NIK has negatively evaluated the contracting of part of the COVID-19 vaccines with an estimated value of PLN 8.4 billion, out of the total value of PLN 13.9 billion for all the contracted vaccines. The decision was taken by the Minister of Health, although he knew that the contracts signed to date secured vaccination of the entire population of Poland several times and that the vaccination rate is decreasing. As a result, over 13.1 million doses were allowed to expire and then disposed of (as of the end of 2022). The total value of damaged vaccines was nearly PLN 1 billion.
To contain the effects of excess purchase of vaccines attempts were made to sell them or transfer as donation. By 31 December 2022, the Governmental Strategic Reserves Agency (RARS) provided to other countries over PLN 27.6 million vaccine doses with an estimated value of PLN 1.4 billion.
The SARS-CoV-2 epidemic caused significant disruptions in the healthcare provision. Above all, a great part of the healthcare system resources were “relocated” to control the epidemic. That resulted in shrinking access to treatment for a broad group of patients, diagnosed with diseases other than COVID-19. Hence, the so-called health debt was growing (that was a situation where the failure to provide a medical service may lead to a disease development or its worsening).
In 2020-2021, an increased number of deaths was reported, as compared with the average of 2015‑2019. In 2020, there were over 85 thousand more of them, including about 56.5 thousand deaths for reasons other than COVID-19. And in the first half of 2021, excess deaths against the number of deaths reported a year before totalled nearly 61 thousand.
The COVID-19 universal vaccination programme was supposed to help prevent those negative phenomena. On the one hand, in line with the assumptions, it should ensure a “return to normal”, on the other it should “unblock” the healthcare system, particularly for patients with diseases other than COVID-19. Thus, a direct objective in the COVID-19 National Vaccination System was:
- to reduce the number of deaths and complications caused by the SARS-CoV-2, particularly in elderly persons,
- to reduce the population “health debt” growth.
In 2021-2023, NIK conducted a range of ad hoc audits to establish if the objectives of the COVID-10 National Vaccination Programme were achieved and how. NIK carried out five audits to look into the Programme execution which cost about PLN 17 billion.
The NIK audit revealed that:
- the Minister of Health improperly estimated needs related to the purchase of an adequate number of COVID-19 vaccine doses;
- Poland did not have to enter into agreements - questioned by NIK - to purchase COVID-19 vaccines. The Minister of Health did not use that right;
Estimating demand
It needs to be underlined that no documents were presented showing how the number of vaccine doses, needed to satisfy the demand of Polish citizens, were estimated. From May 2021, subsequent vaccine doses were contracted for, although Poland was bound with contracts enabling the vaccination of the entire population several times (109 million doses were contracted for at the end of April 2021).
Even assuming that every adult person in Poland, i.e. about 31 million individuals, received the third vaccine dose, the demand would be at the level of 93 million doses, i.e. lower than the number of doses contracted for before May 2021. The Minister of Health made a thesis that before signing the agreements indicated as improper, there were signals that vaccine boosters every 6 months are necessary to maintain the immunological response at an adequately high level. The thesis is not only unconfirmed by the evidence gathered in the audit but also it does not reflect the opinions of specialised EU institutions taking efforts to control the COVID-19 epidemic.
On 31 May 2021, the Minister of Health addressed the EU Health Commissioner concerning the vaccines purchased, pointing to the hazard of huge vaccine surplus in Europe and the need for coordinated cooperation to start talks with individual manufacturers to reduce the volumes of vaccine orders. It needs to be stressed that the Minister stated that the epidemiological situation is about to stabilise and pointed to the “hazard” of significant surpluses of the COVID-19 vaccines, only 11 days after signing the third agreement with Pfizer/BioNTech. It points to complete inconsistency of the Minister’s actions. According to NIK those measures were unreliable and wasteful.
Contracts
The Republic of Poland purchased vaccines as part of the Agreement on the joint mechanism for the COVID-19 vaccine purchase. The Agreement authorised the European Commission to negotiate and conclude vaccine purchase contracts, on behalf of the EU Member States. The EC was responsible for the contracts’ content, including the principles of sharing vaccines among the EU Member States, the pool of vaccines covered by the contract, their prices and delivery dates. The EU Member States notified by the EC about the intention to sign the contract could not amend them. They could, however, decide to sign or withdraw from the vaccine purchase contract. In the vaccine purchasing process two types of contracts were used: contracts defining the right to purchase vaccine doses and contracts defining the obligation to purchase them. In the first case, no participating EU Member State was obliged to sign that contract. In case of the second contract model, the EC was obliged to inform the EU Member States about the intention to sign the contract with an obligation to purchase the vaccine doses, also defining its signing conditions. All the contracts negatively evaluated by NIK were contracts defining the obligation to purchase COVID-19 vaccines. The states that did not agree to sign that contract or its conditions had 5 days to withdraw from the contract or declare a number of vaccines other than set out in the contract (the so-called “opt-out clause”). The opt-out clause required consent of partner states, in cooperation with the EC, to accept extra doses or to give away appurtenant doses.
Supervision of the Chief Pharmaceutical Inspectorate (GIF) over the COVID-19 National Vaccination Programme
NIK has negatively evaluated supervision exercised by the Chief Pharmaceutical Inspector over the vaccine storage and distribution. The body responsible for pharmaceutical safety of the state, obliged with “special supervision”, did not know in which warehouses the vaccines were stored. The relevant information was taken from the media.
Besides, GIF failed to take efforts to withdraw part of vaccines, in which some quality defects were found, also the ones posing a threat to health and life. In consequence, 117.6 thousand hazardous vaccine doses were administered to patients.
Distribution and storage of vaccines
17 pharmaceutical warehouses were involved in the process of the COVID-19 vaccine distribution and storage. In the audited period, GIF carried out only two inspections in one of pharmaceutical warehouses taking part in the COVID-19 vaccine distribution. A lot of critical irregularities were identified, e.g. the vaccine storage conditions in special rooms or the vaccine transport from the Governmental Strategic Reserves Agency (RARS) were not registered. Also, the product safety was not provided during vaccine storage in that warehouse.
Another inspection in the same warehouse showed that the distribution process does not guarantee the safety of vaccines in terms of their quality maintenance. Although GIF was aware of the irregularities affecting the effectiveness and safety of vaccines, no inspections were carried out in the remaining 16 warehouses.
The Minister of Health had a significant, adverse impact on the effectiveness of actions taken by GIF. He made the following statement which was contrary to the applicable law:
- the distribution of COVID-19 vaccines is not the trade in medicinal products, in the light of the Pharmaceutical Law Act, and hence,
- the trade in vaccines may not be monitored via the Integrated System for Monitoring the Trade in Medicinal Products (ZSMOPL).
As a result of the Minister’s efforts, the pharmaceutical warehouses were freed from the obligation to report the vaccine stock availability on a daily basis. Hence, GIF could not monitor the trade in those vaccines. The Inspectorate drew its knowledge about the COVID-19 vaccine warehouses from the media.
The decision of the Minister of Health not to use the monitoring system also had a negative impact on the safety of patients. In two cases GIF did not decide to withdraw from the market a series of vaccines, although the Inspectorate was aware of their quality defects. GIF could not withdraw the vaccines, because their distribution was not subject to the Pharmaceutical Law Act – in line with the interpretation of the Minister of Health, and so GIF had no legal grounds to withdraw them from the market. Besides, the Inspectorate did not know in which warehouses the defective vaccines were found.
Vaccine quality defects
GIF received eight reports of actual or alleged quality defects of the COVID-19 vaccines, of which two were of significant importance.
On 23 April 2021, the Chief Pharmaceutical Inspectorate received information in the Rapid Alert system from the European Medicines Agency, about a possible quality defect in one of the COVID-19 vaccine series, already used in Polish patients. The report dealt with the suspicion of a 2nd class defect, that is the one that could cause an illness or improper effects. GIF failed to issue a decision to withhold or withdraw that vaccine series from the market. Meanwhile, in April 2022 the Federal Agency for Medicinal and Health Products in Belgium informed GIF about withdrawing that series from the market. Having received the report, GIF provided the relevant information to RARS, requesting the Agency to take action to identify distribution channels and inform recipients about the situation. The efforts were pointless, though, because the entire vaccine series was already administered to patients.
In the second case the quality defect of the vaccine series was reported on 7 April 2022 by the Spanish Agency of Medicines and Medical Products (AEMPS). The vaccine quality defect could pose a threat to patients’ health and life (1st class defect), which obliged GIF to withdraw the defective product from the market.
In both cases GIF not only failed to withdraw the vaccine series from the market but also did not know where they can be found. Having received the report, information was passed on to RARS with a request to identify distribution channels and notify recipients about the situation. The Chief Pharmaceutical Inspector explained that in the light of the Minister of Health’s interpretation, the decision to withdraw the vaccine could not be issued for the product that is not in the market. That information was also provided to RARS.
The government's vaccination commissioner
The Chancellery of the Prime Minister and the Government Commissioner for the National Vaccination Programme dealt mainly with conducting campaigns encouraging Polish people to vaccinate. Over PLN 155 million was spent on that purpose. At the same time, the measures to evaluate effects to be achieved were not defined. The Commissioner failed to analyse the legislation in force or the existing solutions relating to prophylactic vaccinations, despite the obligation to do so. He used analyses conducted by the Minister of Health instead.
The Commissioner was also obliged to prepare proposals of new legal solutions and initiatives in terms of the COVID-10 National Vaccination Programme.
In view of the above, according to NIK, it was unjustified to appoint a vaccination commissioner, whose tasks could be discharged by the existing state bodies.
In performing his tasks, particularly in drafting changes to resolutions on the National Vaccination Programme, the vaccination commissioner drew on the information and knowledge of the Government Analysis Centre, the Ministry of Health, the National Health Fund, the e-Health Centre, the Government Security Centre or the Chief Sanitary Inspector.
After the vaccination commissioner’s office was lifted, the Programme supervision was entrusted to the Minister of Health.
