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Half of Romania’s pharmaceutical production is exported


Romania's 2023 medicines exports totaled somewhere around EUR 1.25 billion, at a domestic production of almost EUR 800 million, executive director of the Romanian Association of International Medicines Manufacturers (ARPIM) Dan Zaharescu said on Saturday.

He explained that due to the low price of medicines in Romania, wholesalers buy them from the domestic market and resell them abroad for higher prices and good profit.

"The low price in Romania, set at minimum European level, tempts pharmaceutical wholesalers to buy these drugs in Romania and resell them in markets where the prices are much higher. Such a phenomenon is officially called intra-community trade. It actually distorts Romania's pharmaceutical market, because significant amounts of medicines leave the country to be sold on these markets, to the detriment of Romanian patients. Last year, according to data released by the National Institute for Statistics, Romania's medicine exports amounted to somewhere around EUR 1.25 billion and, if we gather all the figures related to the domestic production of medicines, we get somewhere around EUR 800 million. So, if all of Romania's domestic production of medicines were exported, we would still not reach the figure of EUR 1.25 billion, which represents the amount of Romania's exports," said the ARPIM representative.

He pointed out that this situation puts medicine and drug manufacturers in a difficult position, because they lose twice - as on the one hand, they are obliged to bring the medicines to the country for Romanian patients, but because of traders re-exporting medicines, they lose again, because the revenues go into the pockets of medicine wholesalers, while the manufacturer must again fill the domestic gap of medicines.

Regarding the pricing policy, the representative of the medicines manufacturers explained that in Romania, the price for prescription drugs and medicines is regulated by the state at the lowest level in a basket of 12 EU countries recognized as having the lowest prices.

"So, we have a minimum of European lows in Romania and on top of this comes a 25% tax, the claw back tax drug manufacturers pay on the value settled by the Health Insurance Office for their medicines. So, basically, the net price for the innovative drug manufacturer is the lowest in the European Union: -25%, and for generic drugs it's still the lowest price -15%, which is the value of the claw back tax for generic drugs. The reimbursement policy is regulated by legislation passed in 2014, a Government Decision to which add a series of provisions from Law 95 and joint orders of the Health Minister and the president of the Health Insurance Office, which regulate various aspects of the reimbursement policy; the medicines purchasing policy is regulated by Law 98 from 2016 and by Emergency Ordinance No. 77 on the claw-back and the one that introduces the agreements for patients' access to medicines. This is the regulatory framework, as I said, an extremely rigorous one. It is part of the European legislation and is rooted in the Constitution of the European Union, which introduces the concept of free market, but here we are dealing with a paradox, because the concept of free market is indeed in place and the medicines are part of this concept, they circulate freely in the European space, like any other goods, but they are released to patients according to a legislation that is specific to each EU state," concluded Dan Zaharescu.

The Competition Council and the Romanian Association of International Medicines Manufacturers organized on Saturday in Sinaia a seminar on Pharmaceutical Competition.