I am a cure -all for the citizen’s wallet, but become anti -cheap for the companies that produce them. Result? There are less and less.
In the last 10 years, the use of equivalent drugs in Italy has saved six billion at the National Health Service. The result derives from the fact that the generic composition, once entered the market, does it at a much lower price than the reference medicine and – given that the state deals with paying above all the bench compounds and hospitalers – a lightening for the whole system follows. Basically, the citizens themselves save.
Currently the expenditure for medicines in our country amounts to 36.2 billion a year, 68.7 percent of which are reimbursed by the NHS, while the outlay of private citizens are equal to 1 billion and 400 million euros per year.
The six billion savings mentioned above are calculated on a penetration of generics which at national level reaches 30 percent of the total of the drugs purchased. The European average is around 60 percent and some countries even reach 80 percent of use. In short, that minor disbursement for 6 billion could translate into even higher savings if there was a greater diffusion of these products on the market.
But why are the branded medicines, although cost more, are more sold compared to their equivalent? There are several factors that contribute to the answer, primarily the theme of information. This class of medicines contains the same active ingredient, the same pharmaceutical form, the same dosage and the same way of administration of a reference drug, whose patent has expired. In a nutshell, it is as if the “signature” was missing but the preparation is the same and often it happens that it is made in the same factory that churns out the reference product. Yet it is believed that it is less effective. Less safe. Among the people, in fact, some fallacious information resist about the different percentage of active ingredient rather than the different use of excipients.
This is not the case: in order to obtain the authorization for the marketing on the market, the generics must present the same quality requirements as the reference medicineand in fact they are subjected to the same tests. Their diffusion is growing and if in the retail channel it stands at 30 percent, in the hospital the numbers are much higher and are around 70 and this because in the novocomas, due to the public tenders, they are sold at a price even lower than that imposed by AIFA. In short, the equivalents represent a precious market. Out of 156 companies in Europe that produce out of patent drugs, 45 are found in Italy producing a direct turnover of 3.5 billion euros. 64 percent derives from the internal market and the remainder from exports, ten thousand direct employees, but they become almost 40 thousand if we consider the induced.
However, it happens that this sector, although fundamental result to make up for the serious lack of drugs of the last few years, risks becoming economically unsustainable for the industries that feed it.
“The real theme is becoming the safety of supplies at the health system level”, explains Stefano Colina, president of Eguiliathe Italian Association of Manufacturers of equivalent, biosimilar and Value Aided Medicines. “From Covid onwards, due to the pandemic and geopolitical situation, we have witnessed an increase in drug production costs without having, unlike those with patent, any possibility of being able to recover them by acting on the price of medicines which is the result of a bargaining with the drug agency and subsequent free competition between companies operating out of patent. This has led to a reduction in the margins which, for a series of medicines, goes beyond the limit of economic and industrial sustainability “. In essence, some products are sold at a loss because in many cases they cost more the packaging and transport costs that the drug itself. Building out of patent drugs – is the alarm of the manufacturers – is becoming uneconomical and any renegotiations of prices are evaluated by AIFA only when the price of the active ingredient is increased. According to equal between 2018 and 2022, the total production cost increased by 25 percent, while regulatory charges increased by 8.8 percent between 2022 and 2023. The “annual right” in AIFA, however, grew by 63.68 percent from 2016 to 2022.
To adversely affect the sector, there is also the age -old Payback question, which affects 18 percent on the turnover and is also applied to companies that provide products to hospitals via public tender, where one of the main award criteria concerns the maximum reduction. “The profit margin is dramatically narrow”, continues Collatina, “beyond a certain level a whole series of productions becomes unsustainable which translates into a significant decrease in drugs available in the pharmacy and in the hospital”. It is no coincidence that in 2024 in Italy the marketing of over 1,600 molecules (almost double of 2018) ceased. Molecules that continue, in some cases, to be produced on our territory but intended for foreign markets, more profitable, thorough the phenomenon of deficiencies and the consequent and dangerous interruption of therapies for patients. When possible, therefore, we turn to the drug market with patent, more expensive throughout the system. It is 1 billion and 34 million euros, to be precise, the price differential paid by its own pocket in 2024 by citizens to buy the most expensive brand drugs, instead of equivalent products, less expensive, entirely reimbursed by the national health service.
In Europe, to remedy the deficiencies, we begin to attend the medicinal storage phenomenon that allows you to monitor and control stocks in a more precise way, avoiding excesses or shortcomings of products. «In France to have the authorization to stay on the market you need to have four months of storage of the pharmaceutical product. This solves the problem of the French, but aggravates that of the Italians, “specifies the president of Egagia.
“This government and the commission I presided are very attentive to the requests from this sector, fundamental on the savings front for the health service, but not only, as demonstrated by the numerous interlocutions started, among others, with equal”, explains Senator Franco Zaffini (Fdi), president of the Health Commission in the Senate. “The Association has advanced a series of proposals that we have already taken into consideration, including the suppression of the 1.83 percent burden on the pharmaceutical companies in the form of payback on drugs paid under an agreement. With the Omnibus decree we have already put on the payback on medical devices and soon we will also deal with the theme of the pharmaceutical one with the involvement of all the interested parties ».
