Press review

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Polish national health fund encourages hospitals to use cheaper drugs

WARSAW, 10 Aug (APM) - Poland’s National Health Fund (NHF) will be offering better contracts to hospitals switching patients to cheaper drugs, reported Dziennik Gazeta Prawna (pA4) on Wednesday.
The NHF believes the change should bring savings of 85 million zlotys (€19.9 million) per year and is offering hospitals 13.5 million zlotys (€3.2 million) in return. It also claims the savings would be used to treat more patients and reduce waiting times in healthcare.
The idea is criticised by pharmas - mainly those producing originator drugs - as well as patients and some doctors, who are afraid they will be forced to use drugs that are not consistent with their opinions and knowledge, but in the interest of the medical institutions.
The Employers of Poland organisation says the change could affect competition on the market and turn out to be dangerous to patients with specific needs.
Rafal Janiszewski, a health expert, said there is nothing wrong with switching patients to cheaper equivalents, as this happens in all countries. However, patients must be included in the process and be properly informed about it.
He added that the NHF should not necessarily reward medical institutions for switching patients to cheaper drugs, but rather for treating more patients.

Drugs containing contaminated valsartan can cause cancer

According to the European Medicines Agency (EMA), drugs containing contaminated valsartan are not deadly but can cause cancer, reported Dziennik Gazeta Prawna (pA5) on Monday.
While the contamination of Chinese-made valsartan was not negligible, it was also not significant enough to alarm all patients using drugs for high blood pressure. According to EMA’s experts, taking drugs containing the maximum dosage of the contaminated active ingredient for seven years could cause cancer in one in 5,000 cases. This estimate was based on animal testing, which could lead to the results not being entirely reliable. What is concerning is that the contaminant found in the drugs, namely NDMA, is also contained in some food products, such as smoked ham.
The contamination of drugs containing valsartan was discovered in late June. The factory responsible for the contamination supplied the active ingredient to almost all Polish pharma manufacturers of valsartan drugs, which means a dozen or so companies producing about 50 medicines. The drugs were immediately recalled from the market, affecting up to 800,000 Polish patients. Similar measures were taken in other EU member states.
Professor Zbigniew Fijalek from the Medical University of Warsaw said the system of detecting contaminants in drugs is imperfect and should be improved to avoid such situations. The only reason the contamination was detected was that a Spanish pharma producing drugs with valsartan decided to test the Chinese active ingredient before switching suppliers.
The EMA believes patients using high blood pressure drugs should continue to take them, as the risks of discontinuing treatment are greater than the risks of taking the contaminated medicines, the paper said.

Access to arthritis drugs should be improved

Professor Brygida Kwiatkowska, manager of a Warsaw-based arthritis treatment clinic, has said the situation of patients with ankylosing spondylitis (AS) and psoriatic arthritis (PA) is far from good and access to recommended therapies is restricted, reported Rzeczpospolita (pA11) on Tuesday.
Kwiatkowska said the therapies recommended by the European League Against Rheumatism (EULAR) are mostly unavailable in Poland because of a lack of reimbursement, which is a major disadvantage compared to other European countries.
She added that PA patients only have access to methotrexate or sulfasalazine and, if the therapy does not work, also to two biologic TNF-alpha inhibitors. In the case of AS, patients are first treated with non-steroid anti-inflammatory drugs and can gain access to TNF-alpha inhibitors if the therapy proves unsuccessful or unsuitable. However, once both lines of treatment have been used, patients have no alternatives, as access to IL-17 inhibitors - which are used in other countries - is restricted.
Kwiatkowska concluded that the authorities should ensure that all relevant drugs approved in the EU are available to Polish patients with these diseases, especially as the group of those eligible for treatment is already very small because of the restrictive selection criteria.

Transplant patients want free drugs

Polish transplant patients, who have been protesting against numerous price increases of immunosuppressants and antiviral drugs for the past 18 months, now want free access to post-transplant medication, reported Rzeczpospolita (pA17) on Thursday.
Professor Tomasz Grodzki, who supports transplant patients in their efforts, said he does not understand the logic of increasing the prices of post-transplant drugs, as the group of patients using them is relatively small and savings are miniscule.
He added that the drugs should, in fact, be free, as the potential social cost of patients not using them might prove to be much higher than full reimbursement.

New EU regulations could help Polish pharmas

While the new regulations on drug patent protection suggested by the EU could help Polish pharmas, large foreign players object to them, reported Dziennik Gazeta Prawna (pA4-pA5) on Wednesday.
EU officials intend to start working on the regulations in September and, according to rumours, they would allow European pharma companies to start manufacturing and selling their generics of some patent-protected originator drugs outside the EU before the protection period ends. This would enable companies producing generics to generate an additional €1 billion per year.
While Poland supports such changes, other governments may object to them to protect their originator companies. Under the current regulations, after the standard 20-year patent protection period, European generics manufacturers cannot start producing generics of protected originator drugs for a further five years. This favours American and Asian companies, to which the rule does not apply.
Polish pharmas hope the new regulations will improve their competitiveness, enable them to increase revenues and create new jobs. The Polish balance of trade in drugs is unfavourable, with three times more drugs being imported than exported. Spending by Polish households on imported drugs has increased fivefold since 2000, while the market share of domestic generics has declined from 24% to 4% in value terms.

Health ministry replacing old pneumococcal vaccines

The Polish health ministry (MoH) is looking for ways of minimising the impact of having to replace or dispose of large amounts of pneumococcal vaccines which are due to expire shortly, reported Dziennik Gazeta Prawna (pA9) on Thursday.
The MoH stocked up on the vaccines in 2016 and 2017, but in June, the Supreme Audit Office (NIK) criticised the authorities for these purchases, pointing out that 250,000 vaccines could soon expire.
The problem was initially to have been solved by changing the criteria of the vaccination programme and increasing the number of children to whom the vaccine should be administered.
However, this only accounted for 125,000 of the expiring vaccines, so the MoH has now agreed with the supplier that it will replace the remaining expiring doses, which, according to the officials, is part of the deal and will not generate an additional cost.
The MoH says it currently has 766,000 pneumococcal vaccines in stock and that it had no choice other than to increase the supply, as the money reserved in the 2017 budget would otherwise have been lost.
NIK says the authorities should have been more diligent in their estimates and should have taken into account the fact that demand for pneumococcal vaccines could decline - which is what actually happened, partly because medical institutions were reluctant to order products that were soon to expire.

Bioton’s minority shareholder questions sale of subsidiary

AIS2 Investments, Bioton’s minority shareholder, has decided to go to court over the recent sale of the company’s Singapore subsidiary, SciGen, to Chinese pharma YiFan International Pharmaceutical, reported Parkiet Gazeta Gieldy (p7) on Thursday.
The shareholder is questioning the terms of the deal, particularly the fact that Bioton decided to forgive SciGen’s loan of $28.5 million as part of the deal with YiFan.
Robert Neymann, Bioton’s CEO, said AIS2’s claims are groundless, detrimental to the company and should be set aside by the court.
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