Minus promises. There is no plasma-derived drug factory or even a relevant law

“In Poland, so far, self-sufficiency in the field of blood products has not been ensured. (…) There is no plasma-derived drug factory in Poland” – diagnosis from Law and Justice Program, published on the party’s website in mid-September 2019, is a problem that has been known for years. Surpluses of Polish plasma (according to the latest data about 82 percent plasma collected from patients) buy and process foreign companies, and then sell at a profit to concerns that make drugs from plasma. These drugs also go to Poland, where they are sold with the manufacturer’s margin. For years, successive governments have been trying to break free from this costly mechanism and set about building a Polish plasma fractionation plant, i.e. separating its proteins.

Plasma drugs used in patients after organ and tissue transplantationafter cardiac surgeries and with severe heart failure. They are administered after a serological conflict or in the treatment of burns and shocks. Plasma-derived drugs are the only therapeutic option for patients with primary immunodeficiencies. According to recommendations of the World Health Organization and the Council of Europe, plasma should be mainly used internally in the country of origin.

Promise status: UNFULFILLED

There is still a long way to go before the start of construction of the factory. Public consultations on the bill to appoint the National Plasma Fractionator (NFO) are underway – and this institution will have two more years to present the concept of building a factory to the Minister of Health.

The first ideas to create a Polish plasma fractionation factory date back to 1995. The Plasma Fractionation Laboratory (LFO) was to be established in Mielec. It was not created, because two years later a scandal broke out related to the suspicion of extortion of loans for this investment. The State Treasury, which guaranteed the loan, had to pay back PLN 61 million to the banks. The case was handled by the prosecutor’s office. This scandal cast a shadow on the laboratory construction project. “This story takes away the hope that this time it will be successful. Sooner, another group will do business for public money” – she commented in March 2022 in “Polityka” Joanna Solska.

Successive health ministers in successive governments have attempted to create a factory. Unsuccessfully. Joanna Solska reminded, for example, how Zbigniew Religa, the Minister of Health in the government of PiS, LPR and Self-Defense, in 2006 commissioned an expert opinion on blood management and foreign purchases of blood-derived drugs to an independent expert. His report proved huge financial losses of the state – it was sent to the desks of decision-makers and even to the Central Anti-Corruption Bureau (CBA). “I talked about the need to build a factory with the deputy ministers of all successive governments. They asked what my interest was in it,” reported the unnamed author of the report in an interview with “Polityka”.

In 2009, Biomed Lublin took over the unfinished LFO investment in Mielec. The company has been granted marketing authorization by the Medicines Registration Office for three products, of which two have been introduced to the Polish market. Fortalbia and Nanogy were fully reimbursed by the National Health Fund. However, plasma fractionation was not carried out in Poland – Biomed commissioned this task to a French company. However, one of the banks withdrew from the project, and soon after the Polish Agency for Enterprise Development did not agree to extend the deadline for repayment of advances. Biomed Lublin abandoned the project in 2016.

After winning the 2019 elections, the PiS government started to organize the factory, knowing the baggage of experience of previous cabinets. In April 2020, the first results of the work at the Ministry of Health were published in the media. “The initial schedule showed that the plasma fractionation factory could be built in 2023,” Gazeta Polska reported at the time (quotes for bankier.pl). Documents regarding the establishment of a plasma factory (which were not specified) were secretly sent to the Chancellery of the Prime Minister (KPRM). This unusual solution was explained by the significant importance of the project for the interest of the state. According to the Ministry of Health, the lack of a factory and the need to purchase drugs abroad have already cost the Treasury billions of zlotys. Approximately PLN 500 million was allocated for this annually.

“Gazeta Polska” reported that the then Minister of Health, Łukasz Szumowski, had appointed a special team, in which, in addition to officials from the ministry, there were representatives of, among others: the Chancellery of the Prime Minister, the National Blood Center (NCK), the Chief Pharmaceutical Inspector and national consultants in the field of hematology and clinical transfusiology. “The task of the team was to develop the most favorable solutions for Poland regarding the use of native plasma. After more than two months of work (from April to June 2019), a report was prepared containing detailed recommendations in this regard.

One of the team’s recommendations was to be implemented right away. In contracts with companies that are recipients of plasma, there is a provision that obliges them to sell in Poland at least 20 percent. drugs produced from it.

“I am determined to launch such a factory in Poland within three years,” he said in an interview in November 2020 for “Dziennik Gazeta Prawna” dr hab. Radosław Sierpiński, President of the Medical Research Agency and Plenipotentiary of the Prime Minister for the development of the biotechnology sector and Poland’s independence in the field of blood products.

The cost of building the factory was estimated by Dr. Sierpiński at over PLN 500 million. He announced that legislative work would start in the first quarter of 2021. “We give ourselves next year for legislation, and I hope that at the end of 2021, the National Plasma Factory will function as an entity” – he assessed. A parallel stage of work – explained Dr. Sierpiński – will be the process of obtaining international licenses. The final stage – the construction of the factory. While announcing legislative work, Dr. Sierpiński also spoke about putting the entire plasma distribution system in order in Poland.

On March 1, 2021, he mentioned plans to build a Polish plasma fractionation factory in Program III of Polish Radio Jacek Sasin, Deputy Prime Minister and Minister of State Assets. He announced the installation of a vaccine bottling line in Warsaw’s Polfa Tarchomin. “Today we undertake the great task of rebuilding this industry [farmaceutycznego] and in this context I will mention the Prime Minister’s decision in recent weeks to establish a plasma factory in Poland,” he said.

“By the end of the month, we will provide the Prime Minister with a draft of a special act that will organize the subject of blood donation and blood therapy in Poland, but will also establish the Polish Plasma Fractionator” – said Dr. Sierpiński to “Dziennik Gazeta Prawna” in another interview, published on March 29, 2021. He added that he hoped for efficient proceedings in the parliament, so that the act would be passed by the summer holidays and a special purpose vehicle could be established to build this project.

However, the holidays have passed and the winter holidays of the next year are approaching. Finally, in January 2022, information appeared in the list of legislative and program works of the government on the work on the draft law on blood donation and blood therapy, which was to appoint the National Plasma Fractionator responsible for the creation of the national plasma fractionation factory.

The draft law on blood donation and blood therapy was published on March 6, 2023 in website of the Government Legislation Centre. It assumes the creation of the National Plasma Fractionator (NFO) based in Katowice. In Art. 113 of the draft is a provision obliging the director of the NFO to work towards creating a plasma factory.

The regulatory impact assessment noted that the start of production itself is expected “in about 6 years” – i.e. at the beginning of 2029 at the earliest. The Act provides that in the intermediate period it will be possible for the NFO or the National Blood Center to conclude contracts for plasma fractionation services with foreign manufacturers.

But when will the law be passed? When will the construction of the Polish plasma fractionation plant start? On April 24, 2023, this is still unknown. The Ministry of Health informed us on April 17 that there are no delays in the work on the draft law on blood donation and blood therapy, and the Council of Ministers will deal with it in the second quarter of this year. During inter-ministerial consultations as well as opinions and social consultations, comments were submitted by 58 stakeholders. “The introduction of possible changes to the project in the area of ​​the National Plasma Fractionator depends on the result of the analysis and assessment of comments” – emphasizes the ministry and adds that the information contained in the regulatory impact assessment for the project is up to date.

Dr. hab. Radosław Sierpiński, when asked in September 2022 during the 31st Economic Forum in Karpacz about the time perspective of starting production, stated that “this is not the production of umbrellas” (quote after cowzdrowiu.pl). In the face of so many unknowns, it is difficult to consider this promise as fulfilled.

The Konkret 24 team collected and verified the promises of the United Right camp, which at the end of the second term of office remain unfulfilled. We started looking for promises at the beginning of 2015 – it was then, along with the accelerating presidential campaign of Andrzej Duda, that the right wing’s march for power began. We reviewed the promises from two presidential campaigns, two parliamentary campaigns, local government elections and elections to the European Parliament – because it is before the elections that politicians usually promise a lot. We checked whether the announcements made publicly by the ruling party materialized in the period between the elections. This is how a collection of dozens of promises was created, which the United Right made in recent years, but “did not deliver”. We will publish the next parts of the series on Konkret24.tvn24.pl and on the homepage Tvn24.pl.

The list is open – we check the speeches of the president, PiS politicians, Solidarna Polska and the Republican Party on an ongoing basis. We encourage readers to contact us and submit proposals for verification. This can be done both via the form on the website and by e-mail to konkret24@tvn.pl.