The Association of Manufacturers of Generic Medicines in Romania requests the postponement of the EU Directive on the treatment of urban waste water, warning that it may lead to the disappearance of some essential medicines.
Generic drugs in danger
The Association of Manufacturers of Generic Medicines in Romania (APMGR) warns that the EU Directive on the treatment of urban waste water could affect patients’ access to essential medicines. APMGR, which represents manufacturers of generic and biosimilar medicines, is calling for the directive’s impact on drug supply to be delayed and reassessed, according to a press release.
Specifically, the APMGR companies, which provide over 70% of the medicines used in Romania, maintaining access to essential treatments at affordable prices, say that the EU directive, in its current form, endangers the supply of generic medicines, threatening the availability of critical medicines on the Romanian market and European.
“This directive, probably created with good intentions, poses major risks to public health and access to medicines. That is why APMGR requests the Romanian authorities, especially the Minister of the Environment (the relevant ministry that supported this directive, although we warned about the risks since last year) to carry out a new impact assessment before adopting the directive. This assessment should analyze in detail the effects on the availability and accessibility of medicines, especially generic ones, which represent 7 out of 10 medicines used in Romania and in Europe. We emphasize the importance of finding balanced solutions that protect both the environment and patients’ access to essential treatments.” says Simona Cocoș, President of APMGR.
Specifically, the problem would be the rising production cost of generic drugs, many of which “critical to health”, and that would make them unprofitable for companies.
“In Romania, manufacturers of generic drugs will not be able to manage the cost of the taxes provided by the new directive by increasing prices, because prices are strictly regulated by the Ministry of Health.“, say those from APMGR.
Access to essential treatments at risk
APMGR identifies three major problems with the EU Directive on urban waste water treatment:
1. Unfair treatment: The directive only targets the pharmaceutical and cosmetics sector, ignoring other polluting industries. Generic drug manufacturers already control effluents and are willing to collaborate on sustainable solutions involving all relevant actors.
2. Unavailability of medicines: The directive would impose huge costs on generic manufacturers, making some essential medicines economically unviable and limiting patients’ access to critical treatments.
3. Undermining EU autonomy: The directive could force drug production out of Europe, undermining the Union’s pharmaceutical safety and accessibility goals.
“Generic drugs, having low prices, are vulnerable to taxation and price policies, an aspect that already impacts the availability of drugs on the market and raises barriers both to the entry of new investors/manufacturers into the market and to the development of investments already present. If the Government does not take responsibility for specific local and European legislative projects and keeps increasing the burden on generic drug manufacturers, the impact will be visible in the availability of drugs on the market, respectively in patients’ access to drugs.”, Simona Cocoș explained.
Simona Cocoș, president of APMGR
The President of APMGR asks the Minister of the Environment, “to consider the impact of a legislative measure and to consult with relevant ministers and industry, and now, at the 12th hour, to ask the European Commission to delay the adoption of this directive and to reassess how the directive affects the supply of generic medicines“.
“Swe encourage health authorities to remove barriers to patient access to generic and biosimilar medicines. We communicated both the problems and the solutions to the authorities.“, said Simona Cocoș.
