Companies are no longer investing in these medications and are requesting a "premium" from the EU to reverse the trend. In the background, antimicrobial resistance kills 10,000 individuals in Italy alone each year.
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| Antibiotic shortage in Europe/EUROPEANS24 |
The European Drug Agency issued the latest warning a few days ago: "The lack of antibiotics is a concern" that "affects 25 out of the 27 nations" affected by the embargo, "particularly with regard to amoxicillin," said Steffen Thirstrupp, head physician of the EMA. According to manufacturers, the lack of inventory was driven by the combination of supply chain interruptions, higher energy costs, and an unexpected spike in demand. But there is another factor that may have been even more decisive: manufacturing antibiotics is no longer profitable for Big Pharma. A phenomena that is even more concerning in light of the fact that antibiotic resistance may cause 10 million deaths worldwide.
Antimicrobial resistance and the EU response
Antibiotic resistance emerged more than a half-century ago: bacteria and other microorganisms progressively avoid medications, and it is now estimated that antimicrobial-resistant infections kill over 700,000 people globally each year. According to a committee of United Nations experts, this figure might increase twelvefold between now and mid-century. In the European Union, a recent ECDC research found that of the 35,000 fatalities caused by this occurrence in the EU each year, over a third (10,000) are in Italy. What should I do? "Propositions to combat antimicrobial resistance are generally based on two pillars - writes Benjamin Placket in Nature - The first is to extend the effective life of existing stocks of antimicrobials with disease prevention and measures to combat their overuse. The second is to promote the development of new antimicrobial drugs to fight drug-resistant infections."
Europe is working in both directions: in 2017, the Commission introduced the One Health action plan, with the primary goal of addressing the improper use of antibiotics by people and decreasing the overuse of these treatments in agriculture (a factor considered among the main causes of resistance in humans). The plan's second goal, on the other hand, is to restart research and development of new and revolutionary antibiotics. And here we come to the nub of Big Pharma: European regulations geared at limiting the misuse of these medications are most emphatically not a stimulant to private investment. Due to poor commercial expectations, pharmaceutical giants such as Novartis, AstraZeneca, and Sanofi have ceased research in this field.
A recent study - writes El Pais - revealed that the 18 antibiotics that emerged in the last decade earned an average of just 15.3 million euros a year". A profit that contrasts with the approximately 1.5 billion which, according to the industry lobbies, are to bring a new antimicrobial to market.
The Tees and the battle in Brussels
According to the European Commission's new approach on the subject, which was unveiled two years ago, a solution to the impasse may be found by offering a public incentive to firms. This incentive has a specific name for several players in the sector, notably Efpia, the European Federation of the Pharmaceutical Industry (Tee). It is a kind of "premium" granted to companies that bring a new antibiotic to market: in exchange for this contribution, the companies would receive the right to extend the monopoly in the EU on another drug they own by 12 months (most likely chosen from among the most profitable and with an expiring patent) or resell this right to another company.
This system, according to Efpia, would allow pharmaceutical companies to reduce the risks associated with new antibiotic investments by offsetting them with revenues realized from medicines that are "safer" for the business, as well as reduce public health costs compared to how much it would cost EU governments to fund research. Estimating the indirect impact of a Tee on European governments' budgets is difficult: according to the Lancet, a study commissioned by the industry predicts that it would equal to $1 billion in 12 months. However, an independent assessment determined a worth of $3 billion. Epha, a European organization that brings together doctors and public health experts, has strongly objected the Tees, arguing, among other things, that they would not guarantee fair access to new antibiotics in the EU.
However, for the time being, the Commission appears to be leaning toward include this type of incentive in the plan it will propose to states and the EU Parliament in the coming months. Some Member States, notably the Netherlands, have already expressed their perplexity: "It is a type of indirect, non-transparent financing, which does not necessarily benefit those firms that truly contribute to bringing innovative pharmaceuticals to the market". Amsterdam and 13 other member nations signed a pact.
Source: TODAY