WARSAW, Dec 15 (APM) - The Ministry of Development is working on new regulations to enable the acceleration of the reimbursement negotiations with the national health fund (NHF) for pharma companies paying taxes and investing in R&D facilities in Poland, reported Rzeczpospolita (pA5) on Tuesday.
Deputy development minister Jadwiga Emilewicz said officials appreciate that the pharma industry has the second highest spending on R&D, immediately after the defence industry and want to ensure that companies investing in Poland are properly rewarded. Furthermore, the Economic Committee will be assessing the possibility of allocating 17% of the NHF’s budget on support for innovations.
Legal expert says pricing system of post-transplant drugs could be improved
Juliusz Krzyzanowski, a legal expert from law firm Baker & McKenzie claims the system of grouping reimbursable post-transplant medications into price limit groups could be improved, reported Rzeczpospolita (pC5) on Tuesday.
According to the regulations, drugs included in one limit group should either have the same active ingredients or different active ingredients, but similar therapeutic effects and mechanisms. Each limit group has a reimbursement price cap, which is usually equal to the price of the cheapest drug, while the price differences for more expensive drugs need to be covered by patients.
The way the limit groups work has resulted in the price of the Valcyte suspension for children after transplant operations skyrocketing to 780 zlotys (185 euros), which raised an outcry among parents. However, deputy health minister Marcin Czech said the officials cannot create a new limit group for the drug, as this would be in conflict with the regulations.
Krzyzanowski claims the biggest issue is that the criteria for creating new limit groups or adding new drugs to the existing groups are not entirely clear and that perhaps, instead of creating very big groups, the officials should review the existing groups, reorganise and split them into more manageable and appropriate groups to prevent such cases as that with Valcyte from occurring.
Anti-vaccination movements are becoming stronger
Anti-vaccination movements are growing in strength and coordinating activities at international level, reported Dziennik Gazeta Prawna (pA4) on Wednesday.
The Polish STOP NOP anti-vaccination organisation organises protests against obligatory vaccinations for children domestically and plans to expand to other countries with the help of similar organisations from France, the UK and Italy.
Its members claim their objective is not to antagonise parents against all vaccinations, but to make them non-obligatory and create a reliable system of reporting complications caused by vaccines, while forcing the officials to set up special funds for compensating the victims of such complications.
Health experts say these trends could be dangerous, as the percentage of the vaccinated population in many countries is dropping below the 95% level recommended by the World Health Organization. This is resulting, for instance, in a sharp increase in the number of measles cases in Europe, which has already soared from 1,600 in 2016 to 15,500 in 2017.
Celon Pharma starts new clinical trials
Celon Pharma is starting clinical trials of esketamine in drug-resistant depression therapy, reports Parkiet Gazeta Gieldy (p5) on Friday.
Maciek Wieczorek, Celon Pharma’s CEO, said the company’s only competitor is Johnson & Johnson, which has reached Phase III.
He added that global sales of esketamine in drug-resistant depression could be as high as $3 billion per year, while Celon Pharma’s advantage over Johnson & Johnson is that its drug is an inhalant, which is more convenient for patients and enables more precise control of dosages. Wieczorek believes his company could launch the drug within four to five years.
Celon Pharma’s most important drug is currently Salmex, a generic used in asthma. Salmex is sold primarily in Poland and several smaller markets, but the company intends to launch it in Denmark, Sweden, Norway, Finland and Iceland in the first half of 2018.
Celon Pharma receives R&D funding
Celon Pharma will receive grants of 49.4 million zlotys (11.7 million euros) for the development of two innovative projects from the National Centre for Research and Development, reported Parkiet Gazeta Gieldy (p6) on Thursday.
The first project applies to the pre-clinical and clinical development of an innovative GPR40 receptor agonist in type II diabetes treatment, while the second project applies to the establishment of a platform for developing biosimilars and the pre-clinical and clinical development of a biosimilar based on Fab fragment.
The total cost of these two projects is estimated at 77.6 million zlotys (18.4 million euros).
Teva, an Israeli pharma company employing 1,500 people in Poland, is restructuring its business and intends to dismiss at least 14,000 people globally, reports Puls Biznesu (p9) on Friday.
The company became the world’s largest generics producer. After its 2016 acquisition of Allergan’s drugs portfolio for $40.5 billion, its level of debt rose to 200% of its market capitalisation. That restructuring is expected to reduce this level of debt and bring the company savings of $3 billion per year.