Market Exit to Escape Responsibility
Hear the Pharma Choir Wail: EU's Wastewater Directive Rattles Big Pharma
The drug industry is in a flap over the new EU wastewater directive, set to kick off in November 2024. This tough new rule demands a fourth treatment stage in wastewater treatment plants, aiming to expel even the tiniest bits of substances from water. Meds and their leftovers are amongst the peskyMaterials. They pop up in wastewater from poorly disposing of medications and, in larger quantities, from regular use, mostly through bodily excretions. Contaminations from manufacturing processes in Europe are quite rare, thankfully.
The kerfuffle over implementing the directive is still simmering. So, pharmaceutical giants have recently floated some doomsday scenarios, citing exorbitant costs as their excuse. The EU is pursuing a concept they call "extended manufacturer responsibility," shoving the cost of filtration onto those who produce pharmaceuticals and cosmetics. These heavy-hitters would cover a whopping 80% of the costs. Pharma Germany, the industry's chest-thumping squad, rants that Brussels goofed up on impact assessment and data basis. According to the generic medicines association Pro Generika, pollutants also sneak in from other sources, such as traffic or plant care and cleaning agents.
The timeline for implementing the directive, initiated at the start of the year, stretches from 10 to 20 years. This raises eyebrows about the current dramatics from manufacturers.
Pro Generika also snarls that costs for wastewater treatment can't be jacked up onto medication prices. The reasoning: price caps on manufacturers, imposed by contracts with health insurers, are legally set restrictions on profit margins. This regulation already has manufacturers gnashing their teeth. In this context, there's scope to attack this very regulation.
10-20 years down the line, manufacturers' cries of alarm seem dubious.
A classic example of the tricky nature of this business involves the trusted diabetes medication Metformin. Zentiva and Sandoz dominate the market here. Zentiva churns out around 5 million packs every year in India, meeting almost 40% of the demand in Germany alone. Without Metformin, diabetes treatments could be in a jam. Over 2.9 million Germans rely on the drug. Alternatives, like injected insulin, have more side effects and come with a higher price tag. Plus, medical guidelines suggest treating type 2 diabetes with Metformin, thanks to its low cost of just 20 cents a day, since the patent has expired.
- Ulrike Henning: Vertex Pharmaceuticals' novel pain medication Suzetrigin gets US approval
- Ralph Klingsieck: France wrestles for pharmaceutical independence – 50% of French Sanofi subsidiary goes to US investor CD & R with high demands
- Pauline Jäckels: A law just for Lilly – US pharma giant Eli Lilly invests 2.3 billion euros and apparently reaps a lucrative legal change from the federal government
Although research typically focuses on individual organisms or feeding relationships, the food chain isn't exactly linear along animal and plant species. Scientists guess that a mix of various drugs and their metabolic derivatives could create stronger or entirely new effects at very low concentrations.
The industry has warned that they'll hike up the prices of certain active ingredients, such as Amoxicillin, the most commonly prescribed antibiotic in Germany, and Tamoxifen, a common choice for breast cancer follow-up care.
In light of the threats, the EU Commission has decided to reevaluate the costs involved for manufacturers and assess the impact on the pharmaceutical and cosmetics sectors. Whether the wastewater directive will get a re-do remains to be seen.
- The EU's wastewater directive, set to begin in November 2024, has stirred up debate within the science and policy-and-legislation spheres, particularly surrounding the cost implications for the health-and-wellness sector, especially pharmaceuticals and cosmetics.
- As the food-and-wellness industry grapples with the potential effects of the wastewater directive, there are concerns about the potential creation of stronger or new effects at low concentrations when various drugs and their metabolic derivatives are considered within an environmental-science context.
- The potential price increases for active ingredients like Amoxicillin and Tamoxifen, driven by the new directive, have raised eyebrows within the general-news community, prompting the EU Commission to reassess costs and evaluate the overall impact on the pharmaceutical and cosmetics sectors.
