Press review

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Officials work on incentives to boost pharma investment in Poland

WARSAW, 22 June (APM) - The Ministry of Health (MoH) and the Ministry of Entrepreneurship and Technology (MoE&T) are working on a system of incentives to encourage pharmas to invest and conduct clinical trials in Poland, reported Dziennik Gazeta Prawna (pA5) on Tuesday.
The algorithm being devised by the officials will take into account innovativeness, manufacturing in Poland, job creation, exports, clinical trials and payment of taxes in Poland. Companies which score highest will be granted various reimbursement incentives, such as inclusion of new drugs in the reimbursement list or longer reimbursement periods.
While the MoE&T would also like to set a rigid 16% reimbursement budget mark for drugs financed by the National Health Fund (NHF), the MoH is rather sceptical about this idea, claiming that the budget should be flexible, for example to help reduce waiting times in Polish healthcare.
Another idea is to introduce special tax incentives for pharma companies, but the analyses conducted by the officials showed that they already pay small amounts of tax and the EU Commission could contest this solution and categorise it as unfair state aid. The officials are also thinking about establishing a special fund of 500 million zlotys (€115.5 million) to subsidise clinical trials conducted in Poland.
Bogna Cichowska-Duma from INFARMA said foreign pharmas are very interested in investing in Poland, but for that to happen they need a stable and friendly legal environment. She added that the proposed changes might be a very good foundation for creating such an environment.

Prostate cancer treatment should be improved

Patients and doctors warn that access to innovative prostate cancer treatment in Poland is restricted, report Rzeczpospolita (pA10) on Tuesday and Gazeta Wyborcza (Tylko Zdrowie supplement, p6) on Friday.
The two ground-breaking drugs available to patients in other European countries that could be used with good results are oral hormonal medicines, abiraterone and enzalutamide.
However, the National Health Fund (NHF) decided to split them into two lines of treatment, pre-chemotherapy and post-chemotherapy, whereas it has been proved that both could be used immediately after diagnosis. Only a limited group of Polish pre-chemotherapy patients currently have access to abiraterone.
Additionally, post-chemotherapy patients who were previously treated with abiraterone, are denied access to enzalutamide, which is in conflict with the general treatment standards adopted internationally. However, restrictive selection criteria result in a denial of treatment for patients with either of the two drugs, reported both newspapers.
Additionally, in the case of 20% of patients diagnosed with the disease, the cancer has already metastasised, while access to all types of treatment, such as hormonal therapy, modern chemotherapy and radium treatment, is only fully available to patients with no additional ailments or metastasis, reports Wyborcza.
According to estimates, urinary system cancers account for 25% of all cancers diagnosed in men in Poland and the EU, whereas proper sequential treatment significantly increases the life expectancy of patients suffering from them, reported both newspapers.

Bioton wants to focus on insulin analogues

Bioton expects to report a net profit in 2018 and intends to develop its own insulin analogues within four years, reported Parkiet Gazeta Gieldy (p6) on Wednesday.
Bioton’s CEO, Robert Neymann, said the company is making every effort to maximise sales of human insulin and develop insulin analogues. The global insulin market reached $40 billion in 2017 and sales of insulin analogues have almost doubled over the past six years, from which Bioton wants to benefit by launching two products within four years in Europe, the U.S. and China.
Neymann added that Bioton will need 70-$90 million to achieve its objective, most of which will be spent on clinical trials and registration. It will certainly look for a global partner in its endeavours at the later stages of clinical trials, as it has secured funding for the next 18-24 months of new product development.
Potential partners could include Sandoz, Teva or Novartis, while negotiations should end in 2021. Bioton is particularly interested in the U.S. market, where insulin prices are higher than in Europe or Asia and where the company could compete with prices that are up to 30% lower than the average for such products.
Bioton also claims that its expansion plans will be facilitated by the sales of its Singaporean subsidiary, SciGen, to the Chinese pharma, Yifan. Bioton should receive all the payments from the transaction by the beginning of the third quarter of the year, which should add up to $100 million.

Access to most innovative multiple myeloma treatment restricted

While increasingly more multiple myeloma treatment options become available internationally to patients, the situation in Poland is not so good, as access to the most innovative therapies is still restricted, reported Rzeczpospolita (pA11) on Thursday.
Patients are currently waiting for access to daratumumab which, according to the POLLUX and CASTOR trials, reduces the risk of progression of the disease by up to 60% when combined with other drugs that are already used. There is, however, a chance that Polish patients will finally gain access to the therapy, as the drug will be assessed by the HTA Agency on 25 June.
Professor Krzysztof Giannopoulos from the Medical University of Lublin said that the system is suffering from extremely high social costs of the disease and doctors cannot provide the best available care to their patients because of the restricted access to the most innovative therapies, arising primarily from the poor financial condition of Polish healthcare.

Parents want compensation for vaccine complications

The parents of a child who suffered vaccine complications leading to tuberculosis want compensation of 1 million zlotys (€231,500) from the state, reported Rzeczpospolita (pA1 & pA16) on Monday.
The parents claim that, since vaccination is mandatory and they complied, the State should be liable for the resulting complications. Arkadiusz Tetela, a legal expert representing the parents, said this is the first case in which victims are suing the state instead of pharma companies, medical institutions or doctors, and that the chances of winning the case in court are high.
Health minister Lukasz Szumowski said that as long as there is proof that complications arose from the vaccination, parents are fully entitled to claim compensation, however he did not specify which institution should be responsible for paying it. Marek Posobkiewicz, the chief pharmaceutical inspector, added that there will be a special compensation fund shortly for covering such cases up to a maximum limit of 70,000 zlotys (€16,200) per case.
The claims of parents whose children suffered from vaccination complications are supported by the STOP NOP anti-vaccination organisation, which opposes obligatory vaccinations in Poland.

Supreme Audit Office on vaccine purchases in Poland

The Supreme Audit Office (NIK) has criticised large-scale purchases of pneumococci vaccines, claiming that 250,000 doses could be wasted, reported Dziennik Gazeta Prawna (pA3) on Monday.
In 2017, the Ministry of Health (MoH) bought 900,000 doses of pneumococci vaccines for 70 million zlotys (€16.2 million) and, while the officials reject the concerns that some of them could end up unused, the NIK claims that the shelf life of 250,000 doses could pass, resulting in losses of 21.6 million zlotys (€5 million).
The issue is that the MoH bought a new batch of these vaccines even though the 2016 stock had not been depleted and did not take into account that the demand for them could decline. This happened, as many parents decided to pay for alternative vaccines on their own, partially because the expiry dates of the available, free vaccines were approaching.

Number of parents filing complaints against obligatory vaccinations soaring

According to the Supreme Audit Office (NIK), the number of complaints filed with the Ministry of Health (MoH) by parents against obligatory vaccinations for children almost tripled between 2015 and 2017, reported Dziennik Gazeta Prawna (pA5) on Tuesday.
The number of such complaints about administrative actions taken by officials against parents refusing to vaccinate their children increased from less than 600 in 2015 to almost 1,500 in 2017.
According to the NIK, the MoH is currently unable to process all of them, which has serious consequences, as, until each case is assessed, the children cannot be vaccinated. Between 2015 and 2017, parents filed 3,129 complaints about fines imposed on them, while the MoH was only able to process 12.9% of them, which is why the officials are now seeking help from external law firms to accelerate the process.
While anti-vaccination supporters claim that fining parents who refuse to vaccinate their children is in conflict with the regulations, the courts have been ruling to date in favour of the official interpretation of the rules.
The number of parents who refused to vaccinate their children increased from roughly 16,689 in 2015 to 30,090 in 2017.

New regulations on drug packaging

According to the new regulations being prepared on drug packing, leaflets and packaging must not contain any promotional information, reported Rzeczpospolita (pA15) on Wednesday.
The regulations are based on directive 2001/83/EC and state that all information in drug leaflets and on packaging must fully conform to the official marketing authorisation.
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