WARSAW, 13 Apr (APM) - Officials in Poland are working on an amendment to the Reimbursement Ac that would mean companies producing drugs and running clinical trials in the country would receive reimbursement incentives, reported Rzeczpospolita (pA17) on Wednesday.
Politicians first mentioned such incentives in 2016 when international pharma companies willing to move their production to Poland were to receive special financial assistance during reimbursement negotiations. However, the regulations were never introduced because officials could not agree on whether the money should be provided by the Ministry of Finance or the Ministry of Health.
The Polish government is returning to the idea, however, and wants to give incentives to companies not only moving their production to Poland, but also running clinical trials and opening new R&D centres in the country.
Polish biotech industry needs additional financing and support
Additional financing and better retention of employees is absolutely crucial for accelerating the development of the Polish biotech industry, said Professor Tomasz Ciach from the Warsaw University of Technology, according to a story in Puls Biznesu (p14) on Wednesday.
Ciach said that while Poland has good biotech specialists and sufficient adequate infrastructure, greater attention should be given to creating effective commercialisation mechanisms and ties between science and business. He added that, in contrast with large foreign cities, there is no single business incubator in Warsaw that could help and guide biotech companies.
Tomasz Nocun from Selvita added that, while a great deal of interesting research is being conducted in Poland, mostly with the help of public grants, Poland has an insufficient number of good research teams to fully utilise all opportunities.
Professor Jaroslaw Dastych of Proteon Pharmaceuticals also said that, while it is relatively easy to obtain financing for preliminary laboratory research, obtaining funding for the actual implementation of the ideas, which is much more expensive, is far more difficult, even though the state gives some incentives to private investors.
While the state shortly intends to pump 500 million zlotys (€119.3 million) into scientific research, mostly into biotech and medical technologies, the actual cost of launching a product onto the market could be as high as $2 billion. Polish companies do not have the funding to cover such costs, however, and are forced to look for foreign partners.
The industry is currently working on devising a system of bringing scientists closer together, improving their cooperation and utilising the full potential of the available infrastructure by establishing a Virtual Research Institute to help to achieve these goals.
Selvita and Celon Pharma are investing in their own R&D centres
Two Polish biotechs, Selvita and Celon Pharma, will establish their own R&D centres, partially financing their investments with grants, reported Parkiet Gazeta Gieldy (p7) on Friday.
Selvita will set up its R&D centre in Krakow in the second quarter of 2019 for 77 million zlotys (€18.4 million), of which 34 million zlotys (€8.1 million) will be provided through grants. The company intends to invest 390 million zlotys (€93.1 million) overall in R&D up to 2021, and create 1,000 jobs within the next ten years.
Celon Pharma will establish its R&D centre in Kazun Nowy in 2019, for 97 million zlotys (€23.2 million), of which 35 million zlotys (€8.4 million) will be provided through grants. The investment will double the company’s R&D potential and create 150 jobs.
Access to multiple myeloma therapy is restricted
Access to modern recurrent and drug-resistant multiple myeloma therapy in Poland is restricted, with six new drugs approved in the U.S. and the EU since the most recent reimbursement decision for the condition was made in 2013 for Celgene’s Revlimid (lenalidomide), reported Rzeczpospolita (pA11) on Tuesday.
Although experts agree that the first line of standard multiple myeloma treatment with bortezomib, thalidomide and dexamethasone is working well and is available to patients, the situation is much worse in the case of recurrent and drug-resistant multiple myeloma.
The only available therapy is Revlimid, while patients do not have access to the newer, safer and more expensive therapies including Celgene’s Imnovid (pomalidomide), Amgen’s Kyprolis (carfilzomib), Takeda’s Ninlaro (ixazomib), Novartis’s Farydak (panobinostat), Janssen’s Darzalex (daratumumab) and Bristol-Myers Squibb’s Empliciti (elotuzumab).
There were expectations that patients would have access to Imnovid in January 2018, but a reimbursement decision is still pending. The reimbursement process of the five other drugs could last at least 18 more months.
Low standards for drug management in hospital pharmacies
The standards of drug management in hospital pharmacies are so low that they could endanger the safety of patients, according to an audit conducted by the Supreme Audit Office (NIK) that was reported in Gazeta Wyborcza on Monday (Stoleczna supplement, p10) and on Tuesday (p6).
The most alarming bad practices included storing drugs after the end of their shelf lives, as well as damaged drugs, drugs of unknown origin or drugs that have been withdrawn by the Chief Pharmaceutical Inspectorate. Another problem was that hospital pharmacies often fail to update their computer registers to reflect the actual stock level.
The NIK found irregularities in all 24 hospital pharmacies audited.
GLG Pharma could soon continue its clinical trials in triple negative breast cancer
GLG Pharma received a positive opinion from the ethics commission on phase I/II of its GLG-801 drug that could be used in triple negative breast cancer on Tuesday, reported Parkiet Gazeta Gieldy on Wednesday (p4) and on Friday (p7)
In order to start phase I/II, the company will now only have to receive permission from the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products.
GLG Pharma’s share price soared by around 50% since Tuesday, reported the newspaper on Friday.
Spending on antibiotics is increasing
Poles spent 818 million zlotys (€195.2 million) on antibiotics in 2017, which was a 36 million zloty (€8.6 million) increase over 2016, reported Dziennik Gazeta Prawna (pA2-A3) on Wednesday.
According to IQVIA, the increase was caused not only by the increase in antibiotic prices, but also by growing consumption, as the number of packets bought by patients increased by over a million, to 56.7 million. This trend is confirmed by the European Commission, according to which the percentage of Poles using antibiotics without consulting doctors increased by 7 percentage points to 10% between 2013 and 2016.
Doctors say many patients trade their leftover antibiotics or persuade pharmacists to sell them without prescriptions. Simultaneously, the percentage of Poles who believe that antibiotics can also be used in viral infections is higher than the 46% EU average.
Experts agree that this trend is very dangerous and could lead to the further development of drug-resistant bacteria responsible for diseases costing lives of 700,000 patients worldwide and 25,000 patients in the EU per year. The consensus is that the officials should introduce an efficient drug resistance monitoring system in every voivodship, coordinated by regional branches of the State Sanitary Inspectorate and health consultants of various specialisations to keep the situation under control.
Anti-vaccination lobbies want vaccinations to be voluntary
The STOP NOP anti-vaccination organisation wants to collect 100,000 signatures under its bill to make vaccinations voluntary and submit it to the Polish parliament, reported Gazeta Wyborcza (p6) on Tuesday.
According to the bill, vaccinations would no longer be obligatory, unless the officials announce an epidemic risk alert or state of epidemic. Additionally, the regulations would enable patients or their legal guardians to file complication reports directly with the local sanitary inspectorates and have more influence over the vaccination schedule, while doctors would be required to provide a written disclaimer to parents on all potential complications that could arise from vaccinations and hold a detailed interview with the patients afterwards.
The anti-vaccination lobbies say there is no compensation system for victims of vaccination complications, so the ministry of health (MoH) is currently working on establishing a special fund for patients who need to be hospitalised for over 14 days after obligatory vaccinations. Such patients would receive up to 500 zlotys (€119) per day of hospitalisation, up to a maximum of 70,000 zlotys (€16,706).
More and more cases of parents refusing to vaccinate their children are ending up in court, although it is extremely rare for such parents to have their parental rights restricted.
While the percentage of vaccinated Poles is still high, the number of parents refusing to vaccinate their children increased from around 3,400 in 2010 to over 30,000 in 2017. Although over 95% of the population is vaccinated, experts say the increasing number of parents refusing to vaccinate their children increases the risk of infectious diseases spreading and making all vaccinations voluntary would certainly be a big mistake.
Parents refuse to pay fines for not vaccinating their children
Parents fined for refusing to vaccinate their children are flooding the MoH with complaints, reported Rzeczpospolita (pA6) on Thursday.
So far, parents fined for refusing to vaccinate their children have filed 3,348 complaints with the MoH and the officials have replied to 452 of them. In most cases the MoH upholds the decisions; this means that parents are able to take their cases directly to court, where the fines can be reduced.
The average fine imposed on parents refusing to vaccinate their children is 2,000 zlotys (€477), while the maximum fine imposed on a family with five children was 20,000 zlotys (€4,773).
The number of parents refusing to vaccinate their children in 2017 was over 30,000, which was a 25% increase over 2016.