Press review

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New Polish regulations on penalising illegal drug exports are defective

WARSAW, 14 Dec (APM) - New regulations introducing criminal liability for illegal drug exports, which are being prepared by the Polish government, have a potential loophole and should be corrected before taking effect, reported Dziennik Gazeta Prawna (pA1 & B1) on Tuesday.
The newspaper’s experts found the switch from the administrative liability to criminal liability has created a loophole which could lead to organisations, which are already accused of illegal drug exports, avoiding punishment. This happened in 2015 when administrative liability was first introduced.
The officials have already admitted the regulations need to be corrected.
The value of illegal drug exports in Poland is estimated at 2 billion zlotys (€466.2 million) a year. This encompasses 311 drugs, to which access in pharmacies could be restricted due to such practices. A total of 600 pharma wholesalers and pharmacies have been accused of illegal drug exports over the past five years.

CBA claims increasing prices of reimbursable drugs is admissible

Bogdan Sakowicz from the Central Anticorruption Bureau (CBA) claims the increase in reimbursable drug prices approved by the Ministry of Health (MoH) despite the Reimbursement Act is not a problem, reported Gazeta Wyborcza (p5) on Monday.
The CBA wrote to the Sejm’s health commission raising concerns that the MoH is exposing the National Health Fund (NHF) to unnecessary costs. Sakowicz said any claims of malpractice are unfounded and the CBA is constantly monitoring the pharma market, taking care of the best interests of the state and patients.
The claims of the MoH’s malpractices came to light in July after the officials agreed to an increase in the prices of two popular anticoagulants, namely Pradaxa and Xarelto.
As the patent protection for the drugs was to end shortly and their prices would have to be officially reduced by 25%, the deputy health minister responsible for drug policy, Marcin Czech, agreed to a price increase despite the recommendation of the MoH’s legal department.
Czech also decided to restrict the reimbursement indications for the generic of Roche’s Herceptin, on which the NHF spent 375 million zlotys (€87.4 million) in 2017.
Sakowicz admitted that, while the Reimbursement Act requires pharmas to reduce the prices of originator drugs upon the expiry of their patent protection, the solution has additional important implications, one being that a reduction in the prices of such drugs in Poland could trigger a reduction in other countries, to which major players may not agree.
This would result in the withdrawal of the medicines from the reimbursement list. He added that this alone justifies Czech’s decision and that the price increases did not have a significant impact on the NHF’s budget.
Deputies from the health commission wanting to remain anonymous disagreed with such arguments, saying the letter they received from the CBA looks as if it was written not by Sakowicz, but by Czech himself. The CBA refused to comment any further on this.

Drug reimbursement

Dziennik Gazeta Prawna published an interview on drug reimbursement with the deputy health minister responsible for drug policy, Marcin Czech, on Friday (pA12-A13).
Czech referred to the widely criticised case in which the Ministry of Health agreed to increase the price of two popular anticoagulants, namely Pradaxa and Xarelto, shortly before their patent protection ended and their prices had to be officially reduced by 25%.
Czech admitted the officials had to do this to ensure that the drug remains available to patients, otherwise the manufacturer may have removed it from the reimbursement list.
He added that the issue arises from the fact that drug prices are among the lowest in Europe and, in the case of large multinational pharmas, companies have to consider their pricing strategy very carefully, which means that, in some cases, not having drugs reimbursed in Poland could be better for business than having to reduce prices in the region.
Czech said the officials have no way of predicting such decisions, which is why they sometimes need to honour the demands of key partners to protect patients. He also admitted that, since 2011, when the Reimbursement Act was introduced, the officials have been forced to use the price increase mechanism 22 times with various companies.
Finally, he said the officially negotiated prices that are available to the public are not always in line with the actual confidential negotiation arrangements, as there are additional mechanisms in play enabling the state’s overall costs to be driven down, while protecting the companies from pushing the prices in the region below their acceptable threshold.
Czech also mentioned the recent accusations of favouring individual companies by adding products such as an arthritis drug or a flu vaccine to the reimbursement list at prices that are higher than those of other drugs from the group, which is in conflict with the regulations. He said that, even in those cases, the official prices did not represent the actual spending and that the products were, in fact, cheaper.
Czech concluded that, although he used to work for pharmas, he does not see this as a conflict of interest and that the whole of the negotiation process involves numerous people, is recorded, with the recording being available to designated state agencies for review.

Brexit could affect access to reimbursable drugs

With Brexit approaching, the Ministry of Health needs to issue 350-500 reimbursement decisions for drugs originating from the UK, reported Rzeczpospolita (pA1) on Monday.
In the worst case scenario, namely a hard Brexit, the existing arrangements for the pharma market may not be honoured, thereby resulting in potential drug shortages in the pharmacies of the remaining EU member states.
This means the MoH would have to shorten the current reimbursement decisions and the UK-based pharma companies would have to file new applications, which takes time and involves considerable costs.
The MoH and the registration office are currently working on adjusting the reimbursement application process to the new arrangement.
The terms of Brexit are to be specified on 11 December and, if a deal is struck, the UK could remain as a special EU partner until the end of 2020, giving all interested parties more time to react.
Marcin Czech, the deputy health minister responsible for drug policy, also addressed the concerns of the Polish Association of Pharma Industry Employers, which claims that expiring reimbursement decisions for 2,200 medicines mean that many could become unavailable in pharmacies from January 2019.
The MoH says 1,786 applications were accepted and 190 rejected by 4 December, although the rejected drugs already have generics. Czech admitted that access to just seven drugs, including stiripentol, acyclovir and folic acid, could become restricted.

Access to immunotherapy in Poland still limited

Experts and doctors say access to immunotherapy for cancer patients in Poland is still limited compared with other EU member states, reported Rzeczpospolita (pQ1) on Wednesday.
The process of including new therapy options in drug programmes is very long and often unclear to doctors and patients. One such example is small cell lung cancer, which can be treated with three immunologic drugs registered in the EU, namely nivolumab, pembrolizumab and atezolizumab.
Although the first two were added to the reimbursement list in May, they are only available to patients with high PD-L1 expression in the first line of treatment and to patients with squamous cell lung cancer in the second line of treatment.
A similar situation applies to kidney cancer patients, who recently received access to immunotherapy in the second and third lines of treatment, but the unclear interpretation of the drug programme by the National Health Fund means doctors are uncertain as to whether using nivolumab is admissible in the third line of treatment.
Furthermore, patients with extremely severe melanoma are also waiting for access to immunotherapy. While most advanced melanoma patients received access to immunotherapy, which helped significantly increase their life expectancy, those requiring combined treatment with nivolumab and ipilimumab are still waiting for their opportunity, even though the HTA agency has approved the therapy.
Finally, head and neck cancer patients do not have access to immunotherapy at all.

Establishment of Medical Research Agency confirmed

The government has confirmed the establishment of the Medical Research Agency and referred the bill prepared by the health minister to the Polish Sejm on Tuesday, reported Rzeczpospolita (pA13) and Dziennik Gazeta Prawna (pB10) on Wednesday.
The ABM will be a specialist institution associating domestic and foreign experts and focusing on running non-commercial clinical trials, conducting analyses and initiating further developments of medical sciences, reported both newspapers.
The ABM will be financed from the state and National Health Fund’s budgets, with 50 million zlotys (€11.7 million) at its disposal in the first year and 1 billion zlotys (€233.1 million) over ten years, reported both newspapers.
Some experts say the ABM should not be financed with the NHF’s budget, whereas its total budget will not allow for the completion of all stages of clinical trials, which can cost 2 billion zlotys (€466.2 million), or to even employ top scientists, reported Dziennik Gazeta Prawna.

Medical cannabis is still unavailable in pharmacies

While, according to the European Monitoring Centre for Drugs and Drug Addiction, Poland is the seventh most liberal EU member state in terms of access to cannabis-based drugs, in reality, such products are still unavailable in Polish pharmacies, reported Dziennik Gazeta Prawna (pA1 & A4) on Wednesday.
Medical cannabis was legalised in November 2017, but Spectrum Cannabis, the only importer of medical cannabis in Poland, is still waiting for approval from the Chief Pharmaceutical Inspectorate to import the first batch of the product. Spectrum Cannabis claims that, once the delivery goes through, medical cannabis should be available in the pharmacies served by one of Poland’s largest pharma wholesalers.

Pure Biologics to debut on Newconnect

The Polish biotech, Pure Biologics, is to debut on the parallel market, Newconnect, on Tuesday, reported Puls Biznesu (p8) on Monday.
Pure Biologics has so far obtained 45 million zlotys (€10.5 million) in grants and intends to invest 100 million zlotys (€23.3 million) in R&D within the next five years, of which 70% could come from the EU and 30% from the market. The company’s business is founded on a library of antibodies and aptamers, which could be used in researching new active ingredients.
Pure Biologics is currently researching antibodies that could be used in the development of drugs for bowel and lung cancer. Once candidates for clinical trials are selected and the first stage completed, the company will be looking for bigger partners to sell its licence.
Apart from external funding, Pure Biologics is already providing services to other entities from the industry and selling antibodies. The company currently employs 60 people, but could increase this number to 100 if it obtains all the grants for which it has already applied.
Pure Biologics is also researching alternative therapeutic and diagnostic technologies and managed to obtain a 10.5 million zloty (€2.5 million) grant for a therapy targeted at patients with Devic’s disease.
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