Romanians could run out of Paracetamol and Metformin, the most widely used affordable treatment for diabetes, due to “persistent” legislative and administrative blockages, generic drug manufacturers claim.
Paracetamol will be withdrawn from pharmacies PHOTO: Archive
The Romanian manufacturers of generic drugs draw attention that, without measures “urgently”, patients will be left without access to basic treatments or will pay more for them, and the authorities will lose the opportunity to make significant budget optimizations in the public health system.
“Bureaucracy cannot justify loss of lives or financial resources. We ask the competent authorities, the Ministry of Health, the National Health Insurance House and the National Medicines Agency, to take measures to change the legislation, so that patients have faster access to medicines generics and biosimilars. In this way, the existing financial resources will be able to be used more efficiently to treat a greater number of patients. At a time when public health is a priority and when the budget for drug compensation is not sufficient, optimizing budgets by facilitating patients’ access to drugs with lower prices is a necessary and urgent measure“, said Simona Cocoş, president of the Association of Manufacturers of Generic Medicines from Romania – APMGR, according to Agerpres.
According to APMGR, the EU Directive on the treatment of urban waste water is the “newest blow” given to generic drug manufacturers and, implicitly, to patients, because it imposes new taxes.
“Most likely, it will have a devastating impact on some 100% Romanian generic drug factories and/or on some production lines and will seriously affect the security of the supply of generic drugs, threatening the availability of some critical drugs. For example, it could lead to the disappearance of Paracetamol and Metformin – the most commonly prescribed oral drug for type 2 diabetes patients. What is actually happening is that this directive imposes new taxes on drug manufacturers, who cannot manage costs by raising prices , because they are strictly regulated by the Ministry of Health”the statement explains.
Thus, APMGR states, in the case of Paracetamol, given that it is a drug with an unregulated price, the impact of the directive will be a 45% price increase that will be fully borne by patients.
Also, in the case of Metformin, “the price should increase by 48%”, but since it is a drug with a state-regulated price, “will probably be withdrawn from the market”, no longer being sustainable.
“In the same situation, over 700 generic drugs are compensated with prices of up to 10 lei. (…) In Romania, drug prices are set using a reference system, which takes into account the lowest price among -a basket of 12 EU member states. This system puts many low-priced medicines at a standstill.” transmit APMGR.
According to the representatives of the manufacturers of generic drugs, starting from 2023, in Romania, the clawback tax for generic drugs is 15%, “a value difficult to bear” for drugs with low prices and which makes many of them unsustainable.
APMGR claims that, between 2013 and 2020, more than 2,000 generic drugs disappeared from the market.
“In Romania, the cost-volume contracts between CNAS and drug manufacturers mainly include innovative drugs, and when their patents expire, generic drugs should automatically enter the reimbursement lists. The reality, however, looks different: the access of generic drugs to the list of reimbursed drugs it occurs with a delay of two years after the patent of the innovative medicine expires, which leads to significant expenses and loses the chance to treat more patients”, the APMGR representatives also support.
Generic medicines treat “more than 70%” of patients, enter the market at lower prices than the innovative medicine by 40% (in the first year) – 70% (in the fourth year), provide essential medicines for a wider demographic group.
“In the therapeutic areas where generic drugs entered, the number of treated patients increased up to 3 times (IQVIA study). Between 2016 and 2023, through the entry of generic drugs into the market, more than 1 billion euros of budget optimization was achieved, therefore, CNAS can treat more patients. In the period 2023 – 2028, over 500 million euros of budget optimization are estimated as a result of the entry of generic drugs following the loss of innovative drug patents”it is further explained in the APMGR press release.
