The country's drug manufacturers are calling for pharmaceutical manufacturers and distributors to be protected from restrictions on electricity consumption and supply. They stress that even a short-lived interruption of electricity supplies to pharmaceutical plants risks several days of production interruption and the need to dispose of entire batches of drugs and raw materials for their manufacture that have already been produced.
KPL: Drug production must be exempt from power constraints
Published Nov. 22, 2024 10:02
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- Currently, neither pharmaceutical wholesalers nor drug manufacturers are covered by critical infrastructure. That is, when the power is cut, wholesalers do not work, manufacturers stop producing," warned Lukasz Pietrzak, Chief Pharmaceutical Inspector at the Innovators Forum in Warsaw.
According to the law, the Polish Power Grid (PSE), in the event of a shortage of power for electricity production, can limit the supply of electricity to the largest energy consumers, which means industrial plants first. The last time such power levels were announced was in August 2015.
Meanwhile, pharmaceutical production and distribution in Poland is highly dependent on energy supplies. Each plant has a variety of equipment and systems to ensure efficient control of production while maintaining the quality of drug products.
More than 500 drugs on the reimbursement list are produced in Poland.
- Drug production cannot simply be shut down for a few days and turned back on. Sterile products, biologicals and antibiotics require highly specialized manufacturing conditions, especially heating and cooling. And this means the need for a constant supply of energy," stresses Krzysztof Kopeć, president of National Drug Manufacturers.
Resuming production takes a considerable amount of time due to technical challenges related to temperature requirements, sanitation regime and contamination control, and compliance with good manufacturing practice (GMP) requirements. It must be preceded by a series of maintenance and inspection activities combined with the obligation to perform tests and measurements, such as microbiological measurements or room regeneration tests. Therefore, a lack of energy supply for a few hours causes production to stop for several days.
Energy transmission limitations can also have disastrous consequences for the storage of raw materials, intermediates and finished products. Lack of adequate temperature and humidity degrades drug substances, samples and products.
With the current problems with the availability of active ingredients, the disposal of this raw material or series of drugs due to a power outage can cause months of dramatic product shortages in the market.
This is because contracts for the supply of active and auxiliary substances for the manufacture of medicines are tailored to a demand plan drawn up many months in advance, and it is usually impossible to increase them immediately.
- Therefore, we demand that the regulations treat the pharmaceutical industry as strategic, which should be provided with the longest possible access to electricity and gas supplies in a situation of forced restrictions on their transmission in Poland. It should be clearly indicated in the regulations that the pharmaceutical industry is strategic for the country's security and must be excluded from restrictions on energy supply," Krzysztof Kopeć appeals.
Currently, in accordance with the Decree of November 8, 2021 on detailed rules and procedures for introducing restrictions on the sale of solid fuels and on the supply and consumption of electricity or heat, protection from introduced restrictions on the supply and consumption of electricity is subject to, among others. hospitals and emergency medical facilities, facilities performing tasks for state defense, used for broadcasting nationwide radio and television programs, used to provide air, rail and public mass transport, extracting fossil fuels from deposits, discharging and treating sewage, generating and transmitting electricity or heat.
source: press release
