Drug safety is 1 of the key elements of the state's resilience in situations of armed conflict and crises. This subject was analysed by the combined parliamentary committees: national defence and health. During the meeting, representatives of the government, military and pharmaceutical manufacture stressed that Poland must strengthen its own production capacity of medicines and active substances.
– Strengthening national drug safety through the expansion of generation capacity is simply a key component of the “mining of risks” in the state's medical safety system, including the armed forces," said Dr. Arkadiusz Kosowski, Director, Department of Military wellness Service, at the Wednesday gathering of the Joint Parliamentary Committees on National Defence and Health.
As he stressed, the war in Ukraine and the experience of the COVID-19 pandemic radically changed the perception of the problem of the stableness of supply of medicines and medical materials. He added that as early as the first weeks of fighting in Ukraine, there was a serious problem with the state's drug security. Kiev's ability to independently supply medicines and medical materials proved to be limited, which forced extended global support in this area.
At the same time, Colonel Kosowski recalled that Poland as a NATO associate is not only liable for securing the logistics of its own armed forces, but besides for supporting allied activities. “Therefore, the key condition is to build a strategy that gives us the freedom and safety of drug sovereignty as well as the creation of a production base in this area,” he stressed.
Strategic reserves
State stocks play an crucial function in the pharmaceutical safety system. According to the Ministry of Interior and Administration data in warehouses Government strategical Reserve Agency (RARS) presently has about 400 drug items that may be available if needed. Wiesław Szczepanski, Deputy Minister of Home Affairs and Administration, said that they are mainly antibiotics, painkillers, anesthetics, anticoagulants, insulins, infusion fluids and utilized in chronic diseases.
The Ministry of abroad Affairs is presently preparing a fresh strategical reserve programme for the period 2027 to 2031, and MON and the Ministry of wellness have already presented a list of preparations that should be purchased as part of the creation of state stocks. Szczepański stressed that 1 of the key legislative solutions should be the introduction of the work to prioritise the sale of selected drugs to RARS in the event of their marketplace shortage.
Global dependence on China
In Poland, about 1.4 billion packs of medicines are consumed annually. “There are no warehouses in our country that can accommodate at least 3 months of stock prepared for our population,” said Łukasz Pietrzak, Chief Pharmaceutical Inspector. 1 of his solutions is the usage of a pharmaceutical warehouse as a safety component. retention of critical parts of medicines in the average marketplace would make a ‘safety buffer’ and reduce the problem of disposal of expired preparations. As Pietrzak said, only in Warsaw about 150 t of medicines are destroyed all year.
The inspector besides pointed out another problem. As he pointed out, a large proportion of generic drugs sold in Europe, or cheaper substitutes for first preparations, are now produced in Asia. This is due to China's consistently implemented strategy for 3 decades. According to Pietrzak, Poland has the anticipation to produce APIs, i.e. active pharmaceutical ingredients based on medicines.
– We are ready to produce more – said Krzysztof Kopieć, president of the Polish Association of Employers of Pharmaceutical Industry. He admitted that active substances produced in Poland would increase the safety of the state, but, as he pointed out, they would be more costly than those imported from China. In practice, this would imply a conscious decision by the State to finance pharmaceutical safety. “We must be aware that all safety costs and drug safety also,” Pietrzak said.
Krzysztof Kopeć besides highlighted the geopolitical situation affecting the global natural material marketplace and blocking their transport through the Strait of Ormuz. – At any point it may affect us – he noted. As explained by the president of PZPPF, oil and gas stocks that go to China are used, among others, in the production of active substances for the pharmaceutical industry. Therefore, the disruption of these supplies may translate into the availability of medicines on European markets.
New regulations are intended to strengthen production in Poland
The wellness department is presently preparing legislative changes to encourage companies to invest in pharmaceutical production in the country. The planned amendment to the Drug Refund Act provides for respective mechanisms to strengthen drug safety. 1 of them is the doubling of subsidies for patients choosing medicines entirely produced in Poland. After the changes, the level of subsidies would increase from 15 to 30%. The task besides provides for the introduction of incentives to decision the production of the drug to Poland within 3 years of the reimbursement.
The law is besides intended to regulate the list of critical medicines (preparations essential to save lives or treat serious diseases) and to increase the competitiveness of generic medicines. Among the proposed solutions is the precedence of the reimbursement of Polish medicines in case of failure of all protective periods by the first medicine. At the same time, the strategy is intended to let reimbursement of medicines manufactured outside Poland erstwhile their availability on the home marketplace is limited.