WARSAW, 11 May (APM) - While Poland's Ministry of Health (MoH) is boasting about having introduced innovative lung cancer and Hodgkin lymphoma drugs to the reimbursement list and expanded the list of drugs available to the elderly free of charge, transplant patients are sounding the alarm bells that the prices of transplant medications have gone up again, reported Rzeczpospolita (pA15) on Monday.
The issue applies to the most recent reimbursement list in which the price of Valhit increased from 3.2 zlotys (€0.8) to 116.6 zlotys (€27.4), and Valcyte’s price increased for the sixth time to 859.4 zlotys (€202.2). Patients also complain about the price of Ceglar, which, after several price hikes and drops settled at 173.3 zlotys (€40.8), compared to 3.2 zlotys (€0.8) in March 2017.
Many transplant patients who are afraid of switching from their originally prescribed drugs to cheaper equivalents are outraged by the situation and are considering setting up a protest in front of the Polish Sejm.
MoH will establish national Medical Research Agency
Polish Health Minister Grzegorz Szumowski said the MoH will soon announce a bill establishing a national Medical Research Agency, reported Dziennik Gazeta Prawna (pA7) on Wednesday.
Szumowski said the agency will run non-commercial clinical trials, population and epidemiology studies. It will be completely independent of the industry and will supervise research conducted in Poland. The agency will also help sponsor research by Polish scientists and will help run the final stages of clinical trials, as well preparing new drugs and technologies for commercialisation.
Although the agency’s exact budget has not yet been specified, Szumowski said it would not only be financed from the state budget, as pharmas could also invest in its research in exchange for certain privileges in the drug reimbursement process.
Emergency access to drug technologies restricted
Although the emergency access to drug technologies (EADT) introduced by the MoH was supposed to improve the situation of severely sick patients, only 23 patients have been granted access to this over the past eight months, reported Gazeta Wyborcza (p6) on Friday.
The EADT programme was introduced in the spring of 2017 and, in theory, the procedure provides quick access to drugs registered in the EU, but not reimbursed in Poland.
However, EADT involves a great deal of bureaucracy and the regulations are inconsistent with their actual interpretation by the officials with regard to financing such drugs. While the regulations say the National Health Fund is supposed to fully cover the cost of therapy to hospitals applying for the EADT on behalf of patients, the officials claim that hospitals should finance the drugs from their contracts with the payer.
In addition, if the cost of treatment exceeds 12,000 zlotys (€2,824) a month, the minister of health must first request an opinion from the HTA Agency on whether its financing is justified and then ask the manufacturer to file a reimbursement application for the drug. However, if the manufacturer refuses to do so, the health minister will not agree to finance the treatment.
According to the MoH, the officials received 419 EADT applications up to the end of April and issued 123 positive decisions, but only 23 patients had been given access to their drugs by mid-March.
Krzysztof Landa, a former health minister, said that, in order to make the EADT work, it should be financed from the reimbursement budget and the financing threshold should be increased to 40,000-70,000 zlotys (€9,412-€16,471) per monthly therapy.
The MoH has recently announced that it is not planning to review the EADT regulations.
Pharmacies not allowed to sell drugs through online auction sites
The Supreme Administrative Court ruled that pharmacies are not allowed to offer medicinal products through online auction sites, as the regulations do not allow for any intermediaries in such sales, reported Dziennik Gazeta Prawna (pB4) on Wednesday.
According to the regulations, other than those where sales are restricted because of the patient’s age, remote sales of over-the-counter drugs are allowed. Consequently, many pharmacies have been marketing drugs through online auction sites, which was questioned by the Chief Pharmaceutical Inspectorate (GIF).
The Supreme Administrative Court agreed with the GIF and ruled that such sales are not allowed, as intermediaries cannot be involved in transactions between pharmacies and patients.
Conference on drug patent protection
During a recent conference on drug patent protection organised as part of the World Intellectual Property Day events, experts discussed the possibility of generic drug manufacturers producing equivalents of originator drugs before their Supplementary Protection Certificate (SPC) expires, as long as these generics are intended for markets where the SPC does not apply, reported Dziennik Gazeta Prawna (pB7) on Monday.
The SPC is a mechanism which enables the standard patent protection period to be extended for originator drugs by five years, although it does not apply outside the EU.
Generic manufacturers based in the EU can currently only move their production outside the EU to be able to start production of their generics before the SPC expires. The experts pointed out that the European Commission is currently considering changing the regulations so that EU entities would be allowed to produce generics before the originator drug’s SPC expires, provided that they are not sold within the EU. However, this solution would not be appreciated by the pharmas producing originator drugs, as their R&D process lasts an average of 12 to 14 years and costs €1.9 billion, which is why these companies are interested in extending the patent protection period for their products for as long as possible.
Experts to discuss blood cancer treatment
Haematology experts from Poland and Europe will be discussing new blood cancer therapy options during a conference in Kazimierz Dolny on 11-13 May, reported Rzeczpospolita (pA11) on Tuesday.
One of the guests will be professor Torben Pleasner from Denmark, who is the pioneer of the introduction of the anti-CD28 monoclonal antibody into multiple myeloma therapy which proved extremely effective during the Castor and Pollux clinical trials. Anti-CD28 uses an entirely new mechanism of fighting the disease, not only destroying cancer cells, but also resetting the patient’s immune system and increasing the effectiveness of other drugs to which the disease was resistant.
According to the National Health Fund, Poland has roughly 9,500 multiple myeloma patients, with 1,500 new cases diagnosed each year, mainly in patients aged over 70.
Biggest pharmacy chains in Poland pay little tax
According to the data released by the Ministry of Finance (MoF), the nine biggest pharmacy chains in Poland generating revenues of 9.3 billion zlotys (€2.2 billion) paid only 7.1 million zlotys (€1.7 million) in corporate income tax in 2016, reported Rzeczpospolita (pA1 & A21) on Thursday.
Five of those chains reported an aggregate income of 52 million zlotys (€12.2 million), while the rest reported an aggregate loss of 370 million zlotys (€87.1 million). Marek Tomkow, vice-president of the Supreme Pharmaceutical Council, said this trend is alarming, because the revenues reported by those chains accounted for 25% of the entire pharmacy market. He added that most of them were fuelled by foreign capital.
However, Marcin Piskorski from PharmaNET, said the data released by the MoF only applies to several out of 400 pharmacy chains in Poland, and should not be used to draw conclusions for the whole industry. He added that 2016 and 2017 was a period of extremely intensive growth and investments, due to the approaching regulatory changes curbing the expansion of pharmacy chains in July 2017. During that time, pharmacy chains opened approximately 1,000 new pharmacies and invested a billion zlotys (€235.2 million).
Some tax experts believe the losses reported by the largest pharmacy chains in Poland could be tied to extremely aggressive tax optimisation practices, which the MoF says is currently being analysed.
In terms of market structure, 43% of all pharmacies in Poland are owned by pharmacy chains which control 59.9% of the market.