Press review

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Poland sets out four-year drug strategy aimed at better access and strengthened pharma sector

WARSAW, 13 July (APM) - The Polish Ministry of Health (MoH) presented its drug strategy for 2018-2022, specifying resource allocation plans, methods to boost the local pharma sector and ways improve access to treatments.
According to a report in Dziennik Gazeta Prawna (pA7) on Wednesday, other key objectives are to reduce morbidity rates for contagious diseases, and to introduce better IT systems for the healthcare system.
In terms of improving access to drugs, the officials want to increase the number of clinical trials conducted in Poland, including by state institutions, and increase the list of drugs registered in Poland - including upping the number of generics and vaccines. It aims to curb illegal exports resulting in drug shortages in pharmacies.
The officials also intend to guarantee that 16% to 17% of the NHF’s total budget is spent on drugs and that the unspent money is carried forward to the following year. However, while the Reimbursement Act of 2012 specified that 17% of the NHF’s total budget should be spent on drug reimbursement, the current budget for 2019 plans for spending of less than 16%, Gazeta Wyborcza (Tylko Zdrowie supplement, p8) reported on Friday.
Dziennik Gazeta Prawna added that the MoH also wants to increase the involvement of pharma companies in drug financing. The plan is to strengthen the local pharma industry in general by offering more incentives to companies investing in Poland.
Experts agree that all the changes proposed by the MoH would be very welcome, but they are concerned about whether the MoH will deliver on its promises.
The article adds that Poland will have one of the oldest populations in Europe by 2050, with over 11 million patients aged over 65, which means that the demand for healthcare services and drugs will increase significantly.
According to estimates, the percentage of patients with cardiovascular diseases will increase by 13% by 2050, while the percentage of cancer and diabetes patients will increase by 18% and 8% respectively by 2029.

Big pharma accused of ‘questionable’ reimbursement practices in Poland

Large pharma firms are being accused of questionable practices in Polish drug reimbursement negotiations, according to Dziennik Gazeta Prawna on Friday (pA12-A13).
It quotes Tomasz Latos, an MP of Poland’s PiS (Law and Justice) party as blaming pharma for pressure tactics during reimbursement negotiations, leading Poland to have one of the highest level of co-payment for patients in the EU.
He said that, in reimbursement negotiations between pharma and the MoH the danger of large pharma leaving the table is clear for officials, as well as the fact that patients would suffer were this to happen.
Though he conceded that most negotiations end in an agreement, he said pharma use all their available leverage on politicians who generally do not want to assume responsibility for making the lives of patients more difficult.
Latos added that, fortunately, Poland is a relatively large market, meaning even the largest pharma usually cannot afford to lose it.
Conversely, an undisclosed negotiator working with pharma said negotiations with Polish officials are very difficult, and that Polish officials seem to be very effective at driving the prices down.
Bogna Cichowska-Duma of INFARMA added also highlighted the high costs associated with developing innovative treatments, which takes an average of 12 years, 1,000 employees and $8 billion per drug.

Access to trastuzumab could improve

Access to breast cancer treatment could improve as patent protection for Roche’s Herceptin (trastuzumab) has expired, Gazeta Wyborcza (Tylko Zdrowie supplement, p8) reported on Friday.
The first biosimilar of the therapy was included in the Poland’s most recent reimbursement list, it said. The national health fund (NHF) was spending 634 million zlotys (€146.4 million) on the drug per year, while access to treatment was limited because of its high cost.
Experts say the savings generated from lower prices should now be used to improve access to breast cancer treatment.

Polpharma’s offer of free safe valsartan replacements falls flat

Polpharma has offered to provide its own safe equivalents for valsartan drugs free of charge after a host of manufacturers have had to recall valsartan products found to be contaminated with cancer-causing impurity n-nitrosodimethylamine.
However, according to a report in Dziennik Gazeta Prawna (pB4) on Thursday, the company is unable to do so, as pharmacies agreeing to such a solution could have their licenses revoked.
Manufacturers started recalling blood pressure medicines containing valsartan manufactured by China’s Zhejiang Huahai Pharmaceuticals earlier this month after the European Medicines Agency (EMA) warned of a potential cancer-causing impurity in the ingredient (APMHE 58822).
Polpharma reportedly told pharmacies it would provide safe equivalents for free by issuing a refund against their invoices.
However, the publication notes that pharmacies are prohibited from selling drugs back to wholesalers, which means that pharmacies would be risking having their licences revoked. Pharmacists are also concerned about the credibility of Polpharma’s promises regarding the refund, which is why they are extremely hesitant to take any action, it said.
According to the newspaper, the officials are working on regulations enabling the reversal of the distribution chain in such cases, but the timeframes or specifics are still unknown.
Over 2.5 million packs of drugs containing valsartan were sold in Poland last year, and 50 drugs on the Polish market could potentially contain the contaminated ingredient. The problem applies to over 20 EU member states.

Anti-vaccination supporters submitted their bill

The STOP-NOP anti-vaccination organisation has filed a bill with 120,000 signatures to the lower chamber of Polish parliament in a bid to make vaccination voluntary, according to Rzeczpospolita (pA15) and Gazeta Wyborcza (p3) on Thursday. The association is for parents whose children are said to have suffered from complications from vaccines.
According to the bill, except for officially announced epidemics, all vaccinations would be voluntary and pre-vaccination examinations would be strongly promoted to rule out any potential contraindications. Parents would also be able to report any complications they observe on their own, instead of relying on doctors, both newspapers reported.
The MoH is working on its own vaccination bill, under which parents whose children suffered from vaccination complications would be entitled to receive compensation of up to 70,000 zlotys (€16,166), Rzeczpospolita added.
Marek Posobkiewicz, the chief sanitary Inspector, is concerned that some anti-vaccination supporters may be unaware of the potential consequences of making vaccinations voluntary and adds that this could lead to an outbreak of infectious diseases in the future, it said.
Over the past decade, the number of parents refusing to vaccinate their children has increased tenfold, reaching over 30,000 per year. While the percentage of vaccinated Poles still remains above 95%, the trend is alarming, Wyborcza wrote.

Bioton could soon finalise the sale of SciGen

Bioton is finalising the sale of its human insulin wholesale subsidiary SciGen to the Chinese pharma company, Yifan International Pharmaceutical, reported Parkiet Gazeta Gieldy (p5) on Wednesday.
Bioton will receive $26.7 million in cash and an insulin licence fee estimated at $30 million. The money from the transaction will be used to reduce the company’s debt by 30 to 35 million zlotys (€6.9 to €8.1 million) and to continue the development of insulin analogues.
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