National Drug Manufacturers in the European Parliament

On January 29, the European Parliament held a hearing on "over-reliance on imports of pharmaceutical active ingredients." The Public Health Committee meeting discussed the European Union's dependence on the supply of active ingredients from Asia, which has led to a partial loss of the ability to produce them on its own, posing a potential threat to public health in member states. The public hearing was a prelude to a discussion on ways to promote the production of active substances and finished medicines in Europe.

Chairman of the Public Health Committee (SANT) Adam Jarubas noted that it is necessary to create comprehensive mechanisms for increasing the production of pharmaceutical substances and medicines. These are to be included in the Critical Medicines Act, the assumptions of which are expected to appear in February this year.

Krzysztof Kopeć, chairman of PZPPF - Domestic Drug Manufacturers, reported that Poland - once a potentate in drug production in the socialist bloc - is today dependent on imports from outside Europe. Of the approximately 4,500 reimbursable drugs, only 605 are manufactured in Poland, a mere 13%, and 37 of the substances are produced in Poland, which means that in the event of a blockade of drug supplies from abroad, as many as 87 patients out of 100 will not get their reimbursable drug at the pharmacy.

Dependence on Asia has doubled in the past 20 years. In 2000, the percentage of new certificates allowing Asian manufacturers to sell medicines in the European market was 31%, and by 2020 it will be almost 65%. Meanwhile, the demand for medicines will grow due to the aging population. - Data shows that the percentage of people using medicines at the age of 30 is 25%, while those over 65 are 80%. It should also be remembered that in the first month of the Russian-Ukrainian war alone, 3 million refugees from Ukraine came to Poland. Currently there are about 1.5 million living there, and the war is still going on," Krzysztof Kopeć calculated.

He added that production in Europe of most of the pharmaceuticals on the European Critical Medicines List is unprofitable. In Poland, the continuous decline in drug prices is a property of the reimbursement system. And with each subsequent announcement, average prices decrease by 0.2%. As a result, average drug prices in the pharmacy channel in Poland are among the lowest in the EU.

Meanwhile, production costs are rising through increases in energy, raw material prices. The increase in expenses is also linked to the implementation of the "green" and "blue deal." For example, the cost of the so-called "waste water directive" for the pharmaceutical sector in the EU ranges from 5 billion to 11 billion euros per year. The impact on the Polish pharmaceutical industry was estimated at about 150.5 million euros per year.

- Fortunately, the Polish government and Polish MEPs are aware that access to medicines is part of the state's resilience central to NATO's deterrence doctrine, and that shortages of medicines can cause losses as severe as a military attack. Drug production is part of the state's critical infrastructure, and Poland wants to become a manufacturing hub for the Baltics and Central and Eastern Europe. That is why a national list of critical medicines was created," said Krzysztof Kopeć

Unfortunately, only 25% of the drugs on this national list - 74 - are manufactured in Poland.

- We hope that the Critical Medicines Act can change this. What is needed is direct support for the pharmaceutical sector in the form of grants for capital expenditures, i.e. factories, machinery, production lines. The Critical Medicines Act and support funds should not be subject to the general rules of state aid and regional exemptions," the president of National Drug Manufacturers pointed out.

- It is also important that setting the price and sales guarantees for critical medicines take place at the investment design stage. This is because it is difficult to convince entrepreneurs to invest in the production of something that can be imported more cheaply from Asia. A fast registration and reimbursement pathway is needed so that such drugs can conquer the market. Support under EU development funds should be directed at projects that result in an increase in drug production in the EU, he added.

Source: PZPPF