Manufacturers of drugs in Romania sound a great alarm and warn: some factories risk to close their doors, and others will produce either smaller quantities of drugs or even withdraw certain products from the market.
Soon, cheap drugs will hardly be found in pharmacies. Archive
Basically, we could reach the absurd situation of not even finding in pharmacies even a banal paracetamol. The reason? The European Directive on the treatment of residual urban waters adopted at the end of last year by the European Commission requires producers huge costs to finance advanced residual water treatment processes.
The local drug industry risks bankruptcy
“The application of this directive in its current form is an act of blatant injustice, which will lead to bankruptcy of the local drug industry, leaving patients without the basic treatments they need daily”, said Dr. Dragoș Damian, the executive director of the employers of the industrial drug producers in Romania (Primer).
“We cannot allow this financial burden to be placed exclusively on the shoulders of the pharmaceutical industry, without taking into account the economic realities. We are talking about huge costs that the Romanian factories cannot support, in an already extremely regulated context and with very low financial margins. The consequence will be the disappearance of some essential drugs that millions of Romanians depend on ”, he said.
Simona Cocoș, former president of the Association of Generic Medicines Manufacturers in Romania, said for “Adevărul” that the situation could become an absolutely dramatic one. “This European Directive is part of a larger project. This is the European Green Pact, the so-called” Green Deal “, through which Europe aims to become, until 2030, The first green continentwith zero impact regarding carbon emissions in the environment ”, Simona Cocoș explained.
A decision worthy of all praise, greeted and appreciated. “However, unfortunately, the way in which the implementation of this directive is thought is desired, affecting the producer of drugs ””she continues.
The reason? They will have to pay a fee that cover the costs of advanced residual urban water treatment. The tax will be applied according to the volume of drugs produced by factories on the principle the more polluting, the better payment you are. “The problem is that cheap drugs are produced in the largest quantities: drugs for cardiovascular disease, medicines for joint disease, paracetamol was also targeted. As well as antibiotics.”
Simona Cocoș, General Manager Zentiva Romania & Moldova. Archive
Farm Specialist: “The European Commission requires more than we can carry”
“The treatment of residual urban waters is an extremely advanced one. We are talking about the fourth water filtration stage. It is called quaternary treatment and aims at micropulants that are found in residual urban waters. This stage is crucial to ensure that the water becomes safe for reuse and does not harm the aquatic ecosystems or”, ” explains Simona Cocoș. On the other hand, these particles are not only a consequence of the drug manufacture process, the specialist draws attention. “There are residues, substances contained in drugs, which are not absorbed in the human body and are therefore eliminated.”
However, say pharma officials, the European Commission has seriously underestimated the real costs of implementing this directive. Industry experts and independent studies estimate amounts between 5 and 11 billion euros annually, far exceeding the initial estimate of the European Commission of 1.2 billion euros. “Only Germany, For example, it will have to pay around 1.1 billion euros. The Netherlands and she will pay hundreds of millions ”said Simona Cocoș. For now, it is not known how much the Romanian producers will have to pay.
This money is intended for the purchase of state -of -the -art equipment for wastewater treatment. “Although many European states have pointed out that these amounts of money are very large, the directive was approved in December last year. And if it does not intervene to regulate the situation, starting with 2027 the producers of drugs, especially the little ones, risk to close or no longer produce certain drugs in very large quantities. ”AThis thing, in Romania at least, will lead to a real disaster, practically bankruptcy the health system and so on the logs.
This fee is to be paid annually, starting with 2027. “It is not known, for the moment, the exact amount, because it will depend on the equipment and equipment that will be bought in that year. Because each country will be obliged, year by year, to modernize this system, to implement technologically advanced installations. Therefore, says Simona Cocoș, these amounts of money are not yet predictable. “We do not know how much we will pay from year to year. “
Not having money to pay, many drug factories will close. Others will restrict their activity and, implicitly, the volume of production, because the tax is paid according to how much you produce.
And yet another very important aspect: any producer who is facing additional costs can increase the products he sells. Medications, however, have a special diet. Some of them. “For prescription drugs the price is fixed. This is the legislation in Romania. They sell at the lowest price in Europe. And this price cannot be modified. Therefore, you have to pay an additional fee, but you cannot walk at the price of the products. And let’s say that the ministry will approve this growth. What will happen then? The financial burden will fall on the shoulders of patients who may have to buy at increased prices by up to 50%”. But not everyone will afford, and for many it will be a luxury to buy a pill for gutters.
Solutions
We are in front of a vicious circle with a direct impact on patients and the health system itself. Many drug producers, forced to pay for the treatment of wastewater, will not have the necessary money and will close the factories. Others will produce in smaller quantities, and the usual drugs will no longer be found on the shelf. Moreover, in the case of drugs that are not a fixed price, it will increase considerably. “The European Commission could return to this decision even if it is already approved. It could be simplified, to reduce its impact, to find ways of financing these residual water treatment equipment”, considers Simona Cocoș
The specialist also stated that in its current form the decision contravenes the interests of the European Union, which seems to give the right. “At one point, the European Commission decided that we have to produce medicines here, in Europe, to have medicines, including factories for raw materials. Or, this decision only puts an extra hindrance”, said Simona Cocoș.
