of 2019, after which it could sign partnership agreements for over 200 million euros.

Mabion’s share price soars on promising trials

Mabion’s share price increased by 5% to 99.7 zlotys (23.2 euros) per share on Monday, after the company announced its half-year results and revealed the reports from the clinical trials of its MabThera equivalent, MabiconCD20, reported Rzeczpospolita (pB11) on Tuesday and Parkiet Gazeta Gieldy (p3) on Wednesday.
Mabion is developing a MabThera biosimilar, MabionCD20, which could be used in leukaemia, arthritic sclerosis, rheumatoid arthritis and lymphoma. The company recently received two reports confirming the biosimilarity with MabThera and the effectiveness of the drug, which is currently undergoing clinical trials, reported both newspapers.
The company claims the positive reports accelerated development, as the level of risk of the entire project has declined, reported both newspapers.
Mabion claims that one of its most important objectives is to file the registration documentation for MabionCD20 with the U.S. Food and Drug Administration.
The company’s representatives intend to meet the FDA at the turn of the year to start the procedure as soon as possible, especially since Sandoz, which is also developing a MabThera equivalent, recently filed its registration application, reported Parkiet.
The National Centre of Research and Development gave Mabion a grant of 27 million zlotys (6.3 million euros) to prepare for the large scale production of MabionCD20, reported Parkiet.
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