WARSAW, Nov 3 (APM) - Officials and pharma industry representatives debated the state of the Polish market and ways that the government could support its growth during the 13th Healthcare Market Forum, reported Dziennik Gazeta Prawna (pA10) on Tuesday.
Deputy health minister Marcin Czech said the government is currently working on an amendment to the Reimbursement Act giving pharma companies incentives to invest and expand in Poland.
Katarzyna Sledziowska, managing director of DELab, said the value of the pharma market is directly related to the state of the country’s economy. Although the pharma market accounts for around 1.33% of Polish GDP, which is 2.5 times more than in 2000, Sledziowska said growth could have been better.
She added that, while the number of pharma companies operating in Poland is relatively high, the added value they generate is lower than expected. She believes the pharma market could become one of the driving forces of the Polish economy, but this would require additional government support, such as better drug reimbursement terms for companies working on innovative products, running clinical trials and owning production plants in Poland.
Czech said the Ministry of Health (MoH) wants to collaborate with the Ministry of Development (MoD) in the long term, regardless of the political cycle, to promote the Polish pharma industry abroad and ensure its growth.
He added that the system of incentives that could be introduced with the amendment of the Reimbursement Act must be fair for all companies and consistent with EU regulations. The main criteria for assessing the companies could include tax payments, pharma production or holding clinical trials in Poland. The officials also want to focus on more extensive use of the payback mechanisms in reimbursement and find a middle ground for all its stakeholders.
Jan Stanilko from the MoD said companies already have access to additional funding, but many Polish pharma manufacturers got caught into focusing on expanding their business exclusively on the domestic market and have difficulty competing abroad. Additionally, the Reimbursement Act has forced pharma companies to reduce their prices, while actual National Health Fund (NHF) spending on drug reimbursement is several percentage points lower than the specified 17% mark.
The officials said domestic companies should look for opportunities in biosimilars, as the patent protection of many originator drugs will soon be expiring. Stanilko said Poland needs a leading R&D centre, where global companies could work on innovative projects. He added that the trends are promising, as drug production in Poland is growing much faster than imports, but this could change if domestic companies fail to seize the opportunities arising from biosimilars.
Sebastian Szymanek, Polpharma’s CEO, said Polish companies are ready to expand quickly. Polpharma has already invested 1.5 billion zlotys (354 million euros) in its five production plants and is involved in several 500-700 million zloty (118-165 million euro) biotech projects.
He admitted that access to financing has indeed improved, but the current regulations do not give companies confidence of stability of their businesses, while reimbursement negotiations with the MoH still focus on prices, without taking into account other contributions of the domestic pharma players to industry in general.
New regulations on compensation for vaccination complications
According to the new regulations prepared by the Ministry of Health (MoH), parents of children with vaccination complications will be compensated up to 70,000 zlotys (16,509 euros) from a special fund financed by vaccine producers, reported Rzeczpospolita (pC5) on Thursday.
The compensation will be paid to parents whose children show signs of vaccine harm immediately after being vaccinated and hospitalised for over 14 days. The compensation fund will be financed by vaccine producers and should be around 2.5 million zlotys (590,000 euros) per year, whereas compensated parents will still be eligible to take their claims to court.
Polish antibiotic could be contaminated
Polfa Tarchomin’s antibiotic, Tarcefoksym (cefotaxime), used in severe pneumonia and infections, could be contaminated and was partially recalled from the Polish market by the Chief Pharmaceutical Inspectorate (GIF) on October 27, reported Gazeta Wyborcza (p3) on Monday.
The first signs suggesting that Tarcefoksym could be contaminated started appearing between January and April 2016, when it caused adverse effects in 43 Vietnamese patients and potentially resulted in two deaths.
Eventually, despite Polfa’s claims that the drug was not contaminated, Tarcefoksym was withdrawn from the Vietnamese market on September 11, 2017. Jaroslaw Krol, Polfa’s CEO, said the company suspects malpractice and extortion, as in 2016, after alleged cases of adverse effects caused by the drug, Polfa paid compensation of 3 million zlotys (709,000 euros) to Vietnamese importers.
Furthermore, although Polfa wanted to ship the entire supply of Tarcefoksym back to Poland after it was recalled from the Vietnamese market, the local partners refused to do so, which raises the suspicion that the supplies were not disposed of and could have been illegally resold.
Polfa recently retested 29 out of 32 batches of Tarcefoksym sold on the Polish market and decided on October 27 to conduct further tests, as the National Drug Institute found evidence of unknown residue in one of the batches. The GIF decided to recall the potentially contaminated batch from the Polish market on the same day.
Biomed-Lublin sells one of its brands to Polpharma
Biomed-Lublin sold the rights to its probiotic brand, Lakcid, for 17 million zlotys (4 million euros), which should help the company settle some of its debt, reported Parkiet Gazeta Gieldy (p4) and Puls Biznesu (p10) on Friday.
The transaction applies to all registered product lines, including Lakcid, Lakcid Forte and Lakcid L. Biomed will continue producing Lakcid and will supply it to Polpharma at the negotiated prices for five years, after which the agreement will be automatically extended every two years.
Marcin Pirog, Biomed’s CEO, said the company is satisfied with the deal, as it will enable it to continue to generate revenues from Lakcid sales, without being burdened with distribution and marketing expenses. Additionally, the agreement will help Biomed with foreign expansion of the product, reported both newspapers.
Biomed will use 11.3 million zlotys (2.7 million euros) to pay off some of its debt to the Polish Agency for Enterprise Development (PAED), and 5.7 million zlotys (1.3 million euros) to continue growing its business. The company will also significantly increase the production capacity of Lakcid products, reported both newspapers.
Biomed now intends to focus on increasing the production capacity and sales of its BCG vaccines, Onko-BCG, Distreptaza and Gamma anti-D, which are the most profitable products in its portfolio, reported both newspapers.
Biomed has to pay 30.8 million zlotys (7.3 million euros) to PAED by September 2019, which is a result of the failed investment into establishing its own blood plasma fractionation plant, reported Puls Biznesu.
Nanogroup’s IPO less successful than expected
Nanogroup only received 4.2 million zlotys (993,000 euros), out of the expected 48 million zlotys (11.4 million euros) from its recent stock market flotation, reported Parkiet Gazeta Gieldy (p4) on Monday.
Marek Borzestowski, Nanogroup’s CEO, said the disappointing IPO will not affect the development of its most important R&D projects, but the company will have to reconsider potential acquisitions and establish its own laboratories.
Pharmena needs partner to complete trials
Pharmena is looking for a partner to start Phase III for its 1-MNA molecule, which could be used to develop an arteriosclerosis drug, reported Parkiet Gazeta Gieldy (p4) on Monday.
The company published the results of Phase II in April 2016 and announced that finding a partner who will be required to start phase III should take up to 12 months.
Konrad Palka, Pharmena’s CEO, said the company is still in the process of presenting the results to bigger players. He added that the results of three other Phase III trials for similar drugs have been published over the past year, which should definitely help Pharmena speed up the process of finding a partner willing to support the company with the financing needed to continue its own trials.